Generic Drug Cost Containment in Medicaid: Lessons from Five State MAC Programs

PubMed Central

Abramson, Richard G.; Harrington, Catherine A.; Missmar, Raad; Li, Susan P.; Mendelson, Daniel N.

2004-01-01

In Medicaid, generic drug cost containment revolves around two programs: the Federal upper limit (FUL) program and State maximum allowable cost (MAC) programs. This article analyzes MAC programs in five States and finds considerable variation between these programs and the FUL program in both size and pricing aggressiveness. We conclude that expansion of existing MAC programs and creation of new ones could contribute to cost containment efforts nationwide. Options for States seeking to optimize their efforts include focusing on pricing for drugs with high sales volumes, ensuring that MAC lists include prices for all forms and dosages of listed drug entities, and collaborating with other States or the Federal Government on MAC list operations. PMID:15229994

Drugs Approved for Gastrointestinal Stromal Tumors

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gastrointestinal stromal tumors (GIST). The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Leukemia

Cancer.gov

This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Colon and Rectal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

Drugs Approved for Wilms Tumor

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Head and Neck Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

Drugs Approved for Testicular Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Cervical Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Hodgkin Lymphoma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Myeloproliferative Neoplasms

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Drugs Approved for Multiple Myeloma

Cancer.gov

This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

Naming and outline of Dothideomycetes-2014 including proposals for the protection or suppression of generic names.

PubMed

Wijayawardene, Nalin N; Crous, Pedro W; Kirk, Paul M; Hawksworth, David L; Boonmee, Saranyaphat; Braun, Uwe; Dai, Dong-Qin; D'souza, Melvina J; Diederich, Paul; Dissanayake, Asha; Doilom, Mingkhuan; Hongsanan, Singang; Jones, E B Gareth; Groenewald, Johannes Z; Jayawardena, Ruvishika; Lawrey, James D; Liu, Jian-Kui; Lücking, Robert; Madrid, Hugo; Manamgoda, Dimuthu S; Muggia, Lucia; Nelsen, Matthew P; Phookamsak, Rungtiwa; Suetrong, Satinee; Tanaka, Kazuaki; Thambugala, Kasun M; Wanasinghe, Dhanushka N; Wikee, Saowanee; Zhang, Ying; Aptroot, André; Ariyawansa, H A; Bahkali, Ali H; Bhat, D Jayarama; Gueidan, Cécile; Chomnunti, Putarak; De Hoog, G Sybren; Knudsen, Kerry; Li, Wen-Jing; McKenzie, Eric H C; Miller, Andrew N; Phillips, Alan J L; Piątek, Marcin; Raja, Huzefa A; Shivas, Roger S; Slippers, Bernad; Taylor, Joanne E; Tian, Qing; Wang, Yong; Woudenberg, Joyce H C; Cai, Lei; Jaklitsch, Walter M; Hyde, Kevin D

2014-11-01

Article 59.1, of the International Code of Nomenclature for Algae, Fungi, and Plants (ICN; Melbourne Code), which addresses the nomenclature of pleomorphic fungi, became effective from 30 July 2011. Since that date, each fungal species can have one nomenclaturally correct name in a particular classification. All other previously used names for this species will be considered as synonyms. The older generic epithet takes priority over the younger name. Any widely used younger names proposed for use, must comply with Art. 57.2 and their usage should be approved by the Nomenclature Committee for Fungi (NCF). In this paper, we list all genera currently accepted by us in Dothideomycetes (belonging to 23 orders and 110 families), including pleomorphic and nonpleomorphic genera. In the case of pleomorphic genera, we follow the rulings of the current ICN and propose single generic names for future usage. The taxonomic placements of 1261 genera are listed as an outline. Protected names and suppressed names for 34 pleomorphic genera are listed separately. Notes and justifications are provided for possible proposed names after the list of genera. Notes are also provided on recent advances in our understanding of asexual and sexual morph linkages in Dothideomycetes . A phylogenetic tree based on four gene analyses supported 23 orders and 75 families, while 35 families still lack molecular data.

Naming and outline of Dothideomycetes–2014 including proposals for the protection or suppression of generic names

PubMed Central

Wijayawardene, Nalin N.; Crous, Pedro W.; Kirk, Paul M.; Hawksworth, David L.; Boonmee, Saranyaphat; Braun, Uwe; Dai, Dong-Qin; D’souza, Melvina J.; Diederich, Paul; Dissanayake, Asha; Doilom, Mingkhuan; Hongsanan, Singang; Jones, E. B.Gareth; Groenewald, Johannes Z.; Jayawardena, Ruvishika; Lawrey, James D.; Liu, Jian-Kui; Lücking, Robert; Madrid, Hugo; Manamgoda, Dimuthu S.; Muggia, Lucia; Nelsen, Matthew P.; Phookamsak, Rungtiwa; Suetrong, Satinee; Tanaka, Kazuaki; Thambugala, Kasun M.; Wanasinghe, Dhanushka N.; Wikee, Saowanee; Zhang, Ying; Aptroot, André; Ariyawansa, H. A.; Bahkali, Ali H.; Bhat, D. Jayarama; Gueidan, Cécile; Chomnunti, Putarak; De Hoog, G. Sybren; Knudsen, Kerry; Li, Wen-Jing; McKenzie, Eric H. C.; Miller, Andrew N.; Phillips, Alan J. L.; Piątek, Marcin; Raja, Huzefa A.; Shivas, Roger S.; Slippers, Bernad; Taylor, Joanne E.; Tian, Qing; Wang, Yong; Woudenberg, Joyce H. C.; Cai, Lei; Jaklitsch, Walter M.

2016-01-01

Article 59.1, of the International Code of Nomenclature for Algae, Fungi, and Plants (ICN; Melbourne Code), which addresses the nomenclature of pleomorphic fungi, became effective from 30 July 2011. Since that date, each fungal species can have one nomenclaturally correct name in a particular classification. All other previously used names for this species will be considered as synonyms. The older generic epithet takes priority over the younger name. Any widely used younger names proposed for use, must comply with Art. 57.2 and their usage should be approved by the Nomenclature Committee for Fungi (NCF). In this paper, we list all genera currently accepted by us in Dothideomycetes (belonging to 23 orders and 110 families), including pleomorphic and nonpleomorphic genera. In the case of pleomorphic genera, we follow the rulings of the current ICN and propose single generic names for future usage. The taxonomic placements of 1261 genera are listed as an outline. Protected names and suppressed names for 34 pleomorphic genera are listed separately. Notes and justifications are provided for possible proposed names after the list of genera. Notes are also provided on recent advances in our understanding of asexual and sexual morph linkages in Dothideomycetes. A phylogenetic tree based on four gene analyses supported 23 orders and 75 families, while 35 families still lack molecular data. PMID:27284275

Generic Fortran Containers (GFC)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liakh, Dmitry

2016-09-01

The Fortran language does not provide a standard library that implements generic containers, like linked lists, trees, dictionaries, etc. The GFC software provides an implementation of generic Fortran containers natively written in Fortran 2003/2008 language. The following containers are either already implemented or planned: Stack (done), Linked list (done), Tree (done), Dictionary (done), Queue (planned), Priority queue (planned).

Do case-generic measures of queue performance for bypass surgery accurately reflect the waiting-list experiences of those most urgent?

PubMed

Burstein, Jason; Lee, Douglas S; Alter, David A

2006-02-01

Queue performance is typically assessed using generic measures, which capture the queue in aggregate. The objective of this study was to examine whether case-generic measures of queue performance appropriately reflected the waiting-list experiences of those patients with greatest disease severity. We examined the queue for isolated coronary artery bypass grafting (CABG) in Ontario between April 1993 and March 2000 using data obtained from the Cardiac Care Network. Our primary measure of queue performance was the proportion of patients who received their bypass surgery within their recommended maximum waiting times (%RMWTs) in any given month. We compared case-generic measures of queue performance to case-specific measures of queue performance stratified by urgency level. The queue was largely comprised of elective cases ranging from 73% (1993) to 57%(1999). Urgent patients comprised the minority of the queue ranging from 14% (1993) to 20% (1999). Case-generic month-to-month variations in the percentage of cases completed within RMWTs (an aggregated waiting list measure encompassing the characteristics of all patients in the queue) closely resembled the experiences of elective patients (R2 = 0.81), but conversely, bore little relationship to the waiting-list experiences of those most urgent (R2 = 0.15). Case-generic measures of queue performance for bypass surgery in Ontario were not reflective of the waiting-list experiences of those most urgent. Our results reinforce the concept that urgency-specific waiting list monitoring systems are required to best evaluate and appropriately respond to fluctuations in queue performance.

Larvae of five horticulturally important species of Chrysopodes (Neuroptera, Chrysopidae): shared generic features, descriptions and keys

PubMed Central

Silva, Patrícia S.; Tauber, Catherine A.; Albuquerque, Gilberto S.; Tauber, Maurice J.

2013-01-01

Abstract An expanded list of generic level larval characteristics is presented for Chrysopodes; it includes a reinterpretation of the mesothoracic and metathoracic structure and setation. Keys, descriptions and images of Semaphoront A (first instar) and Semaphoront B (second and third instars) are offered for identifying five species of Chrysopodes (Chrysopodes) that are commonly reported from horticultural habitats in the Neotropical region. PMID:23653514

Encouraging the use of generic medicines: implications for transition economies.

PubMed

King, Derek R; Kanavos, Panos

2002-08-01

Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

NASA thesaurus. Volume 1: Hierarchical listing

NASA Technical Reports Server (NTRS)

1985-01-01

There are 16,835 postable terms and 3,765 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary.

NASA Thesaurus. Volume 1: Hierarchical listing

NASA Technical Reports Server (NTRS)

1982-01-01

There are 16,713 postable terms and 3,716 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary.

NASA thesaurus. Volume 1: Hierarchical Listing

NASA Technical Reports Server (NTRS)

1988-01-01

There are over 17,000 postable terms and nearly 4,000 nonpostable terms approved for use in the NASA scientific and technical information system in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary and Volume 3 - Definitions.

A Guide to Basic Taxonomic Literature for the Genera of North American Chironomidae (Diptera) - Adults, Pupae, and Larvae. Bulletin No. 447.

ERIC Educational Resources Information Center

Simpson, Karl W.

A generic list of North American Chironomidae (Diptera) is presented to help aquatic biologists quickly locate important taxonomic references for the adults, larvae, and pupae of each genus. The list (in chart format) includes literature published through 1981. When recent literature is available, older references are omitted, since the purpose of…

76 FR 60498 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... in all instances, the same kinds of questions are asked in most message testing. This package includes generic questions and formats that can used to develop health message testing data collection instruments. These include a list of screening questions, comprised of demographic and introductory questions...

Chemicals Reported for the 2012 Chemical Data Reporting (CDR) in Alphabetical Order

EPA Pesticide Factsheets

For the 2012 CDR, 7,674 unique chemicals were reported by manufacturers (including importers).Chemicals are listed in alphabetical order by CA Index Name (for non-confidential chemicals) or by generic chemical name.

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Estimated costs of production and potential prices for the WHO Essential Medicines List

PubMed Central

Hill, Andrew M; Barber, Melissa J

2018-01-01

Introduction There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. Methods A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. Results The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. Conclusion A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations. PMID:29564159

76 FR 44589 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... instances, the same kinds of questions are asked in most message testing. This package includes generic questions and formats that can be used to develop health message testing data collection instruments. These include a list of screening questions, comprised of demographic and introductory questions, along with...

[Analysis of generic drug supply in France].

PubMed

Taboulet, F; Haramburu, F; Latry, Ph

2003-09-01

The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

NASA Thesaurus. Volume 1: Hierarchical listing. Volume 2: Access vocabulary. Volume 3: Definitions

NASA Technical Reports Server (NTRS)

1994-01-01

There are over 17,500 postable terms and some 4,000 nonpostable terms approved for use in the NASA Scientific and Technical Information Database in the Hierarchical Listing of the NASA Thesaurus. The generic structure is presented for many terms. The broader term and narrower term relationships are shown in an indented fashion that illustrates the generic structure better than the more widely used BT and NT listings. Related terms are generously applied, thus enhancing the usefulness of the Hierarchical Listing. Greater access to the Hierarchical Listing may be achieved with the collateral use of Volume 2 - Access Vocabulary and Volume 3 - Definitions.

NASA Hazard Analysis Process

NASA Technical Reports Server (NTRS)

Deckert, George

2010-01-01

This viewgraph presentation reviews The NASA Hazard Analysis process. The contents include: 1) Significant Incidents and Close Calls in Human Spaceflight; 2) Subsystem Safety Engineering Through the Project Life Cycle; 3) The Risk Informed Design Process; 4) Types of NASA Hazard Analysis; 5) Preliminary Hazard Analysis (PHA); 6) Hazard Analysis Process; 7) Identify Hazardous Conditions; 8) Consider All Interfaces; 9) Work a Preliminary Hazard List; 10) NASA Generic Hazards List; and 11) Final Thoughts

EVALUATION OF A GENERIC ARRAY APPROACH FOR GENOTYPING NOROVIRUSES

EPA Science Inventory

Noroviruses are the leading cause of nonbacterial gastroenteritis outbreaks in the United States. Because of their potential to contaminate drinking water, the U.S Environmental Protection Agency has included noroviruses on the Contaminant Candidate List (CCL) to assess the publi...

The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study.

PubMed

Danta, M; Ghinea, N

2017-04-01

The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world. As a result, it is possible for patients to bypass regulatory and cost barriers by importing medications directly from generic producers. Importation of the novel hepatitis C direct-acting antiviral therapy into Australia before it was registered in the country is an illustrative case study. This review will characterise generic medications and some of the legal and ethical issues around their utilisation, focusing on the relevant players, including pharma, government, patients and doctors.

NASA Thesaurus. Volume 1: Alphabetical listing

NASA Technical Reports Server (NTRS)

1976-01-01

The NASA Thesaurus -- Volume 1, Alphabetical Listing -- contains all subject terms (postable and nonpostable) approved for use in the NASA scientific and technical information system. Included are the subject terms of the Preliminary Edition of the NASA Thesaurus (NASA SP-7030, December 1967); of the NASA Thesaurus Alphabetical Update (NASA SP-7040, September 1971); and terms approved, added or changed through May 31, 1975. Thesaurus structuring, including scope notes, a generic structure with broader-term/narrower-term (BT-NT) relationships displayed in embedded hierarchies, and other cross references, is provided for each term, as appropriate.

A cost-utility analysis of drug treatments in patients with HBeAg-positive chronic hepatitis B in Thailand

PubMed Central

2014-01-01

Background Only lamivudine has been included for patients with chronic hepatitis B (CHB) in the National List of Essential Drugs (NLED), a pharmaceutical reimbursement list in Thailand. There have also been no economic evaluation studies of CHB drug treatments conducted in Thailand yet. In order to fill this gap in policy research, the objective of this study was to compare the cost-utility of each drug therapy (Figure 1) with palliative care in patients with HBeAg-positive CHB. Methods A cost-utility analysis using an economic evaluation model was performed to compare each drug treatment for HBeAg-positive CHB patients. A Markov model was used to estimate the relevant costs and health outcomes during a lifetime horizon based on a societal perspective. Direct medical costs, direct non-medical costs, and indirect costs were included, and health outcomes were denoted in life years (LYs) and quality-adjusted life years (QALYs). The results were presented as an incremental cost effectiveness ratio (ICER) in Thai baht (THB) per LY or QALY gained. One-way sensitivity and probabilistic sensitivity analyses were applied to investigate the effects of model parameter uncertainties. Results The ICER values of providing generic lamivudine with the addition of tenofovir when drug resistance occurred, generic lamivudine with the addition of tenofovir based on the road map guideline, and tenofovir monotherapy were -14,000 (USD -467), -8,000 (USD -267) , and -5,000 (USD -167) THB per QALY gained, respectively. However, when taking into account all parameter uncertainties in the model, providing generic lamivudine with the addition of tenofovir when drug resistance occurred (78% and 75%) and tenofovir monotherapy (18% and 24%) would yield higher probabilities of being cost-effective at the societal willingness to pay thresholds of 100,000 (USD 3,333) and 300,000 (USD 10,000) THB per QALY gained in Thailand, respectively. Conclusions Based on the policy recommendations from this study, the Thai government decided to include tenofovir into the NLED in addition to generic lamivudine which is already on the list. Moreover, the results have shown that the preferred treatment regimen involves using generic lamivudine as the first-line drug with tenofovir added if drug resistance occurs in HBeAg-positive CHB patients. PMID:24731689

77 FR 36568 - Proposed Information Collection; Comment Request: Generic Customer Satisfaction Surveys

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... Collection; Comment Request: Generic Customer Satisfaction Surveys AGENCY: Office of the Chief Information.... This Notice also lists the following information: Title of Proposal: Generic--Customer Satisfaction... to gather this data directly from our customers. HUD will conduct various customer satisfaction...

Comparative anatomy of the female genitalia of generic-level taxa in tribe Aedini (Diptera: Culicidae). Part XXXVI. Genus Polyleptiomyia Theobald

USDA-ARS?s Scientific Manuscript database

A morphological analysis of the female genitalia of species included in genus Polyleptiomyia Theobald was conducted. Treatment of the genital morphology of the genus includes a description of the genus, a detailed description and illustration of the type species, Po. albocephala (Theobald), a list ...

"The Academic Game" as a Frame Game.

ERIC Educational Resources Information Center

Bredemeier, Mary E.; And Others

1981-01-01

Describes a frame game which focuses on problems of sex, status, and organizational development. "The Academic Game" is a specific model of a generic game that has differential consequences for men and women, and is easily adaptable to other organizational settings, including public administration and industry. Six references are listed.…

Evaluation of RxNorm for Medication Clinical Decision Support.

PubMed

Freimuth, Robert R; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS.

Evaluation of RxNorm for Medication Clinical Decision Support

PubMed Central

Freimuth, Robert R.; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G.

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS. PMID:25954360

Strengthening rehabilitation services in Indonesia: A brief situation analysis.

PubMed

Nugraha, Boya; Setyono, Garry Rahardian; Defi, Irma Ruslina; Gutenbrunner, Christoph

2018-04-18

People with disability (PWD) in Indonesia are often neglected by society. Improving their life situation towards full participation in society is crucial. As a health strategy, rehabilitation can improve func-tioning, quality of life and participation in society. However, rehabilitation services in Indonesia need improvement. Making a situation analysis of rehabilitation services and their provision in the country is a pre-requisite to taking any action towards improvement. This paper compiles available data related to disability and rehabilitation services in Indonesia, using the Rehabilitation Services Assessment Tool (RSAT) as a framework. Gaps in provision were analysed, resulting in the compilation of a list of generic recommendations to improve rehabilitation services in the country. Indonesia faces many challenges in rehabilitation services, including the health workforce and the provision of services. This situation analysis and list of generic recommendations may be used in further discussions with relevant stakeholders in the country to develop a national strategy to strengthen rehabilitation services.

FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).

PubMed

Hui, Yuk Fung

2003-01-01

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.

Competency-based models of learning for engineers: a comparison

NASA Astrophysics Data System (ADS)

Lunev, Alexander; Petrova, Irina; Zaripova, Viktoria

2013-10-01

One of the goals of higher professional education is to develop generic student competencies across a variety of disciplines that play a crucial role in education and that provide wider opportunities for graduates in finding good jobs and more chance of promotion. In this article a list of generic competencies developed in Russian universities is compared with a similar list developed by a consortium of Russian and European universities (project TUNING-RUSSIA). Then there is a second comparison with a list of competencies taken from the CDIO Syllabus. This comparison indicates the degree of similarity among the lists and the possible convergence among universities all over the world. The results are taken from a survey carried out among Russian employers, academics, and graduates. The survey asked to rate each listed competence by its importance and the degree of achieving goals in the process of the education.

Results of a Nationwide Survey: Correctional Education Organizational Structure Trends.

ERIC Educational Resources Information Center

Gehring, Thom

1990-01-01

Describes a state-by-state three-part study of the generic types of organizational structures used to deliver correctional education services. The first product was a list of correctional education state directors; this report, including the models used in each state, is the second; and the third was an analysis of correctional school district…

The impact on health outcome measures of switching to generic medicines consequent to reference pricing: the case of olanzapine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter B

2015-06-01

New Zealand's Pharmaceutical Management Agency (PHARMAC) manages the list of medicines available for prescribing with government subsidy, within a fixed annual medicines budget. PHARMAC achieves this through a mix of pricing strategies including reference pricing. In 2011, PHARMAC applied generic reference pricing to olanzapine tablets. This study sought to evaluate change in outcome measures of patients switching from originator to generic olanzapine consequent to the introduction of the policy. A retrospective study using national health data collections was conducted. Outcome measures included medicines indicators (change in dosage, concomitant therapy and treatment cessation), health care service indicators (use of emergency departments, hospitals and specialist services), surveillance reports of adverse events, and mortality. Subsequent to the removal of funding for originator brand olanzapine tablets, 99.7% of patients meeting the inclusion criteria switched to using generic olanzapine. Limited case reports of suspected therapeutic loss were received in the study time period. No increase in use of additional oral or injectable antipsychotic medication was observed after switching, nor any increase in other unique, non-antipsychotic prescription items. However, a high incidence of multiple switching between available brands was found. No net impact of switching brands on health service utilisation or mortality was found. The study shows that a switch can be made safely from originator olanzapine to a generic brand, and suggests that switching to generics should generally be viewed more positively. Generic reference pricing achieves considerable savings and, as a pricing policy, could be applied more widely.

Annotated check list of the Pyraloidea (Lepidoptera) of America North of Mexico

PubMed Central

Scholtens, Brian G.; Solis, M. Alma

2015-01-01

Abstract An annotated check list of Pyraloidea of North America north of Mexico is presented, including 861 Crambidae and 681 Pyralidae with 1542 total species. It includes all new species described, tropical species with new records in the United States, and species introduced from Europe and Asia since 1983. The Notes section provides the seminal citations, data and/or commentary to all changes since 1983 for easy and future reference. In addition, this list proposes seven new generic combinations, the transfer of a phycitine species, Salebria nigricans (Hulst), to Epipaschiinae and its syn. n. with Pococera fuscolotella (Ragonot), and three new records for the United States. Purposefully, no new taxa are described here, but we found a gradual increase of 10% in the number of species described since 1983. Finally, we also include a list of thirteen species not included or removed from the MONA list. Many higher-level changes have occurred since 1983 and the classification is updated to reflect research over the last 30 years, including exclusion of Thyrididae and Hyblaeidae from the superfamily and recognition of Crambidae and Pyralidae as separate families. The list includes multiple changes to subfamilies based on morphology such as the synonymization of the Dichogamini with the Glaphyriinae, but also incorporating recent molecular phylogenetic results such as the synonymization of the Evergestinae with the Glaphyriinae. PMID:26668552

40 CFR 721.10199 - Substituted aliphatic amine (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... with a tight-fitting face piece (full-face). As an alternative to the respiratory requirements listed... significant new uses subject to reporting. (1) The chemical substance identified generically as substituted aliphatic amine (PMN P-06-702) is subject to reporting under this section for the significant new uses...

Deeply discounted medications: Implications of generic prescription drug wars.

PubMed

Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

2010-01-01

To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

Do generics offer significant savings to the UK National Health Service?

PubMed

Kanavos, Panos

2007-01-01

The UK has traditionally had strong proxy demand-side measures favouring generic drug use, including prescribing guidance, financial incentives and encouraging generic prescribing. At distribution level, pharmacies are paid a salary for their dispensing work, based on volume dispensed, and procure generic products on the basis of discounts given to them by manufacturers or wholesalers. The supply-side has been subject to price regulation, and the recent requirement for manufacturers/wholesalers to report prices net of discounts to the DoH, indicate that reimbursed prices for generics may be higher than commodity level. To investigate the level of discounts off the Drug Tariff Price made available to pharmacies and, determine whether the NHS could have a better deal than currently from generic drug purchasing. Data on net prices were acquired for different presentations of 12 generic molecules selected across different therapeutic categories and included in the 50 most selling generic prescription only products in the UK in the first quarter of 2005. For these products, 31 out of a possible 34 presentations (90%) were surveyed. The data sources were price lists of three leading full-line wholesalers (one national, two regional), out of a possible 11 full-line wholesalers (27.2%), and three leading generic drug manufacturers, out of a possible 15 manufacturers (20%). Generic prescribing in the selected molecules was 94.6%, above the national average of 80%, and the total net ingredient cost (NIC) was 675 million pounds, of which 607.5 million pounds (90%) was generic. In 20 of the product presentations reviewed (64.5%), maximum discounts exceeded 60%, whereas in seven (22.6%) maximum discounts ranged between 50 and 60% off the Drug Tariff Price. Reimbursed prices for leading generic molecules are significantly higher than their pharmacy acquisition cost. The NHS is reimbursing generics at too high prices and a significant proportion of the reimbursed price accrues to the distribution chain in a fashion that resembles an indirect subsidy. The NHS can improve efficiency as well as increase savings, by purchasing generics closer to their market price. This would require changes in the way pharmacies are reimbursed, for instance, by changing the way the clawback is calculated, or altogether abolishing discounts and introducing a fixed dispensing fee; it could also mean introducing transparency in the determination of Drug Tariff prices by the relevant stakeholders. As the cost per generic script is, in the majority of cases, below the dispensing fee, the current reimbursement system for generics results in a re-distribution from patients and the NHS to the retail distribution chain.

Determinants of a successful problem list to support the implementation of the problem-oriented medical record according to recent literature.

PubMed

Simons, Sereh M J; Cillessen, Felix H J M; Hazelzet, Jan A

2016-08-02

A problem-oriented approach is one of the possibilities to organize a medical record. The problem-oriented medical record (POMR) - a structured organization of patient information per presented medical problem- was introduced at the end of the sixties by Dr. Lawrence Weed to aid dealing with the multiplicity of patient problems. The problem list as a precondition is the centerpiece of the problem-oriented medical record (POMR) also called problem-oriented record (POR). Prior to the digital era, paper records presented a flat list of medical problems to the healthcare professional without the features that are possible with current technology. In modern EHRs a POMR based on a structured problem list can be used for clinical decision support, registries, order management, population health, and potentially other innovative functionality in the future, thereby providing a new incentive to the implementation and use of the POMR. On both 12 May 2014 and 1 June 2015 a systematic literature search was conducted. From the retrieved articles statements regarding the POMR and related to successful or non-successful implementation, were categorized. Generic determinants were extracted from these statements. In this research 38 articles were included. The literature analysis led to 12 generic determinants: clinical practice/reasoning, complete and accurate problem list, data structure/content, efficiency, functionality, interoperability, multi-disciplinary, overview of patient information, quality of care, system support, training of staff, and usability. Two main subjects can be distinguished in the determinants: the system that the problem list and POMR is integrated in and the organization using that system. The combination of the two requires a sociotechnical approach and both are equally important for successful implementation of a POMR. All the determinants have to be taken into account, but the weight given to each of the determinants depends on the organizationusing the problem list or POMR.

Thirty-eighth supplement to the American Ornithologists' Union Check-list of North American birds

USGS Publications Warehouse

Monroe, Burt L.; Banks, Richard C.; Fitzpatrick, John W.; Howell, Thomas R.; Johnson, Ned K.; Ouellet, Henri; Remsen, J.V.; Storer, Robert W.

1991-01-01

This fourth supplement after the 6th edition (1983) of the AOU "Check-list of North American Birds" consists of changes adopted by the Committee on Classification and Nomenclature between 1 March 1989 and 1 March 1991. The changes fall into eight categories: (1) five species (Ixobrychus sinensis, Porphyrula flavirostris, Sterna bergii, Streptopelia orientalis, and Ficedula narcissina) are added to the main list because of new distributional information; (2) six species (Pterodroma cervicalis, Ortalis wagleri, Lophornis brachylopha, Corvus sinaloae, Cinclocerthia gutturalis, and Loxops caeruleirostris) are added to the list because of the splitting of species previously in the list; (3) one extinct species (Dysmorodrepanis munroi) is added to the list because of re-identification of the unique type; (4) one scientific name (Speotyto cunicularia) is changed because of generic splitting; (5) one scientific name (Phalacrocorax brasilianus) is changed for nomenclature reasons, accompanied by a change in English name; (6) the spelling of one scientific name (Neocrex colombianus) is corrected; (7) to other English names are changed or corrected; and (8) one sequencing change is made. No new distributional information is included except as noted above (i.e. minor changes of distribution of distributional records within North America are not included). The twelve additions bring the number of species recognized as occurring within the Check-list area (main list) to 1957.

Steady and Periodic Pressure Measurements on a Generic Helicopter Fuselage Model in the Presence of a Rotor

NASA Technical Reports Server (NTRS)

Mineck, Raymond E.; Gorton, Susan A.

2000-01-01

A wind tunnel test of a generic helicopter fuselage model with an independently mounted rotor has been conducted to obtain steady and periodic pressure data on the helicopter body. The model was tested at four advance ratios and three thrust coefficients. The periodic unsteady pressure coefficients are marked by four peaks associated with the passage of the four rotor blades. Blade passage effects are largest on the nose and tail boom of the model. The magnitude of the pulse increases with rotor thrust coefficient. Tabular listings of the unsteady pressure data are included to permit independent analysis. A CD-rom containing the steady and unsteady pressure data presented in the report is available from the authors.

7 CFR 1728.20 - Establishment of standards and specifications.

Code of Federal Regulations, 2010 CFR

2010-01-01

... CONSTRUCTION § 1728.20 Establishment of standards and specifications. (a) National and other standards. RUS... Institute (ANSI), American Wood Preservers' Association (AWPA), the various national engineering societies... the List of Materials are listed by categories of generic items which are used in RUS construction...

Generic worklist handler for workflow-enabled products

NASA Astrophysics Data System (ADS)

Schmidt, Joachim; Meetz, Kirsten; Wendler, Thomas

1999-07-01

Workflow management (WfM) is an emerging field of medical information technology. It appears as a promising key technology to model, optimize and automate processes, for the sake of improved efficiency, reduced costs and improved patient care. The Application of WfM concepts requires the standardization of architectures and interfaces. A component of central interest proposed in this report is a generic work list handler: A standardized interface between a workflow enactment service and application system. Application systems with embedded work list handlers will be called 'Workflow Enabled Application Systems'. In this paper we discus functional requirements of work list handlers, as well as their integration into workflow architectures and interfaces. To lay the foundation for this specification, basic workflow terminology, the fundamentals of workflow management and - later in the paper - the available standards as defined by the Workflow Management Coalition are briefly reviewed.

Savannah River Site generic data base development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blanton, C.H.; Eide, S.A.

This report describes the results of a project to improve the generic component failure data base for the Savannah River Site (SRS). A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear powermore » plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. This information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor) for each component failure mode.« less

Global Infectious Diseases and Epidemiology Network (GIDEON): a world wide Web-based program for diagnosis and informatics in infectious diseases.

PubMed

Edberg, Stephen C

2005-01-01

The Global Infectious Diseases and Epidemiology Network (GIDEON) (http://www.gideononline.com) consists of 4 modules. The first is designed to generate a ranked differential diagnosis list for any infectious diseases scenario in any of 220 countries. The second follows the country-specific epidemiology of 337 individual diseases. The third presents a comprehensive encyclopedia of 308 generic anti-infective drugs and vaccines, including a listing of >9500 trade names. The fourth generates a ranked identification list based on the phenotype of bacteria, mycobacteria, and yeasts. The program performs well and serves as a useful paradigm for World Wide Web-based informatics. GIDEON is an eclectic program that can serve the needs of clinicians, epidemiologists, and microbiologists working in the fields of infectious diseases and geographic medicine.

A generic coding approach for the examination of meal patterns.

PubMed

Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

2015-08-01

Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015 American Society for Nutrition.

Grid Integrated Distributed PV (GridPV) Version 2.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Reno, Matthew J.; Coogan, Kyle

2014-12-01

This manual provides the documentation of the MATLAB toolbox of functions for using OpenDSS to simulate the impact of solar energy on the distribution system. The majority of the functio ns are useful for interfacing OpenDSS and MATLAB, and they are of generic use for commanding OpenDSS from MATLAB and retrieving information from simulations. A set of functions is also included for modeling PV plant output and setting up the PV plant in th e OpenDSS simulation. The toolbox contains functions for modeling the OpenDSS distribution feeder on satellite images with GPS coordinates. Finally, example simulations functions are included tomore » show potential uses of the toolbox functions. Each function i n the toolbox is documented with the function use syntax, full description, function input list, function output list, example use, and example output.« less

A generic Transcriptomics Reporting Framework (TRF) for 'omics data processing and analysis.

PubMed

Gant, Timothy W; Sauer, Ursula G; Zhang, Shu-Dong; Chorley, Brian N; Hackermüller, Jörg; Perdichizzi, Stefania; Tollefsen, Knut E; van Ravenzwaay, Ben; Yauk, Carole; Tong, Weida; Poole, Alan

2017-12-01

A generic Transcriptomics Reporting Framework (TRF) is presented that lists parameters that should be reported in 'omics studies used in a regulatory context. The TRF encompasses the processes from transcriptome profiling from data generation to a processed list of differentially expressed genes (DEGs) ready for interpretation. Included within the TRF is a reference baseline analysis (RBA) that encompasses raw data selection; data normalisation; recognition of outliers; and statistical analysis. The TRF itself does not dictate the methodology for data processing, but deals with what should be reported. Its principles are also applicable to sequencing data and other 'omics. In contrast, the RBA specifies a simple data processing and analysis methodology that is designed to provide a comparison point for other approaches and is exemplified here by a case study. By providing transparency on the steps applied during 'omics data processing and analysis, the TRF will increase confidence processing of 'omics data, and regulatory use. Applicability of the TRF is ensured by its simplicity and generality. The TRF can be applied to all types of regulatory 'omics studies, and it can be executed using different commonly available software tools. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Defining interdisciplinary competencies for audiological rehabilitation: findings from a modified Delphi study.

PubMed

Xue, Lina; Le Bot, Gaëlle; Van Petegem, Wim; van Wieringen, Astrid

2018-02-01

The aim of this study is to derive a consensus on an interdisciplinary competency framework regarding a holistic approach for audiological rehabilitation (AR), which includes disciplines from medicine, engineering, social sciences and humanities. We employed a modified Delphi method. In the first round survey, experts were asked to rate an initial list of 28 generic interdisciplinary competencies and to propose specific knowledge areas for AR. In the second round, experts were asked to reconsider their answers in light of the group answers of the first round. An international panel of 27 experts from different disciplines in AR completed the first round. Twenty-two of them completed the second round. We developed a competency framework consisting of 21 generic interdisciplinary competencies grouped in five domains and nine specific competencies (knowledge areas) in three clusters. Suggestions for the implementation of the generic competencies in interdisciplinary programmes were identified. This study reveals insights into the interdisciplinary competencies that are unique for AR. The framework will be useful for educators in developing interdisciplinary programmes as well as for professionals in considering their lifelong training needs in AR.

Orbital construction support equipment

NASA Technical Reports Server (NTRS)

1977-01-01

Approximately 200 separate construction steps were defined for the three solar power satellite (SPS) concepts. Detailed construction scenarios were developed which describe the specific tasks to be accomplished, and identify general equipment requirements. The scenarios were used to perform a functional analysis, which resulted in the definition of 100 distinct SPS elements. These elements are the components, parts, subsystems, or assemblies upon which construction activities take place. The major SPS elements for each configuration are shown. For those elements, 300 functional requirements were identified in seven generic processes. Cumulatively, these processes encompass all functions required during SPS construction/assembly. Individually each process is defined such that it includes a specific type of activity. Each SPS element may involve activities relating to any or all of the generic processes. The processes are listed, and examples of the requirements defined for a typical element are given.

[Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

PubMed

Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

2009-10-01

A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

Moly99 Production Facility: Report on Beamline Components, Requirements, Costs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bishofberger, Kip A.

2015-12-23

In FY14 we completed the design of the beam line for the linear accelerator production design concept. This design included a set of three bending magnets, quadrupole focusing magnets, and octopoles to flatten the beam on target. This design was generic and applicable to multiple different accelerators if necessary. In FY15 we built on that work to create specifications for the individual beam optic elements, including power supply requirements. This report captures the specification of beam line components with initial cost estimates for the NorthStar production facility.This report is organized as follows: The motivation of the beamline design is introducedmore » briefly, along with renderings of the design. After that, a specific list is provided, which accounts for each beamline component, including part numbers and costs, to construct the beamline. After that, this report details the important sections of the beamline and individual components. A final summary and list of follow-on activities completes this report.« less

Encyclopedia of software components

NASA Technical Reports Server (NTRS)

Vanwarren, Lloyd (Inventor); Beckman, Brian C. (Inventor)

1991-01-01

Intelligent browsing through a collection of reusable software components is facilitated with a computer having a video monitor and a user input interface such as a keyboard or a mouse for transmitting user selections, by presenting a picture of encyclopedia volumes with respective visible labels referring to types of software, in accordance with a metaphor in which each volume includes a page having a list of general topics under the software type of the volume and pages having lists of software components for each one of the generic topics, altering the picture to open one of the volumes in response to an initial user selection specifying the one volume to display on the monitor a picture of the page thereof having the list of general topics and altering the picture to display the page thereof having a list of software components under one of the general topics in response to a next user selection specifying the one general topic, and then presenting a picture of a set of different informative plates depicting different types of information about one of the software components in response to a further user selection specifying the one component.

Encyclopedia of Software Components

NASA Technical Reports Server (NTRS)

Warren, Lloyd V. (Inventor); Beckman, Brian C. (Inventor)

1997-01-01

Intelligent browsing through a collection of reusable software components is facilitated with a computer having a video monitor and a user input interface such as a keyboard or a mouse for transmitting user selections, by presenting a picture of encyclopedia volumes with respective visible labels referring to types of software, in accordance with a metaphor in which each volume includes a page having a list of general topics under the software type of the volume and pages having lists of software components for each one of the generic topics, altering the picture to open one of the volumes in response to an initial user selection specifying the one volume to display on the monitor a picture of the page thereof having the list of general topics and altering the picture to display the page thereof having a list of software components under one of the general topics in response to a next user selection specifying the one general topic, and then presenting a picture of a set of different informative plates depicting different types of information about one of the software components in response to a further user selection specifying the one component.

Patent and exclusivity status of essential medicines for non-communicable disease.

PubMed

Mackey, Tim K; Liang, Bryan A

2012-01-01

The threat of non-communicable diseases ("NCDs") is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights ("IPRs") that may impede generic production and availability and affordability to essential NCD medicines. Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study. We examined the patent and exclusivity status of medicines listed in the World Health Organization's ("WHO") Model List of Essential Drugs (Medicines) ("MLEM") and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA. Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria. We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines.

Topics in Chemical Instrumentation: Robots in the Laboratory--An Overview.

ERIC Educational Resources Information Center

Strimaitis, Janet R.

1989-01-01

Describes the current use of automation in the laboratory. Discusses the need, flexibility, and benefits of automation. Presents a generic system description. Lists commercially available laboratory robots. (MVL)

A Method of Deriving Definitions of Specific Medical Competencies: a Framework for Curriculum Planning and Evaluation.

ERIC Educational Resources Information Center

Stone, David H.

1987-01-01

Definitions of specific medical competencies to be acquired by medical students in the course of their studies may be derived from the juxtaposition of a list of generic competencies with a list of appropriate subject areas. The operation of the method is demonstrated in relation to the curriculum of The Beer Sheva Medical School, Israel.…

Money left on the table: generic drug prices in Canada.

PubMed

Law, Michael R

2013-02-01

Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs - both public and private - and saved $87 million compared to current public sector expenditures. Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. Copyright © 2013 Longwoods Publishing.

Money Left on the Table: Generic Drug Prices in Canada

PubMed Central

Law, Michael R.

2013-01-01

Background: Generic drugs are a major cost-saving opportunity for patients and drug plans. While almost every province has reduced generic drug prices, we have no information on whether these new prices are internationally competitive. Therefore, I compared Canadian prices to those in two other countries. Methods: I used 2009 data from the IMS Brogan Canadian CompuScript and PharmaStat databases and studied the 100 most frequently dispensed generic products in Ontario, which has Canada's lowest generic prices. I compared these prices to those in public drug programs in the United States and New Zealand that use tendering. Using these alternative prices, I calculated the potential savings in Ontario. Results: Of the top 100 generic products, 82 were listed on an international formulary. In 90% of cases, generic products were less expensive in other countries. If Ontario had obtained the lowest comparator price for these products, the annual public sector and overall drug expenditure savings would have been $129 million and $245 million, respectively. Further, the province could have publicly paid for all these generic drugs – both public and private – and saved $87 million compared to current public sector expenditures. Discussion: Even after recent reforms, generic drug prices in Canada remain high by international standards. I found that if Ontario had obtained commonly used generic drugs at international best prices, the province could have publicly paid for all generic drugs and lowered annual expenditures by nearly a quarter-billion dollars. PMID:23968624

An illustrated guide for characters and terminology used in descriptions of Phlebotominae (Diptera, Psychodidae)

PubMed Central

Galati, Eunice A. B.; Galvis-Ovallos, Fredy; Lawyer, Phillip; Léger, Nicole; Depaquit, Jérôme

2017-01-01

Phlebotomine (Diptera, Psychodidae, Phlebotominae) taxonomy has been studied extensively, primarily due to the role of these flies as vectors of various parasites, including species of Leishmania, Bartonella and arboviruses that cause diseases in humans and other vertebrates. We present some topics discussed at a round-table on phlebotomine taxonomy held at the Ninth International Symposium on Phlebotomine Sandflies (ISOPS IX) in Reims, France, in June 2016. To date, approximately one thousand phlebotomine species have been described worldwide, although in varying languages and mostly without standardization of characters and terminology. In the interest of standardization, we list the characters that should minimally be considered in the description of new phlebotomine taxa as well as annotated illustrations of several characters. For these characters, multiple illustrations are provided to show some of the variations. The preferred terms for all pertinent characters are listed as well as their synonyms in English, Portuguese, and French. Finally, we offer an updated list of abbreviations to be used for generic and subgeneric names. PMID:28730992

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

PubMed Central

Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-01-01

Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

Some drugs more equal than others: pseudo-generics and commercial practice.

PubMed

Probyn, Andrew J

2004-11-08

This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

New phenethylamines in Europe.

PubMed

King, L A

2014-01-01

Sixteen phenethylamines are now included in Schedules I and II of the United Nations 1971 Convention on Psychotropic Substances. Most of the ring-substituted compounds are in Schedule I, whereas 2C-B, amphetamine, and methamphetamine are listed in Schedule II. Substances in Schedule IV (e.g. benzphetamine) are now regarded as obsolete pharmaceutical products. They all represent the 'old phenethylamines'. By 2013, nearly 100 illicit phenethylamines had been found in the European Union (EU). Of these, nine (MBDB, 4-MTA, PMMA, 2C-I, 2C-T-2, 2C-T-7, TMA-2, 5-IT and 4-MA) were submitted for risk assessment by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). All except MBDB were recommended for EU-wide control. Of the 'new phenethylamines', 2C-B was the most commonly reported, but other 2C compounds were widespread. Many of the ring-substituted phenethylamines are described in the 1991 book PIHKAL. Many fused ring phenethylamines have appeared in the past few years; they include further benzofurans (e.g. 5-and 6-APB), indanylalkylamines (e.g. 5-IAP), dibenzofurans (e.g. 2C-B-FLY) and 2-aminopropylindoles (e.g.5-IT). The recent and rapid rise of phenethylamines with bulky N-substituents (e.g. 25I-NBOMe) has been particularly significant. Although not phenethylamines, it is notable that the thiophene bioisosteres of amphetamine and methamphetamine as well as certain conformationally-restricted variants (e.g. aminoindanes) have been found in recent drug seizures. In the United Kingdom Misuse of Drugs Act, most ring-substituted phenethylamines are either listed by name or are covered by generic definitions dating from 1977. In 2013, temporary generic legislation included a number of benzofurans, indanylalkylamines and certain 'NBOMe' compounds. Copyright © 2013 John Wiley & Sons, Ltd.

Deriving Competencies for Mentors of Clinical and Translational Scholars

PubMed Central

Abedin, Zainab; Biskup, Ewelina; Silet, Karin; Garbutt, Jane M.; Kroenke, Kurt; Feldman, Mitchell D.; McGee, Jr, Richard; Fleming, Michael; Pincus, Harold Alan

2012-01-01

Abstract Although the importance of research mentorship has been well established, the role of mentors of junior clinical and translational science investigators is not clearly defined. The authors attempt to derive a list of actionable competencies for mentors from a series of complementary methods. We examined focus groups, the literature, competencies derived for clinical and translational scholars, mentor training curricula, mentor evaluation forms and finally conducted an expert panel process in order to compose this list. These efforts resulted in a set of competencies that include generic competencies expected of all mentors, competencies specific to scientists, and competencies that are clinical and translational research specific. They are divided into six thematic areas: (1) Communication and managing the relationship, (2) Psychosocial support, (3) Career and professional development, (4) Professional enculturation and scientific integrity, (5) Research development, and (6) Clinical and translational investigator development. For each thematic area, we have listed associated competencies, 19 in total. For each competency, we list examples that are actionable and measurable. Although a comprehensive approach was used to derive this list of competencies, further work will be required to parse out how to apply and adapt them, as well future research directions and evaluation processes. Clin Trans Sci 2012; Volume 5: 273–280 PMID:22686206

Patented drug extension strategies on healthcare spending: a cost-evaluation analysis.

PubMed

Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

2013-01-01

Drug manufacturers have developed "evergreening" strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole ("spillover effect"). We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. "Extra costs" were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated "extra costs" over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover "extra cost" of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in "extra costs" of €503,600 (95% CI 444,500; 563,100). Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies.

Catalog of the recent taxa of the families Epitoniidae and Nystiellidae (Mollusca: Gastropoda) with a bibliography of the descriptive and systematic literature.

PubMed

Brown, Leonard G; Neville, Bruce D

2015-01-15

This catalog includes 1,487 names recent genera, subgenera, species, subspecies, varieties, and forms that have been referred to the families Epitoniidae and Nystiellidae as well as a bibliography of the descriptive and systematic literature associated with these names. For the names covered herein, we make a determination of whether the name is an available name, as that term is defined in the International Code of Zoological Nomenclature ("ICZN") and, based on a review of the literature listed in the bibliography, indicate whether the taxon is a potentially valid name or a probable synonym. This catalog includes not only includes a list of names, but also includes information on type material, type localities and species' geographic, bathymetric and size ranges. We also suggest generic assignments for many of the species level taxa listed in this work. We herein designate Scalaria acuta J. Sowerby, 1812, to be the type species of Clathrus Agassiz, 1837, designate Scalaria raricostata G.B. Sowerby II, 1844b, to be the type species of Variciscala de Boury, 1909a, designate Turbiniscala sexcosta Jousseaume, 1912, to be the type species of Turbiniscala de Boury, 1909a, and designate Scala dubia 'G. B. Sowerby II' de Boury, 1912b to be the type species of Foliaceiscala de Boury, 1912b. 

Generic drug policy in Australia: a community pharmacy perspective

PubMed Central

Beecroft, Grahame

2007-01-01

This article provides a commentary, from a community pharmacy perspective, on the policy environment for the pharmacy sector in Australia, with a particular focus on present challenges arising from proposals to achieve substantial PBS cost savings from an anticipated surge of new generic drugs. Some $2 billion of medicines currently on the PBS will come off patent in the next 4 years. This growth comes from a low base where generics currently account for only 15% of the total PBS budget. Remuneration for PBS dispensing is fixed through five year agreements with the government, so trading terms on generics are important for the cross-subsidy of other dispensing activities and professional services. These trading terms (discounts provided by generics suppliers) have become part of the overall cost and revenue structure of pharmacies. Despite these arrangements, generic substitution rates in Australia are lower than in most comparable countries, which the government views as an opportunity to promote generic use. The future of generic drug supply via the PBS is important to allow consumers access to medications at the lowest possible price and to provide space for PBS listing of new and expensive drugs. But considerations of PBS reform need to take account of the role and viability of community pharmacy sector as provider of pharmaceuticals in a timely and efficient manner to Australian residents. PMID:17543112

Variation in cash price of the generic medications most prescribed by dermatologists in pharmacies across the United States.

PubMed

Alghanem, Noor; Abokwidir, Manal; Fleischer, Alan B; Feldman, Steven R; Alghanem, Ward

2017-03-01

The United States has the highest drug costs in the world. Consumers complain about large price differences at pharmacies on generic drugs. To evaluate variation in cash prices of generic medications most prescribed in dermatology across different drugstores and states in United States. The 11 generic drugs most prescribed by dermatologists according to National Ambulatory Medical Care Survey were assessed. By using Google, the most common used pharmacies in United States were listed, which are located at a random selection of six states. By calling the first available number of each pharmacy in the six states and asking about the generic cash price of the smallest stock size and the most prescribed type, the data were collected. Drug prices varied; the median cumulative price of the 11 medications was highest at Rite Aid ($1226) and lowest at Walmart ($795.34) with 35% difference. The prices at CVS differed by 20% across different states; however, the prices at Walmart, Rite Aid and Walgreens were consistent. New York has the highest and Iowa the lowest prices, especially at CVS, ($1160.79) versus ($931.32). There are varieties in the prices for the generic medications in different pharmacies and States.

Nuclear power plant Generic Aging Lessons Learned (GALL). Main report and appendix A

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kaza, K.E.; Diercks, D.R.; Holland, J.W.

The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters,more » 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volume s 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This document is Volume 1, consisting of the executive summary, summary and observations, and an appendix listing the GALL literature review tables.« less

Evaluation of zero-order controlled release preparations of nifedipine tablet on dissolution test, together with cost benefit point of view.

PubMed

Sakurai, Miyuki; Naruto, Ikue; Matsuyama, Kenji

2008-05-01

Many generic drugs have been released to decrease medical expenses, but some problems have been reported with regard to bioavailability and safety. In this study, we compared three once-a-day controlled-release preparations of nifedipine by the dissolution test (one branded and two generic preparations). Although the two generic drugs were equivalent to the branded drug according to the criteria listed in the Japanese "Guideline for Bioequivalence Studies of Generic Products", there was still a possibility of problems arising. For example, side effects could be caused by a rapid increase in the blood level of nifedipine with one generic drug, while bioavailability might be inadequate with the other due to its small area under the concentration vs. time curve. When each drug was prescribed at a dosage of 20 mg once daily for two weeks, the difference in the copayment for the patient was only 10 yen. Accordingly, it is important for doctors and pharmacists to carefully consider whether such a slight difference in price is really a benefit for the patient.

The Impact of Price-cap Regulations on Exit by Generic Pharmaceutical Firms.

PubMed

Zhang, Wei; Guh, Daphne; Sun, Huiying; Marra, Carlo A; Lynd, Larry D; Anis, Aslam H

2016-09-01

In 1998, the Province of Ontario in Canada adopted price-cap "70/90" regulations whereby the first generic entrant was required to be priced at ≤70% of the associated brand-name product and subsequent generics were priced at ≤90% of the first generic price. The price-caps were further lowered to 50% in 2006 and 25% in 2010. This study assessed the impact of such price-cap regulations on exit by generic drug firms. Formulary (2003-2012) listings of prescription drugs covered under the Ontario Drug Benefit program were used. The formulary tracks the "status" (on formulary, discontinued by manufacturer, and delisted for other reasons) for each drug. Markets were defined based on unique active ingredient and form within Ontario. Firm exit occurred when a manufacturer discontinued all its generic drugs within a market. The exit rate was defined as the number of generic firm-market exits divided by total generic firm-market follow-up years. Poisson regression was used to compare the exit rates during the 3 policy periods ("25," "50," and "70/90"). A total of 1126 generic manufacturers paired with 290 markets were identified. The exit rate ratio during the 25% price-cap period compared with the 70%/90% period was 2.42 (95% confidence interval, 1.56-3.77). A small manufacturer or a manufacturer in a market with ≥3 competitors or in an older market was more likely to exit. Lowering the price-cap level is associated with a higher incidence of generic firm exit from markets. Continuously reducing price-caps may have the unintended consequence of forcing generic firms to exit.

