A Generic Software Safety Document Generator

NASA Technical Reports Server (NTRS)

Denney, Ewen; Venkatesan, Ram Prasad

2004-01-01

Formal certification is based on the idea that a mathematical proof of some property of a piece of software can be regarded as a certificate of correctness which, in principle, can be subjected to external scrutiny. In practice, however, proofs themselves are unlikely to be of much interest to engineers. Nevertheless, it is possible to use the information obtained from a mathematical analysis of software to produce a detailed textual justification of correctness. In this paper, we describe an approach to generating textual explanations from automatically generated proofs of program safety, where the proofs are of compliance with an explicit safety policy that can be varied. Key to this is tracing proof obligations back to the program, and we describe a tool which implements this to certify code auto-generated by AutoBayes and AutoFilter, program synthesis systems under development at the NASA Ames Research Center. Our approach is a step towards combining formal certification with traditional certification methods.

Registered Nurse to Bachelor of Science in Nursing: nesting a fast-track to traditional generic program, teachings from nursing education in Burkina Faso.

PubMed

Beogo, Idrissa; Liu, Chieh-Yu; Dlamini, Colile P; Gagnon, Marie-Pierre

2015-01-01

Nursing education has evolved over time to fit societies' increasing care needs. Innovations in nursing education draw thorny debates on potential jeopardy in the quality, safety, and efficacy of nurse graduates. Accelerated nursing education programs have been among landmark strategic changes to address the persistent bedside nurse shortage. Despite the dearth of empirical studies in sub-Saharan Africa (SSA), the National School of Public Health of Burkina Faso has developed a State Diploma Nursing (SDN) fast-track program. With innovative features, the program is nested into the traditional SDN program. This study investigates preliminary outcomes of the implemented policy using the initial cohort that went through the program. Comparison of the traditional generic program and the fast-track one is drawn to inform nursing education policy. The study was conducted in the three campuses delivering the SDN program. Data collected from a representative sample included 255 students from the 2006-2009 cohort, after concluding the program. Surveyed students were assessed according to the program entry status. Outcomes were measured using students' academic performance. Besides descriptive analysis, bivariate t-test, F-test, and multivariate ordinary least square regression (OLSR) were employed to determine the comparative pattern between the traditional generic and the newly nested fast-track program. Students' varied statuses (private pre-registration, state pre-registration, private post-registration, and state post-registration) were kept to better outline the findings trend. A fifth (19.6 %) of surveyed students were enrolled in the fast-track stream from which, one third (33.7 %) consisted of post-registered students. Fast-track students comparatively achieved the best academic performance (mean: 73.68/100, SD: 5.52). Multivariate OLSR confirmed that fast-track students performed better (β: 5.559, p < 0.001), and further informed differences between campuses. Students entry status also displayed significant differences, yet the academic performance of post-registered students from traditional generic versus fast-track was similar (p = 0.409). Findings suggest that fast-track program students performed better than the ones from the traditional generic program. The uniqueness and success of this mixed nursing program experience sheds light for nursing educators engaged in policy making. The study results can serve as a crucial foundation for policymakers to alleviate the nurse shortage in SSA.

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

Sharing, samples, and generics: an antitrust framework.

PubMed

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

On assessing bioequivalence and interchangeability between generics based on indirect comparisons.

PubMed

Zheng, Jiayin; Chow, Shein-Chung; Yuan, Mengdie

2017-08-30

As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 2, Part 1

NASA Technical Reports Server (NTRS)

Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

2010-01-01

This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This report contains the Appendices to the findings from the first year of the program's operations.

A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

PubMed

Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

2010-05-01

The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

Safety and efficacy of generic drugs with respect to brand formulation.

PubMed

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-12-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

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.

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

Safety and efficacy of generic drugs with respect to brand formulation

PubMed Central

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-01-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects. PMID:24347975

Ask Your Pharmacist | NIH MedlinePlus the Magazine

MedlinePlus

... you can choose between either a generic or brand name drug. Generic and brand name medicines are alike because they act the ... A generic drug is the same as a brand name drug in dosage, safety, strength, quality, the ...

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

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

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

PubMed Central

2014-01-01

The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

Certifying Domain-Specific Policies

NASA Technical Reports Server (NTRS)

Lowry, Michael; Pressburger, Thomas; Rosu, Grigore; Koga, Dennis (Technical Monitor)

2001-01-01

Proof-checking code for compliance to safety policies potentially enables a product-oriented approach to certain aspects of software certification. To date, previous research has focused on generic, low-level programming-language properties such as memory type safety. In this paper we consider proof-checking higher-level domain -specific properties for compliance to safety policies. The paper first describes a framework related to abstract interpretation in which compliance to a class of certification policies can be efficiently calculated Membership equational logic is shown to provide a rich logic for carrying out such calculations, including partiality, for certification. The architecture for a domain-specific certifier is described, followed by an implemented case study. The case study considers consistency of abstract variable attributes in code that performs geometric calculations in Aerospace systems.

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.

Commercial grade item (CGI) dedication of MDR relays for nuclear safety related applications

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

Das, R.K.; Julka, A.; Modi, G.

1994-08-01

MDR relays manufactured by Potter and Brumfield (P and B) have been used in various safety related applications in commercial nuclear power plants. These include emergency safety features (ESF) actuation systems, emergency core cooling systems (ECCS) actuation, and reactor protection systems. The MDR relays manufactured prior to May 1990 showed signs of generic failure due to corrosion and outgassing of coil varnish. P and B has made design changes to correct these problems in relays manufactured after May 1990. However, P and B does not manufacture the relays under any 10CFR50 Appendix B quality assurance (QA) program. They manufacture themore » relays under their commercial QA program and supply these as commercial grade items. This necessitates CGI Dedication of these relays for use in nuclear-safety-related applications. This paper presents a CGI dedication program that has been used to dedicate the MDR relays manufactured after May 1990. The program is in compliance with current Nuclear Regulatory Commission (NRC) and Electric Power Research Institute (EPRI) guidelines and applicable industry standards; it specifies the critical characteristics of the relays, provides the tests and analysis required to verify the critical characteristics, the acceptance criteria for the test results, performs source verification to qualify P and B for its control of the critical characteristics, and provides documentation. The program provides reasonable assurance that the new MDR relays will perform their intended safety functions.« less

76 FR 24925 - Solicitation for Public Comment on Potential Alternatives To Resolve Generic Safety Issue 191...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... comment on potential alternatives for risk informing the path forward to resolve Generic Safety Issue (GSI... Notation Vote Paper (SECY-10-0113) which presented to the Commission the regulatory path forward options... the staff, in part, to explore alternative paths forward for resolving GSI-191. Discussion While GSI...

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

PubMed

Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

2014-01-01

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

An overview of microbial food safety programs in beef, pork, and poultry from farm to processing in Canada.

PubMed

Rajić, Andrijana; Waddell, Lisa A; Sargeant, Jan M; Read, Susan; Farber, Jeff; Firth, Martin J; Chambers, Albert

2007-05-01

Canada's vision for the agri-food industry in the 21st century is the establishment of a national food safety system employing hazard analysis and critical control point (HACCP) principles and microbiological verification tools, with traceability throughout the gate-to-plate continuum. Voluntary on-farm food safety (OFFS) programs, based in part on HACCP principles, provide producers with guidelines for good production practices focused on general hygiene and biosecurity. OFFS programs in beef cattle, swine, and poultry are currently being evaluated through a national recognition program of the Canadian Food Inspection Agency. Mandatory HACCP programs in federal meat facilities include microbial testing for generic Escherichia coli to verify effectiveness of the processor's dressing procedure, specific testing of ground meat for E. coli O157:H7, with zero tolerance for this organism in the tested lot, and Salmonella testing of raw products. Health Canada's policy on Listeria monocytogenes divides ready-to-eat products into three risk categories, with products previously implicated as the source of an outbreak receiving the highest priority for inspection and compliance. A national mandatory identification program to track livestock from the herd of origin to carcass inspection has been established. Can-Trace, a data standard for all food commodities, has been designed to facilitate tracking foods from the point of origin to the consumer. Although much work has already been done, a coherent national food safety strategy and concerted efforts by all stakeholders are needed to realize this vision. Cooperation of many government agencies with shared responsibility for food safety and public health will be essential.

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

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

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

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

[Evaluation of efficacy and safety of manidipine hydrochloride among essential hypertensive patients: Substitution from branded product (Calslot) to Generic Product (Manidip)].

PubMed

Kobayashi, Hiroko; Obara, Taku; Takahashi, Norio; Takahashi, Takeshi; Igari, Yukie; Oikawa, Takuya; Saito, Shinichiro; Ohkubo, Takayoshi; Imai, Yutaka; Takahashi, Masanobu

2007-12-01

Calcium channel blockers are most commonly used in hypertensive patients in Japan. However, information on the efficacy and safety of generic calcium channel blockers is insufficient. The objective of the present study was to retrospectively evaluate the efficacy and safety of manidipine hydrochloride in 21 essential hypertensive patients (mean age; 70.6+/-10.6 years, male/female; 14/7) in Sendai Postal Services Agency Hospital who were switched (substituted) from a brand product (Calslot) to a generic product (Manidip). For this retrospective study, we used data from patient medical records and drug prescription information. Data from patients who were taking both types of manidipine hydrochloride, whose regimen were not changed for > 6 months before and after switching, and who provided informed consent were included in the analysis. Control values of blood pressure were not significantly different between before and after substitution (systolic/diastolic; from 137.9+/-9.1/78.7+/-5.4 mmHg to 137.3+/-9.1/77.8+/-6.3 mmHg, p=0.73/p=0.36). The level of patient compliance for the antihypertensive drugs was also not different between before and after substitution (from 94.0+/-8.8% to 93.1+/-9.6%, p=0.72). There were 8 cases of adverse effects before substitution and 4 after substitution. No patient stopped taking the generic drug due to an adverse effect. In conclusion, significant differences in the efficacy, safety, and patient compliance were not observed between the brand product and generic product among patients who were switched from the brand product to the generic product.

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

PubMed

Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

2015-01-01

Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

Microbial safety and quality of fresh herbs from Los Angeles, Orange County and Seattle farmers' markets.

PubMed

Levy, Donna J; Beck, Nicola K; Kossik, Alexandra L; Patti, Taylor; Meschke, J Scott; Calicchia, Melissa; Hellberg, Rosalee S

2015-10-01

Farmers' markets have been growing in popularity in the United States, but the microbial quality and safety of the food sold at these markets is currently unknown. The purpose of this study was to assess the microbial safety and quality of fresh basil, parsley and cilantro sold at farmers' markets in the Los Angeles, Orange County and greater Seattle areas. A total of 133 samples (52 basil, 41 cilantro and 40 parsley) were collected from 13 different farmers' markets and tested for Salmonella and generic Escherichia coli. One sample (parsley) was confirmed positive for Salmonella and 24.1% of samples were positive for generic E. coli, with a range of 0.70-3.15 log CFU g(-1) . Among the herbs tested, basil showed the highest percentage of samples with generic E. coli (26.9%), followed by cilantro (24.4%) and then parsley (20.0%). For 12% of samples, the levels of generic E. coli exceeded guidelines established by the Public Health Laboratory Service for microbiological quality of ready-to-eat foods. Overall, this study indicates the presence of Salmonella and generic E. coli in fresh herbs sold at farmers' markets; however, additional studies are needed to determine the sources and extent of contamination. © 2014 Society of Chemical Industry.

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

PubMed

Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

2016-01-01

Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... announcing its intention to hold a public meeting related to generic drug user fees. The Agency continues to...

76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-22

...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for...

Unsteady Aerodynamic Modeling in Roll for the NASA Generic Transport Model

NASA Technical Reports Server (NTRS)

Murphy, Patrick C.; Klein, Vladislav; Frink, Neal T.

2012-01-01

Reducing the impact of loss-of-control conditions on commercial transport aircraft is a primary goal of the NASA Aviation Safety Program. One aspect in developing the supporting technologies is to improve the aerodynamic models that represent these adverse conditions. Aerodynamic models appropriate for loss of control conditions require a more general mathematical representation to predict nonlinear unsteady behaviors. In this paper, a more general mathematical model is proposed for the subscale NASA Generic Transport Model (GTM) that covers both low and high angles of attack. Particular attention is devoted to the stall region where full-scale transports have demonstrated a tendency for roll instability. The complete aerodynamic model was estimated from dynamic wind-tunnel data. Advanced computational methods are used to improve understanding and visualize the flow physics within the region where roll instability is a factor.

Generic Competencies in the Education of Engineers: The Case of Engineering Program in a Public University in Mexico

ERIC Educational Resources Information Center

Serna, Alejandra García; Vega, José Luis Arcos; García, Juan José Sevilla; Ruiz, María Amparo Oliveros

2018-01-01

We present an analysis regarding generic skills on engineering program offered in a public state university in Mexico (UABC). The university implemented a new educational model changing rigid programs to flexible programs based on competencies. The goal is to determine generic skills related to the four pillars of learning: learning to do,…

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.

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.

Generic versus branded medicines: An observational study among patients with chronic diseases attending a public hospital outpatient department

PubMed Central

Das, Manisha; Choudhury, Supriyo; Maity, Somnath; Hazra, Avijit; Pradhan, Tirthankar; Pal, Aishee; Roy, Ranendra Kumar

2017-01-01

Background: The concept of generic prescription is widely accepted in various parts of the world. Nevertheless, it has failed to gain popularity in India due to factors such as nonavailability and distrust on the product quality. However, since 2012, the Government of West Bengal, India, has initiated exclusive generic drug outlets called “fair price medicine shop” (FPMS) inside the government hospital premises in a “public-private-partnership” model. This study was undertaken to evaluate the experience and attitude of patients who were consuming generic drugs purchased from these FPMS. Materials and Methods: It was a questionnaire-based cross-sectional study where we have interviewed 100 patients each consuming generic and branded drugs, respectively. The perceived effectiveness, reported safety, medication adherence, cost of therapy, and availability of drugs was compared between two mentioned groups. Medication adherence was estimated through Drug Attitude Inventory-10. Results: 93% of generic and 87% branded drug users believed that their drugs were effective (P = 0.238) in controlling their ailments. No significant difference (9% generic, 10% branded drug users, P = 1.000) was observed in reported adverse effects between generic and branded drug users. 82% and 77% of patients were adherent generic and branded drugs, respectively (P = 0.289). As expected, a significantly lower cost of generic drugs was observed compared to its branded counterpart. Conclusion: The policy of FPMS implemented by the Government of West Bengal, India appeared to be promising in terms of perceived effectiveness, safety, and adherence of generic drugs from FPMS compared to drugs purchased from open market retailers. Therefore, this study might act as an impetus for the policy-makers to initiate similar models across the country. PMID:28250671

Patterns of use for brand-name versus generic oral bisphosphonate drugs in Ontario over a 13-year period: a descriptive study.

PubMed

Fraser, Lisa-Ann; Albaum, Jordan M; Tadrous, Mina; Burden, Andrea M; Shariff, Salimah Z; Cadarette, Suzanne M

2015-01-01

Bisphosphonates are the first-line therapy for the treatment of osteoporosis. In the province of Ontario, the Ontario Drug Benefit Program funds medications for patients aged 65 years and older. The Ontario Drug Benefit Program has a generic substitution policy that requires lower-cost generic drugs to be dispensed when they are available. However, there is controversy surrounding the efficacy and tolerability of generic bisphosphonates. The objective of this study was to describe patterns in the use of brand-name versus generic formulations when dispensing oral bisphosphonate over a 13-year period. We identified all osteoporotic preparations for alendronate and risedronate that were dispensed through the Ontario Drug Benefit Program from 2001 to 2014. We stratified our sample into community-dwelling residents and residents in long-term care facilities. The number of prescriptions dispensed per month were plotted to illustrate trends over time. We found a rapid switch from brand-name to generic bisphosphonate equivalents immediately after the generic became available on the Ontario Drug Benefit formulary, with generics accounting for > 88% of dispensed drug within 2 months. We also observed a reduction in the number of generic drugs dispensed each time a new brand-name alternative (e.g., monthly risedronate, weekly alendronate plus vitamin D) was introduced to the formulary. The dispensing trends were similar in the community and long-term care settings. The Ontario Drug Benefit Program generic substitution policy resulted in rapid uptake of generic oral bisphosphonates among seniors in Ontario. However, there was a switch away from generic medications to new brand-name alternatives whenever they were introduced to the formulary. Therefore, some patients continued to use brand-name bisphosphonate despite the availability of generic options.

Implementation of Programmatic Quality and the Impact on Safety

NASA Technical Reports Server (NTRS)

Huls, Dale Thomas; Meehan, Kevin

2005-01-01

The purpose of this paper is to discuss the implementation of a programmatic quality assurance discipline within the International Space Station Program and the resulting impact on safety. NASA culture has continued to stress safety at the expense of quality when both are extremely important and both can equally influence the success or failure of a Program or Mission. Although safety was heavily criticized in the media after Colimbiaa, strong case can be made that it was the failure of quality processes and quality assurance in all processes that eventually led to the Columbia accident. Consequently, it is possible to have good quality processes without safety, but it is impossible to have good safety processes without quality. The ISS Program quality assurance function was analyzed as representative of the long-term manned missions that are consistent with the President s Vision for Space Exploration. Background topics are as follows: The quality assurance organizational structure within the ISS Program and the interrelationships between various internal and external organizations. ISS Program quality roles and responsibilities with respect to internal Program Offices and other external organizations such as the Shuttle Program, JSC Directorates, NASA Headquarters, NASA Contractors, other NASA Centers, and International Partner/participants will be addressed. A detailed analysis of implemented quality assurance responsibilities and functions with respect to NASA Headquarters, the JSC S&MA Directorate, and the ISS Program will be presented. Discussions topics are as follows: A comparison of quality and safety resources in terms of staffing, training, experience, and certifications. A benchmark assessment of the lessons learned from the Columbia Accident Investigation (CAB) Report (and follow-up reports and assessments), NASA Benchmarking, and traditional quality assurance activities against ISS quality procedures and practices. The lack of a coherent operational and sustaining quality assurance strategy for long-term manned space flight. An analysis of the ISS waiver processes and the Problem Reporting and Corrective Action (PRACA) process implemented as quality functions. Impact of current ISS Program procedures and practices with regards to operational safety and risk A discussion regarding a "defense-in-depth" approach to quality functions will be provided to address the issue of "integration vs independence" with respect to the roles of Programs, NASA Centers, and NASA Headquarters. Generic recommendations are offered to address the inadequacies identified in the implementation of ISS quality assurance. A reassessment by the NASA community regarding the importance of a "quality culture" as a component within a larger "safety culture" will generate a more effective and value-added functionality that will ultimately enhance safety.

Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions.

PubMed

Balasopoulos, T; Charonis, A; Athanasakis, K; Kyriopoulos, J; Pavi, E

2017-03-01

Since 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics' penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. The empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents' beliefs on the safety and the effectiveness of generic drugs. The empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study - PEDA Study.

PubMed

Sapsirisavat, Vorapot; Vongsutilers, Vorasit; Thammajaruk, Narukjaporn; Pussadee, Kanitta; Riyaten, Prakit; Kerr, Stephen; Avihingsanon, Anchalee; Phanuphak, Praphan; Ruxrungtham, Kiat

2016-01-01

Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia. A total of 42 batches of ARV from 15 sources were sampled from January-March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription. Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity along the HIV treatment and care cascade is available.

Biosimilars: Hope and concern.

PubMed

Emmanouilides, Christos E; Karampola, Maria I; Beredima, Maria

2016-08-01

As patents of the first introduced biologic therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the original agent. These products are called biosimilars. Upon patent expiration, biosimilars would hopefully be a cheaper alternative to the original agent and that is the main reason for their existence. Although the financial aspect is similar to generics, the complex nature of these products generates the need for a distinct regulatory environment. Biosimilars are produced by DNA technology in bacteria, plant cells, or animal cells, while generics are produced by chemical synthesis. Details in the process of synthesis, selection of the microorganism, protein extraction, purification and manufacturing, affect the precise nature of the end product. Monoclonal antibodies are large proteins with four polypeptide chains and interact variably with each other and with the environment. It is important for payors to realize that biosimilars are different from generics; therefore, they need to develop different set of rules for approving, registering, and dispensing biosimilars. Regulators ought to respect the physicians' request for non-interchangeability and facilitate in any possible way of traceability. Such regulations along with a rigorous pharmacovigilance program will satisfy the concerns for true equivalence in activity and long-term safety. This is the only way to accumulate over time reliable safety information for new biosimilars. In conclusion, the wish born by the medical community and the society for a more affordable health system triggers the emergence of biosimilars, which could meet that goal if properly regulated. © The Author(s) 2015.

Generic substitution of anti-epileptic drugs. A needed battle?

PubMed

Al-Baradie, Raidah S

2008-07-01

The clinical and economic consequences of generic antiepileptic drug (AED) substitution are not yet fully understood. Generic substitution may increase pharmacy utilization, but it may not always save health care costs for AEDs. The AEDs are relatively cheap, but high volumes of prescriptions mean that substantial drug-budget savings may be possible by switching from innovator brands to cheaper generic drugs. Such savings have been achieved in many other treatment areas. However, more caution may be needed for epilepsy because of the narrow therapeutic index, low solubility, and non-linear pharmacokinetics of some AEDs. This means that the ranges of bioequivalence that are authorized for generic formulations do not offer the same results regarding effectiveness and safety as those obtained by brand name drugs. This is why seizure control should not be sacrificed on the basis of cost alone, as the major endpoint in treating epilepsy with AEDs is seizure control without adverse effects. Switching to the cheapest generic AED may offer drug-budget savings that outweigh any risk to patient safety. But to date, this cost-benefit analysis has not been carried out. We propose that all changes to established principles of treating epilepsy are evidence based and that the risks of switching are clearly defined.

Preparedness for practice: a systematic cross-specialty evaluation of the alignment between postgraduate medical education and independent practice.

PubMed

Dijkstra, Ids S; Pols, Jan; Remmelts, Pine; Brand, Paul L P

2015-02-01

Postgraduate medical education training programs strive to prepare their trainees optimally for independent practice. Several studies have shown, however, that new consultants feel inadequately prepared for practice, and that this increases the risk of stress and burnout. To analyze across specialties for which tasks and themes new consultants feel inadequately prepared. And, to identify themes that need improved attention in postgraduate medical education programs or after registration. 330 New consultants from all hospital specialities with accredited training programs who completed their training in the north-eastern educational region of The Netherlands between 2004 and 2010 received a questionnaire which was based on a previously validated generic task inventory. 143 respondents (43%) returned the questionnaire. They felt excellently prepared for 40 tasks, well prepared for 25 tasks, marginally sufficiently prepared for 18 tasks and insufficiently prepared for 8 tasks. Preparedness scores were lowest for tasks concerning management administration and leadership, research, end-of-life care, and patient safety-related communication. Surgical specialists felt better prepared for practice than medical specialists, which could not be explained by differences in general self-efficacy. Although new consultants felt well prepared for medical tasks, the scores of more generic tasks indicate that the alignment between the different phases of the medical education continuum and independent practice needs improvement.

Tank 241-C-112 vapor sampling and analysis tank characterization report. Revision 1

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

Huckaby, J.L.

1995-05-31

Tank 241-C-112 headspace gas and vapor samples were collected and analyzed to help determine the potential risks to tank farm workers due to fugitive emissions from the tank. The drivers and objectives of waste tank headspace sampling and analysis are discussed in {open_quotes}Program Plan for the Resolution of Tank Vapor Issues.{close_quotes} Tank 241-C-112 was vapor sampled in accordance with {open_quotes}Data Quality Objectives for Generic In-Tank Health and Safety Issue Resolution.{close_quotes}

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

Ageing management program for the Spanish low and intermediate level waste disposal and spent fuel and high-level waste centralised storage facilities

NASA Astrophysics Data System (ADS)

Zuloaga, P.; Ordoñez, M.; Andrade, C.; Castellote, M.

2011-04-01

The generic design of the centralised spent fuel storage facility was approved by the Spanish Safety Authority in 2006. The planned operational life is 60 years, while the design service life is 100 years. Durability studies and surveillance of the behaviour have been considered from the initial design steps, taking into account the accessibility limitations and temperatures involved. The paper presents an overview of the ageing management program set in support of the Performance Assessment and Safety Review of El Cabril low and intermediate level waste (LILW) disposal facility. Based on the experience gained for LILW, ENRESA has developed a preliminary definition of the Ageing Management Plan for the Centralised Interim Storage Facility of spent Fuel and High Level Waste (HLW), which addresses the behaviour of spent fuel, its retrievability, the confinement system and the reinforced concrete structure. It includes tests plans and surveillance design considerations, based on the El Cabril LILW disposal facility.

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

9 CFR 381.133 - Generically approved labeling.

Code of Federal Regulations, 2011 CFR

2011-01-01

... change in quantity of ingredients complies with any minimum or maximum limits for the use of such... Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... inspection system, in accordance with subpart T of this part, is authorized to use generically approved...

76 FR 81014 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... of Qualitative Feedback on Agency Service Delivery AGENCY: Office of Hazardous Materials Safety... Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of Management and Budget (OMB...: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery Abstract. The...

9 CFR 381.133 - Generically approved labeling.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Generically approved labeling. 381.133 Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCT...

Identification of competencies for Malaysian occupational safety and health professionals.

PubMed

Daud, Rabaayah; Ismail, Maimunah; Omar, Zoharah

2010-01-01

Competencies of occupational safety and health (OSH) professionals have become a concern due to the significance of safety management in the field of safety engineering. The purpose of this article is to identify competencies needed by OSH professionals. These competencies are required by professionals in administrating and enforcing legislations related to OSH in Malaysia. This study used Delphi technique in three rounds of data collection. The benefits of this research approach are the use of experts in gaining opinions without time and geographical restraints. The results show 25 generic competencies with combinations of cognitive, interpersonal and intrapersonal competencies and 33 functional or specific competencies including knowledge and skills needed by OSH professionals. Both generic and functional competencies are also divided into threshold and differentiating competencies that would be used to differentiate average and excellent performance of OSH professionals.

9 CFR 317.5 - Generically approved labeling.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

9 CFR 317.5 - Generically approved labeling.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

9 CFR 317.5 - Generically approved labeling.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

9 CFR 317.5 - Generically approved labeling.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... the Food Safety and Inspection Service in Washington or the field, provided the labeling is in..., and is not otherwise false or misleading in any particular. (2) The Food Safety and Inspection Service...

A Review of Generic Program Visualization Systems for Introductory Programming Education

ERIC Educational Resources Information Center

Sorva, Juha; Karavirta, Ville; Malmi, Lauri

2013-01-01

This article is a survey of program visualization systems intended for teaching beginners about the runtime behavior of computer programs. Our focus is on generic systems that are capable of illustrating many kinds of programs and behaviors. We inclusively describe such systems from the last three decades and review findings from their empirical…

Generic Sensor Failure Modeling for Cooperative Systems.

PubMed

Jäger, Georg; Zug, Sebastian; Casimiro, António

2018-03-20

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application's fault tolerance and thereby promises maintainability of such system's safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques.

Generic Sensor Failure Modeling for Cooperative Systems

PubMed Central

Jäger, Georg; Zug, Sebastian

2018-01-01

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application’s fault tolerance and thereby promises maintainability of such system’s safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques. PMID:29558435

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...

Information Services at the Nuclear Safety Analysis Center.

ERIC Educational Resources Information Center

Simard, Ronald

This paper describes the operations of the Nuclear Safety Analysis Center. Established soon after an accident at the Three Mile Island nuclear power plant near Harrisburg, Pennsylvania, its efforts were initially directed towards a detailed analysis of the accident. Continuing functions include: (1) the analysis of generic nuclear safety issues,…

Space Station flight telerobotic servicer functional requirements development

NASA Technical Reports Server (NTRS)

Oberright, John; Mccain, Harry; Whitman, Ruth I.

1987-01-01

The Space Station flight telerobotic servicer (FTS), a flight robotic system for use on the first Space Station launch, is described. The objectives of the FTS program include: (1) the provision of an alternative crew EVA by supporting the crew in assembly, maintenance, and servicing activities, and (2) the improvement of crew safety by performing hazardous tasks such as spacecraft refueling or thermal and power system maintenance. The NASA/NBS Standard Reference Model provides the generic, hierarchical, structured functional control definition for the system. It is capable of accommodating additional degrees of machine intelligence in the future.

Industry Application ECCS / LOCA Integrated Cladding/Emergency Core Cooling System Performance: Demonstration of LOTUS-Baseline Coupled Analysis of the South Texas Plant Model

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

Zhang, Hongbin; Szilard, Ronaldo; Epiney, Aaron

Under the auspices of the DOE LWRS Program RISMC Industry Application ECCS/LOCA, INL has engaged staff from both South Texas Project (STP) and the Texas A&M University (TAMU) to produce a generic pressurized water reactor (PWR) model including reactor core, clad/fuel design and systems thermal hydraulics based on the South Texas Project (STP) nuclear power plant, a 4-Loop Westinghouse PWR. A RISMC toolkit, named LOCA Toolkit for the U.S. (LOTUS), has been developed for use in this generic PWR plant model to assess safety margins for the proposed NRC 10 CFR 50.46c rule, Emergency Core Cooling System (ECCS) performance duringmore » LOCA. This demonstration includes coupled analysis of core design, fuel design, thermalhydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results. Within this context, a multi-physics best estimate plus uncertainty (MPBEPU) methodology framework is proposed.« less

U.S. pharmacy policy: a public health perspective on safety and cost.

PubMed

Rosenau, Pauline Vaillancourt; Lal, Lincy S; Glasser, Jay H

2009-01-01

A public health perspective based on social justice and a population health point of view emphasizes pharmacy policy innovations regarding safety and costs. Such policies that effectively reduce costs include controlling profits, establishing profit targets, extending prescription providers, revising prescription classification schemes, emphasizing generic medications, and establishing formularies. Public education and universal programs may reduce costs, but co-pays and "cost-sharing" do not. Switching medications to over-the-counter (OTC) status, pill splitting, and importing medication from abroad are poor substitutes for authentic public health pharmacy policy. Where policy changes yield savings, public health insists that these savings should be used to increase access and improve population health. In the future, pharmacy policies may emphasize public health accountability more than individual liberty because of potential cost savings to society. Fear of litigation, as an informal mechanism of focusing manufacturer's attention on safety, is inefficient; public health pharmacy policy regarding safety looks toward a more active regulatory role on the part of government. A case study of direct-to-consumer advertising illustrates the complexity of public health pharmacy policy.

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.

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.

Waste isolation safety assessment program. Task 4. Third contractor information meeting

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

Not Available

1980-06-01

The Contractor Information Meeting (October 14 to 17, 1979) was part of the FY-1979 effort of Task 4 of the Waste Isolation Safety Assessment Program (WISAP): Sorption/Desorption Analysis. The objectives of this task are to: evaluate sorption/desorption measurement methods and develop a standardized measurement procedure; produce a generic data bank of nuclide-geologic interactions using a wide variety of geologic media and groundwaters; perform statistical analysis and synthesis of these data; perform validation studies to compare short-term laboratory studies to long-term in situ behavior; develop a fundamental understanding of sorption/desorption processes; produce x-ray and gamma-emitting isotopes suitable for the study ofmore » actinides at tracer concentrations; disseminate resulting information to the international technical community; and provide input data support for repository safety assessment. Conference participants included those subcontracted to WISAP Task 4, representatives and independent subcontractors to the Office of Nuclear Waste Isolation, representatives from other waste disposal programs, and experts in the area of waste/geologic media interaction. Since the meeting, WISAP has been divided into two programs: Assessment of Effectiveness of Geologic Isolation Systems (AEGIS) (modeling efforts) and Waste/Rock Interactions Technology (WRIT) (experimental work). The WRIT program encompasses the work conducted under Task 4. This report contains the information presented at the Task 4, Third Contractor Information Meeting. Technical Reports from the subcontractors, as well as Pacific Northwest Laboratory (PNL), are provided along with transcripts of the question-and-answer sessions. The agenda and abstracts of the presentations are also included. Appendix A is a list of the participants. Appendix B gives an overview of the WRIT program and details the WRIT work breakdown structure for 1980.« less

INL Generic Robot Architecture

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

2005-03-30

The INL Generic Robot Architecture is a generic, extensible software framework that can be applied across a variety of different robot geometries, sensor suites and low-level proprietary control application programming interfaces (e.g. mobility, aria, aware, player, etc.).

Producing and marketing a specialty egg.

PubMed

Michella, S M; Slaugh, B T

2000-07-01

Eggland's Best, Inc. markets premium quality shell eggs under the Eggland's Best (EB) brand name. The company, started in 1988, is comprised of a franchise network of established egg producers and covers most of the United States. Eggland's Best provides its franchisees with marketing and technical support. The franchisees produce, process, and distribute EB eggs according to the strict program established and monitored by EB. Production follows the all-natural vegetarian feed program in accordance with the company's US patent entitled "Eggs Compatible with a Cholesterol Reducing Diet and Method of Producing the Same." The EB program excludes animal fat and other animal byproducts. Eggland's Best eggs have seven times the generic level of vitamin E, nearly three times more omega-3 fatty acids and iodine, and 25% less saturated fat than regular generic eggs. Eggland's Best has one of the finest shell egg quality assurance programs anywhere. Eggland's Best franchisees submit weekly egg samples that are analyzed for shell quality, interior quality, vitamin E, iodine, cholesterol and fatty acids. Samples of feed and the EB-patented feed supplement are also analyzed. Approximately 28,000 total laboratory tests are conducted annually. Nationwide product and display retail evaluations are contracted through an outside audit company (40 to 50 cities evaluated four times per year). All EB eggs are USDA graded according to EB's strict quality standards. Producers must follow a food safety quality assurance program (United Egg Producers Association 5-Star or equivalent state or company program). Each egg is stamped "EB" as assurance of meeting EB's highest standards of flavor, quality, and nutrition. Eggland's Best has enjoyed record sales growth for the past 3 yr.

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.

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

De novo use of a generic formulation of tacrolimus versus reference tacrolimus in kidney transplantation: evaluation of the clinical results, histology in protocol biopsies, and immunological monitoring.

PubMed

Melilli, Edoardo; Crespo, Elena; Sandoval, Diego; Manonelles, Anna; Sala, Neus; Mast, Richard; Padulles, Ariadna; Grinyo, Josep M; Bestard, Oriol; Cruzado, Josep Maria

2015-11-01

The use of generic formulations of immunosuppressive drugs in renal transplantation has been and still is a controversial subject. The lack of clinical studies about safety and efficacy in transplant patients is one of the factors restricting the diffusion of generic drugs in the renal transplant field. Since March 2013, our transplant unit has incorporated generic tacrolimus (Adoport(®) ; Sandoz), replacing the one we were currently using (Prograf(®) ; Astellas). When carrying out our retrospective analysis comparing the two different formulations, we evaluated several clinical results: tacrolimus trough concentrations (C0) at 5-7 days; 1, 3, and 6 months post-transplantation; concentration/dose ratio at 6 months; acute rejection incidence; delayed graft function (DGF); renal function (as CKD-EPI); and proteinuria at 6 months in 120 patients (1:1 ratio of Prograf(®) versus Adoport(®) ), noticing no important differences. We also evaluated the results of protocol biopsies at 6 months in a subgroup of patients, thus verifying the safety and efficacy of this particular generic drug versus the reference product on a histological basis as well. No difference in the development of dnDSA (de novo donor-specific antibody) was found between the two groups. © 2015 Steunstichting ESOT.

