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Sample records for drug utilization study

  1. Socioeconomic factors, morbidity and drug utilization--an ecological study.

    PubMed

    Henricson, K; Stenberg, P; Rametsteiner, G; Ranstam, J; Hanson, B S; Melander, A

    1998-07-01

    The aim of the present study was to elucidate the relations between demographic and socioeconomic factors, morbidity and the utilization of major drug groups in an urban Swedish population. The study was performed as an ecological analysis during November 1991 in the 17 different districts of Malmö, the third largest Swedish city (235,000 inhabitants). The material comprised 86,228 ACT-coded drug items which corresponded to 76% of all prescriptions dispensed during the study month. Of these, 43,032, dispensed to patients aged 15-64 years, were analysed in the present work. Age standardized drug utilization was expressed as the number of dispensed Defined Daily Doses per 1000 inhabitants per day. Morbidity was measured in terms of reimbursed days on sick leave. The sociodemographic parameters used were socioeconomic status (SES), employment rate, median income per family, households on social allowance, and ethnicity. For four of the five major pharmacological groups (ATC-groups A, C, J, N and R, i.e. alimentation, circulation, infectious diseases, nervous system and respiration), most pronouncedly group N and least so group R, utilization correlated positively with not only the extent of morbidity but also with an unfavourable socioeconomic situation, high proportion of immigrants, and households on social allowance or with low income and/or with a low employment rate. The utilization of antibiotics (group J), however, instead correlated negatively with these parameters. For all five drug groups, these trends were similar among men and women, albeit with varying strength. In conclusion, socioeconomic factors may have a profound influence on the utilization of several major drug groups. At least in the case of antibiotics, the consequence of this influence is irrational drug use.

  2. Drug utilization pattern of anti-epileptic drugs: a pharmacoepidemiologic study in Oman.

    PubMed

    Hanssens, Y; Deleu, D; Al Balushi, K; Al Hashar, A; Al-Zakwani, I

    2002-10-01

    To get an insight into the type and aetiology of epileptic seizures; to describe the drug utilization pattern of anti-epileptic drugs (AEDs) for the treatment of various forms of epileptic seizures in this tertiary referral centre in Oman; and to compare our drug utilization pattern with that from other countries. In addition, the tolerability of AEDs and the use of therapeutic drug monitoring (TDM) were evaluated. In a 6-month study, all epileptic patients aged 14 and above who were prescribed an AED were considered for analysis. Demographic data, type and aetiology of epileptic seizures, AED data, tests performed and adverse drug reaction (ADR) data were collected. A total of 1039 prescriptions originated from 488 epileptic patients. The age ranged from 14 to 77 years (median, 24 years). Generalized tonic-clonic seizures (51%) of idiopathic/cryptogenic origin (83%) were the most common type and aetiology of epileptic seizures, respectively. An average of 1.34 AEDs per patient was prescribed with 78% of patients being on monotherapy. Sodium valproate (49%) was the most frequently prescribed AED, followed by carbamazepine (44%), phenytoin (12%) and lamotrigine (11%). Ten patients suffered an ADR and phenobarbital followed by carbamazepine were most commonly the subject of TDM. Unlike the results in most other studies, generalized seizures represented the majority of epileptic seizures. The selection of the AEDs corresponded well with their known efficacy profiles for specific epileptic seizure types. Monotherapy was the type of therapy most frequently used, and sodium valproate and carbamazepine were the most commonly used AEDs.

  3. Utilization of liposomes for studying drug transfer and uptake.

    PubMed

    Fahr, Alfred; Liu, Xiangli

    2010-01-01

    On entry into the body of the patient, drugs have to overcome many barriers in order to reach the target. The knowledge of the ability of drugs to cross these barriers, which mostly consist of lipid membranes, is of utmost interest in pharmacy.High values of lipophilicity of a drug might be a good pre-requisite for crossing these barriers. It also led liposomologists to think that highly lipophilic drugs may "stick" in the lipophilic interior of liposomal phospholipid membranes and therefore these liposomes may act as a retard formulation of the lipophilic drug.The presented method here estimates the transfer time of lipophilic drugs between liposomal lipid bilayers. This may help to judge the presumed retardation function of a specific liposomal delivery system for a chosen lipophilic drug.