Modeling and analysis of pinhole occulter experiment: Initial study phase

NASA Technical Reports Server (NTRS)

Vandervoort, R. J.

1985-01-01

The feasibility of using a generic simulation, TREETOPS, to simulate the Pinhole/Occulter Facility (P/OF) to be tested on the space shuttle was demonstrated. The baseline control system was used to determine the pointing performance of the P/OF. The task included modeling the structure as a three body problem (shuttle-instrument pointing system- P/OP) including the flexibility of the 32 meter P/OF boom. Modeling of sensors, actuators, and control algorithms was also required. Detailed mathematical models for the structure, sensors, and actuators are presented, as well as the control algorithm and corresponding design procedure. Closed loop performance using this controller and computer listings for the simulator are also given.

Bibliography of work on the heterogeneous photocatalytic removal of hazardous compounds from water and air, Update Number 2 to October 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blake, D.M.

1997-01-01

The Solar Industrial Program has developed processes that destroy hazardous substances in or remove them from water and air. The processes of interest in this report are based on the application of heterogeneous photocatalysts, principally titanium dioxide or modifications thereof, but work on other heterogeneous catalysts is included in this compilation. This report continues bibliographies that were published in May, 1994, and October, 1995. The previous reports included 663 and 574 citations, respectively. This update contains an additional 518 references. These were published during the period from June 1995 to October 1996, or are references from prior years that weremore » not included in the previous reports. The work generally focuses on removing hazardous contaminants from air or water to meet environmental or health regulations. This report also references work on properties of semiconductor photocatalysts and applications of photocatalytic chemistry in organic synthesis. This report follows the same organization as the previous publications. The first part provides citations for work done in a few broad categories that are generic to the process. Three tables provide references to work on specific substances. The first table lists organic compounds that are included in various lists of hazardous substances identified by the US Environmental Protection Agency (EPA). The second table lists compounds not included in those categories, but which have been treated in a photocatalytic process. The third table covers inorganic compounds that are on EPA lists of hazardous materials or that have been treated by a photocatalytic process. A short update on companies that are active in providing products or services based on photocatalytic processes is provided.« less

Patent and Exclusivity Status of Essential Medicines for Non-Communicable Disease

PubMed Central

Mackey, Tim K.; Liang, Bryan A.

2012-01-01

Objective The threat of non-communicable diseases (“NCDs”) is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights (“IPRs”) that may impede generic production and availability and affordability to essential NCD medicines. Methods Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study. Materials We examined the patent and exclusivity status of medicines listed in the World Health Organization’s (“WHO”) Model List of Essential Drugs (Medicines) (“MLEM”) and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA. Results Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria. Conclusions We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines. PMID:23226453

Improvements to the adaptive maneuvering logic program

NASA Technical Reports Server (NTRS)

Burgin, George H.

1986-01-01

The Adaptive Maneuvering Logic (AML) computer program simulates close-in, one-on-one air-to-air combat between two fighter aircraft. Three important improvements are described. First, the previously available versions of AML were examined for their suitability as a baseline program. The selected program was then revised to eliminate some programming bugs which were uncovered over the years. A listing of this baseline program is included. Second, the equations governing the motion of the aircraft were completely revised. This resulted in a model with substantially higher fidelity than the original equations of motion provided. It also completely eliminated the over-the-top problem, which occurred in the older versions when the AML-driven aircraft attempted a vertical or near vertical loop. Third, the requirements for a versatile generic, yet realistic, aircraft model were studied and implemented in the program. The report contains detailed tables which make the generic aircraft to be either a modern, high performance aircraft, an older high performance aircraft, or a previous generation jet fighter.

Health related quality of life measures in Arabic speaking populations: a systematic review on cross-cultural adaptation and measurement properties.

PubMed

Al Sayah, Fatima; Ishaque, Sana; Lau, Darren; Johnson, Jeffrey A

2013-02-01

This systematic review was conducted to identify generic health related quality of life (HRQL) measures translated into Arabic, and evaluate their cross-cultural adaptation and measurement properties. Six databases were searched, relevant journals were hand searched, and reference lists of included studies were reviewed. Previously established criteria were used to evaluate the cross-cultural adaptation of the identified instruments and their measurement properties. Twenty studies that reported the Arabic translations and adaptations of HRQL measures and/or their measurement properties were included in this review. The identified instruments were SF-36, RAND-36, WHOQOL-Bref, COOP/WONCA charts, EQ-5D, and QLI. Cross-cultural adaptations of all measures were of moderate to good quality, and evaluation of measurement properties was limited due to insufficiency of evidence. Based on cross-cultural adaptation evaluation, each instrument is more applicable to the population for whom it was adapted, and to other Arabic populations of similar culture and language specific idioms. This review facilitates the selection among existing Arabic versions of generic HRQL for use in particular Arabic countries. However, each of the translated versions requires further investigation of measurement properties before more concrete recommendations could be made.

Web-Based Communication Strategies Designed to Improve Intention to Minimize Risk for Colorectal Cancer: Randomized Controlled Trial

PubMed Central

Flight, Ingrid; Zajac, Ian T; Turnbull, Deborah; Young, Graeme P; Olver, Ian

2018-01-01

Background People seek information on the Web for managing their colorectal cancer (CRC) risk but retrieve much personally irrelevant material. Targeting information pertinent to this cohort via a frequently asked question (FAQ) format could improve outcomes. Objective We identified and prioritized colorectal cancer information for men and women aged 35 to 74 years (study 1) and built a website containing FAQs ordered by age and gender. In study 2, we conducted a randomized controlled trial (RCT) to test whether targeted FAQs were more influential on intention to act on CRC risk than the same information accessed via a generic topic list. Secondary analyses compared preference for information delivery, usability, relevance, and likelihood of recommendation of FAQ and LIST websites. Methods Study 1 determined the colorectal cancer information needs of Australians (N=600) by sex and age group (35-49, 50-59, 60-74) through a Web-based survey. Free-text responses were categorized as FAQs: the top 5 issues within each of the 6 cohorts were identified. Study 2 (N=240) compared the impact of presentation as targeted FAQ links to information with links presented as a generic list (LIST) and a CONTROL (no information) condition. We also tested preference for presentation of access to information as FAQ or LIST by adding a CHOICE condition (a self-selected choice of FAQs or a list of information topics). Results Study 1 showed considerable consistency in information priorities among all 6 cohorts with 2 main concerns: treatment of CRC and risk factors. Some differences included a focus on general risk factors, excluding diet and lifestyle, in the younger cohort, and on the existence of a test for CRC in the older cohorts. Study 2 demonstrated that, although respondents preferred information access ordered by FAQs over a list, presentation in this format had limited impact on readiness to act on colorectal cancer risk compared with the list or a no-information control (P=.06). Both FAQ and LIST were evaluated as equally usable. Those aged 35 to 49 years rated the information less relevant to them and others in their age group, and information ordered by FAQs was rated, across all age groups and both sexes, as less relevant to people outside the age group targeted within the FAQs. Conclusions FAQs are preferred over a list as a strategy for presenting access to information about CRC. They may improve intention to act on risk, although further research is required. Future research should aim to identify better the characteristics of information content and presentation that optimize perceived relevance and fully engage the target audience. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12618000137291; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=374129 (Archived by WebCite at http://www.webcitation.org/6x2Mr6rPC) PMID:29434013

An Open Source Simulation System

NASA Technical Reports Server (NTRS)

Slack, Thomas

2005-01-01

An investigation into the current state of the art of open source real time programming practices. This document includes what technologies are available, how easy is it to obtain, configure, and use them, and some performance measures done on the different systems. A matrix of vendors and their products is included as part of this investigation, but this is not an exhaustive list, and represents only a snapshot of time in a field that is changing rapidly. Specifically, there are three approaches investigated: 1. Completely open source on generic hardware, downloaded from the net. 2. Open source packaged by a vender and provided as free evaluation copy. 3. Proprietary hardware with pre-loaded proprietary source available software provided by the vender as for our evaluation.

OSTEOPOROSIS DRUGS MARKETED IN THE UNITED STATES: GENERIC COMPETITION, PRICING STRUCTURE, AND DISPERSION AMONG PAYERS.

PubMed

Balkhi, Bander; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa

2016-01-01

Despite the cost of pharmaceuticals, studies assessing prices of osteoporosis drugs are lacking. This study examined trends in prices of osteoporosis drugs in the United States in the period 1988-2014, assessed pricing structure of osteoporosis drugs, and evaluated price trends before and after generic drugs market entry. Data were derived from the U.S. Food and Drug Administration, the RedBook, the Centers for Medicare & Medicaid Services, and the Federal Supply Schedule (FSS). Descriptive statistics and segmented linear regression analyses were performed. In the period 1988-2014, osteoporosis drug prices increased faster than the inflation. The average wholesale price (AWP) of generic products at market entry represented 90 percent of the AWP for the corresponding brand. Prices of brand products continued to increase after generic entry. Drug prices showed a significant variation when compared with the brand AWP. The brand wholesale acquisition cost (WAC) was typically set at 83.3 percent of the AWP. Community pharmacies acquired osteoporosis brand drugs at a median of 80.5 percent of the brand AWP. Significant reductions in brand AWP were observed for Medicare Part B (78.5 percent of the brand AWP), generic National Average Drug Acquisition Cost (33.7 percent), and FSS (22.5 percent). There are significant differences in the manufacturer prices, pharmacy acquisition costs and reimbursement rates of osteoporosis drugs. Pharmaceutical companies listed prices are higher than the pharmacy actual estimated acquisitions costs, and the prices used for reimbursement to providers. Generic drugs entry significantly drives down prices; still, prices of branded drugs facing generic competition continued to increase after generic market entry.

Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis

PubMed Central

Vernaz, Nathalie; Haller, Guy; Girardin, François; Huttner, Benedikt; Combescure, Christophe; Dayer, Pierre; Muscionico, Daniel; Salomon, Jean-Luc; Bonnabry, Pascal

2013-01-01

Background Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”). Methods and Findings We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community. Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100). Conclusions Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies. Please see later in the article for the Editors' Summary PMID:23750120

Trogossitidae: A review of the beetle family, with a catalogue and keys

PubMed Central

Kolibáč, Jiří

2013-01-01

Abstract The family Trogossitidae (Coleoptera: Cleroidea) is reviewed to species level. Keys to its genera, tribes and subfamilies are presented for the first time. All known species and subspecies are listed, together with complete taxonomic references back to 1910, the date of issue of the last catalogue of Trogossitidae. Higher taxa reviews are accompanied by remarks on phylogeny, distribution and biology as well as a brief description of adults and larvae. All known fossil records of Trogossitidae are reviewed and discussed. The work includes maps of distribution, colour photographs of generic representatives, morphological illustrations, SEM photographs and phylogenetic trees. PMID:24453569

Mission operations systems for planetary exploration

NASA Technical Reports Server (NTRS)

Mclaughlin, William I.; Wolff, Donna M.

1988-01-01

The purpose of the paper is twofold: (1) to present an overview of the processes comprising planetary mission operations as conducted at the Jet Propulsion Laboratory, and (2) to present a project-specific and historical context within which this evolving process functions. In order to accomplish these objectives, the generic uplink and downlink functions are described along with their specialization to current flight projects. Also, new multimission capabilities are outlined, including prototyping of advanced-capability software for subsequent incorporation into more automated future operations. Finally, a specific historical ground is provided by listing some major operations software plus a genealogy of planetary missions beginning with Mariner 2 in 1962.

Toward a generic UGV autopilot

NASA Astrophysics Data System (ADS)

Moore, Kevin L.; Whitehorn, Mark; Weinstein, Alejandro J.; Xia, Junjun

2009-05-01

Much of the success of small unmanned air vehicles (UAVs) has arguably been due to the widespread availability of low-cost, portable autopilots. While the development of unmanned ground vehicles (UGVs) has led to significant achievements, as typified by recent grand challenge events, to date the UGV equivalent of the UAV autopilot is not available. In this paper we describe our recent research aimed at the development of a generic UGV autopilot. Assuming we are given a drive-by-wire vehicle that accepts as inputs steering, brake, and throttle commands, we present a system that adds sonar ranging sensors, GPS/IMU/odometry, stereo camera, and scanning laser sensors, together with a variety of interfacing and communication hardware. The system also includes a finite state machine-based software architecture as well as a graphical user interface for the operator control unit (OCU). Algorithms are presented that enable an end-to-end scenario whereby an operator can view stereo images as seen by the vehicle and can input GPS waypoints either from a map or in the vehicle's scene-view image, at which point the system uses the environmental sensors as inputs to a Kalman filter for pose estimation and then computes control actions to move through the waypoint list, while avoiding obstacles. The long-term goal of the research is a system that is generically applicable to any drive-by-wire unmanned ground vehicle.

49 CFR 172.101 - Purpose and use of hazardous materials table.

Code of Federal Regulations, 2010 CFR

2010-10-01

... paragraph (c)(11): For the transportation of samples of self-reactive materials, organic peroxides... hazard class, the material is not a hazardous material. (13) Self-reactive materials and organic peroxides. A generic proper shipping name for a self-reactive material or an organic peroxide, as listed in...

A distributed telerobotics construction set

NASA Technical Reports Server (NTRS)

Wise, James D.

1994-01-01

During the course of our research on distributed telerobotic systems, we have assembled a collection of generic, reusable software modules and an infrastructure for connecting them to form a variety of telerobotic configurations. This paper describes the structure of this 'Telerobotics Construction Set' and lists some of the components which comprise it.

Acquisition of generic memory in amnesia.

PubMed

Verfaellie, M; Cermak, L S

1994-06-01

Amnesic patients' ability to acquire generic, semantic information was assessed relative to their own level of episodic memory. Patients studied a list of words in which some items were presented twice and others once. Upon each presentation, the words were tagged episodically by presenting them in a unique color. Recall of the colors in which words were presented suggested that individual presentations of repeated items were less likely to be recalled than presentations of nonrepeated items; however, actual recall of repeated items exceeded that of nonrepeated items. This outcome demonstrated that amnesics can recall some items generically without recalling either of their individual presentations. However, amnesics' recall of twice-presented items remained far below that of the control group, even when their recall of once-presented items was matched by testing the control group after a delay. This finding suggests that amnesic patients can acquire new generic knowledge but do so much less efficiently than do normal individuals. Furthermore, this deficit occurs independently of the amnesics' episodic memory impairments, reflecting instead a disruption in semantic learning per se.

Multisource drug policies in Latin America: survey of 10 countries.

PubMed Central

Homedes, Núria; Ugalde, Antonio

2005-01-01

Essential drug lists and generic drug policies have been promoted as strategies to improve access to pharmaceuticals and control their rapidly escalating costs. This article reports the results of a preliminary survey conducted in 10 Latin American countries. The study aimed to document the experiences of different countries in defining and implementing generic drug policies, determine the cost of registering different types of pharmaceutical products and the time needed to register them, and uncover the incentives governments have developed to promote the use of multisource drugs. The survey instrument was administered in person in Chile, Ecuador and Peru and by email in Argentina, Brazil, Bolivia, Colombia, Costa Rica, Nicaragua and Uruguay. There was a total of 22 respondents. Survey responses indicated that countries use the terms generic and bioequivalence differently. We suggest there is a need to harmonize definitions and technical concepts. PMID:15682251

Outcome measures for adult critical care: a systematic review.

PubMed

Hayes, J A; Black, N A; Jenkinson, C; Young, J D; Rowan, K M; Daly, K; Ridley, S

2000-01-01

1. To identify generic and disease specific measures of impairment, functional status and health-related quality of life that have been used in adult critical care (intensive and high-dependency care) survivors. 2. To review the validity, reliability and responsiveness of the measures in adult critical care survivors. 3. To consider the implications for future policy and to make recommendations for further methodological research. 4. To review what is currently known of the outcome of adult critical care. Searches of electronic databases (MEDLINE, EMBASE, CINAHL, PsycLIT, The Cochrane Library and SIGLE) from 1970 to August 1998. Manual searches of five journals (1985-98) not indexed in electronic databases and relevant conference proceedings (1993-98). Reference lists of six existing reviews, plus snowballing from reference lists of all relevant articles identified. Randomised trials, non-randomised trials (cohort studies) and case series that included data on outcomes after discharge from adult (16 years and over) critical care. If reported, the following data were extracted from each paper: patient characteristics (age, gender, severity of illness, diagnostic category) number of patients eligible for study, follow-up period, number of deaths before follow-up, number and proportion of survivors included in follow-up method of presentation of outcome data - proportion normal as defined by reference values, or aggregate value (e.g. mean or median), or aggregate values plus an indication of variance (e.g. standard deviation or inter-quartile range). Evidence for three measurement properties was sought for each outcome measure that had been used in at least two studies - their validity, reliability and responsiveness in adult critical care. If the authors did not report these aspects explicitly, an attempt was made to use the data provided to provide these measurement properties. For measures that were used in at least ten studies, information on actual reported outcomes were also extracted. MEASURES USED IN CRITICAL CARE: Measures of impairment were largely confined to the respiratory system so are almost certainly not appropriate for many critical care survivors. They can be categorised as respiratory volumes (e.g. vital capacity), gas flow within the respiratory system (e.g. forced expiratory volume in 1 second (FEV1)), pulmonary diffusing capacity (e.g. carbon monoxide diffusing capacity) and visualisation of the upper airway (e.g. bronchoscopy). Multiple tests are often performed. Eight measures of physical functional status were used, five generic and three disease-specific. The most frequently used generic measures were multi-item scales. Two single-item global measures attempted to capture a person's overall activity level or functional status. Five multi-item measures of mental functional status were used, four generic and one specific to trauma patients. The generic measures were either confined to assessing depressive symptoms or also encompassed a measure of anxiety. Measures of neuropsychological functioning relate to a person's cognition, attention, ability to process information and memory. Apart from one single-item measure, which focused on communication level, six multi-item measures were used with critical care survivors. Such measures are particularly appropriate for use with survivors of head injury or other neurological insult and, in that sense, they are disease-specific rather than generic measures. Single item measures of recovery were frequently used but researchers often invented their own, so there was little consistency in the wording. These measures had five principal foci - return to work, return to own home, degree of recovery, productivity and chronic health status. One multi-item scale was also used. (ABSTRACT TRUNCATED)

A catalog of the types of Staphylinidae (Insecta, Coleoptera) deposited in the Museo Argentino de Ciencias Naturales, Buenos Aires (MACN).

PubMed

Bachmann, Axel O; Chani-Posse, Mariana; Guala, Mariel E; Newton, Alfred F

2017-01-22

The type specimens (all current categories) of Staphylinidae deposited in this Museum are listed; names are recorded, most of them represented by name-bearing types (primary types). The specific and subspecific names are alphabetically ordered in a single list, followed by the generic names (and subgeneric ones, if they were stated) spelled as they were published; later combinations and/ or current binomina are mentioned insofar these are known to the authors. Two lists are added: 2. Specimens labeled as types of names not found in the literature and probably never published, or published as nomina nuda; and 3. Specimens labeled as types, but not originally designated as such. An appendix provides a systematically arranged list of all names discussed, with indication of where they are discussed in the text.

WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

PubMed

2006-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis

PubMed Central

Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

2017-01-01

Objectives The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. Setting This research was carried out in a non-clinical research setting using secondary data. Participants There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Primary and secondary outcome measures Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Results Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74–99.6%. Patent expiry dates were bortezomib 2014–22, dasatinib 2020–26, everolimus 2019–25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Conclusions Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. PMID:28110283

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

Comparison of response rates and cost-effectiveness for a community-based survey: postal, internet and telephone modes with generic or personalised recruitment approaches

PubMed Central

2012-01-01

Background Epidemiological research often requires collection of data from a representative sample of the community or recruitment of specific groups through broad community approaches. The population coverage of traditional survey methods such as mail-outs to residential addresses, and telephone contact via public directories or random-digit-dialing is declining and survey response rates are falling. There is a need to explore new sampling frames and consider multiple response modes including those offered by changes in telecommunications and internet technology. Methods We evaluated response rates and cost-effectiveness for three modes of survey administration (postal invitation/postal survey, postal invitation/internet survey and postal invitation/telephone survey) and two styles of contact approach (personalised and generic) in a community survey of greywater use. Potential respondents were contacted only once, with no follow up of non-responders. Results The telephone survey produced the highest adjusted response rate (30.2%), followed by the personalised postal survey (10.5%), generic postal survey (7.5%) and then the internet survey (4.7% for the personalised approach and 2.2% for the generic approach). There were some differences in household characteristics and greywater use rates between respondents to different survey modes, and between respondents to personalised and generic approaches. These may be attributable to the differing levels of motivations needed for a response, and varying levels of interest in the survey topic among greywater users and non-users. The generic postal survey had the lowest costs per valid survey received (Australian $22.93), followed by the personalised postal survey ($24.75). Conclusions Our findings suggest that postal surveys currently remain the most economic option for population-based studies, with similar costs for personalised and generic approaches. Internet surveys may be effective for specialised groups where email lists are available for initial contact, but barriers other than household internet access still exist for community-based surveys. Given the increasing recruitment challenges facing community-based studies, there is an imperative to gather contemporary comparative data on different survey modes and recruitment approaches in order to determine their strengths, limitations and costs. Researchers also need to document and report on the potential biases in the target and respondent populations and how this may affect the data collected. PMID:22938205

Obesity: a systematic review on parental involvement in long-term European childhood weight control interventions with a nutritional focus.

PubMed

van der Kruk, J J; Kortekaas, F; Lucas, C; Jager-Wittenaar, H

2013-09-01

In Europe, about 20% of children are overweight. Focus on parental responsibility is an effective method in weight control interventions in children. In this systematic review we describe the intensity of parental involvement and behaviour change aimed at parents in long-term European childhood weight control interventions. We include European Union studies targeting parents in order to improve children's weight status in multi-component (parental, behaviour change and nutrition) health promotion or lifestyle interventions. The included studies have at least one objectively measured anthropometric outcome in the weight status of the child. Parental involvement was described and categorized based on the intensity of parental involvement and coded using a validated behaviour change taxonomy specific to childhood obesity. Twenty-four studies were analysed. In effective long-term treatment studies, medium and high intensity parental involvement were identified most frequently; whereas in prevention studies low intensity parental involvement was identified most frequently. Parenting skills, generic and specific to lifestyle behaviour, scored frequently in effective weight control interventions. To list parental skills in generic and specific to lifestyle, descriptions of the included studies were summarized. We conclude that intensity of parental involvement and behaviour change techniques are important issues in the effectiveness of long-term childhood weight control interventions. © 2013 The Authors. obesity reviews © 2013 International Association for the Study of Obesity.

Cultural Capital in Business Higher Education: Reconsidering the Graduate Attributes Movement and the Focus on Employability

ERIC Educational Resources Information Center

Kalfa, Senia; Taksa, Lucy

2015-01-01

This article examines the increased interest being shown by Australian business faculties in the development of students' employability skills. Many universities have demonstrated their commitment to translating such interest into practice by elaborating lists of "graduate attributes" in order to enable the development of generic skills…

Spelling: Computerised Feedback for Self-Correction

ERIC Educational Resources Information Center

Lawley, Jim

2016-01-01

Research has shown that any assumption that L2 learners of English do well to rely on the feedback provided by generic spell checkers (for example, the MS Word spell checker) is misplaced. Efforts to develop spell checkers specifically for L2 learners have focused on training software to offer more appropriate suggestion lists for replacing…

40 CFR Appendix B to Part 72 - Methodology for Conversion of Emissions Limits

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Methodology for Conversion of... Conversion of Emissions Limits For the purposes of the Acid Rain Program, all emissions limits must be... conditions. Generic conversions for these limits are based on the assumed average energy contents listed in...

40 CFR Appendix B to Part 72 - Methodology for Conversion of Emissions Limits

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Methodology for Conversion of... Conversion of Emissions Limits For the purposes of the Acid Rain Program, all emissions limits must be... conditions. Generic conversions for these limits are based on the assumed average energy contents listed in...

78 FR 37848 - ASME Code Cases Not Approved for Use

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC has determined not to be acceptable for use on a generic basis.

Student Press in American Archives, Fall/Winter 1973-74.

ERIC Educational Resources Information Center

National Council of Coll. Publications Advisers.

This issue of the "Student Press in America Archives List" contains 100 entries on current issues and information, as well as cases involving student press editors, advisers, student media, and the generic subject of the campus press, emphasizing censorship practices and principles. Information concerning how and where to obtain documents of…

Information Competences as Fetishized Theoretical Categories--The Example of Youth Pro-Ana Blogs

ERIC Educational Resources Information Center

Siuda, Piotr

2016-01-01

Scientific reflections on information literacy have emphasized that young people must develop information competences related to using the Internet. Among various approaches, in the generic approach, catalogues of competences are constructed and treated as lists of desired behaviors and skills. The article aims to criticize this approach and its…

Manufacturing Math Classes: An Instructional Program Guide for Manufacturing Workers.

ERIC Educational Resources Information Center

McBride, Pamela G.; And Others

This program guide documents a manufacturing job family curriculum that develops competence in generic work force education skills through three courses: Reading Rulers, Charts, and Gauges and Math for Manufacturing Workers I and II. An annotated table of contents lists a brief description of the questions answered in each section. An introduction…

77 FR 67777 - National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-14

... subsequent soil samples showed levels of metals at or below generic residential criteria or background values... 1994- 1996 and additional sampling between 1998 and 2007. Area A--Site Entrance: Soil boring samples... verification samples. Additional soil samples were collected from the same location as the previous collection...

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015.

PubMed

van Hunsel, Florence; de Waal, Susan; Härmark, Linda

2017-08-01

The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as important medical events. The proportion of reports by patients which were included the signals was 2% and 3.9% for health care professional reports and 0.2% for marketing authorization holders reports. Patients had an important contribution to signals overall, but especially for ADRs related to generic drug substitution and psychiatric ADRs. Copyright © 2017 John Wiley & Sons, Ltd.

Effect of Physician Notification Regarding Nonadherence to Colorectal Cancer Screening on Patient Participation in Fecal Immunochemical Test Cancer Screening

PubMed Central

Pogu, Corinne; Le Donné, Delphine; Latour, Chloé; Bianco, Gaelle; Nanin, France; Cowppli-Bony, Anne; Gaultier, Aurélie; Nguyen, Jean-Michel

2017-01-01

Importance Increasing participation in fecal screening tests is a major challenge in countries that have implemented colorectal cancer (CRC) screening programs. Objective To determine whether providing general practitioners (GPs) a list of patients who are nonadherent to CRC screening enhances patient participation in fecal immunochemical testing (FIT). Design, Setting, and Participants A 3-group, cluster-randomized study was conducted from July 14, 2015, to July 14, 2016, on the west coast of France, with GPs in 801 practices participating and involving adult patients (50-74 years) who were at average risk of CRC and not up-to-date with CRC screening. The final follow-up date was July 14, 2016. Interventions General practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10 476 patients), 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10 606 patients), and 455 did not receive any reminders (usual care group, 10 147 patients). Main Outcomes and Measures The primary end point was patient participation in CRC screening 1 year after the intervention. Results Among 1482 randomized GPs (mean age, 53.4 years; 576 women [38.9%]), 1446 participated; of the 33 044 patients of these GPs (mean age, 59.7 years; 17 949 women [54.3%]), follow-up at 1 year was available for 31 229 (94.5%). At 1 year, 24.8% (95% CI, 23.4%-26.2%) of patients in the specific reminders group, 21.7% (95% CI, 20.5%-22.8%) in the generic reminders group, and 20.6% (95% CI, 19.3%-21.8%) in the usual care group participated in the FIT screening. The between-group differences were 3.1% (95% CI, 1.3%-5.0%) for the patient-specific reminders group vs the generic reminders group, 4.2% (95% CI, 2.3%-6.2%) for the patient-specific reminders group vs the usual care group, and 1.1% (95% CI, −0.6% to 2.8%) for generic reminders group vs the usual care group. Conclusions and Relevance Providing French GPs caring for adults at average risk of CRC with a list of their patients who were not up-to-date with their CRC screening resulted in a small but significant increase in patient participation in FIT screening at 1 year compared with patients who received usual care. Providing GPs with generic reminders about regional rates of CRC screening did not increase screening rates compared with usual care. Trial Registration clinicaltrials.gov Identifier: NCT02515344 PMID:28873160

Some design constraints required for the use of generic software in embedded systems: Packages which manage abstract dynamic structures without the need for garbage collection

NASA Technical Reports Server (NTRS)

Johnson, Charles S.

1986-01-01

The embedded systems running real-time applications, for which Ada was designed, require their own mechanisms for the management of dynamically allocated storage. There is a need for packages which manage their own internalo structures to control their deallocation as well, due to the performance implications of garbage collection by the KAPSE. This places a requirement upon the design of generic packages which manage generically structured private types built-up from application-defined input types. These kinds of generic packages should figure greatly in the development of lower-level software such as operating systems, schedulers, controllers, and device driver; and will manage structures such as queues, stacks, link-lists, files, and binary multary (hierarchical) trees. Controlled to prevent inadvertent de-designation of dynamic elements, which is implicit in the assignment operation A study was made of the use of limited private type, in solving the problems of controlling the accumulation of anonymous, detached objects in running systems. The use of deallocator prodecures for run-down of application-defined input types during deallocation operations during satellites.

77 FR 66794 - Proposed Information Collection; Comment Request; Generic Clearance for Master Address File (MAF...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... to measure the quality of the MAF. Test 22 is currently a one-time project scheduled for fiscal year... designed to be kept up-to-date, thereby eliminating the need to develop a completely new address list for future censuses and surveys. The Census Bureau plans to use the MTdb [[Page 66795

76 FR 58455 - Endangered and Threatened Wildlife and Plants; U.S. Captive-Bred Inter-subspecific Crossed or...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-21

...-0027; 96300-1671-0000-R4] RIN 1018-AW81 Endangered and Threatened Wildlife and Plants; U.S. Captive-Bred Inter-subspecific Crossed or Generic Tigers AGENCY: Fish and Wildlife Service, Interior. ACTION... subspecies) from the list of species that are exempt from registration under the captive-bred wildlife...

Developing Professionalism in the Child Care Industry. An Instructional Program Guide for Child Care Workers.

ERIC Educational Resources Information Center

Johnson, Ann; And Others

This program guide documents a child care job family curriculum that develops competence in generic work force education skills through two minicourses: Basic Issues in Child Care and Child Development Associate. An annotated table of contents lists a brief description of the questions answered in each section. An introduction presents a program…

Mapping a Domain Model and Architecture to a Generic Design

DTIC Science & Technology

1994-05-01

Code 103 Aooession Fol [TIS GRA&I Or DTIC TAB 0 Uaannouneed 0 hTst ifI catlon DIstributiqoj.- A Availability 0Qede Avail and,(o viaa~ CMLVSBI44-TF#4...this step is a record (in no specific form) of the selected features. This record (list, highlighted features diagram, or other media ) is used

40 CFR 63.99 - Delegated Federal authorities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... lists the specific source categories that have been delegated to the air pollution control agencies in... Generic MACT: Control Devices SS X X X Eq. Leaks—Level 1 TT X X X Eq. Leaks—Level 2 UU X X X Tanks—Level 2... General Provisions Authorities to State and Local Air Pollution Control Agencies.” 2 Alaska received...

40 CFR 63.99 - Delegated Federal authorities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... lists the specific source categories that have been delegated to the air pollution control agencies in... Generic MACT: Control Devices SS X X X Eq. Leaks—Level 1 TT X X X Eq. Leaks—Level 2 UU X X X Tanks—Level 2... General Provisions Authorities to State and Local Air Pollution Control Agencies.” 2 Alaska received...

General practitioners' views on (long-term) prescription and use of problematic and potentially inappropriate medication for oldest-old patients-A qualitative interview study with GPs (CIM-TRIAD study).

PubMed

Pohontsch, Nadine Janis; Heser, Kathrin; Löffler, Antje; Haenisch, Britta; Parker, Debora; Luck, Tobias; Riedel-Heller, Steffi G; Maier, Wolfgang; Jessen, Frank; Scherer, Martin

2017-02-17

Potentially inappropriate medication (PIM) is defined as medication with uncertain therapeutic effects and/or potential adverse drug reactions outweighing the clinical benefits. The prescription rate of PIM for oldest-old patients is high despite the existence of lists of PIM (e.g. the PRISCUS list) and efforts to raise awareness. This study aims at identifying general practitioners' views on PIM and aspects affecting the (long-term) use of PIM. As part of the CIM-TRIAD study, we conducted semi-structured, qualitative interviews with 47 general practitioners, discussing 25 patients with and 22 without PIM (according to the PRISCUS list). The interview guideline included generic and patient-specific questions. Interviews were digitally recorded and transcribed verbatim. We content analyzed the interviews using deductive and inductive category development. The majority of the general practitioners were not aware of the PRISCUS list. Agents deemed potentially inappropriate from the general practitioners' point of view and the PRISCUS list are not completely superimposable. General practitioners named their criteria to identify appropriate medication for elderly patients (e.g. renal function, cognitive state) and emphasized the importance of monitoring. We identified prescription- (e.g. benzodiazepines on alternative private prescription), medication- (e.g. subjective perception that PIM has no alternative), general practitioner- (e.g. general practitioner relies on specialists), patient- (e.g. "demanding high-user", positive subjective benefit-risk-ratio) and system-related aspects (e.g. specialists lacking holistic view, interface problems) related to the (long term) use of PIM. While the PRISCUS list does not seem to play a decisive role in general practice, general practitioners are well aware of risks associated with PIM. Our study identifies some starting points for a safer handling of PIM, e.g. stronger dissemination of the PRISCUS list, better compensation of medication reviews, "positive lists", adequate patient information, multifaceted interventions and improved communication between general practitioners and specialists.

[Lack of bioavailability of generic lopinavir/ritonavir not prequalified by WHO marketed in Africa (Congo Brazzaville)].

PubMed

Camara, S; Zucman, D; Vasse, M; Goudjo, A; Guillard, E; Peytavin, G

2015-02-01

Although second-line generic antiretroviral drugs are of great value in developing countries there are concerns regarding their quality and safety. This study is a case report and pharmacological study in healthy volunteers. A French subject of sub-saharan origin who visited Republic of Congo received a post-exposure treatment with AZT+3TC and LPV/r (200/50 mg, Arga-L®, India) following unprotected sexual intercourse. Two days later, in France, tests showed that plasma concentrations of lopinavir and ritonavir were undetectable. The WHO prequalification list showed Arga-L® was not prequalified. A pharmacological study in healthy volunteers evaluated oral bioavailability: plasma concentrations of generic LPV/r Arga-L® and LPV/r Kaletra® (400/100 mg) were measured after one single dose at 7 days apart in four healthy volunteers. Concentrations of Arga-L® at 12 h after intake were considerably lower than those of Kaletra®, revealing very low oral bioavailability of generic lopinavir and ritonavir (<10%) compared to the brand-name drug. We found that Arga-L®, despite having adequate qualitative and quantitative drug contents, had very poor bio availability compared to Kaletra®. In order to avoid the selection and the spread of drug-resistant HIV strains, rigorous pharmacological monitoring of generic antiretroviral drugs that are not pre-qualified by WHO, but are marketed in Africa, must be a priority for health authorities.

A review of insect parasitoids associated with Lobesia botrana (Denis & Schiffermüller, 1775) in Italy. 1. DipteraTachinidae and HymenopteraBraconidae (Lepidoptera, Tortricidae).

PubMed

Scaramozzino, Pier Luigi; Loni, Augusto; Lucchi, Andrea

2017-01-01

This paper is aimed to summarize the information available on the parasitoid complex of the European Grapevine Moth (EGVM), Lobesia botrana (Denis & Schiffermüller, 1775) (Lepidoptera Tortricidae) in Italy. The list is the result of the consultation of a vast bibliography published in Italy for almost two hundred years, from 1828 to date. This allowed the clarification and correction of misunderstandings and mistakes on the taxonomic position of each species listed. In Italy the complex of parasitoids detected on EGVM includes approximately 90 species belonging to ten families of Hymenoptera (Braconidae, Ichneumonidae, Chalcididae, Eulophidae, Eupelmidae, Eurytomidae, Pteromalidae, Torymidae, Trichogrammatidae, and Bethylidae) and one family of Diptera (Tachinidae). This paper deals with EGVM parasitoids of the families Tachinidae (Diptera) and Braconidae (Hymenoptera). Only two species of Tachinidae are associated to EGVM larvae in Italy, Actia pilipennis (Fallen) and Phytomyptera nigrina (Meigen), whereas the record of Eurysthaea scutellaris (Robineau-Desvoidy) is doubtful. Moreover, 21 species of Braconidae are reported to live on EGVM, but, unfortunately, eight of them were identified only at generic level. Bracon mellitor Say has been incorrectly listed among the parasitoids of Lobesia botrana . Records concerning Ascogaster rufidens Wesmael, Meteorus sp., Microgaster rufipes Nees, and Microplitis tuberculifer (Wesmael) are uncertain.

A review of insect parasitoids associated with Lobesia botrana (Denis & Schiffermüller, 1775) in Italy. 1. Diptera Tachinidae and Hymenoptera Braconidae (Lepidoptera, Tortricidae)

PubMed Central

Scaramozzino, Pier Luigi; Loni, Augusto; Lucchi, Andrea

2017-01-01

Abstract This paper is aimed to summarize the information available on the parasitoid complex of the European Grapevine Moth (EGVM), Lobesia botrana (Denis & Schiffermüller, 1775) (Lepidoptera Tortricidae) in Italy. The list is the result of the consultation of a vast bibliography published in Italy for almost two hundred years, from 1828 to date. This allowed the clarification and correction of misunderstandings and mistakes on the taxonomic position of each species listed. In Italy the complex of parasitoids detected on EGVM includes approximately 90 species belonging to ten families of Hymenoptera (Braconidae, Ichneumonidae, Chalcididae, Eulophidae, Eupelmidae, Eurytomidae, Pteromalidae, Torymidae, Trichogrammatidae, and Bethylidae) and one family of Diptera (Tachinidae). This paper deals with EGVM parasitoids of the families Tachinidae (Diptera) and Braconidae (Hymenoptera). Only two species of Tachinidae are associated to EGVM larvae in Italy, Actia pilipennis (Fallen) and Phytomyptera nigrina (Meigen), whereas the record of Eurysthaea scutellaris (Robineau-Desvoidy) is doubtful. Moreover, 21 species of Braconidae are reported to live on EGVM, but, unfortunately, eight of them were identified only at generic level. Bracon mellitor Say has been incorrectly listed among the parasitoids of Lobesia botrana. Records concerning Ascogaster rufidens Wesmael, Meteorus sp., Microgaster rufipes Nees, and Microplitis tuberculifer (Wesmael) are uncertain. PMID:28325964

European healthcare policies for controlling drug expenditure.

PubMed

Ess, Silvia M; Schneeweiss, Sebastian; Szucs, Thomas D

2003-01-01

In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by either denying or limiting reimbursement of products and providing an incentive for patients to reduce their consumption of drugs. These interventions include defining a list either of drugs reimbursed (positive list) or one of drugs not reimbursed (negative list), and patient co-payments, which require patients to pay a proportion of the cost of a prescribed product or a fixed charge. Policies intended to affect physicians' prescribing behaviour include guidelines, information (about price and less expensive alternatives) and feedback, and the use of budgetary restrictions.

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).

PubMed

Mercieca-Bebber, Rebecca; Williams, Douglas; Tait, Margaret-Ann; Roydhouse, Jessica; Busija, Lucy; Sundaram, Chindhu Shunmuga; Wilson, Michelle; Langford, Ailsa; Rutherford, Claudia; Roberts, Natasha; King, Madeleine; Vodicka, Elisabeth; Devine, Beth

2018-06-18

It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.

International ranking systems for universities and institutions: a critical appraisal

PubMed Central

Ioannidis, John PA; Patsopoulos, Nikolaos A; Kavvoura, Fotini K; Tatsioni, Athina; Evangelou, Evangelos; Kouri, Ioanna; Contopoulos-Ioannidis, Despina G; Liberopoulos, George

2007-01-01

Background Ranking of universities and institutions has attracted wide attention recently. Several systems have been proposed that attempt to rank academic institutions worldwide. Methods We review the two most publicly visible ranking systems, the Shanghai Jiao Tong University 'Academic Ranking of World Universities' and the Times Higher Education Supplement 'World University Rankings' and also briefly review other ranking systems that use different criteria. We assess the construct validity for educational and research excellence and the measurement validity of each of the proposed ranking criteria, and try to identify generic challenges in international ranking of universities and institutions. Results None of the reviewed criteria for international ranking seems to have very good construct validity for both educational and research excellence, and most don't have very good construct validity even for just one of these two aspects of excellence. Measurement error for many items is also considerable or is not possible to determine due to lack of publication of the relevant data and methodology details. The concordance between the 2006 rankings by Shanghai and Times is modest at best, with only 133 universities shared in their top 200 lists. The examination of the existing international ranking systems suggests that generic challenges include adjustment for institutional size, definition of institutions, implications of average measurements of excellence versus measurements of extremes, adjustments for scientific field, time frame of measurement and allocation of credit for excellence. Conclusion Naïve lists of international institutional rankings that do not address these fundamental challenges with transparent methods are misleading and should be abandoned. We make some suggestions on how focused and standardized evaluations of excellence could be improved and placed in proper context. PMID:17961208

Ada Compiler Validation Summary Report: Certificate Number: 940305W1. 11335 TLD Systems, Ltd. TLD Comanche VAX/i960 Ada Compiler System, Version 4.1.1 VAX Cluster under VMS 5.5 = Tronix JIAWG Execution Vehicle (i960MX) under TLD Real Time Executive, Version 4.1.1

DTIC Science & Technology

1994-03-14

Comanche VAX/i960 Ada Compiler System, Version 4.1.1 Host Computer System: Digital Local Area Network VAX Cluster executing on (2) MicroVAX 3100 Model 90...31 $MAX DIGITS 15 SmNx INT 2147483647 $MAX INT PLUS_1 2147483648 $MIN IN -2_147483648 A-3 MACR PARAMEERIS $NAME NO SUCH INTEGER TYPE $NAME LIST...nested generlcs are Supported and generics defined in libary units are pexitted. zt is not possible to pen ore a macro instantiation for a generic I

Canada’s Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property

PubMed Central

Bian, Henry; McCourt, Conor

2015-01-01

Canada’s Patent Register is a tool created by the Patented Medicines (Notice of Compliance) Regulations to help innovators protect their inventions relating to pharmaceuticals. This tool exists at the intersection between the intellectual property and drug approval regimes. By listing a patent on the Patent Register, an innovator can prevent a generic manufacturer from entering the marketplace rather than having to wait for his or her patent to be infringed. This article provides information on the requirements for listing a patent on the Patent Register and an overview of how the Patent Medicines (Notice of Compliance) Regulations affect the drug approval process. PMID:25573772

Discrete emotion-congruent false memories in the DRM paradigm.

PubMed

Bland, Cassandra E; Howe, Mark L; Knott, Lauren

2016-08-01

Research has shown that false-memory production is enhanced for material that is emotionally congruent with the mood of the participant at the time of encoding. So far this research has only been conducted to examine the influence of generic negative affective mood states and generic negative stimuli on false-memory production. In addition, much of the research is limited as it focuses on valence and arousal dimensions, and fails to take into account the more comprehensive nature of emotions. The current study demonstrates that this effect goes beyond general negative or positive moods and acts at a more discrete emotional level. Participants underwent a standard emotion-induction procedure before listening to negative emotional or neutral associative word lists. The emotions induced, negative word lists, and associated nonpresented critical lures, were related to either fear or anger, 2 negative valence emotions that are also both high in arousal. Results showed that when valence and arousal are controlled for, false memories are more likely to be produced for discrete emotionally congruent compared with incongruent materials. These results support spreading activation theories of false remembering and add to our understanding of the adaptive nature of false-memory production. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Chang, Anne B; Brown, Ngiare

2009-01-21

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Brown, Ngiare; Chang, Anne B

2009-04-15

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Guideline for the utilization of commercial grade items in nuclear safety related applications: Final report. [Contains Glossary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tulay, M.P.; Yurich, F.J.; Schremser, F.M. Jr.

1988-06-01

This guideline provides direction for the procurement and use of Commercial Grade Items (CGI)in safety-related applications. It is divided into five major sections. A glossary of terms and definitions, an acronym listing, and seven appendices have been included. The glossary defines terms used in this guideline. In certain instances, the definitions may be unique to this guideline. Identification of acronyms utilized in this guideline is also provided. Section 1 provides a background of the commercial grade item issues facing the nuclear industry. It provides a historical perspective of commercial grade item issues. Section 2 discusses the generic process for themore » acceptance of a commercial grade item for safety-related use. Section 3 defines the four distinct methods used to accept commercial grade items for safety-related applications. Section 4 lists specific references that are identified in this guideline. Section 5 is a bibliography of documents that were considered in developed this guideline, but were not directly referenced in the document.« less

Lessons Learned in Engineering

NASA Technical Reports Server (NTRS)

Blair, J. C.; Ryan, R. S.; Schutzenhofer, L. A.

2011-01-01

This Contractor Report (CR) is a compilation of Lessons Learned in approximately 55 years of engineering experience by each James C. Blair, Robert S. Ryan, and Luke A. Schutzenhofer. The lessons are the basis of a course on Lessons Learned that has been taught at Marshall Space Flight Center. The lessons are drawn from NASA space projects and are characterized in terms of generic lessons learned from the project experience, which are further distilled into overarching principles that can be applied to future projects. Included are discussions of the overarching principles followed by a listing of the lessons associated with that principle. The lesson with sub-lessons are stated along with a listing of the project problems the lesson is drawn from, then each problem is illustrated and discussed, with conclusions drawn in terms of Lessons Learned. The purpose of this CR is to provide principles learned from past aerospace experience to help achieve greater success in future programs, and identify application of these principles to space systems design. The problems experienced provide insight into the engineering process and are examples of the subtleties one experiences performing engineering design, manufacturing, and operations.

Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

PubMed

Edwards, Catherine

2010-07-01

SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

Generic revision of the ant subfamily Dorylinae (Hymenoptera, Formicidae)

PubMed Central

Borowiec, Marek L.

2016-01-01

Abstract The generic classification of the ant subfamily Dorylinae is revised, with the aim of facilitating identification of easily-diagnosable monophyletic genera. The new classification is based on recent molecular phylogenetic evidence and a critical reappraisal of doryline morphology. New keys and diagnoses based on workers and males are provided, along with reviews of natural history and phylogenetic relationships, distribution maps, and a list of valid species for each lineage. Twenty-eight genera (27 extant and 1 extinct) are recognized within the subfamily, an increase from 20 in the previous classification scheme. Species classified in the polyphyletic Cerapachys and Sphinctomyrmex prior to this publication are here distributed among 9 and 3 different genera, respectively. Amyrmex and Asphinctanilloides are synonymized under Leptanilloides and the currently recognized subgenera are synonymized for Dorylus. No tribal classification is proposed for the subfamily, but several apparently monophyletic genus-groups are discussed. Valid generic names recognized here include: Acanthostichus (= Ctenopyga), Aenictogiton, Aenictus (= Paraenictus, Typhlatta), Cerapachys (= Ceratopachys), Cheliomyrmex, Chrysapace gen. rev., Cylindromyrmex (= Holcoponera, Hypocylindromyrmex, Metacylindromyrmex), Dorylus (= Alaopone syn. n., Anomma syn. n., Cosmaecetes, Dichthadia syn. n., Rhogmus syn. n., Shuckardia, Sphecomyrmex, Sphegomyrmex, Typhlopone syn. n.), Eburopone gen. n., Eciton (= Camptognatha, Holopone, Mayromyrmex), Eusphinctus gen. rev., Labidus (= Nycteresia, Pseudodichthadia), Leptanilloides (= Amyrmex syn. n., Asphinctanilloides syn. n.), Lioponera gen. rev. (= Neophyracaces syn. n., Phyracaces syn. n.), Lividopone, Neivamyrmex (= Acamatus, Woitkowskia), Neocerapachys gen. n., Nomamyrmex, Ooceraea gen. rev. (= Cysias syn. n.), Parasyscia gen. rev., †Procerapachys, Simopone, Sphinctomyrmex, Syscia gen. rev., Tanipone, Vicinopone, Yunodorylus gen. rev., Zasphinctus gen. rev. (= Aethiopopone syn. n., Nothosphinctus syn. n.). PMID:27559303

Vernonieae (Asteraceae) of southern Africa: A generic disposition of the species and a study of their pollen

PubMed Central

Robinson, Harold; Skvarla, John J.; Funk, Vicki A.

2016-01-01

Abstract Current and previously included members of the Tribe Vernonieae (Asteraceae) of southern Africa are listed in their presently recognized genera with complete synonymies and keys to genera and species. The genus Vernonia, as presently delimited, does not occur in Africa. Genera of the Vernonieae presently recognized from southern Africa are Baccharoides, Bothriocline, Cyanthillium, Distephanus, Erlangea, Ethulia, Gymnanthemum, Hilliardiella, Oocephala, Orbivestus, Parapolydora, Polydora, Vernonella, Vernoniastrum, plus two genera that are named as new: Namibithamnus and Pseudopegolettia. Twelve new combinations are provided and two species, Vernonia potamiphila and Vernonia collinii Klatt., hom. illeg., remain unplaced because of a lack of material. Pollen types are illustrated including previously recognized types: non-lophate, sublophate, tricolporate lophate, and non-colpate triporate lophate. A type previously unknown in the Asteraceae is described here and in a separate paper for Oocephala and Polydora; a non-colpate pantoporate lophate type with pores not strictly equatorial. PMID:27081344

Analysis of the drug formulary and the purchasing process at a Moroccan university medical center.

PubMed

Lachhab, Z; Serragui, S; Hassar, M; Cherrah, Y; Errougani, A; Ahid, S

2018-05-31

To give an overview of the pharmaceutical policy in the largest medical center in Morocco, a developing country in socio-economic transition. This is an analytical descriptive study of the drug formulary and the purchasing process carried out at the Ibn Sina University Medical Center. Our formulary included 830 drugs belonging to 14 classes according to the Anatomical, Therapeutic and Chemical (ATC) Classification System. There was a respective predominance of class N (21.8%), class B (13.5%), and class J (12.6%). Injectable route was dominant (46%). Drugs had a significant actual benefit in 70% (according to the French Data), reimbursable in 42.8%, essential in 29.2% according to World Health Organization (WHO) list, and in 36.9% according to the Moroccan list. The calls for tenders included 542 drugs representing 65% of the formulary, and the attribution rate was 71%. The main reason for non-attribution was the lack of offers. Generics accounted for 45% by volume and 26.5% by value. With this first study, we were able to identify key indicators on drugs used in the largest medical center in Morocco. The current challenge is to introduce pharmacoeconomics in decision making concerning the updates of the drug formulary.

Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis.

PubMed

Hill, Andrew; Redd, Christopher; Gotham, Dzintars; Erbacher, Isabelle; Meldrum, Jonathan; Harada, Ryo

2017-01-20

The aim of this study was to estimate lowest possible treatment costs for four novel cancer drugs, hypothesising that generic manufacturing could significantly reduce treatment costs. This research was carried out in a non-clinical research setting using secondary data. There were no human participants in the study. Four drugs were selected for the study: bortezomib, dasatinib, everolimus and gefitinib. These medications were selected according to their clinical importance, novel pharmaceutical actions and the availability of generic price data. Target costs for treatment were to be generated for each indication for each treatment. The primary outcome measure was the target cost according to a production cost calculation algorithm. The secondary outcome measure was the target cost as the lowest available generic price; this was necessary where export data were not available to generate an estimate from our cost calculation algorithm. Other outcomes included patent expiry dates and total eligible treatment populations. Target prices were £411 per cycle for bortezomib, £9 per month for dasatinib, £852 per month for everolimus and £10 per month for gefitinib. Compared with current list prices in England, these target prices would represent reductions of 74-99.6%. Patent expiry dates were bortezomib 2014-22, dasatinib 2020-26, everolimus 2019-25 and gefitinib 2017. The total global eligible treatment population in 1 year is 769 736. Our findings demonstrate that affordable drug treatment costs are possible for novel cancer drugs, suggesting that new therapeutic options can be made available to patients and doctors worldwide. Assessing treatment cost estimations alongside cost-effectiveness evaluations is an important area of future research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Non-Metric Similarity Measures

DTIC Science & Technology

2015-03-26

Sunil Aryal and Kai Ming Ting. (2015) A generic ensemble approach to estimate multi-dimensional likelihood in Bayesian classifier learning...Computational Intelligence. http://onlinelibrary.wiley.com/doi/10.1111/coin.12063/abstract 5.2 List of peer-reviewed conference publications [3] Sunil Aryal...International Conference on Data Mining. 707-711. [4] Sunil Aryal, Kai Ming Ting, Jonathan R. Wells and Takashi Washio. (2014) Improv- ing iForest with

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.