76 FR 33307 - Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-08

...] Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period AGENCY: Food and Drug... on the development of a generic drug user fee program. The Agency is taking this action to allow..., 75 FR 47820, FDA published a notice soliciting comment on development of a generic drug user fee...

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.

Evaluation of nuclear-facility decommissioning projects. Summary report: Ames Laboratory Research Reactor

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

Link, B.W.; Miller, R.L.

1983-07-01

This document summarizes the available information concerning the decommissioning of the Ames Laboratory Research Reactor (ALRR), a five-megawatt heavy water moderated and cooled research reactor. The data were placed in a computerized information retrieval/manipulation system which permits its future utilization for purposes of comparative analysis. This information is presented both in detail in its computer output form and also as a manually assembled summarization which highlights the more important aspects of the decommissioning program. Some comparative information with reference to generic decommissioning data extracted from NUREG/CR 1756, Technology, Safety and Costs of Decommissioning Nuclear Research and Test Reactors, is included.

Extreme Environments Development of Decision Processes and Training Programs for Medical Policy Formulation

NASA Technical Reports Server (NTRS)

Stough, Roger

2004-01-01

The purpose of this workshop was to survey existing health and safety policies as well as processes and practices for various extreme environments; to identify strengths and shortcomings of these processes; and to recommend parameters for inclusion in a generic approach to policy formulation, applicable to the broadest categories of extreme environments. It was anticipated that two additional workshops would follow. The November 7, 2003 workshop would be devoted to the evaluation of different model(s) and a concluding expert evaluation of the usefulness of the model using a policy formulation example. The final workshop was planned for March 2004.

Development of a Bayesian Belief Network Runway Incursion Model

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2014-01-01

In a previous paper, a statistical analysis of runway incursion (RI) events was conducted to ascertain their relevance to the top ten Technical Challenges (TC) of the National Aeronautics and Space Administration (NASA) Aviation Safety Program (AvSP). The study revealed connections to perhaps several of the AvSP top ten TC. That data also identified several primary causes and contributing factors for RI events that served as the basis for developing a system-level Bayesian Belief Network (BBN) model for RI events. The system-level BBN model will allow NASA to generically model the causes of RI events and to assess the effectiveness of technology products being developed under NASA funding. These products are intended to reduce the frequency of RI events in particular, and to improve runway safety in general. The development, structure and assessment of that BBN for RI events by a Subject Matter Expert panel are documented in this paper.

[GENERIC DRUGS: IS BIOEQUIVALENCE SUFFICIENT TO ENSURE QUALITY, EFFICACY AND SAFETY?].

PubMed

Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

2015-05-01

This article is focusing on the current debate that prescription of generic drugs is producing among patients and healthcare professionals. Following European Medicine Agency (EMA) recommendations, a number of generic medicines have recently been withdrawn from the market in Spain. The authorization for these generic drugs was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The EMA inspection of GVK revealed data manipulation of electrocardiograms during the development of some studies of generic medicines. These manipulations had taken place over a period of at least five years. The article is also dealing with the consideration that bioavailability and bioequivalence studies receive as a cornerstone to approve generic drugs, and the discrepancies between the national regulatory agencies of medicines to implement guidelines of approval. Likewise, in the last few years, the rapid expansion of clinical trial activity regarding generic medicines and other drugs in emerging markets, is often leading to doubt on the integrity of the way trials were performed and on the reliability of data obtained from these studies.

77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2010 CFR

2010-01-01

... assurance program at the time of the change; (2) The use of generic organizational position titles that... titles; (3) The use of generic organizational charts to indicate functional relationships, authorities... assurance standards to which the licensee is committed; and (5) Organizational revisions that ensure that...

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.

78 FR 52770 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-26

... Project Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery--NEW... Services (OSELS), Public Health Surveillance and Informatics Program Office (PHSIPO), Informatics Research... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...

G STL: the geostatistical template library in C++

NASA Astrophysics Data System (ADS)

Remy, Nicolas; Shtuka, Arben; Levy, Bruno; Caers, Jef

2002-10-01

The development of geostatistics has been mostly accomplished by application-oriented engineers in the past 20 years. The focus on concrete applications gave birth to many algorithms and computer programs designed to address different issues, such as estimating or simulating a variable while possibly accounting for secondary information such as seismic data, or integrating geological and geometrical data. At the core of any geostatistical data integration methodology is a well-designed algorithm. Yet, despite their obvious differences, all these algorithms share many commonalities on which to build a geostatistics programming library, lest the resulting library is poorly reusable and difficult to expand. Building on this observation, we design a comprehensive, yet flexible and easily reusable library of geostatistics algorithms in C++. The recent advent of the generic programming paradigm allows us elegantly to express the commonalities of the geostatistical algorithms into computer code. Generic programming, also referred to as "programming with concepts", provides a high level of abstraction without loss of efficiency. This last point is a major gain over object-oriented programming which often trades efficiency for abstraction. It is not enough for a numerical library to be reusable, it also has to be fast. Because generic programming is "programming with concepts", the essential step in the library design is the careful identification and thorough definition of these concepts shared by most geostatistical algorithms. Building on these definitions, a generic and expandable code can be developed. To show the advantages of such a generic library, we use G STL to build two sequential simulation programs working on two different types of grids—a surface with faults and an unstructured grid—without requiring any change to the G STL code.

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 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.

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

A generic model for evaluation of the Federal Aviation Administration air traffic control specialist training programs.

DOT National Transportation Integrated Search

1982-03-01

The Systems Analysis Research Unit at the Civil Aeromedical Institute (CAMI) has developed a generic model for Federal Aviation Administration (FAA) Academy training program evaluation. The model will serve as a basis for integrating the total data b...

Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

PubMed

Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

2017-10-01

Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and premature loss of efficacy (shorter duration of action) was described in 98 cases (42.6%) and occurred primarily in the afternoon. Impacts on social functioning, such as disruption in work or school performance or adverse social behaviors, were found in 51 cases (22.2%). The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Generic medications for you, but brand-name medications for me.

PubMed

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

Generics market in Greece: the pharmaceutical industry's beliefs.

PubMed

Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

2006-11-01

The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds.

Performance Analysis of GAME: A Generic Automated Marking Environment

ERIC Educational Resources Information Center

Blumenstein, Michael; Green, Steve; Fogelman, Shoshana; Nguyen, Ann; Muthukkumarasamy, Vallipuram

2008-01-01

This paper describes the Generic Automated Marking Environment (GAME) and provides a detailed analysis of its performance in assessing student programming projects and exercises. GAME has been designed to automatically assess programming assignments written in a variety of languages based on the "structure" of the source code and the correctness…

Generic Skills. Keys to Job Performance.

ERIC Educational Resources Information Center

Smith, Arthur De W.

The generic skills studies in Canada have as their objectives the formulation of generic skills, the identification of their uses for certain occupational groups, and the preparation of specifications for instructional modules in an attempt to provide greater flexibility to workers, employers, and vocational training programs. Another objective of…

Ontario’s plunging price-caps on generics: deeper dives may drown some drugs

PubMed Central

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product’s price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive. PMID:22046229

Ontario's plunging price-caps on generics: deeper dives may drown some drugs.

PubMed

Anis, Aslam; Harvard, Stephanie; Marra, Carlo

2011-01-01

In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product's price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive.

Virtual Frame Buffer Interface Program

NASA Technical Reports Server (NTRS)

Wolfe, Thomas L.

1990-01-01

Virtual Frame Buffer Interface program makes all frame buffers appear as generic frame buffer with specified set of characteristics, allowing programmers to write codes that run unmodified on all supported hardware. Converts generic commands to actual device commands. Consists of definition of capabilities and FORTRAN subroutines called by application programs. Developed in FORTRAN 77 for DEC VAX 11/780 or DEC VAX 11/750 computer under VMS 4.X.

Successful Development of Generic Capabilities in an Undergraduate Medical Education Program

ERIC Educational Resources Information Center

McNeil, H. Patrick; Scicluna, Helen A.; Boyle, Patrick; Grimm, Michael C.; Gibson, Kathryn A.; Jones, Philip D.

2012-01-01

The development of generic capabilities or graduate attributes in communication, teamwork, critical analysis of information, problem solving and ethical practice is widely recognised as a desired outcome of higher education. This emphasis on generic capabilities has emerged despite ongoing debates about the concept and development of such…

78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... costs to total FDA costs of the review of human generic drug activities for the first 3 of the preceding... review of human generic drug activities. Since the first year of the Generic Drug User Fee Program has... activities other than PC&B (see section 744B(c)(1)(C) of the FD&C Act). Table 3 of this document provides the...

The efficacy and safety of on-demand Elonza; a generic product of sildenafil in Thai men with erectile dysfunction.

PubMed

Wijitsettakul, Udomsak; Pempongkosol, Sompol

2013-06-01

To evaluate the efficacy and safety of Elonza (generic product of sildenafil) 100 mg, a phosphodiesterase type 5 (PDE5) inhibitor, in Thai men with erectile dysfunction (ED). This prospective, Cohort study was conducted for eight weeks. Two hundred ten male patients, older than 20 years of age with ED were enrolled to receive generic product of sildenafil 100 mg taken as needed. Efficacy is evaluated through the International Index of Erectile Function (IIEF) scores for the five separate response domains, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domain. After sildenafil administration, erectile function domain scores were significantly increased from baseline, 5.02 (p < 0.001) and 7.19 (p < 0.001) in one month and two months, respectively. Intercourse satisfaction domain scores and overall satisfaction domain scores were significantly increased from baseline, 3.17 (p < 0.001) and 1.74 (p < 0.001) in two months, respectively. Most treatment emergent adverse events were mild or moderate. The most frequent treatment-emergent adverse events were flushing (13.2%), nasal congestion (9.8%), abnormal vision (4.9%), headache (4.4%), dizziness (2.9%), and dyspepsia (0.5%). Elonza, a generic product of sildenafil, was an effective and well-tolerated treatment for ED in Thai men.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

PubMed

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.

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

Programming Languages or Generic Software Tools, for Beginners' Courses in Computer Literacy?

ERIC Educational Resources Information Center

Neuwirth, Erich

1987-01-01

Discussion of methods that can be used to teach beginner courses in computer literacy focuses on students aged 10-12. The value of using a programing language versus using a generic software package is highlighted; Logo and Prolog are reviewed; and the use of databases is discussed. (LRW)

Generic Certificates. Agricultural Economic Report Number 594.

ERIC Educational Resources Information Center

Glauber, Joseph W.

The Food Security Act of 1985 authorizes the U.S. Department of Agriculture to issue generic certificates in lieu of cash payments due to program participants and merchants of agricultural products under provisions of several programs. The certificates may be used to acquire stocks held as collateral on government loans or owned by the Commodity…

Perception of the value of generic drugs in São Paulo, Brazil.

PubMed

Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

2016-02-01

The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

Generic OCs bioequivalent, but much maligned.

PubMed

1989-06-01

Although generic oral contraceptives (OCs) are bioequivalent to brand-name formulations, many family planning professionals do not prescribe the significantly lower-priced generics. The Planned Parenthood Federation of America, for example, has refused to approve generic OCs for use in the organization's clinics, presumably because of concerns about their equivalent efficacy and safety. However, much of this skepticism may be fueled by misleading marketing by brand-name OC manufacturers. Sales representatives have reportedly told clinicians that generic OCs can be as much as 20% different from brand-name formulations, despite evidence collected by the US Food and Drug Administration confirming that there is virtually no difference except in terms of inert ingredients. In the case of many formulations, the variability between the generic and brand-name products is no different than the variability found between different lots of the same brand-name drug. Another obstacle to wider use of generic OCs is that discounts for large volume purchases make brand-name OCs the best buy for family planning clinics. Clinicians also note that clients complain of minor side effects whenever OC brands are changed, even if the compounds are the same. As the price of medication continues to rise, the more widespread availability of generic OCs will be especially important for teenagers and other low-income clients.

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

Readiness for First Crewed Flight

NASA Technical Reports Server (NTRS)

Schaible, Dawn M.

2011-01-01

The NASA Engineering and Safety Center (NESC) was requested to develop a generic framework for evaluating whether any given program has sufficiently complete and balanced plans in place to allow crewmembers to fly safely on a human spaceflight system for the first time (i.e., first crewed flight). The NESC assembled a small team which included experts with experience developing robotic and human spaceflight and aviation systems through first crewed test flight and into operational capability. The NESC team conducted a historical review of the steps leading up to the first crewed flights of Mercury through the Space Shuttle. Benchmarking was also conducted with the United States (U.S.) Air Force and U.S. Navy. This report contains documentation of that review.

A compilation of reports of the Advisory Committee on reactor safeguards. 1996 Annual report

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

NONE

1997-04-01

This compilation contains 47 ACRS reports submitted to the Commission, or to the Executive Director for Operations, during calendar year 1996. It also includes a report to the Congress on the NRC Safety Research Program. All reports have been made available to the public through the NRC Public Document Room, the U.S. Library of Congress, and the Internet at http://www.nrc.gov/ACRSACNW. The reports are divided into two groups: Part 1 contains ACRS reports by project name and by chronological order within project name. Part 2 categorizes the reports by the most appropriate generic subject area and by chronological order within subjectmore » area.« less

Portable Diagnostics Technology Assessment for Space Missions. Part 2; Market Survey

NASA Technical Reports Server (NTRS)

Nelson, Emily S.; Chait, Arnon

2010-01-01

A mission to Mars of several years duration requires more demanding standards for all onboard instruments than a 6-month mission to the Moon or the International Space Station. In Part 1, we evaluated generic technologies and suitability to NASA needs. This prior work considered crew safety, device maturity and flightworthiness, resource consumption, and medical value. In Part 2, we continue the study by assessing the current marketplace for reliable Point-of-Care diagnostics. The ultimate goal of this project is to provide a set of objective analytical tools to suggest efficient strategies for reaching specific medical targets for any given space mission as program needs, technological development, and scientific understanding evolve.

76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

... design estimates. Analyses performed under the Generic Issue program (GIP) indicated the need to evaluate... Examination of External Events (IPEEE) for Severe Accident Vulnerabilities,'' (ADAMS Accession No. ML031150485) to request that each licensee identify and report to the NRC all plant- specific vulnerabilities to...

Safety Case Patterns: Theory and Applications

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh J.

2015-01-01

We develop the foundations for a theory of patterns of safety case argument structures, clarifying the concepts involved in pattern specification, including choices, labeling, and well-founded recursion. We specify six new patterns in addition to those existing in the literature. We give a generic way to specify the data required to instantiate patterns and a generic algorithm for their instantiation. This generalizes earlier work on generating argument fragments from requirements tables. We describe an implementation of these concepts in AdvoCATE, the Assurance Case Automation Toolset, showing how patterns are defined and can be instantiated. In particular, we describe how our extended notion of patterns can be specified, how they can be instantiated in an interactive manner, and, finally, how they can be automatically instantiated using our algorithm.

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

Comparing effectiveness of generic and disease-specific self-management interventions for people with diabetes in a practice context.

PubMed

Ghahari, Setareh; Packer, Tanya; Boldy, Duncan; Melling, Lauren; Parsons, Richard

2015-10-01

The effectiveness of self-management interventions has been demonstrated. However, the benefits of generic vs. disease-specific programs are unclear, and their efficacy within a practice setting has yet to be fully explored. To compare the outcomes of the diabetes-specific self-management program (Diabetes) and the generic chronic disease Self-management Program (Chronic Condition) and to explore whether program characteristics, evaluated using the Quality Self-Management Assessment Framework (Q-SAF), provide insight into the results of the outcome evaluation. A pragmatic pretest, post-test design with 12-week follow up was used to compare the 2 self-management interventions. Outcomes were quality of life, self-efficacy, loneliness, self-management skills, depression, and health behaviours. People with diabetes self-selected attendance at the Diabetes or Chronic Condition program offered as part of routine practice. Participants with diabetes in the 2 programs (Diabetes=200; Chronic Condition=90) differed significantly in almost all demographic and clinical characteristics. Both programs yielded positive outcomes. Controlling for baseline and demographic characteristics, random effects modelling showed an interaction between time and program for 1 outcome: self-efficacy (p=0.029). Participants in the Chronic Condition group experienced greater improvements over time than did those in the Diabetes group. The Q-SAF analysis showed differences in program content, delivery and workforce capacity. People with diabetes benefited from both programs, but participation in the generic program resulted in greater improvements in self-efficacy for participants who had self-selected that program. Both programs in routine care led to health-related improvements. The Q-SAF can be used to assess the quality of programs. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Reusable Rocket Engine Advanced Health Management System. Architecture and Technology Evaluation: Summary

NASA Technical Reports Server (NTRS)

Pettit, C. D.; Barkhoudarian, S.; Daumann, A. G., Jr.; Provan, G. M.; ElFattah, Y. M.; Glover, D. E.

1999-01-01

In this study, we proposed an Advanced Health Management System (AHMS) functional architecture and conducted a technology assessment for liquid propellant rocket engine lifecycle health management. The purpose of the AHMS is to improve reusable rocket engine safety and to reduce between-flight maintenance. During the study, past and current reusable rocket engine health management-related projects were reviewed, data structures and health management processes of current rocket engine programs were assessed, and in-depth interviews with rocket engine lifecycle and system experts were conducted. A generic AHMS functional architecture, with primary focus on real-time health monitoring, was developed. Fourteen categories of technology tasks and development needs for implementation of the AHMS were identified, based on the functional architecture and our assessment of current rocket engine programs. Five key technology areas were recommended for immediate development, which (1) would provide immediate benefits to current engine programs, and (2) could be implemented with minimal impact on the current Space Shuttle Main Engine (SSME) and Reusable Launch Vehicle (RLV) engine controllers.

76 FR 45582 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human... concerning the safety and effectiveness of marketed and investigational human drug products for use in... and evaluates available data concerning the safety and effectiveness of marketed and investigational...

Influence Based Learning Program Scientific Learning Approach to Science Students Generic Skills

ERIC Educational Resources Information Center

Wahyuni, Ida; Amdani, Khairul

2016-01-01

This study aims to determine the influence of scientific approach based learning program (P2BPS) against generic science skills of students. The method used in this research is "quasi experiment" with "two-group pretest posttest" design.The population in this study were all students who take courses in general physics II at the…

Health plans keeping drug cost increases in check with programs that promote generics.

PubMed

2002-07-01

To counter the massive amount of drug company detailing and marketing that is partly responsible for driving up pharmaceutical costs, health plans and some independent practice associations are promoting the use of generics to physicians in their networks. While most physicians in capitated contracts don't directly benefit from the movement to encourage generics unless they have pharmacy risk, some health plans are paying physicians financial incentives to increase generic prescribing.

Commercial grade item (CGI) dedication of generators for nuclear safety related applications

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

Das, R.K.; Hajos, L.G.

1993-03-01

The number of nuclear safety related equipment suppliers and the availability of spare and replacement parts designed specifically for nuclear safety related application are shrinking rapidly. These have made it necessary for utilities to apply commercial grade spare and replacement parts in nuclear safety related applications after implementing proper acceptance and dedication process to verify that such items conform with the requirements of their use in nuclear safety related application. The general guidelines for the commercial grade item (CGI) acceptance and dedication are provided in US Nuclear Regulatory Commission (NRC) Generic Letters and Electric Power Research Institute (EPRI) Report NP-5652,more » Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications. This paper presents an application of these generic guidelines for procurement, acceptance, and dedication of a commercial grade generator for use as a standby generator at Salem Generating Station Units 1 and 2. The paper identifies the critical characteristics of the generator which once verified, will provide reasonable assurance that the generator will perform its intended safety function. The paper also delineates the method of verification of the critical characteristics through tests and provide acceptance criteria for the test results. The methodology presented in this paper may be used as specific guidelines for reliable and cost effective procurement and dedication of commercial grade generators for use as standby generators at nuclear power plants.« less

Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

PubMed

Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

2014-05-01

Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

78 FR 32412 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

...) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic...

77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements... critical and measurable enhancements to FDA's generic drugs program. GDUFA establishes fees for abbreviated... current thinking on generic drug user fee amendments of 2012. It does not create or confer any rights for...

78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...

Fixing Holes Where the Rain Gets in: Problem Areas in the Development of Generic Skills in Business

ERIC Educational Resources Information Center

Calma, Angelito

2013-01-01

Purpose: Little attention is paid to understanding generic skills in business. Even less attention is paid to collecting evidence of students' development of these skills. This paper aims to fill this gap. Design/methodology/approach: Four generic skills in business undergraduate and graduate programs are examined--written communication; critical…

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.

State generic substitution laws can lower drug outlays under medicaid

PubMed Central

Choudhry, Niteesh K.; Agnew-Blais, Jessica; Federman, Alex D.; Liberman, Joshua N.; Liu, Jun; Kesselheim, Aaron S.; Brookhart, M. Alan; Fischer, Michael A.

2011-01-01

To stem the rising costs of medications, states have implemented varying generic substitution policies. These policies differ in the extent to which pharmacists or patients can influence medication choice. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and generic simvastatin use after patent expiration of branded Zocor. States implementing policies that require patient consent prior to generic substitution experienced 25% lower rates of generic substitution. By eliminating patient consent requirements, state Medicaid programs could expect to save over $100 million dollars in coverage for 3 top-selling medications nearing patent expiration. The implications of these regulations on national medication spending should be considered. PMID:20606192

77 FR 15784 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic information, age, membership...

Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

PubMed Central

Vollmar, Johanna; Bellmann, Maren Christina; Darstein, Felix; Hoppe-Lotichius, Maria; Mittler, Jens; Heise, Michael; Rüttger, Bernd; Weyer, Veronika; Zimmermann, Anca; Lang, Hauke; Galle, Peter R; Zimmermann, Tim

2015-01-01

Background Expensive pharmaceuticals are a major reason for cost intensive health care systems. Long-term immunosuppressive therapy plays a relevant role after organ transplantation. Patents of original drugs have expired and cheaper products are available. Little data are available regarding efficacy and safety of generic immunosuppressive agents. Methods In this prospective study, 25 patients, who were clinically stable for a minimum of 2 years after liver transplantation, were converted from the original formulations of tacrolimus (TAC) and mycophenolate mofetil to the generics Tacpan® (TAP) and Mowel® (MOW). Patients were followed-up for 6 months. Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands. Results In the matched-pair analysis of TAC trough level/dose ratio, no significant difference was found between TAP/MOW and TAC/mycophenolate mofetil groups. No acute rejection occurred in either group. In total, 17 patients reported mild side effects in the TAP/MOW group. The most common side effects were gastrointestinal symptoms. Intra-individual analysis of costs revealed a considerable cost reduction in the TAP/MOW group (in median 25.03%; P<0.001). Conclusion In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients. PMID:26604701

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.

Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

PubMed Central

Sun, Dajun; Rouse, Rodney; Patel, Vikram; Wu, Yong; Zheng, Jiwen; Karmakar, Alokita; Patri, Anil K.; Keire, David; Ma, Jia; Jiang, Wenlei

2018-01-01

The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit) and generic sodium ferric gluconate (SFG) in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC) and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS). In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC). The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products. PMID:29303999

Nomenclature and traceability debate for biosimilars: small-molecule surrogates lend support for distinguishable nonproprietary names.

PubMed

Chao, Jingdong; Skup, Martha; Alexander, Emily; Tundia, Namita; Macaulay, Dendy; Wu, Eric; Mulani, Parvez

2015-03-01

The purpose of the present study was to investigate the traceability of adverse events (AEs) for branded and generic drugs with identical nonproprietary names and to consider potential implications for the traceability of AEs for branded and biosimilar biologics. Adverse event reports in the Food and Drug Administration AE Reporting System (FAERS) were compared with those in a commercial insurance claims database (Truven Health MarketScan(®)) for 2 drugs (levetiracetam and enoxaparin sodium) with manufacturing or prescribing considerations potentially analogous to those of some biosimilars. Monthly rates of branded- and generic-attributed AEs were estimated pre- and post-generic entry. Post-entry branded-to-generic AE relative rate ratios were calculated. In FAERS, monthly AE rate ratios during the post-generic period showed a pattern in which AE rates for the branded products were greater than for the generic products. Differences in rates of brand- and generic-attributed AEs were statistically significant for both study drugs; the AE rate for the branded products peaked at approximately 10 times that of the generic levetiracetam products and approximately 4 times that of the generic enoxaparin sodium products. In contrast, monthly ratios for the MarketScan data were relatively constant over time. Use of the same nonproprietary name for generic and branded products may contribute to poor traceability of AEs reported in the FAERS database due to the significant misattribution of AEs to branded products (when those AEs were in fact associated with patient use of generic products). To ensure accurate and robust safety surveillance and traceability for biosimilar products in the United States, improved product identification mechanisms, such as related but distinguishable nonproprietary names for biosimilars and reference biologics, should be considered.

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.

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.

Generic command interpreter for robot controllers

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

Werner, J.

1991-04-09

Generic command interpreter programs have been written for robot controllers at Sandia National Laboratories (SNL). Each interpreter program resides on a robot controller and interfaces the controller with a supervisory program on another (host) computer. We call these interpreter programs monitors because they wait, monitoring a communication line, for commands from the supervisory program. These monitors are designed to interface with the object-oriented software structure of the supervisory programs. The functions of the monitor programs are written in each robot controller's native language but reflect the object-oriented functions of the supervisory programs. These functions and other specifics of the monitormore » programs written for three different robots at SNL will be discussed. 4 refs., 4 figs.« less

Lessons learnt from the development of the Patient Safety Incidents Reporting an Learning System for the Spanish National Health System: SiNASP.

PubMed

Vallejo-Gutiérrez, Paula; Bañeres-Amella, Joaquim; Sierra, Eduardo; Casal, Jesús; Agra, Yolanda

2014-01-01

To describe the development process and characteristics of a patient safety incidents reporting system to be implemented in the Spanish National Health System, based on the context and the needs of the different stakeholders. Literature review and analysis of most relevant reporting systems, identification of more than 100 stakeholder's (patients, professionals, regional governments representatives) expectations and requirements, analysis of the legal context, consensus of taxonomy, development of the software and pilot test. Patient Safety Events Reporting and Learning system (Sistema de Notificación y Aprendizajepara la Seguridad del Paciente, SiNASP) is a generic reporting system for all types of incidents related to patient safety, voluntary, confidential, non punitive, anonymous or nominative with anonimization, system oriented, with local analysis of cases and based on the WHO International Classification for Patient Safety. The electronic program has an on-line form for reporting, a software to manage the incidents and improvement plans, and a scoreboard with process indicators to monitor the system. The reporting system has been designed to respond to the needs and expectations identified by the stakeholders, taking into account the lessons learned from the previous notification systems, the characteristics of the National Health System and the existing legal context. The development process presented and the characteristics of the system provide a comprehensive framework that can be used for future deployments of similar patient safety systems. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

78 FR 69703 - 10-Day Notice of Proposed Information Collection: Generic Customer Satisfaction Surveys; Physical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5683-N-102] 10-Day Notice of Proposed Information Collection: Generic Customer Satisfaction Surveys; Physical Inspection Pilot Program...

Toward an Integrated Design, Inspection and Redundancy Research Program.

DTIC Science & Technology

1984-01-01

William Creelman William H. Silcox National Marine Service Standard Oil Company of California St. Louis, Missouri San Francisco, California .-- N...develop physical models and generic tools for analyzing the effects of redundancy, reserve strength, and residual strength on the system behavior of marine...probabilistic analyses to be applicable to real-world problems, this program needs to provide - the deterministic physical models and generic tools upon

A Generic Qualitative Study of the Experiences of International Students Participating in the Cultural Connections Program at the University of Mississippi

ERIC Educational Resources Information Center

Kholomeydik, Nadezda

2012-01-01

The purpose of this research was to explore the experiences of international students participating in the Cultural Connections Program at The University of Mississippi. A generic qualitative design was utilized using purposeful criterion sampling. The data was collected from two focus group interviews with 11 participants in focus group 1 and 10…

Development of a Bayesian Belief Network Runway Incursion and Excursion Model

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2014-01-01

In a previous work, a statistical analysis of runway incursion (RI) event data was conducted to ascertain the relevance of this data to the top ten Technical Challenges (TC) of the National Aeronautics and Space Administration (NASA) Aviation Safety Program (AvSP). The study revealed connections to several of the AvSP top ten TC and identified numerous primary causes and contributing factors of RI events. The statistical analysis served as the basis for developing a system-level Bayesian Belief Network (BBN) model for RI events, also previously reported. Through literature searches and data analysis, this RI event network has now been extended to also model runway excursion (RE) events. These RI and RE event networks have been further modified and vetted by a Subject Matter Expert (SME) panel. The combined system-level BBN model will allow NASA to generically model the causes of RI and RE events and to assess the effectiveness of technology products being developed under NASA funding. These products are intended to reduce the frequency of runway safety incidents/accidents, and to improve runway safety in general. The development and structure of the BBN for both RI and RE events are documented in this paper.

30 CFR 57.6133 - Powder chests.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., operators must follow the provisions of the Institute of Makers of Explosives (IME) Safety Library... other Explosive Materials,” (May 1993), and the “Generic Loading Guide for the IME-22 Container...

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

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

Nanotechnology, voluntary oversight, and corporate social performance: does company size matter?

NASA Astrophysics Data System (ADS)

Kuzma, Jennifer; Kuzhabekova, Aliya

2011-04-01

In this article, we examine voluntary oversight programs for nanotechnology in the context of corporate social performance (CSP) in order to better understand the drivers, barriers, and forms of company participation in such programs. At the theoretical level, we use the management framework of CSP to understand the voluntary behavior of companies. At the empirical level, we investigate nanotech industry participation in the Environmental Protection Agency's Nanoscale Materials Stewardship Program (NMSP) as an example of CSP, in order to examine the effects of company characteristics on CSP outcomes. The analysis demonstrates that, on the average, older and larger companies for which nanotech is one of the many business activities demonstrate greater CSP as judged by company actions, declarations, and self-evaluations. Such companies tended to submit more of the requested information to the NMSP, including specific information about health and safety, and to claim fewer of the submitted items as confidential business information. They were also more likely to have on-line statements of generic and nano-specific corporate social responsibility principles, policies, and achievements. The article suggests a need to encourage smaller and younger companies to participate in voluntary oversight programs for nanotechnology and presents options for better design of these programs.

Generic Verification Protocol for Verification of Online Turbidimeters

EPA Science Inventory

This protocol provides generic procedures for implementing a verification test for the performance of online turbidimeters. The verification tests described in this document will be conducted under the Environmental Technology Verification (ETV) Program. Verification tests will...

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.

Exploring factors underlying the attitude of community pharmacists to generic substitution: a nationwide study from Poland.

PubMed

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-02-01

Generic uptake will increasingly be promoted by governments in the face of increasing healthcare costs and global economic uncertainties. The purpose of this study was to investigate attitudes towards generic substitution among community pharmacists, with a focus on the perception of the efficacy, knowledge of the generics characteristics, as well as the willingness to recommend generic substitution. Community pharmacies in Poland. The survey was conducted in 2013 by telephone interviews with 802 holders of an MSc degree in pharmacy working as community pharmacists. Stratified sampling was implemented to make the study representative in geographic terms. Pharmacists' attitudes towards generics drugs. The study showed that only 40 % of pharmacists always inform patients about their right to choose a generic substitute. It was also shown that the less time a pharmacist has been practising, the less likely they are to invite consumers to choose between generic and innovator products. The likelihood of informing was not affected by pharmacist's sex or age, or by pharmacy location or status (chain vs. independent pharmacy) (p > 0.05). Pharmacists varied in their approach to their statutory obligation to inform about a generic; a more or less equal share of respondents were either in favour or against it. Approximately 60 % pharmacists were shown to be familiar with the definition of a generic medicine. Pharmacists with shorter time of practice proved to know more about generics. However, more than 30 % respondents failed to choose the correct statement on generic versus reference medicine dosage. The majority of respondents (67 %) believed there are no differences in efficacy between generics and innovator drugs, whereas 31 % claimed that original brands could be more effective. A significant correlation was demonstrated between the views of pharmacists on the therapeutic efficacy and their willingness to substitute for generics whenever permitted by a physician. It is important to address all concerns pharmacists may have over generics, for example by implementing comprehensive awareness-raising campaigns. Also, pharmacotherapy monitoring systems (i.e. provided in a framework of pharmaceutical care) could be considered to identify any safety or quality concerns that may arise.

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.

Generic and therapeutic substitutions in the UK: are they a good thing?

PubMed Central

Duerden, Martin G; Hughes, Dyfrig A

2010-01-01

There is considerable interest and debate concerning the place of generic substitution (switching from a brand to generic product); and on therapeutic substitution, that is, switching to a cheaper, but apparently equivalent, product, usually within the drug class. Generic substitution by pharmacists is standard practice in UK hospital settings, and is being proposed for implementation in primary care. Although most prescriptions are already written generically (83% in the community in England in 2008), there are still cost savings that could be made if generic medicines are substituted against prescriptions written by branded name or by getting prescribers to adhere to advice to prescribe generically. Therapeutic substitution is more contentious, as direct evidence to support equivalence is normally lacking. However, the price differential between established drugs whose patents have expired and for which generics are available and newer, branded medicines within the same therapeutic class, makes therapeutic substitution an attractive application of cost-minimization analysis for the more efficient use of healthcare resources. Here we explore the tension that exists between the clinical appropriateness and safety of switching from an individual patient perspective and the consideration of value for money which is required to maximize population health from a health service perspective. Although substitution may affect individual patients (such as, for instance, reduced adherence, increased potential for medication error), it might be a price worth paying given the opportunity cost associated with the use of medicines that are clinically no better than cheaper alternatives. PMID:20716231

Generic drugs: international trends and policy developments in Australia.

PubMed

Lofgren, Hans

2004-01-01

Public and private third-party payers in many countries encourage or mandate the use of generic drugs. This article examines the development of generics policy in Australia, against the background of a description of international trends in this area, and related experiences of reference pricing programs. The Australian generics market remains underdeveloped due to a historical legacy of small Pharmaceutical Benefits Scheme price differentials between originator brands and generics. It is argued that policy measures open to the Australian government can be conceived as clustering around two different approaches: incremental changes within the existing regulatory framework, or a shift towards a high volume/low price role of generics which would speed up the delivery of substantial cost savings, and could provide enhanced scope for the financing of new, patented drugs.

Knowledge, perceptions and use of generic drugs: a cross sectional study

PubMed Central

de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

2014-01-01

Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

Patient Safety and Generic Labeling Improvement Act

THOMAS, 112th Congress

Sen. Leahy, Patrick J. [D-VT

2012-04-18

Senate - 04/18/2012 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Generic radiological characterization protocol for surveys conducted for DOE remedial action programs

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

Berven, B.A.; Cottrell, W.D.; Leggett, R.W.

1986-05-01

This report describes goals and methodology that can be used by radiological survey contractors in surveys at properties associated with the Department of Energy's remedial action programs. The description includes: (1) a general discussion of the history of the remedial action programs; (2) the types of surveys that may be employed by the Radiological Survey Activities (RASA) contractor; (3) generic survey methods that may be used during radiological surveys; and (4) a format for presenting information and data in a survey report. 9 refs.