  4. Drug Utilization on Neonatal Wards: A Systematic Review of Observational Studies

    PubMed Central

    Rosli, Rosliana; Dali, Ahmad Fauzi; Abd Aziz, Noorizan; Abdullah, Amir Heberd; Ming, Long Chiau; Manan, Mohamed Mansor

    2017-01-01

    Despite limited evidence on safety and efficacy of drug use in neonates, drugs are extensively used in this age group. However, the availability of information on drug consumption in neonates, especially inpatient neonates, is limited. This paper systematically reviews published studies on drug utilization in hospitalized neonates. A systematic literature review was carried out to identify observational studies published from inception of databases used till August 2016. Four search engines, namely Medline, CINAHL, Embase, and PubMed, were used. Publications written in English that described drug utilization in neonatal wards were selected. Assessment of the data was based on the category of the study design, the objective of study and the method used in reporting drug consumption. A total of 20 drug utilization studies were identified, 12 of which focused on all drug classes, while the other eight evaluated antimicrobials. Studies were reported in Europe (n = 7), the United States (n = 6), India (n = 5), Brazil (n = 1), and Iran (n = 1). Substantial variance with regard to study types (study design and methods), data source, and sample size were found among the selected studies. Of the studies included, 45% were cross-sectional or retrospective, 40% were prospective studies, and the remaining 15% were point prevalence surveys. More than 70% of the studies were descriptive studies, describing drug consumption patterns. Fifteen per cent of the descriptive studies evaluated changes in drug utilization patterns in neonates. Volume of units was the most prevalent method used for reporting all drug categories. The ATC/DDD system for reporting drug use was only seen in studies evaluating antimicrobials. The most commonly reported drugs across all studies are anti-infectives for systemic use, followed by drugs for the cardiovascular system, the nervous system and the respiratory system. Ampicillin and gentamicin were the most prescribed antimicrobials in hospitalized

  5. Drug Utilization on Neonatal Wards: A Systematic Review of Observational Studies.

    PubMed

    Rosli, Rosliana; Dali, Ahmad Fauzi; Abd Aziz, Noorizan; Abdullah, Amir Heberd; Ming, Long Chiau; Manan, Mohamed Mansor

    2017-01-01

    Despite limited evidence on safety and efficacy of drug use in neonates, drugs are extensively used in this age group. However, the availability of information on drug consumption in neonates, especially inpatient neonates, is limited. This paper systematically reviews published studies on drug utilization in hospitalized neonates. A systematic literature review was carried out to identify observational studies published from inception of databases used till August 2016. Four search engines, namely Medline, CINAHL, Embase, and PubMed, were used. Publications written in English that described drug utilization in neonatal wards were selected. Assessment of the data was based on the category of the study design, the objective of study and the method used in reporting drug consumption. A total of 20 drug utilization studies were identified, 12 of which focused on all drug classes, while the other eight evaluated antimicrobials. Studies were reported in Europe (n = 7), the United States (n = 6), India (n = 5), Brazil (n = 1), and Iran (n = 1). Substantial variance with regard to study types (study design and methods), data source, and sample size were found among the selected studies. Of the studies included, 45% were cross-sectional or retrospective, 40% were prospective studies, and the remaining 15% were point prevalence surveys. More than 70% of the studies were descriptive studies, describing drug consumption patterns. Fifteen per cent of the descriptive studies evaluated changes in drug utilization patterns in neonates. Volume of units was the most prevalent method used for reporting all drug categories. The ATC/DDD system for reporting drug use was only seen in studies evaluating antimicrobials. The most commonly reported drugs across all studies are anti-infectives for systemic use, followed by drugs for the cardiovascular system, the nervous system and the respiratory system. Ampicillin and gentamicin were the most prescribed antimicrobials in hospitalized

  6. A Drug Utilization Study of Psychotropic Drugs Prescribed in the Psychiatry Outpatient Department of a Tertiary Care Hospital

    PubMed Central

    Thakkar, Karan B.; Jain, Mangal M.; Billa, Gauri; Joshi, Abhijit; Khobragade, Akash A.