PubMed

Dunne, Suzanne; Shannon, Bill; Dunne, Colum; Cullen, Walter

2013-01-05

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study

PubMed Central

2013-01-01

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland’s history with usage of generic medicines and how the proposed changes could affect healthcare provision. PMID:23289757

Morbidity profile and prescribing patterns among outpatients in a teaching hospital in Western Nepal

PubMed Central

Lamichhane, DC; Giri, BR; Pathak, OK; Panta, OB; Shankar, PR

2006-01-01

Background Recent studies on prescribing among outpatients in hospitals in Western Nepal are lacking. The main objectives of the study were to obtain information on the morbidity pattern among outpatients and to analyze prescribing using drug use indicators. Methods A retrospective hospital record based study from 01.01.2004 to 31.12.2004 was carried out among individuals attending the outpatient department (OPD) of the Manipal Teaching hospital, Pokhara, Western Nepal. A total of 32,017 new patients attended the OPD during the study period. Systematic random sampling (1 in every 20 patients) was done and 1600 patients selected. After excluding patients visiting the emergency department, those who got admitted and whose records were not available, 1261 cases were analyzed. The demographic details, morbidity pattern, average number of drugs prescribed, percentage of drugs prescribed by generic names and from the Essential drug list of Nepal (Essential drugs are those which satisfy the priority healthcare needs of the population), percentage of encounters with an antibiotic and an injection prescribed were noted. Results 1261 patients made 1772 visits. Upper respiratory tract infection and acid peptic disease were the most common diagnoses. The mean number of drugs was 1.99. Only 19.5% and 39.6% of drugs were prescribed by generic name and from the Essential drug list. Antibiotics and injections were prescribed in 26.4% and 0.96% of encounters. Cetrizine, vitamins, amoxicillin, the combination of paracetamol and ibuprofen and ranitidine were most commonly prescribed. Conclusions Upper respiratory tract infections and acid peptic disease were the common illnesses. Generic prescribing and use of essential drugs were low. Some of the drug combinations being used were irrational. Prescriber education may be helpful in encouraging rational prescribing. PMID:18523618

Pharma industry in India.

PubMed

Sundaram, V M

2008-01-01

Globally ranked fourth by volume and 13th in value, the Indian pharma industry is a leading producer of high-quality, low-cost generic drugs. Its 14% share of the USD 57 billion world generic market is expected to increase to 50% by 2010. With the advantages of cost competitiveness, ability and experience in reverse engineering, availability of skilled scientific and engineering personnel and the capability to produce raw materials for a wide range of drugs from the basic stage, the industry delivers the entire range of therapeutic products. McKinsey & Co. predict that India's pharmaceutical market could reach a size of USD 20 billion by 2015, becoming one of the top 10 drug markets in the world. Generic versions of the cardiovascular drug carvedilol, ANDA-approved allopurinol, verapamil SR and the anticancer drug paclitaxel are some of the recent products introduced by Indian companies, with Caraco, Ranbaxy, Dabur, Dr. Reddy's, Nicholas Piramal India, leading the list. Setting up of integrated drug development companies and aggressive entries into the Japanese drug market have provided further impetus to the country's pharma manufacturing arena.

Canada's Patented Medicines (Notice of Compliance) Proceedings and Intellectual Property.

PubMed

Bian, Henry; McCourt, Conor

2015-01-08

Canada's Patent Register is a tool created by the Patented Medicines (Notice of Compliance) Regulations to help innovators protect their inventions relating to pharmaceuticals. This tool exists at the intersection between the intellectual property and drug approval regimes. By listing a patent on the Patent Register, an innovator can prevent a generic manufacturer from entering the marketplace rather than having to wait for his or her patent to be infringed. This article provides information on the requirements for listing a patent on the Patent Register and an overview of how the Patent Medicines (Notice of Compliance) Regulations affect the drug approval process. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

Computer listing of the effects of drugs on laboratory data

PubMed Central

Young, D. S.; Thomas, D. W.; Friedman, R. B.

1972-01-01

A listing of approximately 10000 effects of drugs on tests performed in clinical laboratories has been developed in a time-shared computer. The list contains a directory for matching proprietary and generic names of drugs and an explanation for the mode of action of the drug on each test. Each entry is supported by a bibliographical reference that contains the author's names, and the title of the article and journal. It is possible to search for specific `character strings' (word or words, number, etc) to obtain all the effects of a particular drug, or all drugs that affect a particular test, or even to search for a specific explanation for an effect. The system is undergoing trial in the Department's own computer to permit of automatic correlation of the effects of drugs with laboratory data from patients in one hospital ward. PMID:4648544

Transparency ethics in practice: Revisiting financial conflicts of interest disclosure forms in clinical practice guidelines

PubMed Central

Sharara, Nour; Kaltenbach, Tonya; Laine, Loren; McQuaid, Kenneth; Soetikno, Roy; Subramanian, Venkataraman

2017-01-01

Background Authors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations? Methods For an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained. Findings 26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations". Discussion Accurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency. PMID:28841650

The replacement of dry heat in generic reliability assurance requirements for passive optical components

NASA Astrophysics Data System (ADS)

Ren, Xusheng; Qian, Longsheng; Zhang, Guiyan

2005-12-01

According to Generic Reliability Assurance Requirements for Passive Optical Components GR-1221-CORE (Issue 2, January 1999), reliability determination test of different kinds of passive optical components which using in uncontrolled environments is taken. The test condition of High Temperature Storage Test (Dry Test) and Damp Test is in below sheet. Except for humidity condition, all is same. In order to save test time and cost, after a sires of contrast tests, the replacement of Dry Heat is discussed. Controlling the Failure mechanism of dry heat and damp heat of passive optical components, the contrast test of dry heat and damp heat for passive optical components (include DWDM, CWDM, Coupler, Isolator, mini Isolator) is taken. The test result of isolator is listed. Telcordia test not only test the reliability of the passive optical components, but also test the patience of the experimenter. The cost of Telcordia test in money, manpower and material resources, especially in time is heavy burden for the company. After a series of tests, we can find that Damp heat could factually test the reliability of passive optical components, and equipment manufacturer in accord with component manufacture could omit the dry heat test if damp heat test is taken first and passed.

EnsMart: A Generic System for Fast and Flexible Access to Biological Data

PubMed Central

Kasprzyk, Arek; Keefe, Damian; Smedley, Damian; London, Darin; Spooner, William; Melsopp, Craig; Hammond, Martin; Rocca-Serra, Philippe; Cox, Tony; Birney, Ewan

2004-01-01

The EnsMart system (www.ensembl.org/EnsMart) provides a generic data warehousing solution for fast and flexible querying of large biological data sets and integration with third-party data and tools. The system consists of a query-optimized database and interactive, user-friendly interfaces. EnsMart has been applied to Ensembl, where it extends its genomic browser capabilities, facilitating rapid retrieval of customized data sets. A wide variety of complex queries, on various types of annotations, for numerous species are supported. These can be applied to many research problems, ranging from SNP selection for candidate gene screening, through cross-species evolutionary comparisons, to microarray annotation. Users can group and refine biological data according to many criteria, including cross-species analyses, disease links, sequence variations, and expression patterns. Both tabulated list data and biological sequence output can be generated dynamically, in HTML, text, Microsoft Excel, and compressed formats. A wide range of sequence types, such as cDNA, peptides, coding regions, UTRs, and exons, with additional upstream and downstream regions, can be retrieved. The EnsMart database can be accessed via a public Web site, or through a Java application suite. Both implementations and the database are freely available for local installation, and can be extended or adapted to `non-Ensembl' data sets. PMID:14707178

Baryon non-invariant couplings in Higgs effective field theory

NASA Astrophysics Data System (ADS)

Merlo, Luca; Saa, Sara; Sacristán-Barbero, Mario

2017-03-01

The basis of leading operators which are not invariant under baryon number is constructed within the Higgs effective field theory. This list contains 12 dimension six operators, which preserve the combination B-L, to be compared to only 6 operators for the standard model effective field theory. The discussion of the independent flavour contractions is presented in detail for a generic number of fermion families adopting the Hilbert series technique.

2012 in review - part II: overcoming the obstacles in the pharma/biotech industry.

PubMed

Rabasseda, X; Dulsat, C; Navarro, D; Cruces, E; Graul, A I; Jago, C; Tracy, M

2013-02-01

As highlighted in the first part of this review published last month, the year 2012 saw the approval of a remarkable number of new drugs, and among the new drugs reaching the market, a significant proportion were orphan drugs developed for treating less prevalent diseases. These drugs are certainly not expected to become blockbusters, but are of high interest because of their efficacy in a narrow spectrum of patients. This trend aligns with the general tendency of staying away from fit-for-all blockbusters into personalized medicine as one of the strategies for overcoming the patent cliff that resulted in a long list of drugs going off patent and being approved as generics also during last year. The emerging scenario resulting from new developments in the form of new drugs and biosimilars and newly available generic medications paralleled by strategic movements within the pharmaceutical industry to reinforce their position in the market, as reflected by merger and acquisition deals accompanied by significant efforts into prioritization resulting in spin-off and split transactions, is reviewed in this second part. This paper includes a significant amount of data in tables for quick review and to profile the new strategic movements in drug pipelines. Further information, including details on mechanisms of action, current status, itemized pharmacology, pharmacokinetic and clinical trial research findings and updated information can be found in the proprietary databases Thomson Reuters Integrity(SM) and Thomson Reuters Cortellis™. Copyright 2013 Prous Science, S.A.U. or its licensors. All rights reserved.

Brand loyalty, patients and limited generic medicines uptake.

PubMed

Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

2014-06-01

The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Evidence on the cost of breast cancer drugs is required for rational decision making.

PubMed

Berghuis, Anne Margreet Sofie; Koffijberg, Hendrik; Terstappen, Leonardus Wendelinus Mathias Marie; Sleijfer, Stefan; IJzerman, Maarten Joost

2018-01-01

For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology-Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL). A literature review was performed to identify currently reimbursed breast cancer drugs in the NL. Treatment costs were determined by multiplying list prices with the average length of treatment and dosing schedule. Comparing list prices to the estimated treatment cost resulted in substantial differences in the ranking of costliness of the drugs. The average mean treatment length was unknown for 11/31 breast cancer drugs (26.2%). The differences in the 15 highest-cost drugs were largest for Bevacizumab, Lapatinib and everolimus, with list prices of €541, €158, €1,168 and estimated treatment cost of €174,400, €18,682 and €31,207, respectively. The lowest-cost (patented) targeted drug is €1,818 more expensive than the highest-cost (off-patent) generic drug according to the estimated drug treatment cost. A lack of evidence on the reimbursement and cost of high-cost breast cancer drugs complicates rapid and transparent evidence synthesis, necessary to focus strategies aiming to limit the increasing healthcare costs. Interestingly, the findings show that off-patent generics (such as paclitaxel or doxorubicin), although substantially cheaper than patented drugs, are still relatively costly. Extending standardisation and increasing European and national regulations on presenting information on costs per cancer drug is highly recommended.

Face masks and basketball: NCAA division I consumer trends and a review of over-the-counter face masks.

PubMed

Gandy, Jessica R; Fossett, Lela; Wong, Brian J F

2016-05-01

This study aims to: 1) determine the current consumer trends of over-the-counter (OTC) and custom-made face mask usage among National Collegiate Athletic Association (NCAA) Division I athletic programs; and 2) provide a literature review of OTC face guards and a classified database. Literature review and survey. Consumer trends were obtained by contacting all 352 NCAA Division I programs. Athletic trainers present in the office when called answered the following questions: 1) "When an athlete breaks his or her nose, is a custom or generic face guard used?" and 2) "What brand is the generic face guard that is used?" Data was analyzed to determine trends among athletic programs. Also, a database of OTC devices available was generated using PubMed, Google, and manufacturer Web sites. Among the 352 NCAA Division I athletic programs, 254 programs participated in the survey (72% response rate). The majority preferred custom-made guards (46%). Disadvantages included high cost and slow manufacture turnaround time. Only 20% of the programs strictly used generic brands. For the face mask database, 10 OTC products were identified and classified into four categories based on design, with pricing ranging between $35.99 and $69.95. Only a handful of face masks exist for U.S. consumers, but none of them have been reviewed or classified by product design, sport application, price, and collegiate consumer use. This project details usage trends among NCAA Division I athletic programs and provides a list of available devices that can be purchased to protect the nose and face during sports. NA. Laryngoscope, 126:1054-1060, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Prescribing pattern of analgesics in orthopedic in-patient department at tertiary care hospital in Guwahati, Assam, Northeast India

PubMed Central

Choudhury, Dwijen Kumar; Bezbaruah, Babul Kumar

2016-01-01

Objectives: The aim of this study is to evaluate the prescribing pattern of analgesics and analyze the rational use of analgesic in orthopedic in-patient department of tertiary care teaching hospital, Guwahati, Assam. Subjects and Methods: An observational and cross-sectional study was carried out for 1 month from April to May 2014. Collected data included age, sex, diagnosis and line of management during the study. The generic name and the average cost of treatment per patient were evaluated using Indian Drug Review, 2014. The prescribed drugs were assessed with respective National Model List of Essential Medicines (NLEM), 2011 and the rationality of prescriptions was determined using the World Health Organization indicators of drug utilization. The patients’ details were recorded in a predeigned data collection form and results were analyzed by descriptive statistics. Results: Out of 200 patients, 123 were male and 77 were female. The average number of analgesic per prescription was 1.46. In this study, 55.5% of patients had received single analgesic. Diclofenac was the most commonly prescribed analgesic (43.49%). During hospitalization, majority of the patients have received parenteral preparation. Gastroprotective agents and antimicrobials were frequently prescribed along with analgesics. Out of 292 analgesics prescribed, 183 (62.67%) were from the NLEM, India. Furthermore, 176 (57.19%) analgesics were prescribed by generic name. The average cost of treatment per patient was 2151.72 INR. Utilization of analgesic in terms of defined daily dose/100 bed-days was 104.01. Conclusion: The percentages of analgesics prescribing from NLEM and the use of analgesic by generic name were found satisfactory. Regular educational interventions to improve prescribing practices among physicians at different levels may further promote rational prescribing. PMID:27756947

Therapeutic equivalence of antipsychotics and antidepressants - A systematic review.

PubMed

Cessak, Grzegorz; Rokita, Konrad; Dąbrowska, Marta; Sejbuk-Rozbicka, Katarzyna; Zaremba, Anna; Mirowska-Guzel, Dagmara; Bałkowiec-Iskra, Ewa

2016-04-01

The number of newly approved generic psychotropic drugs increases every year and, in many countries, their sales exceed the sales of brand-name counterparts. In order for any generic drug to receive an approval of regulatory authorities, its bioequivalence with the corresponding reference product must be demonstrated. Moreover, generic drugs must meet the same quality standards as reference drugs. However, many psychiatrists express concerns about use of generic drugs. We carried out a systematic analysis of the relevant literature indexed in PubMed and Cochrane databases. The MeSH term "generic" was combined with terms describing antipsychotic and antidepressive drugs, including their pharmaceutical names and relevant mental disorders. All 26 articles including either clinical studies or case reports have been qualified for a detailed analysis. No cases describing switches between two generics were found. Therapeutic equivalence studies evaluating antipsychotics included clozapine, olanzapine, and risperidone. The clinical status was judged to have worsened in 15.7% patients treated with clozapine. The number of relapses before and after the switch was not significantly different in patients treated with olanzapine. Two case reports showed clinical state deterioration after switch to generic risperidone. The clinical outcome after conversion to a generic antidepressant was evaluated only in one retrospective study. That study analyzed the outcomes of treatment with citalopram and revealed mental state deterioration in 11.6% of patients. Only single reports describe cases of impaired efficacy or adverse events after the switch to a generic antidepressant, including fluoxetine, mirtazapine, and venlafaxine. No cases of suicidal attempt after the switch were reported. Although the overall number of described cases is rather modest, health professionals should be aware of possible changes in the therapeutic effectiveness after changing to a generic medicine. Copyright © 2015 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Patent life of antiretroviral drugs approved in the US from 1987 to 2007.

PubMed

Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

2009-06-01

This study analyzes the effective patent life of antiretroviral (ARV) new molecular entities (NMEs) approved for marketing in the United States (US) between 1987 and 2007. The study includes all NMEs approved during the study period with at least one patent listed in the Orange Book (OB). Drugs discontinued from the market were excluded from the analysis. Data sources are the US Food and Drug Administration (FDA) and the US Patent and Trademark Office. A comparison between the effective patent life of ARV NMEs and NMEs from other therapeutic classes was performed. The first and last patents were used to estimate the minimum and maximum effective patent life of NMEs. Group differences were assessed using group comparison t-tests, Chi-Square and Fishers' exact tests. The FDA approved 547 NMEs during the study period; 153 NMEs did not have a patent listed in the OB or were discontinued from the US market. The patent analysis included 22 ARV NMEs and 372 other NMEs. ARV MNEs had a range from 1 to 15 patents listed in the OB. The FDA new drug application (NDA) review time was shorter for ARVs (5.8+/-2.3 months) than for other NMEs (23.6+/-18.7 months). ARV NMEs had an average of 13.2+/-3.8 years of effective patent life for the first patent versus 11.0+/-4.2 years for other NMEs. ARV NMEs had an average of 17.5+/-3.6 years of effective patent life for the last patent versus the 14.8+/-4.8 years for other NMEs. The effective patent life listed for the last patent of seven ARV NMEs (31.8%) exceeded 20 years. Shortening the drug approval process increased the effective patent life of ARVs and facilitated faster entry of new drugs into the market. ARVs had an average of 2-3 more years of effective patent life than other therapeutic classes and, therefore, a longer period without generic competition.

Lessons Learned in Engineering. Supplement

NASA Technical Reports Server (NTRS)

Blair, James C.; Ryan, Robert S.; Schultzenhofer, Luke A.

2011-01-01

This Contractor Report (CR) is a compilation of Lessons Learned in approximately 55 years of engineering experience by each James C. Blair, Robert S. Ryan, and Luke A. Schutzenhofer. The lessons are the basis of a course on Lessons Learned that has been taught at Marshall Space Flight Center. The lessons are drawn from NASA space projects and are characterized in terms of generic lessons learned from the project experience, which are further distilled into overarching principles that can be applied to future projects. Included are discussions of the overarching principles followed by a listing of the lessons associated with that principle. The lesson with sub-lessons are stated along with a listing of the project problems the lesson is drawn from, then each problem is illustrated and discussed, with conclusions drawn in terms of Lessons Learned. The purpose of this CR is to provide principles learned from past aerospace experience to help achieve greater success in future programs, and identify application of these principles to space systems design. The problems experienced provide insight into the engineering process and are examples of the subtleties one experiences performing engineering design, manufacturing, and operations. The supplemental CD contains accompanying PowerPoint presentations.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, E J; Kruske, S G; Morris, P S; Cates, C J; Chang, A B

2008-04-16

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in March 2007. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Three studies were eligible for inclusion in the review. A total of 396 patients, aged from 7 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41) and asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53). There was no significant difference between groups in occurrence of asthma exacerbations, but the width of the confidence interval means that effects on exacerbation rates cannot be ruled out, rate ratio 0.93 (95% CI 0.80 to 1.10). Culture-specific programmes for adults and children from minority groups with asthma, have been found to be more effective than generic programmes in improving some (Quality of Life and asthma knowledge) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Space station protective coating development

NASA Technical Reports Server (NTRS)

Pippin, H. G.; Hill, S. G.

1989-01-01

A generic list of Space Station surfaces and candidate material types is provided. Environmental exposures and performance requirements for the different Space Station surfaces are listed. Coating materials and the processing required to produce a viable system, and appropriate environmental simulation test facilities are being developed. Mass loss data from the original version of the atomic oxygen test chamber and the improved facility; additional environmental exposures performed on candidate materials; and materials properties measurements on candidate coatings to determine the effects of the exposures are discussed. Methodologies of production, and coating materials, used to produce the large scale demonstration articles are described. The electronic data base developed for the contract is also described. The test chamber to be used for exposure of materials to atomic oxygen was built.

A Generic and Target Architecture For Command and Control Information Systems

DTIC Science & Technology

1991-09-01

forces, logistics, and optimum routing of forces to destination; supports development of the force, material and personnel 9 lists, schedules , and...recommendations T.5, T.6, and T.73 for Telefax. Teletex, Textfax, and Telefax are not currently scheduled to become a part of GOSIP. In the 1995-1997 time...defining application interfaces to the func- tional areas that impact resource management, for example, priority scheduling , real-time files, and

Generic drug prices and policy in Australia: room for improvement? a comparative analysis with England.

PubMed

Mansfield, Sarah J

2014-02-01

To assess the degree to which reimbursement prices in Australia and England differ for a range of generic drugs, and to analyse the supply- and demand-side factors that may contribute to these differences. Australian and English reimbursement prices were compared for a range of generic drugs using pricing information obtained from government websites. Next, a literature review was conducted to identify supply- and demand-side factors that could affect generic prices in Australia and England. Various search topics were identified addressing potential supply-side (e.g. market approval, intellectual property protection of patented drugs, generic pricing policy, market size, generic supply chain and discounting practices) and demand-side (consumers, prescribers and pharmacists) factors. Related terms were searched in academic databases, official government websites, national statistical databases and internet search engines. Analysis of drug reimbursement prices for 15 generic molecules (representing 45 different drug presentations) demonstrated that Australian prices were on average over 7-fold higher than in England. Significant supply-side differences included aspects of pricing policy, the relative size of the generics markets and the use of clawback policies. Major differences in demand-side policies related to generic prescribing, pharmacist substitution and consumer incentives. Despite recent reforms, the Australian Government continues to pay higher prices than its English counterpart for many generic medications. The results suggest that particular policy areas may benefit from review in Australia, including the length of the price-setting process, the frequency of subsequent price adjustments, the extent of price competition between originators and generics, medical professionals' knowledge about generic medicines and incentives for generic prescribing. WHAT IS KNOWN ABOUT THE TOPIC? Prices of generic drugs have been the subject of much scrutiny over recent years. From 2005 to 2010 the Australian Government responded to observations that Pharmaceutical Benefits Scheme prices for many generics were higher than in numerous comparable countries by instituting several reforms aimed at reducing the prices of generics. Despite this, several studies have demonstrated that prices for generic statins (one class of cholesterol-lowering drug) are higher in Australia compared with England and many other developed countries, and prices of numerous other generics remain higher than in the USA and New Zealand. Recently there has been increasing interest in why these differences exist. WHAT DOES THIS PAPER ADD? By including a much larger range of commonly used and costly generic drugs, this paper builds significantly on the limited previous investigations of generic drug prices in Australia and England. Additionally, this is the first comprehensive investigation of multiple supply- and, in particular, demand-side factors that may explain any price differences between these countries. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners may contribute to the higher prices of generic medications in Australia compared with England through relatively low rates of generic prescribing. There are also significant implications for health policy makers, as this paper demonstrates that if Australia achieved the same prices as England for many generic drugs there could be substantial savings for the Pharmaceutical Benefits Scheme.

Development of a comprehensive list of criteria for evaluating consumer education materials on colorectal cancer screening

PubMed Central

2013-01-01

Background Appropriate patient information materials may support the consumer’s decision to attend or not to attend colorectal cancer (CRC) screening tests (fecal occult blood test and screening colonoscopy). The aim of this study was to develop a list of criteria to assess whether written health information materials on CRC screening provide balanced, unbiased, quantified, understandable, and evidence-based health information (EBHI) about CRC and CRC screening. Methods The list of criteria was developed based on recommendations and assessment tools for health information in the following steps: (1) Systematic literature search in 13 electronic databases (search period: 2000–2010) and completed by an Internet search (2) Extraction of identified criteria (3) Grouping of criteria into categories and domains (4) Compilation of a manual of adequate answers derived from systematic reviews and S3 guidelines (5) Review by external experts (6) Modification (7) Final discussion with external experts. Results Thirty-one publications on health information tools and recommendations were identified. The final list of criteria includes a total of 230 single criteria in three generic domains (formal issues, presentation and understandability, and neutrality and balance) and one CRC-specific domain. A multi-dimensional rating approach was used whenever appropriate (e.g., rating for the presence, correctness, presentation and level of evidence of information). Free text input was allowed to ensure the transparency of assessment. The answer manual proved to be essential to the rating process. Quantitative analyses can be made depending on the level and dimensions of criteria. Conclusions This comprehensive list of criteria clearly has a wider range of evaluation than previous assessment tools. It is not intended as a final quality assessment tool, but as a first step toward thorough evaluation of specific information materials for their adherence to EBHI requirements. This criteria list may also be used to revise leaflets and to develop evidence-based health information on CRC screening. After adjustment for different procedure-specific criteria, the list of criteria can also be applied to other cancer screening procedures. PMID:24028691

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

What strategies to boost production of affordable fixed-dose anti-retroviral drug combinations for children in the developing world?

PubMed

Dionisio, Daniele; Gass, Robert; McDermott, Peter; Racalbuto, Vincenzo; Madeo, Marina; Braghieri, Giuseppe; Crowley, Siobhan; Pinheiro, Eloan Dos Santos; Graaff, Peter; Vasan, Ashwin; Eksaengsri, Achara; Moller, Helene; Khanna, Arun Kumar; Kraisintu, Krisana; Juneja, Sandeep; Nicolaou, Stavros; Sengupta, Aloka; Esperti, Francesco; Messeri, Daniela

2007-03-01

No more than 8% of HIV positive children needing treatment in low- and middle-income countries have access to antiretroviral drugs (ARVs). Children presently account for about 4% of all treated patients, while for equitable access they should make up at least 13%. This study explores key issues, implications and interaction dynamics to boost production of easy-to-use and affordable fixed-dose combination (FDC) ARVs for children in the developing world. Potentials for equitable solutions are examined including priority steps and actions, appropriate treatment options and reliable forecasting methods for paediatric ARVs, as well as combination incentives to generic companies against market unattractiveness and enforced intellectual property (IP) rights. Moreover, implementation strategies to enhance the development and production of affordable ARV paediatric formulations and appropriate supply systems to ensure availability are investigated. The current market for FDC paediatric ARVs is already substantial and will only grow with improved and scaled up diagnosis and monitoring of children. This provides an argument for immediate increase of production and development of FDC ARVs for children. These formulations must be low cost and included in the list of Essential Medicines to avoid children continuing to lag behind in access to treatment. Access-oriented, long-term drug policy strategies with the ability to pass muster of governments, the UN system, as well as generic and research-based enterprises are needed to let children gain expanded and sustained access to FDC ARVs. Under the requirements listed above, IP-bound Voluntary License (VL) flexibilities do appear, if coupled with substantial combination incentives to generic firms, as a fitting tool into the needs. Policies must consider enhancing human resource capacity in the area of caregivers and social and health workers aiming to spread correct information and awareness on effectiveness and rationale of FDC ARVs for children. Policies should urge that paediatric ARV treatment programmes entwine with extant interventions on prevention of mother-to-child transmission, as well as with HIV treatment initiatives focused on mothers and household members. Policies, again, should consider centralising functions and pooling resources to help overcome drug supply barriers. WHO's brokering role in VL-based agreements between wealthy and developing country industries, as well as its technical guidance in setting international standards should not be waived while looking for sustained access to optimised ARV treatments for children. Strategies discussed in this paper, while taking unavoidability of marketing and profit rules into account, look closely into the trade and drug policy directions of China and India according to frontier crossing implications of their IP management trends as well as their multi-faceted penetration strategies of both the wealthy and under-served markets the world over.

Generic health/safety/environment cases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kelland, A.N.; Primrose, M.; Pickles, J.C.

1996-12-31

A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less

A unified representation of findings in clinical radiology using the UMLS and DICOM.

PubMed

Bertaud, Valérie; Lasbleiz, Jérémy; Mougin, Fleur; Burgun, Anita; Duvauferrier, Régis

2008-09-01

Collecting and analyzing findings constitute the basis of medical activity. Computer assisted medical activity raises the problem of modelling findings. We propose a unified representation of findings integrating the representations of findings in the GAMUTS in Radiology [M.M. Reeder, B. Felson, GAMUTS in radiology Comprehensive lists of roentgen differential diagnosis, fourth ed., 2003], the Unified Medical Language System (UMLS), and the Digital Imaging and Communication in Medicine Structured Report (DICOM-SR). Starting from a corpus of findings in bone and joint radiology [M.M. Reeder, B. Felson, GAMUTS in Radiology comprehensive lists of roentgen differential diagnosis, fourth ed., 2003] (3481 words), an automated mapping to the UMLS was performed with the Metamap Program. The resulting UMLS terms and Semantic Types were analyzed in order to find a generic template in accordance with DICOM-SR structure. UMLS Concepts were missing for 45% of the GAMUTS findings. Three kinds of regularities were observed in the way the Semantic Types were combined: "pathological findings", "physiological findings" and "anatomical findings". A generic and original DICOM-SR template modelling finding was proposed. It was evaluated for representing GAMUTS jaws findings. 21% missing terms had to be picked up from Radlex (5%) or created (16%). This article shows that it is possible to represent findings using the UMLS and the DICOM SR formalism with a semi-automated method. The Metamap program helped to find a model to represent the semantic structure of free texts with standardized terms (UMLS Concepts). Nevertheless, the coverage of the UMLS is not comprehensive. This study shows that the UMLS should include more technical concepts and more concepts regarding findings, signs and symptoms to be suitable for radiology representation. The semi-automated translation of the whole GAMUTS using the UMLS concepts and the DICOM SR relations could help to create or supplement the DCMR Templates and Context Groups pertaining to the description of imaging findings.

Generic redescription, two new species, and a key to the species of the cicada genus Ariasa Distant, 1905 with the description of a new genus (Hemiptera: Cicadidae: Cicadinae: Fidicinini).

PubMed

Sanborn, Allen F

2016-07-13

The cicada genus Ariasa Distant, 1905 is redescribed.  Ariasa albimaculosa n. sp. is described from Colombia and A. bartletti n. sp. is described from Peru.  The current 14 species of Ariasa are listed along with their synonymies, known distribution of each species, and a key to the species is provided.  The first records of Ariasa bilaqueata (Uhler, 1903) for Peru and French Guiana are provided. Cracenpsaltria brasiliorum (Kirkaldy, 1909) rev. stat., n. comb. is determined to be the correct name for the taxon Cicada marginata Olivier, 1790 and the new genus Cracenpsaltria n. gen. is erected for the taxon.  The distribution of C. brasiliorum rev. stat., n. comb. is expanded to include Bolivia and Peru.

Canada's Patented Medicine Notice of Compliance regulations: balancing the scales or tipping them?

PubMed Central

2011-01-01

Background In order to comply with the provisions of the North American Free Trade Agreement, in 1993 the Canadian federal government introduced the Patented Medicine Notice of Compliance Linkage Regulations. These regulations were meant to achieve a balance between the timely entry of generic medicines and the rights of patent holders. The regulations tied the regulatory approval of generic medicines to the patent status of the original brand-name product. Discussion Since their introduction the regulations have been a source of contention between the generic and the brand-name industry. While the regulations have generated a considerable amount of work for the Federal Court of Canada both sides dispute the interpretation of the "win rate" in the court cases. Similarly, there is no agreement on whether multiple patents on single drugs represent a legitimate activity by the brand-name industry or an "evergreening" tactic. The generic industry's position is that the regulations are being abused leading to the delay in the introduction of lower cost generic products by as much as 8 years. The brand-name companies counter that the regulations are necessary because injunctions against the introduction of generic products are frequently unavailable to them. The regulations were amended in 2006 and again in 2008 but both sides continue to claim that the regulations favour the other party. The battle around the regulations also has an international dimension with interventions by PhRMA, the trade association representing the United States based multinational companies, arguing that the regulations are not stringent enough and that Canada needs to be placed on the U.S. Priority Watch List of countries. Finally, there are multiple costs to Canadian society as a result of the NOC regulations. Summary Despite the rhetoric there has been almost no empiric academic research done into the effect of the regulations. In order to develop rational policy in this area a number of key research questions have been formulated. PMID:21435247

Freedom of information applications as an "evergreening" tactic: Secretary, Department of Health and Ageing v iNOVA Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442.

PubMed

Vines, Tim; Faunce, Thomas

2011-09-01

A recent decision of the Federal Court of Australia illustrates how patent-holding pharmaceutical companies are attempting to use Australia's Freedom of Information Act 1982 (Cth) to force Australian safety, quality and efficacy regulators to disclose whether generic competitors are attempting to enter the market. In Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Ltd (2010) 191 FCR 573; [2010] FCA 1442 a single judge of the Federal Court overturned a decision of the Administrative Appeals Tribunal (AAT) that would have compelled the Australian Therapeutic Goods Administration (TGA) to reveal whether they were in possession of an application to register generic versions of two iNova products: imiquimod and phentermine. In its justification to the AAT for refusing to confirm or deny the existence of any application, the TGA argued that to reveal the existence of such a document would prejudice the proper administration of the National Health Act 1953 (Cth) as it could compromise the listing of a generic on the Pharmaceutical Benefits Scheme. The AAT failed to appreciate the extent to which this revelation to a competitor would have undercut 2004 amendments to the Therapeutic Goods Act 1989 (Cth) that provided penalties for evergreening tactics involving TGA notifications to drug patent-holders and 2006 amendments to the Patents Act 1990 (Cth) which protected the right of generic manufacturers to "springboard". The decision of the Federal Court is one of the first to explore the use of freedom of information legislation by patent-holders as a potential "evergreening" technique to prolong royalties by marginalising generic competition. Because of the significant amounts of money involved in ensuring rapid market entry of low-cost generic products, the issue has considerable public health significance.

Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia

PubMed Central

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-01-01

Background Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. Methods and Findings The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. Conclusions The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required. PMID:17388660

Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

PubMed

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-03-27

Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.

Estimated effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada.

PubMed

Morgan, Steven G; Li, Winny; Yau, Brandon; Persaud, Nav

2017-02-27

Canada's universal health care system does not include universal coverage of prescription drugs. We sought to estimate the effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada. We used administrative and market research data to estimate the 2015 shares of the volume and cost of prescriptions filled in the community setting that were for 117 drugs on a model list of essential medicines for Canada. We compared prices of these essential medicines in Canada with prices in the United States, Sweden and New Zealand. We estimated the cost of adding universal public drug coverage of these essential medicines based on anticipated effects on medication use and pricing. The 117 essential medicines on the model list accounted for 44% of all prescriptions and 30% of total prescription drug expenditures in 2015. Average prices of generic essential medicines were 47% lower in the US, 60% lower in Sweden and 84% lower in New Zealand; brand-name drugs were priced 43% lower in the US. Estimated savings from universal public coverage of these essential medicines was $4.27 billion per year (range $2.72 billion to $5.83 billion; 28% reduction) for patients and private drug plan sponsors, at an incremental government cost of $1.23 billion per year (range $373 million to $1.98 billion; 11% reduction). Our analysis showed that adding universal public coverage of essential medicines to the existing public drug plans in Canada could address most of Canadians' pharmaceutical needs and save billions of dollars annually. Doing so may be a pragmatic step forward while more comprehensive pharmacare reforms are planned. © 2017 Canadian Medical Association or its licensors.

The ECHI project: health indicators for the European Community.

PubMed

Kramers, Pieter G N

2003-09-01

Within the EU Health Monitoring Programme (HMP), the ECHI project has proposed a comprehensive list of 'European Community Health Indicators'. In the design of the indicator set, a set of explicit criteria was applied. These included: i) be comprehensive and coherent, i.e. cover all domains of the public health field; ii) take account of earlier work, especially that by WHO-Europe, OECD and Eurostat; and iii) cover the priority areas that Member States and Community health policies currently pursue. Flexibility is an important characteristic of the present proposal. In ECHI, this has been emphasized by the definition of 'user-windows'. These are subsets from the overall indicator list, each of which should reflect a specific user's requirement or interest. The proposed indicators are, in most cases, defined as generic indicators, i.e. their actual operational definitions have not yet been attempted. This work has been, and is being carried out to a large part by other projects financed under the HMP, which cover specific areas of public health or areas of data collection. Apart from indicators covered by regularly available data, indicators (or issues) have been proposed for which data are currently difficult to collect but which from a policy point of view would be needed. All this points to the fact that establishing an indicator list which is actually used by Member States is a continuously developing process. This process is now continued by the first strand of the new EU Public Health Action Programme.

Identification and nomenclature of the genus Penicillium.

PubMed

Visagie, C M; Houbraken, J; Frisvad, J C; Hong, S-B; Klaassen, C H W; Perrone, G; Seifert, K A; Varga, J; Yaguchi, T; Samson, R A

2014-06-01

Penicillium is a diverse genus occurring worldwide and its species play important roles as decomposers of organic materials and cause destructive rots in the food industry where they produce a wide range of mycotoxins. Other species are considered enzyme factories or are common indoor air allergens. Although DNA sequences are essential for robust identification of Penicillium species, there is currently no comprehensive, verified reference database for the genus. To coincide with the move to one fungus one name in the International Code of Nomenclature for algae, fungi and plants, the generic concept of Penicillium was re-defined to accommodate species from other genera, such as Chromocleista, Eladia, Eupenicillium, Torulomyces and Thysanophora, which together comprise a large monophyletic clade. As a result of this, and the many new species described in recent years, it was necessary to update the list of accepted species in Penicillium. The genus currently contains 354 accepted species, including new combinations for Aspergillus crystallinus, A. malodoratus and A. paradoxus, which belong to Penicillium section Paradoxa. To add to the taxonomic value of the list, we also provide information on each accepted species MycoBank number, living ex-type strains and provide GenBank accession numbers to ITS, β-tubulin, calmodulin and RPB2 sequences, thereby supplying a verified set of sequences for each species of the genus. In addition to the nomenclatural list, we recommend a standard working method for species descriptions and identifications to be adopted by laboratories working on this genus.

A new entity for the negotiation of public procurement prices for patented medicines in Mexico.

PubMed

Gómez-Dantés, Octavio; Wirtz, Veronika J; Reich, Michael R; Terrazas, Paulina; Ortiz, Maki

2012-10-01

As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure. To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico's list of essential medicines. Mexico's public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines. Since 2008, the CCPNM has improved procurement practices in Mexico's public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure. The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM.

Identification and nomenclature of the genus Penicillium

PubMed Central

Visagie, C.M.; Houbraken, J.; Frisvad, J.C.; Hong, S.-B.; Klaassen, C.H.W.; Perrone, G.; Seifert, K.A.; Varga, J.; Yaguchi, T.; Samson, R.A.

2014-01-01

Penicillium is a diverse genus occurring worldwide and its species play important roles as decomposers of organic materials and cause destructive rots in the food industry where they produce a wide range of mycotoxins. Other species are considered enzyme factories or are common indoor air allergens. Although DNA sequences are essential for robust identification of Penicillium species, there is currently no comprehensive, verified reference database for the genus. To coincide with the move to one fungus one name in the International Code of Nomenclature for algae, fungi and plants, the generic concept of Penicillium was re-defined to accommodate species from other genera, such as Chromocleista, Eladia, Eupenicillium, Torulomyces and Thysanophora, which together comprise a large monophyletic clade. As a result of this, and the many new species described in recent years, it was necessary to update the list of accepted species in Penicillium. The genus currently contains 354 accepted species, including new combinations for Aspergillus crystallinus, A. malodoratus and A. paradoxus, which belong to Penicillium section Paradoxa. To add to the taxonomic value of the list, we also provide information on each accepted species MycoBank number, living ex-type strains and provide GenBank accession numbers to ITS, β-tubulin, calmodulin and RPB2 sequences, thereby supplying a verified set of sequences for each species of the genus. In addition to the nomenclatural list, we recommend a standard working method for species descriptions and identifications to be adopted by laboratories working on this genus. PMID:25505353

State prescription drug price Web sites: how useful to consumers?

PubMed

Tu, Ha T; Corey, Catherine G

2008-02-01

To aid consumers in comparing prescription drug costs, many states have launched Web sites to publish drug prices offered by local retail pharmacies. The current push to make retail pharmacy prices accessible to consumers is part of a much broader movement to increase price transparency throughout the health-care sector. Efforts to encourage price-based shopping for hospital and physician services have encountered widespread concerns, both on grounds that prices for complex services are difficult to measure and compare accurately and that quality varies substantially across providers. Experts agree, however, that prescription drugs are much easier to shop for than other, more complex health services. However, extensive gaps in available price information--the result of relying on Medicaid data--seriously hamper the effectiveness of state drug price-comparison Web sites, according to a new study by the Center for Studying Health System Change (HSC). An alternative approach--requiring pharmacies to submit price lists to the states--would improve the usefulness of price information, but pharmacies typically oppose such a mandate. Another limitation of most state Web sites is that price information is restricted to local pharmacies, when online pharmacies, both U.S. and foreign, often sell prescription drugs at substantially lower prices. To further enhance consumer shopping tools, states might consider expanding the types of information provided, including online pharmacy comparison tools, lists of deeply discounted generic drugs offered by discount retailers, and lists of local pharmacies offering price matches.

High prices for generics in Australia - more competition might help.

PubMed

Bulfone, Liliana

2009-05-01

It is commonly believed that dispensed prices of medicines in Australia are substantially lower than those in other developed countries, particularly the US. This article reports the results of an analysis comparing dispensed prices for the most commonly prescribed and the highest cost items in Australia with dispensed prices in the US. Although a large majority of items are less expensive in Australia than in the US, Australian prices are higher for a substantial number of products, particularly generic drugs. This article examines various policies affecting the pricing of generics in Australia. It is postulated that the main cause for higher prices for a substantial number of generic products is the lack of price competition. This results from government policy which ensures that a price reduction by one company is communicated immediately to all competitors in that market along with an invitation to match the reduced price. The dominant strategy for all suppliers is to only reduce their price in response to a reduction in price by a competitor. The result is a lack of differentiation in pricing across brands of a medicine on the Schedule of Pharmaceutical Benefits. The government could improve the structure of the generics market and encourage greater competition by ceasing to disclose competitor firms' offers to other competitors. The government could conduct pricing reviews of each generic product relatively infrequently (eg, only once annually or every 18 months). At the time of the pricing review, the government would request confidential offers on price for a generic from all players in the market. Brands should then all be listed under the Pharmaceutical Benefits Scheme (PBS) at the offered price. Prices offered by the individual supplier would apply until the next pricing review. The PBS would continue to subsidise up to the price of the lowest priced brand, with brand premiums applying to all brands priced higher than the benchmark price. Such an approach would provide opportunity for players in the market to capture market share by being the lowest priced brand.

Report on final recommendations for IMPS engineering-science payload

NASA Technical Reports Server (NTRS)

Garrett, H. B.

1984-01-01

Six general categories of key scientific and engineering concerns for the interactions measurements payload for shuttle (IMPS) mission are addressed: (1) dielectric charging; (2) material property changes; (3) electromagnetic interference, plasma interactions, and plasma wake effects associated with high-voltage solar arrays and large space structures; (4) radio frequency distortion and nonlinearities due to the enhanced plasma in the shuttle ram/wake; (5) shuttle glow and contamination; and (6) plasma interactions with the space-based radar. Lesser concerns are the interactions associated with EVA; the radiation and SEU effects peculiar to the auroral/polar cap environments; and space debris. The measurements needed to address the concerns associated with the general categories are described and a list of generic investigations capable of making the required measurements, emphasizing the spectrum of measurements necessary to quantize the interactions in the auroral/polar environments are included. A suggested ground-test plan for the IMPS project, a description of proposed follow-on IMPS missions, and a detailed bibliography for each of the interactions discussed are included.

Generic extravehicular (EVA) and telerobot task primitives for analysis, design, and integration. Version 1.0: Reference compilation for the EVA and telerobotics communities

NASA Technical Reports Server (NTRS)

Smith, Jeffrey H.; Drews, Michael

1990-01-01

The results are described of an effort to establish commonality and standardization of generic crew extravehicular (crew-EVA) and telerobotic task analysis primitives used for the study of spaceborne operations. Although direct crew-EVA plans are the most visible output of spaceborne operations, significant ongoing efforts by a wide variety of projects and organizations also require tools for estimation of crew-EVA and telerobotic times. Task analysis tools provide estimates for input to technical and cost tradeoff studies. A workshop was convened to identify the issues and needs to establish a common language and syntax for task analysis primitives. In addition, the importance of such a syntax was shown to have precedence over the level to which such a syntax is applied. The syntax, lists of crew-EVA and telerobotic primitives, and the data base in diskette form are presented.

Generic Skills. Secondary School Vocational Model for Craft Trades. Based on Data on the Use of 588 Tool Skills from 1600 Workers and Supervisors in 131 Occupations.

ERIC Educational Resources Information Center

Smith, Arthur De W.

This pamphlet provides a hierarchy of skills, from those most often used in the craft trades to those less frequently used, indicating the extent to which these skills are used by workers in 24 different occupational groups. The pamphlet also provides a secondary school vocational model for craft trades along with lists of the identified skills.…

40 CFR 721.6205 - Hexamethylenediamine adduct of substituted piperidinyloxy (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time... specified in § 721.63 (a)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5...

40 CFR 721.6205 - Hexamethylenediamine adduct of substituted piperidinyloxy (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time... specified in § 721.63 (a)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5...

40 CFR 721.6205 - Hexamethylenediamine adduct of substituted piperidinyloxy (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time... specified in § 721.63 (a)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5...

40 CFR 721.6205 - Hexamethylenediamine adduct of substituted piperidinyloxy (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time... specified in § 721.63 (a)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5...

40 CFR 721.6205 - Hexamethylenediamine adduct of substituted piperidinyloxy (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.2 ug/m3 as an 8-hour time... specified in § 721.63 (a)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii), (a)(5...

Delay correlation analysis and representation for vital complaint VHDL models

DOEpatents

Rich, Marvin J.; Misra, Ashutosh

2004-11-09

A method and system unbind a rise/fall tuple of a VHDL generic variable and create rise time and fall time generics of each generic variable that are independent of each other. Then, according to a predetermined correlation policy, the method and system collect delay values in a VHDL standard delay file, sort the delay values, remove duplicate delay values, group the delay values into correlation sets, and output an analysis file. The correlation policy may include collecting all generic variables in a VHDL standard delay file, selecting each generic variable, and performing reductions on the set of delay values associated with each selected generic variable.

Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.

PubMed

Lexchin, Joel

2017-09-01

This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The changing patterns of dispensing branded and generic drugs for the treatment of gastroesophageal reflux disease between 2006 and 2011 in Japan: a retrospective cohort study.

PubMed

Murata, Kyoko; Hinotsu, Shiro; Hamada, Shota; Ezoe, Yasumasa; Muto, Manabu; Kawakami, Koji

2015-02-27

Despite rising healthcare costs, generic drugs are less frequently dispensed in Japan compared with other developed countries. This study aimed to describe changes in dispensing of branded and generic drugs and to explore possible factors that promote the use of generic drugs. We conducted a retrospective cohort study using a Japanese medical and pharmacy claims database. All proton pump inhibitors (PPIs) and histamine H2-receptor antagonists (H2RAs) with indications for gastroesophageal reflux disease (GERD) described on Japanese labels were included. Patterns of dispensing branded and generic drugs for the treatment of GERD between 2006 and 2011 were analyzed. Multivariate logistic regression was applied to investigate factors associated with receiving generic drugs. The study cohort included 14,590 patients (male: 50.2%, mean age: 43.1 years). Branded drugs for GERD were still frequently dispensed despite an increase in the share of generic drugs. Only 4.3% of patients who initially received branded drugs switched to generic drugs. The percentage of patients who received only generic drugs increased over time (6.5% to 22.1%). The frequency of generic drug dispensing was the highest in the setting where both prescription and dispensing were implemented in clinics (43.3%), while the lowest in the setting where both prescription and dispensing were implemented in hospitals (11.5%). Factors associated with receiving generic drugs included year of dispensing (adjusted OR 2.22, 95% CI 1.94 to 2.55 for 2009-11 v 2006-8), prescription and dispensing setting (OR 1.81, 95% CI 1.44 to 2.26 for prescription in hospitals and dispensing in community pharmacies; OR 2.21, 95% CI 1.80 to 2.72 for prescription in clinics and dispensing in community pharmacies; and OR 4.55, 95% CI 3.68 to 5.62 for prescription and dispensing in clinics v prescription and dispensing in hospitals) and H2RAs (OR 1.64, 95% CI 1.49 to 1.81 compared to PPIs). The share of generic drugs for the treatment of GERD increased over time although branded drugs for GERD were still dispensed frequently. The use of generic drugs for GERD was influenced not only by government policies but also by changes in treatment approach and the setting of prescription and dispensing.

Multiple Drug Cost Containment Policies in Michigan’s Medicaid Program Saved Money Overall, Although Some Increased Costs

PubMed Central

Kibicho, Jennifer; Pinkerton, Steven D.

2014-01-01

Michigan’s Medicaid program implemented four policies (preferred lists, joint and multi-state purchasing arrangements, and maximum allowable cost) in 2002–2004 for its dual-eligible Medicaid and Medicare beneficiaries, taking antihypertensives and antihyperlipidemics prescriptions. We used interrupted time series analysis to evaluate the impact of each individual policy while holding the effect of all other policies constant. Preferred lists increased preferred and generic market share, and reduced daily cost. In contrast, maximum allowable cost increased daily cost, and is the only policy that did not generate cost savings. The joint and multi-state arrangements did not impact daily cost. Despite policy tradeoffs, the cumulative effect was a 10% decrease in daily cost and an annualized cost savings of $46,195. PMID:22492899

An exploration of risk for recurrent falls in two geriatric care settings

PubMed Central

2013-01-01

Background Fall events were examined in two distinct geriatric populations to identify factors associated with repeat fallers, and to examine whether patients who use gait aids, specifically a walker, were more likely to experience repeat falls. Each unit already had a generic program for falls prevention in place. Methods Secondary data analysis was conducted on information collected during the pilot testing of a new quality assurance Incident Reporting Tool between October 2006 and September 2008. The study settings included an in-patient geriatric rehabilitation unit (GRU) and a long stay veterans’ unit (LSVU) in a rehabilitation and long-stay hospital in Ontario. Participants were two hundred and twenty three individuals, aged 65 years or older on these two units, who experienced one or more fall incidents during the study period. Results Logistic regression analyses showed that on the GRU age was significantly associated with repeat falls. On the LSVU first falls in the morning or late evening were associated with repeat falling. Walker as a gait aid listed at time of first fall was not associated with repeat falls. Conclusions This study suggests that different intervention may be necessary in different geriatric settings to identify, for secondary prevention, certain individuals for which the generic programs prove inadequate. Information collection with a specific focus on the issue of repeat falls may be necessary for greater insight. PMID:24106879

Accuracy and completeness of drug information in Wikipedia medication monographs.

PubMed

Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Generic procedure for designing and implementing plan management systems for space science missions operations

NASA Astrophysics Data System (ADS)

Chaizy, P. A.; Dimbylow, T. G.; Allan, P. M.; Hapgood, M. A.