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.

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.

An intelligent position-specific training system for mission operations

NASA Technical Reports Server (NTRS)

Schneider, M. P.

1992-01-01

Marshall Space Flight Center's (MSFC's) payload ground controller training program provides very good generic training; however, ground controller position-specific training can be improved by including position-specific training systems in the training program. This report explains why MSFC needs to improve payload ground controller position-specific training. The report describes a generic syllabus for position-specific training systems, a range of system designs for position-specific training systems, and a generic development process for developing position-specific training systems. The report also describes a position-specific training system prototype that was developed for the crew interface coordinator payload operations control center ground controller position. The report concludes that MSFC can improve the payload ground controller training program by incorporating position-specific training systems for each ground controller position; however, MSFC should not develop position-specific training systems unless payload ground controller position experts will be available to participate in the development process.

GENERIC VERIFICATION PROTOCOL: DISTRIBUTED GENERATION AND COMBINED HEAT AND POWER FIELD TESTING PROTOCOL

EPA Science Inventory

This report is a generic verification protocol by which EPA’s Environmental Technology Verification program tests newly developed equipment for distributed generation of electric power, usually micro-turbine generators and internal combustion engine generators. The protocol will ...

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.

Flight demonstration of flight termination system and solid rocket motor ignition using semiconductor laser initiated ordnance

NASA Astrophysics Data System (ADS)

Schulze, Norman R.; Maxfield, B.; Boucher, C.

1995-01-01

Solid State Laser Initiated Ordnance (LIO) offers new technology having potential for enhanced safety, reduced costs, and improved operational efficiency. Concerns over the absence of programmatic applications of the technology, which has prevented acceptance by flight programs, should be abated since LIO has now been operationally implemented by the Laser Initiated Ordnance Sounding Rocket Demonstration (LOSRD) Program. The first launch of solid state laser diode LIO at the NASA Wallops Flight Facility (WFF) occurred on March 15, 1995 with all mission objectives accomplished. This project, Phase 3 of a series of three NASA Headquarters LIO demonstration initiatives, accomplished its objective by the flight of a dedicated, all-LIO sounding rocket mission using a two-stage Nike-Orion launch vehicle. LIO flight hardware, made by The Ensign-Bickford Company under NASA's first Cooperative Agreement with Profit Making Organizations, safely initiated three demanding pyrotechnic sequence events, namely, solid rocket motor ignition from the ground and in flight, and flight termination, i.e., as a Flight Termination System (FTS). A flight LIO system was designed, built, tested, and flown to support the objectives of quickly and inexpensively putting LIO through ground and flight operational paces. The hardware was fully qualified for this mission, including component testing as well as a full-scale system test. The launch accomplished all mission objectives in less than 11 months from proposal receipt. This paper concentrates on accomplishments of the ordnance aspects of the program and on the program's implementation and results. While this program does not generically qualify LIO for all applications, it demonstrated the safety, technical, and operational feasibility of those two most demanding applications, using an all solid state safe and arm system in critical flight applications.

The Analysis of the Contribution of Human Factors to the In-Flight Loss of Control Accidents

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2012-01-01

In-flight loss of control (LOC) is currently the leading cause of fatal accidents based on various commercial aircraft accident statistics. As the Next Generation Air Transportation System (NextGen) emerges, new contributing factors leading to LOC are anticipated. The NASA Aviation Safety Program (AvSP), along with other aviation agencies and communities are actively developing safety products to mitigate the LOC risk. This paper discusses the approach used to construct a generic integrated LOC accident framework (LOCAF) model based on a detailed review of LOC accidents over the past two decades. The LOCAF model is comprised of causal factors from the domain of human factors, aircraft system component failures, and atmospheric environment. The multiple interdependent causal factors are expressed in an Object-Oriented Bayesian belief network. In addition to predicting the likelihood of LOC accident occurrence, the system-level integrated LOCAF model is able to evaluate the impact of new safety technology products developed in AvSP. This provides valuable information to decision makers in strategizing NASA's aviation safety technology portfolio. The focus of this paper is on the analysis of human causal factors in the model, including the contributions from flight crew and maintenance workers. The Human Factors Analysis and Classification System (HFACS) taxonomy was used to develop human related causal factors. The preliminary results from the baseline LOCAF model are also presented.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics.

PubMed

Straka, Robert J; Keohane, Denis J; Liu, Larry Z

2017-05-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003-2013 using key words of "generic switching" or "substitution" was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

PubMed Central

Straka, Robert J.; Keohane, Denis J.; Liu, Larry Z.

2017-01-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases. PMID:26099048

Comparison of original and generic clopidogrel 600 mg loading dose in the patients who planned undergoing coronary angiography.

PubMed

Srimahachota, Suphot; Rojnuckarin, Ponlapat; Udayachalerm, Wasan; Buddhari, Wacin; Chaipromprasit, Jarkarpun; Lertsuwunseri, Vorarit; Akkawat, Benjaporn; Jirapattrathamrong, Somboon

2012-12-01

To compare the efficacy and safety of original (Plavix) and generic (Apolets) clopidogrel 600 mg loading in patients planning to undergo coronary angiography. This is an experimental design, parallel, randomized-controlled study. Coronary artery disease patients planned for cardiac catheterization were recruited Patients were randomized to receive either original or generic clopidogrel 600 mg loading dose. Platelet aggregation induced by 5 micromol/L and 20 micromol/L adenosine diphosphate (ADP) was measured by light transmission aggregometry (LTA) at baseline and 6 hours after clopidogrel 600 mg administration. Forty-nine patients were enrolled, 24 patients received original clopidogrel, and 25 patients received generic clopidogrel. After six hours of loading, there was significantly reduction in platelet aggregation induced by adenosine 5 micromol/L from 41.08 +/- 3.04% to 19.50 +/- 1.68% (p < 0.001) in original group compared to 36.76 +/- 2.66% to 21.32 +/- 2.60% (p < 0.001) in generic group. When induced by 20 micromol/L, the platelet aggregation was reduced from 58.50 +/- 2.09% to 32.25 +/- 2.30% (p < 0.001) in original group and from 61.12 +/- 2.54% to 30.04 +/- 3.14% (p < 0.001) in generic group. There was no significant difference between original and generic clopidogrel in reducing platelet aggregation induced by both adenosine 5 and 20 micromol/L. Groin hematoma was found in one case (4.2%) in the original clopidogrel group. Generic clopidogrel (Apolets) 600 mg loading dose is as effective as original clopidogrel (Plavix) in term of platelet aggregation inhibition.

Biosimilars: Considerations for Oncology Nurses
.

PubMed

Vizgirda, Vida; Jacobs, Ira

2017-04-01

Biosimilars are developed to be highly similar to and treat the same conditions as licensed biologics. As they are approved and their use becomes more widespread, oncology nurses should be aware of their development and unique considerations. This article reviews properties of biosimilars; their regulation and approval process; the ways in which their quality, safety, and efficacy are evaluated; their postmarketing safety monitoring; and their significance to oncology nurses and oncology nursing.
. A search of PubMed and regulatory agency websites was conducted for references related to the development and use of biosimilars in oncology. 
. Because biologics are large, structurally complex molecules, biosimilars cannot be considered generic equivalents to licensed biologic products. Consequently, regulatory approval for biosimilars is different from approval for small-molecule generics. Oncology nurses are in a unique position to educate themselves, other clinicians, and patients and their families about biosimilars to ensure accurate understanding, as well as optimal and safe use, of biosimilars.

Concerns about the safety of obesity agents from a manufacturing perspective.

PubMed

Kanfer, Isadore

2008-07-01

Salt derivatives of active pharmaceutical ingredients (API), such as hydrochloride and mesylate salts, are frequently used during drug product development. Compared with the underivatized API, salt derivatives are often associated with beneficial properties, including improved solubility and better absorption. Although the obesity agent sibutramine was initially approved as the hydrochloride salt, it has also been formulated as a mesylate salt (sibutramine mesylate). In order to qualify as interchangeable, generic products generally must be both pharmaceutically equivalent and bioequivalent to an approved reference product. Because generic versions of hydrochloride salt formulations that have been reformulated as mesylate salts are not pharmaceutically equivalent to the approved reference products, they would not be interchangeable, even if bioequivalent. The safety of APIs and drug products manufactured outside the United States in non-Food and Drug Administration-regulated facilities are of concern, particularly agents that may contain harmful impurities, such as obesity products formulated as mesylate salts.

Biosimilars: it's not as simple as cost alone.

PubMed

Roger, S D; Goldsmith, D

2008-10-01

Biosimilars or follow-on biologics (FoB) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FoB require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FoB marketing approval are not feasible. To determine the balance between costs surrounding FoB (including relatively extensive developmental programmes and subsequent price to the market) and the necessity to ensure efficacy and safety. It is important that FoB are sufficiently tested to ensure patient safety is not compromised. Conducting such a development programme followed by sound pharmacovigilance is very challenging and costly. Cost-savings associated with FoB may be limited.

Reliability analysis of the F-8 digital fly-by-wire system

NASA Technical Reports Server (NTRS)

Brock, L. D.; Goodman, H. A.

1981-01-01

The F-8 Digital Fly-by-Wire (DFBW) flight test program intended to provide the technology for advanced control systems, giving aircraft enhanced performance and operational capability is addressed. A detailed analysis of the experimental system was performed to estimated the probabilities of two significant safety critical events: (1) loss of primary flight control function, causing reversion to the analog bypass system; and (2) loss of the aircraft due to failure of the electronic flight control system. The analysis covers appraisal of risks due to random equipment failure, generic faults in design of the system or its software, and induced failure due to external events. A unique diagrammatic technique was developed which details the combinatorial reliability equations for the entire system, promotes understanding of system failure characteristics, and identifies the most likely failure modes. The technique provides a systematic method of applying basic probability equations and is augmented by a computer program written in a modular fashion that duplicates the structure of these equations.

L1 Adaptive Control Law for Flexible Space Launch Vehicle and Proposed Plan for Flight Test Validation

NASA Technical Reports Server (NTRS)

Kharisov, Evgeny; Gregory, Irene M.; Cao, Chengyu; Hovakimyan, Naira

2008-01-01

This paper explores application of the L1 adaptive control architecture to a generic flexible Crew Launch Vehicle (CLV). Adaptive control has the potential to improve performance and enhance safety of space vehicles that often operate in very unforgiving and occasionally highly uncertain environments. NASA s development of the next generation space launch vehicles presents an opportunity for adaptive control to contribute to improved performance of this statically unstable vehicle with low damping and low bending frequency flexible dynamics. In this paper, we consider the L1 adaptive output feedback controller to control the low frequency structural modes and propose steps to validate the adaptive controller performance utilizing one of the experimental test flights for the CLV Ares-I Program.

NGNP High Temperature Materials White Paper

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

Lew Lommers; George Honma

2012-08-01

This white paper is one in a series of white papers that address key generic issues of the combined construction and operating license (COL) pre-application program key generic issues for the Next Generation Nuclear Plant reactor using the prismatic block fuel technology. The purpose of the pre-application program interactions with the NRC staff is to reduce the time required for COL application review by identifying and addressing key regulatory issues and, if possible, obtaining agreements for their resolution

Critical attributes of transdermal drug delivery system (TDDS)--a generic product development review.

PubMed

Ruby, P K; Pathak, Shriram M; Aggarwal, Deepika

2014-11-01

Bioequivalence testing of transdermal drug delivery systems (TDDS) has always been a subject of high concern for generic companies due to the formulation complexity and the fact that they are subtle to even minor manufacturing differences and hence should be clearly qualified in terms of quality, safety and efficacy. In recent times bioequivalence testing of transdermal patches has gained a global attention and many regulatory authorities worldwide have issued recommendations to set specific framework for demonstrating equivalence between two products. These current regulatory procedures demand a complete characterization of the generic formulation in terms of its physicochemical sameness, pharmacokinetics disposition, residual content and/or skin irritation/sensitization testing with respect to the reference formulation. This paper intends to highlight critical in vitro tests in assessing the therapeutic equivalence of products and also outlines their valuable applications in generic product success. Understanding these critical in vitro parameters can probably help to decode the complex bioequivalence outcomes, directing the generic companies to optimize the formulation design in reduced time intervals. It is difficult to summarize a common platform which covers all possible transdermal products; hence few case studies based on this approach has been presented in this review.

Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

PubMed

Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

2016-01-01

Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

Computing Lives And Reliabilities Of Turboprop Transmissions

NASA Technical Reports Server (NTRS)

Coy, J. J.; Savage, M.; Radil, K. C.; Lewicki, D. G.

1991-01-01

Computer program PSHFT calculates lifetimes of variety of aircraft transmissions. Consists of main program, series of subroutines applying to specific configurations, generic subroutines for analysis of properties of components, subroutines for analysis of system, and common block. Main program selects routines used in analysis and causes them to operate in desired sequence. Series of configuration-specific subroutines put in configuration data, perform force and life analyses for components (with help of generic component-property-analysis subroutines), fill property array, call up system-analysis routines, and finally print out results of analysis for system and components. Written in FORTRAN 77(IV).

Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: A real-life observational study.

PubMed

Zeng, Qing-Lei; Xu, Guang-Hua; Zhang, Ji-Yuan; Li, Wei; Zhang, Da-Wei; Li, Zhi-Qin; Liang, Hong-Xia; Li, Chun-Xia; Yu, Zu-Jiang

2017-06-01

Few patients from developing countries can afford brand name direct-acting antiviral agents for treating hepatitis C virus (HCV) infection, and controversy regarding the bioequivalence of generics exists. This study aimed to observe the safety and efficacy of 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin for Chinese genotype 1b HCV-infected patients. In this open-labelled observational study, 63 cirrhotic (group 1) and 65 non-cirrhotic (group 2) patients were administered generic ledipasvir-sofosbuvir plus 1000-1200mg of ribavirin daily for 12 and 8weeks, respectively; and 64 non-cirrhotic patients (group 3) received ledipasvir-sofosbuvir for 8weeks. The primary efficacy endpoint was undetectable HCV RNA at week 12 (SVR12) after cessation of therapy. Safety and pharmacokinetic data were collected. One hundred and eighty-seven patients completed treatment, and the latest undetectable HCV RNA was observed in three patients with cirrhosis at week 5 during treatment. Intention-to-treat analysis revealed 96.8% (61/63), 96.9% (63/65), and 96.9% (62/64) of SVR12 rates in groups 1, 2, and 3, respectively. One patient in group 3 relapsed at post-treatment week 4. The regimens were generally well-tolerated. The most common adverse events were fatigue (17.8%), diarrhea (10.9%), and headache (9.9%). Four patients discontinued therapy due to diarrhea and vomiting. One patient from group 2 discontinued treatment on day 29 because of drug-unaffordability; fortunately, she achieved SVR12. This study demonstrated that 8 or 12weeks of generic ledipasvir-sofosbuvir with or without ribavirin are safe and effective for patients with genotype 1b HCV infection. The price of Harvoni® has led to restrictions and access limitations in many developing and even developed countries with limited healthcare budgets. Gilead approved generic ledipasvir-sofosbuvir costs far less than Harvoni® and presents a similar cure rate for patients with chronic hepatitis C. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

A generic model for evaluating payor net cost savings from a disease management program.

PubMed

McKay, Niccie L

2006-01-01

Private and public payors increasingly are turning to disease management programs as a means of improving the quality of care provided and controlling expenditures for individuals with specific medical conditions. This article presents a generic model that can be adapted to evaluate payor net cost savings from a variety of types of disease management programs, with net cost savings taking into account both changes in expenditures resulting from the program and the costs of setting up and operating the program. The model specifies the required data, describes the data collection process, and shows how to calculate the net cost savings in a spreadsheet format. An accompanying hypothetical example illustrates how to use the model.

Nuclear Criticality Safety Data Book

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

Hollenbach, D. F.

The objective of this document is to support the revision of criticality safety process studies (CSPSs) for the Uranium Processing Facility (UPF) at the Y-12 National Security Complex (Y-12). This design analysis and calculation (DAC) document contains development and justification for generic inputs typically used in Nuclear Criticality Safety (NCS) DACs to model both normal and abnormal conditions of processes at UPF to support CSPSs. This will provide consistency between NCS DACs and efficiency in preparation and review of DACs, as frequently used data are provided in one reference source.

40 CFR 721.10029 - Isocyanate compound, modified with methoxysilane (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... to those contained in the corresponding section 5(e) consent order. (ii) Hazard communication program...) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate compound, modified with methoxysilane (PMN P-01-918) is subject to reporting under...

GENERIC VERIFICATION PROTOCOL FOR THE VERIFICATION OF PESTICIDE SPRAY DRIFT REDUCTION TECHNOLOGIES FOR ROW AND FIELD CROPS

EPA Science Inventory

This ETV program generic verification protocol was prepared and reviewed for the Verification of Pesticide Drift Reduction Technologies project. The protocol provides a detailed methodology for conducting and reporting results from a verification test of pesticide drift reductio...

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...

76 FR 74802 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

.... Currie, Program Analyst, Office of policy for Extramural Research Administration, 6705 Rockledge Drive... perceptions and opinions, but are not statistical surveys that yield quantitative results that can be... generic clearance for qualitative information will not be used for quantitative information collections...

Modeling Increased Complexity and the Reliance on Automation: FLightdeck Automation Problems (FLAP) Model

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

This paper highlights the development of a model that is focused on the safety issue of increasing complexity and reliance on automation systems in transport category aircraft. Recent statistics show an increase in mishaps related to manual handling and automation errors due to pilot complacency and over-reliance on automation, loss of situational awareness, automation system failures and/or pilot deficiencies. Consequently, the aircraft can enter a state outside the flight envelope and/or air traffic safety margins which potentially can lead to loss-of-control (LOC), controlled-flight-into-terrain (CFIT), or runway excursion/confusion accidents, etc. The goal of this modeling effort is to provide NASA's Aviation Safety Program (AvSP) with a platform capable of assessing the impacts of AvSP technologies and products towards reducing the relative risk of automation related accidents and incidents. In order to do so, a generic framework, capable of mapping both latent and active causal factors leading to automation errors, is developed. Next, the framework is converted into a Bayesian Belief Network model and populated with data gathered from Subject Matter Experts (SMEs). With the insertion of technologies and products, the model provides individual and collective risk reduction acquired by technologies and methodologies developed within AvSP.

Descriptive Model of Generic WAMS

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

Hauer, John F.; DeSteese, John G.

The Department of Energy’s (DOE) Transmission Reliability Program is supporting the research, deployment, and demonstration of various wide area measurement system (WAMS) technologies to enhance the reliability of the Nation’s electrical power grid. Pacific Northwest National Laboratory (PNNL) was tasked by the DOE National SCADA Test Bed Program to conduct a study of WAMS security. This report represents achievement of the milestone to develop a generic WAMS model description that will provide a basis for the security analysis planned in the next phase of this study.

Commercial Generic Bioprocessing Apparatus Science Insert - 03

NASA Technical Reports Server (NTRS)

Moreno, Nancy; Stodieck, Louis; Cushing, Paula; Stowe, Mark; Hamilton, Mary Ann; Werner, Ken

2008-01-01

Commercial Generic Bioprocessing Apparatus Science Insert - 03 (CSI-03) is the third set of investigations in the CSI program series. The CSI program provides the K-12 community opportunities to utilize the unique microgravity environment of the International Space Station as part of the regular classroom to encourage learning and interest in science, technology, engineering and math. CSI-03 will examine the complete life cycle of the painted lady butterfly and the ability of an orb weaving spider to spin a web, eat and remain healthy in space.

Stay Alive--Simulation for Situational Safety Awareness

NASA Technical Reports Server (NTRS)

Ruder, Michelle

2008-01-01

STAY ALIVE is an idea for a safety awareness simulation prototype, powered by gaming technology, that would make safety training enlightening, engaging and fun. Recalling initial instructions and using situational awareness principles, participants would escape a fire by choosing the appropriate door. Escape times would be measured while stressors increased. This presentation describes how STAY ALIVE utilizes first person point of view (PoV), a generic scenario, immersion- and presence-enhancing design, and ease of distribution to provide more people opportunity to realize, review, analyze and practice effective awareness behaviors. The goals for this prototype include facilitating interest in first-person PoV safety training and eliciting further suggestions on prevention technologies.

Deep Borehole Disposal Safety Analysis.

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

Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

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…

78 FR 23743 - Proposed Information Collection; Comment Request; Generic Clearance for Questionnaire Pretesting...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-22

...; Generic Clearance for Questionnaire Pretesting Research AGENCY: Census Bureau, Commerce. ACTION: Notice.... This research program will be used by the Census Bureau and survey sponsors to improve questionnaires... involve one of the following methods of identifying measurement problems with the questionnaire or survey...

76 FR 75809 - Prior Label Approval System: Generic Label Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... tracking and reporting systems; and (4) design and implement a survey of the effects of the limited generic... and poultry product inspection programs designed to assure consumers that meat and poultry products... mandatory features are designed to ensure that meat and poultry products are accurately and truthfully...

ORE's GENeric Evaluation SYStem: GENESYS 1988-89.

ERIC Educational Resources Information Center

Baenen, Nancy; And Others

GENESYS--GENeric Evaluation SYStem--is a method of streamlining data collection and evaluation through the use of computer technology. GENESYS has allowed the Office of Research and Evaluation (ORE) of the Austin (Texas) Independent School District to evaluate a multitude of contrasting programs with limited resources. By standardizing methods and…

Environmental Technology Verification Program Materials Management and Remediation Center Generic Protocol for Verification of In Situ Chemical Oxidation

EPA Science Inventory

The protocol provides generic procedures for implementing a verification test for the performance of in situ chemical oxidation (ISCO), focused specifically to expand the application of ISCO at manufactured gas plants with polyaromatic hydrocarbon (PAH) contamination (MGP/PAH) an...

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.

Evaluating community pharmacists' perspectives and practices concerning generic medicines substitution in Saudi Arabia: A cross-sectional study.

PubMed

Alkhuzaee, Fahad S; Almalki, Hamdan M; Attar, Ammar Y; Althubiani, Shoeab I; Almuallim, Wassam Ali; Cheema, Ejaz; Hadi, Muhammad Abdul

2016-12-01

To assess the community pharmacists' knowledge, attitude, perception and current practices towards generic medicines substitution in Saudi Arabia. A cross-sectional study was conducted between February and March 2016 in the Makkah region, Saudi Arabia. A 25-item, structured, validated, pilot-tested and self-completed questionnaire was used to achieve study objectives. A 4-step systematic sampling technique was used to recruit community pharmacists. Data were analysed using SPSS version 20. Of 128 community pharmacists approached, 121 participated in the study (response rate=95%). Majority of the participants (n=108; 89.3%) had graduated from Egypt, were working as staff pharmacists (n=85; 70%) and had BPharm degree (97; 80.2%). Only 26 (22%) of the participants correctly answered all knowledge questions accurately. No statistically significant difference in total knowledge score was observed across different sociodemographic characteristics of participants (all P>0.05).Two-thirds of the respondents (83; 68.2%) supported the use of generic substitution. Medicines cost and patients' request were the most commonly cited reasons for performing generic substitution. Country of graduation (P=0.01) and number of years of practicing in Saudi Arabia (P=0.02) was associated with the pharmacists' support towards generic substitution. The community pharmacists had clear knowledge deficits about generic medicines and their substitution which may partly explain low consumption of generic medicines in Saudi Arabia. Healthcare policy makers need to improve awareness about the safety and efficacy of generic medicines and promote their use in order to cut down cost of medicines and overall healthcare expenditure. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Automatically producing tailored web materials for public administration

NASA Astrophysics Data System (ADS)

Colineau, Nathalie; Paris, Cécile; Vander Linden, Keith

2013-06-01

Public administration organizations commonly produce citizen-focused, informational materials describing public programs and the conditions under which citizens or citizen groups are eligible for these programs. The organizations write these materials for generic audiences because of the excessive human resource costs that would be required to produce personalized materials for everyone. Unfortunately, generic materials tend to be longer and harder to understand than materials tailored for particular citizens. Our work explores the feasibility and effectiveness of automatically producing tailored materials. We have developed an adaptive hypermedia application system that automatically produces tailored informational materials and have evaluated it in a series of studies. The studies demonstrate that: (1) subjects prefer tailored materials over generic materials, even if the tailoring requires answering a set of demographic questions first; (2) tailored materials are more effective at supporting subjects in their task of learning about public programs; and (3) the time required to specify the demographic information on which the tailoring is based does not significantly slow down the subjects in their information seeking task.

Need for multicriteria evaluation of generic drug policies.

PubMed

Kaló, Zoltán; Holtorf, Anke-Peggy; Alfonso-Cristancho, Rafael; Shen, Jie; Ágh, Tamás; Inotai, András; Brixner, Diana

2015-03-01

Policymakers tend to focus on improving patented drug policies because they are under pressure from patients, physicians, and manufacturers to increase access to novel therapies. The success of pharmaceutical innovation over the last few decades has led to the availability of many off-patent drugs to treat disease areas with the greatest public health need. Therefore, the success of public health programs in improving the health status of the total population is highly dependent on the efficiency of generic drug policies. The objective of this article was to explore factors influencing the true efficiency of generic prescription drug policies in supporting public health initiatives in the developed world. Health care decision makers often assess the efficiency of generic drug policies by the level of price erosion and market share of generics. Drug quality, bioequivalence, in some cases drug formulations, supply reliability, medical adherence and persistence, health outcomes, and nondrug costs, however, are also attributes of success for generic drug policies. Further methodological research is needed to measure and improve the efficiency of generic drug policies. This also requires extension of the evidence base of the impact of generic drugs, partly based on real-world evidence. Multicriteria decision analysis may assist policymakers and researchers to evaluate the true value of generic drugs. Copyright © 2015. Published by Elsevier Inc.

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

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.

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

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

Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease

PubMed Central

Kesselheim, Aaron S.; Misono, Alexander S.; Lee, Joy L.; Stedman, Margaret R.; Brookhart, M. Alan; Choudhry, Niteesh K.; Shrank, William H.

2009-01-01

Context Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. Objectives To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Study Selection Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors’ positions on generic substitution as negative, positive, or neutral. Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs. PMID:19050195

Automating Embedded Analysis Capabilities and Managing Software Complexity in Multiphysics Simulation, Part II: Application to Partial Differential Equations

DOE PAGES

Pawlowski, Roger P.; Phipps, Eric T.; Salinger, Andrew G.; ...

2012-01-01

A template-based generic programming approach was presented in Part I of this series of papers [Sci. Program. 20 (2012), 197–219] that separates the development effort of programming a physical model from that of computing additional quantities, such as derivatives, needed for embedded analysis algorithms. In this paper, we describe the implementation details for using the template-based generic programming approach for simulation and analysis of partial differential equations (PDEs). We detail several of the hurdles that we have encountered, and some of the software infrastructure developed to overcome them. We end with a demonstration where we present shape optimization and uncertaintymore » quantification results for a 3D PDE application.« less

Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

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

Curtis Smith; Diego Mandelli

Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very highmore » degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. As the lead Department of Energy (DOE) Laboratory for this Pathway, the Idaho National Laboratory (INL) is tasked with developing and deploying methods and tools that support the quantification and management of safety margin and uncertainty.« less

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...

75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381... fee program. The number of human generic drug applications awaiting FDA action and the median review... needed for presentations, FDA reserves the right to terminate the meeting early. If you need special...

40 CFR Appendix A1 to Subpart F of... - Generic Maximum Contaminant Levels

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 18 2012-07-01 2012-07-01 false Generic Maximum Contaminant Levels A1 Appendix A1 to Subpart F of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction Pt. 82...

40 CFR Appendix A1 to Subpart F of... - Generic Maximum Contaminant Levels

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Generic Maximum Contaminant Levels A1 Appendix A1 to Subpart F of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction Pt. 82...

40 CFR Appendix A1 to Subpart F of... - Generic Maximum Contaminant Levels

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 18 2013-07-01 2013-07-01 false Generic Maximum Contaminant Levels A1 Appendix A1 to Subpart F of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction Pt. 82...

40 CFR Appendix A1 to Subpart F of... - Generic Maximum Contaminant Levels

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Generic Maximum Contaminant Levels A1 Appendix A1 to Subpart F of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction Pt. 82...

40 CFR Appendix A1 to Subpart F of... - Generic Maximum Contaminant Levels

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Generic Maximum Contaminant Levels A1 Appendix A1 to Subpart F of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Recycling and Emissions Reduction Pt. 82...

TRAC-BF1 thermal-hydraulic, ANSYS stress analysis for core shroud cracking phenomena

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

Shoop, U.; Feltus, M.A.; Baratta, A.J.

1996-12-31

The U.S. Nuclear Regulatory Commission sent Generic Letter 94-03 informing all licensees about the intergranular stress corrosion cracking (IGSCC) of core shrouds found in both Dresden unit I and Quad Cities unit 1. The letter directed all licensees to perform safety analysis of their boiling water reactor (BWR) units. Two transients of special concern for the core shroud safety analysis include the main steam line break (MSLB) and recirculation line break transient.

ASSIP Study of Real-Time Safety-Critical Embedded Software-Intensive System Engineering Practices

DTIC Science & Technology

2008-02-01

and assessment 2. product engineering processes 3. tooling processes 6 | CMU/SEI-2008-SR-001 Slide 1 Process Standards IEC/ ISO 12207 Software...and technical effort to align with 12207 IEC/ ISO 15026 System & Software Integrity Levels Generic Safety SAE ARP 4754 Certification Considerations...Process Frameworks in revision – ISO 9001, ISO 9004 – ISO 15288/ ISO 12207 harmonization – RTCA DO-178B, MOD Standard UK 00-56/3, … • Methods & Tools

Space Generic Open Avionics Architecture (SGOAA): Overview

NASA Technical Reports Server (NTRS)

Wray, Richard B.; Stovall, John R.

1992-01-01

A space generic open avionics architecture created for NASA is described. It will serve as the basis for entities in spacecraft core avionics, capable of being tailored by NASA for future space program avionics ranging from small vehicles such as Moon ascent/descent vehicles to large ones such as Mars transfer vehicles or orbiting stations. The standard consists of: (1) a system architecture; (2) a generic processing hardware architecture; (3) a six class architecture interface model; (4) a system services functional subsystem architectural model; and (5) an operations control functional subsystem architectural model.

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.

[The patents game. Generic and biosimilar drugs].

PubMed

Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

2016-01-01

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

ACE Inhibitor and ARB utilization and expenditures in the Medicaid fee-for-service program from 1991 to 2008.

PubMed

Bian, Boyang; Kelton, Christina M L; Guo, Jeff J; Wigle, Patricia R

2010-01-01

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are widely prescribed for the treatment of hypertension and heart failure, as well as for kidney disease prevention in patients with diabetes mellitus and the management of patients after myocardial infarction. To (a) describe ACE inhibitor and ARB utilization and spending in the Medicaid fee-for-service program from 1991 through 2008, and (b) estimate the potential cost savings for the collective Medicaid programs from a higher ratio of generic ACE inhibitor utilization. A retrospective, descriptive analysis was performed using the National Summary Files from the Medicaid State Drug Utilization Data, which are composed of pharmacy claims that are subject to federally mandated rebates from pharmaceutical manufacturers. For the years 1991-2008, quarterly claim counts and expenditures were calculated by summing data for individual ACE inhibitors and ARBs. Quarterly per-claim expenditure as a proxy for drug price was computed for all brand and generic drugs. Market shares were calculated based on the number of pharmacy claims and Medicaid expenditures. In the Medicaid fee-for-service program, ACE inhibitors accounted for 100% of the claims in the combined market for ACE inhibitors and ARBs in 1991, 80.6% in 2000, and 64.7% in 2008. The Medicaid expenditure per ACE inhibitor claim dropped from $37.24 in 1991 to $24.03 in 2008 when generics accounted for 92.5% of ACE inhibitor claims; after adjusting for inflation for the period from 1991 to 2008, the real price drop was 59.2%. Brand ACE inhibitors accounted for only 7.5% of the claims in 2008 for all ACE inhibitors but 32.1% of spending; excluding the effects of manufacturer rebates, Medicaid spending would have been reduced by $28.7 million (9%) in 2008 if all ACE inhibitor claims were generic. The average price per ACE inhibitor claim in 2008 was $24.03 ($17.64 per generic claim vs. $103.45 per brand claim) versus $81.98 per ARB claim. If the ACE inhibitor ratio had been 75% in 2008 rather than 64.7%, the Medicaid program would have saved approximately 13% or about $41.8 million, again excluding the effects of manufacturer rebates. If the ACE inhibitor ratio had been 90% in 2008, the cost savings for the combined Medicaid fee-forservice programs would have been about 33% or about $102.3 million. The total cost savings opportunity with 100% generic ACE inhibitor utilization in 2008 and an ACE inhibitor ratio of 75% was $75.1 million (24%) or $142.3M (46%) with a 90% ACE inhibitor ratio. Factors that affect Medicaid spending by contributing to increased utilization of ACE inhibitors and ARBs, such as the rising prevalence of hypertension, heart disease, and diabetes, can be offset by reduction in the average price attained through a higher proportion of ACE inhibitors and a higher percentage of generic versus brand ACE inhibitors.

Printing Our Way to Safety: Applications of 3-D Printing in Lockout/Tagout

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

Clark, Phil; Bender, Guido

2016-12-01

This article describes how a team at the National Renewable Energy Laboratory used 3-D printing to manufacture custom lockout/tagout devices to isolate valves that were clustered too tightly to allow for generic lockout/tagout devices to be used.

Asymptotic safety of gravity-matter systems

NASA Astrophysics Data System (ADS)

Meibohm, J.; Pawlowski, J. M.; Reichert, M.

2016-04-01

We study the ultraviolet stability of gravity-matter systems for general numbers of minimally coupled scalars and fermions. This is done within the functional renormalization group setup put forward in [N. Christiansen, B. Knorr, J. Meibohm, J. M. Pawlowski, and M. Reichert, Phys. Rev. D 92, 121501 (2015).] for pure gravity. It includes full dynamical propagators and a genuine dynamical Newton's coupling, which is extracted from the graviton three-point function. We find ultraviolet stability of general gravity-fermion systems. Gravity-scalar systems are also found to be ultraviolet stable within validity bounds for the chosen generic class of regulators, based on the size of the anomalous dimension. Remarkably, the ultraviolet fixed points for the dynamical couplings are found to be significantly different from those of their associated background counterparts, once matter fields are included. In summary, the asymptotic safety scenario does not put constraints on the matter content of the theory within the validity bounds for the chosen generic class of regulators.

The use of mental models in chemical risk protection: developing a generic workplace methodology.

PubMed

Cox, Patrick; Niewöhmer, Jörg; Pidgeon, Nick; Gerrard, Simon; Fischhoff, Baruch; Riley, Donna

2003-04-01

We adopted a comparative approach to evaluate and extend a generic methodology to analyze the different sets of beliefs held about chemical hazards in the workplace. Our study mapped existing knowledge structures about the risks associated with the use of perchloroethylene and rosin-based solder flux in differing workplaces. "Influence diagrams" were used to represent beliefs held by chemical experts; "user models" were developed from data elicited from open-ended interviews with the workplace users of the chemicals. The juxtaposition of expert and user understandings of chemical risks enabled us to identify knowledge gaps and misunderstandings and to reinforce appropriate sets of safety beliefs and behavior relevant to chemical risk communications. By designing safety information to be more relevant to the workplace context of users, we believe that employers and employees may gain improved knowledge about chemical hazards in the workplace, such that better chemical risk management, self-protection, and informed decision making develop over time.