    2013-01-01

    Background: Psychiatric disorders are one of the major causes of morbidity. Development of newer drugs like SSRIs and atypical antipsychotics has altered the treatment paradigms. Various factors like cost of drugs, local paradigms, etc. play a role in the selection of drug therapy and hence, affect the outcome. Keeping this in mind, we conducted a study to delineate the various drugs used in psychiatric disorders, to find discrepancies, if any, between the actual and the ideal prescribing pattern of psychotropic drugs and to conduct a cost analysis. Material and Methods: After our institutional ethics committee approved, a retrospective cross sectional drug utilization study of 600 prescriptions was undertaken. Preparation of the protocol and conduct of the study was as per the WHO – DUS and the STROBE guidelines. Results: Drug use indicators – In 600 prescriptions, 1074 (88.25%) were psychotropic drugs. The utilization from the National and WHO EML was 100% and 90%, respectively. Average number of psychotropic drugs per prescription was 1.79 ± 1.02 (SD). 22.5% of the prescriptions contained psychotropic FDCs. 76.01% of drugs were prescribed by generic name. Percentage of psychotropic drugs prescribed from the hospital drug schedule and psychotropic drugs actually dispensed from the hospital drug store were 73.1% and 62.3%, respectively. Drug utilization pattern in different psychiatric disorders – Most commonly prescribed drugs for schizophrenia, bipolar disorders, depression and anxiety disorders were trifluoperazine + trihexiphenydyl (63.9%), carbamazepine (17.2%), amitriptyline (34.9%), and diazepam (23.8%), respectively. The least commonly prescribed drugs were levosulpiride (1.7%), lithium (1.3%), bupropion (4.7%) and clozapine (1.9%), respectively. The PDD/DDD ratio of three drugs – haloperidol, pimozide and amitriptyline – was equal to one. The cost borne by the hospital was 116, i.e., 65.2% of the total cost. The cost index of clozapine was 11

  7. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

    PubMed

    Sequi, Marco; Campi, Rita; Clavenna, Antonio; Bonati, Maurizio

    2013-03-01

    To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population. Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation. A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of <6. Our findings document that only a few of the studies reviewed applied statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

  8. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    PubMed Central

    2009-01-01

    Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD) and DDD/1000 persons/day/(DID). Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67) and average annual expense (€21.55 v. €41.14). Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID) being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline) and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities. PMID:19995453

  9. Drug utilization study in ophthalmology outpatients at a tertiary care teaching hospital.

    PubMed

    Jadhav, Pradeep R; Moghe, Vijay V; Deshmukh, Yeshwant A

    2013-12-22

    In view of the advancement in drug development and availability of new ocular therapeutics in the discipline of ophthalmology, we attempted to study the drug utilization and describe the prescribing practices of ophthalmologists in a tertiary care teaching hospital. Method. A prospective, cross-sectional, observational study was conducted on patients attending Outpatient Department of Ophthalmology for curative complaints. Prescriptions of 600 patients treated were analyzed by the WHO prescribing indicators and additional indices. Results. Analysis showed that the average number of drugs per prescription was 1.49. Percentage of drugs prescribed by generic name was 2.35%. Percentage of encounters with antibiotics was 44.83%. Percentage of drugs prescribed from National Essential drug list (NEDL)/National Formulary of India (NFI) was 19.48%. Patient's knowledge of correct dosage was 93.83%. Antimicrobial agents were the most commonly prescribed drugs followed by antiallergy drugs and ocular lubricants. Fluoroquinolones accounted for 60% of the total antimicrobial drugs, of which gatifloxacin was the most frequently prescribed fluoroquinolone. Conclusion. The study indicated an awareness of polypharmacy, but showed ample scope for improvement in encouraging the ophthalmologists to prescribe by generic name and selection of essential drugs from NEDL/NFI.