2011-09-01

This paper is one of the components of a larger framework of activities whose purpose is to improve the performance and productivity of space mission systems, i.e. to increase both what can be achieved and the cost effectiveness of this achievement. Some of these activities introduced the concept of Functional Architecture Module (FAM); FAMs are basic blocks used to build the functional architecture of Plan Management Systems (PMS). They also highlighted the need to involve Science Operations Planning Expertise (SOPE) during the Mission Design Phase (MDP) in order to design and implement efficiently operation planning systems. We define SOPE as the expertise held by people who have both theoretical and practical experience in operations planning, in general, and in space science operations planning in particular. Using ESA's methodology for studying and selecting science missions we also define the MDP as the combination of the Mission Assessment and Mission Definition Phases. However, there is no generic procedure on how to use FAMs efficiently and systematically, for each new mission, in order to analyse the cost and feasibility of new missions as well as to optimise the functional design of new PMS; the purpose of such a procedure is to build more rapidly and cheaply such PMS as well as to make the latter more reliable and cheaper to run. This is why the purpose of this paper is to provide an embryo of such a generic procedure and to show that the latter needs to be applied by people with SOPE during the MDP. The procedure described here proposes some initial guidelines to identify both the various possible high level functional scenarii, for a given set of possible requirements, and the information that needs to be associated with each scenario. It also introduces the concept of catalogue of generic functional scenarii of PMS for space science missions. The information associated with each catalogued scenarii will have been identified by the above procedure and will be relevant only for some specific mission requirements. In other words, each mission that shares the same type of requirements that lead to a list of specific catalogued scenarii can use this latter list of scenarii (regardless of whether the mission is a plasma, planetary, astronomy, etc. mission). The main advantages of such a catalogue are that it speeds-up the execution of the procedure and makes the latter more reliable. Ultimately, the information associated to each relevant scenario (from the catalogue or freshly generated by the procedure) will then be used by mission designers to make informed decisions, including the modification of the mission requirements, for any missions. In addition, to illustrate the use of such a procedure, the latter is applied to a case study, i.e. the Cross-Scale mission. One of the outcomes of this study is an initial set of generic functional scenarii. Finally, although border line with the above purpose of this paper, we also discuss multi-spacecraft specific issues and issues related to the on-board execution of the plan update system (PUS). In particular, we show that the operation planning cost of N spacecraft is not equal to N times the cost of 1 spacecraft and that on-board non-synchronised operation will not require inter-spacecraft communication. We also believe that on-board PUS should be made possible for all missions as a standard.

Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?

PubMed

Shrank, William H; Cadarette, Suzanne M; Cox, Emily; Fischer, Michael A; Mehta, Jyotsna; Brookhart, Alan M; Avorn, Jerry; Choudhry, Niteesh K

2009-03-01

Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

The impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic medication in Finland.

PubMed

Koskinen, Hanna; Ahola, Elina; Saastamoinen, Leena K; Mikkola, Hennamari; Martikainen, Jaana E

2014-12-01

To assess the impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic drugs in Finland during the first year after its launch. Furthermore, the additional impact of reference pricing on prior implemented generic substitution is assessed. A retrospective analysis was performed between 2006 and 2010. A segmented linear regression analysis of interrupted time series was used to estimate changes in the levels and trends in the cost of one day of treatment. Of the study drugs, clozapine belonged to generic substitution already at the start of the study period while olanzapine and quetiapine were included in generic substitution alongside with reference pricing in 2009. Risperidone was included in generic substitution in 2008, before reference pricing. A substantial decrease in the daily cost of all four antipsychotic substances was seen after one year of the implementation of reference pricing and the extension of generic substitution. The impact ranged from -29.9% to -66.3%, and it was most substantial on the daily cost of olanzapine. Also in the daily cost of risperidone a substantial decrease of -43.3% was observed. However, most of these savings, -32.6%, were generated by generic substitution which had been adopted prior. Reference pricing and the extension of generic substitution produced substantial savings on antipsychotic medication costs during the first year after its launch, but the intensity of the impact differed between active substances. Furthermore, our results suggest that the additional cost savings from reference pricing after prior implemented generic substitution, are comparatively low.

Availability and cost of major and first-line antiepileptic drugs: a comprehensive evaluation in the capital of Madagascar.

PubMed

Jost, Jeremy; Raharivelo, Adeline; Ratsimbazafy, Voa; Nizard, Mandy; Auditeau, Emilie; Newton, Charles R; Preux, Pierre-Marie

2016-01-01

The prevalence of epilepsy is high in Madagascar (23.5/1000), as is the treatment gap (estimated at 92 %). The health system of the country is underfunded; some AEDs are used, and the national drug policy does not encourage price regulation or the administration of generic agents. We conducted a cross-sectional study to assess the availability and cost of solid oral AED formulations in Antananarivo, capital of Madagascar. Data were gathered from all officially registered pharmacies (according to the drug agency list, updated in 2015) by means of telephone interviews lasting no more than 10 min and conducted by a native Malagasy speaker. With regard to other sources (hospitals, illicit sales) data were obtained at specific visits. The study received ethical approval from the Madagascar Ministry of Health. A total of 91 of 100 pharmacies (the nine not included were because of an inoperative phone number), two of three public hospitals, and two illegal outlets were investigated. Sodium valproate was available in 84.6 % of the pharmacies, while carbamazepine and phenobarbital were available in 68.1 % and 36.3 % of the pharmacies, respectively, but phenytoin was not available in any supply chain. There were more originator brands than generic formulations, with a higher cost (range 20.3-81.1 %, median 40.7 %) compared to the equivalent generic. The public system had only a very limited choice of AED, but offered the lowest costs. Illicit sources were more expensive by 54.3 % for carbamazepine and 62.5 % for phenobarbital. Concerning the annual cost of treatment, the average percentage of the gross national income per capita based on the purchasing power parity was 29.8 %/19.0 % (brand/generic) for sodium valproate, 16.4 %/7.3 % (brand/generic) for carbamazepine, 8.9 %/5.1 % (brand/generic) for phenobarbital. The main sources of AEDs were private pharmacies, but the stocks held were low. The financial burden was still important in the capital of Madagascar, mainly the consequence of a highly developed private sector at the expense of the public sector. Although sodium valproate remains the most expensive solution, it still remains the most available instead of phenobarbital. The most striking feature of this study concerns the cost of AEDs in the informal sector, mostly used because they are deemed to provide less costly drugs, the opposite was observed there. The assessment of the cost and availability of medicines was easily and quickly implemented. It provided a relevant focus of the situation in areas difficult to investigate, in terms of road network and geographical situation.

A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss.

PubMed

Treur, Maarten; Heeg, Bart; Möller, Hans-Jürgen; Schmeding, Annette; van Hout, Ben

2009-02-18

As schizophrenia patients are typically suspicious of, or are hostile to changes they may be reluctant to accept generic substitution, possibly affecting compliance. This may counteract drug costs savings due to less symptom control and increased hospitalization risk. Although compliance losses following generic substitution have not been quantified so far, one can estimate the possible health-economic consequences. The current study aims to do so by considering the case of risperidone in Germany. An existing DES model was adapted to compare staying on branded risperidone with generic substitution. Differences include the probability of non-compliance and medication costs. Incremental probability of non-compliance after generic substitution was varied between 2.5% and 10%, while generic medication costs were assumed to be 40% lower. Effect of medication price was assessed as well as the effect of applying compliance losses to all treatment settings. The probability of staying on branded risperidone being cost-effective was calculated for various outcomes of a hypothetical study that would investigate non-compliance following generic substitution of risperidone. If the incremental probability of non-compliance after generic substitution is 2.5%, 5.0%, 7.5% and 10% respectively, incremental effects of staying on branded risperidone are 0.004, 0.007, 0.011 and 0.015 Quality Adjusted Life Years (QALYs). Incremental costs are euro757, euro343, -euro123 and -euro554 respectively. Benefits of staying on branded risperidone include improved symptom control and fewer hospitalizations. If generic substitution results in a 5.2% higher probability of non-compliance, the model predicts staying on branded risperidone to be cost-effective (NICE threshold of 30,000 per QALY gained). Compliance losses of more than 6.9% makes branded risperidone the dominant alternative. Results are sensitive to the locations at which compliance loss is applied and the price of generic risperidone. The probability that staying on branded risperidone is cost-effective would increase with larger compliance differences and more patients included in the hypothetical study. The model predicts that it is cost-effective to keep a patient with schizophrenia in Germany on branded risperidone instead of switching him/her to generic risperidone (assuming a 40% reduction in medication costs), if the incremental probability of becoming non-compliant after generic substitution exceeds 5.2%.

Is There a Relationship Between Patient Beliefs or Communication About Generic Drugs and Medication Utilization?

PubMed Central

Shrank, William H.; Cadarette, Suzanne M.; Cox, Emily; Fischer, Michael A.; Mehta, Jyotsna; Brookhart, Alan M.; Avorn, Jerry; Choudhry, Niteesh K.

2009-01-01

Background Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. Objectives To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. Research Design and Subjects We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. Measures We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. Results The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Conclusions Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use. PMID:19194329

Health related quality of life in disorders of defecation: the Defecation Disorder List

PubMed Central

Voskuijl, W; van der Zaag-Loon..., H J; Ketel, I; Grootenhuis, M; Derkx, B; Benninga, M

2004-01-01

Background: Constipation and encopresis frequently cause problems with respect to emotional wellbeing, and social and family life. Instruments to measure Health Related Quality of Life (HRQoL) in these disorders are not available. Methods: A disease specific HRQoL instrument, the "Defecation Disorder List" (DDL) for children with constipation or functional non-retentive faecal soiling (FNRFS) was developed using accepted guidelines. For each phase of the process, different samples of patients were used. The final phase of development included 27 children. Reliability was assessed in two ways: internal consistency of domains with Cronbach's alpha, and test-retest reliability with intra-class correlation coefficients (ICC). To assess validity, comparable items and domains were correlated with Tacqol, a generic HRQoL instrument for children (TNO-AZL). Results: In the final phase of the development, 27 children completed the instrument. It consisted of 37 items in four domains. The response rate was 96%. Reliability was good for all domains, with Cronbach's alpha values ranging from 0.61 to 0.76. Measures of test-retest stability were good for all four domains with ICCs ranging from 0.82 to 0.92. Validity based on comparison with the Tacqol instrument was moderate. Conclusion: The DDL is promising as a measure of HRQoL in childhood defecation disorders. PMID:15557046

Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

PubMed

Kanavos, Panos

2014-11-01

This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

PubMed

Babovic, Sonja; Wasan, Kishor M

2011-03-01

This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

Comparative cost evaluation of brand name and generic ophthalmology medications in Ontario.

PubMed

Popovic, Marko; Chan, Clara; Lattanzio, Nisha; El-Defrawy, Sherif; Schlenker, Matthew B

2018-04-01

Medication cost for the same indication can vary considerably and can affect patient compliance. In this comparative cost analysis of commonly prescribed ophthalmology medications, the differences in cost between generic and brand name medications as well as different medications within an individual drug class were evaluated. Eye preparations from the Ontario Drug Benefit Formulary were identified, and further agents commonly prescribed by ophthalmologists were included. The standardized prescription drug cost, which includes the cost of the medication, mark-up, and dispensing cost, was provided by Ontario Shoppers Drug Mart stores in July 2016 for 103 common medications using typical dosages and durations. Based on medication class, the highest and lowest cost medications were antiallergy agents (Zaditor [ketotifen], Vasocon [naphazoline]), antibiotic ophthalmic solutions (Vigamox [moxifloxacin], generic ciprofloxacin), oral antibiotics (Cipro [ciprofloxacin], generic cephalexin), antibiotic ophthalmic ointments (generic erythromycin, Tobrex [tobramycin]), antiviral treatment (Valtrex [oral valacyclovir], Viroptic [topical trifluridine]), blepharitis treatment (Zithromax [oral azithromycin], generic oral tetracycline), beta-adrenergic inhibitors (Timoptic [topical timolol], generic topical timolol), topical prostaglandin analogues (Xalatan [latanoprost], generic travoprost), oral carbonic anhydrase inhibitors (methazolamide, acetazolamide), topical carbonic anhydrase solutions (Trusopt preservative-free [dorzolamide], Azopt [brinzolamide]), topical alpha-adrenergic agonists (Alphagan [brimonidine], generic brimonidine), topical muscarinic agonists (Isopto carpine [pilocarpine], Diocarpine [pilocarpine]), topical combination glaucoma agents (Cosopt [dorzolamide-timolol], generic dorzolamide-timolol), topical lubricants (Lacri-lube, Isopto tears), topical nonsteroidal anti-inflammatory drugs (Acuvail [ketorolac], Ilevro [nepafenac]), and steroids (Durezol [difluprednate], Pred mild [prednisolone]). Substantial cost differences exist between ophthalmology medications of the same class. We encourage ophthalmologists to be aware of the associated costs of the medications they prescribe and to use this information in their decision making. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Identification of energy conservation research opportunities: a review and synthesis of the literature

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hopp, W.J.; Hane, G.J.; Gurwell, W.E.

1982-03-01

Thirty-eight studies of energy conservation research opportunities are reviewed. The 38 studies chosen for review include many of the major efforts in the identification of energy conservation research and development (R and D) opportunities and provide a representative sample of the types of studies that have been performed. The sample includes studies that focus on specific energy use (e.g., auto transport), as well as studies that focus on specific types of research (e.g., materials science). The sample also includes studies that can be further contrasted in terms of long-term vs. short-term projects, evolutionary vs. revolutionary ideas, generic vs. process-specific activities,more » and technology base research vs. hardware development. Each of these perspectives contributes toward assuring coverage of the breadth of energy conservation R and D opportunities. In each review the technical or end-use focus is described, the research ideas identified in the study are listed, and a critical summary is given. The reviews also indicate whether the studies present end-use consumption data, estimate potential energy savings, estimate times to commercialization, summarize existing research programs, or describe the identification methodology. In Section 2.0 the various research studies are compared. In Section 3.0 the characteristics of an aggregate list of research ideas are discussed. The characteristics were collected from the research opportunities studies, which are included in Appendix A. Appendix A contains a compilation of energy conservation R and D opportunities arranged by energy end-use applications. Appendix B contains an outline of the format followed in writing the critical reviews of the studies, the individual study reviews, and the extended bibliography of 88 studies that describe energy conservation research opportunities.« less

Development of performance matrix for generic product equivalence of acyclovir topical creams.

PubMed

Krishnaiah, Yellela S R; Xu, Xiaoming; Rahman, Ziyaur; Yang, Yang; Katragadda, Usha; Lionberger, Robert; Peters, John R; Uhl, Kathleen; Khan, Mansoor A

2014-11-20

The effect of process variability on physicochemical characteristics and in vitro performance of qualitatively (Q1) and quantitatively (Q2) equivalent generic acyclovir topical dermatological creams was investigated to develop a matrix of standards for determining their in vitro bioequivalence with reference listed drug (RLD) product (Zovirax®). A fractional factorial design of experiment (DOE) with triplicate center point was used to create 11 acyclovir cream formulations with manufacturing variables such as pH of aqueous phase, emulsification time, homogenization speed, and emulsification temperature. Three more formulations (F-12-F-14) with drug particle size representing RLD were also prepared where the pH of the final product was adjusted. The formulations were subjected to physicochemical characterization (drug particle size, spreadability, viscosity, pH, and drug concentration in aqueous phase) and in vitro drug release studies against RLD. The results demonstrated that DOE formulations were structurally and functionally (e.g., drug release) similar (Q3) to RLD. Moreover, in vitro drug permeation studies showed that extent of drug bioavailability/retention in human epidermis from F-12-F-14 were similar to RLD, although differed in rate of permeation. The results suggested generic acyclovir creams can be manufactured to obtain identical performance as that of RLD with Q1/Q2/Q3. Published by Elsevier B.V.

Generic antibiotics in Japan.

PubMed

Fujimura, Shigeru; Watanabe, Akira

2012-08-01

Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk particle and amount of solubilizer. The Japanese government hopes to increase the diffusion rate of generic drugs (in terms of quantity) from 20.2 % in 2010 to 30 % or more in 2012, and therefore it will be necessary to clarify the advantages of generic antibiotics in terms of expenditure and equivalency with the branded drugs.

Strategies that delay or prevent the timely availability of affordable generic drugs in the United States

PubMed Central

Jones, Gregory H.; Carrier, Michael A.; Silver, Richard T.

2016-01-01

High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented. PMID:26817958

A new entity for the negotiation of public procurement prices for patented medicines in Mexico

PubMed Central

Wirtz, Veronika J; Reich, Michael R; Terrazas, Paulina; Ortiz, Maki

2012-01-01

Abstract Problem As countries expand health insurance coverage, their expenditures on medicines increase. To address this problem, WHO has recommended that every country draw up a list of essential medicines. Although most medicines on the list are generics, in many countries patented medicines represent a substantial portion of pharmaceutical expenditure. Approach To help control expenditure on patented medicines, in 2008 the Mexican Government created the Coordinating Commission for Negotiating the Price of Medicines and other Health Inputs (CCPNM), whose role, as the name suggests, is to enter into price negotiations with drug manufacturers for patented drugs on Mexico’s list of essential medicines. Local setting Mexico’s public expenditure on pharmaceuticals has increased substantially in the past decade owing to government efforts to achieve universal health-care coverage through Seguro Popular, an insurance programme introduced in 2004 that guarantees access to a comprehensive package of health services and medicines. Relevant changes Since 2008, the CCPNM has improved procurement practices in Mexico’s public health institutions and has achieved significant price reductions resulting in substantial savings in public pharmaceutical expenditure. Lessons learnt The CCPNM has successfully changed the landscape of price negotiation for patented medicines in Mexico. However, it is also facing challenges, including a lack of explicit indicators to assess CCPNM performance; a shortage of permanent staff with sufficient technical expertise; poor coordination among institutions in preparing background materials for the annual negotiation process in a timely manner; insufficient communication among committees and institutions; and a lack of political support to ensure the sustainability of the CCPNM. PMID:23109747

How should we build a generic open-source water management simulator?

NASA Astrophysics Data System (ADS)

Khadem, M.; Meier, P.; Rheinheimer, D. E.; Padula, S.; Matrosov, E.; Selby, P. D.; Knox, S.; Harou, J. J.

2014-12-01

Increasing water needs for agriculture, industry and cities mean effective and flexible water resource system management tools will remain in high demand. Currently many regions or countries use simulators that have been adapted over time to their unique system properties and water management rules and realities. Most regions operate with a preferred short-list of water management and planning decision support systems. Is there scope for a simulator, shared within the water management community, that could be adapted to different contexts, integrate community contributions, and connect to generic data and model management software? What role could open-source play in such a project? How could a genericuser-interface and data/model management software sustainably be attached to this model or suite of models? Finally, how could such a system effectively leverage existing model formulations, modeling technologies and software? These questions are addressed by the initial work presented here. We introduce a generic water resource simulation formulation that enables and integrates both rule-based and optimization driven technologies. We suggest how it could be linked to other sub-models allowing for detailed agent-based simulation of water management behaviours. An early formulation is applied as an example to the Thames water resource system in the UK. The model uses centralised optimisation to calculate allocations but allows for rule-based operations as well in an effort to represent observed behaviours and rules with fidelity. The model is linked through import/export commands to a generic network model platform named Hydra. Benefits and limitations of the approach are discussed and planned work and potential use cases are outlined.

The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

PubMed Central

Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted. PMID:24098644

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

PubMed

Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

Pharmacy discounts on generic medicines in France: is there room for further efficiency savings?

PubMed

Kanavos, Panos; Taylor, David

2007-10-01

In France control of pharmaceutical expenditure has been a policy priority for many years and generic policies have featured prominently on the policy agenda. Measures including reference pricing, generic substitution and international non-proprietary name (INN) prescribing have been introduced in recent years. Generic manufacturers and wholesalers may offer discounts, rebates or promotions to pharmacies in order to gain an edge over their competitors, but their true extent is unknown. To identify the amplitude of discounts on generic medicines, and whether wholesalers or generic manufacturers offer these beyond officially negotiated margins and allowable discounts, by conducting a pilot study. Data on net prices were acquired for all available presentations of 11 generic molecules selected across different therapeutic categories included in the 40 most selling generic products in 2005. Data were obtained via a questionnaire survey followed by interview with selected pharmacies (n = 4) and whole-salers (n = 2). Pharmacies and wholesalers participated in this study subject to confidentiality and anonymity. Pharmacies usually prefer to buy generic products directly from manufacturers rather than from wholesalers in order to avoid paying additional margins imposed by wholesalers. Discounts are mostly price-related and generally vary from 20 to 70% off the wholesaler selling price (WSP), on top of the officially allowed 10.74%. Discounts on the ex-factory price (EFP) are much lower, typically around 7.5%. Discounts are prohibited for branded products, beyond the officially allowed ceiling of 2.5%. While horizontal integration among pharmacies is disallowed, pharmacies may form purchasing groups allowing them to realise greater discounts from suppliers. Overall, the evidence suggests that discounts occur in France beyond what may be allowable and their extent can be significant. If general discount levels for generic medicines are as high as this pilot study suggests, then this may imply that health insurance in France may be overpaying for commodity generic medicines.

A simplified method of performance indicators development for epidemiological surveillance networks--application to the RESAPATH surveillance network.

PubMed

Sorbe, A; Chazel, M; Gay, E; Haenni, M; Madec, J-Y; Hendrikx, P

2011-06-01

Develop and calculate performance indicators allows to continuously follow the operation of an epidemiological surveillance network. This is an internal evaluation method, implemented by the coordinators in collaboration with all the actors of the network. Its purpose is to detect weak points in order to optimize management. A method for the development of performance indicators of epidemiological surveillance networks was developed in 2004 and was applied to several networks. Its implementation requires a thorough description of the network environment and all its activities to define priority indicators. Since this method is considered to be complex, our objective consisted in developing a simplified approach and applying it to an epidemiological surveillance network. We applied the initial method to a theoretical network model to obtain a list of generic indicators that can be adapted to any surveillance network. We obtained a list of 25 generic performance indicators, intended to be reformulated and described according to the specificities of each network. It was used to develop performance indicators for RESAPATH, an epidemiological surveillance network of antimicrobial resistance in pathogenic bacteria of animal origin in France. This application allowed us to validate the simplified method, its value in terms of practical implementation, and its level of user acceptance. Its ease of use and speed of application compared to the initial method argue in favor of its use on broader scale. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Generically Used Expert Scheduling System (GUESS): User's Guide Version 1.0

NASA Technical Reports Server (NTRS)

Liebowitz, Jay; Krishnamurthy, Vijaya; Rodens, Ira

1996-01-01

This user's guide contains instructions explaining how to best operate the program GUESS, a generic expert scheduling system. GUESS incorporates several important features for a generic scheduler, including automatic scheduling routines to generate a 'first' schedule for the user, a user interface that includes Gantt charts and enables the human scheduler to manipulate schedules manually, diagnostic report generators, and a variety of scheduling techniques. The current version of GUESS runs on an IBM PC or compatible in the Windows 3.1 or Windows '95 environment.

A developmental analysis of generic nouns in Southern Peruvian Quechua.

PubMed

Mannheim, Bruce; Gelman, Susan A; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., "Cats like to drink milk") are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like "all") and distinct from indefinite reference ("some"). However, there was a developmental lag before children understood that generics, unlike "all", can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression.

A developmental analysis of generic nouns in Southern Peruvian Quechua

PubMed Central

Mannheim, Bruce; Gelman, Susan A.; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., “Cats like to drink milk”) are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like “all”) and distinct from indefinite reference (“some”). However, there was a developmental lag before children understood that generics, unlike “all”, can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression. PMID:21779154

Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review.

PubMed

Hassali, Mohamed Azmi; Wong, Zhi Yen; Alrasheedy, Alian A; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-09-01

This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Sixteen articles were included in this review. The majority (n=11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians' knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians' concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Variation in Prescription Drug Coverage for Triptans: Analysis of Insurance Formularies.

PubMed

Minen, Mia T; Lindberg, Kate; Langford, Aisha; Loder, Elizabeth

2017-09-01

To analyze triptan coverage by insurers to examine (1) possible disparities in coverage for different formulations (oral, intranasal, etc) and (2) quantity limits and stepped care requirements to obtain triptans. Triptans are FDA approved migraine abortive medications. Patients frequently state that they have difficulty accessing triptans prescribed to them. We searched the 2015 drug formularies of commercial and government health insurers providing coverage in NY State. We created a spreadsheet with all of the commercially available triptans and included information about covered formulations, tier numbers and quantity limits for each drug. We then calculated the number of listed plans that cover or do not cover each triptan or triptan formulation, the total number of medications not covered by an insurance provided across all of its plans, as well as the percentage of plans offered by individual companies and across all companies that covered each drug. We also calculated the number and proportion of plans that imposed quantity limits or step therapy for each drug. Of the 100 formularies searched, generic sumatriptan (all formulations), naratriptan, and zolmitriptan tablets were covered by all plans, and rizatriptan tablets and ODTs were covered by 98% of plans. Brand triptans were less likely to be covered: 4/36 Medicaid plans covered brand triptans. Commercial insurers were more likely to cover brand triptans. All plans imposed quantity limits on 1+ triptan formulations, with >80% imposing quantity limits on 14/19 formulations studied. Almost all plans used tiers for cost allocation for different medications. Generic triptans were almost always in Tier 1. Brand triptans were most commonly in Tier 3. Approximately 40% of brand triptans required step therapy, compared with 11% of generic triptans. There are substantial variations in coverage and quantity limits and a high degree of complexity in triptan coverage for both government and commercial plans. © 2017 American Headache Society.

[SF-36 and EQ-5D in the evaluation of QOL in the osteoporotic patients as the generic questionnaires].

PubMed

Tanaka, Kiyoshi; Fujii, Ayano; Kuwabara, Akiko

2012-02-01

Health-related quality of life (HRQOL) , abbreviated as QOL, can be evaluated by various questionnaires, which are classified as generic and disease-targeted ones. Generic questionnaires are further subdivided into profile-type and preference-based ones. SF-36 and EQ-5D are the best known examples for the former and the latter, respectively. In SF-36 and its shortened one SF-8, the subjects' QOL is expressed by several profiles or subscales. Their advantages include well-conducted validation and availability of national norms. In EQ-5D, a single value representing the subjects' QOL status (utility) is obtained through 5 questions. These generic questionnaires are applicable to patients with various diseases or even to healthy citizens. In contrast, disease-targeted questionnaires lack such features, but can include items that are specifically related to the disease but devoid of general applicability. Thus, generic and disease-targeted questionnaires have their own pros and cons. Selection of the questionnaires depends on the object of the study.

Tripal v1.1: a standards-based toolkit for construction of online genetic and genomic databases.

PubMed

Sanderson, Lacey-Anne; Ficklin, Stephen P; Cheng, Chun-Huai; Jung, Sook; Feltus, Frank A; Bett, Kirstin E; Main, Dorrie

2013-01-01

Tripal is an open-source freely available toolkit for construction of online genomic and genetic databases. It aims to facilitate development of community-driven biological websites by integrating the GMOD Chado database schema with Drupal, a popular website creation and content management software. Tripal provides a suite of tools for interaction with a Chado database and display of content therein. The tools are designed to be generic to support the various ways in which data may be stored in Chado. Previous releases of Tripal have supported organisms, genomic libraries, biological stocks, stock collections and genomic features, their alignments and annotations. Also, Tripal and its extension modules provided loaders for commonly used file formats such as FASTA, GFF, OBO, GAF, BLAST XML, KEGG heir files and InterProScan XML. Default generic templates were provided for common views of biological data, which could be customized using an open Application Programming Interface to change the way data are displayed. Here, we report additional tools and functionality that are part of release v1.1 of Tripal. These include (i) a new bulk loader that allows a site curator to import data stored in a custom tab delimited format; (ii) full support of every Chado table for Drupal Views (a powerful tool allowing site developers to construct novel displays and search pages); (iii) new modules including 'Feature Map', 'Genetic', 'Publication', 'Project', 'Contact' and the 'Natural Diversity' modules. Tutorials, mailing lists, download and set-up instructions, extension modules and other documentation can be found at the Tripal website located at http://tripal.info. DATABASE URL: http://tripal.info/.

Tripal v1.1: a standards-based toolkit for construction of online genetic and genomic databases

PubMed Central

Sanderson, Lacey-Anne; Ficklin, Stephen P.; Cheng, Chun-Huai; Jung, Sook; Feltus, Frank A.; Bett, Kirstin E.; Main, Dorrie

2013-01-01

Tripal is an open-source freely available toolkit for construction of online genomic and genetic databases. It aims to facilitate development of community-driven biological websites by integrating the GMOD Chado database schema with Drupal, a popular website creation and content management software. Tripal provides a suite of tools for interaction with a Chado database and display of content therein. The tools are designed to be generic to support the various ways in which data may be stored in Chado. Previous releases of Tripal have supported organisms, genomic libraries, biological stocks, stock collections and genomic features, their alignments and annotations. Also, Tripal and its extension modules provided loaders for commonly used file formats such as FASTA, GFF, OBO, GAF, BLAST XML, KEGG heir files and InterProScan XML. Default generic templates were provided for common views of biological data, which could be customized using an open Application Programming Interface to change the way data are displayed. Here, we report additional tools and functionality that are part of release v1.1 of Tripal. These include (i) a new bulk loader that allows a site curator to import data stored in a custom tab delimited format; (ii) full support of every Chado table for Drupal Views (a powerful tool allowing site developers to construct novel displays and search pages); (iii) new modules including ‘Feature Map’, ‘Genetic’, ‘Publication’, ‘Project’, ‘Contact’ and the ‘Natural Diversity’ modules. Tutorials, mailing lists, download and set-up instructions, extension modules and other documentation can be found at the Tripal website located at http://tripal.info. Database URL: http://tripal.info/ PMID:24163125

Generic robot architecture

DOEpatents

Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

2010-09-21

The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

Using Structured Chemistry Examinations (SCHemEs) as an Assessment Method to Improve Undergraduate Students' Generic, Practical, and Laboratory-Based Skills

ERIC Educational Resources Information Center

Kirton, Stewart B.; Al-Ahmad, Abdullah; Fergus, Suzanne

2014-01-01

Increase in tuition fees means there will be renewed pressure on universities to provide "value for money" courses that provide extensive training in both subject-specific and generic skills. For graduates of chemistry this includes embedding the generic, practical, and laboratory-based skills associated with industrial research as an…

Comparison between Utility of the Thai Pediatric Quality of Life Inventory 4.0 Generic Core Scales and 3.0 Cerebral Palsy Module

ERIC Educational Resources Information Center

Tantilipikorn, Pinailug; Watter, Pauline; Prasertsukdee, Saipin

2013-01-01

Health-related quality of life (HRQOL) is increasingly being considered in the management of patients with various conditions. HRQOL instruments can be broadly classified as generic or disease-specific measures. Several generic HRQOL instruments in different languages have been developed for paediatric populations including the Pediatric Quality…

A methodology to compile food metrics related to diet sustainability into a single food database: Application to the French case.

PubMed

Gazan, Rozenn; Barré, Tangui; Perignon, Marlène; Maillot, Matthieu; Darmon, Nicole; Vieux, Florent

2018-01-01

The holistic approach required to assess diet sustainability is hindered by lack of comprehensive databases compiling relevant food metrics. Those metrics are generally scattered in different data sources with various levels of aggregation hampering their matching. The objective was to develop a general methodology to compile food metrics describing diet sustainability dimensions into a single database and to apply it to the French context. Each step of the methodology is detailed: indicators and food metrics identification and selection, food list definition, food matching and values assignment. For the French case, nutrient and contaminant content, bioavailability factors, distribution of dietary intakes, portion sizes, food prices, greenhouse gas emission, acidification and marine eutrophication estimates were allocated to 212 commonly consumed generic foods. This generic database compiling 279 metrics will allow the simultaneous evaluation of the four dimensions of diet sustainability, namely health, economic, social and environmental, dimensions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Strategies that delay or prevent the timely availability of affordable generic drugs in the United States.

PubMed

Jones, Gregory H; Carrier, Michael A; Silver, Richard T; Kantarjian, Hagop

2016-03-17

High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented. © 2016 by The American Society of Hematology.

Drug Dosing Toolkit

MedlinePlus

... drugs can have several names, the most popular brand and generic names are included. Aptivus (tipranavir) Atripla ( ... Note: Generic versions are usually less expensive than brand-name products. The brand names appearing in this ...

Generic substitution of antiretrovirals: patients' and health care providers' opinions.

PubMed

Kieran, Jennifer A; O'Reilly, Eimear; O'Dea, Siobhan; Bergin, Colm; O'Leary, Aisling

2017-10-01

There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

PubMed

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Policies and perceptions on generic drugs: The case of Greece.

PubMed

Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina

2018-01-01

The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients' and doctors' attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (b) a questionnaire survey of 242 hospital patients and 85 doctors regarding their perceptions on generics. A small increase in the volume of generics is recorded, yet not followed by sales value, over the recent years that the measures for promoting generics prescription took effect. Distrust from both patients and doctors was observed toward generics' effectiveness and toward the appropriateness of the regulatory authorities' quality controls. The study presents a structured set of viable measures, applicable to many countries, for promoting generic drug consumption that can lead to economic efficiency without degrading the health care quality.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

PubMed

Löfgren, Hans

2007-06-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

Patients' perceptions of generic drugs in Greece.

PubMed

Skaltsas, Leonora N; Vasileiou, Konstantinos Z

2015-11-01

The use of generic drugs is growing increasingly around the world and in Greece, in particular, in order to reduce pharmaceutical expenditure. However, patients' perceptions and attitudes about generics have only partially been studied so far in Greece. This study aimed to examine the factors that influence the attitude of patients and consumers regarding generic drugs. A questionnaire survey of 364 patients visiting a pharmacy was conducted. The questionnaire consisted of 29 questions, including questions regarding their knowledge about generics, the reasons for using them, their previous experience, their willingness for generic substitution, and the factors behind these choices. Nearly half of the participants in the survey know the term 'generic' and that it has a lower price compared to the brand name drug. Their views on safety and efficacy vary significantly and the main source of information on generics is the media and the internet. The lack of knowledge is the main barrier for attitudes of doctors. Health professionals play the most influential role for the substitution of a branded drug by a generic, followed by the cost of the generic. Almost half of the patients know about generic drugs, with their lower price being the most popular feature which most patients are familiar with. It seems that primarily the doctor and, subsequently the pharmacist play the most important role in a patient's decision to replace his/her medicine with a generic. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Generic particulate-monitoring system for retrofit to Hanford exhaust stacks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Camman, J.W.; Carbaugh, E.H.

1982-11-01

Evaluations of 72 sampling and monitoring systems were performed at Hanford as the initial phase of a program to upgrade such systems. Each evaluation included determination of theoretical sampling efficiencies for particle sizes ranging from 0.5 to 10 micrometers aerodynamic equivalent diameter, addressing anisokinetic bias, sample transport line losses, and collector device efficiency. Upgrades needed to meet current Department of Energy guidance for effluent sampling and monitoring were identified, and a cost for each upgrade was estimated. A relative priority for each system's upgrade was then established based on evaluation results, current operational status, and future plans for the facilitymore » being exhausted. Common system upgrade requirements lead to the development of a generic design for common components of an exhaust stack sampling and monitoring system for airborne radioactive particulates. The generic design consists of commercially available off-the-shelf components to the extent practical and will simplify future stack sampling and monitoring system design, fabrication, and installation efforts. Evaluation results and their significance to system upgrades are empasized. A brief discussion of the analytical models used and experience to date with the upgrade program is included. Development of the generic stack sampling and monitoring system design is outlined. Generic system design features and limitations are presented. Requirements for generic system retrofitting to existing exhaust stacks are defined and benefits derived from generic system application are discussed.« less

Space Generic Open Avionics Architecture (SGOAA) standard specification

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1994-01-01

This standard establishes the Space Generic Open Avionics Architecture (SGOAA). The SGOAA includes a generic functional model, processing structural model, and an architecture interface model. This standard defines the requirements for applying these models to the development of spacecraft core avionics systems. The purpose of this standard is to provide an umbrella set of requirements for applying the generic architecture models to the design of a specific avionics hardware/software processing system. This standard defines a generic set of system interface points to facilitate identification of critical services and interfaces. It establishes the requirement for applying appropriate low level detailed implementation standards to those interfaces points. The generic core avionics functions and processing structural models provided herein are robustly tailorable to specific system applications and provide a platform upon which the interface model is to be applied.

Quality of life and psychosocial issues in ventilated patients with amyotrophic lateral sclerosis and their caregivers.

PubMed

Kaub-Wittemer, Dagmar; Steinbüchel, Nicole von; Wasner, Maria; Laier-Groeneveld, Gerhard; Borasio, Gian Domenico

2003-10-01

Non-invasive ventilation (NIV) is an efficient palliative measure for symptoms of chronic hypoventilation in patients with amyotrophic lateral sclerosis (ALS), and can also lengthen survival. A subset of ALS patients undergoes tracheostomy ventilation (TV) for life prolongation. We investigated the quality of life (QOL) and psychosocial situation of 52 home ventilated ALS patients and their caregivers. The battery included sociodemographic, generic, and disease-specific variables, as well as the Profile of Mood States and the Munich Quality of Life Dimensions List. Data were compared between the NIV (n=32) and the TV (n=21) groups. Mean ventilation time was 14 months for NIV and 35 months for TV. Eighty-one percent of TV patients had been tracheotomized without informed consent. The data show a good overall QOL for both NIV and TV patients, but a very high burden of care for TV caregivers, 30% of whom rated their own QOL lower than their patient's QOL. Sexuality was an important issue. Thus, any assessment of QOL in a home palliative care situation should include the primary caregivers.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

PubMed

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-06-26

The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

Innovation strategies for generic drug companies: moving into supergenerics.

PubMed

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland.

PubMed

Babar, Zaheer-Ud-Din; Stewart, Joanna; Reddy, Shiwangni; Alzaher, Woroud; Vareed, Prateeka; Yacoub, Nineweh; Dhroptee, Bandhana; Rew, Anne

2010-08-01

The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers' willingness to use generics. Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.

Covalent Electron Transfer Theory of Superconductivity

DTIC Science & Technology

1992-06-19

carriers. This situation is analogous to a vacuum diode without space charge, where each electron emitted from the cathode arrives at the anode before...Generic MO energy level diagram for a do cation in an oxygen octahedral complex. 89 53 Band model approximation of the MO states of a Cu perovskite ...C2) CuO4 complex. 94 57 p-type 3d 2,2-2p a Cu2+-O-Cu3+ covalent transfer in I 80-deg perovskite bond 95 geometry for d9 - d8(low-spin). xi LIST OF

Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

PubMed

Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

2015-09-01

To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs in patients with epilepsy, who may be at increased risk for problems with brand-to-generic switching. Bioequivalence results in "generic-brittle" patients with epilepsy under clinical conditions support the soundness of the FDA bioequivalence standards. Adverse events on generic were not related to the small, allowable PK differences between generic and brand. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Towards a Web-Based Handbook of Generic, Process-Oriented Learning Designs

ERIC Educational Resources Information Center

Marjanovic, Olivera

2005-01-01

Process-oriented learning designs are innovative learning activities that include a set of inter-related learning tasks and are generic (could be used across disciplines). An example includes a problem-solving process widely used in problem-based learning today. Most of the existing process-oriented learning designs are not documented, let alone…

Fuzzyics =CATEGORYICS =PRAGMATYICS (``Son of ``TRIZ''')/CATEGORY-SEMANTICS Cognition (fcp/csc) of Plato-Aristotle ``SQUARE-of-OPPOSITION''(SoO): Linguistics: Antonyms VS ``SYNONYMS'' VS Analogy/ Metaphor: Coarsest-Possible Topology: Shocks/High-Pressures Applications

NASA Astrophysics Data System (ADS)

Siegel, Edward Plato Aristotle Archimedes Carl-Ludwig; Young, Frederic; Lewis, Thomas

2013-06-01

Siegel[MRS Fall-Mtgs,:Symp.Fractals(89)-5-papers!!!;Symp.Scaling(90)] FCP/CSC {aka SPD}(Tic-Tac-Toe-Matrix/Tabular List-Format) ``COMMON-FUNCTIONING-PRINCIPLE'' DI/TRI-CHOTOMY GENERIC ``INEVITABILITY_-WEB'' PURPOSEFUL PARSIMONY-of-DI/TRI-CHOTOMY STRATEGY REdiscovery of SoO automatically/optimality is in NON-list-format/matrix: DIMENSIONALITY-DOMINATION -INEVIT-ABILITY ROOT-CAUSE(RC) ULTIMATE-ORIGIN(UO): (level-0.-logic) DIMENSIONALITY (level-0. logic): [dst = ODD-Z] <->{Dst=FRACTAL-UNcertainty FLUCTUATIONS} <->(dst = EVEN-Z): CAUSES: (level- I.-logic): EXTENT/SCALE/RADIUS: (relative)-[LOCALITY] <-> (relative)-(...GLOBALITY...) & (level-II.-logic): POWER-SPECTRUM{noise ≅generalized-susceptibility}: [``l''/ω0-White] <->(...-``l''/ω 1 . 000 . . . - HYPERBOLICITY...) & (level-III.-logic) CRITICAL-EXPONENT:n =0 <->n = 1.000... ; BUT ALL 3 ALSO CAUSED BY ANOTHER INdependent RCUO (level-IV.-logic):

Generic versus disorder specific cognitive behavior therapy for social anxiety disorder in youth: A randomized controlled trial using internet delivery.

PubMed

Spence, Susan H; Donovan, Caroline L; March, Sonja; Kenardy, Justin A; Hearn, Cate S

2017-03-01

The study examined whether the efficacy of cognitive behavioral treatment for Social Anxiety Disorder for children and adolescents is increased if intervention addresses specific cognitive and behavioral factors linked to the development and maintenance of SAD in young people, over and above the traditional generic CBT approach. Participants were 125 youth, aged 8-17 years, with a primary diagnosis of SAD, who were randomly assigned to generic CBT (CBT-GEN), social anxiety specific CBT (CBT-SAD) or a wait list control (WLC). Intervention was delivered using a therapist-supported online program. After 12-weeks, participants who received treatment (CBT-SAD or CBT-GEN) showed significantly greater reduction in social anxiety and post-event processing, and greater improvement in global functioning than the WLC but there was no significant difference between CBT-SAD and CBT-GEN on any outcome variable at 12-weeks or 6-month follow-up. Despite significant reductions in anxiety, the majority in both treatment conditions continued to meet diagnostic criteria for SAD at 6-month follow-up. Decreases in social anxiety were associated with decreases in post-event processing. Future research should continue to investigate disorder-specific interventions for SAD in young people, drawing on evidence regarding causal or maintaining factors, in order to enhance treatment outcomes for this debilitating condition. Copyright © 2016 Elsevier Ltd. All rights reserved.

Process management using component thermal-hydraulic function classes

DOEpatents

Morman, James A.; Wei, Thomas Y. C.; Reifman, Jaques

1999-01-01

A process management expert system where following malfunctioning of a component, such as a pump, for determining system realignment procedures such as for by-passing the malfunctioning component with on-line speeds to maintain operation of the process at full or partial capacity or to provide safe shut down of the system while isolating the malfunctioning component. The expert system uses thermal-hydraulic function classes at the component level for analyzing unanticipated as well as anticipated component malfunctions to provide recommended sequences of operator actions. Each component is classified according to its thermal-hydraulic function, and the generic and component-specific characteristics for that function. Using the diagnosis of the malfunctioning component and its thermal hydraulic class, the expert system analysis is carried out using generic thermal-hydraulic first principles. One aspect of the invention employs a qualitative physics-based forward search directed primarily downstream from the malfunctioning component in combination with a subsequent backward search directed primarily upstream from the serviced component. Generic classes of components are defined in the knowledge base according to the three thermal-hydraulic functions of mass, momentum and energy transfer and are used to determine possible realignment of component configurations in response to thermal-hydraulic function imbalance caused by the malfunctioning component. Each realignment to a new configuration produces the accompanying sequence of recommended operator actions. All possible new configurations are examined and a prioritized list of acceptable solutions is produced.

Process management using component thermal-hydraulic function classes

DOEpatents

Morman, J.A.; Wei, T.Y.C.; Reifman, J.

1999-07-27

A process management expert system where following malfunctioning of a component, such as a pump, for determining system realignment procedures such as for by-passing the malfunctioning component with on-line speeds to maintain operation of the process at full or partial capacity or to provide safe shut down of the system while isolating the malfunctioning component. The expert system uses thermal-hydraulic function classes at the component level for analyzing unanticipated as well as anticipated component malfunctions to provide recommended sequences of operator actions. Each component is classified according to its thermal-hydraulic function, and the generic and component-specific characteristics for that function. Using the diagnosis of the malfunctioning component and its thermal hydraulic class, the expert system analysis is carried out using generic thermal-hydraulic first principles. One aspect of the invention employs a qualitative physics-based forward search directed primarily downstream from the malfunctioning component in combination with a subsequent backward search directed primarily upstream from the serviced component. Generic classes of components are defined in the knowledge base according to the three thermal-hydraulic functions of mass, momentum and energy transfer and are used to determine possible realignment of component configurations in response to thermal-hydraulic function imbalance caused by the malfunctioning component. Each realignment to a new configuration produces the accompanying sequence of recommended operator actions. All possible new configurations are examined and a prioritized list of acceptable solutions is produced. 5 figs.

Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamad Izham Mohamad; Hassali, Mohamad Azmi; Sharrad, Adheed Khalid; Shafie, Asrul Akmal; Babar, Zaheer-Ud-Din

2015-01-01

General objective To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute). When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04). Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001). With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001). More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001). Conclusion The current study identified a positive perception toward generic medicines but also gaps in the understanding of generic medicines. Pharmacy students lacked a thorough understanding of the concepts of bioequivalence. Pharmacy academia should address these issues, which will help build confidence in generic medicines and increase the generic medicine use in Pakistan. PMID:26028981

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

PubMed Central

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-01-01

ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14), age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41). CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil. PMID:28678909

The crisis in access to essential medicines in India: key issues which call for action.

PubMed

Bhargava, Anurag; Kalantri, S P

2013-01-01

The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

Does the market share of generic medicines influence the price level?: a European analysis.

PubMed

Dylst, Pieter; Simoens, Steven

2011-10-01

After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

PubMed

Kuribayashi, Ryosuke; Appleton, Scott

2017-09-01

Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

PubMed Central

Löfgren, Hans

2007-01-01

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products. PMID:17543115

Life history and spatial traits predict extinction risk due to climate change

NASA Astrophysics Data System (ADS)

Pearson, Richard G.; Stanton, Jessica C.; Shoemaker, Kevin T.; Aiello-Lammens, Matthew E.; Ersts, Peter J.; Horning, Ned; Fordham, Damien A.; Raxworthy, Christopher J.; Ryu, Hae Yeong; McNees, Jason; Akçakaya, H. Reşit

2014-03-01

There is an urgent need to develop effective vulnerability assessments for evaluating the conservation status of species in a changing climate. Several new assessment approaches have been proposed for evaluating the vulnerability of species to climate change based on the expectation that established assessments such as the IUCN Red List need revising or superseding in light of the threat that climate change brings. However, although previous studies have identified ecological and life history attributes that characterize declining species or those listed as threatened, no study so far has undertaken a quantitative analysis of the attributes that cause species to be at high risk of extinction specifically due to climate change. We developed a simulation approach based on generic life history types to show here that extinction risk due to climate change can be predicted using a mixture of spatial and demographic variables that can be measured in the present day without the need for complex forecasting models. Most of the variables we found to be important for predicting extinction risk, including occupied area and population size, are already used in species conservation assessments, indicating that present systems may be better able to identify species vulnerable to climate change than previously thought. Therefore, although climate change brings many new conservation challenges, we find that it may not be fundamentally different from other threats in terms of assessing extinction risks.

Clinical experience with generic levetiracetam in people with epilepsy

PubMed Central

Chaluvadi, Siresha; Chiang, Sharon; Tran, Larry; Goldsmith, Corey E.; Friedman, David E.

2015-01-01

SUMMARY Purpose To describe the clinical outcomes of a compulsory switch from branded to generic levetiracetam (LEV) among people with epilepsy (PWE) in an outpatient setting. Methods We conducted a retrospective chart review of 760 unduplicated consecutive adult patients attending a tertiary care epilepsy clinic at Ben Taub General Hospital. On November 1, 2008 hospital policy required all patients receiving branded LEV to be automatically switched to generic LEV. We calculated the proportion of patients switching back to branded LEV and reasons for the switch back. Key Findings Of the 260 patients (34%) being prescribed LEV (generic and brand name) during the study period, 105 (42.9%) were switched back to brand name LEV by their treating physicians. Reasons for switch back included increase in seizure frequency (19.6% vs. 1.6%; p < 0.0001) and adverse effects (AEs) (3.3%). AEs included headache, fatigue, and aggression. Patient age was associated with switchback when controlling for gender, epilepsy classification, and treatment characteristics [relative risk (RR) 2.44; 95% confidence interval (CI) 2.09–2.84; p < 0.05)]. An increase in seizure frequency subsequent to generic substitution was associated with polytherapy compared to monotherapy (3.225; 1.512–6.880; p < 0.05). Significance A significant proportion of patients in our cohort on generic LEV required switch back to the branded drug. Careful monitoring is imperative because a compulsory switch from branded to generic LEV may lead to poor clinical outcomes, with risk of AEs and increased seizure frequency. PMID:21426334

'Better medicines for children' within the Integrated Management of Childhood Illness framework: a qualitative inquiry in Uganda.

PubMed

Nsabagasani, Xavier; Ogwal-Okeng, Japer; Hansen, Ebba Holme; Mbonye, Anthony; Muyinda, Herbert; Ssengooba, Freddie

2016-01-01

The Integrated Management of Childhood Illnesses is the main approach for treating children in more than 100 low income countries worldwide. In 2007, the World Health Assembly urged countries to integrate 'better medicines for children' into their essential medicines lists and treatment guidelines. WHO regularly provides generic algorithms for IMCI and publishes the Model Essential Medicines List with child-friendly medicines based on new evidence for member countries to adopt. However, the status of 'better medicines for children' within the Integrated Management of Childhood Illnesses approach in Uganda has not been studied. Qualitative interviews were conducted with: two officials from the ministry of health; two district health officials and, 22 health workers from public health facilities. Interview transcripts were manually analyzed for manifest and latent content. Child-appropriate dosage formulations were not included in the package for the Integrated Management of Childhood Illnesses and ministry officials attributed this to resource constraints and lack of initial guidance from the World Health Organization. Underfunding reportedly undercut efforts to: orient health workers; do support supervision and update treatment guidelines to reflect 'better medicines for children'. Health workers reported difficulties in administering tablets and capsules to under-five children and that's why they preferred liquid oral dosage formulations, suppositories and injections. The IMCI strategy in Uganda was not revised to reflect child-appropriate dosage formulations - a missed opportunity for improving the quality of management of childhood illnesses. Funding was an obstacle to the integration of child-appropriate dosage formulations. Ministry of health should prioritize funding for the Integrated Management of Childhood Illnesses and revising the Essential Medicines and Health Supplies List of Uganda, the Uganda Clinical Guidelines and, the Treatment Charts for the Integrated Management of Childhood Illnesses to reflect child-appropriate dosage formulations.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

PubMed

Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E

2012-09-01

Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR₄ = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Generic immunosuppression in solid organ transplantation: a Canadian perspective.

PubMed

Harrison, Jennifer J; Schiff, Jeffrey R; Coursol, Christian J; Daley, Christopher J A; Dipchand, Anne I; Heywood, Norine M; Keough-Ryan, Tammy M; Keown, Paul A; Levy, Gary A; Lien, Dale C; Wichart, Jenny R; Cantarovich, Marcelo

2012-04-15

The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.

Scenario tree model for animal disease freedom framed in the OIE context using the example of a generic swine model for Aujeszky's disease in commercial swine in Canada.