Services provided by community pharmacies in Wayne County, Michigan: a comparison by ZIP code characteristics.

PubMed

Erickson, Steven R; Workman, Paul

2014-01-01

To document the availability of selected pharmacy services and out-of-pocket cost of medication throughout a diverse county in Michigan and to assess possible associations between availability of services and price of medication and characteristics of residents of the ZIP codes in which the pharmacies were located. Cross-sectional telephone survey of pharmacies coupled with ZIP code-level census data. 503 pharmacies throughout the 63 ZIP codes of Wayne County, MI. The out-of-pocket cost for a 30 days' supply of levothyroxine 50 mcg and brand-name atorvastatin (Lipitor-Pfizer) 20 mg, availability of discount generic drug programs, home delivery of medications, hours of pharmacy operation, and availability of pharmacy-based immunization services. Census data aggregated at the ZIP code level included race, annual household income, age, and number of residents per pharmacy. The overall results per ZIP code showed that the average cost for levothyroxine was $10.01 ± $2.29 and $140.45 + $14.70 for Lipitor. Per ZIP code, the mean (± SD) percentages of pharmacies offering discount generic drug programs was 66.9% ± 15.0%; home delivery of medications was 44.5% ± 22.7%; and immunization for influenza was 46.7% ± 24.3% of pharmacies. The mean (± SD) hours of operation per pharmacy per ZIP code was 67.0 ± 25.2. ZIP codes with higher household income as well as higher percentage of residents being white had lower levothyroxine price, greater percentage of pharmacies offering discount generic drug programs, more hours of operation per week, and more pharmacy-based immunization services. The cost of Lipitor was not associated with any ZIP code characteristic. Disparities in the cost of generic levothyroxine, the availability of services such as discount generic drug programs, hours of operation, and pharmacy-based immunization services are evident based on race and household income within this diverse metropolitan county.

State generic substitution laws can lower drug outlays under Medicaid.

PubMed

Shrank, William H; Choudhry, Niteesh K; Agnew-Blais, Jessica; Federman, Alex D; Liberman, Joshua N; Liu, Jun; Kesselheim, Aaron S; Brookhart, M Alan; Fischer, Michael A

2010-07-01

To stem the rising costs of medications provided to patients enrolled in Medicaid, states have implemented varying policies about generic substitution. These policies differ in the extent to which pharmacists or patients can influence which medications they choose. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and the use of generic simvastatin, a cholesterol-lowering drug, after the patent for the brand-name equivalent, Zocor, expired. States that implemented policies requiring patients' consent prior to generic substitution experienced rates of substitution that were 25 percent lower than those of states that did not require patient consent. By eliminating patient consent requirements, state Medicaid programs could expect to save more than $100 million in coverage for three top-selling medications that are nearing patent expiration. Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs.

Economic savings versus health losses: The cost-effectiveness of generic antiretroviral therapy in the United States

PubMed Central

Walensky, Rochelle P.; Sax, Paul E.; Nakamura, Yoriko M.; Weinstein, Milton C.; Pei, Pamela P.; Freedberg, Kenneth A.; Paltiel, A. David; Schackman, Bruce R.

2013-01-01

Background US HIV treatment guidelines recommend branded once-daily, one-pill efavirenz/emtricitabine/tenofovir as preferred first-line antiretroviral treatment (ART). With the anticipated approval of generic efavirenz in 2012 in the US, the cost of a once-daily, three-pill alternative (generic efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and virologic suppression may be reduced. Objectives To assess the clinical impact, costs, and cost-effectiveness of the generic-based three-pill regimen compared to the branded, co-formulated regimen. To project the potential national savings in the first year of a switch to generic-based ART. Design Mathematical simulation of HIV disease. Data Sources Published data from US clinical trials and observational cohorts. Target Population HIV-infected patients eligible to start on or switch to an efavirenz-based generic ART regimen. Time Horizon Lifetime, One-year Perspective US health system Interventions No ART (for comparison), Three-pill Generic ART, and Branded ART Outcome Measures Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICER, $/quality-adjusted life expectancy [QALY]). Results of Base-Case Analysis Compared to No ART, Generic ART has an ICER of $21,100/QALY. Compared to Generic ART, Branded ART increases lifetime costs by $42,500, and per-person survival gains by 0.37 QALYs, for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible US patients start on or switch to Generic ART, are $920 million. Results of Sensitivity Analysis Most plausible assumptions about Generic ART efficacy and costs lead to Branded ART ICERs >$100,000/QALY. Limitations The efficacy and price reduction associated with generics are unknown; estimates are intended to be conservative. Conclusions Compared to a slightly less effective generic-based regimen, the cost-effectiveness of first-line Branded ART exceeds $100,000/QALY. Generic-based ART in the US could yield substantial budgetary savings to HIV programs. PMID:23318310

Preparing for the workplace: fostering generic attributes in allied health education programs.

PubMed

Higgs, J; Hunt, A

1999-01-01

Allied health curricula need to extend beyond the learning of discipline-specific skills to encompass broader learning goals. In particular, the acquisition of generic skills is necessary to enable graduates to function more competently and confidently within their rapidly changing work, professional, and societal environments. In health sciences education particularly, the rate of change in practice and education is rapid and unprecedented. If educators focus on components of the curriculum rather than the entire learning experience, they are likely to significantly limit the students' acquisition of such generic skills. To achieve the desired generic skills outcomes, an overarching, integrated, and consistently applied curriculum strategy is advocated. This article considers a number of such strategies relevant to allied health education.

40 CFR Table 5 to Subpart Fff of... - Generic Compliance Schedules and Increments of Progress

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 8 2010-07-01 2010-07-01 false Generic Compliance Schedules and Increments of Progress 5 Table 5 to Subpart FFF of Part 62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS Federal Plan...

40 CFR Table 5 to Subpart Fff of... - Generic Compliance Schedules and Increments of Progress

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 8 2011-07-01 2011-07-01 false Generic Compliance Schedules and Increments of Progress 5 Table 5 to Subpart FFF of Part 62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS Federal Plan...

40 CFR 721.3025 - Fatty acids C12-18, C18 unsaturated, C12-18 alkyl esters (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

..., C12-18 alkyl esters (generic). 721.3025 Section 721.3025 Protection of Environment ENVIRONMENTAL... communication program. A significant new use of these substances is any manner or method of manufacture, import, or processing associated with any use of these substances without providing risk notification as...

40 CFR Table 5 to Subpart Fff of... - Generic Compliance Schedules and Increments of Progress

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 9 2012-07-01 2012-07-01 false Generic Compliance Schedules and Increments of Progress 5 Table 5 to Subpart FFF of Part 62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS Federal Plan...

40 CFR Table 5 to Subpart Fff of... - Generic Compliance Schedules and Increments of Progress

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 9 2014-07-01 2014-07-01 false Generic Compliance Schedules and Increments of Progress 5 Table 5 to Subpart FFF of Part 62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS Federal Plan...

40 CFR Table 5 to Subpart Fff of... - Generic Compliance Schedules and Increments of Progress

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 9 2013-07-01 2013-07-01 false Generic Compliance Schedules and Increments of Progress 5 Table 5 to Subpart FFF of Part 62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS Federal Plan...

The Challenges of Introducing a Generic Graduate Skills Unit into a Business Degree in Malaysia

ERIC Educational Resources Information Center

Stein, Andrew; Licciardi, Raquel

2012-01-01

The School of Management and Information Systems at Victoria University Australia resides within the Business Faculty and has a range of Management and Information Systems degrees. In 2008 all degree programs in the Business Faculty introduced a compulsory generic graduate skills unit that focussed on problem-solving, critical thinking,…

75 FR 41392 - Sorghum Promotion and Research Program: Procedures for the Conduct of Referenda

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-16

... Programs Branch, Livestock and Seed Program, AMS, USDA, Room 2628-S, STOP 0251, 1400 Independence Avenue... to consider industry proposals for generic programs of promotion, research, and information for... through industry-funded, Government-supervised, commodity promotion programs. Section 518 of the Act...

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2015-10-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activaties are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focalizing on the input structure.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2016-02-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by input files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focusing on the input structure.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2017-03-01

RAVEN is a generic software framework to perform parametric and probabilistic analy- sis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncer- tainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters thatmore » need to be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused to- ward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is in- terested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assess- ment capability to RELAP-7, currently under develop-ment at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with soft- ware such as RELAP5-3D, etc. The aim of this document is the explaination of the input requirements, focalizing on the input structure.« less

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

PubMed

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

DTIC Science & Technology

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

Driver compliance to take-over requests with different auditory outputs in conditional automation.

PubMed

Forster, Yannick; Naujoks, Frederik; Neukum, Alexandra; Huestegge, Lynn

2017-12-01

Conditionally automated driving (CAD) systems are expected to improve traffic safety. Whenever the CAD system exceeds its limit of operation, designers of the system need to ensure a safe and timely enough transition from automated to manual mode. An existing visual Human-Machine Interface (HMI) was supplemented by different auditory outputs. The present work compares the effects of different auditory outputs in form of (1) a generic warning tone and (2) additional semantic speech output on driver behavior for the announcement of an upcoming take-over request (TOR). We expect the information carried by means of speech output to lead to faster reactions and better subjective evaluations by the drivers compared to generic auditory output. To test this assumption, N=17 drivers completed two simulator drives, once with a generic warning tone ('Generic') and once with additional speech output ('Speech+generic'), while they were working on a non-driving related task (NDRT; i.e., reading a magazine). Each drive incorporated one transition from automated to manual mode when yellow secondary lanes emerged. Different reaction time measures, relevant for the take-over process, were assessed. Furthermore, drivers evaluated the complete HMI regarding usefulness, ease of use and perceived visual workload just after experiencing the take-over. They gave comparative ratings on usability and acceptance at the end of the experiment. Results revealed that reaction times, reflecting information processing time (i.e., hands on the steering wheel, termination of NDRT), were shorter for 'Speech+generic' compared to 'Generic' while reaction time, reflecting allocation of attention (i.e., first glance ahead), did not show this difference. Subjective ratings were in favor of the system with additional speech output. Copyright © 2017 Elsevier Ltd. All rights reserved.

The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function.

PubMed

Momper, J D; Ridenour, T A; Schonder, K S; Shapiro, R; Humar, A; Venkataramanan, R

2011-09-01

Bioequivalence of the recently available generic tacrolimus formulation, manufactured by Sandoz, to the reference product (Prograf; Astellas Pharma, Tokyo, Japan) has been demonstrated in healthy subjects. However, the safety and efficacy of substitution with generic tacrolimus in transplant patients have not been evaluated. Tacrolimus trough concentrations and indices of liver and kidney function were recorded before and after generic substitution in 48 liver and 55 kidney transplant recipients. In liver transplant patients, the mean tacrolimus concentration/dose (C/D) ratio (± SD) was 184.1 (± 123.2) ([ng/mL]/[mg/kg/day]) for the reference product and 154.7 (± 87.8) ([ng/mL]/[mg/kg/day]) for the generic product (p < 0.05). The mean C/D-ratios in kidney transplant patients were 125.3 (± 92.7) and 110.4 (± 79.2) ([ng/mL]/[mg/kg/day]) for the reference and generic products, respectively (p < 0.05). Actual trough concentrations declined by an average of 1.98 ng/mL in liver and 0.87 ng/mL in kidney transplant patients following the switch, after accounting for all significant covariates. No change was observed in biochemical indices of liver or kidney function and no cases of acute rejection occurred following the substitution. These results suggest that transplant patients currently taking the reference tacrolimus formulation may be safely switched to the Sandoz-generic product provided trough concentrations are closely monitored following the substitution. © 2011 The Authors Journal compilation © 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.

A discussion on the methodology for calculating radiological and toxicological consequences for the spent nuclear fuel project at the Hanford Site

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

RITTMANN, P.D.

1999-07-14

This report contains technical information used to determine accident consequences for the Spent Nuclear Fuel Project safety documents. It does not determine accident consequences or describe specific accident scenarios, but instead provides generic information.

A portable MPI-based parallel vector template library

NASA Technical Reports Server (NTRS)

Sheffler, Thomas J.

1995-01-01

This paper discusses the design and implementation of a polymorphic collection library for distributed address-space parallel computers. The library provides a data-parallel programming model for C++ by providing three main components: a single generic collection class, generic algorithms over collections, and generic algebraic combining functions. Collection elements are the fourth component of a program written using the library and may be either of the built-in types of C or of user-defined types. Many ideas are borrowed from the Standard Template Library (STL) of C++, although a restricted programming model is proposed because of the distributed address-space memory model assumed. Whereas the STL provides standard collections and implementations of algorithms for uniprocessors, this paper advocates standardizing interfaces that may be customized for different parallel computers. Just as the STL attempts to increase programmer productivity through code reuse, a similar standard for parallel computers could provide programmers with a standard set of algorithms portable across many different architectures. The efficacy of this approach is verified by examining performance data collected from an initial implementation of the library running on an IBM SP-2 and an Intel Paragon.

A Portable MPI-Based Parallel Vector Template Library

NASA Technical Reports Server (NTRS)

Sheffler, Thomas J.

1995-01-01

This paper discusses the design and implementation of a polymorphic collection library for distributed address-space parallel computers. The library provides a data-parallel programming model for C + + by providing three main components: a single generic collection class, generic algorithms over collections, and generic algebraic combining functions. Collection elements are the fourth component of a program written using the library and may be either of the built-in types of c or of user-defined types. Many ideas are borrowed from the Standard Template Library (STL) of C++, although a restricted programming model is proposed because of the distributed address-space memory model assumed. Whereas the STL provides standard collections and implementations of algorithms for uniprocessors, this paper advocates standardizing interfaces that may be customized for different parallel computers. Just as the STL attempts to increase programmer productivity through code reuse, a similar standard for parallel computers could provide programmers with a standard set of algorithms portable across many different architectures. The efficacy of this approach is verified by examining performance data collected from an initial implementation of the library running on an IBM SP-2 and an Intel Paragon.

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital

PubMed Central

Calligaris, Laura; Panzera, Angela; Arnoldo, Luca; Londero, Carla; Quattrin, Rosanna; Troncon, Maria G; Brusaferro, Silvio

2009-01-01

Background The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. Methods The point prevalence survey, carried out in May 26–30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Results Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD ± 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. Conclusion The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections. Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produce. PMID:19439066

Errors and omissions in hospital prescriptions: a survey of prescription writing in a hospital.

PubMed

Calligaris, Laura; Panzera, Angela; Arnoldo, Luca; Londero, Carla; Quattrin, Rosanna; Troncon, Maria G; Brusaferro, Silvio

2009-05-13

The frequency of drug prescription errors is high. Excluding errors in decision making, the remaining are mainly due to order ambiguity, non standard nomenclature and writing illegibility. The aim of this study is to analyse, as a part of a continuous quality improvement program, the quality of prescriptions writing for antibiotics, in an Italian University Hospital as a risk factor for prescription errors. The point prevalence survey, carried out in May 26-30 2008, involved 41 inpatient Units. Every parenteral or oral antibiotic prescription was analysed for legibility (generic or brand drug name, dose, frequency of administration) and completeness (generic or brand name, dose, frequency of administration, route of administration, date of prescription and signature of the prescriber). Eight doctors (residents in Hygiene and Preventive Medicine) and two pharmacists performed the survey by reviewing the clinical records of medical, surgical or intensive care section inpatients. The antibiotics drug category was chosen because its use is widespread in the setting considered. Out of 756 inpatients included in the study, 408 antibiotic prescriptions were found in 298 patients (mean prescriptions per patient 1.4; SD +/- 0.6). Overall 92.7% (38/41) of the Units had at least one patient with antibiotic prescription. Legibility was in compliance with 78.9% of generic or brand names, 69.4% of doses, 80.1% of frequency of administration, whereas completeness was fulfilled for 95.6% of generic or brand names, 76.7% of doses, 83.6% of frequency of administration, 87% of routes of administration, 43.9% of dates of prescription and 33.3% of physician's signature. Overall 23.9% of prescriptions were illegible and 29.9% of prescriptions were incomplete. Legibility and completeness are higher in unusual drugs prescriptions. The Intensive Care Section performed best as far as quality of prescription writing was concerned when compared with the Medical and Surgical Sections.Nevertheless the overall illegibility and incompleteness (above 20%) are unacceptably high. Values need to be improved by enhancing the safety culture and in particular the awareness of the professionals on the consequences that a bad prescription writing can produce.

Space Shuttle Day-of-Launch Trajectory Design and Verification

NASA Technical Reports Server (NTRS)

Harrington, Brian E.

2010-01-01

A top priority of any launch vehicle is to insert as much mass into the desired orbit as possible. This requirement must be traded against vehicle capability in terms of dynamic control, thermal constraints, and structural margins. The vehicle is certified to a specific structural envelope which will yield certain performance characteristics of mass to orbit. Some envelopes cannot be certified generically and must be checked with each mission design. The most sensitive envelopes require an assessment on the day-of-launch. To further minimize vehicle loads while maximizing vehicle performance, a day-of-launch trajectory can be designed. This design is optimized according to that day s wind and atmospheric conditions, which will increase the probability of launch. The day-of-launch trajectory verification is critical to the vehicle's safety. The Day-Of-Launch I-Load Uplink (DOLILU) is the process by which the Space Shuttle Program redesigns the vehicle steering commands to fit that day's environmental conditions and then rigorously verifies the integrated vehicle trajectory's loads, controls, and performance. The Shuttle methodology is very similar to other United States unmanned launch vehicles. By extension, this method would be similar to the methods employed for any future NASA launch vehicles. This presentation will provide an overview of the Shuttle's day-of-launch trajectory optimization and verification as an example of a more generic application of dayof- launch design and validation.

TDWR 1991 Program Review

NASA Technical Reports Server (NTRS)

Elmore, Kim

1992-01-01

The topics addressed are: (1) Terminal Doppler Weather Radar (TDWR) 1991 program review; (2) TDWR demonstrations notable results/events; (3) TDWR demonstration Denver chronology; (4) overview of generic integration concepts; (5) TDWR 1991 program review; (6) Denver operation 1991; and (7) FY-92 plans.

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.

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

75 FR 57537 - Sunshine Act; Notice of Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

..., 2010 9:30 a.m. Briefing on Security Issues (Closed--Ex. 1). * * * * * * The schedule for Commission..., 2010 1 p.m. Briefing on Resolution of Generic Safety Issue (GSI)--191, Assessment of Debris... 18, 2010 1:30 p.m. NRC All Employees Meeting (Public Meeting) Marriott Bethesda North Hotel, 5701...

78 FR 79465 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... Essential Medicines and Health Products (EMP): http://www.who.int/medicines/areas/quality_safety/ECDD/en... medicine: --Please mention other, if any, medical use not included in the approved indications (off label...: (Controlled substances act/ Medicines law/Poisons acts/Consumer protection acts/Generic legislation/Analogue...

40 CFR 721.7500 - Nitrate polyether polyol (generic name).

Code of Federal Regulations, 2010 CFR

2010-07-01

... information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described...). 721.7500 Section 721.7500 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC... substance is any manner or method of manufacture, import, or processing associated with any use of this...

Manned Orbital Transfer Vehicle (MOTV). Volume 4: Supporting analysis

NASA Technical Reports Server (NTRS)

Boyland, R. E.; Sherman, S. W.; Morfin, H. W.

1979-01-01

Generic missions were defined to enable potential users to determine the parameters for suggested user projects. Mission modes were identified for providing operation, interfaces, performance, and cost data for studying payloads. Safety requirements for emergencies during various phases of the mission are considered with emphasis on radiation hazards.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic.

PubMed

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p  = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p  > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p  > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications.

Clinical tolerability of generic versus brand beta blockers in heart failure with reduced left ventricular ejection fraction: a retrospective cohort from heart failure clinic

PubMed Central

Chanchai, Rattanachai; Kanjanavanit, Rungsrit; Leemasawat, Krit; Amarittakomol, Anong; Topaiboon, Paleerat; Phrommintikul, Arintaya

2018-01-01

Abstract Background: Beta-blockers have been shown to decrease mortality and morbidity in heart failure with reduced ejection fraction (HFrEF) patients. However, the side effects are also dose-related, leading to the underdosing. Cost constraint may be one of the limitations of appropriate beta-blocker use; this can be improved with generic drugs. However, the effects in real life practice have not been investigated. Methods and results: This study aimed to compare the efficacy and safety of generic and brand beta-blockers in HFrEF patients. We performed a retrospective cohort analysis in HFrEF patients who received either generic or brand beta-blocker in Chiang Mai Heart Failure Clinic. The primary endpoint was the proportion of patients who received at least 50% target dose of beta-blocker between generic and brand beta-blockers. Adverse events were secondary endpoints. 217 patients (119 and 98 patients received generic and brand beta-blocker, respectively) were enrolled. There were no differences between groups regarding age, gender, etiology of heart failure, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), rate of receiving angiotensin converting enzyme inhibitor (ACEI), angiotensin recepter blocker (ARB), or spironolactone. Patients receiving brand beta-blockers had lower resting heart rate at baseline (74.9 and 84.2 bpm, p = .001). Rate of achieved 50% target dose and target daily dose did not differ between groups (40.4 versus 44.5% and 48.0 versus 55.0%, p > .05, respectively). Rate of side effects was not different between groups (32.3 versus 29.5%, p > .05) and the most common side effect was hypotension. Conclusion: This study demonstrated that beta-blocker tolerability was comparable between brand and generic formulations. Generic or brand beta-blockers should be prescribed to HFrEF patients who have no contraindications. PMID:29379674

De novo use of generic tacrolimus in liver transplantation - a single center experience with one-yr follow-up.

PubMed

Dannhorn, E; Cheung, M; Rodrigues, S; Cooper, H; Thorburn, D; Patch, D; Burroughs, A K; O'Beirne, J

2014-12-01

Use of generic tacrolimus in liver transplantation (LT) could result in cost savings. Generic tacrolimus has been shown to be bioequivalent to innovator tacrolimus in healthy volunteers and renal transplant patients. There are limited data on the de novo use of generic tacrolimus in LT. This study aimed to determine whether the de novo use of generic tacrolimus (Adoport, Sandoz,UK) was associated with differences in outcomes, safety, and cost compared with innovator tacrolimus (Prograf, Astellas, Japan). Patients were studied before and after a programmatic change from de novo IS with Prograf to Adoport. Outcomes, tacrolimus levels, doses, and costs were compared for the first-yr post-LT. Ninety-four patients were studied, 46 Prograf, 48 Adoport. No significant differences in rejection, cytomegalovirus infection, acute kidney injury, sepsis, or graft loss were observed between groups. Tacrolimus costs were significantly reduced with the de novo use of Adoport. Day 14 dose normalized levels in Adoport patients showed significant variation but at the day 30 and one yr, there were no significant differences in the doses or levels of tacrolimus between groups. Adoport is safe and effective compared to Prograf when used de novo in LT patients. Tacrolimus costs were significantly reduced by the use of Adoport. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[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.

APhA 2011 REMS white paper: Summary of the REMS stakeholder meeting on improving program design and implementation.

PubMed

American Pharmacists Association; Bough, Marcie

2011-01-01

To develop an improved risk evaluation and mitigation strategies (REMS) system for maximizing effective and safe patient medication use while minimizing burden on the health care delivery system. 34 stakeholders gathered October 6-7, 2010, in Arlington, VA, for the REMS Stakeholder Meeting, convened by the American Pharmacists Association (APhA). Participants included national health care provider associations, including representatives for physicians, physician assistants, nurses, nurse practitioners, and pharmacists, as well as representatives for patient advocates, drug distributors, community pharmacists (chain and independent), drug manufacturer associations (brand, generic, and biologic organizations), and health information technology, standards, and safety organizations. Staff from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research participated as observers. The meeting built on themes from the APhA's 2009 REMS white paper. The current REMS environment presents many challenges for health care providers due to the growing number of REMS programs and the lack of standardization or similarities among various REMS programs. A standardized REMS process that focuses on maximizing patient safety and minimizing impacts on patient access and provider implementation could offset these challenges. A new process that includes effective provider interventions and standardized tools and systems for implementing REMS programs may improve patient care and overcome some of the communication issues providers and patients currently face. Metrics could be put in place to evaluate the effectiveness of REMS elements. By incorporating REMS program components into existing technologies and data infrastructures, achieving REMS implementation that is workflow neutral and minimizes administrative burden may be possible. An appropriate compensation model could ensure providers have adequate resources for patient care and REMS implementation. Overall, stakeholders should continue to work collaboratively with FDA and manufacturers to improve REMS program design and implementation issues. A workable REMS system will require effective patient interventions, standardized elements that limit barriers to implementation for both patients and providers, standardized yet flexible implementation strategies, use of existing technologies in practice settings, increased opportunities for provider input early in REMS design processes, improved communication strategies and awareness of program requirements, and viable provider compensation models needed to offset costs to implement and comply with REMS program requirements.

Reference drug programs: effectiveness and policy implications.

PubMed

Schneeweiss, Sebastian

2007-04-01

In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering them. This paper summarizes the mechanism and rationale of RDPs, presents evidence of their economic effectiveness and clinical safety, and concludes with some practical implications of implementing RDP policies.

Reference drug programs: Effectiveness and policy implications☆

PubMed Central

Schneeweiss, Sebastian

2010-01-01

In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering them. This paper summarizes the mechanism and rationale of RDPs, presents evidence of their economic effectiveness and clinical safety, and concludes with some practical implications of implementing RDP policies. PMID:16777256

Generic drug names and social welfare.

PubMed

Lobo, Félix; Feldman, Roger

2013-06-01

This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

Air Force Ni-Cd cell qualification program update

NASA Technical Reports Server (NTRS)

Hall, Steve; Brown, Harry; Collins, G.; Hwang, W.; Bui, Q.

1993-01-01

The generic qualification of aerospace nickel-cadmium cells is discussed. The test program includes the following: all available manufacturers, all available designs, cells from the previous program, and high and low orbit life cycling. It is the purpose of this program to characterize the beginning of life performance.

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.

Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

PubMed

Di Paolo, Antonello; Arrigoni, Elena

2018-03-01

Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.

Mentoring the Mentors of Underrepresented Racial/Ethnic Minorities Who are Conducting HIV Research: Beyond Cultural Competency.

PubMed

Walters, Karina L; Simoni, Jane M; Evans-Campbell, Teresa Tessa; Udell, Wadiya; Johnson-Jennings, Michelle; Pearson, Cynthia R; MacDonald, Meg M; Duran, Bonnie

2016-09-01

The majority of literature on mentoring focuses on mentee training needs, with significantly less guidance for the mentors. Moreover, many mentoring the mentor models assume generic (i.e. White) mentees with little attention to the concerns of underrepresented racial/ethnic minorities (UREM). This has led to calls for increased attention to diversity in research training programs, especially in the field of HIV where racial/ethnic disparities are striking. Diversity training tends to address the mentees' cultural competency in conducting research with diverse populations, and often neglects the training needs of mentors in working with diverse mentees. In this article, we critique the framing of diversity as the problem (rather than the lack of mentor consciousness and skills), highlight the need to extend mentor training beyond aspirations of cultural competency toward cultural humility and cultural safety, and consider challenges to effective mentoring of UREM, both for White and UREM mentors.

Mentoring the Mentors of Underrepresented Racial/Ethnic Minorities Who are Conducting HIV Research: Beyond Cultural Competency

PubMed Central

Simoni, Jane M.; Evans-Campbell, Teresa (Tessa); Udell, Wadiya; Johnson-Jennings, Michelle; Pearson, Cynthia R.; MacDonald, Meg M.; Duran, Bonnie

2016-01-01

The majority of literature on mentoring focuses on mentee training needs, with significantly less guidance for the mentors. Moreover, many mentoring the mentor models assume generic (i.e. White) mentees with little attention to the concerns of underrepresented racial/ethnic minorities (UREM). This has led to calls for increased attention to diversity in research training programs, especially in the field of HIV where racial/ethnic disparities are striking. Diversity training tends to address the mentees' cultural competency in conducting research with diverse populations, and often neglects the training needs of mentors in working with diverse mentees. In this article, we critique the framing of diversity as the problem (rather than the lack of mentor consciousness and skills), highlight the need to extend mentor training beyond aspirations of cultural competency toward cultural humility and cultural safety, and consider challenges to effective mentoring of UREM, both for White and UREM mentors. PMID:27484060

How to reduce out-of-pocket costs for prescription medications.

PubMed

Eliason, Mark J; Sontheimer, Richard D

2015-06-16

The cost of prescription medicines has recently been rising faster than other healthcare costs.  This is also true for traditionally inexpensive generic medications that have long served as a fundamental healthcare safety net in the USA.  These changes increasingly present challenges for individuals to obtain common medications.  Owing to rising insurance co-pays, even patients who have prescription medication insurance coverage are beginning to experience challenges in this area.  This document was created to help patients and their families consider various strategies and programs that exist in 2015 for reducing their out-of-pocket costs for their prescription medications.  We believe that this information can also be helpful to healthcare providers when counseling patients about managing rapidly rising prescription drug costs.  An effort has been made to make this document readable to patients and their families as well as to healthcare providers.

The role of the PIRT process in identifying code improvements and executing code development

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

Wilson, G.E.; Boyack, B.E.

1997-07-01

In September 1988, the USNRC issued a revised ECCS rule for light water reactors that allows, as an option, the use of best estimate (BE) plus uncertainty methods in safety analysis. The key feature of this licensing option relates to quantification of the uncertainty in the determination that an NPP has a {open_quotes}low{close_quotes} probability of violating the safety criteria specified in 10 CFR 50. To support the 1988 licensing revision, the USNRC and its contractors developed the CSAU evaluation methodology to demonstrate the feasibility of the BE plus uncertainty approach. The PIRT process, Step 3 in the CSAU methodology, wasmore » originally formulated to support the BE plus uncertainty licensing option as executed in the CSAU approach to safety analysis. Subsequent work has shown the PIRT process to be a much more powerful tool than conceived in its original form. Through further development and application, the PIRT process has shown itself to be a robust means to establish safety analysis computer code phenomenological requirements in their order of importance to such analyses. Used early in research directed toward these objectives, PIRT results also provide the technical basis and cost effective organization for new experimental programs needed to improve the safety analysis codes for new applications. The primary purpose of this paper is to describe the generic PIRT process, including typical and common illustrations from prior applications. The secondary objective is to provide guidance to future applications of the process to help them focus, in a graded approach, on systems, components, processes and phenomena that have been common in several prior applications.« less

7 CFR 1486.101 - What special definitions apply to this program?

Code of Federal Regulations, 2012 CFR

2012-01-01

... of Agriculture whose primary mission is to review proposals requesting funding under the EMP and make... World Bank. EMP—Emerging Markets Program. FAS—Foreign Agricultural Service. Generic Promotion—an...

7 CFR 1486.101 - What special definitions apply to this program?

Code of Federal Regulations, 2014 CFR

2014-01-01

... of Agriculture whose primary mission is to review proposals requesting funding under the EMP and make... World Bank. EMP—Emerging Markets Program. FAS—Foreign Agricultural Service. Generic Promotion—an...

7 CFR 1486.101 - What special definitions apply to this program?

Code of Federal Regulations, 2013 CFR

2013-01-01

... of Agriculture whose primary mission is to review proposals requesting funding under the EMP and make... World Bank. EMP—Emerging Markets Program. FAS—Foreign Agricultural Service. Generic Promotion—an...

Granite disposal of U.S. high-level radioactive waste.

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

Freeze, Geoffrey A.; Mariner, Paul E.; Lee, Joon H.

This report evaluates the feasibility of disposing U.S. high-level radioactive waste in granite several hundred meters below the surface of the earth. The U.S. has many granite formations with positive attributes for permanent disposal. Similar crystalline formations have been extensively studied by international programs, two of which, in Sweden and Finland, are the host rocks of submitted or imminent repository license applications. This report is enabled by the advanced work of the international community to establish functional and operational requirements for disposal of a range of waste forms in granite media. In this report we develop scoping performance analyses, basedmore » on the applicable features, events, and processes (FEPs) identified by international investigators, to support generic conclusions regarding post-closure safety. Unlike the safety analyses for disposal in salt, shale/clay, or deep boreholes, the safety analysis for a mined granite repository depends largely on waste package preservation. In crystalline rock, waste packages are preserved by the high mechanical stability of the excavations, the diffusive barrier of the buffer, and favorable chemical conditions. The buffer is preserved by low groundwater fluxes, favorable chemical conditions, backfill, and the rigid confines of the host rock. An added advantage of a mined granite repository is that waste packages would be fairly easy to retrieve, should retrievability be an important objective. The results of the safety analyses performed in this study are consistent with the results of comprehensive safety assessments performed for sites in Sweden, Finland, and Canada. They indicate that a granite repository would satisfy established safety criteria and suggest that a small number of FEPs would largely control the release and transport of radionuclides. In the event the U.S. decides to pursue a potential repository in granite, a detailed evaluation of these FEPs would be needed to inform site selection and safety assessment.« less

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.

Triangulation and the importance of establishing valid methods for food safety culture evaluation.

PubMed

Jespersen, Lone; Wallace, Carol A

2017-10-01

The research evaluates maturity of food safety culture in five multi-national food companies using method triangulation, specifically self-assessment scale, performance documents, and semi-structured interviews. Weaknesses associated with each individual method are known but there are few studies in food safety where a method triangulation approach is used for both data collection and data analysis. Significantly, this research shows that individual results taken in isolation can lead to wrong conclusions, resulting in potentially failing tactics and wasted investments. However, by applying method triangulation and reviewing results from a range of culture measurement tools it is possible to better direct investments and interventions. The findings add to the food safety culture paradigm beyond a single evaluation of food safety culture using generic culture surveys. Copyright © 2017. Published by Elsevier Ltd.

A mathematical modeling approach to resource allocation for railroad-highway crossing safety upgrades.

PubMed

Konur, Dinçer; Golias, Mihalis M; Darks, Brandon

2013-03-01

State Departments of Transportation (S-DOT's) periodically allocate budget for safety upgrades at railroad-highway crossings. Efficient resource allocation is crucial for reducing accidents at railroad-highway crossings and increasing railroad as well as highway transportation safety. While a specific method is not restricted to S-DOT's, sorting type of procedures are recommended by the Federal Railroad Administration (FRA), United States Department of Transportation for the resource allocation problem. In this study, a generic mathematical model is proposed for the resource allocation problem for railroad-highway crossing safety upgrades. The proposed approach is compared to sorting based methods for safety upgrades of public at-grade railroad-highway crossings in Tennessee. The comparison shows that the proposed mathematical modeling approach is more efficient than sorting methods in reducing accidents and severity. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

GENERIC VERIFICATION PROTOCOL FOR DETERMINATION OF EMISSIONS REDUCTIONS OBTAINED BY USE OF ALTERNATIVE OR REFORMULATED LIQUID FUELS, FUEL ADDITIVES, FUEL EMULSIONS AND LUBRICANTS FOR HIGHWAY AND NONROAD USE DISEL ENGINES AND LIGHT DUTY GASOLINE ENGINES AND VEHICLES

EPA Science Inventory

This report sets standards by which the emissions reduction provided by fuel and lubricant technologies can be tested and be tested in a comparable way. It is a generic protocol under the Environmental Technology Verification program.