  10. Systematic review of cross-national drug utilization studies in Latin America: methods and comparability.

    PubMed

    Durán, Carlos E; Christiaens, Thierry; Acosta, Ángela; Vander Stichele, Robert

    2016-01-01

    We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies including LA countries and comparing drug exposure data on volume were included. The data validity was judged independently by two authors as having low, medium, high, or unclear risk of bias. Out of 1191 articles, 25 were kept for full text reading. Finally, five studies were selected. Eight different Latin American countries were involved in the comparisons. The selected studies analyzed wholesale data from a private research company collecting information from the private healthcare sector. In three studies, a high risk of bias in the extrapolation method applied was identified. In one study, a risk of data collection bias was detected. The most frequent limitation detected by the original authors was related to the unavailability of information from the public sector in LA. Drug utilization studies comparing data cross-nationally are scarce in LA. In general, validity of the comparisons is hampered by a potential risk of extrapolation bias given the lack of available data on drug consumption from the public healthcare sector. Setting up systems to remediate this situation is a future challenge for researchers and (supra)national authorities in the region. Copyright © 2015 John Wiley & Sons, Ltd.

  11. Drug utilization studies: a tool for determining the effectiveness of drug use.

    PubMed Central

    Laporte, J R; Porta, M; Capella, D

    1983-01-01

    To evaluate the quality of the consumption of medicines in Spain, its potential efficacy, and its evolution during the last years, an assessment of the 'intrinsic value' of the most sold pharmaceutical specialities (amounting to more than 50% of total pharmaceutical market) was carried out. A panel of five clinical pharmacologist classified medicines, according to their intrinsic value, in four groups: (i) 'high value' (41% of analyzed medicines in 1980); (ii) 'relative value' (12% in 1980); (iii) 'doubtful value' (3%); (iv) 'no value' (23%), and (v) 'unacceptable value' (21%). Drugs were also classified according to their expected potential of use; and three groups were formed: (i) 'high' (32%); (ii) 'relatively high' (14%), and (iii) 'reduced' (10%). A fourth group of 'not applicable' (44%) in this classification was formed with pharmaceuticals considered unvaluable or unacceptable in the first classification. The results of this study suggest that this kind of analysis may be a useful tool to evaluate the efficacy of drugs in the community, and to identify priorities and guidelines in the selection of drugs in each country. PMID:6626422

  12. Systematic review of drug utilization studies & the use of the drug classification system in the WHO-SEARO Region.

    PubMed

    Bachhav, Sagar S; Kshirsagar, Nilima A

    2015-08-01

    Information available on drug consumption is inadequate in most low and middle income countries. This systematic review was conducted to analyse published work on drug utilization research/studies (DUR) in the SEARO region of WHO for study objectives, methodology, results and recommendations and to identify the need for improving DUR and the use of the ATC/DDD system. A literature search for DUR was carried out in biomedical databases (PubMed, Scirus, Scopus and Google Scholar) up to May 2012. Publications were selected if those were in the English language, describing DUR or prescription practices, and study conducted in the WHO-SEARO countries. A total of 318 publications were included in the review. Of these, 67 per cent were from India and 13 per cent were from Thailand. Majority of the publications were hospital based; only 16 per cent were community based. The ATC/DDD system was used in only 20 per cent of the publications, of which 73 per cent publications used DDD indicators. Several publications focused on antibiotics (31%). Publications that recommended the need for a policy or intervention to improve prescription practices/rational drug use amounted to 35 per cent. Drug utilization studies using ATC/DDD system need to be promoted and carried out on an ongoing basis. DUR is important for rational use of drugs. Its relevance to policy making and resource allocation needs to be emphasized.

  13. A Study On the Drug Utilization Trends in the Cardiovascular Emergencies in A Tertiary Care Hospital

    PubMed Central

    Pendhari, Shabbir Rafiq; Chaudhari, Devendra Ramesh; Burute, Shreyas Ramchandra; Bite, Bapurao Motiram