PubMed

Christensen, Jette; Vallières, André

2016-01-01

"Freedom from animal disease" is an ambiguous concept that may have a different meaning in trade and science. For trade alone, there are different levels of freedom from OIE listed diseases. A country can: be recognized by OIE to be "officially free"; self-declare freedom, with no official recognition by the OIE; or report animal disease as absent (no occurrence) in six-monthly reports. In science, we apply scenario tree models to calculate the probability of a population being free from disease at a given prevalence to provide evidence of freedom from animal disease. Here, we link science with application by describing how a scenario tree model may contribute to a country's claim of freedom from animal disease. We combine the idea of a standardized presentation of scenario tree models for disease freedom and having a similar model for two different animal diseases to suggest that a simple generic model may help veterinary authorities to build and evaluate scenario tree models for disease freedom. Here, we aim to develop a generic scenario tree model for disease freedom that is: animal species specific, population specific, and has a simple structure. The specific objectives were: to explore the levels of freedom described in the OIE Terrestrial Animal Health Code; to describe how scenario tree models may contribute to a country's claim of freedom from animal disease; and to present a generic swine scenario tree model for disease freedom in Canada's domestic (commercial) swine applied to Aujeszky's disease (AD). In particular, to explore how historical survey data, and data mining may affect the probability of freedom and to explore different sampling strategies. Finally, to frame the generic scenario tree model in the context of Canada's claim of freedom from AD. We found that scenario tree models are useful to support a country's claim of freedom either as "recognized officially free" or as part of a self-declaration but the models should not stand alone in a claim. The generic AD scenario tree model demonstrated the benefit of combining three sources of surveillance data and helped to design the surveillance for the next year. The generic AD scenario model is one piece in Canada's self-declaration of freedom from AD. The model is strongly supported by the fact that AD has never been detected in Canada. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Generic substitution of lamotrigine among medicaid patients with diverse indications: a cohort-crossover study.

PubMed

Hartung, Daniel M; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C

2012-08-01

Controversy exists about the safety of substituting generic antiepileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient's past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine, although a type II error cannot be ruled out.

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2014-10-01

Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

A geometrical upper bound on the inflaton range

NASA Astrophysics Data System (ADS)

Cicoli, Michele; Ciupke, David; Mayrhofer, Christoph; Shukla, Pramod

2018-05-01

We argue that in type IIB LVS string models, after including the leading order moduli stabilisation effects, the moduli space for the remaining flat directions is compact due the Calabi-Yau Kähler cone conditions. In cosmological applications, this gives an inflaton field range which is bounded from above, in analogy with recent results from the weak gravity and swampland conjectures. We support our claim by explicitly showing that it holds for all LVS vacua with h 1,1 = 3 obtained from 4-dimensional reflexive polytopes. In particular, we first search for all Calabi-Yau threefolds from the Kreuzer-Skarke list with h 1,1 = 2, 3 and 4 which allow for LVS vacua, finding several new LVS geometries which were so far unknown. We then focus on the h 1,1 = 3 cases and show that the Kähler cones of all toric hypersurface threefolds force the effective 1-dimensional LVS moduli space to be compact. We find that the moduli space size can generically be trans-Planckian only for K3 fibred examples.

Expert systems for fault diagnosis in nuclear reactor control

NASA Astrophysics Data System (ADS)

Jalel, N. A.; Nicholson, H.

1990-11-01

An expert system for accident analysis and fault diagnosis for the Loss Of Fluid Test (LOFT) reactor, a small scale pressurized water reactor, was developed for a personal computer. The knowledge of the system is presented using a production rule approach with a backward chaining inference engine. The data base of the system includes simulated dependent state variables of the LOFT reactor model. Another system is designed to assist the operator in choosing the appropriate cooling mode and to diagnose the fault in the selected cooling system. The response tree, which is used to provide the link between a list of very specific accident sequences and a set of generic emergency procedures which help the operator in monitoring system status, and to differentiate between different accident sequences and select the correct procedures, is used to build the system knowledge base. Both systems are written in TURBO PROLOG language and can be run on an IBM PC compatible with 640k RAM, 40 Mbyte hard disk and color graphics.

The WHO/PEPFAR collaboration to prepare an operations manual for HIV prevention, care, and treatment at primary health centers in high-prevalence, resource-constrained settings: defining laboratory services.

PubMed

Spira, Thomas; Lindegren, Mary Lou; Ferris, Robert; Habiyambere, Vincent; Ellerbrock, Tedd

2009-06-01

The expansion of HIV/AIDS care and treatment in resource-constrained countries, especially in sub-Saharan Africa, has generally developed in a top-down manner. Further expansion will involve primary health centers where human and other resources are limited. This article describes the World Health Organization/President's Emergency Plan for AIDS Relief collaboration formed to help scale up HIV services in primary health centers in high-prevalence, resource-constrained settings. It reviews the contents of the Operations Manual developed, with emphasis on the Laboratory Services chapter, which discusses essential laboratory services, both at the center and the district hospital level, laboratory safety, laboratory testing, specimen transport, how to set up a laboratory, human resources, equipment maintenance, training materials, and references. The chapter provides specific information on essential tests and generic job aids for them. It also includes annexes containing a list of laboratory supplies for the health center and sample forms.

Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.

PubMed

Setnik, Beatrice; Cone, Edward J

2016-01-01

Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

PubMed Central

Johnston, Atholl

2013-01-01

The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation, the implications of the approval process for generic drugs on treatment efficacy and safety, and the effective management of substitutions between products. PMID:24089632

A new generic system for the pantropical Caesalpinia group (Leguminosae).

PubMed

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E; de Queiroz, Luciano Paganucci; Lewis, Gwilym P

2016-01-01

The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera ( Poincianella , Erythrostemon , Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera ( Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others ( Moullava , Cenostigma , Libidibia and Erythrostemon ), contraction of Caesalpinia s.s. and description of four new ones ( Gelrebia , Paubrasilia , Hererolandia and Hultholia ), and make 75 new nomenclatural combinations in this new generic system.

THttpServer class in ROOT

NASA Astrophysics Data System (ADS)

Adamczewski-Musch, Joern; Linev, Sergey

2015-12-01

The new THttpServer class in ROOT implements HTTP server for arbitrary ROOT applications. It is based on Civetweb embeddable HTTP server and provides direct access to all objects registered for the server. Objects data could be provided in different formats: binary, XML, GIF/PNG, and JSON. A generic user interface for THttpServer has been implemented with HTML/JavaScript based on JavaScript ROOT development. With any modern web browser one could list, display, and monitor objects available on the server. THttpServer is used in Go4 framework to provide HTTP interface to the online analysis.

User requirements for NASA data base management systems. Part 1: Oceanographic discipline

NASA Technical Reports Server (NTRS)

Fujimoto, B.

1981-01-01

Generic oceanographic user requirements were collected and analyzed for use in developing a general multipurpose data base management system for future missions of the Office of Space and Terrestrial Applications (OSTA) of NASA. The collection of user requirements involved; studying the state-of-the-art technology in data base management systems; analyzing the results of related studies; formulating a viable and diverse list of scientists to be interviewed; developing a presentation format and materials; and interviewing oceanographic data users. More effective data management systems are needed to handle the increasing influx of data.

Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

PubMed

Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

2014-06-13

Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation.

Purely in silico BCS classification: science based quality standards for the world's drugs.

PubMed

Dahan, Arik; Wolk, Omri; Kim, Young Hoon; Ramachandran, Chandrasekharan; Crippen, Gordon M; Takagi, Toshihide; Bermejo, Marival; Amidon, Gordon L

2013-11-04

BCS classification is a vital tool in the development of both generic and innovative drug products. The purpose of this work was to provisionally classify the world's top selling oral drugs according to the BCS, using in silico methods. Three different in silico methods were examined: the well-established group contribution (CLogP) and atom contribution (ALogP) methods, and a new method based solely on the molecular formula and element contribution (KLogP). Metoprolol was used as the benchmark for the low/high permeability class boundary. Solubility was estimated in silico using a thermodynamic equation that relies on the partition coefficient and melting point. The validity of each method was affirmed by comparison to reference data and literature. We then used each method to provisionally classify the orally administered, IR drug products found in the WHO Model list of Essential Medicines, and the top-selling oral drug products in the United States (US), Great Britain (GB), Spain (ES), Israel (IL), Japan (JP), and South Korea (KR). A combined list of 363 drugs was compiled from the various lists, and 257 drugs were classified using the different in silico permeability methods and literature solubility data, as well as BDDCS classification. Lastly, we calculated the solubility values for 185 drugs from the combined set using in silico approach. Permeability classification with the different in silico methods was correct for 69-72.4% of the 29 reference drugs with known human jejunal permeability, and for 84.6-92.9% of the 14 FDA reference drugs in the set. The correlations (r(2)) between experimental log P values of 154 drugs and their CLogP, ALogP and KLogP were 0.97, 0.82 and 0.71, respectively. The different in silico permeability methods produced comparable results: 30-34% of the US, GB, ES and IL top selling drugs were class 1, 27-36.4% were class 2, 22-25.5% were class 3, and 5.46-14% were class 4 drugs, while ∼8% could not be classified. The WHO list included significantly less class 1 and more class 3 drugs in comparison to the countries' lists, probably due to differences in commonly used drugs in developing vs industrial countries. BDDCS classified more drugs as class 1 compared to in silico BCS, likely due to the more lax benchmark for metabolism (70%), in comparison to the strict permeability benchmark (metoprolol). For 185 out of the 363 drugs, in silico solubility values were calculated, and successfully matched the literature solubility data. In conclusion, relatively simple in silico methods can be used to estimate both permeability and solubility. While CLogP produced the best correlation to experimental values, even KLogP, the most simplified in silico method that is based on molecular formula with no knowledge of molecular structure, produced comparable BCS classification to the sophisticated methods. This KLogP, when combined with a mean melting point and estimated dose, can be used to provisionally classify potential drugs from just molecular formula, even before synthesis. 49-59% of the world's top-selling drugs are highly soluble (class 1 and class 3), and are therefore candidates for waivers of in vivo bioequivalence studies. For these drugs, the replacement of expensive human studies with affordable in vitro dissolution tests would ensure their bioequivalence, and encourage the development and availability of generic drug products in both industrial and developing countries.

Perceptions and utilization of generic medicines in Guatemala: a mixed-methods study with physicians and pharmacy staff.

PubMed

Flood, David; Mathieu, Irène; Chary, Anita; García, Pablo; Rohloff, Peter

2017-01-13

Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted. Interview questions related to perceptions of low-cost generic medicines, prescription and dispensing practices of generics in the treatment of two NCDs, diabetes and hypertension, and opinions about the roles of pharmacy staff and physicians in selecting medicines for patients. Pharmacy staff were recruited from a random sample of pharmacies and physicians were recruited from a convenience sample. Interview data were analyzed using a thematic approach for qualitative data as well as basic quantitative statistics. Pharmacy staff and physicians expressed doubt as to the safety and efficacy of low-cost generic medicines in Guatemala. The low cost of generic medicines was often perceived as proof of their inferior quality. In the case of diabetes and hypertension, the decision to utilize a generic medicine was based on multiple factors including the patient's financial situation, consumer preference, and, to a large extent, physician recommendations. Interventions to improve generic medication utilization in Guatemala must address the negative perceptions of physicians and pharmacy staff toward low-cost generics. Strengthening state capacity and transparency in the regulation and monitoring of the drug supply is a key goal of access-to-medicines advocacy in Guatemala.

Evaluation of safety in clinical use of generic paclitaxel [NK] for injection.

PubMed

Tsukiyama, Ikuto; Hotta, Kazuo; Takeuchi, Masayuki; Onishi, Masahumi; Toyama, Yukio; Saito, Hiroko; Sai, Yoshimichi; Miyamoto, Ken-Ichi; Hasegawa, Takaaki

2012-04-01

The introduction of generic drugs is a favored strategy in reducing medical costs, but some clinicians are often reluctant to use them because of lack of information with regard to their side effects. Generic paclitaxel [NK] differs from the proprietary version, Taxol®, in containing added citric acid and a more pure form of castor oil. However, little information exists regarding the effects of these additives on adverse events such as vascular pain, phlebitis, hypersensitivity and hepatic dysfunction. To compensate for this lack of information and to validate the safety of using generic paclitaxel, we investigated adverse events in response to generic paclitaxel [NK]. Our investigation focused on patients treated with both the proprietary formulation (Taxol® for injection) and the generic version(paclitaxel [NK] for injection)sequentially from April 2008 to March 2009. Adverse events were investigated retrospectively. Incidence of vascular pain, phlebitis and hypersensitivity was similar to that with the original product. Although the expression of some liver enzymes was slightly increased and some gastrointestinal events were reduced following generic paclitaxel [NK] treatment there was no statistically significant difference. The profiles of other adverse events were not significantly different. Increased vascular pain and phlebitis, predicted due to low pH conditions caused by citric acid, were not observed. Similarly, the pure castor oil included in generic paclitaxel [NK] did not influence hypersensitivity and hepatic function. We found no significant differences in our study of proprietary and generic paclitaxel [NK]. Thus, clinicians have no reason for prejudice against using generic paclitaxel [NK] on the basis of increased risk of side effects.

Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin.

PubMed

Olsson, Erika; Kälvemark Sporrong, Sofia

2012-12-01

Generic drug substitution reduces costs for medicines, but the downsides include unintentional double medication, confusion and anxiety among patients. Information from pharmacists affects patients' experiences of substitution with generic drugs. The aim of this study was to explore experiences and attitudes to generic substitution among Swedish community pharmacists. An interview guide was developed. Semi-structured interviews with community pharmacists were conducted and transcribed verbatim. Analysis was inductive; extracts from the transcripts were compared and combined to form themes and subcategories. Pharmacists from a heterogeneous convenience sample of pharmacies were interviewed until data saturation had been achieved. Sixteen pharmacists were interviewed. Three main themes and twelve subcategories were identified, with the main themes being the role of the pharmacist, pharmacists' concerns regarding patients, and the generic drug. Pharmacists found it positive that generic substitution decreases the costs for pharmaceuticals but also emphasized that the switch can confuse and worry patients, which could result in less benefit from treatment. Respondents claimed that generic substitution has changed the focus in the pharmacist-patient meeting towards economics and regulations. According to the interviewed pharmacists generic substitution is not primarily an issue of generic versus brand-name products, but concerns above all the challenges that the switch implies for patients and pharmacists. To prevent known confusion and concerns among patients it is important that community pharmacists acquire the necessary tools and knowledge to manage this situation; pharmacists themselves as well as pharmacy owners and authorities share responsibility for this. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Strategies That Delay Market Entry of Generic Drugs.

PubMed

Vokinger, Kerstin Noëlle; Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

2017-11-01

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

Knowledge and abilities catalog for nuclear power plant operators: Boiling water reactors, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-08-01

The Knowledge and Abilities Catalog for Nuclear Power Plant Operators: Boiling-Water Reactors (BWRs) (NUREG-1123, Revision 1) provides the basis for the development of content-valid licensing examinations for reactor operators (ROs) and senior reactor operators (SROs). The examinations developed using the BWR Catalog along with the Operator Licensing Examiner Standards (NUREG-1021) and the Examiner`s Handbook for Developing Operator Licensing Written Examinations (NUREG/BR-0122), will cover the topics listed under Title 10, Code of Federal Regulations, Part 55 (10 CFR 55). The BWR Catalog contains approximately 7,000 knowledge and ability (K/A) statements for ROs and SROs at BWRs. The catalog is organized intomore » six major sections: Organization of the Catalog, Generic Knowledge and Ability Statements, Plant Systems grouped by Safety Functions, Emergency and Abnormal Plant Evolutions, Components, and Theory. Revision 1 to the BWR Catalog represents a modification in form and content of the original catalog. The K/As were linked to their applicable 10 CFR 55 item numbers. SRO level K/As were identified by 10 CFR 55.43 item numbers. The plant-wide generic and system generic K/As were combined in one section with approximately one hundred new K/As. Component Cooling Water and Instrument Air Systems were added to the Systems Section. Finally, High Containment Hydrogen Concentration and Plant Fire On Site evolutions added to the Emergency and Abnormal Plant Evolutions section.« less

Generic versus brand-name drugs used in cardiovascular diseases.

PubMed

Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

2016-04-01

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.

76 FR 12960 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... population to which generalizations will be made, the sampling frame, the sample design (including... for submission for other generic mechanisms that are designed to yield quantitative results. The... generic clearance for qualitative information will not be used for quantitative information collections...

Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

PubMed

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

Generic tacrolimus in solid organ transplantation.

PubMed

Taube, D; Jones, G; O'Beirne, J; Wennberg, L; Connor, A; Rasmussen, A; Backman, L

2014-05-01

The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other SOT patients, including lung and heart recipients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pharmaceutical policies in European countries.

PubMed

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Allergenic Ingredients in Facial Wet Wipes.

PubMed

Aschenbeck, Kelly A; Warshaw, Erin M

Allergic contact dermatitis commonly occurs on the face. Facial cleansing wipes may be an underrecognized source of allergens. The aim of this study was to determine the frequency of potentially allergenic ingredients in facial wet wipes. Ingredient lists from name brand and generic facial wipes from 4 large retailers were analyzed. In the 178 facial wipes examined, a total of 485 ingredients were identified (average, 16.7 ingredients per wipe). Excluding botanicals, the top 15 potentially allergenic ingredients were glycerin (64.0%), fragrance (63.5%), phenoxyethanol (53.9%), citric acid (51.1%), disodium EDTA (44.4%), sorbic acid derivatives (39.3%), tocopherol derivatives (38.8%), polyethylene glycol derivatives (32.6%), glyceryl stearate (31.5%), sodium citrate (29.8%), glucosides (27.5%), cetearyl alcohol (25.8%), propylene glycol (25.3%), sodium benzoate (24.2%), and ceteareth-20 (23.6%)/parabens (23.6%). Of note, methylisothiazolinone (2.2%) and methylchloroisothiazolinone (1.1%) were uncommon. The top potential allergens of botanical origin included Aloe barbadensis (41.0%), chamomile extracts (27.0%), tea extracts (21.3%), Cucumis sativus (20.2%), and Hamamelis virginiana (10.7%). Many potential allergens are present in facial wet wipes, including fragrances, preservatives, botanicals, glucosides, and propylene glycol.

A case study in generic drug use: should there be risk adjustment in incentive payments for the use of generic medications?

PubMed

Walton, Surrey M; Rash, Christine; Lambert, Bruce L; Galanter, William L

2014-11-01

Encouraging generic drug use has reduced health care costs for payers and consumers, but the availability of therapeutically interchangeable medications or generic medications of choice is not equal across disease states. The extent to which systems of care are able to substitute with generics is not well understood.  To (a) define and measure the maximum generic rate (MGR) of currently prescribed drugs within an academic medical group in and (b) illustrate differences across drugs associated with selected underlying diseases.   Prescription claims data were examined from an academic medical group in Chicago, Illinois. Based on pharmacologic and therapeutic criteria, drugs were classified into 2 categories-potentially substitutable and not potentially substitutable-based on whether the drugs are branded forms of the same chemical entities that are available as generics or are therapeutically interchangeable with other medications that have different chemical compositions but the same mechanisms of action and potential efficacy. A medication was considered potentially substitutable if it (a) did not have a narrow therapeutic index as defined by the FDA; (b) did not belong to 1 of 6 protected classes of drugs in the Medicare D provisions; (c) was substitutable with a generic medication containing the same chemical entity; or (d) was therapeutically interchangeable with a therapeutically equivalent medication. MGR was defined as the percentage of prescriptions that could potentially be prescribed in generic form. This rate was examined overall and across drugs known to be associated with illustrative diseases including hypertension, diabetes mellitus, and obstructive lung diseases.   The MGR ranged from 100% for drugs used in hypertension to 26.7% for drugs used in obstructive lung diseases. The MGR was 83.6%.  Payers wishing to promote generic substitution should incorporate the potential for substitution of clinically appropriate generic medications as part of incentives for generic utilization to avoid unintended consequences of using a fixed target rate. A practical methodology for determining an MGR is offered.

[Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

PubMed

González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

2003-01-01

Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

Generic Escherichia coli Contamination of Spinach at the Preharvest Stage: Effects of Farm Management and Environmental Factors

PubMed Central

Navratil, Sarah; Gregory, Ashley; Bauer, Arin; Srinath, Indumathi; Jun, Mikyoung; Szonyi, Barbara; Nightingale, Kendra; Anciso, Juan; Ivanek, Renata

2013-01-01

The objective of this study was to determine the effects of farm management and environmental factors on preharvest spinach contamination with generic Escherichia coli as an indicator of fecal contamination. A repeated cross-sectional study was conducted by visiting spinach farms up to four times per growing season over a period of 2 years (2010 to 2011). Spinach samples (n = 955) were collected from 12 spinach farms in Colorado and Texas as representative states of the Western and Southwestern United States, respectively. During each farm visit, farmers were surveyed about farm-related management and environmental factors using a questionnaire. Associations between the prevalence of generic E. coli in spinach and farm-related factors were assessed by using a multivariable logistic regression model including random effects for farm and farm visit. Overall, 6.6% of spinach samples were positive for generic E. coli. Significant risk factors for spinach contamination with generic E. coli were the proximity (within 10 miles) of a poultry farm, the use of pond water for irrigation, a >66-day period since the planting of spinach, farming on fields previously used for grazing, the production of hay before spinach planting, and the farm location in the Southwestern United States. Contamination with generic E. coli was significantly reduced with an irrigation lapse time of >5 days as well as by several factors related to field workers, including the use of portable toilets, training to use portable toilets, and the use of hand-washing stations. To our knowledge, this is the first report of an association between field workers' personal hygiene and produce contamination with generic E. coli at the preharvest level. Collectively, our findings support that practice of good personal hygiene and other good farm management practices may reduce produce contamination with generic E. coli at the preharvest level. PMID:23666336

Prescribing patterns of rural family physicians: a study in Kermanshah Province, Iran.

PubMed

Ahmadi, Fariba; Zarei, Ehsan

2017-11-28

The inappropriate use of drugs due to irrational prescriptions is a common problem in Iran, but there is little evidence of prescription patterns in rural family physicians. This study aimed to explore the prescribing pattern and rational drug use indicators for family physicians using Index of Rational Drug Prescribing (IRDP) in Kermanshah Province, Iran. In this retrospective study, 352,399 prescriptions from 184 family physicians in 103 primary health care (PHC) centers were examined. As stated, an analysis was done for rational use indicators suggested by World Health Organization (WHO): e.g., the percentage of prescriptions containing antibiotics, injections, and those prescribed by a generic name and from a national essential medicine list, plus the average number of drugs per prescription; these factors were all taken into account. Rational drug use was studied with the IRDP. The average number of drugs per prescription was 3.14 (± 1.2) and the average cost per prescription was 116,740 IRR (USD 3.6). Around 19% of prescriptions had more than four drugs, while the percentage of prescriptions involving antibiotics and injections was 52.1% and 24.4%, respectively. There was 95.1% drugs prescribed by their generic name and 95.9% were retrieved from the essential drugs list. The value of the IRDP was 3.70 out of 5. The findings of this study showed that some degree of irrational drug prescribing exists among family physicians, especially in terms of injections, antibiotics, and polypharmacy. It is recommended that there be continuing education programs for physicians regarding rational prescribing for different kinds of medical indications. Clinical practice guidelines should also assist with the rational use of medicine.

Qualitative screening of undesirable compounds from feeds to fish by liquid chromatography coupled to mass spectrometry.

PubMed

Nácher-Mestre, Jaime; Ibáñez, María; Serrano, Roque; Pérez-Sánchez, Jaume; Hernández, Félix

2013-03-06

This paper describes the development, validation, and application of a rapid screening method for the detection and identification of undesirable organic compounds in aquaculture products. A generic sample treatment was applied without any purification or preconcentration step. After extraction of the samples with acetonitrile/water 80:20 (0.1% formic acid), the extracts were centrifuged and directly injected in the LC-HRMS system, consisting of ultra-high performance liquid chromatography coupled to hybrid quadrupole time-of-flight mass spectrometry (UHPLC-QTOF MS). A qualitative validation was carried out for over 70 representative compounds, including antibiotics, pesticides, and mycotoxins, in fish feed and fish fillets spiked at 20 and 100 μg/kg. At the highest level, the great majority of compounds were detected (using the most abundant ion, typically the protonated molecule) and unequivocally identified (on the basis of the presence of two accurate-mass measured ions). At the 20 μg/kg level, many contaminants could already be detected, although identification using two ions was not fully reached for some of them, mainly in fish feed due to the complexity of this matrix. Subsequent application of this screening methodology to aquaculture samples made it possible to find several compounds from the target list, such as the antibiotic ciprofloxacin, the insecticide pirimiphos-methyl, and the mycotoxins fumonisin B2 and zearalenone. A retrospective analysis of accurate-mass full-spectrum acquisition data provided by QTOF MS was also made, without either reprocessing or injecting the samples. This allowed the detection and tentative identification of other organic undesirables different from those included in the validated list.

The Effectiveness of a Web-Based Computer-Tailored Intervention on Workplace Sitting: A Randomized Controlled Trial.

PubMed

De Cocker, Katrien; De Bourdeaudhuij, Ilse; Cardon, Greet; Vandelanotte, Corneel

2016-05-31

Effective interventions to influence workplace sitting are needed, as office-based workers demonstrate high levels of continued sitting, and sitting too much is associated with adverse health effects. Therefore, we developed a theory-driven, Web-based, interactive, computer-tailored intervention aimed at reducing and interrupting sitting at work. The objective of our study was to investigate the effects of this intervention on objectively measured sitting time, standing time, and breaks from sitting, as well as self-reported context-specific sitting among Flemish employees in a field-based approach. Employees (n=213) participated in a 3-group randomized controlled trial that assessed outcomes at baseline, 1-month follow-up, and 3-month follow-up through self-reports. A subsample (n=122) were willing to wear an activity monitor (activPAL) from Monday to Friday. The tailored group received an automated Web-based, computer-tailored intervention including personalized feedback and tips on how to reduce or interrupt workplace sitting. The generic group received an automated Web-based generic advice with tips. The control group was a wait-list control condition, initially receiving no intervention. Intervention effects were tested with repeated-measures multivariate analysis of variance. The tailored intervention was successful in decreasing self-reported total workday sitting (time × group: P<.001), sitting at work (time × group: P<.001), and leisure time sitting (time × group: P=.03), and in increasing objectively measured breaks at work (time × group: P=.07); this was not the case in the other conditions. The changes in self-reported total nonworkday sitting, sitting during transport, television viewing, and personal computer use, objectively measured total sitting time, and sitting and standing time at work did not differ between conditions. Our results point out the significance of computer tailoring for sedentary behavior and its potential use in public health promotion, as the effects of the tailored condition were superior to the generic and control conditions. Clinicaltrials.gov NCT02672215; http://clinicaltrials.gov/ct2/show/NCT02672215 (Archived by WebCite at http://www.webcitation.org/6glPFBLWv).

The Effectiveness of a Web-Based Computer-Tailored Intervention on Workplace Sitting: A Randomized Controlled Trial

PubMed Central

De Bourdeaudhuij, Ilse; Cardon, Greet; Vandelanotte, Corneel

2016-01-01

Background Effective interventions to influence workplace sitting are needed, as office-based workers demonstrate high levels of continued sitting, and sitting too much is associated with adverse health effects. Therefore, we developed a theory-driven, Web-based, interactive, computer-tailored intervention aimed at reducing and interrupting sitting at work. Objective The objective of our study was to investigate the effects of this intervention on objectively measured sitting time, standing time, and breaks from sitting, as well as self-reported context-specific sitting among Flemish employees in a field-based approach. Methods Employees (n=213) participated in a 3-group randomized controlled trial that assessed outcomes at baseline, 1-month follow-up, and 3-month follow-up through self-reports. A subsample (n=122) were willing to wear an activity monitor (activPAL) from Monday to Friday. The tailored group received an automated Web-based, computer-tailored intervention including personalized feedback and tips on how to reduce or interrupt workplace sitting. The generic group received an automated Web-based generic advice with tips. The control group was a wait-list control condition, initially receiving no intervention. Intervention effects were tested with repeated-measures multivariate analysis of variance. Results The tailored intervention was successful in decreasing self-reported total workday sitting (time × group: P<.001), sitting at work (time × group: P<.001), and leisure time sitting (time × group: P=.03), and in increasing objectively measured breaks at work (time × group: P=.07); this was not the case in the other conditions. The changes in self-reported total nonworkday sitting, sitting during transport, television viewing, and personal computer use, objectively measured total sitting time, and sitting and standing time at work did not differ between conditions. Conclusions Our results point out the significance of computer tailoring for sedentary behavior and its potential use in public health promotion, as the effects of the tailored condition were superior to the generic and control conditions. Trial Registration Clinicaltrials.gov NCT02672215; http://clinicaltrials.gov/ct2/show/NCT02672215 (Archived by WebCite at http://www.webcitation.org/6glPFBLWv) PMID:27245789

Comparative effectiveness and costs of generic and brand-name gabapentin and venlafaxine in patients with neuropathic pain or generalized anxiety disorder in Spain.

PubMed

Sicras-Mainar, Antoni; Rejas-Gutiérrez, Javier; Navarro-Artieda, Ruth

2015-01-01

To explore adherence/persistence with generic gabapentin/venlafaxine versus brand-name gabapentin/venlafaxine (Neurontin(®)/Vandral(®)) in peripheral neuropathic pain (pNP) or generalized anxiety disorder (GAD), respectively, and whether it is translated into different costs and patient outcomes in routine medical practice. A retrospective, new-user cohort study was designed. Electronic medical records (EMR) of patients included in the health plan of Badalona Serveis Assistencials SA, Barcelona, Spain were exhaustively extracted for analysis. Participants were beneficiaries aged 18+ years, followed between 2008 and 2012, with a pNP/GAD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code, who initiated treatment with generic or brand-name gabapentin or venlafaxine. Assessments included 1-year treatment persistence and adherence (medication possession ratio), health care costs, and reduction in severity of pain and anxiety symptoms. A total of 2,210 EMR were analyzed; 1,369 on gabapentin (brand 400; generic 969) and 841 on venlafaxine (brand 370 and generic 471). Brand-name gabapentin and venlafaxine were both significantly associated with longer persistence than generic: 7.3 versus 6.3 months, P<0.001; and 8.8 versus 8.1 months, P<0.05, respectively. Brand-name was associated with higher adherence: 86.5% versus 81.3%, P<0.001; and 82.1% versus 79.0%, P<0.05, respectively. Adjusted average costs were higher with generic compared with brand: €1,277 versus €1,057 (difference of €220 per patient; P<0.001) for gabapentin; and €1,110 versus €928 (difference of €182 per patient; P=0.020) for venlafaxine, both because of more use of medical visits and concomitant medication. Compared with generic, brand-name was associated with higher reduction in pain (7.8%; P<0.001) and anxiety (13.2%; P<0.001). Patients initiating brand-name gabapentin or venlafaxine were more likely to adhere and persist on treatment of pNP or GAD, have lower health care costs, and show further reduction of pain and anxiety symptoms than with generic drugs in routine medical practice.

A new generic system for the pantropical Caesalpinia group (Leguminosae)

PubMed Central

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E.; de Queiroz, Luciano Paganucci; Lewis, Gwilym P.

2016-01-01

Abstract The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera (Poincianella, Erythrostemon, Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera (Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others (Moullava, Cenostigma, Libidibia and Erythrostemon), contraction of Caesalpinia s.s. and description of four new ones (Gelrebia, Paubrasilia, Hererolandia and Hultholia), and make 75 new nomenclatural combinations in this new generic system. PMID:28814915

77 FR 32144 - Agency Information Collection Activities: Comment Request; Generic Survey Clearance for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... Survey Clearance for the Directorate of Education and Human Resources (EHR) AGENCY: National Science.... The scope of the EHR Generic Clearance primarily covers descriptive information gathered from... evaluations of individual programs. The collections generally include three categories of descriptive data: (1...

77 FR 75110 - Agency Information Collection Activities: Proposed Collection; Comment Request-Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-19

...: Proposed Collection; Comment Request--Generic Clearance To Conduct Formative Research AGENCY: Food and.... This information collection will conduct research in support of FNS' goal of delivering science-based... target audience, FNS plans to conduct data collections that involve formative research including focus...

Incorporating a Generic Model of Subcutaneous Insulin Absorption into the AIDA v4 Diabetes Simulator 3. Early Plasma Insulin Determinations

PubMed Central

Lehmann, Eldon D.; Tarín, Cristina; Bondia, Jorge; Teufel, Edgar; Deutsch, Tibor

2009-01-01

Introduction AIDA is an interactive educational diabetes simulator that has been available without charge via the Internet for over 12 years. Recent articles have described the incorporation of a novel generic model of insulin absorption into AIDA as a way of enhancing its capabilities. The basic model components to be integrated have been overviewed, with the aim being to provide simulations of regimens utilizing insulin analogues, as well as insulin doses greater than 40 IU (the current upper limit within the latest release of AIDA [v4.3a]). Some preliminary calculated insulin absorption results have also recently been described. Methods This article presents the first simulated plasma insulin profiles from the integration of the generic subcutaneous insulin absorption model, and the currently implemented model in AIDA for insulin disposition. Insulin absorption has been described by the physiologically based model of Tarín and colleagues. A single compartment modeling approach has been used to specify how absorbed insulin is distributed in, and eliminated from, the human body. To enable a numerical solution of the absorption model, a spherical subcutaneous depot for the injected insulin dose has been assumed and spatially discretized into shell compartments with homogeneous concentrations, having as its center the injection site. The number of these compartments will depend on the dose and type of insulin. Insulin inflow arises as the sum of contributions to the different shells. For this report the first bench testing of plasma insulin determinations has been done. Results Simulated plasma insulin profiles are provided for currently available insulin preparations, including a rapidly acting insulin analogue (e.g., lispro/Humalog or aspart/Novolog), a short-acting (regular) insulin preparation (e.g., Actrapid), intermediate-acting insulins (both Semilente and neutral protamine Hagedorn types), and a very long-acting insulin analogue (e.g., glargine/Lantus), as well as for insulin doses up to 50 IU. Discussion The methodology to be adopted for implementing the generic absorption model within AIDA has been overviewed, and the first plasma insulin profiles based on this approach have been demonstrated. Ideas for future work and development are discussed. It is expected that an updated release of AIDA (v4.5), based on this collaborative approach, will become available for free—in due course—via the www.2aida.org Web site. Readers who wish to be informed when the new software is launched can join the very low volume AIDA announcement list by sending a blank email note to subscribe@2aida.org. PMID:20046665

Comparative analysis of the cost and effectiveness of generic and brand-name antibiotics: the case of uncomplicated urinary tract infection.

PubMed

Lin, Yu-Shiuan; Jan, I-Shiow; Cheng, Shou-Hsia

2017-03-01

Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

PubMed

Qian, Jingjing; Hansen, Richard A; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

2017-07-01

Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p < 0.001). The receipt of industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Switching between phenytoin generics in patients with epilepsy may lead to increased risk of breakthrough seizure: chart analysis and practice recommendations.

PubMed

Shin, Jung-Won; Chu, Kon; Jung, Keun-Hwa; Lee, Soon-Tae; Moon, Jangsup; Lee, Sang Kun

2014-12-01

The Food and Drug Administration (FDA) only requires bioequivalence testing of generic substitutions in order for them to be deemed equivalen to the original product. There may be a large difference of bioavailability among the generic drugs that especially have a narrow therapeutic index, and this may affect clinical outcomes. We aimed to determine whether switching from generic-to-generic equivalent anti-epileptic drugs (AEDs) in patients with epilepsy is associated with clinical outcomes. We performed a retrospective study using the electronic medical records of a tertiary hospital. Adults with a history of epilepsy who used a generic phenytoin and whose therapy was switched to another generic phenytoin between January 2012 and June 2013 were included (n = 80). We compared the drug concentration of phenytoin and seizure events before and after the switch. After switching their generic phenytoin, 33 out of 80 patients (41%) suffered from increasing seizure events (pre-interchange period, 0.44 ± 0.97; post-interchange period, 1.24 ± 2.05; p < 0.0001). The number of medical visits for acute seizure significantly increased in the post-interchange period. The phenytoin serum concentration of all the patients was lesser in the post-interchange period than in the pre-interchange period. (pre-interchange period, 12.79 μg/mL; post-interchange period, 6.36 μg/mL; p < 0.0001). Among the patients with drug resistant epilepsy (DRE), 17 patients (84.2%) had increasing seizure events in the post-interchange period. We confirmed that there was a significant difference in bioavailability between generic phenytoin. Therefore, when using or switching generic anti-epileptic drugs, therapeutic drug monitoring must be done, and the patients' condition must be considered.

Economic evaluations of Internet interventions for mental health: a systematic review.

PubMed

Donker, T; Blankers, M; Hedman, E; Ljótsson, B; Petrie, K; Christensen, H

2015-12-01

Internet interventions are assumed to be cost-effective. However, it is unclear how strong this evidence is, and what the quality of this evidence is. A comprehensive literature search (1990-2014) in Medline, EMBASE, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database, Compendex and Inspec was conducted. We included economic evaluations alongside randomized controlled trials of Internet interventions for a range of mental health symptoms compared to a control group, consisting of a psychological or pharmaceutical intervention, treatment-as-usual (TAU), wait-list or an attention control group. Of the 6587 abstracts identified, 16 papers met the inclusion criteria. Nine studies featured a societal perspective. Results demonstrated that guided Internet interventions for depression, anxiety, smoking cessation and alcohol consumption had favourable probabilities of being more cost-effective when compared to wait-list, TAU, group cognitive behaviour therapy (CBGT), attention control, telephone counselling or unguided Internet CBT. Unguided Internet interventions for suicide prevention, depression and smoking cessation demonstrated cost-effectiveness compared to TAU or attention control. In general, results from cost-utility analyses using more generic health outcomes (quality of life) were less favourable for unguided Internet interventions. Most studies adhered reasonably to economic guidelines. Results of guided Internet interventions being cost-effective are promising with most studies adhering to publication standards, but more economic evaluations are needed in order to determine cost-effectiveness of Internet interventions compared to the most cost-effective treatment currently available.

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market.

PubMed

Coelho Neto, José; Lisboa, Fernanda L C

2017-07-01

Viagra and Cialis are among the most counterfeited medicines in many parts of the world, including Brazil. Despite the many studies that have been made regarding discrimination between genuine and counterfeit samples, most published works do not contemplate generic and similar versions of these medicines and also do not explore excipients/adjuvants contributions when characterizing genuine and suspected samples. In this study, we present our findings in exploring ATR-FTIR spectral profiles for characterizing both genuine and questioned samples of several generic and brand-name sildenafil- and tadalafil-based tablets available on the Brazilian market, including Viagra and Cialis. Multi-component spectral matching (deconvolution), objective visual comparison and correlation tests were used during analysis. Besides from allowing simple and quick identification of counterfeits, results obtained evidenced the strong spectral similarities between generic and brand-named tablets employing the same active ingredient and the indistinguishability between samples produced by the same manufacturer, generic or not. For all sildenafil-based and some tadalafil-based tablets tested, differentiation between samples from different manufacturers, attributed to slight variations in excipients/adjuvants proportions, was achieved, thus allowing the possibility of tracing an unknown/unidentified tablet back to a specific manufacturer. Copyright © 2017 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

Employability for Music Graduates: Malaysian Educational Reform and the Focus on Generic Skills

ERIC Educational Resources Information Center

Ghazali, Ghaziah; Bennett, Dawn

2017-01-01

In Malaysia, the demand for employable higher education graduates has resulted in a national strategy that outlines desirable graduate attributes including "hard," discipline-specific skills and "soft," generic skills. As a result, music programs are under pressure to become more relevant to the conditions and characteristics…

76 FR 29763 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... precision requirements or power calculations that justify the proposed sample size, the expected response... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' Also include...

Implementation of the Generic Safety Analysis Report - Lessons Learned

DOE Office of Scientific and Technical Information (OSTI.GOV)

Blanchard, A.

1999-06-02

The Savannah River Site has completed the development, review and approval process for the Generic Safety Analysis Report (GSAR) and implemented this information in facility SARs and BIOs. This includes the yearly revision of the GSAR and the facility-specific SARs. The process has provided us with several lessons learned.

Classrooms that Work: Teaching and Learning Generic Skills.

ERIC Educational Resources Information Center

Stasz, Cathleen

1994-01-01

Eight vocational and academic classes taught by four different teachers at three comprehensive high schools were studied to identify classroom practices that facilitate teaching and learning generic skills. The teachers studied had a mix of instructional goals for students, including subject matter knowledge and skills, complex reasoning skills…

76 FR 13436 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-11

... target population to which generalizations will be made, the sampling frame, the sample design (including... for submission for other generic mechanisms that are designed to yield quantitative results. The MSPB... insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that...

Impact of European pharmaceutical price regulation on generic price competition: a review.

PubMed

Puig-Junoy, Jaume

2010-01-01

Although economic theory indicates that it should not be necessary to intervene in the generic drug market through price regulation, most EU countries intervene in this market, both by regulating the maximum sale price of generics (price cap) and by setting the maximum reimbursement rate, especially by means of reference pricing systems. We analyse current knowledge of the impact of direct price-cap regulation of generic drugs and the implementation of systems regulating the reimbursement rate, particularly through reference pricing and similar tools, on dynamic price competition between generic competitors in Europe. A literature search was carried out in the EconLit and PubMed databases, and on Google Scholar. The search included papers published in English or Spanish between January 2000 and July 2009. Inclusion criteria included that studies had to present empirical results of a quantitative nature for EU countries of the impact of price capping and/or regulation of the reimbursement rate (reference pricing or similar systems) on price dynamics, corresponding to pharmacy sales, in the generic drug market. The available evidence indicates that price-cap regulation leads to a levelling off of generic prices at a higher level than would occur in the absence of this regulation. Reference pricing systems cause an obvious and almost compulsory reduction in the consumer price of all pharmaceuticals subject to this system, to a varying degree in different countries and periods, the reduction being greater for originator-branded drugs than for generics. In several countries with a reference pricing system, it was observed that generics with a consumer price lower than the reference price do not undergo price reductions until the reference price is reduced, even when there are other lower-priced generics on the market (absence of price competition below the reference price). Beyond the price reduction forced by the price-cap and/or reference pricing regulation itself, the entry of new generic competitors is useful for lowering the real transaction price of purchases made by pharmacies (dynamic price competition at ex-factory level), although this effect is weaker or non-significant for official ex-factory prices and consumer prices in some countries. When maximum reimbursement systems such as reference pricing or similar types are applied, pharmacies are seen to receive large discounts on the price they pay for the pharmaceuticals, although these discounts are not transferred to the consumer price. The percentage discount offered to pharmacies in a country that uses a price-cap system combined with reference pricing is positively and significantly related to the number of generic competitors in the market for the pharmaceutical (dynamic price competition at ex-factory level).

Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.

PubMed

Kohli, Erol; Buller, Allison

2013-02-01

US consumers spend more than $20 billion/year on over-the-counter (OTC) drugs. Although generic and brand name OTC drugs share the same active ingredients and undergo the same rigorous Food and Drug Administration approval process, brand name formulations continue to lead the OTC drug market with a higher market share. There is a limited amount of publicly available information regarding consumer perceptions and awareness about generic and brand name OTC drugs. The main objective of this research was to understand what factors influence US consumers to purchase generic versus brand name OTC drugs. The researchers used a 20-question, self-administered, multiple-choice survey to collect data on the factors influencing consumers' preferences for generic versus brand name OTC drugs. Results revealed that the single most influential factor for participants when purchasing OTC drugs was lower cost. Although economic factors play an important role in influencing consumers to choose generic formulations, a variety of other factors including advertisements, duration of the OTC effectiveness, severity of sickness, preferable form of OTC medication, safety of the OTC, relief of multiple symptoms, and preferred company will persuade others to pay more for brand name drugs. Ultimately, increased awareness and use of generic OTC drugs may result in substantial cost savings for consumers.

Branded versus generic clopidogrel in cardiovascular diseases: a systematic review.

PubMed

Caldeira, Daniel; Fernandes, Ricardo M; Costa, João; David, Cláudio; Sampaio, Cristina; Ferreira, Joaquim J

2013-04-01

In the United States, patent for branded Plavix has recently expired. Some studies have compared branded and generic clopidogrel in terms of pharmacokinetic parameters in healthy volunteers, but data on patients and clinical outcomes are scarce. We aimed to review efficacy and safety data from studies comparing Plavix with generic clopidogrel in patients with cardiovascular disease. Electronic databases were searched (from inception to May 2012) for prospective studies evaluating branded versus generic clopidogrel in patients with cardiovascular diseases. Studies' characteristics and data estimates were retrieved. Pooled risk ratio (RR) and 95% confidence intervals (95% CIs) were estimated through a random-effects model. Three studies evaluating 760 patients were included: 2 randomized controlled trials and 1 cohort study. The RR for major cardiovascular events was 1.01 (95% CI, 0.67-1.52). Incidence of adverse events was similar between Plavix and generic (RR 0.85; 95% CI, 0.49-1.48). The risks of mortality, bleeding, and drug discontinuation were also not different between groups. There are a limited number of studies comparing Plavix and generic clopidogrel in patients with cardiovascular diseases and reporting hard clinical end points. The available evidence is therefore limited and does not support the existence of differences in efficacy or safety between branded and generic clopidogrel.

Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?

PubMed

Allard, Julie; Fortin, Marie-Chantal

2014-01-01

This review was conducted to determine the ethical acceptability of prescribing generic immunosuppressive drugs to renal transplant patients. The literature search was conducted using Pubmed and Google Scholar. The use of generic immunosuppressive drugs (ISDs) in transplantation is a controversial topic. There is a consensus among transplant societies that clinical data is lacking and that caution should be exercised. The reluctance to use generic ISDs in organ transplantation is partly related to the fact that most are "critical dose drugs", and that either low dosing or overdosing could have serious adverse consequences for both patients and society (i.e., the loss of scarce organs). In this paper, we examine the various ethical issues involved such as distributive justice, physician duties, risks versus benefits, conflict of interest, informed consent, and logistical and economic issues. Our analysis was limited by the paucity of clinical data on generic ISDs and the absence of health economics studies to quantify the benefits of prescribing generic ISDs. Our study led us to conclude that it would be ethical to prescribe generic ISDs provided certain conditions were met. These include regulatory safeguards to minimize the risks of substitution; education of patients; and further clinical and health economics studies to better inform clinicians, patients and society of the risks and costs related to drug substitution.

Sick-listed persons' experiences with taking part in an in-patient occupational rehabilitation program based on Acceptance and Commitment Therapy: a qualitative focus group interview study.

PubMed

Rise, Marit B; Gismervik, Sigmund Ø; Johnsen, Roar; Fimland, Marius S

2015-11-27

Occupational medicine has shifted emphasis from disease treatment to disability rehabilitation and management. Hence, newly developed occupational rehabilitation programs are often generic and multicomponent, aiming to influence the sick-listed persons' perception on return to work, and thereby support the return to work process. The aim of this study was to explore sick-listed persons' experiences with taking part in an in-patient occupational rehabilitation program based on Acceptance and Commitment Therapy. Twenty-nine adults on sickness benefit or work assessment allowance due to musculoskeletal and/or common mental health disorders participated in this study. They were interviewed in focus groups at the beginning and at the end of a 3.5 week inpatient group-based occupational rehabilitation program in Central Norway. Key elements in the program were Acceptance and Commitment Therapy (ACT), physical exercise and creating a work-participation plan. The program was mainly group-based including participants with different diagnoses. Data was analyzed according to a phenomenological approach. At the start of the program most participants expressed frustration regarding being sick-listed, external anticipations as well as hindrances towards returning to work, and described hope that the program would provide them with the skills and techniques necessary to cope with health problems and being able to return to work. At the end of the program the participants described that they had embarked upon a long process of increased awareness. This process encompassed four areas; an increased awareness of what was important in life, realizing the strain from external expectations and demands, a need to balance different aspects of life, and return to work as part of a long and complex process. The occupational rehabilitation program induced a perceived meaningful reorientation encompassing several aspects of life. However, the return to work process was described as diffuse and uncertain for most participants. The providers of occupational rehabilitation program should balance this reorientation with specific steps towards return to work. Effect studies and long-term qualitative studies evaluating how this affects long-term work- and health outcomes are underway.

Rendering hospital budgets volume based and open ended to reduce waiting lists: does it work?

PubMed

van de Vijsel, Aart R; Engelfriet, Peter M; Westert, Gert P

2011-04-01

In the past decades fixed budgets for hospitals were replaced by reimbursement based on outputs in several countries in order to bring down waiting lists. This was also the case in the Netherlands where fixed global budgets were replaced by budgets that are to a large extent volume based and in practice open-ended. The objective of this study was to examine the effectiveness of this Dutch policy measure, which was implemented in 2001. We carried out a statistical analysis and interpretation of trends in Dutch hospital admission rates. We observed a significant turn in the development of in-patient admission rates after the abolition of budget caps in 2001: decreasing admission rates turned into an internationally exceptional increase of more than 3% per year. Day care admissions had already been rising explosively for two decades, but the pace increased after 2001. The increase in the number of admissions includes a broad range of patient categories that were not in the first place associated with long waiting times. The growth was attributable for a large part to admissions for observation of the patient and the evaluation of symptoms, not resulting in a definite medical diagnosis. We considered several factors, other than the availability of more resources, to explain the growth: the ageing of the population, making up for waiting list arrears, ditto for "under consumption" of unplanned care and, as to the growth of day care, substitution for inpatient care. However, these factors were all found to fall short as an explanation. Although waiting times have dropped since the change in the budget system, they continue to be long for several procedures. Our study indicates that making available more resources to admit patients, or otherwise an increase in hospital activity, do not in itself lead to equilibrium between demand and supply because the volume and composition of demand are partly induced by supply. We conclude that abolishing budget caps to solve waiting list problems is not efficient. Instead of a generic measure, a more focused approach is necessary. We suggest ingredients for such an approach. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®.

PubMed

Gasser, Urs E; Fischer, Anton; Timmermans, Jan P; Arnet, Isabelle

2013-04-23

By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson's disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original "shelf-life" specifications in use by Roche. Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to -7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical.

An annotated checklist of the planthoppers of Iran (Hemiptera, Auchenorrhyncha, Fulgoromorpha) with distribution data

PubMed Central

Mozaffarian, Fariba; Wilson, Michael R

2011-01-01

Abstract A list of Hemiptera Fulgoromorpha (planthoppers) of Iran is provided, based primarily on literature records from 1902 to the present. In total 15 families and 235 species are recorded, with taxonomic details. Distribution data in Iran are given. Iranissus ephedrinus Dlabola, 1980 is transferred from Issidae to Nogodinidae. To resolve nomenclatural difficulty the following new combinations in Issidae are given: Iranodus dumetorus (Dlabola, 1981), Iranodus khatunus (Dlabola, 1981) and Iranodus repandus (Dlabola, 1981). Due to published generic synonomy the following are new combinations: Duilius seticulosus (Lethierry, 1874), Duilius tamaricis (Puton & Lethierry, 1887), Duilius tamaricicola (Dubovsky, 1966) and Duilius v-atrum (Dlabola, 1985). PMID:22287883

DOE Office of Scientific and Technical Information (OSTI.GOV)

Collins, Benjamin S.

The Futility package contains the following: 1) Definition of the size of integers and real numbers; 2) A generic Unit test harness; 3) Definitions for some basic extensions to the Fortran language: arbitrary length strings, a parameter list construct, exception handlers, command line processor, timers; 4) Geometry definitions: point, line, plane, box, cylinder, polyhedron; 5) File wrapper functions: standard Fortran input/output files, Fortran binary files, HDF5 files; 6) Parallel wrapper functions: MPI, and Open MP abstraction layers, partitioning algorithms; 7) Math utilities: BLAS, Matrix and Vector definitions, Linear Solver methods and wrappers for other TPLs (PETSC, MKL, etc), preconditioner classes;more » 8) Misc: random number generator, water saturation properties, sorting algorithms.« less

Oxyuroids of palearctic Testudinidae--new definition for Alaeuris Seurat, 1918 (Nematoda: Pharyngodonidae) and redescription of Alaeuris numidica (Seurat, 1918).