Technology to Enhance Mathematics and Science Instruction: Changes in Teacher Perceptions after Participating in a Yearlong Professional Development Program

ERIC Educational Resources Information Center

Kersaint, Gladis; Ritzhaupt, Albert D.; Liu, Feng

2014-01-01

The purpose of this study is to examine the extent to which teachers of mathematics or science who were engaged in a year-long initiative to help them integrate technological tools were (a) familiar with generic and mathematics- or science-specific technology, (b) comfortable integrating generic and content-specific technology, (c) believe that…

[Bioequivalence of dermatological topical medicines:the Brazilian scenario and the challenges for health surveillance].

PubMed

Soares, Kelen Carine Costa; Moraes, Marcelo Vogler; Gelfuso, Guilherme Martins; Gratieri, Taís

2015-11-01

The comparative evaluation required for the registration of generic topical medicines in Brazil is conducted by means of a pharmaceutical equivalence study, which merely assesses the physical/chemical and microbiological parameters of the formulations. At the international level, clinical or pharmacodynamic studies are now being required to prove the efficacy and safety of semisolid topical generic formulations. This work presents a comparison of the different requirements for the registration of topical formulations, taking into consideration the various regulatory authorities, and presents a survey of topical medicines registered in Brazil prior to 2013. The survey revealed that in comparison with the USA there were many more copies of these formulations registered in Brazil. This fact, together with the large number of studies in the literature showing the lack of bioequivalence of topical medication, is clear proof of the major importance of the need to realign Brazilian legislation with respect to the technical requirements for the registration of generic and similar medication for dermatological topical application in Brazil.

Generic Airspace Concepts and Research

NASA Technical Reports Server (NTRS)

Mogford, Richard H.

2010-01-01

The purpose of this study was to evaluate methods for reducing the training and memorization required to manage air traffic in mid-term, Next Generation Air Transportation System (NextGen) airspace. We contrasted the performance of controllers using a sector information display and NextGen automation tools while working with familiar and unfamiliar sectors. The airspace included five sectors from Oakland and Salt Lake City Centers configured as a "generic center" called "West High Center." The Controller Information Tool was used to present essential information for managing these sectors. The Multi Aircraft Control System air traffic control simulator provided data link and conflict detection and resolution. There were five experienced air traffic controller participants. Each was familiar with one or two of the five sectors, but not the others. The participants rotated through all five sectors during the ten data collection runs. The results addressing workload, traffic management, and safety, as well as controller and observer comments, supported the generic sector concept. The unfamiliar sectors were comparable to the familiar sectors on all relevant measures.

Generic HTML Form Processor: A versatile PHP script to save web-collected data into a MySQL database.

PubMed

Göritz, Anja S; Birnbaum, Michael H

2005-11-01

The customizable PHP script Generic HTML Form Processor is intended to assist researchers and students in quickly setting up surveys and experiments that can be administered via the Web. This script relieves researchers from the burdens of writing new CGI scripts and building databases for each Web study. Generic HTML Form Processor processes any syntactically correct HTML forminput and saves it into a dynamically created open-source database. We describe five modes for usage of the script that allow increasing functionality but require increasing levels of knowledge of PHP and Web servers: The first two modes require no previous knowledge, and the fifth requires PHP programming expertise. Use of Generic HTML Form Processor is free for academic purposes, and its Web address is www.goeritz.net/brmic.

40 CFR 721.10101 - Copolymer of alkyl acrylate and ethyleneglycol dimethacrylate (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... workplace. Requirements as specified in § 721.63 (a)(4), (a)(5), (a)(6)(i), (a)(6)(ii), (b), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators with an... PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES...

Automating Embedded Analysis Capabilities and Managing Software Complexity in Multiphysics Simulation, Part I: Template-Based Generic Programming

DOE PAGES

Pawlowski, Roger P.; Phipps, Eric T.; Salinger, Andrew G.

2012-01-01

An approach for incorporating embedded simulation and analysis capabilities in complex simulation codes through template-based generic programming is presented. This approach relies on templating and operator overloading within the C++ language to transform a given calculation into one that can compute a variety of additional quantities that are necessary for many state-of-the-art simulation and analysis algorithms. An approach for incorporating these ideas into complex simulation codes through general graph-based assembly is also presented. These ideas have been implemented within a set of packages in the Trilinos framework and are demonstrated on a simple problem from chemical engineering.

An expert system based software sizing tool, phase 2

NASA Technical Reports Server (NTRS)

Friedlander, David

1990-01-01

A software tool was developed for predicting the size of a future computer program at an early stage in its development. The system is intended to enable a user who is not expert in Software Engineering to estimate software size in lines of source code with an accuracy similar to that of an expert, based on the program's functional specifications. The project was planned as a knowledge based system with a field prototype as the goal of Phase 2 and a commercial system planned for Phase 3. The researchers used techniques from Artificial Intelligence and knowledge from human experts and existing software from NASA's COSMIC database. They devised a classification scheme for the software specifications, and a small set of generic software components that represent complexity and apply to large classes of programs. The specifications are converted to generic components by a set of rules and the generic components are input to a nonlinear sizing function which makes the final prediction. The system developed for this project predicted code sizes from the database with a bias factor of 1.06 and a fluctuation factor of 1.77, an accuracy similar to that of human experts but without their significant optimistic bias.

Managing occupational risk in creative practice: a new perspective for occupational health and safety.

PubMed

Oughton, Nicholas

2013-01-01

There has been little recognition of the fact that creative production operates in a somewhat different environment and timeframe to that associated with traditional industries. This has resulted in the application of an orthodox, generic or ``one size fits all'' framework of Occupational Health and Safety (OHS) systems across all industries. With the rapid growth of ``creative industry,'' certain challenges arise from the application of this "generic" strategy, mainly because the systems currently employed may not be entirely suitable for creative practice. Some OHS practitioners suggest that the current OHS paradigm is failing. This paper questions the appropriateness of applying a twentieth century OHS model in the present industrial context, and considers what framework will best provide for the well-being of creative workers and their enterprise in the twenty-first century. The paper questions the notion of "Risk" and the paradox associated with "Risk Management," particularly in the context of the creative process. Clearly, risk taking contributes to creative enterprise and effective risk management should accommodate both risk minimization and risk exploitation.

[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.

Work Experience Report

NASA Technical Reports Server (NTRS)

Guo, Daniel

2017-01-01

The NASA Platform for Autonomous Systems (NPAS) toolkit is currently being used at the NASA John C. Stennis Space Center (SSC) to develop the INSIGHT program, which will autonomously monitor and control the Nitrogen System of the High Pressure Gas Facility (HPGF) on site. The INSIGHT program is in need of generic timing capabilities in order to perform timing based actions such as pump usage timing and sequence step timing. The purpose of this project was to develop a timing module that could fulfill these requirements and be adaptable for expanded use in the future. The code was written in Gensym G2 software platform, the same as INSIGHT, and was written generically to ensure compatibility with any G2 program. Currently, the module has two timing capabilities, a stopwatch function and a countdown function. Although the module has gone through some functionality testing, actual integration of the module into NPAS and the INSIGHT program is contingent on the module passing later checks.

Using generic tool kits to build intelligent systems

NASA Technical Reports Server (NTRS)

Miller, David J.

1994-01-01

The Intelligent Systems and Robots Center at Sandia National Laboratories is developing technologies for the automation of processes associated with environmental remediation and information-driven manufacturing. These technologies, which focus on automated planning and programming and sensor-based and model-based control, are used to build intelligent systems which are able to generate plans of action, program the necessary devices, and use sensors to react to changes in the environment. By automating tasks through the use of programmable devices tied to computer models which are augmented by sensing, requirements for faster, safer, and cheaper systems are being satisfied. However, because of the need for rapid cost-effect prototyping and multi-laboratory teaming, it is also necessary to define a consistent approach to the construction of controllers for such systems. As a result, the Generic Intelligent System Controller (GISC) concept has been developed. This concept promotes the philosophy of producing generic tool kits which can be used and reused to build intelligent control systems.

Safety and efficacy of generic cyclosporine arpimune in Filipino low-risk primary kidney transplant recipients.

PubMed

Pamugas, G E P; Danguilan, R A; Lamban, A B; Mangati, V B; Ona, E T

2012-01-01

In the Philippines, maintenance of immunosuppression may not always be affordable, leading to acute rejection and graft loss. The availability of the generic cyclosporine Arpimune could be economically beneficial, but its safety and efficacy should be established. This prospective cohort study enrolled 30 renal transplant patients who received Arpimune with mycophenolate/prednisone. Their results were compared up to 6 months with 30 matched control patients who received Neoral during the same period. Areas under the receiver operating characteristic curves (AUC) after intake of Arpimune and therapeutic drug monitoring using cyclosporine levels 2 hours after each dose were done. Pearson correlation was performed to determine linearity of relationship between the generic cyclosporine concentrations and AUC 0-4. Chi-square test was used in obtaining cyclosporine Arpimune concentrations. The abbreviated concentration AUC of Arpimune was similar to that of Neoral, and the 2-hour sampling point (r = 0.813; P < .001) showed the best correlation. Calculated creatinine clearance (mL/min) versus Neoral was 71.36 ± 13 versus 68.03 ± 16.6 (P = .61) at 1 month, 70.4 ± 14.8 versus 64.2 ± 11.4 (P = .12) at 3 months, and 74.02 ± 15.8 versus 62.03 ± 12.1 (P = .002) at 6 months. Two Arpimune versus 4 Neoral patients (P = .67) developed biopsy-proven acute rejection. One septic death occurred in the Arpimune group. Graft survival was 100% in both groups. Hyperlipidemia was the most frequent side effect for both. The AUC of Arpimune was similar to that of Neoral. Use of the generic cyclosporine Arpimune provided effective immunosuppression in the 6 months after transplantation. Renal allograft function was similar to that of Neoral, with minimal rates of acute rejection and adverse events. Copyright © 2012 Elsevier Inc. All rights reserved.

Evaluating Site-Specific and Generic Spatial Models of Aboveground Forest Biomass Based on Landsat Time-Series and LiDAR Strip Samples in the Eastern USA

Treesearch

Ram Deo; Matthew Russell; Grant Domke; Hans-Erik Andersen; Warren Cohen; Christopher Woodall

2017-01-01

Large-area assessment of aboveground tree biomass (AGB) to inform regional or national forest monitoring programs can be efficiently carried out by combining remotely sensed data and field sample measurements through a generic statistical model, in contrast to site-specific models. We integrated forest inventory plot data with spatial predictors from Landsat time-...

Generic Skills. Trade Families. 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.

The Generic Skills studies were designed to provide training specifications that will enable graduates of trades training programs to compete for job placement in a range of occupations rather than in a single occupation. The studies identified a number of trade families, classified on the basis of skills used in work performance, and also…

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Refills of Maintenance Medications Through Military Treatment Facility Pharmacies or National Mail Order Pharmacy Program. Final rule.

PubMed

2016-11-02

This final rule implements section 702 (c) of the Carl Levin and Howard P. "Buck" McKeon National Defense Authorization Act for Fiscal Year 2015 which states that beginning October 1, 2015, the pharmacy benefits program shall require eligible covered beneficiaries generally to refill non-generic prescription maintenance medications through military treatment facility pharmacies or the national mail-order pharmacy program. An interim final rule is in effect. Section 702(c) of the National Defense Authorization Act for Fiscal Year 2015 also terminates the TRICARE For Life Pilot Program on September 30, 2015. The TRICARE For Life Pilot Program described in section 716(f) of the National Defense Authorization Act for Fiscal Year 2013, was a pilot program which began in March 2014 requiring TRICARE For Life beneficiaries to refill non-generic prescription maintenance medications through military treatment facility pharmacies or the national mail-order pharmacy program. TRICARE for Life beneficiaries are those enrolled in the Medicare wraparound coverage option of the TRICARE program. This rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail order pharmacy program.

Conventional curing practices reduce generic Escherichia coli and Salmonella spp. on dry bulb onions produced with contaminated irrigation water.

PubMed

Emch, Alexander W; Waite-Cusic, Joy G

2016-02-01

Food Safety Modernization Act (FSMA) has emphasized microbial risks associated with irrigation water. Treasure Valley (eastern Oregon/western Idaho) has the highest yield of dry bulb onions in the country; however, their irrigation water is often non-compliant with current industry and proposed federal standards for fresh produce. Conventional curing practices may provide a mechanism to mitigate irrigation water quality to comply with FSMA regulations. Dry bulb onions were grown in Owyhee silt loam and Semiahmoo muck soils in greenhouses and irrigated with water containing a cocktail of rifampicin-resistant generic Escherichia coli and Salmonella spp. (4.80 log CFU/ml). To mimic conventional practices, mature onions remained undisturbed in soil without irrigation for 12 days prior to being lifted and cured for 16 additional days. Surviving generic E. coli and Salmonella spp. were selectively enumerated on using standard plating (Hektoen Enteric Agar with rifampicin; HE + rif) or most probable number (lactose broth with rifampicin; HE + rif) methods. Generic E. coli and Salmonella spp. on onions decreased 0.19-0.26 log CFU/g·d during the initial 12 days of finishing. At lifting, generic E. coli and Salmonella spp. had been reduced to <1 CFU/g and persisted through the end of curing. This study demonstrates conventional curing practices as an effective mitigation strategy for dry bulb onions produced with water of poor microbiological quality. Copyright © 2015 Elsevier Ltd. All rights reserved.

Can increases in CHIP copayments reduce program expenditures on prescription drugs?

PubMed

Sen, Bisakha; Blackburn, Justin; Morrisey, Michael; Becker, David; Kilgore, Meredith; Caldwell, Cathy; Menachemi, Nir

2014-01-01

The primary aim is to explore whether prescription drug expenditures by enrollees changed in Alabama's CHIP program, ALL Kids, after copayment increases in fiscal year 2004. The subsidiary aim is to explore whether non-pharmaceutical expenditures also changed. Data on ALL Kids enrollees between 1999-2007, obtained from claims files and the state's administrative database. We used data on children who were enrolled between one and three years both before and after the changes to the copayment schedule, and estimate regression models with individual-level fixed effects to control for time-invariant heterogeneity at the child level. This allows an accurate estimate of how program expenditures change for the same individual following copayment changes. Primary outcomes of interest are expenditures for prescription drugs by class and brand-name and generic versions. We estimate models for the likelihood of any use of prescription drugs and expenditure level conditional on use. Following the copayment increase, the probability of any expenditure decline by 5.8%, brand name drugs by 6.9%, generic drugs by 7.4%. Conditional on any use, program expenditures decline by 7.9% for all drugs, by 9.6% for brand name drugs, and 6.2% for generic drugs. The largest declines are for antihistamine drugs; the least declines are for Central Nervous System agents. Declines are smaller and statistically weaker for children with chronic health conditions. Concurrent declines are also seen for non-pharmaceutical medical expenditures. Copayment increases appear to reduce program expenditures on prescription drugs per enrollee and may be a useful tool for controlling program costs.

A comprehensive conceptual framework for road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2016-05-01

Road safety strategies (generally called Strategic Highway Safety Plans in the USA) provide essential guidance for actions to improve road safety, but often lack a conceptual framework that is comprehensive, systems theory based, and underpinned by evidence from research and practice. This paper aims to incorporate all components, policy tools by which they are changed, and the general interactions between them. A framework of nine mutually interacting components that contribute to crashes and ten generic policy tools which can be applied to reduce the outcomes of these crashes was developed and used to assess 58 road safety strategies from 22 countries across 15 years. The work identifies the policy tools that are most and least widely applied to components, highlighting the potential for improvements to any individual road safety strategy, and the potential strengths and weaknesses of road safety strategies in general. The framework also provides guidance for the development of new road safety strategies, identifying potential consequences of policy tool based measures with regard to exposure and risk, useful for both mobility and safety objectives. Copyright © 2016 Elsevier Ltd. All rights reserved.

Generic concept to program the time domain of self-assemblies with a self-regulation mechanism.

PubMed

Heuser, Thomas; Steppert, Ann-Kathrin; Lopez, Catalina Molano; Zhu, Baolei; Walther, Andreas

2015-04-08

Nature regulates complex structures in space and time via feedback loops, kinetically controlled transformations, and under energy dissipation to allow non-equilibrium processes. Although man-made static self-assemblies realize excellent control over hierarchical structures via molecular programming, managing their temporal destiny by self-regulation is a largely unsolved challenge. Herein, we introduce a generic concept to control the time domain by programming the lifetimes of switchable self-assemblies in closed systems. We conceive dormant deactivators that, in combination with fast promoters, enable a unique kinetic balance to establish an autonomously self-regulating, transient pH-state, whose duration can be programmed over orders of magnitude-from minutes to days. Coupling this non-equilibrium state to pH-switchable self-assemblies allows predicting their assembly/disassembly fate in time, similar to a precise self-destruction mechanism. We demonstrate a platform approach by programming self-assembly lifetimes of block copolymers, nanoparticles, and peptides, enabling dynamic materials with a self-regulation functionality.

Cultural safety as an ethic of care: a praxiological process.

PubMed

McEldowney, Rose; Connor, Margaret J

2011-10-01

New writings broadening the construct of cultural safety, a construct initiated in Aotearoa New Zealand, are beginning to appear in the literature. Therefore, it is considered timely to integrate these writings and advance the construct into a new theoretical model. The new model reconfigures the constructs of cultural safety and cultural competence as an ethic of care informed by a postmodern perspective. Central to the new model are three interwoven, co-occurring components: an ethic of care, which unfolds within a praxiological process shaped by the context. Context is expanded through identifying the three concepts of relationality, generic competence, and collectivity, which are integral to each client-nurse encounter. The competence associated with cultural safety as an ethic of care is always in the process of development. Clients and nurses engage in a dialogue to establish the level of cultural safety achieved at given points in a care trajectory.

The nine-year sustained cost-containment impact of swiss pilot physicians-pharmacists quality circles.

PubMed

Niquille, Anne; Ruggli, Martine; Buchmann, Michel; Jordan, Dominique; Bugnon, Olivier

2010-04-01

Six pioneer physicians-pharmacists quality circles (PPQCs) located in the Swiss canton of Fribourg (administratively corresponding to a state in the US) were under the responsibility of 6 trained community pharmacists moderating the prescribing process of 24 general practitioners (GPs). PPQCs are based on a multifaceted collaborative process mediated by community pharmacists for improving compliance with clinical guidelines within GPs' prescribing practices. To assess, over a 9-year period (1999-2007), the cost-containment impact of the PPQCs. The key elements of PPQCs are a structured continuous quality improvement and education process; local networking; feedback of comparative and detailed data regarding costs, drug choice, and frequency of prescribed drugs; and structured independent literature review for interdisciplinary continuing education. The data are issued from the community pharmacy invoices to the health insurance companies. The study analyzed the cost-containment impact of the PPQCs in comparison with GPs working in similar conditions of care without particular collaboration with pharmacists, the percentage of generic prescriptions for specific cardiovascular drug classes, and the percentage of drug costs or units prescribed for specific cardiovascular drugs. For the 9-year period, there was a 42% decrease in the drug costs in the PPQC group as compared to the control group, representing a $225,000 (USD) savings per GP only in 2007. These results are explained by better compliance with clinical and pharmacovigilance guidelines, larger distribution of generic drugs, a more balanced attitude toward marketing strategies, and interdisciplinary continuing education on the rational use of drugs. The PPQC work process has yielded sustainable results, such as significant cost savings, higher penetration of generics and reflection on patient safety, and the place of "new" drugs in therapy. The PPQCs may also constitute a solid basis for implementing more comprehensive collaborative programs, such as medication reviews, adherence-enhancing interventions, or disease management approaches.

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.

Regulatory experience in applying a radiological environmental protection framework for existing and planned nuclear facilities.

PubMed

Mihok, S; Thompson, P

2012-01-01

Frameworks and methods for the radiological protection of non-human biota have been evolving rapidly at the International Commission on Radiological Protection and through various European initiatives. The International Atomic Energy Agency has incorporated a requirement for environmental protection in the latest revision of its Basic Safety Standards. In Canada, the Canadian Nuclear Safety Commission has been legally obligated to prevent unreasonable risk to the environment since 2000. Licensees have therefore been meeting generic legal requirements to demonstrate adequate control of releases of radioactive substances for the protection of both people and biota for many years. In the USA, in addition to the generic requirements of the Environmental Protection Agency and the Nuclear Regulatory Commission, Department of Energy facilities have also had to comply with specific dose limits after a standard assessment methodology was finalised in 2002. Canadian regulators developed a similar framework for biota dose assessment through a regulatory assessment under the Canadian Environmental Protection Act in the late 1990s. Since then, this framework has been applied extensively to satisfy legal requirements under the Canadian Environmental Assessment Act and the Nuclear Safety and Control Act. After approximately a decade of experience in applying these methods, it is clear that simple methods are fit for purpose, and can be used for making regulatory decisions for existing and planned nuclear facilities. Copyright © 2012. Published by Elsevier Ltd.

Generic phytosanitary irradiation treatments

NASA Astrophysics Data System (ADS)

Hallman, Guy J.

2012-07-01

The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

Generic E. coli levels in surface and nontraditional irrigation water in the mid Atlantic in relation to FSMA water quality standards: A CONSERVE study

USDA-ARS?s Scientific Manuscript database

Introduction: The use of surface (pond and river) and nontraditional (reclaimed wastewater, produce wash water) irrigation water (SNIW) could reduce stress on ground water resources. However, it is essential to understand how these irrigation sources may influence the microbiological safety of fresh...

Microcomputer Software for Libraries: A Survey.

ERIC Educational Resources Information Center

Nolan, Jeanne M.

1983-01-01

Reports on findings of research done by Nolan Information Management Services concerning availability of microcomputer software for libraries. Highlights include software categories (specific, generic-database management programs, original); number of programs available in 1982 for 12 applications; projections for 1983; and future software…

The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center.

PubMed

Mcphillamy, Austin; Gurnea, Taylor P; Moody, Alastair E; Kurnik, Christopher G; Lu, Minggen

2016-12-01

In today's climate of cost containment and fiscal responsibility, generic implant alternatives represent an interesting area of untapped resources. As patents have expired on many commonly used trauma implants, generic alternatives have recently become available from a variety of sources. The purpose of this study was to examine the clinical and economic impact of a cost containment program using high quality, generic orthopaedic locking plates. The implants available for study were anatomically precontoured plates for the clavicle, proximal humerus, distal radius, proximal tibia, distal tibia, and distal fibula. Retrospective review. Level II Trauma center. 828 adult patients with operatively managed clavicle, proximal humerus, distal radius, proximal tibia, tibial pilon, and ankle fractures. Operative treatment with conventional or generic implants. The 414 patients treated with generic implants were compared with 414 patients treated with conventional implants. There were no significant differences in age, sex, presence of diabetes, smoking history or fracture type between the generic and conventional groups. No difference in operative time, estimated blood loss or intraoperative complication rate was observed. No increase in postoperative infection rate, hardware failure, hardware loosening, malunion, nonunion or need for hardware removal was noted. Overall, our hospital realized a 56% reduction in implant costs, an average savings of $1197 per case, and a total savings of $458,080 for the study period. Use of generic orthopaedic implants has been successful at our institution, providing equivalent clinical outcomes while significantly reducing implant expenditures. Based on our data, the use of generic implants has the potential to markedly reduce operative costs as long as quality products are used. Therapeutic Level III.

Generic Assessment Rubrics for Computer Programming Courses

ERIC Educational Resources Information Center

Mustapha, Aida; Samsudin, Noor Azah; Arbaiy, Nurieze; Mohammed, Rozlini; Hamid, Isredza Rahmi

2016-01-01

In programming, one problem can usually be solved using different logics and constructs but still producing the same output. Sometimes students get marked down inappropriately if their solutions do not follow the answer scheme. In addition, lab exercises and programming assignments are not necessary graded by the instructors but most of the time…

Effectiveness and safety of generic fixed-dose combination of tenofovir/emtricitabine/efavirenz in HIV-1-infected patients in Western India.

PubMed

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshi, Kedar; Bele, Vivek

2008-01-01

To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India.

PubMed

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshix, Kedar; Bele, Vivek

2008-08-20

To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.

Generic exposure scenarios: their development, application, and interpretation under REACH.

PubMed

Money, Chris; Margary, Alison; Noij, Dook; Hommes, Kees

2011-06-01

The European Union Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation (EC 1907/2006) places significant new obligations on the manufacturers or importers (M/Is) of chemicals in Europe. It also places new responsibilities on downstream users (DUs) of these chemicals i.e. those that purchase and use chemical products. In particular, for registered classified substances, the M/I is expected to communicate how any substance can be safely used without risk to man or the environment. This communication is in the form of an exposure scenario (ES), which is included in an Annex to the REACH extended safety data sheet. DUs then have certain obligations relating to adopting the control conditions described in the ES. The REACH Technical Guidance Documents lay down the expectations for the process of risk assessment that M/Is should adopt when developing ESs. But with many thousands of chemicals in daily commerce, it is also necessary to ensure that what is communicated to DUs not only meets the requirements of REACH but is also understandable to these groups, as well as being consistent across different chemical suppliers and supply chains. In cooperation with relevant DU groups, the European solvents industry has developed generic approaches for describing how solvents are commonly used, in order that these can subsequently be used as the basis for REACH registrations and related safety data sheet communications on health risk control. The utility of these approaches (termed 'generic exposure scenarios') is acknowledged under REACH and they are now publicly available for use both by M/Is and DUs.

[Enhancement of the medical care system for crews on space missions].

PubMed

Bogomolov, V V; Egorov, A D

2013-01-01

An overview of structural, operational and research aspects of the Russian system of medical support to health and performance of cosmonauts on the International space station (ISS) is presented. The backbone of the current tactics of cosmonauts' health maintenance is the original Russian medical care system developed for long-term piloted space fights. Over 12 years of its existence, the ISS has been operated by 33 main crews. The ISS program entrusted the established multilateral medical boards and panels with laying down the health standards as well as the generic and specific medical and engineering requirements mandatory to all international partners. Due to the program international nature, MedOps planning and implementation are coordinated within the network of working level groups with members designated by each IP. The article sums up the experiences and outlines future trends of the Russian medical care system for ISS cosmonauts. The authors pay tribute to academician Anatoli I. Grigoriev for his contribution to creation of the national system of medical safety in long-term piloted space missions, setting the ISS health and environmental standards and uniform principles of integrated crew health management, and gaining consensus on medical policy and operational issues equally during the ISS construction and utilization.

Current external beam radiation therapy quality assurance guidance: does it meet the challenges of emerging image-guided technologies?

PubMed

Palta, Jatinder R; Liu, Chihray; Li, Jonathan G

2008-01-01

The traditional prescriptive quality assurance (QA) programs that attempt to ensure the safety and reliability of traditional external beam radiation therapy are limited in their applicability to such advanced radiation therapy techniques as three-dimensional conformal radiation therapy, intensity-modulated radiation therapy, inverse treatment planning, stereotactic radiosurgery/radiotherapy, and image-guided radiation therapy. The conventional QA paradigm, illustrated by the American Association of Physicists in Medicine Radiation Therapy Committee Task Group 40 (TG-40) report, consists of developing a consensus menu of tests and device performance specifications from a generic process model that is assumed to apply to all clinical applications of the device. The complexity, variation in practice patterns, and level of automation of high-technology radiotherapy renders this "one-size-fits-all" prescriptive QA paradigm ineffective or cost prohibitive if the high-probability error pathways of all possible clinical applications of the device are to be covered. The current approaches to developing comprehensive prescriptive QA protocols can be prohibitively time consuming and cost ineffective and may sometimes fail to adequately safeguard patients. It therefore is important to evaluate more formal error mitigation and process analysis methods of industrial engineering to more optimally focus available QA resources on process components that have a significant likelihood of compromising patient safety or treatment outcomes.

Raster Metafile And Raster Metafile Translator Programs

NASA Technical Reports Server (NTRS)

Randall, Donald P.; Gates, Raymond L.; Skeens, Kristi M.

1994-01-01

Raster Metafile (RM) computer program is generic raster-image-format program, and Raster Metafile Translator (RMT) program is assortment of software tools for processing images prepared in this format. Processing includes reading, writing, and displaying RM images. Such other image-manipulation features as minimal compositing operator and resizing option available under RMT command structure. RMT written in FORTRAN 77 and C language.

A Piloted Evaluation of Damage Accommodating Flight Control Using a Remotely Piloted Vehicle

NASA Technical Reports Server (NTRS)

Cunningham, Kevin; Cox, David E.; Murri, Daniel G.; Riddick, Stephen E.

2011-01-01

Toward the goal of reducing the fatal accident rate of large transport airplanes due to loss of control, the NASA Aviation Safety Program has conducted research into flight control technologies that can provide resilient control of airplanes under adverse flight conditions, including damage and failure. As part of the safety program s Integrated Resilient Aircraft Control Project, the NASA Airborne Subscale Transport Aircraft Research system was designed to address the challenges associated with the safe and efficient subscale flight testing of research control laws under adverse flight conditions. This paper presents the results of a series of pilot evaluations of several flight control algorithms used during an offset-to-landing task conducted at altitude. The purpose of this investigation was to assess the ability of various flight control technologies to prevent loss of control as stability and control characteristics were degraded. During the course of 8 research flights, data were recorded while one task was repeatedly executed by a single evaluation pilot. Two generic failures, which degraded stability and control characteristics, were simulated inflight for each of the 9 different flight control laws that were tested. The flight control laws included three different adaptive control methodologies, several linear multivariable designs, a linear robust design, a linear stability augmentation system, and a direct open-loop control mode. Based on pilot Cooper-Harper Ratings obtained for this test, the adaptive flight control laws provided the greatest overall benefit for the stability and control degradation scenarios that were considered. Also, all controllers tested provided a significant improvement in handling qualities over the direct open-loop control mode.

Failure to Treat Life-Threatening Ventricular Tachyarrhythmias in Contemporary Implantable Cardioverter–Defibrillators

PubMed Central

Thøgersen, Anna Margrethe; Larsen, Jacob Moesgaard; Johansen, Jens Brock; Abedin, Moeen

2017-01-01

Background: In clinical trials, manufacturer-specific, strategic programming of implantable cardioverter–defibrillators (ICDs), including faster detection rates, reduces unnecessary therapy but permits therapy for ventricular tachycardia/ventricular fibrillation (VF). Present consensus recommends a generic rate threshold between 185 and 200 beats per minute, which exceeds the rate tested in clinical trials for some manufacturers. In a case series, we sought to determine the relationship between programmed parameters and failure of modern ICDs to treat VF. Methods and Results: We reviewed cases in which normally functioning ICDs failed to deliver timely therapy for VF from April 2015 to January 2017 at 4 institutions. Of 10 ambulatory patients, 5 died from untreated VF, 4 had cardiac arrests requiring external shocks, and 1 was rescued by a delayed ICD shock. VF did not satisfy programmed detection criteria in 9 patients (90%). Seven of these patients had slowest detection rates that were consistent with generic recommendations but not tested in a peer-reviewed trial for their manufacturer’s ICDs. Manufacturer-specific factors interacted with fast detection rates to withhold therapy, including strict VF episode termination rules, enhancements to minimize T-wave oversensing, and features that restrict therapy to regular rhythms in ventricular tachycardia zones. Untreated VF despite recommended programming accounted for 56% of sudden deaths and 11% of all deaths during the study period. Conclusions: Complex and unanticipated interactions between manufacturer-specific features and generic programming can prevent therapy for VF. More data are needed to assess the risks and benefits of translating evidence-based detection parameters from one manufacturer to another. PMID:28916511

(abstract) Generic Modeling of a Life Support System for Process Technology Comparisons

NASA Technical Reports Server (NTRS)

Ferrall, J. F.; Seshan, P. K.; Rohatgi, N. K.; Ganapathi, G. B.

1993-01-01

This paper describes a simulation model called the Life Support Systems Analysis Simulation Tool (LiSSA-ST), the spreadsheet program called the Life Support Systems Analysis Trade Tool (LiSSA-TT), and the Generic Modular Flow Schematic (GMFS) modeling technique. Results of using the LiSSA-ST and the LiSSA-TT will be presented for comparing life support systems and process technology options for a Lunar Base and a Mars Exploration Mission.

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates

PubMed Central

Olszynski, Wojciech P.; Adachi, Jonathan D.; Davison, K. Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies. PMID:25349772

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates.

PubMed

Olszynski, Wojciech P; Adachi, Jonathan D; Davison, K Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.

[Can we transfer the mechanisms of the generics market to biosimilars?

PubMed

Jacke, Ch O; Wild, F

2016-12-15

Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period. Price competition similar to that found in the generic markets has been established for erythropoietin and filgrastim. The same has not been observed for follitropin alfa and somatropin due to the limited number of competitors and products available at this stage. No definitive conclusions can be drown from the results at this stage. Time will tell whether it will be possible for physicians and individuals with private health insurance to fully leverage the savings potential of biosimilars while safeguarding patient safety.

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

ENVIRONMENTAL TECHNOLOGY VERIFICATION COATINGS AND COATING EQUIPMENT PROGRAM (ETV CCEP) HIGH TRANSFER EFFICIENCE SPRAY EQUIPMENT--GENERIC VERIFICATION PROTOCOL

EPA Science Inventory

The Environmental Technology Verification (ETV) Program has been established to verify the performance characteristics of innovative environmental technologies and report this objective information, thus, accelerating the entrance of these new technologies into the marketplace. V...

7 CFR 1485.18 - Advances.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AGRICULTURE EXPORT PROGRAMS COOPERATIVE AGREEMENTS FOR THE DEVELOPMENT OF FOREIGN MARKETS FOR AGRICULTURAL COMMODITIES Market Access Program § 1485.18 Advances. (a) Policy. In general, CCC operates MAP and EIP/MAP on... participant for generic promotion activities. Prior to making an advance, CCC may require the participant to...

49 CFR 268.11 - Project eligibility standards.

Code of Federal Regulations, 2012 CFR

2012-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MAGNETIC LEVITATION TRANSPORTATION TECHNOLOGY DEPLOYMENT PROGRAM... from the technology (e.g. energy consumption compared to other transportation options); generic noise...

49 CFR 268.11 - Project eligibility standards.

Code of Federal Regulations, 2014 CFR

2014-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MAGNETIC LEVITATION TRANSPORTATION TECHNOLOGY DEPLOYMENT PROGRAM... from the technology (e.g. energy consumption compared to other transportation options); generic noise...

49 CFR 268.11 - Project eligibility standards.

Code of Federal Regulations, 2013 CFR

2013-10-01

... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MAGNETIC LEVITATION TRANSPORTATION TECHNOLOGY DEPLOYMENT PROGRAM... from the technology (e.g. energy consumption compared to other transportation options); generic noise...

NLEdit: A generic graphical user interface for Fortran programs

NASA Technical Reports Server (NTRS)

Curlett, Brian P.