    2013-01-01

    Objectives: To observe the cardiovascular emergencies which were most frequently treated and to quantify the drug utilization trends in the cardiovascular emergencies, in terms of the Defined Daily Doses [DDD] and the prescribing prevalence in the cardiovascular emergencies. Methods: This prescription based study was undertaken in the Medicine ICU of the government medical hospital. The age, sex, diagnosis (only cardiovascular) and the drugs which were prescribed, were recorded for each patient. Also, the brand names and the generic names of the prescribed drugs were noted. The collected data was analyzed to study the drug utilization trends. Results: It was observed that the most commonly treated cardiovascular disease was IHD. The IHD was more in males than in females who were below 50 years of age and it was nearly equal in the age groups which were above 50 years. The use of Angiotensin Converting Enzyme (ACE) inhibitors was higher than that of the beta blockers and the calcium channel blockers. The patients with cardiovascular emergencies also had preceding associated diseases like diabetes mellitus and hypertension. Conclusions: The protocol of the management which was followed by the college in the treatment of cardiovascular emergencies was competent enough, as the clinical outcomes of the patients were favourable. But there was a guideline incongruent prescribing behaviour which was statistically significant, for which there is a need to undertake large scale studies. PMID:23730642

  14. Neuroleptic drug utilization in out-patients--a prescription database study.

    PubMed Central

    Rosholm, J U; Hansen, L J; Hallas, J; Gram, L F

    1993-01-01

    1 A prescription database study was conducted to describe the out-patient utilization of neuroleptics in the Odense area (207,000 inhabitants) during a period of 1 year. 2 Neuroleptic drug use is widespread, the period prevalence being 2.45% of the population. 3 The prevalence increases with increasing age. Fifteen percent of the population aged 90 years or more received neuroleptic drugs in spite of the many warnings against side effects in the elderly. 4 Estimated daily doses of neuroleptics were considerably lower than the Defined Daily Dose, probably as a reflection of many neuroleptics being prescribed to non-psychotic patients, in whom lower doses are used. 5 For perphenazine, a comparison of estimated daily doses from this study with doses from patients whose treatment had been adjusted by plasma concentration monitoring showed that generally much lower doses were used by patients included in this study. PMID:12959276

  15. Use of proton-pump inhibitors among adults: a Danish nationwide drug utilization study

    PubMed Central

    Pottegård, Anton; Broe, Anne; Hallas, Jesper; de Muckadell, Ove B. Schaffalitzky; Lassen, Annmarie T.; Lødrup, Anders B.

    2016-01-01

    Background: The use of proton-pump inhibitors (PPIs) has increased over the last decade. The objective of this study was to provide detailed utilization data on PPI use over time, with special emphasis on duration of PPI use and concomitant use of ulcerogenic drugs. Methods: Using the nationwide Danish Prescription Registry, we identified all Danish adults filling a PPI between 2002 and 2014. Using descriptive statistics, we reported (i) the distribution of use between single PPI entities, (ii) the development in incidence and prevalence of use over time, (iii) measures of duration and intensity of treatment, and (iv) the prevalence of use of ulcerogenic drugs among users of PPIs. Results: We identified 1,617,614 adults using PPIs during the study period. The prevalence of PPI use increased fourfold during the study period to 7.4% of all Danish adults in 2014. PPI use showed strong age dependency, reaching more than 20% among those aged at least 80 years. The proportion of users maintaining treatment over time increased with increasing age, with less than10% of those aged 18–39 years using PPIs 2 years after their first prescription, compared with about 40% among those aged at least 80 years. The overall use of ulcerogenic drugs among PPI users increased moderately, from 35% of users of PPI in 2002 to 45% in 2014. Conclusions: The use of PPIs is extensive and increasing rapidly, especially among the elderly. PMID:27582879

  16. Utilization of psychotropic drugs prescribed to persons with and without HIV infection: a Danish nationwide population-based cohort study.

    PubMed

    Rasmussen, L D; Obel, D; Kronborg, G; Larsen, C S; Pedersen, C; Gerstoft, J; Obel, N