PubMed

Bouamer, S; Morand, S; Bourgat, R

2001-02-01

The generic diagnosis of Alaeuris is emended based on the study and redescription of Alaeuris numidica from the cecum of Testudo graeca collected in Settat, Morocco and of Testudo hermanni collected in Catalonia, Spain. Scanning electron microscopy studies revealed that the papillae previously described as adanal are simple lobes because of the lack of terminal nerves, and that both preanal and postanal papillae are pedunculate. These new findings allowed us to emend the diagnosis of the genus and the species. A list of species of Alaeuris with biogeographic regions and hosts is provided.

Vehicle health management technology needs

NASA Technical Reports Server (NTRS)

Hammond, Walter E.; Jones, W. G.

1992-01-01

Background material on vehicle health management (VHM) and health monitoring/control is presented. VHM benefits are described and a list of VHM technology needs that should be pursued is presented. The NASA funding process as it impacts VHM technology funding is touched upon, and the VHM architecture guidelines for generic launch vehicles are described. An example of a good VHM architecture, design, and operational philosophy as it was conceptualized for the National Launch System program is presented. Consideration is given to the Strategic Avionics Technology Working Group's role in VHM, earth-to-orbit, and space vehicle avionics technology development considerations, and some actual examples of VHM benefits for checkout are given.

Analysis of 100 pharmaceuticals and their degradates in water samples by liquid chromatography/quadrupole time-of-flight mass spectrometry.

PubMed

Ferrer, Imma; Thurman, E Michael

2012-10-12

A straightforward methodology for the chromatographic separation and accurate mass identification of 100 pharmaceuticals including some of their degradation products was developed using liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF-MS). A table compiling the protonated or deprotonated exact masses for all compounds, as well as the exact mass of several fragment ions obtained by MS-MS is included. Excellent chromatographic separation was achieved by using 3.5 μm particle size columns and a slow and generic 30-min gradient. Isobaric and isomeric compounds (same nominal mass and same exact mass, respectively) were distinguished by various methods, including chromatography separation, MS-MS fragmentation, and isotopic signal identification. Method reporting limits of detection ranged from 1 to 1000 ng/L, after solid-phase extraction of 100mL aqueous samples. The methodology was successfully applied to the analysis of surface water impacted by wastewater effluent by identifying many of the pharmaceuticals and metabolites included in the list. Examples are given for some of the most unusual findings in environmental samples. This paper is meant to serve as a guide for those doing analysis of pharmaceuticals in environmental samples, by providing exact mass measurements of several well known, as well as newly identified and environmentally relevant pharmaceuticals in water samples. Copyright © 2012 Elsevier B.V. All rights reserved.

Pharmacists' views and reported practices in relation to a new generic drug substitution policy in Lebanon: a mixed methods study.

PubMed

El-Jardali, Fadi; Fadlallah, Racha; Morsi, Rami Z; Hemadi, Nour; Al-Gibbawi, Mounir; Haj, Magda; Khalil, Suzan; Saklawi, Youssef; Jamal, Diana; Akl, Elie A

2017-02-17

Governments in both developed and developing countries have adopted generic drug substitution policies to decrease pharmaceutical expenditures and improve access to medicine. In August 2015, the Ministry of Public Health (MOPH) in Lebanon introduced generic drug substitution and a unified medical prescription form as policy instruments to promote generic drug use. The objective of this exploratory study was to examine the attitudes of community pharmacists and the reported practices in relation to the implementation of the new generic drug substitution policy. We used a cross-sectional mixed methods approach composed of self-administered questionnaires and semi-structured interviews. The study population consisted of community pharmacists in Lebanon. We randomly approached one pharmacy personnel from each selected community pharmacy. We conducted descriptive analyses to assess responses to questionnaire and regression analyses to understand associations between responses and respondent demographics. We analyzed qualitative data thematically. Out of 204 invited community pharmacies, 153 pharmacies participated (75% response rate). The majority of respondents (64%) were in favor of generic drug substitution; however, less than half (40%) indicated they have substituted brand drugs for generic equivalents. Moreover, 57% indicated that the existing pricing system discourages them from performing generic drug substitution. Most respondents indicated that physicians are overusing the "non-substitutable" option (84%) and that there are technical problems with processing the new prescription form (78%). Less than half (47%) reported that the MOPH is performing regular audits on the forms collected by the pharmacy. While 45% of the respondents indicated that consumers have accepted most of the generic substitutions, 21% perceived the increase in generic drug dispensing to be significant. Findings suggested a potentially significant association between being informed about generic drugs and respondents' support of the policy. Suggested strategies to address implementation challenges included strengthening stewardship function of MOPH, securing full commitment of health care providers, conducting educational and awareness campaigns about generic drugs and generic drug substitution, and aligning incentive systems of the key stakeholders. The majority of community pharmacists were supportive of generic drug substitution in general but not of the current implementation of the policy in Lebanon. Findings revealed implementation challenges at the provider, patient, and system level which are hindering attainment of the policy objectives. The key lessons derived from this study can be used for continuous improvement of the policy and its implementation.

Pharmaceutical quality of generic isotretinoin products, compared with Roaccutane.

PubMed

Taylor, Peter W; Keenan, Michael H J

2006-03-01

Isotretinoin is the drug of choice for the management of severe recalcitrant nodular acne. Several generic products are available. However, their pharmaceutical quality, in particular particle size distribution, which may affect safety and efficacy is unknown. Hence, prescribing of some generic products may be problematic. To assess the pharmaceutical quality of 14 generic isotretinoin products compared with Roaccutane (F. Hoffmann-La Roche Ltd). Tests were performed according to Roche standard procedures, European and US pharmacopoeia specifications. Tests included isotretinoin content, identity and amount of impurities and degradation products, effect of accelerated shelf-life studies on stability, particle size distribution and composition of non-active ingredients. The 14 isotretinoin products differed by 30-fold in median particle size and showed variation in their non-active ingredients. The average isotretinoin content of Acnotin and Acne-Tretin fell outside the 95-105% Roche specifications. Following accelerated shelf-life tests, only four products retained isotretinoin content within Roche specifications, whilst Acne-Tretin (the only powder formulation) lost 72.5% isotretinoin content. Two generic products exceeded the +/- 2% specification (Ph. Eur.) and a further three exceeded the +/- 1% (USP) for tretinoin content, eight exceeded the 2.54% specification for total impurities and six contained >or= 5 unknown impurities. Isotretinoin-5.6-epoxide content exceeded the 1.04% specification in five generic products. Thirteen generic products failed to match Roaccutane in one or more tests and 11 failed in three or more tests. It cannot be assumed that all generic isotretinoin products are as therapeutically effective or safe as Roaccutane.

Preliminary Analysis of Assessment Instrument Design to Reveal Science Generic Skill and Chemistry Literacy

ERIC Educational Resources Information Center

Sumarni, Woro; Sudarmin; Supartono, Wiyanto

2016-01-01

The purpose of this research is to design assessment instrument to evaluate science generic skill (SGS) achievement and chemistry literacy in ethnoscience-integrated chemistry learning. The steps of tool designing refers to Plomp models including 1) Investigation Phase (Prelimenary Investigation); 2) Designing Phase (Design); 3)…

11 CFR 106.5 - Allocation of expenses between federal and non-federal activities by national party committees.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; (ii) Percentages to be allocated for administrative expenses and costs of generic voter drives by... drives, and of fundraising costs by national party committees; and (iv) Procedures for payment of... one committee through such program or event; and (iii) [Reserved] (iv) Generic voter drives including...

11 CFR 106.5 - Allocation of expenses between federal and non-federal activities by national party committees.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; (ii) Percentages to be allocated for administrative expenses and costs of generic voter drives by... drives, and of fundraising costs by national party committees; and (iv) Procedures for payment of... one committee through such program or event; and (iii) [Reserved] (iv) Generic voter drives including...

11 CFR 106.5 - Allocation of expenses between federal and non-federal activities by national party committees.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; (ii) Percentages to be allocated for administrative expenses and costs of generic voter drives by... drives, and of fundraising costs by national party committees; and (iv) Procedures for payment of... one committee through such program or event; and (iii) [Reserved] (iv) Generic voter drives including...

A Narrative Review of Generic Intervention Fidelity Measures

ERIC Educational Resources Information Center

Di Rezze, Briano; Law, Mary; Gorter, Jan Willem; Eva, Kevin; Pollock, Nancy

2012-01-01

To increase the rigor of pediatric rehabilitation research, there is a need to evaluate the degree to which an intervention is conducted as planned (i.e., fidelity). Generic fidelity measures evaluate more than one intervention and often include nonspecific attributes of the therapy process common to both interventions. The objective of this study…

Price regulation and generic competition in the pharmaceutical market.

PubMed

Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

2006-09-01

In March 2003 the Norwegian government implemented yardstick-based price regulation schemes on a selection of drugs subjected to generic competition. The retail price cap, termed the "index price," on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the six drugs (chemical entities) included in the index price system, we estimate a structural model enabling us to examine the impact of the reform on both demand and market power. Our results suggest that the index price helped to increase the market shares of generic drugs and succeeded in triggering price competition.

Impact of Internally Developed Electronic Prescription on Prescribing Errors at Discharge from the Emergency Department

PubMed Central

Hitti, Eveline; Tamim, Hani; Bakhti, Rinad; Zebian, Dina; Mufarrij, Afif

2017-01-01

Introduction Medication errors are common, with studies reporting at least one error per patient encounter. At hospital discharge, medication errors vary from 15%–38%. However, studies assessing the effect of an internally developed electronic (E)-prescription system at discharge from an emergency department (ED) are comparatively minimal. Additionally, commercially available electronic solutions are cost-prohibitive in many resource-limited settings. We assessed the impact of introducing an internally developed, low-cost E-prescription system, with a list of commonly prescribed medications, on prescription error rates at discharge from the ED, compared to handwritten prescriptions. Methods We conducted a pre- and post-intervention study comparing error rates in a randomly selected sample of discharge prescriptions (handwritten versus electronic) five months pre and four months post the introduction of the E-prescription. The internally developed, E-prescription system included a list of 166 commonly prescribed medications with the generic name, strength, dose, frequency and duration. We included a total of 2,883 prescriptions in this study: 1,475 in the pre-intervention phase were handwritten (HW) and 1,408 in the post-intervention phase were electronic. We calculated rates of 14 different errors and compared them between the pre- and post-intervention period. Results Overall, E-prescriptions included fewer prescription errors as compared to HW-prescriptions. Specifically, E-prescriptions reduced missing dose (11.3% to 4.3%, p <0.0001), missing frequency (3.5% to 2.2%, p=0.04), missing strength errors (32.4% to 10.2%, p <0.0001) and legibility (0.7% to 0.2%, p=0.005). E-prescriptions, however, were associated with a significant increase in duplication errors, specifically with home medication (1.7% to 3%, p=0.02). Conclusion A basic, internally developed E-prescription system, featuring commonly used medications, effectively reduced medication errors in a low-resource setting where the costs of sophisticated commercial electronic solutions are prohibitive. PMID:28874948

Impact of Internally Developed Electronic Prescription on Prescribing Errors at Discharge from the Emergency Department.

PubMed

Hitti, Eveline; Tamim, Hani; Bakhti, Rinad; Zebian, Dina; Mufarrij, Afif

2017-08-01

Medication errors are common, with studies reporting at least one error per patient encounter. At hospital discharge, medication errors vary from 15%-38%. However, studies assessing the effect of an internally developed electronic (E)-prescription system at discharge from an emergency department (ED) are comparatively minimal. Additionally, commercially available electronic solutions are cost-prohibitive in many resource-limited settings. We assessed the impact of introducing an internally developed, low-cost E-prescription system, with a list of commonly prescribed medications, on prescription error rates at discharge from the ED, compared to handwritten prescriptions. We conducted a pre- and post-intervention study comparing error rates in a randomly selected sample of discharge prescriptions (handwritten versus electronic) five months pre and four months post the introduction of the E-prescription. The internally developed, E-prescription system included a list of 166 commonly prescribed medications with the generic name, strength, dose, frequency and duration. We included a total of 2,883 prescriptions in this study: 1,475 in the pre-intervention phase were handwritten (HW) and 1,408 in the post-intervention phase were electronic. We calculated rates of 14 different errors and compared them between the pre- and post-intervention period. Overall, E-prescriptions included fewer prescription errors as compared to HW-prescriptions. Specifically, E-prescriptions reduced missing dose (11.3% to 4.3%, p <0.0001), missing frequency (3.5% to 2.2%, p=0.04), missing strength errors (32.4% to 10.2%, p <0.0001) and legibility (0.7% to 0.2%, p=0.005). E-prescriptions, however, were associated with a significant increase in duplication errors, specifically with home medication (1.7% to 3%, p=0.02). A basic, internally developed E-prescription system, featuring commonly used medications, effectively reduced medication errors in a low-resource setting where the costs of sophisticated commercial electronic solutions are prohibitive.

High prevalence of body dysmorphic disorder symptoms in patients seeking rhinoplasty.

PubMed

Picavet, Valerie A; Prokopakis, Emmanuel P; Gabriëls, Lutgardis; Jorissen, Mark; Hellings, Peter W

2011-08-01

Nasal aesthetic deformities may be associated with significant body image dissatisfaction. The only diagnostic category in the current list of psychiatric disorders that directly addresses these concerns is body dysmorphic disorder. This large-scale study determined the prevalence of body dysmorphic disorder and its symptoms in patients seeking rhinoplasty and evaluated the clinical profile of these patients. Two hundred twenty-six patients were given questionnaires including demographic characteristics, visual analogue scales for nasal shape, the Yale-Brown Obsessive Compulsive Scale modified for body dysmorphic disorder to assess severity of symptoms, a generic quality-of-life questionnaire, and the Derriford Appearance Scale 59, to assess appearance-related disruption of everyday living. Independent observers scored the nasal shape. Thirty-three percent of patients showed at least moderate symptoms of body dysmorphic disorder. Aesthetic goals (p < 0.001), revision rhinoplasty (p = 0.003), and psychiatric history (p = 0.031) were associated with more severe symptoms. There was no correlation between the objective and subjective scoring of the nasal shape. Yale-Brown scale modified for body dysmorphic disorder scores correlated inversely with the subjective nasal scoring (n = 210, p < 0.001), without relation to the objective deformity of the nose. Body dysmorphic disorder symptoms significantly reduced the generic quality of life (n = 160, p < 0.001) and led to significant appearance-related disruption of everyday living (n = 161, p < 0.001). The prevalence of moderate to severe body dysmorphic disorder symptoms in an aesthetic rhinoplasty population is high. Patients undergoing revision rhinoplasty and with psychiatric history are particularly at risk. Body dysmorphic disorder symptoms significantly reduce the quality of life and cause significant appearance-related disruption of everyday living. Risk, III.

[Clinical experience with 53 consecutive heart transplants].

PubMed

Villavicencio, Mauricio; Rossel, Víctor; Larrea, Ricardo; Peralta, Juan Pablo; Larraín, Ernesto; Sung Lim, Jong; Rojo, Pamela; Gajardo, Francesca; Donoso, Erika; Hurtado, Margarita

2013-12-01

Heart transplantation is the therapy of choice for advance heart failure. Our group developed two transplant programs at Instituto Nacional del Tórax and Clínica Dávila. We report our clinical experience based on distinctive clinical policies. Fifty-three consecutive patients were transplanted between November 2008 and April 2013, representing 51% of all Chilean cases. Distinctive clinical policies include intensive donor management, generic immunosuppression and VAD (ventricular assist devices) insertion. Ischemic or dilated cardiomyopathy were the main indications (23 (43%) each), age 48 ± 13 years and 48 (91%) were male. Transplant listing Status: IA 14 (26%) (VAD or 2 inotropes), IB 14 (26%) (1 inotrope) and II25 (47%) (no inotrope). Mean waiting time 70 ± 83 days. Twelve (24%) were transplanted during VAD support (median support: 36 days). orthotopic bicaval transplant with ischemia time: 175 ± 54 min. Operative mortality: 3 (6%), all due to right ventricular failure. Re-exploration for bleeding 2 (4%), stroke 3 (6%), mediastinitis 0 (0%), pneumonia 4 (8%), and transient dialysis 6 (11%). Mean follow-up was 21 ± 14 months. Three-year survival was 86 ± 6%. One patient died of Pneumocystis jirovecii pneumonia and the other died suddenly (non-compliance). Freedom from rejection requiring specific therapy was 80 ± 7% at 3 years of follow-up. Four hundred eighty four endomyocardial biopsies were done: 11 (2.3%) had 2R rejection. All survivors are in NYHA (New York Heart Association) functional class I and all but one have normal biventricular function. Mid-term results are similar to those reported by the registry of the International Society for Heart and Lung Transplantation. This experience has a higher proportion of VAD support than previous national series. Rejection rates are low in spite of generic immunosuppression.

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

PubMed Central

Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

2018-01-01

Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine-benazepril capsules), with an overall rate of 8.2 per 100 person years across all drug products. Adjusted switchback rates were consistently lower for patients who switched from branded to authorized generic drug products compared with branded to generic drug products in the primary cohort (pooled hazard ratio 0.72, 95% confidence interval 0.64 to 0.81). Similar results (0.75, 0.62 to 0.91) were observed in the replication cohort. Conclusion Switching from branded to authorized generic drug products was associated with lower switchback rates compared with switching from branded to generic drug products. PMID:29615391

Comparing the effectiveness of using generic and specific search terms in electronic databases to identify health outcomes for a systematic review: a prospective comparative study of literature search methods

PubMed Central

MacLean, Alice; Sweeting, Helen; Hunt, Kate

2012-01-01

Objective To compare the effectiveness of systematic review literature searches that use either generic or specific terms for health outcomes. Design Prospective comparative study of two electronic literature search strategies. The ‘generic’ search included general terms for health such as ‘adolescent health’, ‘health status’, ‘morbidity’, etc. The ‘specific’ search focused on terms for a range of specific illnesses, such as ‘headache’, ‘epilepsy’, ‘diabetes mellitus’, etc. Data sources The authors searched Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO and the Education Resources Information Center for studies published in English between 1992 and April 2010. Main outcome measures Number and proportion of studies included in the systematic review that were identified from each search. Results The two searches tended to identify different studies. Of 41 studies included in the final review, only three (7%) were identified by both search strategies, 21 (51%) were identified by the generic search only and 17 (41%) were identified by the specific search only. 5 of the 41 studies were also identified through manual searching methods. Studies identified by the two ELS differed in terms of reported health outcomes, while each ELS uniquely identified some of the review's higher quality studies. Conclusions Electronic literature searches (ELS) are a vital stage in conducting systematic reviews and therefore have an important role in attempts to inform and improve policy and practice with the best available evidence. While the use of both generic and specific health terms is conventional for many reviewers and information scientists, there are also reviews that rely solely on either generic or specific terms. Based on the findings, reliance on only the generic or specific approach could increase the risk of systematic reviews missing important evidence and, consequently, misinforming decision makers. However, future research should test the generalisability of these findings. PMID:22734117

[Policies encouraging price competition in the generic drug market: Lessons from the European experience].

PubMed

Puig-Junoy, Jaume

2010-01-01

To describe alternative policies aimed at encouraging price competition in generic drug markets in countries with strict price regulation, and to present some case studies drawn from the European experience. Systematic literature review of articles and technical reports published after 1999. The shortcomings in consumer price competition observed in some European generic markets, including Spain, may be reduced through three types of public reimbursement or financing reforms: policies aimed at improving the design of current maximum reimbursement level policies; policies aimed at monitoring competitive prices in order to reimburse real acquisition cost to pharmacies; and, more radical and market-oriented policies such as competitive tendering of public drug purchases. The experience of recent reforms adopted in Germany, Belgium, Holland, Norway, and Sweden offers a useful guide for highly price-regulated European countries, such as Spain, currently characterized by limited consumer price competition and the high discounts offered to pharmacy purchases. Direct price regulation and/or the generic reference pricing systems used to reduce generic drug prices in many European countries can be successfully reformed by adopting measures more closely aimed at encouraging consumer price competition in generic drug markets. Copyright 2009 SESPAS. Published by Elsevier Espana. All rights reserved.

Patient socioeconomic determinants of the choice of generic versus brand name drugs in the context of a reference price system: evidence from Belgian prescription data.

PubMed

Farfan-Portet, Maria-Isabel; Van de Voorde, Carine; Vrijens, France; Vander Stichele, Robert

2012-06-01

The generic reference price system (RPS) can impose a financial penalty for patients using a brand name drug instead of its generic alternative. Previous studies on the impact of the RPS have not considered the potentially differential effect of using generic alternatives for individuals with a different socioeconomic background. However, patients' characteristics might determine their overall knowledge of the existence of the system and thus of the financial burden to which they may be confronted. The association between patients' characteristics and the use of generic drugs versus brand name drugs was analyzed for ten highly prescribed pharmaceutical molecules included in the Belgian generic reference price system. Prescriptions were obtained from a 10% sample of all general practitioners in 2008 (corresponding to 120,670 adult patients and 368,101 prescriptions). For each pharmaceutical molecule, logistic regression models were performed, with independent variables for patient socioeconomic background at the individual level (work status, having a guaranteed income and being entitled to increased reimbursement of co-payments) and at the level of the neighborhood (education). The percentage of generic prescriptions ranged from 24.7 to 76.4%, and the mean reference supplement in 2008 ranged from €4.3 to €37.8. For seven molecules, higher use of a generic alternative was associated with either having a guaranteed income, with receiving increased reimbursement of co-payments or with living in areas with the lowest levels of education. Globally, results provided evidence that the generic RPS in Belgium does not lead to a higher financial burden on individuals from a low socioeconomic background.

Generic entry, reformulations and promotion of SSRIs in the US.

PubMed

Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

2008-01-01

Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays. The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.

Efficacy of generic allometric equations for estimating biomass: a test in Japanese natural forests.

PubMed

Ishihara, Masae I; Utsugi, Hajime; Tanouchi, Hiroyuki; Aiba, Masahiro; Kurokawa, Hiroko; Onoda, Yusuke; Nagano, Masahiro; Umehara, Toru; Ando, Makoto; Miyata, Rie; Hiura, Tsutom

2015-07-01

Accurate estimation of tree and forest biomass is key to evaluating forest ecosystem functions and the global carbon cycle. Allometric equations that estimate tree biomass from a set of predictors, such as stem diameter and tree height, are commonly used. Most allometric equations are site specific, usually developed from a small number of trees harvested in a small area, and are either species specific or ignore interspecific differences in allometry. Due to lack of site-specific allometries, local equations are often applied to sites for which they were not originally developed (foreign sites), sometimes leading to large errors in biomass estimates. In this study, we developed generic allometric equations for aboveground biomass and component (stem, branch, leaf, and root) biomass using large, compiled data sets of 1203 harvested trees belonging to 102 species (60 deciduous angiosperm, 32 evergreen angiosperm, and 10 evergreen gymnosperm species) from 70 boreal, temperate, and subtropical natural forests in Japan. The best generic equations provided better biomass estimates than did local equations that were applied to foreign sites. The best generic equations included explanatory variables that represent interspecific differences in allometry in addition to stem diameter, reducing error by 4-12% compared to the generic equations that did not include the interspecific difference. Different explanatory variables were selected for different components. For aboveground and stem biomass, the best generic equations had species-specific wood specific gravity as an explanatory variable. For branch, leaf, and root biomass, the best equations had functional types (deciduous angiosperm, evergreen angiosperm, and evergreen gymnosperm) instead of functional traits (wood specific gravity or leaf mass per area), suggesting importance of other traits in addition to these traits, such as canopy and root architecture. Inclusion of tree height in addition to stem diameter improved the performance of the generic equation only for stem biomass and had no apparent effect on aboveground, branch, leaf, and root biomass at the site level. The development of a generic allometric equation taking account of interspecific differences is an effective approach for accurately estimating aboveground and component biomass in boreal, temperate, and subtropical natural forests.

Evaluation of the clinical and economic impact of a brand name-to-generic warfarin sodium conversion program.

PubMed

Witt, Daniel M; Tillman, Donald J; Evans, Christy M; Plotkin, Tatyana V; Sadler, Melanie A

2003-03-01

Substitution of generic warfarin initially was discouraged because of concerns regarding therapeutic failure or toxicity. Although subsequent research with AB-rated (i.e., bioequivalent) warfarin did not confirm initial concerns, the issue is not settled for all clinicians. We sought to provide additional information regarding the clinical and economic impact of warfarin conversion by analyzing a real-life sample of patients receiving long-term anticoagulation therapy who were switched from brand name to generic warfarin. Patients who had been taking warfarin for at least 180 days and had received uninterrupted oral anticoagulation 90 days before and 90 days after switching to generic warfarin were included. The switch date was based on the first time generic warfarin was dispensed from our pharmacies. The primary end point was the calculated amount of time each patient's international normalized ratio (INR) values were within the patient-specific target INR range in the 90 days before and after the switch. Data regarding adverse events and medical resource utilization were also collected. Pharmacoeconomic analyses were performed. The analysis included 2299 patients. The overall difference in calculated time INR values were below (22.6% before vs 26.1% after switch, p<0.0001) and within (65.9% before vs 63.3% after switch, p=0.0002) the therapeutic INR range was statistically but not clinically significant. Only 28.0% of patients experienced a change in therapeutic INR control of 10% or less, 33.1% experienced INR control that improved by greater than 10%, and 38.9% experienced INR control that worsened by more than 10%. The difference in total treatment costs associated with brand name and generic warfarin was 3128 dollars/100 patient-years in favor of the generic product. Sensitivity analyses revealed that cost savings associated with warfarin conversion in this health care system were highly dependent on the difference between warfarin costs and cost of treating anticoagulation-related adverse events. Most of these patients were successfully switched from brand name to generic warfarin. However, supplemental INR monitoring is warranted when one warfarin product is substituted for another to allow timely detection of those patients who experience significant changes in anticoagulation response.

Space Station Furnace Facility. Volume 3: Program cost estimate

NASA Technical Reports Server (NTRS)

1992-01-01

The approach used to estimate costs for the Space Station Furnace Facility (SSFF) is based on a computer program developed internally at Teledyne Brown Engineering (TBE). The program produces time-phased estimates of cost elements for each hardware component, based on experience with similar components. Engineering estimates of the degree of similarity or difference between the current project and the historical data is then used to adjust the computer-produced cost estimate and to fit it to the current project Work Breakdown Structure (WBS). The SSFF Concept as presented at the Requirements Definition Review (RDR) was used as the base configuration for the cost estimate. This program incorporates data on costs of previous projects and the allocation of those costs to the components of one of three, time-phased, generic WBS's. Input consists of a list of similar components for which cost data exist, number of interfaces with their type and complexity, identification of the extent to which previous designs are applicable, and programmatic data concerning schedules and miscellaneous data (travel, off-site assignments). Output is program cost in labor hours and material dollars, for each component, broken down by generic WBS task and program schedule phase.

Resource use and cost implications of switching among warfarin formulations in atrial fibrillation patients.

PubMed

Kwong, Winghan Jacqueline; Kamat, Siddhesh; Fang, Christy

2012-12-01

Despite the uncertainty surrounding the safety of switching warfarin formulations, limited data exist on the resource use and costs associated with this switching pattern. To evaluate health care resource use and costs associated with switching warfarin formulations among patients with atrial fibrillation (AF) in a managed care organization. Patients diagnosed with AF (ICD-9 427.31) between July 2004 and August 2008 and who received warfarin therapy were identified in the HealthCore Integrated Research Database and categorized into 3 groups: users of generic warfarin formulations from a single drug manufacturer (generic-only group), users of branded warfarin formulations only (brand-only group), and patients who used generic and branded warfarin therapy interchangeably or who may have used generic drugs from 1 or more manufacturers (generic/brand switching group). Patients were followed 12 months or longer after their index warfarin prescription date to compare all-cause resource use and costs using multivariable regression analysis. The analysis included 12,908 patients: 71.82% were in the genericonly group, 9.61% were in the brand-only group, and 18.57% were in the generic/brand switching group. Patients in the generic/brand switching group were more likely to be hospitalized (relative risk [RR] = 1.43, p < 0.0001) or to use emergency department services (RR = 1.20, p < 0.01), compared to the brand-only users. Hospitalizations were more likely (RR = 1.26, p < 0.001) to occur among generic-only users versus brand-only users. Adjusted mean pharmacy costs per member per month were lower in the generic/brand switching group compared to the brand-only group ($257 vs $273, p = 0.038), but inpatient costs were higher ($1250 vs $972, p < 0.001), resulting in higher ($2125 vs $1847, p < 0.001) total costs. Generic-only users had lower pharmacy costs compared to brand-only users ($246 vs $273, p < 0.001), but total health care costs trended to be higher in the generic-only group ($1957 vs $1847, p = 0.053). The use of both generic and branded formulations of warfarin interchangeably, or the use of generics from more than 1 manufacturer, was associated with increased use of all-cause health care resources and total costs in patients with AF.

Calibration data Analysis Package (CAP): An IDL based widget application for analysis of X-ray calibration data

NASA Astrophysics Data System (ADS)

Vaishali, S.; Narendranath, S.; Sreekumar, P.

An IDL (interactive data language) based widget application developed for the calibration of C1XS (Narendranath et al., 2010) instrument on Chandrayaan-1 is modified to provide a generic package for the analysis of data from x-ray detectors. The package supports files in ascii as well as FITS format. Data can be fitted with a list of inbuilt functions to derive the spectral redistribution function (SRF). We have incorporated functions such as `HYPERMET' (Philips & Marlow 1976) including non Gaussian components in the SRF such as low energy tail, low energy shelf and escape peak. In addition users can incorporate additional models which may be required to model detector specific features. Spectral fits use a routine `mpfit' which uses Leven-Marquardt least squares fitting method. The SRF derived from this tool can be fed into an accompanying program to generate a redistribution matrix file (RMF) compatible with the X-ray spectral analysis package XSPEC. The tool provides a user friendly interface of help to beginners and also provides transparency and advanced features for experts.

A faculty development workshop in narrative-based reflective writing.

PubMed

Boudreau, J Donald; Liben, Stephen; Fuks, Abraham

2012-08-01

Narrative approaches are used increasingly in the health professions with a range of objectives. We must acquaint educators with this burgeoning field and prepare them for the incorporation of story-telling in their pedagogical practices. The authors describe a template for a faculty development workshop designed to foster self-reflection through the use of narrative techniques and prepare clinical teachers to deploy such approaches. The design is based on a six-year experience in delivering introductory workshops in narrative approaches to medical teachers. The workshops, which served as a model for the template, have been offered to a total of 92 clinicians being trained to mentor medical students. A generic template is described. It includes a table of core concepts from narrative theory, a set of probing questions useful in a basic technical analysis of texts and a list of initiating prompts for exercises in reflective writing. A workshop organized and deployed using this template is deliverable over a half-day. The model has proven to be feasible and highly valued by participants. It can be adapted for other contexts by educators across the continuum of health professional education.

Measures of Readiness to Transition to Adult Health Care for Youth With Chronic Physical Health Conditions: A Systematic Review and Recommendations for Measurement Testing and Development

PubMed Central

Daniel, Lauren C.; Brumley, Lauren D.; Barakat, Lamia P.; Wesley, Kimberly M.; Tuchman, Lisa K.

2014-01-01

Objective Review measures of readiness to transition to adult-oriented care for youth with chronic physical health conditions. Methods Identified measures via online searches and reference lists and reviewed methods of development, theoretical underpinnings, characteristics, and psychometrics. Measures were classified according to American Psychological Association Division 54 Evidence-Based Assessment (EBA) Task Force criteria. Strengths and weaknesses of reviewed measures were described. Results 56 measures were identified, of which 10 met inclusion criteria for this review. 6 were disease specific and 4 were generic. Some psychometric properties were reported for each; none reported predictive validity for transition outcomes. According to EBA criteria, the 10 measures met criteria for “promising” assessment. Conclusions Measurement development in transition readiness is still an underdeveloped area. Measures require further testing and new measures are needed. Recommendations include testing measures with larger and diverse samples, ground measures in theory, test psychometrics, and involve multiple stakeholders in measure development. PMID:24891440

Cost-effectiveness analysis of valsartan versus losartan and the effect of switching.

PubMed

Baker, Timothy M; Goh, Jowern; Johnston, Atholl; Falvey, Heather; Brede, Yvonne; Brown, Ruth E

2012-01-01

Losartan will shortly become generic, and this may encourage switching to the generic drug. However, valsartan was shown in a meta-analysis to be statistically superior in lowering blood pressure (BP) to losartan. This paper examines the costs of treatment with these two drugs and the potential consequences of switching established valsartan patients to generic losartan. A US payer cost-effectiveness model was developed incorporating the risk of cardiovascular disease (CVD) events related to systolic blood pressure (SBP) control comparing valsartan to continual losartan and switching from valsartan to generic losartan. The model, based upon a meta-analysis by Nixon et al. and Framingham equations, included first CVD event costs calculated from US administrative data sets and utility values from published sources. The modeled outcomes were number of CVD events, costs and incremental cost per quality-adjusted life-year (QALY) and life-year (LY). Fewer patients had fatal and non-fatal CVD events with valsartan therapy compared with continual losartan and with patients switched from valsartan to generic losartan. The base-case model results indicated that continued treatment with valsartan had an incremental cost-effectiveness ratio of $27,268 and $25,460 per life year gained, and $32,313 and $30,170 per QALY gained, relative to continual losartan and switching treatments, respectively. Sensitivity analyses found that patient discontinuation post-switching was a sensitive parameter. Including efficacy offsets with lowered adherence or discontinuation resulted in more favorable ratios for valsartan compared to switching therapy. The model does not evaluate post-primary CVD events and considers change in SBP from baseline level as the sole predictor of CVD risk. Valsartan appears to be cost-effective compared to switching to generic losartan and switching to the generic drug does not support a cost offset argument over the longer term. Physicians should continue to consider the needs of individual patient and not cost offsets.

[Competition for the promotion of essential generic drugs in Africa].

PubMed

Bruneton, C; Favre, I; Fontaine, D; Maritoux, J; Rey, J L

1999-01-01

in most sub-Saharan countries, an extensive economic crisis coupled with a low level of existing resources has put most pharmaceuticals beyond the reach of the general public. This situation was worsened by the devaluation of the Franc CFA in 1994. The supply of lowprice drugs and the improvement of rational drug use is now a priority. Unfortunately, essential generic drugs are little known and used in Africa. 1. To improve the knowledge of and confidence in essential and generic drugs among providers, prescribers and consumers, through the participation of the general public in an incentive-based, creative competition; 2. To collect locally-adapted promotional material, to be used in the future promotion of essential and generic drugs in Africa. Design, setting and method: a competition was announced in June 1995, via various networks, in French-speaking Africa: the population was invited to create one or several items promoting essential generic drugs. These items included slogans, posters, songs and short plays. Over 550 entries were received before the deadline (15 October 1995), from 22 countries (mostly Sub-Saharan and French-speaking). The entries included 387 slogans, 94 posters, 22 plays, and various (photos, comic strips, songs, poems). 1. Greater awareness of essential generic drugs in Western Africa, through the publicity given to the competition; 2. Selection of a pool of approximately 200 promotional items, produced by the target populations, to be published in a catalog and distributed in African countries; 3. Insights into popular practices and representations of Western medications, and local re-interpretation of the concept. this public competition was effective at achieving three important goals: 1. Dynamic promotion (the competition was the opportunity for school projects, radio talkshows, etc. on generic drugs); 2. Re appropriation of a policy, thanks to a participative approach; 3. Analysis of the population's general comprehension of pharmaceuticals, through analysis of competition entries.

Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study.

PubMed

Corrao, Giovanni; Soranna, Davide; Merlino, Luca; Mancia, Giuseppe

2014-10-01

Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

Product-line extensions and pricing strategies of brand-name drugs facing patent expiration.

PubMed

Hong, Song Hee; Shepherd, Marvin D; Scoones, David; Wan, Thomas T H

2005-01-01

This study proposed an alternative to brand loyalty as the explanation for the continued price rigidity of patent-expired brand-name prescription drugs despite the increase in market entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act. Study hypotheses were to test (1) whether market entries of new-product extensions are associated with market success of original brand-name drugs before generic drug entry, and (2) whether original brand-name drugs exhibit price rigidity to generic entry only when they are extended. The design is a retrospective follow-up study for the prescription drug brands that lost their patents between 1987 and 1992. The drug brands were limited to nonantibiotic, orally administered drugs containing only 1 active pharmaceutical ingredient. Information on patent expiration, entry of a product extension, and market success were determined from the U.S. Food and Drug Administration.s Orange Book, First DataBank, and American Druggist, respectively. Market success was defined as whether an original drug brand was listed in the top 100 prescriptions most frequently dispensed before facing generic entry. Product-line extension was defined as the appearance of another product that a company introduces within the same market after its existing product. Drug prices were average wholesale prices from the Drug Topics Red Book. The relationship between product-line extension and market success was examined using a logistic regression analysis. The price rigidity to entry was tested using a panel regression analysis. A total of 27 drug brands lost their patents between 1987 and 1992. Drug brands that achieved market success were 16 times more likely to be extended than were those that did not (OR=16, 95% confidence interval, 2.12-120.65). The price rigidity to entry existed in drug brands with extensions (beta=2.65%, P <0.033), but not in those brands without extensions (beta=-2.40%, P <0.001). This study provided some support for the alternative explanation to brand loyalty that a new product-line extension introduced for an original brand helps the original price be rigid despite the entry of generic drugs facilitated by the 1984 Drug Price Competition and Patent Term Restoration Act.

Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

PubMed

Sheingold, Steven; Nguyen, Nguyen Xuan

2014-01-01

This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment

PubMed Central

Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

2016-01-01

Objective To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). Background TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Methods Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. Results API costs per kg were $347–$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128–$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Conclusions Mass generic production of several TKIs could achieve treatment prices in the range of $128–$4020 per person-year, versus current US prices of $75161–$139 138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. PMID:26817636

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

PubMed

Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

2015-07-06

The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®

PubMed Central

2013-01-01

Background By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson’s disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Methods Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original “shelf-life” specifications in use by Roche. Results Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to −7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Conclusions Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical. PMID:23617953

Projected economic impact of clinical findings of generic entry of topiramate on G4 European countries.

PubMed

Paradis, Pierre Emmanuel; Latrémouille-Viau, Dominick; Moore, Yuliya; Mishagina, Natalia; Lafeuille, Marie-Hélène; Lefebvre, Patrick; Gaudig, Maren; Duh, Mei Sheng

2009-07-01

To explore the effects of generic substitution of the antiepileptic drug (AED) topiramate (Topamax) in Canada; to convert observed Canadian costs into the settings of France, Germany, Italy, and the United Kingdom (UK); and to forecast the economic impact of generic topiramate entry in these four European countries. Health claims from Régie de l'assurance maladie du Québec (RAMQ) plan (1/2006-9/2008) and IMS Health data (1998-2008) were used. Patients with epilepsy and > or = 2 topiramate dispensings were selected. An open-cohort design was used to classify observation into mutually-exclusive periods of branded versus generic use of topiramate. Canadian healthcare utilization and costs (2007 CAN$/person-year) were compared between periods using multivariate models. Annualized per-patient costs (2007 euro or 2007 pound sterling/person-year) were converted using Canadian utilization rates, European prices and service-use ratios. Non-parametric bootstrap served to assess statistical significance of cost differences. Topiramate market was forecasted following generic entry (09/2009-09/2010) using autoregressive models based on the European experience. The economic impact of generic topiramate entry was estimated for each country. A total of 1164 patients (mean age: 39.8 years, 61.7% female) were observed for 2.6 years on average. After covariates adjustment, generic-use periods were associated with increased pharmacy dispensings (other AEDs: +0.95/person-year, non-AEDs: +12.28/person-year, p < 0.001), hospitalizations ( + 0.08/person-year, p = 0.015), and lengths of hospital stays (+0.51 days/person-year, p < 0.001). Adjusted costs, excluding topiramate, were CAN$1060/person-year higher during generic use (p = 0.005). Converted per-patient costs excluding topiramate were significantly higher for generic relative to brand periods in all European countries (adjusted cost differences per person-year: 706-815 euro, p < 0.001 for all comparisons). System-wide costs would increase from 3.5 to 24.4% one year after generic entry. Study limitations include the absence of indirect costs, possible claim inaccuracies, and IMS data limitations. Higher health costs were projected for G4 European countries from the Canadian experience following the generic entry of topiramate.

Addition of generic medication vouchers to a pharmacist academic detailing program: effects on the generic dispensing ratio in a physician-hospital organization.

PubMed

Bhargava, Vinay; Greg, Mark E; Shields, Mark C

2010-01-01

Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid pharmacy claims for 108 prescriber identification numbers (Drug Enforcement Administration [DEA] or National Provider Identifier [NPI]) for 9 intervention groups [n = 53 PCPs] and 9 control groups [n = 55 PCPs]). For both intervention and control arms, the GDR for each month from July 2007 (start of 2007 Q3, intervention start date) through September 2008 (end of 2008 Q3, 6 months after intervention end date) was compared with the same month in the previous year. A descriptive analysis compared a 9-month baseline period from 2006 Q3 through 2007 Q1 with a 9-month voucher period from 2007 Q3 to 2008 Q1. A panel data regression analysis assessed GDR for 18 practices over 27 months (12 months pre-intervention and 15 months post-intervention). A total of 656 vouchers were redeemed over the 9-month voucher period from July 1, 2007, through March 31, 2008, for an average of about 12 vouchers per participating physician; approximately one-third of the redeemed vouchers were for generic simvastatin. The GDR increase for all drugs, including the 8 voucher drugs, was 7.4 points for the 9 PCP group practices with access to generic medication vouchers, from 53.4% in the 9-month baseline period to 60.8% in the 9-month voucher period, compared with a 6.2 point increase for the control group from 55.9% during baseline to 62.1% during the voucher period. The panel data regression model estimated that the medication voucher program was associated with a 1.77-point increase in overall GDR compared with academic detailing alone (P = 0.047). Compared with academic detailing alone, a generic medication voucher program providing a 30-day supply of 8 specific medications in addition to academic detailing in PCP groups with low GDR and high prescribing volume in an outpatient setting was associated with a small but statistically significant increase in adjusted overall GDR.

Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-10-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprising six health economists and one Delphi methodologist. A two-round, modified Delphi survey, with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorized within six sections: (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS Explanation and Elaboration paper. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of the reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-08-01

"Mapping" onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite the publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist that aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of 6 health economists and 1 Delphi methodologist. A 2-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies, and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorized within 6 sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency, and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by 7 health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years.

The generic world-sheet action of irrational conformal field theory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clubok, K.; Halpern, M.B.

1995-05-01

We review developments in the world-sheet action formulation of the generic irrational conformal field theory, including the non-linear and the linearized forms of the action. These systems form a large class of spin-two gauged WZW actions which exhibit exotic gravitational couplings. Integrating out the gravitational field, we also speculate on a connection with sigma models.

Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

PubMed

Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

2016-03-01

The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

Professional practices and perception towards rational use of medicines according to WHO methodology in United Arab Emirates

PubMed Central

Abdul Rasool, Bazigha K.; Fahmy, Sahar A.; Abu-Gharbieh, Eman F.; Ali, Heyam S.

2009-01-01

Inappropriate prescribing reduces the quality of medical care and leads to a waste of resources. No study has been reported concerning rational drug use in United Arab Emirates, UAE, recently. Objectives assessing patterns of use and defining problems regarding the rational drug use.Setting baseline situational analysis study for practices in the health care system relevant to drug use. Method A descriptive pilot study, consisting of pharmacists, physicians and patients (100 of each of category) from four private hospitals, (12) medical clinics, (80) community pharmacies in addition to 150 prescriptions. A questionnaire of three sections was designed to include WHO indicators regarding patients, facility and prescribing patterns that are relevant to rational drug use was carried out in four emirates of the UAE in the period December 2008-Febreuary 2009. Results Consultation and dispensing times were 10 (SD=2.75) min and 68 (SD=9.7) seconds, respectively. Average no. of drugs per prescription was (2.9 + 0.97), % of prescriptions using generic name (7.35%), % of antibiotic containing prescriptions (31.1%), % of injection containing prescriptions (2.9%), adherence to Standard Treatment Protocols (46%), adherence to the essential drug list (64%), patient’s knowledge of correct dosage (55%), adequately labeled drugs (45%), patient’s information (65%). Conclusions Several areas of deficiency in rational drug use had been defined in the private sector through UAE that can be remedied through adopting several strategies such as adherence to national standard treatment guidelines and essential drug list based on treatments of choice, interaction between health care system and providing drugs information to consumers. PMID:25152796

Professional practices and perception towards rational use of medicines according to WHO methodology in United Arab Emirates.

PubMed

Rasool, Bazigha K Abdul; Fahmy, Sahar A; Abu-Gharbieh, Eman F; Ali, Heyam S

2010-01-01

Inappropriate prescribing reduces the quality of medical care and leads to a waste of resources. No study has been reported concerning rational drug use in United Arab Emirates, UAE, recently. assessing patterns of use and defining problems regarding the rational drug use.Setting baseline situational analysis study for practices in the health care system relevant to drug use. A descriptive pilot study, consisting of pharmacists, physicians and patients (100 of each of category) from four private hospitals, (12) medical clinics, (80) community pharmacies in addition to 150 prescriptions. A questionnaire of three sections was designed to include WHO indicators regarding patients, facility and prescribing patterns that are relevant to rational drug use was carried out in four emirates of the UAE in the period December 2008-Febreuary 2009. Consultation and dispensing times were 10 (SD=2.75) min and 68 (SD=9.7) seconds, respectively. Average no. of drugs per prescription was (2.9 + 0.97), % of prescriptions using generic name (7.35%), % of antibiotic containing prescriptions (31.1%), % of injection containing prescriptions (2.9%), adherence to Standard Treatment Protocols (46%), adherence to the essential drug list (64%), patient's knowledge of correct dosage (55%), adequately labeled drugs (45%), patient's information (65%). Several areas of deficiency in rational drug use had been defined in the private sector through UAE that can be remedied through adopting several strategies such as adherence to national standard treatment guidelines and essential drug list based on treatments of choice, interaction between health care system and providing drugs information to consumers.

The HLA dictionary 1999: a summary of HLA-A, -B, -C, -DRB1/3/4/5, -DQB1 alleles and their association with serologically defined HLA-A, -B, -C, -DR, and -DQ antigens.

PubMed

Schreuder, G M; Hurley, C K; Marsh, S G; Lau, M; Maiers, M; Kollman, C; Noreen, H

1999-11-01

This report presents serologic equivalents of 90 HLA-A, 190 HLA-B, and 145 HLA-DRB1 alleles. The equivalents cover over 70% of the presently identified HLA-A, -B, and -DRB1 alleles. The dictionary is an update of the one published in 1997 and now also includes equivalents for HLA-C, DRB3, DRB4, DRB5, and DQB1 alleles. The data summarize information obtained by the WHO HLA Nomenclature Committee, the International Cell Exchange (UCLA), the National Marrow Donor Program (NMDP), and by individual laboratories. In addition, a listing is provided of alleles that are expressed as antigens with serologic reaction patterns that differ from the well-established HLA specificities and that often lack official WHO nomenclature. The provided equivalents will be useful in guiding searches for unrelated donors in which patients and/or potential donors are typed by either serology or DNA-based methods. These equivalents will also serve typing and matching procedures for organ transplant programs where HLA typings from donors and from recipients on waiting lists represent mixtures of serologic and molecular typings. Some guidelines are provided for the use of appropriate WHO HLA nomenclature for serologic typings and for generic and allele specific typings obtained with molecular methods. The tables with HLA equivalents and the questionnaire for submission of serology on poorly identified alleles will also be available at the WMDA web page: www.bmdw.org/wmda.

Estándares Consolidados de Reporte de Evaluaciones Económicas Sanitarias: Versión en Español de la Lista de Comprobación CHEERS.

PubMed

Augustovski, Federico; García Martí, Sebastián; Pichon-Riviere, Andrés

2013-12-01

It is important to have adequate and updated guides for reporting health economic evaluations (HEE). Due to their nature and methodological complexity, HEE have particular challenges for adequate reporting, which can be greater than more traditional study designs such as randomized controlled trials. CHEERS (Consolidated Health Economic Evaluation Reporting Standards) have recently been published in English. Our objectives were to adapt the CHEERS list to Spanish. We followed the recommended methods of the Equator (Enhancing the Quality and Transparency Of health Research) network. We made an initial translation to Spanish, a back translation to English, and an initial Spanish version that was circulated through ISPOR and REDETSA. Finally, a final Spanish version was consolidated. The list contains 24 items grouped in Title and Abstract; Introduction; Methods; Results; Discussion; and Other (which included conflict of interest reporting). The scope of use is independent of methodological vehicle (either single-study or evidence synthesis-based HEE); type of strategies to evaluate (clinical or public health; preventive, diagnostic, curative, palliative). Most of the items are generic and apply to any study design; while some of them are particularly oriented to single-study or evidence-synthesis/modeling studies. Diffusion and use of the CHEERS checklist in Spanish will contribute to a more consistent and transparent reporting of health economic evaluations in Spanish speaking contexts. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Published by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) All rights reserved.

Teaching implementation science in a new Master of Science Program in Germany: a survey of stakeholder expectations.

PubMed

Ullrich, Charlotte; Mahler, Cornelia; Forstner, Johanna; Szecsenyi, Joachim; Wensing, Michel

2017-04-27

Implementation science in healthcare is an evolving discipline in German-speaking countries. In 2015, the Medical Faculty of the University of Heidelberg, Germany, implemented a two-year full-time Master of Science program Health Services Research and Implementation Science. The curriculum introduces implementation science in the context of a broader program that also covers health services research, healthcare systems, research methods, and generic academic skills. Our aim was to assess the expectations of different stakeholder groups regarding the master's program. An online survey listing desired competencies of prospective graduates was developed and administered to four groups: national experts in the field (including potential employers of graduates), teaching staff, enrolled students, and prospective students (N = 169). Competencies were extracted from the curriculum's module handbook. A five-point Likert scale was used for the assessment of 42 specific items. Data were analyzed descriptively. A total of 83 people participated in the survey (response rate 49%). The online survey showed a strong agreement across the groups concerning the desired competencies of graduates. About two-thirds of the listed competencies (27 items) were felt to be crucial or very important by 80% or more of participants, with little difference between stakeholder groups. Of the eight items specifically related to implementation in practice, six were in this category. Knowledge of implementation strategies (90% very important), knowledge of barriers and enablers of implementation (89%), and knowledge of evidence-based practice (89%) were the top priorities. The master's program is largely orientated towards the desired competencies of graduates according to students, teaching staff, and national experts.

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.

PubMed

Grampp, Gustavo; Bonafede, Machaon; Felix, Thomas; Li, Edward; Malecki, Michael; Sprafka, J Michael

2015-03-01

This retrospective analysis assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the USA for branded and generic enoxaparin, a complex injectable subject to immune-related and other adverse events (AEs). Analysis of heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims for commercial and Medicare supplemental-insured individuals newly treated with enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, spontaneous reports from the FDA AE Reporting System were reviewed to identify incidence and attribution of enoxaparin-related reports to specific manufacturers. Specific, dispensed products were identifiable from National Drug Codes only in pharmacy-benefit databases, permitting sensitive comparison of HIT incidence in nearly a third of patients treated with brand or generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of spontaneous reports were processed by generic manufacturers; reports attributable to specific generics were approximately ninefold lower than expected based on market share. Claims data were useful for active surveillance of enoxaparin generics dispensed under pharmacy benefits but not for products administered under medical benefits. These findings suggest that the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars.

Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

PubMed

Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward; Johnson, Dayna; Considine, Shannon; Bourgeois, Renee; Melkonian, Christina; Miree, Cheryl; Johnson, Christine Cole; Lu, Mei

2016-01-01

Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings. We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention. 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

A Geographical Heuristic Routing Protocol for VANETs

PubMed Central

Urquiza-Aguiar, Luis; Tripp-Barba, Carolina; Aguilar Igartua, Mónica

2016-01-01

Vehicular ad hoc networks (VANETs) leverage the communication system of Intelligent Transportation Systems (ITS). Recently, Delay-Tolerant Network (DTN) routing protocols have increased their popularity among the research community for being used in non-safety VANET applications and services like traffic reporting. Vehicular DTN protocols use geographical and local information to make forwarding decisions. However, current proposals only consider the selection of the best candidate based on a local-search. In this paper, we propose a generic Geographical Heuristic Routing (GHR) protocol that can be applied to any DTN geographical routing protocol that makes forwarding decisions hop by hop. GHR includes in its operation adaptations simulated annealing and Tabu-search meta-heuristics, which have largely been used to improve local-search results in discrete optimization. We include a complete performance evaluation of GHR in a multi-hop VANET simulation scenario for a reporting service. Our study analyzes all of the meaningful configurations of GHR and offers a statistical analysis of our findings by means of MANOVA tests. Our results indicate that the use of a Tabu list contributes to improving the packet delivery ratio by around 5% to 10%. Moreover, if Tabu is used, then the simulated annealing routing strategy gets a better performance than the selection of the best node used with carry and forwarding (default operation). PMID:27669254

A Geographical Heuristic Routing Protocol for VANETs.

PubMed

Urquiza-Aguiar, Luis; Tripp-Barba, Carolina; Aguilar Igartua, Mónica

2016-09-23

Vehicular ad hoc networks (VANETs) leverage the communication system of Intelligent Transportation Systems (ITS). Recently, Delay-Tolerant Network (DTN) routing protocols have increased their popularity among the research community for being used in non-safety VANET applications and services like traffic reporting. Vehicular DTN protocols use geographical and local information to make forwarding decisions. However, current proposals only consider the selection of the best candidate based on a local-search. In this paper, we propose a generic Geographical Heuristic Routing (GHR) protocol that can be applied to any DTN geographical routing protocol that makes forwarding decisions hop by hop. GHR includes in its operation adaptations simulated annealing and Tabu-search meta-heuristics, which have largely been used to improve local-search results in discrete optimization. We include a complete performance evaluation of GHR in a multi-hop VANET simulation scenario for a reporting service. Our study analyzes all of the meaningful configurations of GHR and offers a statistical analysis of our findings by means of MANOVA tests. Our results indicate that the use of a Tabu list contributes to improving the packet delivery ratio by around 5% to 10%. Moreover, if Tabu is used, then the simulated annealing routing strategy gets a better performance than the selection of the best node used with carry and forwarding (default operation).

50 CFR 15.33 - Species included in the approved list.

Code of Federal Regulations, 2010 CFR

2010-10-01

... WILDLIFE AND PLANTS WILD BIRD CONSERVATION ACT Approved List of Species Listed in the Appendices to the Convention. § 15.33 Species included in the approved list. (a) Captive-bred species. The list in this paragraph includes species of captive-bred exotic birds for which importation into the United States is not...

Describing one generic and two new species record to the flora of Pakistan using LM and SEM methods.

PubMed

Jamshed, Shayan; Ullah, Asad; Khan, Raees; Hussain, Altaf

2018-05-01

Common mulberry weed (Fatoua villosa (Thunb.) Nakai) and creeping amaranth (Amaranthus crassipes Schlecht) are reported for the first time in Pakistan's flora as these were not listed in any other literature nor identified before in Pakistan. Plants were found as a result of taxonomic studies performed in 2013 in Peshawar, Pakistan. Detail study was performed for the exact identification. Morphological results were compared with Flora of China and Flora of North America. Plant distribution along with its habitat and adjacent species was also recorded. Scanning electron and light microscopy was performed for the confirmation of epidermal appendages on leaf epidermis and palyno-morphological characters. © 2018 Wiley Periodicals, Inc.

Auxiliary feedwater system risk-based inspection guide for the Salem Nuclear Power Plant

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pugh, R.; Gore, B.F. Vo, T.V.

In a study by the US Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory has developed and applied a methodology for deriving plant-specific risk-based inspection guidance for the auxiliary feedwater (AFW) system at pressurized water reactors that have not undergone probabilistic risk assessment (PRA). This methodology uses existing PRA results and plant operating experience information. Existing PRA-based inspection guidance information recently developed for the NRC for various plants was used to identify generic component failure modes. This information was then combined with plant-specific and industry-wide component information and failure data to identify failure modes and failure mechanisms for the AFW systemmore » at the selected plants. Salem was selected as the fifth plant for study. The product of this effort is a prioritized listing of AFW failures which have occurred at the plant and at other PWRs. This listing is intended for use by NRC inspectors in the preparation of inspection plans addressing AFW risk-important components at the Salem plant. 23 refs., 1 fig., 1 tab.« less

Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi.

PubMed

Abuelkhair, Mohammed; Abdu, Shajahan; Godman, Brian; Fahmy, Sahar; Malmström, Rickard E; Gustafsson, Lars L

2012-02-01

Pharmaceutical expenditure has risen rapidly in Abu Dhabi, resulting in policies surrounding generics. However, various circumstances will reduce potential savings, including pharmacists still being free to dispense either originator or branded generics and be fully reimbursed. To research the changes in utilization patterns of proton pump inhibitors (PPIs) and lipid-lowering drugs before and after combined reforms on generics; and subsequently, calculate potential savings based on 'best practices' among Western European countries. An uncontrolled before-and-after observational study of utilization and expenditure of PPIs, statins and ezetimibe between 2004 and 2010, as well as up to 12 months before the first generic policy, to 1 year after the second generic policy, was carried out. Utilization was converted to defined daily doses (DDDs; 2011 DDDs) and DDDs/1000 inhabitants per day. Expenditure/DDD was calculated for omeprazole and simvastatin. PPI utilization rose by 6.5-fold from 2004 to 2010, principally driven by increased utilization of patent-protected PPIs, although more recently stabilization in esomperazole utilization has occurred. Similar changes were seen for statins. Introduction of best practices would reduce PPI expenditure in 2010 by 32.8 million United Arab Emirates dirham (AED; €6.26 million) and statins by over 27 million AED (€5.15 million). Limited demand-side measures led to increased utilization of patent-protected products in Abu Dhabi following the generic reforms. Successful measures will release considerable resources.

An Evaluation of Health Service Impacts Consequent to Switching from Brand to Generic Venlafaxine in New Zealand under Conditions of Price Neutrality.

PubMed

Lessing, Charon; Ashton, Toni; Davis, Peter

2015-07-01

To study the health impact on adult New Zealand patients who switch from originator brand to generic venlafaxine. The national pharmacy database was used to select patients using venlafaxine for at least 6 months. Switchers and nonswitchers were identified, and switch behavior was compared for a 12-month follow-up period. Change in health service use following switching was also compared between switchers and nonswitchers including use of the emergency department, hospital, and specialist outpatient services over the same period. Approximately 12% of all originator brand users switched to generic venlafaxine, at least half of whom continued to use the generic throughout the follow-up period to August 1, 2012. Almost 60% of new users of the generic venlafaxine, however, switched to using the originator brand. Aside from a slight reduction in the use of outpatient services among switchers, there were no significant differences in health services use between switchers and nonswitchers for either existing or new venlafaxine users. Although both products remain fully subsidized and available, there is little incentive for prescribers, pharmacists, or patients to switch to the less expensive generic brand. If savings to the national New Zealand budget are to be realized, additional policy measures should be implemented to minimize incentives for multiple and reverse switching, and prescribers, as key opinion leaders, could take the lead in promoting generics to their patients. Copyright © 2015. Published by Elsevier Inc.

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

PubMed

Gothe, H; Schall, I; Saverno, K; Mitrovic, M; Luzak, A; Brixner, D; Siebert, U

2015-08-01

Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Patients' Preferences for Generic and Branded Over-the-Counter Medicines: An Adaptive Conjoint Analysis Approach.

PubMed

Halme, Merja; Linden, Kari; Kääriä, Kimmo

2009-12-01

: Despite increased use of generic medicines, little is known about either the attitudes of patients towards them or the decision-making process surrounding them. Young adults use over-the-counter (OTC) analgesics relatively often. : To assess the preferences of patients for generic and branded OTC pain medicines, to identify clusters with different preference structures, and to estimate the price elasticity of a generic alternative among university students. : Finnish university students (n = 256; students in courses at the Helsinki School of Economics) responded to an adaptive conjoint analysis (ACA) questionnaire on the choice between branded and generic OTC ibuprofen products. Product attributes of price, brand, onset time of effect, place of purchase and source of information were included in the questionnaire on the basis of the literature, a focus group and a previous pilot study. Several socioeconomic and health behavior descriptors were employed. Individual-level utility functions were estimated, preference clusters were identified, and the price elasticity of the generic medicine was assessed. : Five clusters with characteristic individual-level preferences and price elasticity but few differences in socioeconomic background were detected. Approximately half of the respondents were strongly price sensitive while the others had other preferences such as brand or an opportunity to buy the medicine at a pharmacy or to have a physician or a pharmacist as an information source. : The study provided new information on the concomitant effects of brand, price and other essential product attributes on the choice by patients between branded and generic medicines.

Seeking to understand: using generic qualitative research to explore access to medicines and pharmacy services among resettled refugees.

PubMed

Bellamy, Kim; Ostini, Remo; Martini, Nataly; Kairuz, Therese

2016-06-01

Introduction There are challenges associated with selecting a qualitative research approach. In a field abundant with terminology and theories, it may be difficult for a pharmacist to know where and how to begin a qualitative research journey. The purpose of this paper is to provide insight into generic qualitative research and to describe the journey of data collection of a novice qualitative researcher in the quest to answer her research question: 'What are the barriers to accessing medicines and pharmacy services for resettled refugees in Queensland, Australia?' Methodology Generic qualitative research draws on the strengths of one or more qualitative approaches. The aim is to draw out participants' ideas about things that are 'outside themselves'; rather than focussing on their inner feelings the research seeks to understand a phenomenon, a process, or the perspectives of participants. Sampling is designed to obtain a broad range of opinions about events and experiences and data collection includes interviews, questionnaires or surveys; thematic analysis is often used to analyse data. When to use Generic qualitative research provides an opportunity to develop research designs that fit researchers' epistemological stance and discipline, with research choices, including methodology and methods, being informed by the research question. Limitations Generic qualitative research is one of many methodologies that may be used to answer a research question and there is a paucity of literature about how to do it well. There is also debate about its validity as a qualitative methodology.

The Effects of Text Message Content on the Use of an Internet-Based Physical Activity Intervention in Hong Kong Chinese Adolescents.

PubMed

Lau, Erica Y; Lau, Patrick W C; Cai, Bo; Archer, Edward

2015-01-01

This study examined the effects of text message content (generic vs. culturally tailored) on the login rate of an Internet physical activity program in Hong Kong Chinese adolescent school children. A convenience sample of 252 Hong Kong secondary school adolescents (51% female, 49% male; M age = 13.17 years, SD = 1.28 years) were assigned to one of 3 treatments for 8 weeks. The control group consisted of an Internet physical activity program. The Internet plus generic text message group consisted of the same Internet physical activity program and included daily generic text messages. The Internet plus culturally tailored text message group consisted of the Internet physical activity program and included daily culturally tailored text messages. Zero-inflated Poisson mixed models showed that the overall effect of the treatment group on the login rates varied significantly across individuals. The login rates over time were significantly higher in the Internet plus culturally tailored text message group than the control group (β = 46.06, 95% CI 13.60, 156.02; p = .002) and the Internet plus generic text message group (β = 15.80, 95% CI 4.81, 51.9; p = .021) after adjusting for covariates. These findings suggest that culturally tailored text messages may be more advantageous than generic text messages on improving adolescents' website login rate, but effects varied significantly across individuals. Our results support the inclusion of culturally tailored messaging in future online physical activity interventions.

Developing multiple-choices test items as tools for measuring the scientific-generic skills on solar system

NASA Astrophysics Data System (ADS)

Bhakti, Satria Seto; Samsudin, Achmad; Chandra, Didi Teguh; Siahaan, Parsaoran

2017-05-01

The aim of research is developing multiple-choices test items as tools for measuring the scientific of generic skills on solar system. To achieve the aim that the researchers used the ADDIE model consisting Of: Analyzing, Design, Development, Implementation, dan Evaluation, all of this as a method research. While The scientific of generic skills limited research to five indicator including: (1) indirect observation, (2) awareness of the scale, (3) inference logic, (4) a causal relation, and (5) mathematical modeling. The participants are 32 students at one of junior high schools in Bandung. The result shown that multiple-choices that are constructed test items have been declared valid by the expert validator, and after the tests show that the matter of developing multiple-choices test items be able to measuring the scientific of generic skills on solar system.

Comparison of the effectiveness of brand-name and generic antipsychotic drugs for treating patients with schizophrenia in Taiwan.

PubMed

Hsu, Chih-Wei; Lee, Sheng-Yu; Wang, Liang-Jen

2018-03-01

The purpose of this nationwide population-based study is to compare the long-term effectiveness of brand-name antipsychotics with generic antipsychotics for treating schizophrenia. We identified patients with schizophrenia who were prescribed antipsychotics from a random sample of one million records from Taiwan's National Health Insurance database, observed between January 1, 2000 and December 31, 2012. Only those with no prior use of antipsychotics for at least 180days were included. We selected patients who were prescribed brand-name risperidone (N=404), generic risperidone (N=145), brand-name sulpiride (N=334), or generic sulpiride (N=991). The effectiveness of the treatments researched in this study consisted of average daily doses, rates of treatment discontinuation, augmentation therapy, and psychiatric hospitalization. We found that compared to patients treated with generic risperidone, those treated with brand-name risperidone required lower daily doses (2.14mg vs. 2.61mg). However, the two groups demonstrated similar rates of treatment discontinuation, augmentation, and psychiatric hospitalization. On the other hand, in comparison with patients prescribed generic sulpiride, those treated with brand-name sulpiride not only required lower daily doses (302.72mg vs. 340.71mg) but also had lower psychiatric admission rates (adjusted hazard ratio: 0.24, 95% confidence interval: 0.10-0.56). In conclusion, for both risperidone and sulpiride, higher daily doses of the respective generic drugs were prescribed than with brand-name drugs in clinical settings. Furthermore, the brand-name sulpiride is more effective at preventing patients from hospitalization than generic sulpiride. These findings can serve as an important reference for clinical practices and healthcare economics for treating schizophrenic patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison between utility of the Thai Pediatric Quality of Life Inventory 4.0 Generic Core Scales and 3.0 Cerebral Palsy Module.

PubMed

Tantilipikorn, Pinailug; Watter, Pauline; Prasertsukdee, Saipin

2013-03-01

Health-related quality of life (HRQOL) is increasingly being considered in the management of patients with various conditions. HRQOL instruments can be broadly classified as generic or disease-specific measures. Several generic HRQOL instruments in different languages have been developed for paediatric populations including the Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0) Generic Core Scale. This tool and a condition-specific tool, PedsQL 3.0 Cerebral Palsy (CP) Module, are widely used in children with CP. No psychometric properties have been reported for Thai PedsQL 4.0. Therefore, this study aimed to explore the psychometric properties of the Thai version of the PedsQL 4.0 Generic Core Scales and compare these with the values for the Thai PedsQL 3.0 CP Module reported previously. Thai PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 CP Module were completed, respectively, by children with CP and their parents or caregivers twice within 2-4 weeks. Respondents were 97 parents or caregivers and 54 children. Minimal missing data were found in most scales. Acceptable internal consistency was supported, except for Emotional, Social, and School Functioning. Intraclass correlation coefficients for parent-proxy report and self-report were good to excellent (0.625-0.849). The feasibility and reliability of the Thai PedsQL 4.0 Generic Core Scales were supported. The Thai PedsQL 3.0 CP Module showed higher values for the psychometric properties. Low-to-good correlations were found among the scales between the PedsQL 4.0 Generic Core Scales and the 3.0 CP Module. Both instruments could be used to measure HRQOL for children with CP, and may provide different information.

Classification of processes involved in sharing individual participant data from clinical trials.

PubMed

Ohmann, Christian; Canham, Steve; Banzi, Rita; Kuchinke, Wolfgang; Battaglia, Serena

2018-01-01

Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services/tools to support data sharing are available, but what is missing is a detailed, structured and comprehensive list of processes/subprocesses involved and tools/services needed. Methods : Principles and recommendations from a published data sharing consensus document are analysed in detail by a small expert group. Processes/subprocesses involved in data sharing are identified and linked to actors and possible services/tools. Definitions are adapted from the business process model and notation (BPMN) and applied in the analysis. Results: A detailed and comprehensive list of individual processes/subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools/services to support these processes/subprocesses are identified and grouped according to major type of support. Conclusions: The list of individual processes/subprocesses and tools/services identified is a first step towards development of a generic framework or architecture for sharing of data from clinical trials. Such a framework is strongly needed to give an overview of how various actors, research processes and services could form an interoperable system for data sharing.

Classification of processes involved in sharing individual participant data from clinical trials

PubMed Central

Ohmann, Christian; Canham, Steve; Banzi, Rita; Kuchinke, Wolfgang; Battaglia, Serena

2018-01-01

Background: In recent years, a cultural change in the handling of data from research has resulted in the strong promotion of a culture of openness and increased sharing of data. In the area of clinical trials, sharing of individual participant data involves a complex set of processes and the interaction of many actors and actions. Individual services/tools to support data sharing are available, but what is missing is a detailed, structured and comprehensive list of processes/subprocesses involved and tools/services needed. Methods: Principles and recommendations from a published data sharing consensus document are analysed in detail by a small expert group. Processes/subprocesses involved in data sharing are identified and linked to actors and possible services/tools. Definitions are adapted from the business process model and notation (BPMN) and applied in the analysis. Results: A detailed and comprehensive list of individual processes/subprocesses involved in data sharing, structured according to 9 main processes, is provided. Possible tools/services to support these processes/subprocesses are identified and grouped according to major type of support. Conclusions: The list of individual processes/subprocesses and tools/services identified is a first step towards development of a generic framework or architecture for sharing of data from clinical trials. Such a framework is strongly needed to give an overview of how various actors, research processes and services could form an interoperable system for data sharing. PMID:29623192

Generic Entry, Reformulations, and Promotion of SSRIs

PubMed Central

Donohue, Julie M.; Koss, Catherine; Berndt, Ernst R.; Frank, Richard G.

2009-01-01

Background Previous research has shown that a manufacturer’s promotional strategy for a brand-name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. Objective To examine the relationship between promotional expenditures, generic entry, reformulation entry, and new indication approval. Study Design/Setting We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising (DTCA), and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997 through 2004. We estimated econometric models of detailing, DTCA, and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations, and Food and Drug Administration (FDA) approval for new clinical indications for existing medications in the SSRI class. Main Outcome Measure Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications. Results Over the period 1997–2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers’ detailing expenditures but did result in a greater likelihood of DTCA outlays. Conclusion The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers that introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact pharmaceutical promotion has on demand for prescription drugs, these findings have important implications for prescription drug spending and public health. PMID:18563951

Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis

PubMed Central

Molnar, Amber O; Fergusson, Dean; Tsampalieros, Anne K; Bennett, Alexandria; Fergusson, Nicholas; Ramsay, Timothy

2015-01-01

Objective To compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants. Design Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs. Data sources Medline and Embase from 1980 to September 2014. Review methods A literature search was performed for all studies comparing a generic to an innovator immunosuppressive drug in solid organ transplantation. Two reviewers independently extracted data and assessed quality of studies. Meta-analyses of prespecified outcomes were performed when deemed appropriate. Outcomes included patient survival, allograft survival, acute rejection, adverse events and bioequivalence. Results 1679 citations were screened, of which 50 studies met eligibility criteria (17 randomized trials, 15 non-randomized interventional studies, and 18 observational studies). Generics were compared with Neoral (cyclosporine) (32 studies), Prograf (tacrolimus) (12 studies), and Cellcept (mycophenolate mofetil) (six studies). Pooled analysis of randomized controlled trials in patients with kidney transplants that reported bioequivalence criteria showed that Neoral (two studies) and Prograf (three studies) were not bioequivalent with generic preparations according to criteria of the European Medicines Agency. The single Cellcept trial also did not meet bioequivalence. Acute rejection was rare but did not differ between groups. For Neoral, the pooled Peto odds ratio was 1.23 (95% confidence interval 0.64 to 2.36) for kidney randomized controlled trials and 0.66 (0.40 to 1.08) for observational studies. For kidney observational studies, the pooled Peto odds ratios were 0.98 (0.37 to 2.60) for Prograf and 0.49 (0.09 to 2.56) for Cellcept. Meta-analyses for non-renal solid organ transplants were not performed because of a lack of data.There were insufficient data reported on patient or graft survival. Pooling of results was limited by inconsistent study methods and reporting of outcomes. Many studies did not report standard criteria used to determine bioequivalence. While rates of acute rejection seemed similar and were relatively rare, few studies were designed to properly compare clinical outcomes. Most studies had short follow-up times and included stable patients without a history of rejection. Conclusions High quality data showing bioequivalence and clinical efficacy of generic immunosuppressive drugs in patients with transplants are lacking. Given the serious consequences of rejection and allograft failure, well designed studies on bioequivalence and safety of generic immunosuppression in transplant recipients are needed. PMID:26101226

'CHEATS': a generic information communication technology (ICT) evaluation framework.

PubMed

Shaw, Nicola T

2002-05-01

This paper describes a generic framework for the evaluation of information communication technologies. This framework, CHEATS, utilises both qualitative and quantitative research methods and has proved appropriate in multiple clinical settings including telepsychiatry, teledermatology and teleeducation. The paper demonstrates how a multidisciplinary approach is essential when evaluating new and emerging technologies, particularly when such systems are implemented in real service as opposed to a research setting.

Rocketdyne/Westinghouse nuclear thermal rocket engine modeling

NASA Technical Reports Server (NTRS)

Glass, James F.

1993-01-01

The topics are presented in viewgraph form and include the following: systems approach needed for nuclear thermal rocket (NTR) design optimization; generic NTR engine power balance codes; rocketdyne nuclear thermal system code; software capabilities; steady state model; NTR engine optimizer code-logic; reactor power calculation logic; sample multi-component configuration; NTR design code output; generic NTR code at Rocketdyne; Rocketdyne NTR model; and nuclear thermal rocket modeling directions.

Clinical outcomes associated with brand-to-generic phenytoin interchange.

PubMed

Kinikar, Shilpa A; Delate, Thomas; Menaker-Wiener, C Mindy; Bentley, William H

2012-05-01

Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. However, little within-patient evidence exists examining such interchanges. To compare within-patient seizure control before and after the interchange of a branded to a single-source generic phenytoin among patients with seizures in a managed care organization. This was a pre-post, self-controlled, retrospective study. Adults with a history of seizure who used Dilantin Kapseals 100 mg extended phenytoin sodium, USP, capsules and whose therapy was interchanged to Taro Pharmaceuticals' AB-rated generic extended phenytoin sodium capsules, USP, 100 mg between July 2007 and May 2008 were included. Study outcomes included the comparisons of the proportions of patients with at least emergency department (ED) visit/inpatient hospitalization and medical office visit/nonoffice consultation for acute seizure in the 6 months before and after interchange. Outcomes were confirmed with manual chart reviews and adjusted for potential confounding medication use. A total of 222 patients were included in the study. Patients were primarily middle-aged (mean 56 years), equally mixed by sex (47% female); most had nonintractable seizures. The majority of patients (~70%) were on phenytoin as monotherapy and had equivalent rates of purchases for potentially confounding medications in both pre- and postinterchange time periods (all p > 0.05). Low serum concentrations were detected more often in the postinterchange study period (adjusted p < 0.001). Despite this, there were low proportions of patients with confirmed seizure events that resulted in an ED visit/inpatient hospitalization in both pre- and postinterchange periods (both 6.3%, adjusted p = 0.937). The proportion of patients with confirmed seizure events diagnosed at a medical office visit was not significantly different between the preinterchange and postinterchange periods (12.2% vs 11.3%, adjusted p = 0.545). No increased proportion of seizures was observed within patients when branded phenytoin was interchanged to an AB-rated, single-source, generic equivalent. More rigorous studies should be conducted to more thoroughly evaluate patient tolerability and drug efficacy when antiepileptic drugs are interchanged from brand to generic formulations.

National Space Science Data Center (NSSDC) Data Listing

NASA Technical Reports Server (NTRS)

1980-01-01

Satellite and nonsatellite data available from the National Space Science Data Center are listed. The Satellite Data listing includes the spacecraft name, launch date, and an alphabetical list of experiments. The Non-Satellite Data listing contains ground based data, models, computer routines, and composite spacecraft data. The data set name, data form code, quantity of data, and the time space covered are included in the data sets of both listings where appropriate. Geodetic tracking data sets are also included.

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

PubMed Central

Vinks, Alexander A.; Fukuda, Tsuyoshi; King, Eileen C.; Zou, Yuanshu; Jiang, Wenlei; Klawitter, Jelena; Christians, Uwe

2017-01-01

Background Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, “brand”) product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. Methods and findings From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC) (range 12.11–15.81) and the concentration maximum (Cmax) (range 17.96–24.72) for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE) 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%–118.13% and 80.00%–125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA) acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney) and 112.12% (liver). These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD) test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not allow for the impact of nonadherence or feeding on the possible pharmacokinetic differences. Generic Hi and Lo were selected based upon bioequivalence data in healthy volunteers because no pharmacokinetic data in recipients were available for all products. The safety data should be interpreted in light of the small number of participants and the short observation periods. Lastly, only the 1 mg tacrolimus strength was utilized in this study. Conclusions Using an innovative, controlled bioequivalence study design, we observed equivalence between tacrolimus innovator and 2 generic products as well as between 2 generic products in individuals after kidney or liver transplantation following current FDA bioequivalence metrics. These results support the position that bioequivalence for the narrow therapeutic index drug tacrolimus translates from healthy volunteers to individuals receiving a kidney or liver transplant and provides evidence that generic products that are bioequivalent with the innovator product are also bioequivalent to each other. Trial registration ClinicalTrials.gov NCT01889758. PMID:29135993

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

PubMed

Alloway, Rita R; Vinks, Alexander A; Fukuda, Tsuyoshi; Mizuno, Tomoyuki; King, Eileen C; Zou, Yuanshu; Jiang, Wenlei; Woodle, E Steve; Tremblay, Simon; Klawitter, Jelena; Klawitter, Jost; Christians, Uwe

2017-11-01

Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC) (range 12.11-15.81) and the concentration maximum (Cmax) (range 17.96-24.72) for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE) 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%-118.13% and 80.00%-125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA) acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney) and 112.12% (liver). These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD) test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not allow for the impact of nonadherence or feeding on the possible pharmacokinetic differences. Generic Hi and Lo were selected based upon bioequivalence data in healthy volunteers because no pharmacokinetic data in recipients were available for all products. The safety data should be interpreted in light of the small number of participants and the short observation periods. Lastly, only the 1 mg tacrolimus strength was utilized in this study. Using an innovative, controlled bioequivalence study design, we observed equivalence between tacrolimus innovator and 2 generic products as well as between 2 generic products in individuals after kidney or liver transplantation following current FDA bioequivalence metrics. These results support the position that bioequivalence for the narrow therapeutic index drug tacrolimus translates from healthy volunteers to individuals receiving a kidney or liver transplant and provides evidence that generic products that are bioequivalent with the innovator product are also bioequivalent to each other. ClinicalTrials.gov NCT01889758.

A cross-sectional study examining the prevalence and risk factors for anti-microbial-resistant generic Escherichia coli in domestic dogs that frequent dog parks in three cities in south-western Ontario, Canada.

PubMed

Procter, T D; Pearl, D L; Finley, R L; Leonard, E K; Janecko, N; Reid-Smith, R J; Weese, J S; Peregrine, A S; Sargeant, J M

2014-06-01

Anti-microbial resistance can threaten health by limiting treatment options and increasing the risk of hospitalization and severity of infection. Companion animals can shed anti-microbial-resistant bacteria that may result in the exposure of other dogs and humans to anti-microbial-resistant genes. The prevalence of anti-microbial-resistant generic Escherichia coli in the faeces of dogs that visited dog parks in south-western Ontario was examined and risk factors for shedding anti-microbial-resistant generic E. coli identified. From May to August 2009, canine faecal samples were collected at ten dog parks in three cities in south-western Ontario, Canada. Owners completed a questionnaire related to pet characteristics and management factors including recent treatment with antibiotics. Faecal samples were collected from 251 dogs, and 189 surveys were completed. Generic E. coli was isolated from 237 of the faecal samples, and up to three isolates per sample were tested for anti-microbial susceptibility. Eighty-nine percent of isolates were pan-susceptible; 82.3% of dogs shed isolates that were pan-susceptible. Multiclass resistance was detected in 7.2% of the isolates from 10.1% of the dogs. Based on multilevel multivariable logistic regression, a risk factor for the shedding of generic E. coli resistant to ampicillin was attending dog day care. Risk factors for the shedding of E. coli resistant to at least one anti-microbial included attending dog day care and being a large mixed breed dog, whereas consumption of commercial dry and home cooked diets was protective factor. In a multilevel multivariable model for the shedding of multiclass-resistant E. coli, exposure to compost and being a large mixed breed dog were risk factors, while consumption of a commercial dry diet was a sparing factor. Pet dogs are a potential reservoir of anti-microbial-resistant generic E. coli; some dog characteristics and management factors are associated with the prevalence of anti-microbial-resistant generic E. coli in dogs. © 2013 Blackwell Verlag GmbH.

BRST theory without Hamiltonian and Lagrangian

NASA Astrophysics Data System (ADS)

Lyakhovich, S. L.; Sharapov, A. A.

2005-03-01

We consider a generic gauge system, whose physical degrees of freedom are obtained by restriction on a constraint surface followed by factorization with respect to the action of gauge transformations; in so doing, no Hamiltonian structure or action principle is supposed to exist. For such a generic gauge system we construct a consistent BRST formulation, which includes the conventional BV Lagrangian and BFV Hamiltonian schemes as particular cases. If the original manifold carries a weak Poisson structure (a bivector field giving rise to a Poisson bracket on the space of physical observables) the generic gauge system is shown to admit deformation quantization by means of the Kontsevich formality theorem. A sigma-model interpretation of this quantization algorithm is briefly discussed.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Detect-And-Avoid (DAA) Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is "generic" in that it makes no assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Accordingly, GRACE is well suited to research applications where alerting and guidance is a central feature and requirements are fluid involving a wide range of aviation technologies. GRACE has been used at NASA in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

Mathematical Modeling Of Life-Support Systems

NASA Technical Reports Server (NTRS)

Seshan, Panchalam K.; Ganapathi, Balasubramanian; Jan, Darrell L.; Ferrall, Joseph F.; Rohatgi, Naresh K.

1994-01-01

Generic hierarchical model of life-support system developed to facilitate comparisons of options in design of system. Model represents combinations of interdependent subsystems supporting microbes, plants, fish, and land animals (including humans). Generic model enables rapid configuration of variety of specific life support component models for tradeoff studies culminating in single system design. Enables rapid evaluation of effects of substituting alternate technologies and even entire groups of technologies and subsystems. Used to synthesize and analyze life-support systems ranging from relatively simple, nonregenerative units like aquariums to complex closed-loop systems aboard submarines or spacecraft. Model, called Generic Modular Flow Schematic (GMFS), coded in such chemical-process-simulation languages as Aspen Plus and expressed as three-dimensional spreadsheet.

Information provided by generic and brand-name pharmaceutical manufacturers in response to a request.

PubMed

Fernandez-Llimos, Fernando; Vazquez Gomez, Isabel

2007-12-01

To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. Community pharmacy in Spain. A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

PubMed

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Searches for Randomized Controlled Trials of Drugs in MEDLINE and EMBASE Using Only Generic Drug Names Compared with Searches Applied in Current Practice in Systematic Reviews

ERIC Educational Resources Information Center

Waffenschmidt, Siw; Guddat, Charlotte

2015-01-01

Background: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bibliographic search using only the generic drug name produces sufficient results for the generation…

Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment.

PubMed

Hill, Andrew; Gotham, Dzintars; Fortunak, Joseph; Meldrum, Jonathan; Erbacher, Isabelle; Martin, Manuel; Shoman, Haitham; Levi, Jacob; Powderly, William G; Bower, Mark

2016-01-27

To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs). TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production. Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated. API costs per kg were $347-$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128-$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually. Mass generic production of several TKIs could achieve treatment prices in the range of $128-$4020 per person-year, versus current US prices of $75161-$139,138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Preferred reporting items for studies mapping onto preference-based outcome measures: the MAPS statement.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2016-02-01

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MApping onto Preference-based measures reporting Standards (MAPS) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorised within six sections, namely (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

PREFERRED REPORTING ITEMS FOR STUDIES MAPPING ONTO PREFERENCE-BASED OUTCOME MEASURES: THE MAPS STATEMENT.

PubMed

Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

2015-01-01

"Mapping" onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. In the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items was created by a working group comprised of six health economists and one Delphi methodologist. A two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies, and the biomedical journal editorial community was used to identify a list of essential reporting items from this larger list. From the initial de novo list of twenty-nine candidate items, a set of twenty-three essential reporting items was developed. The items are presented numerically and categorized within six sections, namely: (i) title and abstract, (ii) introduction, (iii) methods, (iv) results, (v) discussion, and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency. and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.

Patent information - towards simplicity or complexity?

NASA Astrophysics Data System (ADS)

Shenton, Written By Kathleen; Norton, Peter; Onodera, Translated By Natsuo

Since the advent of online services, the ability to search and find chemical patent information has improved immeasurably. Recently, integration of a multitude of files (through file merging as well as cross-file/simultaneous searches), 'intelligent' interfaces and optical technology for large amounts of data seem to achieve greater simplicity and convenience in the retrieval of patent information. In spite of these progresses, there is more essential problem which increases complexity. It is a tendency to expand indefinitely the range of claim for chemical substances by a ultra-generic description of structure (overuse of optional substituents, variable divalent groups, repeating groups, etc.) and long listing of prophetic examples. Not only does this tendency worry producers and searchers of patent databases but also prevents truly worthy inventions in future.

Artificial intelligence applications in space and SDI: A survey

NASA Technical Reports Server (NTRS)

Fiala, Harvey E.

1988-01-01

The purpose of this paper is to survey existing and planned Artificial Intelligence (AI) applications to show that they are sufficiently advanced for 32 percent of all space applications and SDI (Space Defense Initiative) software to be AI-based software. To best define the needs that AI can fill in space and SDI programs, this paper enumerates primary areas of research and lists generic application areas. Current and planned NASA and military space projects in AI will be reviewed. This review will be largely in the selected area of expert systems. Finally, direct applications of AI to SDI will be treated. The conclusion covers the importance of AI to space and SDI applications, and conversely, their importance to AI.

[Competition and prices in the Mexican pharmaceutical market].

PubMed

Molina-Salazar, Raúl E; González-Marín, Eloy; Carbajal-de Nova, Carolina

2008-01-01

The forms of market competition define prices. The pharmaceutical market contains submarkets with different levels of competition; on the one hand are the innovating products with patents, and on the other, generic products with or without trade names. Innovating medicines generally have monopolistic prices, but when the patents expire prices drop because of competition from therapeutic alternatives. The trade name makes it easier to maintain monopolistic prices. In Mexico, medicine prices in the private market are high--according to aggregated estimates and prices for specific medicines--which reflect the limitations of pharmaceutical market competition and the power of the trade name. The public segment enjoys competitive prices using the WHO strategy for essential medicines on the basis of the Essential List.

Operationally Efficient Propulsion System Study (OEPSS) data book. Executive summary

NASA Technical Reports Server (NTRS)

Wong, George S.

1990-01-01

The study was initiated to identify operations problems and cost drivers for current propulsion systems and to identify technology and design approaches to increase the operational efficiency and reduce operations costs for future propulsion systems. To provide readily usable data for the Advanced Launch System (ALS) program, the results of the Operationally Efficient Propulsion System Study (OEPSS) were organized into a series of OEPSS Data Books as follows: Volume 1, Generic Ground Operations Data; Volume 2, Ground Operations Problems; Volume 3, Operations Technology; Volume 4, OEPSS Design Concepts; and Volume 5, OEPSS Final Review Briefing, which summarizes the activities and results of the study. Summarized here are the salient results of the first year. A synopsis of each volume listed above is presented.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

PubMed Central

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored. PMID:28152215

Leininger's model for discoveries at The Farm and midwifery services to the Amish.

PubMed

Finn, J

1995-01-01

This paper is a descriptive report and analysis of a transcultural nurse's experiences immersed in a hippie subculture at The Farm near Summertown, Tennessee. This subcultural group initially was established over 20 years ago as a community with a unique worldview which included pacifistic, vegetarian, and collective values and beliefs. This community prefers health care provided by their own community members who serve as generic care providers and also as folk midwives for home births. Leininger's (1991) Theory of Culture Care Diversity and Universality and her Sunrise Model provided the framework for discovering and understanding this unique subcultural group. The major components of Leininger's Sunrise Model including worldview, cultural values, and lifeways were used in the analysis. The important social structure factors discovered included environmental context, technological factors, religious and philosophical factors, political and legal factors, economic factors, and educational factors. The Farm community's culture care expressions, patterns and practices for health and well being were discovered including generic and folk systems of care. The farm midwives provide primary care and home birthing care to a nearby Old Order Amish community. The Amish culture and health care seeking patterns are discussed including their selective use of generic, folk, and professional care systems. The discoveries that resulted from the application of Leininger's Sunrise Model are presented including implications for transcultural nurse caregiving.

An avionics scenario and command model description for Space Generic Open Avionics Architecture (SGOAA)

NASA Technical Reports Server (NTRS)

Stovall, John R.; Wray, Richard B.

1994-01-01

This paper presents a description of a model for a space vehicle operational scenario and the commands for avionics. This model will be used in developing a dynamic architecture simulation model using the Statemate CASE tool for validation of the Space Generic Open Avionics Architecture (SGOAA). The SGOAA has been proposed as an avionics architecture standard to NASA through its Strategic Avionics Technology Working Group (SATWG) and has been accepted by the Society of Automotive Engineers (SAE) for conversion into an SAE Avionics Standard. This architecture was developed for the Flight Data Systems Division (FDSD) of the NASA Johnson Space Center (JSC) by the Lockheed Engineering and Sciences Company (LESC), Houston, Texas. This SGOAA includes a generic system architecture for the entities in spacecraft avionics, a generic processing external and internal hardware architecture, and a nine class model of interfaces. The SGOAA is both scalable and recursive and can be applied to any hierarchical level of hardware/software processing systems.

Review of ongoing initiatives to improve prescribing efficiency in China; angiotensin receptor blockers as a case history.

PubMed

Zeng, Wenjie; Gustafsson, Lars L; Bennie, Marion; Finlayson, Alexander E; Godman, Brian

2015-02-01

Pharmaceutical expenditure is rising by 16% per annum in China and is now 46% of total expenditure. Initiatives to moderate growth include drug pricing regulations and encouraging international non-proprietary name prescribing. However, there is no monitoring of physician prescribing quality and perverse incentives. Assess changes in angiotensin receptor blocker (ARB) utilization and expenditure as more generics become available; compare findings to Europe. Observational retrospective study of ARB utilization and expenditure between 2006 and 2012 in the largest hospital in Chongqing district. Variable and low use of generics versus originators with a maximum of 31% among single ARBs. Similar for fixed dose combinations. Prices typically reduced over time, greatest for generic telmisartan (-54%), mirroring price reductions in some European countries. However, no preferential increase in prescribing of lower cost generics. Accumulated savings of 33 million CNY for this large provider if they adopted European practices. Considerable opportunities to improve prescribing efficiency in China.

SmartSIM - a virtual reality simulator for laparoscopy training using a generic physics engine.

PubMed

Khan, Zohaib Amjad; Kamal, Nabeel; Hameed, Asad; Mahmood, Amama; Zainab, Rida; Sadia, Bushra; Mansoor, Shamyl Bin; Hasan, Osman

2017-09-01

Virtual reality (VR) training simulators have started playing a vital role in enhancing surgical skills, such as hand-eye coordination in laparoscopy, and practicing surgical scenarios that cannot be easily created using physical models. We describe a new VR simulator for basic training in laparoscopy, i.e. SmartSIM, which has been developed using a generic open-source physics engine called the simulation open framework architecture (SOFA). This paper describes the systems perspective of SmartSIM including design details of both hardware and software components, while highlighting the critical design decisions. Some of the distinguishing features of SmartSIM include: (i) an easy-to-fabricate custom-built hardware interface; (ii) use of a generic physics engine to facilitate wider accessibility of our work and flexibility in terms of using various graphical modelling algorithms and their implementations; and (iii) an intelligent and smart evaluation mechanism that facilitates unsupervised and independent learning. Copyright © 2016 John Wiley & Sons, Ltd.

21 CFR 884.1640 - Culdoscope and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the female genital organs. This generic type of device may include trocar and cannula, instruments... instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula...

21 CFR 884.1640 - Culdoscope and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the female genital organs. This generic type of device may include trocar and cannula, instruments... instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula...

77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Safety Databases (NPSD). The Common Formats include two general types of formats, generic and event... Common Formats. The inventory includes many systems from the private sector, including prominent academic...

A new species of Brasineura Silva-Neto & García Aldrete (Psocodea, 'Psocoptera', Ptiloneuridae), with comments on morphological variation in B. troglophilica and a revised generic diagnosis.

PubMed

Neto, Alberto Moreira Da Silva; Aldrete, Alfonso N García; Rafael, José Albertino

2016-03-03

Brasineura serranortensis sp. n. is here described and illustrated. This is the third known species of Brasineura and differs from the other species in the genus in phallosome, hypandrium and paraproct structure. Comments on variation in fore wing venation, and new records for B. troglophilica are included. A revised generic diagnosis is also presented.

Security Policy for a Generic Space Exploration Communication Network Architecture

NASA Technical Reports Server (NTRS)

Ivancic, William D.; Sheehe, Charles J.; Vaden, Karl R.

2016-01-01

This document is one of three. It describes various security mechanisms and a security policy profile for a generic space-based communication architecture. Two other documents accompany this document- an Operations Concept (OpsCon) and a communication architecture document. The OpsCon should be read first followed by the security policy profile described by this document and then the architecture document. The overall goal is to design a generic space exploration communication network architecture that is affordable, deployable, maintainable, securable, evolvable, reliable, and adaptable. The architecture should also require limited reconfiguration throughout system development and deployment. System deployment includes subsystem development in a factory setting, system integration in a laboratory setting, launch preparation, launch, and deployment and operation in space.

Bioethical considerations in animal production.

PubMed

Reynnells, R D

2004-03-01

The Western Coordinating Committee-204 (WCC-204) on animal bioethics is a multistate research committee that was formed through the cooperation of several university and government personnel having diverse backgrounds. The WCC-204 is pleased to provide this symposium to Poultry Science Association (PSA) members and invite their participation in the committee. Generic objectives of the committee include facilitation of dialogue to improve our understanding of complex ethical issues related to animal production and utilization by humans, to encourage research and educational programs in this area, and to create a means for critical analysis of the animal sciences professions. The basis for philosophical discussions and religious implications of bioethical discussions that create profound differences of opinion between people is discussed. The various and often underappreciated contributions of society to the structure of our current food production system, and society's approach to change (taking marketplace responsibility for demands vs. regulations), are briefly discussed. Several factors that may contribute to the creation of conflicts and misunderstandings are listed. Speakers will discuss the WCC-204 organization, the need to define where there is agreement between opposing entities, education of students and others through contemporary issues classes, and global issues related to animal well-being.

Overview study of Space Power Technologies for the advanced energetics program. [spacecraft

NASA Technical Reports Server (NTRS)

Taussig, R.; Gross, S.; Millner, A.; Neugebauer, M.; Phillips, W.; Powell, J.; Schmidt, E.; Wolf, M.; Woodcock, G.

1981-01-01

Space power technologies are reviewed to determine the state-of-the-art and to identify advanced or novel concepts which promise large increases in performance. The potential for incresed performance is judged relative to benchmarks based on technologies which have been flight tested. Space power technology concepts selected for their potentially high performance are prioritized in a list of R & D topical recommendations for the NASA program on Advanced Energetics. The technology categories studied are solar collection, nuclear power sources, energy conversion, energy storage, power transmission, and power processing. The emphasis is on electric power generation in space for satellite on board electric power, for electric propulsion, or for beamed power to spacecraft. Generic mission categories such as low Earth orbit missions and geosynchronous orbit missions are used to distinguish general requirements placed on the performance of power conversion technology. Each space power technology is judged on its own merits without reference to specific missions or power systems. Recommendations include 31 space power concepts which span the entire collection of technology categories studied and represent the critical technologies needed for higher power, lighter weight, more efficient power conversion in space.

Method for the prediction of the installation aerodynamics of a propfan at subsonic speeds: User manual

NASA Technical Reports Server (NTRS)

Chandrasekaran, B.

1986-01-01

This document is the user's guide for the method developed earlier for predicting the slipstream wing interaction at subsonic speeds. The analysis involves a subsonic panel code (HESS code) modified to handle the propeller onset flow. The propfan slipstream effects are superimposed on the normal flow boundary condition and are applied over the surface washed by the slipstream. The effects of the propeller slipstream are to increase the axial induced velocity, tangential velocity, and a total pressure rise in the wake of the propeller. Principles based on blade performance theory, momentum theory, and vortex theory were used to evaluate the slipstream effects. The code can be applied to any arbitrary three dimensional geometry, expressed in the form of HESS input format. The code can handle a propeller alone configuration or a propeller/nacelle/airframe configuration, operating up to high subcritical Mach numbers over a range of angles of attack. Inclusion of a viscous modelling is briefly outlined. Wind tunnel results/theory comparisons are included as examples for the application of the code to a generic supercritical wing/overwing Nacelle with a powered propfan. A sample input/output listing is provided.

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PubMed

Piovani, Daniele; Clavenna, Antonio; Cartabia, Massimo; Bortolotti, Angela; Fortino, Ida; Merlino, Luca; Bonati, Maurizio

2015-02-01

The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics. Copyright © 2014 John Wiley & Sons, Ltd.

Generic switch after ramipril patent expiry is not associated with decreased pharmacy refill compliance: a retrospective study using the DAPI database.

PubMed

Ude, Miriam; Schuessel, Katrin; Quinzler, Renate; Leuner, Kristina; Müller, Walter E; Schulz, Martin

2011-09-01

For treatment success in chronic diseases such as hypertension, adequate adherence to long-term pharmacotherapy is a prerequisite. The purpose of this study was to evaluate whether switching from brand name ramipril to a generic product after patent expiry may negatively affect patients' refill compliance. Claims data for ambulatory prescriptions within the statutory health insurance system were evaluated. Patients were included if they had filled a ramipril prescription (index) for either brand name or generic ramipril products between September 2003 and June 2004. Patients had to be continuously treated with ramipril for at least 12 months before and after the index date. Patients with a change from brand name to generic product or vice versa during follow-up after the index date were excluded from the analyses, as were patients who could not be unequivocally allocated to characteristics of covariates. Refill compliance was analysed by calculating the medication possession ratio (MPR), assuming that patients were prescribed one unit dose per day (MPR(UD)). In total, 142,690 and 79,191 patients were classified as brand name or generic therapy, respectively. Median MPR(UD) values were 0.95 and 0.96 (P < 0.001). In a logistic regression model adjusting for covariates, the probability for noncompliance (MPR(UD) < 0.8) was marginally lower in the generic compared with the brand name group (odds ratio 0.926, 99% confidence interval 0.901-0.951, P < 0.001). These results suggest that refill compliance is not negatively affected by a physician-induced switch from brand name to generic ramipril products after patent expiry.

Generic skills in medical education: developing the tools for successful lifelong learning.

PubMed

Murdoch-Eaton, Deborah; Whittle, Sue

2012-01-01

Higher education has invested in defining the role of generic skills in developing effective, adaptable graduates fit for a changing workplace. Research confirms that the development of generic skills that underpin effectiveness and adaptability in graduates is highly context-dependent and is shaped by the discipline within which these skills are conceptualised, valued and taught. This places the responsibility for generic skills enhancement clearly within the remit of global medical education. Many factors will influence the skill set with which students begin their medical training and experience at entry needs to be taken into account. Learning and teaching environments enhance effective skill development through active learning, teaching for understanding, feedback, and teacher-student and student-student interaction. Medical curricula need to provide students with opportunities to practise and develop their generic skills in a range of discipline-specific contexts. Curricular design should include explicit and integrated generic skills objectives against which students' progress can be monitored. Assessment and feedback serve as valuable reinforcements of the professed importance of generic skills to both learner and teacher, and will encourage students to self-evaluate and take responsibility for their own skill development. The continual need for students to modify their practice in response to changes in their environment and the requirements of their roles will help students to develop the ability to transfer these skills at transition points in their training and future careers. If they are to take their place in an ever-changing profession, medical students need to be competent in the skills that underpin lifelong learning. Only then will the doctors of the future be well placed to adapt to changes in knowledge, update their practice in line with the changing evidence base, and continue to contribute effectively as societal needs change. © Blackwell Publishing Ltd 2012.

Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.

PubMed

Kim, Jong Man; Kwon, Choon Hyuck David; Joh, Jae-Won; Sinn, Dong Hyun; Choi, Gyu-Seong; Park, Jae Berm; Kang, Eun-Suk; Lee, Suk-Koo

2017-01-01

In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients. Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test. Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p < 0.05). The level of CD4+Foxp3+ T cells was higher in the brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients. © 2017 S. Karger AG, Basel.

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses

PubMed Central

2014-01-01

Objectives To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession – a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal – on utilization of, as a proxy for access to, antipsychotic medicines. Methodology We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Results Both countries’ policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Conclusions Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended – increased use of generics – and likely unintended – slightly decreased overall sales, possibly consistent with decreased access to needed medicines – impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes. PMID:25062657

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses.

PubMed

Leopold, Christine; Zhang, Fang; Mantel-Teeuwisse, Aukje K; Vogler, Sabine; Valkova, Silvia; Ross-Degnan, Dennis; Wagner, Anita K

2014-07-25

To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.

Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study.

PubMed

Loch, Alexander; Bewersdorf, Jan Philipp; Kofink, Daniel; Ismail, Dzafir; Abidin, Imran Zainal; Veriah, Ramesh Singh

2017-07-17

In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin. This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor ® ) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups. 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p < 0.05) between proprietary and generic atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups. Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.

How to translate therapeutic recommendations in clinical practice guidelines into rules for critiquing physician prescriptions? Methods and application to five guidelines

PubMed Central

2010-01-01

Background Clinical practice guidelines give recommendations about what to do in various medical situations, including therapeutical recommendations for drug prescription. An effective way to computerize these recommendations is to design critiquing decision support systems, i.e. systems that criticize the physician's prescription when it does not conform to the guidelines. These systems are commonly based on a list of "if conditions then criticism" rules. However, writing these rules from the guidelines is not a trivial task. The objective of this article is to propose methods that (1) simplify the implementation of guidelines' therapeutical recommendations in critiquing systems by automatically translating structured therapeutical recommendations into a list of "if conditions then criticize" rules, and (2) can generate an appropriate textual label to explain to the physician why his/her prescription is not recommended. Methods We worked on the therapeutic recommendations in five clinical practice guidelines concerning chronic diseases related to the management of cardiovascular risk. We evaluated the system using a test base of more than 2000 cases. Results Algorithms for automatically translating therapeutical recommendations into "if conditions then criticize" rules are presented. Eight generic recommendations are also proposed; they are guideline-independent, and can be used as default behaviour for handling various situations that are usually implicit in the guidelines, such as decreasing the dose of a poorly tolerated drug. Finally, we provide models and methods for generating a human-readable textual critique. The system was successfully evaluated on the test base. Conclusion We show that it is possible to criticize physicians' prescriptions starting from a structured clinical guideline, and to provide clear explanations. We are now planning a randomized clinical trial to evaluate the impact of the system on practices. PMID:20509903

[Bioequivalence and generics of index drugs with narrow therapeutic margins].