1994-01-01

NLEdit is a generic graphical user interface for the preprocessing of Fortran namelist input files. The interface consists of a menu system, a message window, a help system, and data entry forms. A form is generated for each namelist. The form has an input field for each namelist variable along with a one-line description of that variable. Detailed help information, default values, and minimum and maximum allowable values can all be displayed via menu picks. Inputs are processed through a scientific calculator program that allows complex equations to be used instead of simple numeric inputs. A custom user interface is generated simply by entering information about the namelist input variables into an ASCII file. There is no need to learn a new graphics system or programming language. NLEdit can be used as a stand-alone program or as part of a larger graphical user interface. Although NLEdit is intended for files using namelist format, it can be easily modified to handle other file formats.

Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2011-07-01

To explore the current status (2010) of tendering programs for outpatient pharmaceuticals in the European countries and how these programs operate. A survey was designed to assess the features of tendering programs in European countries. All 27 countries of the European Union plus Norway were included in the study. The survey was sent to national representatives of authorities and organizations and to academic researchers with expertise in the domain. Nineteen of the 28 countries have responded to the questionnaire (68%). Seven countries have adopted tendering programs for pharmaceuticals in ambulatory care. Tendering was more popular in countries with a mature generic medicines market (54%) than in countries with a developing generic medicines market (12.5%). A legal basis, criteria to grant the tender, the number of winners and the duration of the tender were amongst the features for the program to work. Tendering programs can achieve savings in the short term. There are however some problems allied with the policy and the effects in the long term are still unclear. It can be concluded that the policy can work, but the features of the programs have to be well-thought-out. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The Administrator Training Program. A Model of Educational Leadership.

ERIC Educational Resources Information Center

Funderburg, Jean; And Others

This paper describes the Administrator Training Program (ATP), a joint venture between San Jose Unified School District and Stanford University. A discussion of the ATP's theoretical framework is followed by an outline of the structure and content of the program and a review of the ATP outcomes. Then the generic elements of the ATP model are…

Developing Student Programming and Problem-Solving Skills with Visual Basic

ERIC Educational Resources Information Center

Siegle, Del

2009-01-01

Although most computer users will never need to write a computer program, many students enjoy the challenge of creating one. Computer programming enhances students' problem solving by forcing students to break a problem into its component pieces and reassemble it in a generic format that can be understood by a nonsentient entity. It promotes…

European solvent industry group generic exposure scenario risk and exposure tool

PubMed Central

Zaleski, Rosemary T; Qian, Hua; Zelenka, Michael P; George-Ares, Anita; Money, Chris

2014-01-01

The European Solvents Industry Group (ESIG) Generic Exposure Scenario (GES) Risk and Exposure Tool (EGRET) was developed to facilitate the safety evaluation of consumer uses of solvents, as required by the European Union Registration, Evaluation and Authorization of Chemicals (REACH) Regulation. This exposure-based risk assessment tool provides estimates of both exposure and risk characterization ratios for consumer uses. It builds upon the consumer portion of the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) tool by implementing refinements described in ECETOC TR107. Technical enhancements included the use of additional data to refine scenario defaults and the ability to include additional parameters in exposure calculations. Scenarios were also added to cover all frequently encountered consumer uses of solvents. The TRA tool structure was modified to automatically determine conditions necessary for safe use. EGRET reports results using specific standard phrases in a format consistent with REACH exposure scenario guidance, in order that the outputs can be readily assimilated within safety data sheets and similar information technology systems. Evaluation of tool predictions for a range of commonly encountered consumer uses of solvents found it provides reasonable yet still conservative exposure estimates. PMID:23361440

European solvent industry group generic exposure scenario risk and exposure tool.

PubMed

Zaleski, Rosemary T; Qian, Hua; Zelenka, Michael P; George-Ares, Anita; Money, Chris

2014-01-01

The European Solvents Industry Group (ESIG) Generic Exposure Scenario (GES) Risk and Exposure Tool (EGRET) was developed to facilitate the safety evaluation of consumer uses of solvents, as required by the European Union Registration, Evaluation and Authorization of Chemicals (REACH) Regulation. This exposure-based risk assessment tool provides estimates of both exposure and risk characterization ratios for consumer uses. It builds upon the consumer portion of the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) tool by implementing refinements described in ECETOC TR107. Technical enhancements included the use of additional data to refine scenario defaults and the ability to include additional parameters in exposure calculations. Scenarios were also added to cover all frequently encountered consumer uses of solvents. The TRA tool structure was modified to automatically determine conditions necessary for safe use. EGRET reports results using specific standard phrases in a format consistent with REACH exposure scenario guidance, in order that the outputs can be readily assimilated within safety data sheets and similar information technology systems. Evaluation of tool predictions for a range of commonly encountered consumer uses of solvents found it provides reasonable yet still conservative exposure estimates.

Do drug advertisements in Russian medical journals provide essential information for safe prescribing?

PubMed Central

Vlassov, Vasiliy; Mansfield, Peter; Lexchin, Joel; Vlassova, Anna

2001-01-01

Objective To examine pharmaceutical advertisements in medical journals for their adequacy of information. Methods We selected a convenience sample of 5 major Russian medical journals covering different fields of medicine and different types of publications. We evaluated all the ads in all the issues of the selected journals published during 1998. We counted the number of appearances of trade, chemical, and generic names; indication and contraindication; pharmacologic group; safety warnings; and references. Counts in all categories were aggregated for each advertiser. Results There were 397 placements of 207 distinct advertisements. Only 154 placements (40%) mentioned the generic name, 177 (45%) mentioned any indication, 42 (11%) mentioned safety warnings and contraindications, 21 (5%) warned about drug interactions, and 8 (2%) provided references. The 6 companies responsible for the most ads on average provided less information than the other companies. Conclusions Almost none of the drug ads published in Russian medical journals provide the basic information required for appropriate prescribing. This is despite the fact that in Russia, ads that omit essential information and that could lead consumers to misunderstandings about an advertised product are illegal. The arrival of drug advertising in Russia has brought little information and has been potentially damaging. PMID:11381003

Energy use in the marine transportation industry. Task III. Efficiency improvements. Draft report

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

Not Available

1977-06-02

Research and development areas that hold promise for maritime energy conservation are identified and evaluated. The methodology used is discussed in Chapter II. The technology base of the commercial marine transportation industry relating to energy usage is made up of: main propulsion plants, propulsors, hydrodynamics, vessel operations, and fuels. Fifteen specific program areas in the first four generic technologies are identified and are evaluated. An economic and energy impact analysis and technological risk assessment was performed on the specific program areas and the results are summarized in Chapter III. The first five appendices address the generic technologies. The sixth appendixmore » contains the baseline operating and cost parameters against which the 15 program areas were evaluated, and the last appendix contains sample printouts of the MTEM model used to evaluate the energy consumption and economic impacts associated with the candidate technology areas. (MCW)« less

A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression.

PubMed

Durkalski, Valerie; Wenle Zhao; Dillon, Catherine; Kim, Jaemyung

2010-04-01

Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost. To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression. The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems. The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports. Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is increased and the value of using this system for other trials is reduced. Web-based central computerized systems offer time-saving, secure options for managing clinical trial data. The choice of a commercially available system or an internally developed system is determined by the requirements of the study and users. Pros and cons to both approaches were discussed. If the intention is to use the system for various trials (single and multi-center, phases I-III) across various therapeutic areas, then the overall design should be a generic structure that simplifies the general application with minimal loss of functionality.

Managing prescription drug costs: a case study.

PubMed

DuBois, R W; Feinberg, P E

1994-06-01

Pharmacy costs in most private insurance companies and public concerns have risen over the past several years. To address the problem of increased expenditures in its government employee pharmacy program, the State of New York sought bids from outside vendors to help it control pharmaceutical costs. The following is a case study of the tools the state employed in that effort. Over time, both prescription drug coverage and mental health and substance abuse benefits were carved out of the medical plan and are now provided under free-standing programs. In order to participate, an independent pharmacy must accept a discount of 10% off the average wholesale price of brand name drugs and 25% off the average generic price of generic drugs.

Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients.

PubMed

Söderlund, Carl; Rådegran, Göran

2015-07-01

Generic immunosuppressants may offer economic advantages, but their use is still controversial. At our center, 55 heart transplant patients were switched from CellCept(®) to Myfenax Teva(®) (MT) (n = 51, 18% female, 8.1 ± 6.6 yr post-transplantation) and/or Prograf(®) to Tacrolimus Sandoz(®) (TS) (n = 17, 41% female, 6.6 ± 5.8 yr post-transplantation). We conducted an acute monitoring and a retrospective follow-up with regard to safety and efficacy. Acute cellular rejections (ACRs) on endomyocardial biopsies (EMBs) four wk after the MT switch were specifically compared to a matched retrospective control group. Tacrolimus C0 levels (TS switch) as well as hemoglobin, leukocytes, and thrombocytes (MT switch) did not change (p = NS) during the three wk after each respective switch (8.7 ± 2.9 vs. 8.4 ± 1.9 μg/L, 129.1 ± 12.6 vs. 130.1 ± 12.8 g/L, 6.3 vs. 6.2 × 10(9) /L, and 217.4 ± 56.6 vs. 219.3 ± 61.8 × 10(9) /L, respectively). 0% of the EMBs in the MT switch vs. 3% of the EMBs in the control group showed ACR>grade 1R (p = NS). After six months, survival was 96% (MT switch) and 100% (TS switch), and the frequency of severe ACR was low. Safety parameters measured at the next annual follow-up were also stable following each switch. Switching to MT and/or TS several years after heart transplantation appeared safe in the short-term perspective, showing no detectable changes in tacrolimus C0 levels, safety or efficacy, during an average follow-up of six months. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Managing emergencies and abnormal situations in air traffic control (part II): teamwork strategies.

PubMed

Malakis, Stathis; Kontogiannis, Tom; Kirwan, Barry

2010-07-01

Team performance has been studied in many safety-critical organizations including aviation, nuclear power plant, offshore oil platforms and health organizations. This study looks into teamwork strategies that air traffic controllers employ to manage emergencies and abnormal situations. Two field studies were carried out in the form of observations of simulator training in emergency and unusual scenarios of novices and experienced controllers. Teamwork strategies covered aspects of team orientation and coordination, information exchange, change management and error handling. Several performance metrics were used to rate the efficiency of teamwork and test the construct validity of a prototype model of teamwork. This is a companion study to an earlier investigation of taskwork strategies in the same field (part I) and contributes to the development of a generic model for Taskwork and Teamwork strategies in Emergencies in Air traffic Management (T(2)EAM). Suggestions are made on how to use T(2)EAM to develop training programs, assess team performance and improve mishap investigations. Copyright 2010 Elsevier Ltd. All rights reserved.

SP-100 - The national space reactor power system program in response to future needs

NASA Astrophysics Data System (ADS)

Armijo, J. S.; Josloff, A. T.; Bailey, H. S.; Matteo, D. N.

The SP-100 system has been designed to meet comprehensive and demanding NASA/DOD/DOE requirements. The key requirements include: nuclear safety for all mission phases, scalability from 10's to 100's of kWe, reliable performance at full power for seven years of partial power for ten years, survivability in civil or military threat environments, capability to operate autonomously for up to six months, capability to protect payloads from excessive radiation, and compatibility with shuttle and expendable launch vehicles. The authors address of major progress in terms of design, flexibility/scalability, survivability, and development. These areas, with the exception of survivability, are discussed in detail. There has been significant improvement in the generic flight system design with substantial mass savings and simplification that enhance performance and reliability. Design activity has confirmed the scalability and flexibility of the system and the ability to efficiently meet NASA, AF, and SDIO needs. SP-100 development continues to make significant progress in all key technology areas.

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

PubMed

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Follow-on biologics: competition in the biopharmaceutical marketplace.

PubMed

Devine, Joshua W; Cline, Richard R; Farley, Joel F

2006-01-01

To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

PubMed

Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

2014-04-01

The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

Family Centered Care. Triennial Report 1986-1989.

ERIC Educational Resources Information Center

Michigan State Dept. of Public Health, Lansing, MI. Div. of Services to Crippled Children.

The report describes services, administration, and future directions of the Children's Special Health Care Services program, part of the Michigan Department of Public Health. Division programs are carried out at local, regional, and state levels and provide: preventive services (through generic and newborn screening services and neonatal intensive…

Environmental Technology Verification Coatings and Coating Equipment Program (ETV CCEP) High Transfer Efficiency Spray Equipment--Generic Verification Protocol

EPA Science Inventory

The Environmental Technology Verification (ETV) Program has been established by the U.S. Environmental Protection Agency (EPA) to verify the performance characteristics of innovative environmental technologies across all media and report this objective information to the states, ...

Composite structural materials

NASA Technical Reports Server (NTRS)

Loewy, R.; Wiberley, S. E.

1986-01-01

Overall emphasis is on basic long-term research in the following categories: constituent materials, composite materials, generic structural elements, processing science technology; and maintaining long-term structural integrity. Research in basic composition, characteristics, and processing science of composite materials and their constituents is balanced against the mechanics, conceptual design, fabrication, and testing of generic structural elements typical of aerospace vehicles so as to encourage the discovery of unusual solutions to present and future problems. Detailed descriptions of the progress achieved in the various component parts of this comprehensive program are presented.

Performance degradation of a model helicopter rotor with a generic ice shape

NASA Technical Reports Server (NTRS)

Korkan, K. D.; Cross, E. J., Jr.; Miller, T. L.

1984-01-01

An experimental program using a commercially available remotely controlled model helicopter in the Texas A&M University (TAMU) subsonic wind tunnel has been conducted to investigate the performance degradation resulting from the simulated formation of ice on the leading edge of the main rotor blades in both hover and forward flight. The rotor blades utilized a NACA 0012 airfoil with a 2.5-in. constant chord. A generic ice shape derived from a predetermined natural ice condition was applied to the 53.375-in.-diameter main rotor, and thrust and torque coefficients were measured for the main rotor as functions of velocity, main rotor rpm, fuselage angle of incidence, collective pitch angle, and spanwise extent of icing. The model helicopter test exhibited significant performance degradation of the main rotor when generic ice was added. An increase of approximately 150 percent in torque coefficient to maintain a constant thrust coefficient was noted when generic ice had been applied to the 85 percent rotor radial location. Also, considerable additional degradation occurred when generic ice was applied to the 100 percent rotor radial location, as compared with the 85 percent simulated ice performance values, indicating the sensitivity of the rotor tip region.

New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance.

PubMed

LaPointe, Nancy M Allen; Pamer, Carol A; Kramer, Judith M

2003-10-01

To determine how well dofetilide and Betapace AF (sotalol, approved solely for atrial fibrillation and atrial flutter), with their detailed dosing and monitoring guidelines for safety, were accepted into clinical practice during the 2 calendar years after their introduction. We reviewed the number of new, refill, and total prescriptions of all antiarrhythmic agents in the United States from April 2000-December 2001 to assess use of dofetilide and Betapace AF in the drug market. Both were prescribed very infrequently throughout the study period. In addition, the infrequent reported use of these drugs for patients with atrial fibrillation and flutter indicated poor acceptance of these agents by prescribing physicians. We speculated that the restricted distribution and required educational program for dofetilide, as well as the availability of generic sotalol products, may have discouraged physicians from prescribing both dofetilide and Betapace AE CONCLUSION: A common goal for both the dofetilide risk-management program and the creation of a sotalol product indicated solely for atrial fibrillation and atrial flutter was to provide safer treatment for patients with these arrhythmias. Unfortunately, limited penetration of dofetilide and Betapace AF into the U.S. market suggests that drugs without a risk-management program or detailed dosing guidelines were more likely than dofetilide or Betapace AF to be selected for treatment of atrial fibrillation and atrial flutter.

Psychometric properties of the Norwegian version of the Safety Attitudes Questionnaire (SAQ), Generic version (Short Form 2006).

PubMed

Deilkås, Ellen T; Hofoss, Dag

2008-09-22

How to protect patients from harm is a question of universal interest. Measuring and improving safety culture in care giving units is an important strategy for promoting a safe environment for patients. The Safety Attitudes Questionnaire (SAQ) is the only instrument that measures safety culture in a way which correlates with patient outcome. We have translated the SAQ to Norwegian and validated the translated version. The psychometric properties of the translated questionnaire are presented in this article. The questionnaire was translated with the back translation technique and tested in 47 clinical units in a Norwegian university hospital. SAQ's (the Generic version (Short Form 2006) the version with the two sets of questions on perceptions of management: on unit management and on hospital management) were distributed to 1911 frontline staff. 762 were distributed during unit meetings and 1149 through the postal system. Cronbach alphas, item-to-own correlations, and test-retest correlations were calculated, and response distribution analysis and confirmatory factor analysis were performed, as well as early validity tests. 1306 staff members completed and returned the questionnaire: a response rate of 68%. Questionnaire acceptability was good. The reliability measures were acceptable. The factor structure of the responses was tested by confirmatory factor analysis. 36 items were ascribed to seven underlying factors: Teamwork Climate, Safety Climate, Stress Recognition, Perceptions of Hospital Management, Perceptions of Unit Management, Working conditions, and Job satisfaction. Goodness-of-Fit Indices showed reasonable, but not indisputable, model fit. External validity indicators - recognizability of results, correlations with "trigger tool"-identified adverse events, with patient satisfaction with hospitalization, patient reports of possible maltreatment, and patient evaluation of organization of hospital work - provided preliminary validation. Based on the data from Akershus University Hospital, we conclude that the Norwegian translation of the SAQ showed satisfactory internal psychometric properties. With data from one hospital only, we cannot draw strong conclusions on its external validity. Further validation studies linking the SAQ-scores to patient outcome data should be performed.

Criticality Safety Evaluation of Standard Criticality Safety Requirements #1-520 g Operations in PF-4

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

Yamanaka, Alan Joseph Jr.

Guidance has been requested from the Nuclear Criticality Safety Division (NCSD) regarding processes that involve 520 grams of fissionable material or less. This Level-3 evaluation was conducted and documented in accordance with NCS-AP-004 (Ref. 1), formerly NCS-GUIDE-01. This evaluation is being written as a generic evaluation for all operations that will be able to operate using a 520-gram mass limit. Implementation for specific operations will be performed using a Level 1 CSED, which will confirm and document that this CSED can be used for the specific operation as discussed in NCS-MEMO-17-007 (Ref. 2). This Level 3 CSED updates and supersedesmore » the analysis performed in NCS-TECH-14-014 (Ref. 3).« less

Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study.

PubMed

Marciano, Sebastián; Haddad, Leila; Reggiardo, María V; Peralta, Mirta; Vistarini, Cecilia; Marino, Mónica; Descalzi, Valeria I; D'Amico, Claudia; Figueroa Escuti, Sebastián; Gaite, Luis A; Perez Ravier, Roberto; Longo, Cristina; Borzi, Silvia M; Galdame, Omar A; Bessone, Fernando; Fainboim, Hugo A; Frías, Silvia; Cartier, Mariano; Gadano, Adrián C

2018-05-01

We report the first real-world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir-based regimens in patients with chronic hepatitis C in Latin America. The main endpoints were assessment of sustained virological response and serious adverse events rates. A total of 321 patients with chronic hepatitis C treated with the following regimens were included: sofosbuvir plus daclatasvir for 12 (n = 34) or 24 (n = 135) weeks, sofosbuvir plus daclatasvir plus ribavirin for 12 (n = 84) or 24 (n = 56) weeks, or sofosbuvir plus ribavirin for 12 (n = 8) or 24 (n = 2) weeks. Patients received either original sofosbuvir (Sovaldi ® , Gilead Sciences, n = 135) or generic sofosbuvir (Probirase ® , Laboratorios RICHMOND, n = 184) which were randomly assigned by the National Ministry of Health. Overall, 292 (91%) patients had cirrhosis, 136 (42%) were treatment experienced, and 240 (75%) genotype 1. The overall sustained virological response was 90% (95% CI 86-93%); 91% (95% CI 84-95%) in patients who received Sovaldi ® , and 89% (95% CI 84-93%) in patients who received Probirase ® . Anemia was the most common adverse event and was reported in 52 (17%) patients. Bacterial infection, gastrointestinal bleeding, worsening of ascites or encephalopathy occurred in less than 5% of the patients. During the study, seven (2%) patients died, four of whom died of cirrhosis-related complications. In summary, we observed similar sustained virological response rates than prior studies, both in patients who received Sovaldi ® or Probirase ® . Serious adverse events were infrequent, in line with prior studies that included patients with cirrhosis treated with protease-inhibitor-free regimes. © 2018 Wiley Periodicals, Inc.

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India

PubMed Central

2008-01-01

Objective To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Methods Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. Results One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3–4 central nervous system disturbances, 4 for grade 3–4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3–4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. Conclusion A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions. PMID:19825144

Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India

PubMed Central

Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshi, Kedar; Bele, Vivek

2008-01-01

Objective To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Methods Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. Results One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. Conclusion A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions. PMID:18924648

Architectural design for a low cost FPGA-based traffic signal detection system in vehicles

NASA Astrophysics Data System (ADS)

López, Ignacio; Salvador, Rubén; Alarcón, Jaime; Moreno, Félix

2007-05-01

In this paper we propose an architecture for an embedded traffic signal detection system. Development of Advanced Driver Assistance Systems (ADAS) is one of the major trends of research in automotion nowadays. Examples of past and ongoing projects in the field are CHAMELEON ("Pre-Crash Application all around the vehicle" IST 1999-10108), PREVENT (Preventive and Active Safety Applications, FP6-507075, http://www.prevent-ip.org/) and AVRT in the US (Advanced Vision-Radar Threat Detection (AVRT): A Pre-Crash Detection and Active Safety System). It can be observed a major interest in systems for real-time analysis of complex driving scenarios, evaluating risk and anticipating collisions. The system will use a low cost CCD camera on the dashboard facing the road. The images will be processed by an Altera Cyclone family FPGA. The board does median and Sobel filtering of the incoming frames at PAL rate, and analyzes them for several categories of signals. The result is conveyed to the driver. The scarce resources provided by the hardware require an architecture developed for optimal use. The system will use a combination of neural networks and an adapted blackboard architecture. Several neural networks will be used in sequence for image analysis, by reconfiguring a single, generic hardware neural network in the FPGA. This generic network is optimized for speed, in order to admit several executions within the frame rate. The sequence will follow the execution cycle of the blackboard architecture. The global, blackboard architecture being developed and the hardware architecture for the generic, reconfigurable FPGA perceptron will be explained in this paper. The project is still at an early stage. However, some hardware implementation results are already available and will be offered in the paper.

Competitive Strategy in Continuing Education.

ERIC Educational Resources Information Center

Baden, Clifford

1987-01-01

Reviews strategic variables available to those planning continuing education marketing programs. Discusses generic competitive strategies: (1) overall cost leadership, (2) differentiation, and (3) specialization. Mentions several potential problems. (CH)

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.

Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

PubMed

Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

2007-11-13

Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir/r, efavirenz, tenofovir, atazanavir, enfuvirtide, and a locally produced generic, fixed-dose combination of zidovudine and lamivudine (AZT/3TC). Because prices declined for many of the patented drugs that constitute the largest share of drug costs, nearly the entire increase in overall drug expenditures between 2001 and 2005 is attributable to increases in drug quantities. Had all drug quantities been held constant from 2001 until 2005 (or for those drugs entering treatment guidelines after 2001, held constant between the year of introduction and 2005), total costs would have increased by only an estimated US$7 million. We estimate that in the absence of price declines for patented drugs, Brazil would have spent a cumulative total of US$2 billion on drugs for HAART between 2001 and 2005, implying a savings of US$1.2 billion from price declines. Finally, in comparing Brazilian prices for locally produced generic ARVs to the lowest international prices meeting global pharmaceutical quality standards, we find that current prices for Brazil's locally produced generics are generally much higher than corresponding global prices, and note that these prices have risen in Brazil while declining globally. We estimate the excess costs of Brazil's locally produced generics totaled US$110 million from 2001 to 2005. Despite Brazil's more costly generic ARVs, the net result of ARV price changes has been a cost savings of approximately US$1 billion since 2001. HAART costs have nevertheless risen steeply as Brazil has scaled up treatment. These trends may foreshadow future AIDS treatment cost trends in other developing countries as more people start treatment, AIDS patients live longer and move from first-line to second and third-line treatment, AIDS treatment becomes more complex, generic competition emerges, and newer patented drugs become available. The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.

Supporting Individuals with Autism Spectrum Disorder in Recreation

ERIC Educational Resources Information Center

Coyne, Phyllis; Fullerton, Ann

2004-01-01

This book was developed to assist recreation service providers, as well as families, to understand strategies for supporting individuals with ASD in community and school recreation programs. The ideas have many practical uses in generic and specialized recreation programs. A variety of audiences, including teachers, recreation service providers,…

A Network Design Architecture for Distribution of Generic Scene Graphs

DTIC Science & Technology

1999-09-01

with UML. Addison Wesley. Deitel, H. and Deitel, P. 1994. C++ How to Program . Prentice Hall. Deitel, H. and Deitel, P. 1998. JAVA How ... to . Program . Prentice.Hall. Eckel, B. 1998. Thinking in JAVA. Prentice Hall. 141 Edwards, J. 1997. 3-Tier Client/Server At Work. John

Community-Based Prevention Specialist. Trainer Manual.

ERIC Educational Resources Information Center

University Research Corp., Bethesda, MD.

This trainer manual is designed to assist facilitators in the design of entry-level courses and programs for substance abuse prevention specialists. The manual initially concentrates on a basic, generic approach to community work, and introduces the knowledge and skills needed to implement substance abuse prevention programs by using the community…

Online Collaborative Communities of Learning for Pre-Service Teachers of Languages

ERIC Educational Resources Information Center

Morgan, Anne-Marie

2015-01-01

University programs for preparing preservice teachers of languages for teaching in schools generally involve generic pedagogy, methodology, curriculum, programming and issues foci, that provide a bridge between the study of languages (or recognition of existing language proficiency) and the teaching of languages. There is much territory to cover…

Kmonodium, a Program for the Numerical Solution of the One-Dimensional Schrodinger Equation

ERIC Educational Resources Information Center

Angeli, Celestino; Borini, Stefano; Cimiraglia, Renzo

2005-01-01

A very simple strategy for the solution of the Schrodinger equation of a particle moving in one dimension subjected to a generic potential is presented. This strategy is implemented in a computer program called Kmonodium, which is free and distributed under the General Public License (GPL).

76 FR 5841 - Agency Information Collection Activities: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-02

... renewal of program accountability and communication data collections (e.g., surveys, face-to-face and... Performance and Results Acts (GPRA) of 1993. Under this generic survey clearance (OMB 3145-0136), data from... descriptive information gathered from education and training projects that are funded by NSF. Most programs...

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.

The economics of biosimilars.

PubMed

Blackstone, Erwin A; Joseph, P Fuhr

2013-09-01

The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. To examine information related to biosimilars to determine their potential impact on competition in the biologic market. Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.

Low Concentration of Salmonella enterica and Generic Escherichia coli in Farm Ponds and Irrigation Distribution Systems Used for Mixed Produce Production in Southern Georgia.

PubMed

Antaki, Elizabeth M; Vellidis, George; Harris, Casey; Aminabadi, Peiman; Levy, Karen; Jay-Russell, Michele T

2016-10-01

Studies have shown that irrigation water can be a vector for pathogenic bacteria. Due to this, the Food Safety Modernization Act's (FSMA) produce safety rule requires that agricultural water directly applied to produce be safe and of adequate sanitary quality for use, which may pose a challenge for some farmers. The purpose of this research was to assess the presence and concentration of Salmonella and generic Escherichia coli in irrigation water from distribution systems in a mixed produce production region of southern Georgia. Water samples were collected during three growing seasons at three farms irrigating crops with surface water (Pond 1, Pond 2) or groundwater (Well) during 2012-2013. Salmonella and generic E. coli populations were monitored by culture and Most Probable Number (MPN). Confirmed isolates were characterized by pulsed-field gel electrophoresis and serotyping. In Pond 1, Salmonella was detected in 2/21 surface, 5/26 subsurface, 10/50 center pivot, and 0/16 solid set sprinkler head water samples. In Pond 2, Salmonella was detected in 2/18 surface, 1/18 subsurface, 6/36 drip line start, and 8/36 drip line end water samples. Twenty-six well pumps and 64 associated drip line water samples were negative. The overall mean Salmonella concentration for positive water samples was 0.03 MPN/100 mL (range <0.0011-1.8 MPN/100 mL). Nine Salmonella serovars comprising 22 pulsotypes were identified. Identical serovars and subtypes were found three times on the same day and location: Pond 1-Pivot-Cantaloupe (serovar Rubislaw), Pond 1-Pivot-Peanut (serovar Saintpaul), and Pond 2-Drip Line Start-Drip Line End-Yellow Squash (serovar III_16z10:e,n,x,z15). Generic E. coli was detected in water from both farm ponds and irrigation distribution systems, but the concentrations met FSMA microbial water quality criteria. The results from this study will allow producers in southern Georgia to better understand how potential pathogens move through irrigation distribution systems.

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

Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: A questionnaire based study

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad; Masood, Imran; Low, Bee Yean; Shafie, Asrul Akmal; Babar, Zaheer-ud-din

2012-01-01

Objectives: In developing countries out-of-pocket payments (OOP) are as high as 80% of healthcare spending. Generic medicines can be instrumental in reducing this expenditure. The current study is aimed to explore the knowledge, perception, and attitude of general practitioners towards generic medicines in Karachi, Pakistan. Methods: This exploratory, descriptive study was conducted on a sample of 289 randomly selected general practitioners who were dispensing at their private clinics in Karachi, Pakistan. The questionnaires were distributed and collected by hand. Data was entered to SPSS version 17. Fischer’s exact test was applied to see the association between variables. Results: A total of 206 questionnaires were included in the study. A response rate of 71.3% was achieved. Out of 206 respondents, 139 (67.5%) were male while 67 (32.5%) respondents were female. Close to three quaters of the respondents (n= 148; 71.8%) showed correct knowledge about generic medicines being a ‘copy of the brand name medicines’ and ‘interchangeable with brand name medicines’ (n= 148; 71.8%). In terms of safety, the majority of respondents (n=85; 41.26%) incorrectly understood that the generic medicines are less safe than brand name medicines. The total percentage of correct responses was seen in 53% of the respondents. More than half of the respondents agreed that locally manufactured medicines are of the same effectiveness as brand name medicines (n=114; 55.4%). Male practitioners with practice experience of 11-15 years showed positive perception towards the quality of multinational products. The Majority of respondents believed that their prescribing decision is influenced by medical representatives (n=117; 56.8%). More than three-quarters of the respondents expressed their wish to prescribe low cost medicines in their practice (n=157; 76.2%). More than one third of the respondents expressed their uneasiness to prescribe products from all local manufacturers (n=72; 35%). Conclusion: There were gaps identified in the knowledge of respondents. Although good perception and attitude were noted among the respondents, dissemination of information regarding generic medicines may perhaps strengthen generic prescribing. There is a need to introduce ‘Quality by Design’ concept in local manufacturing units. This, in turn, can inculcate confidence in prescribers towards locally manufactured generic medicines. PMID:23093896

Ports and Waterways Safety Assessment Workshop Report, Buzzards Bay, MA

DTIC Science & Technology

2003-09-10

Light tower observations show the highest average sustained winds along this coast. The Bay develops wind chop more than swell. • The National...beaches and shellfish beds pursuant to public health requirements. Well developed notification plans are in place. • Public health agencies are...implementing selected risk mitigation measures. The PAWSA methodology employs a generic model of waterway risk that was conceptually developed by a

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet.

PubMed

Veronin, Michael A; Nutan, Mohammad T; Dodla, Uday Krishna Reddy

2014-10-01

The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet.

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

PubMed Central

Nutan, Mohammad T.; Dodla, Uday Krishna Reddy

2014-01-01

Background: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. Objective: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. Methods: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Results: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet. PMID:25360239

Generic icing effects on forward flight performance of a model helicopter rotor

NASA Technical Reports Server (NTRS)

Tinetti, Ana F.; Korkan, Kenneth D.

1989-01-01

An experimental program using a commercially available model helicopter has been conducted in the TAMU 7 ft x 10 ft Subsonic Wind Tunnel to investigate main rotor performance degradation due to generic ice adhesion. Base and iced performance data were gathered as functions of fuselage incidence, blade collective pitch, main rotor rotational velocity, and freestream velocity. The experimental values have shown that, in general, the presence of generic ice introduces decrements in performance caused by leading edge separation regions and increased surface roughness. In addition to the expected changes in aerodynamic forces caused by variations in test Reynolds number, forward flight data seemed to be influenced by changes in freestream and rotational velocity. The dependence of the data upon such velocity variations was apparently enhanced by increases in blade chord.

An automation-assisted generic approach for biological sample preparation and LC-MS/MS method validation.

PubMed

Zhang, Jie; Wei, Shimin; Ayres, David W; Smith, Harold T; Tse, Francis L S

2011-09-01

Although it is well known that automation can provide significant improvement in the efficiency of biological sample preparation in quantitative LC-MS/MS analysis, it has not been widely implemented in bioanalytical laboratories throughout the industry. This can be attributed to the lack of a sound strategy and practical procedures in working with robotic liquid-handling systems. Several comprehensive automation assisted procedures for biological sample preparation and method validation were developed and qualified using two types of Hamilton Microlab liquid-handling robots. The procedures developed were generic, user-friendly and covered the majority of steps involved in routine sample preparation and method validation. Generic automation procedures were established as a practical approach to widely implement automation into the routine bioanalysis of samples in support of drug-development programs.

A Generic Ground Framework for Image Expertise Centres and Small-Sized Production Centres

NASA Astrophysics Data System (ADS)

Sellé, A.

2009-05-01

Initiated by the Pleiadas Earth Observation Program, the CNES (French Space Agency) has developed a generic collaborative framework for its image quality centre, highly customisable for any upcoming expertise centre. This collaborative framework has been design to be used by a group of experts or scientists that want to share data and processings and manage interfaces with external entities. Its flexible and scalable architecture complies with the core requirements: defining a user data model with no impact on the software (generic access data), integrating user processings with a GUI builder and built-in APIs, and offering a scalable architecture to fit any preformance requirement and accompany growing projects. The CNES jas given licensing grants for two software companies that will be able to redistribute this framework to any customer.

Knowledge Management Initiatives Used to Maintain Regulatory Expertise in Transportation and Storage of Radioactive Materials - 12177

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

Lindsay, Haile; Garcia-Santos, Norma; Saverot, Pierre

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) was established in 1974 with the mission to license and regulate the civilian use of nuclear materials for commercial, industrial, academic, and medical uses in order to protect public health and safety, and the environment, and promote the common defense and security. Currently, approximately half (∼49%) of the workforce at the NRC has been with the Agency for less than six years. As part of the Agency's mission, the NRC has partial responsibility for the oversight of the transportation and storage of radioactive materials. The NRC has experienced a significant level of expertise leavingmore » the Agency due to staff attrition. Factors that contribute to this attrition include retirement of the experienced nuclear workforce and mobility of staff within or outside the Agency. Several knowledge management (KM) initiatives have been implemented within the Agency, with one of them including the formation of a Division of Spent Fuel Storage and Transportation (SFST) KM team. The team, which was formed in the fall of 2008, facilitates capturing, transferring, and documenting regulatory knowledge for staff to effectively perform their safety oversight of transportation and storage of radioactive materials, regulated under Title 10 of the Code of Federal Regulations (10 CFR) Part 71 and Part 72. In terms of KM, the SFST goal is to share critical information among the staff to reduce the impact from staff's mobility and attrition. KM strategies in place to achieve this goal are: (1) development of communities of practice (CoP) (SFST Qualification Journal and the Packaging and Storing Radioactive Material) in the on-line NRC Knowledge Center (NKC); (2) implementation of a SFST seminar program where the seminars are recorded and placed in the Agency's repository, Agency-wide Documents Access and Management System (ADAMS); (3) meeting of technical discipline group programs to share knowledge within specialty areas; (4) development of written guidance to capture 'administrative and technical' knowledge (e.g., office instructions (OIs), generic communications (e.g., bulletins, generic letters, regulatory issue summary), standard review plans (SRPs), interim staff guidance (ISGs)); (5) use of mentoring strategies for experienced staff to train new staff members; (6) use of Microsoft SharePoint portals in capturing, transferring, and documenting knowledge for staff across the Division from Division management and administrative assistants to the project managers, inspectors, and technical reviewers; and (7) development and implementation of a Division KM Plan. A discussion and description of the successes and challenges of implementing these KM strategies at the NRC/SFST will be provided. (authors)« less

Constraints in Genetic Programming

NASA Technical Reports Server (NTRS)

Janikow, Cezary Z.

1996-01-01

Genetic programming refers to a class of genetic algorithms utilizing generic representation in the form of program trees. For a particular application, one needs to provide the set of functions, whose compositions determine the space of program structures being evolved, and the set of terminals, which determine the space of specific instances of those programs. The algorithm searches the space for the best program for a given problem, applying evolutionary mechanisms borrowed from nature. Genetic algorithms have shown great capabilities in approximately solving optimization problems which could not be approximated or solved with other methods. Genetic programming extends their capabilities to deal with a broader variety of problems. However, it also extends the size of the search space, which often becomes too large to be effectively searched even by evolutionary methods. Therefore, our objective is to utilize problem constraints, if such can be identified, to restrict this space. In this publication, we propose a generic constraint specification language, powerful enough for a broad class of problem constraints. This language has two elements -- one reduces only the number of program instances, the other reduces both the space of program structures as well as their instances. With this language, we define the minimal set of complete constraints, and a set of operators guaranteeing offspring validity from valid parents. We also show that these operators are not less efficient than the standard genetic programming operators if one preprocesses the constraints - the necessary mechanisms are identified.

Highway Safety Program Manual: Volume 13: Traffic Engineering Services.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 13 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on traffic engineering services. The introduction outlines the purposes and objectives of Highway Safety Program Standard 13 and the Highway Safety Program Manual. Program development and…

Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

PubMed

Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P

2012-01-01

  In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing supply on July 1, 2006, was the index claim. Members with a Kmart pharmacy index claim were excluded, since the Kmart membership drug discount program began prior to July 1, 2006. Levothyroxine claims capture nonpersistency, defined as the occurrence of a claim supply end date prior to a 180-day gap, was the primary outcome variable and was assessed from July 1, 2006, through June 30, 2010 (follow-up period). The odds of levothyroxine claims capture nonpersistency by pharmacy group were assessed using a logistic regression analysis adjusted for the following covariates: age, gender, median income in the ZIP code of residence (binomial for ≤ $50,000 vs. greater than $50,000), switch to a brand levothyroxine product during the follow-up period, index levothyroxine claim supply of 90 days or more, and index levothyroxine claim member cost share per 30-day supply in tertiles (≤ $5.00, $5.01-$7.99, ≥ $8.00). Of 2,632,855 eligible members aged 18 years or older, 13,427 met all study eligibility criteria. The baseline pharmacy groups were membership with 3,595 (26.8%), nonmembership with 1,919 (14.3%), and all other pharmacies with 7,913 (58.9%) members. The rates of levothyroxine claims capture persistency throughout the 4-year follow-up period were 85.4% for nonmembership (P = 0.593 vs. all other pharmacies), 77.7% for the membership group (P  less than  0.001 vs. all other pharmacies), and 85.9% for all other pharmacies. The Kaplan-Meier comparison of claims capture persistency found nearly identical claims capture loss for the nonmembership compared with all other pharmacies group, and when compared in a multivariate logistic regression model, there was no difference in the odds of levothyroxine claims capture over 4 years follow-up (OR = 1.01, 95% CI = 0.88-1.16, P = 0.900). The membership generic drug discount programs (Walgreens, CVS, Alberstons, and Savon pharmacies) had a statistically significant 61% higher odds (OR = 1.61, 95% CI = 1.45-1.79, P  less than  0.001) of levothyroxine claims capture nonpersistency. The onset of the difference between the membership group and the all other pharmacies group was temporally associated with the launch of the membership programs. In comparison to index levothyroxine member cost of ≤ $5.00 per 30-day supply, higher cost shares were associated with higher levothyroxine claims capture nonpersistency ($5.01 to $7.99 OR 1.34, 95% CI 1.19-1.52 and ≥ $8.00 OR 1.60, 95% CI 1.40-1.82). Among levothyroxine utilizers in 2006 (prior to the advent of drug discount programs), those with claims from a pharmacy that subsequently implemented a nonmembership generic drug discount program did not appear to have a different rate of levothyroxine claims capture than members from the reference group when followed through June 2010. Utilizers with claims from a pharmacy that subsequently implemented a membership program had a significantly lower levothyroxine claims capture rate. Increasing index levothyroxine member cost was associated with higher levothyroxine claims capture loss. Because the analysis could not directly measure claims capture loss associated with members who switched to a new pharmacy group without presenting their insurance information (e.g., membership discount programs), further research is needed to confirm these findings.

Generic, Type-Safe and Object Oriented Computer Algebra Software

NASA Astrophysics Data System (ADS)

Kredel, Heinz; Jolly, Raphael

Advances in computer science, in particular object oriented programming, and software engineering have had little practical impact on computer algebra systems in the last 30 years. The software design of existing systems is still dominated by ad-hoc memory management, weakly typed algorithm libraries and proprietary domain specific interactive expression interpreters. We discuss a modular approach to computer algebra software: usage of state-of-the-art memory management and run-time systems (e.g. JVM) usage of strongly typed, generic, object oriented programming languages (e.g. Java) and usage of general purpose, dynamic interactive expression interpreters (e.g. Python) To illustrate the workability of this approach, we have implemented and studied computer algebra systems in Java and Scala. In this paper we report on the current state of this work by presenting new examples.

Physics-Based Design Tools for Lightweight Ceramic Composite Turbine Components with Durable Microstructures

NASA Technical Reports Server (NTRS)

DiCarlo, James A.

2011-01-01

Under the Supersonics Project of the NASA Fundamental Aeronautics Program, modeling and experimental efforts are underway to develop generic physics-based tools to better implement lightweight ceramic matrix composites into supersonic engine components and to assure sufficient durability for these components in the engine environment. These activities, which have a crosscutting aspect for other areas of the Fundamental Aero program, are focusing primarily on improving the multi-directional design strength and rupture strength of high-performance SiC/SiC composites by advanced fiber architecture design. This presentation discusses progress in tool development with particular focus on the use of 2.5D-woven architectures and state-of-the-art constituents for a generic un-cooled SiC/SiC low-pressure turbine blade.

South Carolina Industrial Arts Safety Guide. Student Section.

ERIC Educational Resources Information Center

South Carolina State Dept. of Education, Columbia.

This student section of a South Carolina industrial arts safety guide includes guidelines for developing a student safety program and three sections of shop safety practices. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on developing a student safety program. Set forth…

Vocational Education Safety Instruction Manual.

ERIC Educational Resources Information Center

Cropley, Russell, Ed.; Doherty, Susan Sloan, Ed.

This manual describes four program areas in vocational education safety instruction: (1) introduction to a safety program; (2) resources to ensure laboratory safety; (3) safety program implementation; and (4) safety rules and safety tests. The safety rules and tests included in section four are for the most common tools and machines used in…

At the Crossroads of Learning and Culture: Identifying a Construct for Effective Computer-Assisted Language Learning for English Language Learners

ERIC Educational Resources Information Center

Shaw, Yun

2010-01-01

Many of the commercial Computer-Assisted Language Learning (CALL) programs available today typically take a generic approach. This approach standardizes the program so that it can be used to teach any language merely by translating the content from one language to another. These CALL programs rarely consider the cultural background or preferred…

7 CFR 1485.18 - Advances.

Code of Federal Regulations, 2010 CFR

2010-01-01

... MARKETS FOR AGRICULTURAL COMMODITIES Market Access Program § 1485.18 Advances. (a) Policy. In general, CCC... payments to an MAP participant for generic promotion activities. Prior to making an advance, CCC may...

7 CFR 1485.18 - Advances.

Code of Federal Regulations, 2011 CFR

2011-01-01

... MARKETS FOR AGRICULTURAL COMMODITIES Market Access Program § 1485.18 Advances. (a) Policy. In general, CCC... payments to an MAP participant for generic promotion activities. Prior to making an advance, CCC may...

Nursing Predictors Study, Phase One.

ERIC Educational Resources Information Center

Dean, Janet H.; Fischer, Susanne E.

In an effort to identify the minimum qualifications necessary for an entering student to succeed in a selective admission Nursing Program at Saint Petersburg Junior College in Florida, a study was conducted of 424 generic nursing students who started the program in January 1988, August 1988, January 1989, and August 1989. A successful student was…

Self-Regulation with Rules: Lessons Learned from a New Quality Assurance Process for Ontario

ERIC Educational Resources Information Center

Lang, Daniel W.

2015-01-01

Purpose: The purpose of this paper is to discuss how the province over time has addressed problems that are generic to many jurisdictions in assuring quality -- level of aggregation, pooling, definition of new and continuing programs, scope of jurisdiction, role of governors, performance indicators, relationship to accreditation, programs versus…

Integration Experiences Casebook: Program Ideas in Aging and Developmental Disabilities.

ERIC Educational Resources Information Center

Janicki, Matthew P.; Keefe, Robert M.

An assortment of 38 case studies illustrates efforts to integrate elderly individuals with developmental disabilities into generic aging services and into community life. The case studies include models and practice experiences that aided seniors to retire, participate in programs and services, and become part of their community's aging network.…

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…

Pharmacy benefits management in the Veterans Health Administration: 1995 to 2003.

PubMed

Sales, Mariscelle M; Cunningham, Francesca E; Glassman, Peter A; Valentino, Michael A; Good, Chester B

2005-02-01

The Department of Veterans Affairs (VA) Pharmacy Benefits Management Strategic Healthcare Group (VA PBM) oversees the formulary for the entire VA system, which serves more than 4 million veterans and provides more than 108 million prescriptions per year. Since its establishment in 1995, the VA PBM has managed pharmaceuticals and pharmaceutical-related policies, including drug safety and efficacy evaluations, pharmacologic management algorithms, and criteria for drug use. These evidence-based practices promote, optimize, and assist VA providers with the safe and appropriate use of pharmaceuticals while allowing for formulary decisions that can result in substantial cost savings. The VA PBM also has utilized various contracting techniques to standardize generic agents as well as specific drugs and drug classes (eg, antihistamines, angiotensin-converting enzyme inhibitors, alpha-blockers, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [statins]). These methods have enabled the VA to save approximately dollar 1.5 billion since 1996 even as drug expenditures continued to rise from roughly dollar 1 billion in fiscal year (FY) 1996 to more than dollar 3 billion in FY 2003. Furthermore, the VA PBM has established an outcomes research section to undertake quality-improvement and safety initiatives that ultimately monitor and determine the clinical impact of formulary decisions on the VA system nationwide. The experiences of this pharmacy benefits program, including clinical and contracting processes/procedures and their impact on the VA healthcare system, are described.

Modeling Techniques Used to Analyze Safety of Payloads for Generic Missile Type Weapons Systems During an Indirect Lightning Strike

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

Perkins, M P; Ong, M M; Crull, E W

2009-07-21

During lightning strikes buildings and other structures can act as imperfect Faraday Cages, enabling electromagnetic fields to be developed inside the facilities. Some equipment stored inside these facilities may unfortunately act as antenna systems. It is important to have techniques developed to analyze how much voltage, current, or energy dissipation may be developed over valuable components. In this discussion we will demonstrate the modeling techniques used to accurately analyze a generic missile type weapons system as it goes through different stages of assembly. As work is performed on weapons systems detonator cables can become exposed. These cables will form differentmore » monopole and loop type antenna systems that must be analyzed to determine the voltages developed over the detonator regions. Due to the low frequencies of lightning pulses, a lumped element circuit model can be developed to help analyze the different antenna configurations. We will show an example of how numerical modeling can be used to develop the lumped element circuit models used to calculate voltage, current, or energy dissipated over the detonator region of a generic missile type weapons system.« less

Design of compound libraries for fragment screening

NASA Astrophysics Data System (ADS)

Blomberg, Niklas; Cosgrove, David A.; Kenny, Peter W.; Kolmodin, Karin

2009-08-01

Approaches to the design of libraries for fragment screening are illustrated with reference to a 20 k generic fragment screening library and a 1.2 k generic NMR screening library. Tools and methods for library design that have been developed within AstraZeneca are described, including Foyfi fingerprints and the Flush program for neighborhood characterization. It will be shown how Flush and the BigPicker, which selects maximally diverse sets of compounds, are used to apply the Core and Layer method for library design. Approaches to partitioning libraries into cocktails are also described.

Energy use in the marine transportation industry. Task II. Efficiency improvements. Draft report

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

Not Available

1977-06-02

Research and development areas that hold promise for maritime energy conservation are identified and evaluated. The methodology used in the evaluation of potential research areas and results, conclusions, and recommendations are presented. Fifteen programs are identified in four generic technologies and these are discussed in detail in appendices A-D. The areas are: main propulsion plants, propulsors, hydrodynamics, and vessel operations. Fuels are discussed briefly in appendix E. Additional information is presented on the generic US flag baseline operational and cost parameters; a sample output model is presented. (MCW)

Highway Safety Program Manual: Volume 14: Pedestrian Safety.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and health... evaluating an agency's occupational safety and health program. To accomplish this, the Secretary shall...

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

Industrial Arts Safety Guide. Thai. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Thai. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Japanese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practice in both English and Japanese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Cambodian. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide includes guidelines for developing a student safety program and three sections of shop safety practices in both English and Cambodian. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Korean. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Korean. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Ilokano. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Ilokano. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Industrial Arts Safety Guide. Chinese. Bilingual Education Resource Series.

ERIC Educational Resources Information Center

Seattle School District 1, WA.

Designed for use in bilingual education programs, this industrial arts safety guide presents guidelines for developing a student safety program and three sections of shop safety practices in both English and Chinese. Safety program format, safety committees, safety inspection, and student accident investigation are discussed in the section on…

Evidence Arguments for Using Formal Methods in Software Certification

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganesh

2013-01-01

We describe a generic approach for automatically integrating the output generated from a formal method/tool into a software safety assurance case, as an evidence argument, by (a) encoding the underlying reasoning as a safety case pattern, and (b) instantiating it using the data produced from the method/tool. We believe this approach not only improves the trustworthiness of the evidence generated from a formal method/tool, by explicitly presenting the reasoning and mechanisms underlying its genesis, but also provides a way to gauge the suitability of the evidence in the context of the wider assurance case. We illustrate our work by application to a real example-an unmanned aircraft system- where we invoke a formal code analysis tool from its autopilot software safety case, automatically transform the verification output into an evidence argument, and then integrate it into the former.

Evaluation of the safety of mobile units for the conditioning of radioactive waste

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

Filss, Martin; Wallner, Christian

2013-07-01

In Germany mobile units are used to treat and condition radioactive waste. On behalf of the relevant authorities TUV SUD Industrie Service GmbH evaluates their safety. In this paper we outline the general procedure we apply and point out typical results. Generally, a generic safety case evaluates the effects of incidents and accidents and its consequences for the workers and the public. Special care is necessary to define the radioactive inventory, the nuclide composition and the mobility of the radioactive substances. A systems analysis is carried out. Typical aspects to be considered are the handling procedures, the measurement devices andmore » automatic actions. From the various possible malfunctions the critical ones have to be identified. Generally one or only a few scenarios have to be considered in detail. (authors)« less

Working in disadvantaged communities: What additional competencies do we need?

PubMed Central

Harris, Elizabeth; Harris, Mark F; Madden, Lynne; Wise, Marilyn; Sainsbury, Peter; MacDonald, John; Gill, Betty

2009-01-01

Background Residents of socioeconomically disadvantaged locations are more likely to have poor health than residents of socioeconomically advantaged locations and this has been comprehensively mapped in Australian cities. These inequalities present a challenge for the public health workers based in or responsible for improving the health of people living in disadvantaged localities. The purpose of this study was to develop a generic workforce needs assessment tool and to use it to identify the competencies needed by the public health workforce to work effectively in disadvantaged communities. Methods A two-step mixed method process was used to identify the workforce needs. In step 1 a generic workforce needs assessment tool was developed and applied in three NSW Area Health Services using focus groups, key stakeholder interviews and a staff survey. In step 2 the findings of this needs assessment process were mapped against the existing National Health Training Package (HLT07) competencies, gaps were identified, additional competencies described and modules of training developed to fill identified gaps. Results There was a high level of agreement among the AHS staff on the nature of the problems to be addressed but less confidence indentifying the work to be done. Processes for needs assessments, community consultations and adapting mainstream programs to local needs were frequently mentioned as points of intervention. Recruiting and retaining experienced staff to work in these communities and ensuring their safety were major concerns. Workforce skill development needs were seen in two ways: higher order planning/epidemiological skills and more effective working relationships with communities and other sectors. Organisational barriers to effective practice were high levels of annual compulsory training, balancing state and national priorities with local needs and giving equal attention to the population groups that are easy to reach and to those that are difficult to engage. A number of additional competency areas were identified and three training modules developed. Conclusion The generic workforce needs assessment tool was easy to use and interpret. It appears that the public health workforce involved in this study has a high level of understanding of the relationship between the social determinants and health. However there is a skill gap in identifying and undertaking effective intervention. PMID:19393091

Developing Coping Typologies of Minority Adolescents: A Latent Profile Analysis

PubMed Central

Aldridge, Arianna A.; Roesch, Scott C.

2008-01-01

Latent profile analysis (LPA) was used to develop a coping typology of minority adolescents (M = 15.5 yrs). A multiethnic sample (n = 354) was recruited from a program aimed at serving low-income students. LPA revealed three distinct coping profiles. The first comprised adolescents who used a number of specific coping strategies at a low level (Low Generic Copers). The second comprised adolescents who emphasized active/approach strategies (e.g., planning; Active Copers). The third comprised adolescents who emphasized avoidant/passive strategies (e.g., substance abuse; Avoidant Copers). Active Copers experienced significantly less depression and more stress-related growth than Low Generic Copers. Low Generic Copers experienced significantly less depression than Avoidant Copers but also significantly less stress-related growth than Active Copers. Discussion focuses on integrating the current typology with traditional coping taxomonies. PMID:17904631

[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.

Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba.

PubMed

Shankar, P Ravi; Herz, Burton L; Dubey, Arun K; Hassali, Mohamed A

2016-10-01

Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t -test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

NSR&D Program Fiscal Year (FY) 2015 Call for Proposals Mitigation of Seismic Risk at Nuclear Facilities using Seismic Isolation

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

Coleman, Justin

2015-02-01

Seismic isolation (SI) has the potential to drastically reduce seismic response of structures, systems, or components (SSCs) and therefore the risk associated with large seismic events (large seismic event could be defined as the design basis earthquake (DBE) and/or the beyond design basis earthquake (BDBE) depending on the site location). This would correspond to a potential increase in nuclear safety by minimizing the structural response and thus minimizing the risk of material release during large seismic events that have uncertainty associated with their magnitude and frequency. The national consensus standard America Society of Civil Engineers (ASCE) Standard 4, Seismic Analysismore » of Safety Related Nuclear Structures recently incorporated language and commentary for seismically isolating a large light water reactor or similar large nuclear structure. Some potential benefits of SI are: 1) substantially decoupling the SSC from the earthquake hazard thus decreasing risk of material release during large earthquakes, 2) cost savings for the facility and/or equipment, and 3) applicability to both nuclear (current and next generation) and high hazard non-nuclear facilities. Issue: To date no one has evaluated how the benefit of seismic risk reduction reduces cost to construct a nuclear facility. Objective: Use seismic probabilistic risk assessment (SPRA) to evaluate the reduction in seismic risk and estimate potential cost savings of seismic isolation of a generic nuclear facility. This project would leverage ongoing Idaho National Laboratory (INL) activities that are developing advanced (SPRA) methods using Nonlinear Soil-Structure Interaction (NLSSI) analysis. Technical Approach: The proposed study is intended to obtain an estimate on the reduction in seismic risk and construction cost that might be achieved by seismically isolating a nuclear facility. The nuclear facility is a representative pressurized water reactor building nuclear power plant (NPP) structure. Figure 1: Project activities The study will consider a representative NPP reinforced concrete reactor building and representative plant safety system. This study will leverage existing research and development (R&D) activities at INL. Figure 1 shows the proposed study steps with the steps in blue representing activities already funded at INL and the steps in purple the activities that would be funded under this proposal. The following results will be documented: 1) Comparison of seismic risk for the non-seismically isolated (non-SI) and seismically isolated (SI) NPP, and 2) an estimate of construction cost savings when implementing SI at the site of the generic NPP.« less

[Cost of drugs used to treat cardiovascular disease in Brazil].

PubMed

Bueno, Cristiane Schmalz; Moreira, Angélica Cristiane; Oliveira, Karla Renata de

2012-01-01

Diseases of the circulatory system are a principal cause of mortality in Brazil. Using as a basis drugs dispensed through Brazil's Popular Pharmacy Program (FPB, for its name in Portuguese), prices for drugs used to treat circulatory diseases were analyzed to identify the advantages of using generic drugs and the FPB. Drug prices were obtained using Brazil's Pharmacy Price Guide and FPB price tables. The costs of 15 drugs available through the FPB were compared with those of three generic pharmaceutical products, three similar products, and the reference drug. The generic drugs were lower in price for 10 of the drugs and for four of the similar products. The FPB drugs were of the lowest price. Generic and FPB drugs are easily accessed by the population and thus facilitate the continuity of pharmacotherapy when these drugs are not available through the Unified Health System and/or are not affordable through other means. Access to drugs should be taken into consideration at the time prescriptions are filled, especially as regards those used to treat chronic diseases.

Methodology for assessing the safety of Hydrogen Systems: HyRAM 1.1 technical reference manual

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

Groth, Katrina; Hecht, Ethan; Reynolds, John Thomas

The HyRAM software toolkit provides a basis for conducting quantitative risk assessment and consequence modeling for hydrogen infrastructure and transportation systems. HyRAM is designed to facilitate the use of state-of-the-art science and engineering models to conduct robust, repeatable assessments of hydrogen safety, hazards, and risk. HyRAM is envisioned as a unifying platform combining validated, analytical models of hydrogen behavior, a stan- dardized, transparent QRA approach, and engineering models and generic data for hydrogen installations. HyRAM is being developed at Sandia National Laboratories for the U. S. De- partment of Energy to increase access to technical data about hydrogen safety andmore » to enable the use of that data to support development and revision of national and international codes and standards. This document provides a description of the methodology and models contained in the HyRAM version 1.1. HyRAM 1.1 includes generic probabilities for hydrogen equipment fail- ures, probabilistic models for the impact of heat flux on humans and structures, and computa- tionally and experimentally validated analytical and first order models of hydrogen release and flame physics. HyRAM 1.1 integrates deterministic and probabilistic models for quantifying accident scenarios, predicting physical effects, and characterizing hydrogen hazards (thermal effects from jet fires, overpressure effects from deflagrations), and assessing impact on people and structures. HyRAM is a prototype software in active development and thus the models and data may change. This report will be updated at appropriate developmental intervals.« less

77 FR 15139 - Agency Information Collection Activities: Comment Request; Generic Survey Clearance for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... order to conduct program- or portfolio-level evaluations, however, both experimental and quasi-experimental evaluation research studies on STEM education interventions require researchers to identify...

75 FR 20038 - Railroad Safety Technology Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

...] Railroad Safety Technology Grant Program AGENCY: Federal Railroad Administration, Department of Transportation. ACTION: Notice of Funds Availability, Railroad Safety Technology Program-Correction of Grant... Railroad Safety Technology Program, in the section, ``Requirements and Conditions for Grant Applications...

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

Safety assurance of non-deterministic flight controllers in aircraft applications

NASA Astrophysics Data System (ADS)

Noriega, Alfonso

Loss of control is a serious problem in aviation that primarily affects General Aviation. Technological advancements can help mitigate the problem, but the FAA certification process makes certain solutions economically unfeasible. This investigation presents the design of a generic adaptive autopilot that could potentially lead to a single certification for use in several makes and models of aircraft. The autopilot consists of a conventional controller connected in series with a robust direct adaptive model reference controller. In this architecture, the conventional controller is tuned once to provide outer-loop guidance and navigation to a reference model. The adaptive controller makes unknown aircraft behave like the reference model, allowing the conventional controller to successfully provide navigation without the need for retuning. A strong theoretical foundation is presented as an argument for the safety and stability of the controller. The stability proof of direct adaptive controllers require that the plant being controlled has no unstable transmission zeros and has a nonzero high frequency gain. Because most conventional aircraft do not readily meet these requirements, a process known as sensor blending was used. Sensor blending consists of using a linear combination of the plant's outputs that has no unstable transmission zeros and has a nonzero high frequency gain to drive the adaptive controller. Although this method does not present a problem for regulators, it can lead to a steady state error in tracking applications. The sensor blending theory was expanded to take advantage of the system's dynamics to allow for zero steady state error tracking. This method does not need knowledge of the specific system's dynamics, but instead uses the structure of the A and B matrices to perform the blending for the general case. The generic adaptive autopilot was tested in two high-fidelity nonlinear simulators of two typical General Aviation aircraft. The results show that the autopilot was able to adapt appropriately to the different aircraft and was able to perform three-dimensional navigation and an ILS approach, without any modification to the controller. The autopilot was tested in moderate atmospheric turbulence, using consumer-grade sensors and actuators currently available in General Aviation aircraft. The generic adaptive autopilot was shown to be robust to atmospheric turbulence and sensor and actuator random noise. In both aircraft simulators, the autopilot adapted successfully to changes in airspeed, altitude, and configuration. This investigation proves the feasibility of a generic autopilot using direct adaptive controller. The autopilot does not need a priori information of the specific aircraft's dynamics to maintain its safety and stability arguments. Real-time parameter estimation of the aircraft dynamics are not needed. Recommendations for future work are provided.

Safety in Outdoor Adventure Programs. S.O.A.P. Safety Policy.

ERIC Educational Resources Information Center

MacDonald, Wayne, Comp.; And Others

Drafted in 1978 as a working document for Safety in Outdoor Adventure Programs (S.O.A.P.) by a council of outdoor adventure programmers, checklists outline standard accepted safety policy for Outdoor Adventure Programs and Wilderness Adventure Programs conducted through public or private agencies in California. Safety policy emphasizes: the…

78 FR 43091 - Technical Operations Safety Action Program (T-SAP) and Air Traffic Safety Action Program (ATSAP)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

... Administration 14 CFR Part 193 [Docket No.: FAA-2013-0375] Technical Operations Safety Action Program (T-SAP) and Air Traffic Safety Action Program (ATSAP) AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of Proposed Order Designating Safety Information as Protected from...

75 FR 68829 - Agency Information Collection Activities: Comment Request; Generic Survey Clearance for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-09

... evaluation studies. In order to conduct program- or portfolio-level evaluations, however, both experimental and quasi-experimental evaluation research studies on STEM education interventions require researchers...

21 CFR 892.5700 - Remote controlled radionuclide applicator system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and...

FMCSA safety program effectiveness measurement : Roadside Intervention Effectiveness Model, fiscal year 2010 : [analysis brief].

DOT National Transportation Integrated Search

2014-11-01

Two of the Federal Motor Carrier Safety Administrations (FMCSAs) key safety programs are the Roadside Inspection and Traffic Enforcement programs. The Roadside Inspection program consists of roadside inspections performed by qualified safety in...

Product-based Safety Certification for Medical Devices Embedded Software.

PubMed

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

C++ Programming Language

NASA Technical Reports Server (NTRS)

Shaykhian, Gholam Ali

2007-01-01

C++ Programming Language: The C++ seminar covers the fundamentals of C++ programming language. The C++ fundamentals are grouped into three parts where each part includes both concept and programming examples aimed at for hands-on practice. The first part covers the functional aspect of C++ programming language with emphasis on function parameters and efficient memory utilization. The second part covers the essential framework of C++ programming language, the object-oriented aspects. Information necessary to evaluate various features of object-oriented programming; including encapsulation, polymorphism and inheritance will be discussed. The last part of the seminar covers template and generic programming. Examples include both user defined and standard templates.

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…

An Introduction to X Window Application Development

DTIC Science & Technology

1992-03-23

Acquisition and Policy Evaluation program using Cognitive Feed- back ( ESKAPE /CF) from the SunView windowing system to X Window. The new application...the generic X Window System. This thesis converts an Expert System Knowledge Acquisition and Policy Evaluation program using Cognitive Feedback ( ESKAPE ...15 IV. XESKAPE/CF: THE X WINDOW VERSION OF ESKAPE /CF ........................ 16 A. FUNCTIONAL COMPARISON TO

76 FR 49381 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-10

... promotion law should fund an independent evaluation of the effectiveness of their generic promotion program..., trapping, and bait spray programs; $425,000 for promotion; and $250,737 for management, administration, and... production area, few have sufficient acreage to generate sales in excess of $750,000. Thus, half of the...

76 FR 61249 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... under the oversight of the Secretary of Agriculture pursuant to a commodity promotion law should fund an independent evaluation of the effectiveness of their generic promotion program, which is now commonly known as..., trapping, and bait spray programs; $425,000 for promotion; and $250,737 for management, administration, and...

Employer Perceptions of Graduates from Hawai'i Business Education and Office Skills Programs.

ERIC Educational Resources Information Center

Broadbent, William A.

Conducted at the University of Hawaii in 1997, this study examined the satisfaction level of employers who hired graduates from business education and office skills programs. Since Hawaii's economic focus has changed from agriculture to service-oriented tourism, a large number of employees with generic business skills have become necessary.…

Canadian Pacific Railway mechanical services' 5-Alive safety program shows promise in reducing injuries.

DOT National Transportation Integrated Search

2006-09-01

The Federal Railroad Administration (FRA) Human Factors Research and Development (R&D) Program is sponsoring an Alternative Safety Measures Program to explore alternative methods for evaluating whether safety programs improve safety outcomes and the ...

Biosimilar safety considerations in clinical practice.

PubMed

Choy, Edwin; Jacobs, Ira Allen

2014-02-01

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed. © 2014 Elsevier Inc. All rights reserved.

Spacecraft fire-safety experiments for space station: Technology development mission

NASA Technical Reports Server (NTRS)

Youngblood, Wallace W.

1988-01-01

Three concept designs for low-gravity, fire-safety related experiments are presented, as selected for the purpose of addressing key issues of enhancing safety and yet encouraging access to long-duration, manned spacecraft such as the NASA space station. The selected low-gravity experiments are the following: (1) an investigation of the flame-spread rate and combustion-product evolution of the burning of typical thicknesses of spacecraft materials in very low-speed flows; (2) an evaluation of the interaction of fires and candidate extinguishers in various fire scenarios; and (3) an investigation of the persistence and propagation of smoldering and deep-seated combustion. Each experiment is expected to provide fundamental combustion-science data, as well as the fire-safety applications, and each requires the unique long-duration, low-gravity environment of the space station. Two generic test facilities, i.e., the Combustion Tunnel Facility and the Combustion Facility, are proposed for space station accommodation to support the selected experiments. In addition, three near-term, fire-safety related experiments are described along with other related precursor activities.

Design an optimum safety policy for personnel safety management - A system dynamic approach

NASA Astrophysics Data System (ADS)

Balaji, P.

2014-10-01

Personnel safety management (PSM) ensures that employee's work conditions are healthy and safe by various proactive and reactive approaches. Nowadays it is a complex phenomenon because of increasing dynamic nature of organisations which results in an increase of accidents. An important part of accident prevention is to understand the existing system properly and make safety strategies for that system. System dynamics modelling appears to be an appropriate methodology to explore and make strategy for PSM. Many system dynamics models of industrial systems have been built entirely for specific host firms. This thesis illustrates an alternative approach. The generic system dynamics model of Personnel safety management was developed and tested in a host firm. The model was undergone various structural, behavioural and policy tests. The utility and effectiveness of model was further explored through modelling a safety scenario. In order to create effective safety policy under resource constraint, DOE (Design of experiment) was used. DOE uses classic designs, namely, fractional factorials and central composite designs. It used to make second order regression equation which serve as an objective function. That function was optimized under budget constraint and optimum value used for safety policy which shown greatest improvement in overall PSM. The outcome of this research indicates that personnel safety management model has the capability for acting as instruction tool to improve understanding of safety management and also as an aid to policy making.

10 CFR 851.11 - Development and approval of worker safety and health program.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Development and approval of worker safety and health program. 851.11 Section 851.11 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.11 Development and approval of worker safety and health program. (a) Preparation and...

Reimbursement of biosimilars in Poland: is there a link to health technology assessment?

PubMed

Neumann, Dominika; Jabłecka, Anna

2016-12-01

Due to their complex structures, biosimilars are not generics. The differences between them are considered during market authorization processes but remain unclear during reimbursement decision-making. We analyzed the reimbursement of biopharmaceuticals in Poland with an emphasis on biosimilars and compared the health technology assessment (HTA) process with that defined in other countries. Recommendations provided by the Polish HTA organization and those in other countries were included as source documents. The period of interest covered January 2012 to December 2014. The reimbursement process for biosimilars in Poland is the same as that for generics. In contrast to other countries, a HTA is not involved in decision-making in Poland. The short administrative procedure for reimbursement of biosimilars in Poland accelerates the decision-making process; therefore, therapies can be made available to patients more quickly. However, this procedure can potentially lead to underestimation of aspects concerning the effectiveness and safety of biosimilars.

Implications of bilateral free trade agreements on access to medicines.

PubMed Central

Correa, Carlos María

2006-01-01

The TRIPS Agreement of the World Trade Organization (WTO) mandated the introduction of protection of intellectual property rights, notably patents, for pharmaceutical products. While the implications for the access to medicines contained in the terms of this Agreement raised significant concerns, a recent new wave of free trade agreements, negotiated outside the WTO, requires even higher levels of intellectual property protection for medicines than those mandated by that Agreement. The measures involved include the extension of the patent term beyond 20 years; prohibition of use of test data on drug efficacy and safety for certain periods for the approval of generic products; the linkage between drug registration and patent protection; in some cases, limitations to the grounds for granting compulsory licences. This article reviews some of these measures that further limit the competition of generic products and discusses their possible implication for access to medicines. PMID:16710551

Statistical Primer on Biosimilar Clinical Development.

PubMed

Isakov, Leah; Jin, Bo; Jacobs, Ira Allen

A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.