PubMed

Le Corre, Pascal

2010-02-01

The market share of generic drugs in France is quite low compared to that in other European countries. Because the scientific aspects of bioequivalence that govern the use of generics are sometimes described ambiguously in the literature, they are not always perceived clearly by health professionals. This lack of clarity may be an obstacle to their use. Two drugs are considered bioequivalent if the upper and lower limits of the 90% confidence interval (90% CI) of the generic-to-brand ratio for the area under the curve (AUC) and for the maximum plasma concentration (Cmax) are included in the [-20%, +25%] interval. This interval applies to the 90% CI of the ratios of the AUC (or Cmax) and not directly to the ratio of their values. Hence, it is wrong to consider that there is a -20% to + 25% variation in the AUC (and thus in the bioavailability) between a generic and a brand-name drug. This mistake can sometimes be seen in the medical literature, however, with incorrect extrapolations. The bioequivalence is defined for a generic in relation to a brand-name drug. Consequently, two different generics of the same proprietary drug do not automatically meet the criteria for bioequivalence. Their interchangeability can present problems, especially for drugs with a narrow therapeutic index, that is, those that have a<2-fold difference between the minimum toxic concentration and minimum effective concentration in blood. More restrictive criteria have been proposed for narrow therapeutic index drugs, but there is currently no international consensus on the subject. Determining individual bioequivalence would require modified study protocols to guaranty the interchangeability of the brand-name and generic drugs so that a patient taking one formulation could change to another that would provide the same efficacy and safety. Some antiepileptic drugs have biopharmaceutical and pharmacokinetic properties inducing high levels of intraindividual variability, which can cause problems. According to the French drug agency (AFSSAPS), however, a link between epileptic attacks and treatment with generic drugs has not been established. The economic evaluation of generics should go beyond the simple comparison of the sales price, especially for drugs with a narrow therapeutic range for which therapeutic drug monitoring (plasma assays) can be used. Copyright 2009 Elsevier Masson SAS. All rights reserved.

The generic drug user fee amendments: an economic perspective

PubMed Central

Berndt, Ernst R; Murphy, Stephen J

2018-01-01

Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

Occurrence of foodborne bacteria in Alberta feedlots.

PubMed

Van Donkersgoed, Joyce; Bohaychuk, Valerie; Besser, Thomas; Song, Xin-Ming; Wagner, Bruce; Hancock, Dale; Renter, David; Dargatz, David

2009-02-01

The occurrence of generic Escherichia coli, E. coli O157, Salmonella, and Campylobacter in cattle manure, beef carcasses, catch basin water, and soils receiving manure application was determined in 21 Alberta feedlots. In cattle manure, generic E. coli (98%, 2069/2100) and Campylobacter (76%, 1590/2100) were frequently detected; E. coli O157 (7%, 143/2100) and Salmonella (1%, 20/2100) were less frequently detected. Samples from beef carcasses in the cooler following Hazard Analysis Critical Control Point interventions yielded only 1 isolate each of generic E. coli and Campylobacter (1/1653) and no Salmonella (0/1653). Catch basin water specimens were positive for generic E. coli in both the spring (62%, 13/21) and the fall (52%, 11/21). Other bacteria were detected only in the spring water specimens, including E. coli O157 (29%, 6/21), Salmonella (5%, 1/21), and Campylobacter (52%, 11/21). Generic E. coli was frequently isolated from soil specimens (30%, 27/88), but E. coli O157 was not found in soil samples obtained in the spring and was only occasionally detected in the fall samples (9%, 3/32). Salmonella were occasionally found in the soil specimens collected in the spring (3%, 2/56), but not in the fall season (0/32). Campylobacter jejuni was frequent in cattle manure (66%, 1070/1623), but rare in carcass and environmental samples. E. coli O157 and Salmonella were rarely detected in cattle or the environment. Generic E. coli and Salmonella were rarely detected on carcasses.

Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

PubMed

Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

2004-06-01

This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

The Role of Condition-Specific Preference-Based Measures in Health Technology Assessment.

PubMed

Rowen, Donna; Brazier, John; Ara, Roberta; Azzabi Zouraq, Ismail

2017-12-01

A condition-specific preference-based measure (CSPBM) is a measure of health-related quality of life (HRQOL) that is specific to a certain condition or disease and that can be used to obtain the quality adjustment weight of the quality-adjusted life-year (QALY) for use in economic models. This article provides an overview of the role and the development of CSPBMs, and presents a description of existing CSPBMs in the literature. The article also provides an overview of the psychometric properties of CSPBMs in comparison with generic preference-based measures (generic PBMs), and considers the advantages and disadvantages of CSPBMs in comparison with generic PBMs. CSPBMs typically include dimensions that are important for that condition but may not be important across all patient groups. There are a large number of CSPBMs across a wide range of conditions, and these vary from covering a wide range of dimensions to more symptomatic or uni-dimensional measures. Psychometric evidence is limited but suggests that CSPBMs offer an advantage in more accurate measurement of milder health states. The mean change and standard deviation can differ for CSPBMs and generic PBMs, and this may impact on incremental cost-effectiveness ratios. CSPBMs have a useful role in HTA where a generic PBM is not appropriate, sensitive or responsive. However, due to issues of comparability across different patient groups and interventions, their usage in health technology assessment is often limited to conditions where it is inappropriate to use a generic PBM or sensitivity analyses.

Differentiating low-molecular-weight heparins based on chemical, biological, and pharmacologic properties: implications for the development of generic versions of low-molecular-weight heparins.

PubMed

Jeske, Walter P; Walenga, Jeanine M; Hoppensteadt, Debra A; Vandenberg, Curtis; Brubaker, Aleah; Adiguzel, Cafer; Bakhos, Mamdouh; Fareed, Jawed

2008-02-01

Low-molecular-weight heparins (LMWHs) are polypharmacologic drugs used to treat thrombotic and cardiovascular disorders. These drugs are manufactured using different chemical and enzymatic methods, resulting in products with distinct chemical and pharmacologic profiles. Generic LMWHs have been introduced in Asia and South America, and several generic suppliers are seeking regulatory approval in the United States and the European Union. For simple small-molecule drugs, generic drugs have the same chemical structure, potency, and bioavailability as the innovator drug. Applying this definition to complex biological products such as the LMWHs has proved difficult. One major issue is defining appropriate criteria to demonstrate bioequivalence; pharmacopoeial specifications alone appear to be inadequate. Whereas available generic versions of LMWHs exhibit similar molecular and pharmacopoeial profiles, marked differences in their biological and pharmacologic behavior have been noted. Preliminary studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release after subcutaneous administration, as well as antiplatelet and profibrinolytic effects. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs with complex structures and activities and also underscore the importance of further pharmacologic studies involving animal models and human clinical trials. The U.S. Food and Drug Administration and the European Medicine Evaluation Agency are currently developing guidelines for the acceptance of biosimilar agents including LMWHs. Until such guidelines are complete, generic interchange may not be feasible.

21 CFR 884.1720 - Gynecologic laparoscope and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... genital organs. This generic type of device may include: Trocar and cannula, instruments used through an... accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips...

21 CFR 884.1720 - Gynecologic laparoscope and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... genital organs. This generic type of device may include: Trocar and cannula, instruments used through an... accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips...

Approaches to pharmacy benefit management and the impact of consumer cost sharing.

PubMed

Olson, Bridget M

2003-01-01

Numerous mechanisms have been introduced to deliver prescription drug benefits while controlling pharmaceutical costs. An understanding of the most prominent mechanisms of benefit management is an important step in determining the most effective approach to take in future years. The aims of this review were to illustrate the mechanisms by which managed care has attempted to efficiently and equitably deliver pharmacy benefits and to discuss the impact of such programs, including consumer cost sharing. A review of the literature was conducted using the PreMedline and MEDLINE databases from the years 1966 to 2002, reference lists from relevant articles, and online sources, including news releases, conference materials, and pharmacy benefit management reports. Numerous pharmacy benefit management tools and their impact on utilization, expenditures, and health outcomes are reviewed, including disease state management; utilization management (ie, quantity limitations and prior authorization); drug utilization review; formulary management (ie, open and closed); delivery systems (ie, retail and mail order); and mechanisms for implementing consumer cost sharing (ie, generic incentives, multitiered copayments, and co-insurance). Although there is some evidence to suggest that certain benefit management tools have been successful in reducing health plan expenditures, a more thorough investigation of their potential unintended consequences is needed. Implementing adequate levels of consumer cost sharing is necessary if employers and health plans are to continue offering prescription drug benefits. It is important to remember, however, that quality health care cannot be forfeited for the sake of short-term cost savings.

Self-report pain and symptom measures for primary dysmenorrhoea: a critical review.

PubMed

Chen, C X; Kwekkeboom, K L; Ward, S E

2015-03-01

Primary dysmenorrhoea (PD) is highly prevalent among women of reproductive age and it can have significant short- and long-term consequences for both women and society as a whole. Validated symptom measures are fundamental for researchers to understand women's symptom experience of PD and to test symptom interventions. The objective of this paper was to critically review the content and psychometric properties of self-report tools to measure symptoms of PD. Databases including PubMed, PsychoINFO, Cumulative Index of Nursing and Allied Health Literature, and Health and Psychosocial Instruments were searched for self-report symptom measures that had been used among women with either PD or perimenstrual symptoms. A total of 15 measures met inclusion criteria and were included in the final analysis. The measures were categorized into generic pain measures, dysmenorrhoea-specific measures, and tools designed to measure perimenstrual symptoms. These measures had varying degrees of comprehensiveness of symptoms being measured, relevance to PD, multidimensionality and psychometric soundness. No single measure was found to be optimal for use, but some dysmenorrhoea-specific measures could be recommended if revised and further tested. Key issues in symptom measurement for PD are discussed. Future research needs to strengthen dysmenorrhoea-specific symptom measures by including a comprehensive list of symptoms based on the pathogenesis of PD, exploring relevant symptom dimensions beyond symptom severity (e.g., frequency, duration, symptom distress), and testing psychometric properties of the adapted tools using sound methodology and diverse samples. © 2014 European Pain Federation - EFIC®

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

A generic method for evaluating crowding in the emergency department.

PubMed

Eiset, Andreas Halgreen; Erlandsen, Mogens; Møllekær, Anders Brøns; Mackenhauer, Julie; Kirkegaard, Hans

2016-06-14

Crowding in the emergency department (ED) has been studied intensively using complicated non-generic methods that may prove difficult to implement in a clinical setting. This study sought to develop a generic method to describe and analyse crowding from measurements readily available in the ED and to test the developed method empirically in a clinical setting. We conceptualised a model with ED patient flow divided into separate queues identified by timestamps for predetermined events. With temporal resolution of 30 min, queue lengths were computed as Q(t + 1) = Q(t) + A(t) - D(t), with A(t) = number of arrivals, D(t) = number of departures and t = time interval. Maximum queue lengths for each shift of each day were found and risks of crowding computed. All tests were performed using non-parametric methods. The method was applied in the ED of Aarhus University Hospital, Denmark utilising an open cohort design with prospectively collected data from a one-year observation period. By employing the timestamps already assigned to the patients while in the ED, a generic queuing model can be computed from which crowding can be described and analysed in detail. Depending on availability of data, the model can be extended to include several queues increasing the level of information. When applying the method empirically, 41,693 patients were included. The studied ED had a high risk of bed occupancy rising above 100 % during day and evening shift, especially on weekdays. Further, a 'carry over' effect was shown between shifts and days. The presented method offers an easy and generic way to get detailed insight into the dynamics of crowding in an ED.

The Generic Short Patient Experiences Questionnaire (GS-PEQ): identification of core items from a survey in Norway

PubMed Central

2011-01-01

Background Questionnaires are commonly used to collect patient, or user, experiences with health care encounters; however, their adaption to specific target groups limits comparison between groups. We present the construction of a generic questionnaire (maximum of ten questions) for user evaluation across a range of health care services. Methods Based on previous testing of six group-specific questionnaires, we first constructed a generic questionnaire with 23 items related to user experiences. All questions included a "not applicable" response option, as well as a follow-up question about the item's importance. Nine user groups from one health trust were surveyed. Seven groups received questionnaires by mail and two by personal distribution. Selection of core questions was based on three criteria: applicability (proportion "not applicable"), importance (mean scores on follow-up questions), and comprehensiveness (content coverage, maximum two items per dimension). Results 1324 questionnaires were returned providing subsample sizes ranging from 52 to 323. Ten questions were excluded because the proportion of "not applicable" responses exceeded 20% in at least one user group. The number of remaining items was reduced to ten by applying the two other criteria. The final short questionnaire included items on outcome (2), clinician services (2), user involvement (2), incorrect treatment (1), information (1), organisation (1), and accessibility (1). Conclusion The Generic Short Patient Experiences Questionnaire (GS-PEQ) is a short, generic set of questions on user experiences with specialist health care that covers important topics for a range of groups. It can be used alone or with other instruments in quality assessment or in research. The psychometric properties and the relevance of the GS-PEQ in other health care settings and countries need further evaluation. PMID:21510871

A generic multi-flex-body dynamics, controls simulation tool for space station

NASA Technical Reports Server (NTRS)

London, Ken W.; Lee, John F.; Singh, Ramen P.; Schubele, Buddy

1991-01-01

An order (n) multiflex body Space Station simulation tool is introduced. The flex multibody modeling is generic enough to model all phases of Space Station from build up through to Assembly Complete configuration and beyond. Multibody subsystems such as the Mobile Servicing System (MSS) undergoing a prescribed translation and rotation are also allowed. The software includes aerodynamic, gravity gradient, and magnetic field models. User defined controllers can be discrete or continuous. Extensive preprocessing of 'body by body' NASTRAN flex data is built in. A significant aspect, too, is the integrated controls design capability which includes model reduction and analytic linearization.

Initial Kernel Timing Using a Simple PIM Performance Model

NASA Technical Reports Server (NTRS)

Katz, Daniel S.; Block, Gary L.; Springer, Paul L.; Sterling, Thomas; Brockman, Jay B.; Callahan, David

2005-01-01

This presentation will describe some initial results of paper-and-pencil studies of 4 or 5 application kernels applied to a processor-in-memory (PIM) system roughly similar to the Cascade Lightweight Processor (LWP). The application kernels are: * Linked list traversal * Sun of leaf nodes on a tree * Bitonic sort * Vector sum * Gaussian elimination The intent of this work is to guide and validate work on the Cascade project in the areas of compilers, simulators, and languages. We will first discuss the generic PIM structure. Then, we will explain the concepts needed to program a parallel PIM system (locality, threads, parcels). Next, we will present a simple PIM performance model that will be used in the remainder of the presentation. For each kernel, we will then present a set of codes, including codes for a single PIM node, and codes for multiple PIM nodes that move data to threads and move threads to data. These codes are written at a fairly low level, between assembly and C, but much closer to C than to assembly. For each code, we will present some hand-drafted timing forecasts, based on the simple PIM performance model. Finally, we will conclude by discussing what we have learned from this work, including what programming styles seem to work best, from the point-of-view of both expressiveness and performance.

The challenges of developing a generic extraction procedure to analyze multi-class veterinary drug residues in milk and honey using ultra-high pressure liquid chromatography quadrupole time-of-flight mass spectrometry.

PubMed

Wang, Jian; Leung, Daniel

2012-08-01

This paper discusses the analytical challenges to develop a generic extraction procedure to analyze or screen multi-class veterinary drugs in milk and honey using ultra-high pressure liquid chromatography quadrupole time-of-flight mass spectrometry (UHPLC QqTOF MS). The veterinary drugs in this study included aminoglycosides, endectocides, fluoroquinolones, ionophores, β-lactams or penicillins, macrolides, NSAIDs, phenicols, sulfonamides and tetracyclines. Veterinary drugs were extracted using a QuEChERS (quick, easy, cheap, effective, rugged, and safe) method, which entailed the use of acetonitrile containing 1% acetic acid, sodium acetate, ethylenediaminetetra acetic acid disodium (EDTA) and magnesium sulfate, and no clean-up was performed. Chromatographic separation was achieved on a reversed-phase Acquity UPLC BEH C(18) , 100 × 2.1 mm, 1.7 µm column with 0.1% formic acid and 10 mM ammonium formate in water, and acetonitrile as mobile phases. Due to poor chromatographic retention, aminoglycosides were first dropped from the list, and because of poor extractability, β-lactams and tetracyclines were also excluded from the method. The method was able to quantify 31 or screen up to 54 drugs (unbound) in honey, and to quantify 34 or screen up to 59 drugs in milk. UHPLC QqTOF data were acquired in TOF MS full-scan mode that allowed both quantification and confirmation of veterinary drugs and identification of their degradation products in samples. The method could achieve detection limits as low as 1 µg/kg with analytical range from 1 to 100 µg/kg. The developed method was intended to be used for screening of as many analytes as possible in one single analysis, or unequivocal confirmation of positive findings and degradation product identification based on accurate mass measurement and isotopic patterns. © Her Majesty the Queen in Right of Canada 2012. Reproduced with the permission of the Minister of Agriculture.

Impact of universal health insurance coverage in Thailand on sales and market share of medicines for non-communicable diseases: an interrupted time series study.

PubMed

Garabedian, Laura Faden; Ross-Degnan, Dennis; Ratanawijitrasin, Sauwakon; Stephens, Peter; Wagner, Anita Katharina

2012-01-01

In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes. Interrupted time-series design, with a non-equivalent comparison group. Thailand, 1998-2006. Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006. UCS implementation, April-October 2001. Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status. The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors. Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed.

Organizational performance, Marketing strategy, and Financial strategic alignment: an empirical study on Iranian pharmaceutical firms.

PubMed

Mohammadzadeh, Mehdi; Aarabi, Sied Mohammad; Salamzadeh, Jamshid

2013-08-02

Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006-2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing's rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Managers should not consider decisions regarding marketing strategy independently of their financial strategy.

Organizational performance, Marketing strategy, and Financial strategic alignment: an empirical study on Iranian pharmaceutical firms

PubMed Central

2013-01-01

Background Strategic Functional-level planning should be aligned with business level and other functional strategies of a company. It is presumed that assimilating the strategies could have positive contribution to business performance, in this regard alignment between marketing strategy and financial strategy seems to be the most important strategies being studied. An empirical work in generic pharmaceutical manufacturing companies for evaluating effect of alignment between these two functions on organizational performance was developed in this paper. Methods All Iranian pharmaceutical generic manufactures listed in Tehran stock market have been tested for period of five years between 2006–2010 and their marketing strategies were determined by using Slater and Olson taxonomy and their financial strategies have been developed by calculating total risk and total return of sample companies for five years based on rate of risk and return in the frame of a 2 × 2 matrix. For the business performance three profitability indices including Q-Tubin (Rate of market value to net asset value), ROA (Return on Asset), ROE (Return on Equity) have been tested. For analysis, a series of one-way ANOVAs as a collection of statistical models within marketing strategies considering financial strategy as independent variable and the three performance measures as dependent variables was used. Results Results show strategic alignment between financial and marketing has significant impact on profitability of company resulting in arise of all three profitability indices. Q tubing’s rate were 2.33,2.09,2.29,2.58 and rate of ROA were 0.21,0.194,0.25,0.22 and rate of ROE were 0.44,0.46,0.45,0.42 for matched strategy types, respectively the rates shown here are more than average meaning that specific type of marketing strategy is fitted with specific type of financial strategy. Conclusion Managers should not consider decisions regarding marketing strategy independently of their financial strategy. PMID:23915467

Impact of universal health insurance coverage in Thailand on sales and market share of medicines for non-communicable diseases: an interrupted time series study

PubMed Central

Garabedian, Laura Faden; Ross-Degnan, Dennis; Ratanawijitrasin, Sauwakon; Stephens, Peter; Wagner, Anita Katharina

2012-01-01

Objective In 2001, Thailand implemented the Universal Coverage Scheme (UCS), a public insurance system that aimed to achieve universal access to healthcare, including essential medicines, and to influence primary care centres and hospitals to use resources efficiently, via capitated payment for outpatient services and other payment policies for inpatient care. Our objective was to evaluate the impact of the UCS on utilisation of medicines in Thailand for three non-communicable diseases: cancer, cardiovascular disease and diabetes. Design Interrupted time-series design, with a non-equivalent comparison group. Setting Thailand, 1998–2006. Data Quarterly purchases of medicines from hospital and retail pharmacies collected by IMS Health between 1998 and 2006. Intervention UCS implementation, April–October 2001. Outcome measures Total pharmaceutical sales volume and percent market share by licensing status and National Essential Medicine List status. Results The UCS was associated with long-term increases in sales of medicines for conditions that are typically treated in outpatient primary care settings, such as diabetes, high cholesterol and high blood pressure, but not for medicines for diseases that are typically treated in secondary or tertiary care settings, such as heart failure, arrhythmias and cancer. Although the majority of increases in sales were for essential medicines, there were also postpolicy increases in sales of non-essential medicines. Immediately following the reform, there was a significant shift in hospital sector market share by licensing status for most classes of medicines. Government-produced products often replaced branded generic or generic competitors. Conclusions Our results suggest that expanding health insurance coverage with a medicine benefit to the entire Thai population increased access to medicines in primary care. However, our study also suggests that the UCS may have had potentially undesirable effects. Evaluations of the long-term impacts of universal health coverage on medicine utilisation are urgently needed. PMID:23192243

Essential medicines are more available than other medicines around the globe.

PubMed

Bazargani, Yaser T; Ewen, Margaret; de Boer, Anthonius; Leufkens, Hubert G M; Mantel-Teeuwisse, Aukje K

2014-01-01

The World Health Organization (WHO) promotes the development of national Essential Medicines Lists (EMLs) in order to improve the availability and use of medicines considered essential within health care systems. However, despite over 3 decades of international efforts, studies show an inconsistent pattern in the availability of essential medicines. We evaluated and compared the availability of essential medicines, and medicines not included in national EMLs, at global and regional levels. Medicine availability in the public and private sector were calculated based on data obtained from national and provincial facility-based surveys undertaken in 23 countries using the WHO/HAI methodology. The medicines were grouped according to their inclusion ('essential') or exclusion (termed 'non-essential') in each country's EML current at the time of the survey. Availability was calculated for originator brands, generics and any product type (originator brands or generics) and compared between the two groups. Results were aggregated by WHO regions, World Bank country income groups, a wealth inequality measure, and therapeutic groups. Across all sectors and any product type, the median availability of essential medicines was suboptimal at 61·5% (IQR 20·6%-86·7%) but significantly higher than non-essential medicines at 27·3% (IQR 3·6%-70·0%). The median availability of essential medicines was 40·0% in the public sector and 78·1% in the private sector; compared to 6·6% and 57·1% for non-essential medicines respectively. A reverse trend between national income level categories and the availability of essential medicines was identified in the public sector. EMLs have influenced the provision of medicines and have resulted in higher availability of essential medicines compared to non-essential medicines particularly in the public sector and in low and lower middle income countries. However, the availability of essential medicines, especially in the public sector does not ensure equitable access.

Your business in court and at Federal agencies: 2011-2012.

PubMed

Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan

2013-01-01

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

PubMed

O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

2015-12-15

The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic medicines.

Advisory List of Instructional Media--16MM Films.

ERIC Educational Resources Information Center

North Carolina State Dept. of Public Instruction, Raleigh. Div. of Educational Media.

These two advisory lists include information on 16mm films appropriate for the K-12 instructional program. In both bibliographies films are listed in the following categories: communication skills; guidance; health, physical education, safety, and sports; science; and social studies. The list for the 1982-1983 school year also includes categories…

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Unmanned Aircraft Detect-And-Avoid Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is generic since it was designed without any assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Therefore, GRACE was adopted as a core component of the Java Architecture for Detect-And-Avoid (DAA) Extensibility and Modeling, developed by NASA as a research and modeling tool for Unmanned Aerial Systems Integration in the National Airspace System (NAS). GRACE has been used in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

Operational Concepts for a Generic Space Exploration Communication Network Architecture

NASA Technical Reports Server (NTRS)

Ivancic, William D.; Vaden, Karl R.; Jones, Robert E.; Roberts, Anthony M.

2015-01-01

This document is one of three. It describes the Operational Concept (OpsCon) for a generic space exploration communication architecture. The purpose of this particular document is to identify communication flows and data types. Two other documents accompany this document, a security policy profile and a communication architecture document. The operational concepts should be read first followed by the security policy profile and then the architecture document. The overall goal is to design a generic space exploration communication network architecture that is affordable, deployable, maintainable, securable, evolvable, reliable, and adaptable. The architecture should also require limited reconfiguration throughout system development and deployment. System deployment includes: subsystem development in a factory setting, system integration in a laboratory setting, launch preparation, launch, and deployment and operation in space.

Generic, Extensible, Configurable Push-Pull Framework for Large-Scale Science Missions

NASA Technical Reports Server (NTRS)

Foster, Brian M.; Chang, Albert Y.; Freeborn, Dana J.; Crichton, Daniel J.; Woollard, David M.; Mattmann, Chris A.

2011-01-01

The push-pull framework was developed in hopes that an infrastructure would be created that could literally connect to any given remote site, and (given a set of restrictions) download files from that remote site based on those restrictions. The Cataloging and Archiving Service (CAS) has recently been re-architected and re-factored in its canonical services, including file management, workflow management, and resource management. Additionally, a generic CAS Crawling Framework was built based on motivation from Apache s open-source search engine project called Nutch. Nutch is an Apache effort to provide search engine services (akin to Google), including crawling, parsing, content analysis, and indexing. It has produced several stable software releases, and is currently used in production services at companies such as Yahoo, and at NASA's Planetary Data System. The CAS Crawling Framework supports many of the Nutch Crawler's generic services, including metadata extraction, crawling, and ingestion. However, one service that was not ported over from Nutch is a generic protocol layer service that allows the Nutch crawler to obtain content using protocol plug-ins that download content using implementations of remote protocols, such as HTTP, FTP, WinNT file system, HTTPS, etc. Such a generic protocol layer would greatly aid in the CAS Crawling Framework, as the layer would allow the framework to generically obtain content (i.e., data products) from remote sites using protocols such as FTP and others. Augmented with this capability, the Orbiting Carbon Observatory (OCO) and NPP (NPOESS Preparatory Project) Sounder PEATE (Product Evaluation and Analysis Tools Elements) would be provided with an infrastructure to support generic FTP-based pull access to remote data products, obviating the need for any specialized software outside of the context of their existing process control systems. This extensible configurable framework was created in Java, and allows the use of different underlying communication middleware (at present, both XMLRPC, and RMI). In addition, the framework is entirely suitable in a multi-mission environment and is supporting both NPP Sounder PEATE and the OCO Mission. Both systems involve tasks such as high-throughput job processing, terabyte-scale data management, and science computing facilities. NPP Sounder PEATE is already using the push-pull framework to accept hundreds of gigabytes of IASI (infrared atmospheric sounding interferometer) data, and is in preparation to accept CRIMS (Cross-track Infrared Microwave Sounding Suite) data. OCO will leverage the framework to download MODIS, CloudSat, and other ancillary data products for use in the high-performance Level 2 Science Algorithm. The National Cancer Institute is also evaluating the framework for use in sharing and disseminating cancer research data through its Early Detection Research Network (EDRN).

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011.

PubMed

Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard A

Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. Drugs and dose/formulations with versus without an authorized generic drug marketed. Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished. Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Estimation of Potential Savings Through Therapeutic Substitution.

PubMed

Johansen, Michael E; Richardson, Caroline

2016-06-01

Therapeutic substitution offers potential to decrease pharmaceutical expenditures and potentially improve the efficiency of the health care system. To estimate potential savings through therapeutic substitution in terms of both overall and out-of-pocket expenditures of branded drugs when a generic in the same class with the same indication was available. Repeated cross-sectional study using the 107 132 individuals included in the nationally representative Medical Expenditure Panel Survey (2010-2012) along with their reported prescribed medicine use. The Orange Book, company financial statements, US Food and Drug Administration records, and published research were used for adjunctive information. Estimated excess expenditure due to branded drug overuse when a lower-cost generic in the same class with the same indication was available. The study included 107 132 individuals between 2010 and 2012, of whom 62.1% (95% CI, 61.4%-62.8%) reported use of any prescribed medicine. A total of 31.5% (95% CI, 30.7%-32.2%) used a medication from an included drug class, whereas 16.6% (95% CI, 16.0%-17.1%) of the population used a branded drug from the included classes compared with 24.0% (95% CI, 23.4%-24.7%) who used a generic and 9.1% (95% CI, 8.7%-9.4%) who used both. In the included drug classes, the majority of the drugs were generics, with a total of 93.5 billion standardized doses compared with 47.4 billion standardized doses of branded drugs. Total expenditure of the branded drugs accounted for $147 (95% CI, $137-$156) billion compared with $62.7 (95% CI, $58.9-$66.5) billion for the generics. Between 2010 and 2012, an estimated $73.0 (95% CI, $67.6-$78.5) billion in total excess expenditure and $24.6 (95% CI, $22.6-$26.5) billion in out-of-pocket excess expenditure was attributable to branded drug overuse. The excess was present across numerous drug classes throughout many aspects of medicine and equates to 9.6% of total and 14.1% of out-of-pocket prescribed medicine expenses. The drug classes with the highest excess expenditure included statins ($10.9 [SE, $0.41] billion), atypical antipsychotics ($9.99 [SE, $1.03] billion), proton pump inhibitors ($6.12 [SE, $0.38] billion), selective serotonin reuptake inhibitors ($6.08 [SE, $0.49] billion), and angiotensin receptor blockers ($5.53 [SE, $0.35] billion). Although therapeutic substitution is controversial, it offers a potential mechanism to significantly decrease drug costs if it can be implemented in a way that does not negatively affect quality of care.

Human life support during interplanetary travel and domicile. VI - Generic modular flow schematic for hybrid physical/chemical-biological life support systems

NASA Technical Reports Server (NTRS)

Ganapathi, Gani B.; Seshan, P. K.; Ferrall, Joseph; Rohatgi, Naresh

1992-01-01

An extension is proposed for the NASA Space Exploration Initiative's Generic Modular Flow Schematics for physical/chemical life support systems which involves the addition of biological processes. The new system architecture includes plant, microbial, and animal habitat, as well as the human habitat subsystem. Major Feedstock Production and Food Preparation and Packaging components have also been incorporated. Inedible plant, aquaculture, microbial, and animal solids are processed for recycling.

CFD validation experiments at the Lockheed-Georgia Company

NASA Technical Reports Server (NTRS)

Malone, John B.; Thomas, Andrew S. W.

1987-01-01

Information is given in viewgraph form on computational fluid dynamics (CFD) validation experiments at the Lockheed-Georgia Company. Topics covered include validation experiments on a generic fighter configuration, a transport configuration, and a generic hypersonic vehicle configuration; computational procedures; surface and pressure measurements on wings; laser velocimeter measurements of a multi-element airfoil system; the flowfield around a stiffened airfoil; laser velocimeter surveys of a circulation control wing; circulation control for high lift; and high angle of attack aerodynamic evaluations.

Buckling Behavior of Long Anisotropic Plates Subjected to Fully Restrained Thermal Expansion

NASA Technical Reports Server (NTRS)

Nemeth, Michael P.

2003-01-01

An approach for synthesizing buckling results and behavior for thin, balanced and unbalanced symmetric laminates that are subjected to uniform heating or cooling and which are fully-restrained against thermal expansion or contraction is presented. This approach uses a nondimensional analysis for infinitely long, flexurally anisotropic plates that are subjected to combined mechanical loads and is based on useful nondimensional parameters. In addition, stiffness-weighted laminate thermal-expansion parameters are derived and used to determine critical temperature changes in terms of physically intuitive mechanical buckling coefficients. The effects of membrane orthotropy and anisotropy are included. Many results are presented for some common laminates that are intended to facilitate a structural designer's transition to the use of the generic buckling design curves that are presented in the paper. Several generic buckling design curves are presented that provide physical insight into buckling response and provide useful design data. Examples are presented that demonstrate the use of generic design curves. The analysis approach and generic results indicate the effects and characteristics of laminate thermal expansion, membrane orthotropy and anisotropy, and flexural orthotropy and anisotropy in a very general, unifying manner.

Advisory List of Reference Books for Grades K-6.

ERIC Educational Resources Information Center

North Carolina State Dept. of Public Instruction, Raleigh. Div. of Educational Media.

Intended to serve as a guide rather than as a comprehensive listing, this advisory list includes reference books appropriate for school media collections for grades K-6. Entries included on the list were selected from those materials submitted by publishers which received favorable reviews by educators. Single volumes and sets of books are listed…

76 FR 63921 - Central Vermont Public Service Corporation; Notice of Proposed Restricted Service List for a...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

... Service List for a Programmatic Agreement for Managing Properties Included in or Eligible for Inclusion in... a programmatic agreement for managing properties included in, or eligible for inclusion in, the... list for the above-captioned proceeding may request inclusion on the restricted service list, or may...

Application of computer-generated models using low-bandwidth vehicle data

NASA Astrophysics Data System (ADS)

Heyes, Neil J.

2002-05-01

One of the main issues with remote teleoperation of vehicles is that during visual operation, one relies on fixed camera positions that ultimately constrain the operator's view of the real world. The paper describes a solution that has been developed at QinetiQ where the operator his given a unique virtual perspective of the vehicle and the surrounding terrain as the vehicle operates. This system helps to solve problems that are generic to remote systems, such as reduction of high data transmission rates and providing 360 degree(s) three dimensional operator view positions regardless of terrain features, light levels and near real time operation. A summary of technologies is listed that could be applied to different types of vehicles and placed in many different situations in order to enhance operator spatial awareness.

Au pairs are rarely male: norms on the gender perception of role names across English, French, and German.

PubMed

Gabriel, Ute; Gygax, Pascal; Sarrasin, Oriane; Garnham, Alan; Oakhill, Jane

2008-02-01

A list of role names for future use in research on gender stereotyping was created and evaluated. In two studies, 126 role names were rated with reference to their gender stereotypicality by English-, French-, and German-speaking students of universities in Switzerland (French and German) and in the U.K. (English). Role names were either presented in specific feminine and masculine forms (Study 1) or in the masculine form (generic masculine) only (Study 2). The rankings of the stereotypicality ratings were highly reliable across languages and questionnaire versions, but the overall mean of the ratings was less strongly male if participants were also presented with the female versions of the role names and if the latter were presented on the left side of the questionnaires.

On-Board Software Reference Architecture for Payloads

NASA Astrophysics Data System (ADS)

Bos, Victor; Rugina, Ana; Trcka, Adam

2016-08-01

The goal of the On-board Software Reference Architecture for Payloads (OSRA-P) is to identify an architecture for payload software to harmonize the payload domain, to enable more reuse of common/generic payload software across different payloads and missions and to ease the integration of the payloads with the platform.To investigate the payload domain, recent and current payload instruments of European space missions have been analyzed. This led to a Payload Catalogue describing 12 payload instruments as well as a Capability Matrix listing specific characteristics of each payload. In addition, a functional decomposition of payload software was prepared which contains functionalities typically found in payload systems. The definition of OSRA-P was evaluated by case studies and a dedicated OSRA-P workshop to gather feedback from the payload community.

Challenges for Australia's Bio/Nanopharma Policies: trade deals, public goods and reference pricing in sustainable industrial renewal

PubMed Central

Faunce, Thomas A

2007-01-01

Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy. Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics. There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention. Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector. PMID:17543114

[Key-point investigation list of traditional Chinese medicinal materials for national survey of Chinese material medica resources].

PubMed

Zhang, Xiao-Bo; Guo, Lan-Ping; Zhang, Yan; Zhou, Liang-Yun; Huang, Lu-Qi

2014-04-01

Base on the traditional Chinese medicinal materials list that include Pharmacopoeia of the People's Republic of China, Dao-di Herbs, the common used herbs, endangered species, to analyze the key-point investigation traditional Chinese medicinal materials list was analysed. Results displayed that the variety number of traditional Chinese medicinal materials in Pharmacopoeia of the People's Republic of China is 894, the variety number of Dao-di Herbs is 495, the variety number of the common use is 326, the variety number of traditional Chinese medicinal materials from endangered species is 280, and during the third national survey of Chinese material medica resources the variety number of traditional Chinese medicinal materials that were analysed is 360. In the list of Dao-di Herbs and common used herbs over 85% are in the list of Pharmacopoeia of the People's Republic of China, in the list of the common used herbs over 80% are in the list of Dao-di Herbs, in the list of Pharmacopoeia of the People's Republic of China and Dao-di Herbs over 10% are in the list of endangered species. The key-point investigation traditional Chinese medicinal materials list includes three part, the first part includes 563 variery traditional Chinese medicinal materials that need to statistics quantity of resource by field investigation, the second part includes 457 variery that need to monitor the changing situation, the third part includes 280 variery that need to estimated endangered situation.

Sensitivity of estimated muscle force in forward simulation of normal walking

PubMed Central

Xiao, Ming; Higginson, Jill

2009-01-01

Generic muscle parameters are often used in muscle-driven simulations of human movement estimate individual muscle forces and function. The results may not be valid since muscle properties vary from subject to subject. This study investigated the effect of using generic parameters in a muscle-driven forward simulation on muscle force estimation. We generated a normal walking simulation in OpenSim and examined the sensitivity of individual muscle to perturbations in muscle parameters, including the number of muscles, maximum isometric force, optimal fiber length and tendon slack length. We found that when changing the number muscles included in the model, only magnitude of the estimated muscle forces was affected. Our results also suggest it is especially important to use accurate values of tendon slack length and optimal fiber length for ankle plantarflexors and knee extensors. Changes in force production one muscle were typically compensated for by changes in force production by muscles in the same functional muscle group, or the antagonistic muscle group. Conclusions regarding muscle function based on simulations with generic musculoskeletal parameters should be interpreted with caution. PMID:20498485

Calling it what it is. Thesauri in the Flanders Heritage Agency: History, Importance, Use and Technological Advances

NASA Astrophysics Data System (ADS)

Mortier, S.; Van Daele, K.; Meganck, L.

2017-08-01

Heritage organizations in Flanders started using thesauri fairly recently compared to other countries. This paper starts with examining the historical use of thesauri and controlled vocabularies in computer systems by the Flemish Government dealing with immovable cultural heritage. Their evolution from simple, flat, controlled lists to actual thesauri with scope notes, hierarchical and equivalence relations and links to other thesauri will be discussed. An explanation will be provided for the evolution in our approach to controlled vocabularies, and how they radically changed querying and the way data is indexed in our systems. Technical challenges inherent to complex thesauri and how to overcome them will be outlined. These issues being solved, thesauri have become an essential feature of the Flanders Heritage inventory management system. The number of vocabularies rose over the years and became an essential tool for integrating heritage from different disciplines. As a final improvement, thesauri went from being a core part of one application (the inventory management system) to forming an essential part of a new general resource oriented system architecture for Flanders Heritage influenced by Linked Data. For this purpose, a generic SKOS based editor was created. Due to the SKOS model being generic enough to be used outside of Flanders Heritage, the decision was made early on to develop this editor as an open source project called Atramhasis and share it with the larger heritage world.

Geothermal energy: opportunities for California commerce. Phase I report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Longyear, A.B.

1981-12-01

The potential geothermal direct-use energy market and its application to projects in California are assessed. Project identification effort is to be focused on those that have the highest probability for near-term successful commercial operations. Near-term herein means 2 to 5 years for project implementation. Phase I has been focused on defining and assessing: (1) the geothermal direct-use resources that are suitable for near-term utilization; and (2) the generic applications (municipal heating districts, horticultural greenhouse firms, laundries, etc.) that are suitable for near-term projects. Five economic development regions in the state, containing recognized geothermal direct-use resources, have been defined. Thirty-eight directmore » use resources have been evaluated in these regions. After assessment against pre-selected criteria, twenty-seven have been rated with a priority of I, II or III, thereby qualifying them for further marketing effort. The five areas with a priority of I are summarized. These areas have no perceived impediments to near-term development. Twenty-nine generic categories of applications were assessed against previously selected criteria to determine their near term potential for direct use of geothermal fluids. Some twenty industry, commercial and institutional application categories were rated with a priority of I, II or III and warrant further marketing efforts. The seven categories with a priority of I are listed. These categories were found to have the least impediments to near-term application projects.« less

CAD: Designs on Business.

ERIC Educational Resources Information Center

Milburn, Ken

1988-01-01

Provides a general review of the field of Computer-Aided Design Software including specific reviews of "Autosketch,""Generic CADD,""Drafix 1 Plus,""FastCAD," and "Autocad Release 9." Brief articles include "Blueprint for Generation,""CAD for Every Department,""Ideas…

Building generic anatomical models using virtual model cutting and iterative registration.

PubMed

Xiao, Mei; Soh, Jung; Meruvia-Pastor, Oscar; Schmidt, Eric; Hallgrímsson, Benedikt; Sensen, Christoph W

2010-02-08

Using 3D generic models to statistically analyze trends in biological structure changes is an important tool in morphometrics research. Therefore, 3D generic models built for a range of populations are in high demand. However, due to the complexity of biological structures and the limited views of them that medical images can offer, it is still an exceptionally difficult task to quickly and accurately create 3D generic models (a model is a 3D graphical representation of a biological structure) based on medical image stacks (a stack is an ordered collection of 2D images). We show that the creation of a generic model that captures spatial information exploitable in statistical analyses is facilitated by coupling our generalized segmentation method to existing automatic image registration algorithms. The method of creating generic 3D models consists of the following processing steps: (i) scanning subjects to obtain image stacks; (ii) creating individual 3D models from the stacks; (iii) interactively extracting sub-volume by cutting each model to generate the sub-model of interest; (iv) creating image stacks that contain only the information pertaining to the sub-models; (v) iteratively registering the corresponding new 2D image stacks; (vi) averaging the newly created sub-models based on intensity to produce the generic model from all the individual sub-models. After several registration procedures are applied to the image stacks, we can create averaged image stacks with sharp boundaries. The averaged 3D model created from those image stacks is very close to the average representation of the population. The image registration time varies depending on the image size and the desired accuracy of the registration. Both volumetric data and surface model for the generic 3D model are created at the final step. Our method is very flexible and easy to use such that anyone can use image stacks to create models and retrieve a sub-region from it at their ease. Java-based implementation allows our method to be used on various visualization systems including personal computers, workstations, computers equipped with stereo displays, and even virtual reality rooms such as the CAVE Automated Virtual Environment. The technique allows biologists to build generic 3D models of their interest quickly and accurately.

Generic Kalman Filter Software

NASA Technical Reports Server (NTRS)

Lisano, Michael E., II; Crues, Edwin Z.

2005-01-01

The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on the basis of the aforementioned templates. The GKF software can be used to develop many different types of unfactorized Kalman filters. A developer can choose to implement either a linearized or an extended Kalman filter algorithm, without having to modify the GKF software. Control dynamics can be taken into account or neglected in the filter-dynamics model. Filter programs developed by use of the GKF software can be made to propagate equations of motion for linear or nonlinear dynamical systems that are deterministic or stochastic. In addition, filter programs can be made to operate in user-selectable "covariance analysis" and "propagation-only" modes that are useful in design and development stages.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

PubMed

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar between AG and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be explored further. © 2017 Pharmacotherapy Publications, Inc.

Longitudinal factorial invariance of the PedsQL 4.0 Generic Core Scales child self-report Version: one year prospective evidence from the California State Children's Health Insurance Program (SCHIP).

PubMed

Varni, James W; Limbers, Christine A; Newman, Daniel A; Seid, Michael

2008-11-01

The measurement of health-related quality of life (HRQOL) in pediatric medicine and health services research has grown significantly over the past decade. The paradigm shift toward patient-reported outcomes (PROs) has provided the opportunity to emphasize the value and critical need for pediatric patient self-report. In order for changes in HRQOL/PRO outcomes to be meaningful over time, it is essential to demonstrate longitudinal factorial invariance. This study examined the longitudinal factor structure of the PedsQL 4.0 Generic Core Scales over a one-year period for child self-report ages 5-17 in 2,887 children from a statewide evaluation of the California State Children's Health Insurance Program (SCHIP) utilizing a structural equation modeling framework. Specifying four- and five-factor measurement models, longitudinal structural equation modeling was used to compare factor structures over a one-year interval on the PedsQL 4.0 Generic Core Scales. While the four-factor conceptually-derived measurement model for the PedsQL 4.0 Generic Core Scales produced an acceptable fit, the five-factor empirically-derived measurement model from the initial field test of the PedsQL 4.0 Generic Core Scales produced a marginally superior fit in comparison to the four-factor model. For the five-factor measurement model, the best fitting model, strict factorial invariance of the PedsQL 4.0 Generic Core Scales across the two measurement occasions was supported by the stability of the comparative fit index between the unconstrained and constrained models, and several additional indices of practical fit including the root mean squared error of approximation, the non-normed fit index, and the parsimony normed fit index. The findings support an equivalent factor structure on the PedsQL 4.0 Generic Core Scales over time. Based on these data, it can be concluded that over a one-year period children in our study interpreted items on the PedsQL 4.0 Generic Core Scales in a similar manner.

Generic and therapeutic statin switches and disruptions in therapy.

PubMed

Chapman, Richard H; Benner, Joshua S; Girase, Prafulla; Benigno, Michael; Axelsen, Kirsten; Liu, Larry Z; Nichol, Michael B

2009-05-01

The study objective was to compare dose-equivalence, adherence and subsequent switch rates among patients recently switched from a branded to generic version of the same statin (generic substitution, GS) vs. those switched from branded statin to generic version of a different statin (therapeutic substitution, TS). In a retrospective cohort analysis among adult enrollees in over 90 US health plans, the authors identified adult patients who switched from a branded to generic statin from July-December 2006 (simvastatin became generic in June 2006). Patients were classified by type of statin switch: GS (e.g., branded simvastatin --> generic simvastatin), and TS (e.g., branded atorvastatin --> generic simvastatin). Demographic and clinical data were collected from claims before switch through 6 months follow-up. Separate outcomes of interest included proportion of patients that switched to a less potent daily dose, that switched back to previous branded statin after switch, and that were at least 80% adherent during the 6 months after initial switch. Significant predictors of each clinical outcome were identified using multivariable logistic regression models, adjusting for differences between groups in covariates and potential confounders. The 6-month TS (n = 3807) and GS (n = 40,165) groups were generally similar demographically. Compared to GS, TS patients were significantly more likely to be switched to a less potent dose (26.2% vs. 0.5%, adjusted odds ratio [AOR] in patients with high-potency index medication = 83.4, p < 0.0001); 33% less likely to be adherent in the 6 months after switch (67.7% vs. 75.9%, AOR in patients with no switch in first 6 months follow-up = 0.67, p < 0.0001); and four times more likely to switch back to previous branded statin (11.3% vs. 2.9%, AOR = 4.1, p < 0.0001). This study did not account for co-payment changes, lipid measurements, or changes in pill burden. While this study did not have data on why patients had TS (e.g., for cost or clinical reasons), TS was more likely to involve a subsequent disruption to statin therapy than GS. TS could potentially lead to adverse impacts on patients' outcomes, and should be studied further.

Generic quality of life in persons with hearing loss: a systematic literature review.

PubMed

Nordvik, Øyvind; Laugen Heggdal, Peder O; Brännström, Jonas; Vassbotn, Flemming; Aarstad, Anne Kari; Aarstad, Hans Jørgen

2018-01-01

To the best of our knowledge, no empirically based consensus has been reached as to if, and to what extent, persons with hearing loss (HL) have reduced generic Quality of life (QoL). There seems to be limited knowledge regarding to what extent a hearing aid (HA) would improve QoL. The main aim of the present study was to review studies about the relationship between HL and QoL. A supporting aim was to study the association between distress and HL. Literature databases (Cinahl, Pub Med and Web of Science) were searched to identify relevant journal articles published in the period from January 2000 to March 17, 2016. We performed a primary search pertaining to the relationship between HL, HA and QoL (search number one) followed by a supporting search pertaining to the relationship between distress/mood/anxiety and HL (search number two). After checking for duplications and screening the titles of the papers, we read the abstracts of the remaining papers. The most relevant papers were read thoroughly, leaving us with the journal articles that met the inclusion criteria. Twenty journal articles were included in the present review: 13 were found in the primary search (HL and QoL), and seven in the supporting search (HL and distress). The literature yields equivocal findings regarding the association between generic QoL and HL. A strong association between distress and HL was shown, where distressed persons tend to have a lowered generic QoL. It is suggested that QoL is lowered among HL patients. Some studies suggest an increased generic QoL following the use of HA, especially during the first few months after initiation of treatment. Other studies suggest that HA use is one of several possible factors that contribute to improve generic QoL. The majority of the studies suggest that HL is associated with reduced generic QoL. Using hearing aids seem to improve general QoL at follow-up within the first year. HL is a risk factor for distress. Further research is needed to explore the relationship between HL and generic QoL, in addition to the importance of influencing variables on this relationship.

Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke.

PubMed

Mehrholz, Jan; Hädrich, Anja; Platz, Thomas; Kugler, Joachim; Pohl, Marcus

2012-06-13

Electromechanical and robot-assisted arm training devices are used in rehabilitation, and might help to improve arm function after stroke. To assess the effectiveness of electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength in patients after stroke. We will also assess the acceptability and safety of the therapy. We searched the Cochrane Stroke Group's Trials Register (last searched July 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 7), MEDLINE (1950 to July 2011), EMBASE (1980 to July 2011), CINAHL (1982 to July 2011), AMED (1985 to July 2011), SPORTDiscus (1949 to July 2011), PEDro (searched August 2011), COMPENDEX (1972 to July 2011), and INSPEC (1969 to July 2011). We also handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts and researchers in our field, as well as manufacturers of commercial devices. Randomised controlled trials (RCTs) comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation or placebo interventions, or no treatment, for patients after stroke. Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data. We contacted trialists for additional information. We analysed the results as standardised mean differences (SMDs) for continuous variables and risk differences (RDs) for dichotomous variables. We included 19 trials (involving 666 participants) in this update of our review. Electromechanical and robot-assisted arm training did improve activities of daily living (SMD 0.43, 95% confidence interval (CI) 0.11 to 0.75, P = 0.009, I(2) = 67%) as well as arm function (SMD 0.45, 95% CI 0.20 to 0.69, P = 0.0004, I(2) = 45%), but arm muscle strength did not improve (SMD 0.48, 95% CI -0.06 to 1.03, P = 0.08, I(2) = 79%). Electromechanical and robot-assisted arm training did not increase the risk of patients to drop out (RD 0.00, 95% CI -0.04 to 0.04, P = 0.82, I(2) = 0.0%), and adverse events were rare. Patients who receive electromechanical and robot-assisted arm training after stroke are more likely to improve their generic activities of daily living. Paretic arm function may also improve, but not arm muscle strength. However, the results must be interpreted with caution because there were variations between the trials in the duration and amount of training, type of treatment, and in the patient characteristics.

Encouraging generic use can yield significant savings.

PubMed

Zimmerman, Christina

2012-11-01

Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

78 FR 56695 - Proposed Listing of Additional Waters To Be Included on Indiana's 2010 List of Impaired Waters...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

... for its notice which announces the availability of EPA's proposed decision identifying water quality limited segments and associated pollutants in Indiana to be listed pursuant to the Clean Water Act Section... Be Included on Indiana's 2010 List of Impaired Waters Under the Clean Water Act AGENCY: Environmental...

A Guide to Internet Resources in Language Arts.

ERIC Educational Resources Information Center

Homme, John, Comp.; And Others

This paper presents a list of 154 Internet resources (listservs, freenets, telnet sites, gophers, etc.) dealing with language arts. Each entry in the list includes the name of the resource, and subscription and electronic mail addresses. Some of the entries in the list include a brief description of the resource. The paper lists 17 language arts…