A Silent Safety Program

NASA Technical Reports Server (NTRS)

Goodin, James Ronald

2006-01-01

NASA's Columbia Accident Investigation Board (CAIB) referred 8 times to the NASA "Silent Safety Program." This term, "Silent Safety Program" was not an original observation but first appeared in the Rogers Commission's Investigation of the Challenger Mishap. The CAIB on page 183 of its report in the paragraph titled 'Encouraging Minority Opinion,' stated "The Naval Reactor Program encourages minority opinions and "bad news." Leaders continually emphasize that when no minority opinions are present, the responsibility for a thorough and critical examination falls to management. . . Board interviews revealed that it is difficult for minority and dissenting opinions to percolate up through the agency's hierarchy. . ." The first question and perhaps the only question is - what is a silent safety program? Well, a silent safety program may be the same as the dog that didn't bark in Sherlock Holmes' "Adventure of the Silver Blaze" because system safety should behave as a devil's advocate for the program barking on every occasion to insure a critical review inclusion. This paper evaluates the NASA safety program and provides suggestions to prevent the recurrence of the silent safety program alluded to in the Challenger Mishap Investigation. Specifically targeted in the CAM report, "The checks and balances the safety system was meant to provide were not working." A silent system safety program is not unique to NASA but could emerge in any and every organization. Principles developed by Irving Janis in his book, Groupthink, listed criteria used to evaluate an organization's cultural attributes that allows a silent safety program to evolve. If evidence validates Jams's criteria, then Jams's recommendations for preventing groupthink can also be used to improve a critical evaluation and thus prevent the development of a silent safety program.

VIRTUAL FRAME BUFFER INTERFACE

NASA Technical Reports Server (NTRS)

Wolfe, T. L.

1994-01-01

Large image processing systems use multiple frame buffers with differing architectures and vendor supplied user interfaces. This variety of architectures and interfaces creates software development, maintenance, and portability problems for application programs. The Virtual Frame Buffer Interface program makes all frame buffers appear as a generic frame buffer with a specified set of characteristics, allowing programmers to write code which will run unmodified on all supported hardware. The Virtual Frame Buffer Interface converts generic commands to actual device commands. The virtual frame buffer consists of a definition of capabilities and FORTRAN subroutines that are called by application programs. The virtual frame buffer routines may be treated as subroutines, logical functions, or integer functions by the application program. Routines are included that allocate and manage hardware resources such as frame buffers, monitors, video switches, trackballs, tablets and joysticks; access image memory planes; and perform alphanumeric font or text generation. The subroutines for the various "real" frame buffers are in separate VAX/VMS shared libraries allowing modification, correction or enhancement of the virtual interface without affecting application programs. The Virtual Frame Buffer Interface program was developed in FORTRAN 77 for a DEC VAX 11/780 or a DEC VAX 11/750 under VMS 4.X. It supports ADAGE IK3000, DEANZA IP8500, Low Resolution RAMTEK 9460, and High Resolution RAMTEK 9460 Frame Buffers. It has a central memory requirement of approximately 150K. This program was developed in 1985.

Main steam-line break core shroud loading calculations for BWRs

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

Shoop, U.; Feltus, M.A.; Baratta, A.J.

1995-12-31

In July 1994, the U.S. Nuclear regulatory Commission sent out Generic Letter 94-03 to all boiling water reactors in the United States, informing them of intergranular stress corrosion cracking of core shrouds found in 2 reactors. The letter directed all to perform safety analysis of the BWR units. Penn State performed scoping calculations to determine the forces experienced by the core shroud during a main-stream line break transient.

77 FR 70409 - System Safety Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

...-0060, Notice No. 2] 2130-AC31 System Safety Program AGENCY: Federal Railroad Administration (FRA... passenger railroads to develop and implement a system safety program (SSP) to improve the safety of their... Division, U.S. Department of Transportation, Federal Railroad Administration, Office of Railroad Safety...

40 CFR 721.555 - Alkyl amino nitriles (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... (c). A full face shield is required if splashing or spraying occurs. (ii) Hazard communication program. Requirements as specified in § 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph...

40 CFR 721.555 - Alkyl amino nitriles (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... (c). A full face shield is required if splashing or spraying occurs. (ii) Hazard communication program. Requirements as specified in § 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph...

40 CFR 721.555 - Alkyl amino nitriles (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... (c). A full face shield is required if splashing or spraying occurs. (ii) Hazard communication program. Requirements as specified in § 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph...

40 CFR 721.555 - Alkyl amino nitriles (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... (c). A full face shield is required if splashing or spraying occurs. (ii) Hazard communication program. Requirements as specified in § 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph...

How to save money on infant formula

MedlinePlus

... from now, and those coupons will save you money. Sign up for newsletters, special programs, and deals on formula company websites. They often send out coupons and free samples. Ask your pediatrician for samples. Consider generic ...

78 FR 30930 - Proposed Collection; 60-Day Comment Request: Generic Clearance To Support Programs and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

..., mechanical, or other technological collection techniques or other forms of information technology. To Submit... aggregate contact information, history, preferences, opinions, and/or other data that does not necessitate...

What Happened, and Why: Toward an Understanding of Human Error Based on Automated Analyses of Incident Reports. Volume 1

NASA Technical Reports Server (NTRS)

Maille, Nicolas P.; Statler, Irving C.; Ferryman, Thomas A.; Rosenthal, Loren; Shafto, Michael G.; Statler, Irving C.

2006-01-01

The objective of the Aviation System Monitoring and Modeling (ASMM) project of NASA s Aviation Safety and Security Program was to develop technologies that will enable proactive management of safety risk, which entails identifying the precursor events and conditions that foreshadow most accidents. This presents a particular challenge in the aviation system where people are key components and human error is frequently cited as a major contributing factor or cause of incidents and accidents. In the aviation "world", information about what happened can be extracted from quantitative data sources, but the experiential account of the incident reporter is the best available source of information about why an incident happened. This report describes a conceptual model and an approach to automated analyses of textual data sources for the subjective perspective of the reporter of the incident to aid in understanding why an incident occurred. It explores a first-generation process for routinely searching large databases of textual reports of aviation incident or accidents, and reliably analyzing them for causal factors of human behavior (the why of an incident). We have defined a generic structure of information that is postulated to be a sound basis for defining similarities between aviation incidents. Based on this structure, we have introduced the simplifying structure, which we call the Scenario as a pragmatic guide for identifying similarities of what happened based on the objective parameters that define the Context and the Outcome of a Scenario. We believe that it will be possible to design an automated analysis process guided by the structure of the Scenario that will aid aviation-safety experts to understand the systemic issues that are conducive to human error.

Oak Ridge National Laboratory Health and Safety Long-Range Plan: Fiscal years 1989--1995

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

Not Available

1989-06-01

The health and safety of its personnel is the first concern of ORNL and its management. The ORNL Health and Safety Program has the responsibility for ensuring the health and safety of all individuals assigned to ORNL activities. This document outlines the principal aspects of the ORNL Health and Safety Long-Range Plan and provides a framework for management use in the future development of the health and safety program. Each section of this document is dedicated to one of the health and safety functions (i.e., health physics, industrial hygiene, occupational medicine, industrial safety, nuclear criticality safety, nuclear facility safety, transportationmore » safety, fire protection, and emergency preparedness). Each section includes functional mission and objectives, program requirements and status, a summary of program needs, and program data and funding summary. Highlights of FY 1988 are included.« less

Some theoretical models and constructs generic to substance abuse prevention programs for adolescents: possible relevance and limitations for problem gambling.

PubMed

Evans, Richard I

2003-01-01

For the past several years the author and his colleagues have explored the area of how social psychological constructs and theoretical models can be applied to the prevention of health threatening behaviors in adolescents. In examining the need for the development of gambling prevention programs for adolescents, it might be of value to consider the application of such constructs and theoretical models as a foundation to the development of prevention programs in this emerging problem behavior among adolescents. In order to provide perspective to the reader, the present paper reviews the history of various psychosocial models and constructs generic to programs directed at prevention of substance abuse in adolescents. A brief history of some of these models, possibly most applicable to gambling prevention programs, are presented. Social inoculation, reasoned action, planned behavior, and problem behavior theory, are among those discussed. Some deficits of these models, are also articulated. How such models may have relevance to developing programs for prevention of problem gambling in adolescents is also discussed. However, the inherent differences between gambling and more directly health threatening behaviors such as substance abuse must, of course, be seriously considered in utilizing such models. Most current gambling prevention programs have seldom been guided by theoretical models. Developers of gambling prevention programs should consider theoretical foundations, particularly since such foundations not only provide a guide for programs, but may become critical tools in evaluating their effectiveness.

Evaluating the effectiveness of the Safety Investment Program (SIP) policies for Oregon.

DOT National Transportation Integrated Search

2009-10-01

The Safety Investment Program (SIP) was originally called the Statewide Transportation Improvement Program - : Safety Investment Program (STIP-SIP). The concept of the program was first discussed in October 1997 and the : program was adopted by the O...

23 CFR Appendix C to Part 1200 - ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM

Code of Federal Regulations, 2013 CFR

2013-04-01

... 23 Highways 1 2013-04-01 2013-04-01 false ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM C APPENDIX C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C APPENDIX C TO PART 1200—ASSURANCES FOR TEEN TRAFFIC SAFETY PROGRAM State: Fiscal Year: The State has elected to implement a Teen Traffic Safety Program—a...

23 CFR Appendix C to Part 1200 - Assurances for Teen Traffic Safety Program

Code of Federal Regulations, 2014 CFR

2014-04-01

... 23 Highways 1 2014-04-01 2014-04-01 false Assurances for Teen Traffic Safety Program C Appendix C... STATE HIGHWAY SAFETY GRANT PROGRAMS Pt. 1200, App. C Appendix C to Part 1200—Assurances for Teen Traffic Safety Program State: Fiscal Year: The State has elected to implement a Teen Traffic Safety Program—a...

Health and safety programs for art and theater schools.

PubMed

McCann, M

2001-01-01

A wide variety of health and safety hazards exist in schools and colleges of art and theater due to a lack of formal health and safety programs and a failure to include health and safety concerns during planning of new facilities and renovation of existing facilities. This chapter discusses the elements of a health and safety program as well as safety-related structural and equipment needs that should be in the plans for any school of art or theater. These elements include curriculum content, ventilation, storage, housekeeping, waste management, fire and explosion prevention, machine and tool safety, electrical safety, noise, heat stress, and life safety and emergency procedures and equipment. Ideally, these elements should be incorporated into the plans for any new facilities, but ongoing programs can also benefit from a review of existing health and safety programs.

OIL AND GAS FACILITY EMERGENCY AWARENESS PARTNERSHIP

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

Tod Bryant

2002-08-31

Energy Education Partnership, Inc. (EEPI) is a 501(c) (3) subsidiary of the Interstate Oil and Gas Compact Commission (IOGCC). The organization was formed four years ago for charitable, educational, and scientific purposes. EEPI adheres to the same mission of IOGCC, and that is to promote conservation and efficient recovery of domestic oil and natural gas resources while protecting health, safety and the environment. The membership of EEPI/IOCGG is composed of the governors of the 30 oil and gas producing states, seven associate member states, and five international affiliates. The governors appoint official representatives and committee members to participate in themore » programs. The membership of EEPI/IOGCC is dedicated to the conservation and prudent utilization of oil and natural gas resources through education and training. Engineers, geologist, environmental scientists and researchers who perform the majority of fossil energy research in the United States all work with EEPI/IOGCC on projects. The ''Oil and Gas Facility Emergency Awareness Program'' consists of three main parts, with two optional projects for the states involved in the pilot program. The three main parts of the program consist of the following: (1) Create a generic publication using the Ohio Oil and Gas Energy Education Program's publication, ''Responding to Oilfield Emergencies'', which is not state-specific. (2) Prepare a training program for emergency response teams, state and federal regulators, oil and gas facility owners and operators, and local citizens. The program will be developed as a PowerPoint presentation and will assist the students in becoming more aware of emergency situations at an oil or gas facility. The students learn who is the designated ''first responder'' in charge, how all people can work together in preventing and controlling problems at an oil or gas facility, and what to do during an emergency. Familiarity with equipment and hazardous substances are introduced as part of the program. (3) Once the publication and the training program are developed, a video that will be used as an introduction to the actual training class, as a refresher for the class, or in a ''train-the-trainer'' program will be produced. In addition to the above-noted three steps, optional projects were considered by the pilot program states. Two optional projects were considered by the states: (1) Working with the local, regional or state firefighters, a training facility would be created using oil and gas equipment. This part of the project will require cooperation between firefighters and industry, and will assist especially the emergency responders in learning more about oil and gas equipment. (2) Also under consideration was a related web site that would include the location of all oil and gas wells and accessible only by password. The overall ''Oil and Gas Facility Emergency Awareness Program'' has many benefits, some of which are: The process will provide opportunity for key industry leaders to develop relationships with local emergency management agencies. Industry personnel will be able to better understand emergency planning, and emergency personnel will better understand industry operations. Health, safety and environment will be better protected because of training. Better risk management will improve the operating climate for independent oil and gas producers. The ''Oil and Gas Facility Emergency Awareness Program'' benefits the emergency response teams, oil and gas facility owners and operators, state and federal regulators, the environment, and most especially the citizens. All groups must work together for the health, safety and protection of the community and the environment.« less

Generic Stellarator-like Magnetic Fusion Reactor

NASA Astrophysics Data System (ADS)

Sheffield, John; Spong, Donald

2015-11-01

The Generic Magnetic Fusion Reactor paper, published in 1985, has been updated, reflecting the improved science and technology base in the magnetic fusion program. Key changes beyond inflation are driven by important benchmark numbers for technologies and costs from ITER construction, and the use of a more conservative neutron wall flux and fluence in modern fusion reactor designs. In this paper the generic approach is applied to a catalyzed D-D stellarator-like reactor. It is shown that an interesting power plant might be possible if the following parameters could be achieved for a reference reactor: R/ < a > ~ 4 , confinement factor, fren = 0.9-1.15, < β > ~ 8 . 0 -11.5 %, Zeff ~ 1.45 plus a relativistic temperature correction, fraction of fast ions lost ~ 0.07, Bm ~ 14-16 T, and R ~ 18-24 m. J. Sheffield was supported under ORNL subcontract 4000088999 with the University of Tennessee.

25 CFR 170.143 - How can IRR Program funds be used for highway safety?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false How can IRR Program funds be used for highway safety? 170... RESERVATION ROADS PROGRAM Indian Reservation Roads Program Policy and Eligibility Highway Safety Functions § 170.143 How can IRR Program funds be used for highway safety? A tribe, tribal organization, tribal...

25 CFR 170.143 - How can IRR Program funds be used for highway safety?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false How can IRR Program funds be used for highway safety? 170... RESERVATION ROADS PROGRAM Indian Reservation Roads Program Policy and Eligibility Highway Safety Functions § 170.143 How can IRR Program funds be used for highway safety? A tribe, tribal organization, tribal...

25 CFR 170.143 - How can IRR Program funds be used for highway safety?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true How can IRR Program funds be used for highway safety? 170... RESERVATION ROADS PROGRAM Indian Reservation Roads Program Policy and Eligibility Highway Safety Functions § 170.143 How can IRR Program funds be used for highway safety? A tribe, tribal organization, tribal...

25 CFR 170.143 - How can IRR Program funds be used for highway safety?

Code of Federal Regulations, 2011 CFR

2011-04-01

... RESERVATION ROADS PROGRAM Indian Reservation Roads Program Policy and Eligibility Highway Safety Functions § 170.143 How can IRR Program funds be used for highway safety? A tribe, tribal organization, tribal... 25 Indians 1 2011-04-01 2011-04-01 false How can IRR Program funds be used for highway safety? 170...

25 CFR 170.143 - How can IRR Program funds be used for highway safety?

Code of Federal Regulations, 2010 CFR

2010-04-01

... RESERVATION ROADS PROGRAM Indian Reservation Roads Program Policy and Eligibility Highway Safety Functions § 170.143 How can IRR Program funds be used for highway safety? A tribe, tribal organization, tribal... 25 Indians 1 2010-04-01 2010-04-01 false How can IRR Program funds be used for highway safety? 170...

23 CFR 1200.11 - Contents.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 402 program. (g) Teen Traffic Safety Program. If the State elects to include the Teen Traffic Safety... of the Teen Traffic Safety Program—a statewide program to improve traffic safety for teen drivers—and...

23 CFR 1200.11 - Contents.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 402 program. (g) Teen Traffic Safety Program. If the State elects to include the Teen Traffic Safety... of the Teen Traffic Safety Program—a statewide program to improve traffic safety for teen drivers—and...

Generic Modeling of a Life Support System for Process Technology Comparison

NASA Technical Reports Server (NTRS)

Ferrall, J. F.; Seshan, P. K.; Rohatgi, N. K.; Ganapathi, G. B.

1993-01-01

This paper describes a simulation model called the Life Support Systems Analysis Simulation Tool (LiSSA-ST), the spreadsheet program called the Life Support Systems Analysis Trade Tool (LiSSA-TT), and the Generic Modular Flow Schematic (GMFS) modeling technique. Results of using the LiSSA-ST and the LiSSA-TT will be presented for comparing life support system and process technology options for a Lunar Base with a crew size of 4 and mission lengths of 90 and 600 days. System configurations to minimize the life support system weight and power are explored.

Options for demonstrating the use of solar energy in california buildings

NASA Technical Reports Server (NTRS)

Davis, E. S.; Yanow, G.

1976-01-01

Three programmatic options for demonstrating the most economically attractive applications of solar energy to buildings located in California are formulated. The unique characteristics of solar energy demonstration programs and the involvement of key decision makers are discussed in detail. The demonstration programs are related to specific purposes. The priority structure used to select the generic projects making up each program is discussed in relationship to the purposes of the program. In addition, some implications of the nature of the demonstration program for management are outlined.

AN ADA NAMELIST PACKAGE

NASA Technical Reports Server (NTRS)

Klumpp, A. R.

1994-01-01

The Ada Namelist Package, developed for the Ada programming language, enables a calling program to read and write FORTRAN-style namelist files. A namelist file consists of any number of assignment statements in any order. Features of the Ada Namelist Package are: the handling of any combination of user-defined types; the ability to read vectors, matrices, and slices of vectors and matrices; the handling of mismatches between variables in the namelist file and those in the programmed list of namelist variables; and the ability to avoid searching the entire input file for each variable. The principle user benefits of this software are the following: the ability to write namelist-readable files, the ability to detect most file errors in the initialization phase, a package organization that reduces the number of instantiated units to a few packages rather than to many subprograms, a reduced number of restrictions, and an increased execution speed. The Ada Namelist reads data from an input file into variables declared within a user program. It then writes data from the user program to an output file, printer, or display. The input file contains a sequence of assignment statements in arbitrary order. The output is in namelist-readable form. There is a one-to-one correspondence between namelist I/O statements executed in the user program and variables read or written. Nevertheless, in the input file, mismatches are allowed between assignment statements in the file and the namelist read procedure statements in the user program. The Ada Namelist Package itself is non-generic. However, it has a group of nested generic packages following the nongeneric opening portion. The opening portion declares a variety of useraccessible constants, variables and subprograms. The subprograms are procedures for initializing namelists for reading, reading and writing strings. The subprograms are also functions for analyzing the content of the current dataset and diagnosing errors. Two nested generic packages follow the opening portion. The first generic package contains procedures that read and write objects of scalar type. The second contains subprograms that read and write one and two-dimensional arrays whose components are of scalar type and whose indices are of either of the two discrete types (integer or enumeration). Subprograms in the second package also read and write vector and matrix slices. The Ada Namelist ASCII text files are available on a 360k 5.25" floppy disk written on an IBM PC/AT running under the PC DOS operating system. The largest subprogram in the package requires 150k of memory. The package was developed using VAX Ada v. 1.5 under DEC VMS v. 4.5. It should be portable to any validated Ada compiler. The software was developed in 1989, and is a copyrighted work with all copyright vested in NASA.

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

A Compilation of Boiling Water Reactor Operational Experience for the United Kingdom's Office for Nuclear Regulation's Advanced Boiling Water Reactor Generic Design Assessment

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

Wheeler, Timothy A.; Liao, Huafei

2014-12-01

United States nuclear power plant Licensee Event Reports (LERs), submitted to the United States Nuclear Regulatory Commission (NRC) under law as required by 10 CFR 50.72 and 50.73 were evaluated for reliance to the United Kingdom’s Health and Safety Executive – Office for Nuclear Regulation’s (ONR) general design assessment of the Advanced Boiling Water Reactor (ABWR) design. An NRC compendium of LERs, compiled by Idaho National Laboratory over the time period January 1, 2000 through March 31, 2014, were sorted by BWR safety system and sorted into two categories: those events leading to a SCRAM, and those events which constitutedmore » a safety system failure. The LERs were then evaluated as to the relevance of the operational experience to the ABWR design.« less

A Safety Program that Integrated Behavior-Based Safety and Traditional Safety Methods and Its Effects on Injury Rates of Manufacturing Workers

ERIC Educational Resources Information Center

Hermann, Jaime A.; Ibarra, Guillermo V.; Hopkins, B. L.

2010-01-01

The present research examines the effects of a complex safety program that combined Behavior-Based Safety (BBS) and traditional safety methods. The study was conducted in an automobile parts plant in Mexico. Two sister plants served as comparison. Some of the components of the safety programs addressed behaviors of managers and included methods…

Applying U.S. EOP Analytical Justification Experience for VVER Plants in the Ukraine

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

Linn, Paul A.; Julian, Harold V.; Chapman, James R.

2002-07-01

The foundation for new Emergency Operating Instructions (EOIs) being developed at several plants in the Ukraine is the Westinghouse Owners Group (WOG) Emergency Response Guidelines (ERGs) developed in the U.S. The ERGs were chosen as a base for the new EOIs for several reasons. First the overall structure and format was adaptable to VVER Pressurized Water Reactor (PWR) designs. Second, the ERGs have served as a base for many plant EOIs in both the U.S. and internationally. Third, key information supporting the ERGs was available. This paper describes the method used at one of the Ukrainian plants to provide anmore » analytical justification for their EOIs. The method being employed by a second plant is very similar, differing only slightly in how it is implemented. The WOG ERG development program, which started shortly after the accident at Three Mile Island Unit 2, used many sources of technical information on plant and system transient response, which were available in support of the plant design and licensing efforts. In addition, operating experience from many operating PWR plants in the U.S. and around the world was used. For example, design basis accident (DBA) analyses, documented in a plant's Safety Analysis Report (SAR) and other design documents, had been performed by Nuclear Steam Supply System (NSSS) vendors, utilities, or the Architect/Engineer. All relevant sources were considered in the development of the ERGs. Limited Probabilistic Risk Assessment (PRA) analyses were available during that time period. When a technical basis for a recovery strategy and associated operator actions was not available, an analysis was defined and performed. In general, these analyses were performed on a generic basis, and addressed the different categories of design (e.g., number of reactor coolant loops and/or low/high pressure safety injection system design). U.S. Nuclear Power plants that were in the WOG program were responsible for implementing the generic ERGs. This required the utilities to review the generic analyses to ensure that they were applicable and to justify any deviations from the ERG methodology. Modern PRA analyses are similar to the analyses supporting the ERGs since they address multiple failures and assume better estimate or expected assumptions for equipment availability and operator performance. The process being employed by Ukrainian plants is similar to the WOG. That is, available analyses and operating experience are being reviewed and pertinent information extracted to assist in the analytical justification of the EOIs. This includes the use of recently updated PRA and DBA analyses, other 'original' design information and operating experience. A systematic review of the EOIs is being conducted to identify items requiring analytical justification. For each analysis identified, the specific purpose of the analysis is being documented. The analysis needs are then compared to the available analyses and operating experience. From this review, new analyses needed to justify the EOIs are developed, and a basis for using existing analyses is established. The work is being conducted in two phases. The first phase performs all of the reviews and assessments necessary to determine the new analyses required to justify the EOIs. In the second phase, these new analyses will be conducted and documented, and the EOI Analytical Justification (AJ) report will be written. (authors)« less

Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

PubMed

Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

2018-04-01

We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 9 2012-07-01 2012-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 9 2014-07-01 2014-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 9 2013-07-01 2013-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 9 2011-07-01 2011-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs...

AirSTAR: A UAV Platform for Flight Dynamics and Control System Testing

NASA Technical Reports Server (NTRS)

Jordan, Thomas L.; Foster, John V.; Bailey, Roger M.; Belcastro, Christine M.

2006-01-01

As part of the NASA Aviation Safety Program at Langley Research Center, a dynamically scaled unmanned aerial vehicle (UAV) and associated ground based control system are being developed to investigate dynamics modeling and control of large transport vehicles in upset conditions. The UAV is a 5.5% (seven foot wingspan), twin turbine, generic transport aircraft with a sophisticated instrumentation and telemetry package. A ground based, real-time control system is located inside an operations vehicle for the research pilot and associated support personnel. The telemetry system supports over 70 channels of data plus video for the downlink and 30 channels for the control uplink. Data rates are in excess of 200 Hz. Dynamic scaling of the UAV, which includes dimensional, weight, inertial, actuation, and control system scaling, is required so that the sub-scale vehicle will realistically simulate the flight characteristics of the full-scale aircraft. This testbed will be utilized to validate modeling methods, flight dynamics characteristics, and control system designs for large transport aircraft, with the end goal being the development of technologies to reduce the fatal accident rate due to loss-of-control.

NASA Iced Aerodynamics and Controls Current Research

NASA Technical Reports Server (NTRS)

Addy, Gene

2009-01-01

This slide presentation reviews the state of current research in the area of aerodynamics and aircraft control with ice conditions by the Aviation Safety Program, part of the Integrated Resilient Aircraft Controls Project (IRAC). Included in the presentation is a overview of the modeling efforts. The objective of the modeling is to develop experimental and computational methods to model and predict aircraft response during adverse flight conditions, including icing. The Aircraft icing modeling efforts includes the Ice-Contaminated Aerodynamics Modeling, which examines the effects of ice contamination on aircraft aerodynamics, and CFD modeling of ice-contaminated aircraft aerodynamics, and Advanced Ice Accretion Process Modeling which examines the physics of ice accretion, and works on computational modeling of ice accretions. The IRAC testbed, a Generic Transport Model (GTM) and its use in the investigation of the effects of icing on its aerodynamics is also reviewed. This has led to a more thorough understanding and models, both theoretical and empirical of icing physics and ice accretion for airframes, advanced 3D ice accretion prediction codes, CFD methods for iced aerodynamics and better understanding of aircraft iced aerodynamics and its effects on control surface effectiveness.

The Economics of Biosimilars

PubMed Central

Blackstone, Erwin A.; Joseph, P. Fuhr

2013-01-01

Background The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars. Objective To examine information related to biosimilars to determine their potential impact on competition in the biologic market. Method Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars. Discussion This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics. Conclusion Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky. PMID:24991376

A Community Health Worker "logic model": towards a theory of enhanced performance in low- and middle-income countries.

PubMed

Naimoli, Joseph F; Frymus, Diana E; Wuliji, Tana; Franco, Lynne M; Newsome, Martha H

2014-10-02

There has been a resurgence of interest in national Community Health Worker (CHW) programs in low- and middle-income countries (LMICs). A lack of strong research evidence persists, however, about the most efficient and effective strategies to ensure optimal, sustained performance of CHWs at scale. To facilitate learning and research to address this knowledge gap, the authors developed a generic CHW logic model that proposes a theoretical causal pathway to improved performance. The logic model draws upon available research and expert knowledge on CHWs in LMICs. Construction of the model entailed a multi-stage, inductive, two-year process. It began with the planning and implementation of a structured review of the existing research on community and health system support for enhanced CHW performance. It continued with a facilitated discussion of review findings with experts during a two-day consultation. The process culminated with the authors' review of consultation-generated documentation, additional analysis, and production of multiple iterations of the model. The generic CHW logic model posits that optimal CHW performance is a function of high quality CHW programming, which is reinforced, sustained, and brought to scale by robust, high-performing health and community systems, both of which mobilize inputs and put in place processes needed to fully achieve performance objectives. Multiple contextual factors can influence CHW programming, system functioning, and CHW performance. The model is a novel contribution to current thinking about CHWs. It places CHW performance at the center of the discussion about CHW programming, recognizes the strengths and limitations of discrete, targeted programs, and is comprehensive, reflecting the current state of both scientific and tacit knowledge about support for improving CHW performance. The model is also a practical tool that offers guidance for continuous learning about what works. Despite the model's limitations and several challenges in translating the potential for learning into tangible learning, the CHW generic logic model provides a solid basis for exploring and testing a causal pathway to improved performance.

Evaluation of Nuclear Facility Decommissioning Projects program: a reference research reactor. Project summary report

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

Baumann, B.L.; Miller, R.L.

1983-10-01

This document presents, in summary form, generic conceptual information relevant to the decommissioning of a reference research reactor (RRR). All of the data presented were extracted from NUREG/CR-1756 and arranged in a form that will provide a basis for future comparison studies for the Evaluation of Nuclear Facility Decommissioning Projects (ENFDP) program.

Understanding and Enabling Marketplace Literacy in Subsistence Contexts: The Development of a Consumer and Entrepreneurial Literacy Educational Program in South India

ERIC Educational Resources Information Center

Viswanathan, Madhubalan; Gajendiran, S.; Venkatesan, R.

2008-01-01

To function in the economic realm, two important resources that individuals need are finances and know-how. Whereas there has been considerable attention on microfinancing, we describe an educational program that focuses on enabling generic skills about the marketplace and complements these important efforts. We conducted research aimed at…

2011 Annual Criticality Safety Program Performance Summary

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

Andrea Hoffman

The 2011 review of the INL Criticality Safety Program has determined that the program is robust and effective. The review was prepared for, and fulfills Contract Data Requirements List (CDRL) item H.20, 'Annual Criticality Safety Program performance summary that includes the status of assessments, issues, corrective actions, infractions, requirements management, training, and programmatic support.' This performance summary addresses the status of these important elements of the INL Criticality Safety Program. Assessments - Assessments in 2011 were planned and scheduled. The scheduled assessments included a Criticality Safety Program Effectiveness Review, Criticality Control Area Inspections, a Protection of Controlled Unclassified Information Inspection,more » an Assessment of Criticality Safety SQA, and this management assessment of the Criticality Safety Program. All of the assessments were completed with the exception of the 'Effectiveness Review' for SSPSF, which was delayed due to emerging work. Although minor issues were identified in the assessments, no issues or combination of issues indicated that the INL Criticality Safety Program was ineffective. The identification of issues demonstrates the importance of an assessment program to the overall health and effectiveness of the INL Criticality Safety Program. Issues and Corrective Actions - There are relatively few criticality safety related issues in the Laboratory ICAMS system. Most were identified by Criticality Safety Program assessments. No issues indicate ineffectiveness in the INL Criticality Safety Program. All of the issues are being worked and there are no imminent criticality concerns. Infractions - There was one criticality safety related violation in 2011. On January 18, 2011, it was discovered that a fuel plate bundle in the Nuclear Materials Inspection and Storage (NMIS) facility exceeded the fissionable mass limit, resulting in a technical safety requirement (TSR) violation. The TSR limits fuel plate bundles to 1085 grams U-235, which is the maximum loading of an ATR fuel element. The overloaded fuel plate bundle contained 1097 grams U-235 and was assembled under an 1100 gram U-235 limit in 1982. In 2003, the limit was reduced to 1085 grams citing a new criticality safety evaluation for ATR fuel elements. The fuel plate bundle inventories were not checked for compliance prior to implementing the reduced limit. A subsequent review of the NMIS inventory did not identify further violations. Requirements Management - The INL Criticality Safety program is organized and well documented. The source requirements for the INL Criticality Safety Program are from 10 CFR 830.204, DOE Order 420.1B, Chapter III, 'Nuclear Criticality Safety,' ANSI/ANS 8-series Industry Standards, and DOE Standards. These source requirements are documented in LRD-18001, 'INL Criticality Safety Program Requirements Manual.' The majority of the criticality safety source requirements are contained in DOE Order 420.1B because it invokes all of the ANSI/ANS 8-Series Standards. DOE Order 420.1B also invokes several DOE Standards, including DOE-STD-3007, 'Guidelines for Preparing Criticality Safety Evaluations at Department of Energy Non-Reactor Nuclear Facilities.' DOE Order 420.1B contains requirements for DOE 'Heads of Field Elements' to approve the criticality safety program and specific elements of the program, namely, the qualification of criticality staff and the method for preparing criticality safety evaluations. This was accomplished by the approval of SAR-400, 'INL Standardized Nuclear Safety Basis Manual,' Chapter 6, 'Prevention of Inadvertent Criticality.' Chapter 6 of SAR-400 contains sufficient detail and/or reference to the specific DOE and contractor documents that adequately describe the INL Criticality Safety Program per the elements specified in DOE Order 420.1B. The Safety Evaluation Report for SAR-400 specifically recognizes that the approval of SAR-400 approves the INL Criticality Safety Program. No new source requirements were released in 2011. A revision to LRD-18001 is planned for 2012 to clarify design requirements for criticality alarms. Training - Criticality Safety Engineering has developed training and provides training for many employee positions, including fissionable material handlers, facility managers, criticality safety officers, firefighters, and criticality safety engineers. Criticality safety training at the INL is a program strength. A revision to the training module developed in 2010 to supplement MFC certified fissionable material handlers (operators) training was prepared and presented in August of 2011. This training, 'Applied Science of Criticality Safety,' builds upon existing training and gives operators a better understanding of how their criticality controls are derived. Improvements to 00INL189, 'INL Criticality Safety Principles' are planned for 2012 to strengthen fissionable material handler training.« less

Investigating the dissolution profiles of amoxicillin, metronidazole, and zidovudine formulations used in Trinidad and Tobago, West Indies.

PubMed

Stuart, Arlene Villarroel; Zuo, Jieyu; Löbenberg, Raimar

2014-10-01

Trinidad and Tobago is a twin-island Republic in the Caribbean and like many developing countries, it has included generic drugs on the national drug formulary to decrease the financial burden of pharmaceutical medications. However, to ensure that medications received by patients are beneficial, generic drugs need to be interchangeable with the innovator which has demonstrated safety, efficacy, and quality. The objective of the study was to compare the dissolution profiles and weight variations for different formulations of amoxicillin, metronidazole, and zidovudine that are on the national drug formulary and marketed in Trinidad and Tobago. All the products investigated are categorized as class 1 drugs according to the Biopharmaceutics Classification System (BCS) and the dissolution profiles were assessed according to the World Health Organization (WHO) criteria for interchangeability between products. The similarity factor, f 2, was used to determine sameness between the products. No generic formulation was found to be similar to Amoxil® 500-mg capsules. The two generic products for metronidazole 200-mg tablets demonstrated more than 85% drug release within 15 min in all three of the buffers; however, their 400-mg counterparts did not fulfill this requirement. The zidovudine 300-mg tablet complied with the requirements in buffer pH 4.5 and simulated gastric fluid (SGF) but not for simulated intestinal fluid (SIF). Some Class 1 pharmaceutical formulations may possess the same active ingredient and amount of drug but may show significant differences to in vitro equivalence requirements. Nevertheless, the dissolution process is suitable to detect these variations.

49 CFR 659.19 - System safety program plan: contents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false System safety program plan: contents. 659.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.19 System safety program plan: contents. The system safety plan shall...