    2014-09-01

    The objective was to estimate the utilization of psychotropic drugs in HIV-infected individuals compared with that in the background population. Using data obtained from the Danish HIV Cohort Study and the Danish National Prescription Registry, we analysed aggregated data on redeemed prescription of psychotropic drugs during 1995-2009. We primarily focused our analyses on HIV-infected individuals with no history of injecting drug use (IDU) or hepatitis C virus (HCV) infection. Drug utilization was expressed as defined daily doses per 1000 person-days (DDD/1000PD). The utilization rate ratio (URR) was calculated as utilization in the HIV-infected cohort compared with that in the comparison cohort. We estimated longitudinal trends in utilization and potential associations with HIV and exposure to highly active antiretroviral therapy (HAART), especially efavirenz. During 1995-2009, 54.5% of the HIV-infected cohort (3615 non-IDU/non-HCV-infected HIV-infected individuals) and 29.2% of the comparison cohort (32 535 individuals) had at least one prescription of a psychotropic drug. HIV infection was associated with a URR of 1.13 for antipsychotics, 1.76 for anxiolytics, 4.42 for hypnotics and sedatives, and 2.28 for antidepressants. Antidepressants were confined primarily to men who have sex with men (MSM). Older age, more recent calendar time, and increased time after HIV diagnosis were associated with increased drug utilization. However, no association with exposure to HAART or efavirenz was found. HIV-infected individuals had a higher utilization of psychotropic drugs than the background population, which was not confined to individuals with a history of IDU or HCV infection. This emphasizes the need to focus on diagnosis of, and appropriate psychopharmacological interventions for, mental disorders in this population. © 2014 British HIV Association.

  17. Prescription patterns of antihypertensives in a community health centre in Mexico City: a drug utilization study.

    PubMed

    Alba-Leonel, Adela; Carvajal, Alfonso; Fierro, Immaculada; Castillo-Nájera, Fernando; Campos-Ramos, Oscar; Villa-Romero, Antonio; Molina-Guarneros, Juan

    2016-06-01

    Hypertension is highly prevalent; in Mexico, the 2012 National Health and Nutrition Survey reported a prevalence of hypertension of 31.5% in the adult population. Pharmacological treatment is the commonest intervention and has been shown to reduce cardiovascular mortality and morbidity, and total mortality. Accordingly, the type and number of antihypertensives used and the outcome - in terms of blood pressure (BP) control - are important. Therefore, our purpose is to learn the pattern of antihypertensive drug prescription and explore the determinants of BP control in an urban population in Mexico. A retrospective cross-sectional drug utilization study was conducted. Medical records from a community health centre were searched to identify those corresponding to patients diagnosed with hypertension; information upon antihypertensives used and control of the disease was carefully retrieved. A logistic regression model was built to know the main determinants of BP control. A sample of 345 clinical records of interest was identified. Most patients received antihypertensives (86.4%); the leading medications used were angiotensin-converting enzyme inhibitors, 63.8%; beta-blockers (26.5%), diuretics (19.8%), angiotensin-receptor blockers (15.8%) and calcium-channel blockers (6.4%). Only the age (≥55 years) and BMI (>30) of the patients, and the age of the doctors (≥55 years), had an important influence on BP control. Obesity is a particular and important determinant of uncontrolled hypertension; it is worth to act on body weight, on an individual basis. As lack of control has been also tied to elderly doctors, an education programme could be envisaged. © 2016 The Authors Fundamental & Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of Société Française de Pharmacologie et de Thérapeutique.

  18. Clinical utility of genetic testing in pediatric drug-resistant epilepsy: a pilot study.

    PubMed

    Ream, Margie A; Mikati, Mohamad A

    2014-08-01

    The utility of genetic testing in pediatric drug-resistant epilepsy (PDRE), its yield in "real life" clinical practice, and the practical implications of such testing are yet to be determined. To start to address the above gaps in our knowledge as they apply to a patient population seen in a tertiary care center. We retrospectively reviewed our experience with the use of clinically available genetic tests in the diagnosis and management of PDRE in one clinic over one year. Genetic testing included, depending on clinical judgment, one or more of the following: karyotype, chromosomal microarray, single gene sequencing, gene sequencing panels, and/or whole exome sequencing (WES). We were more likely to perform genetic testing in patients with developmental delay, epileptic encephalopathy, and generalized epilepsy. In our unique population, the yield of specific genetic diagnosis was relatively high: karyotype 14.3%, microarray 16.7%, targeted single gene sequencing 15.4%, gene panels 46.2%, and WES 16.7%. Overall yield of diagnosis from at least one of the above tests was 34.5%. Disease-causing mutations that were not clinically suspected based on the patients' phenotypes and representing novel phenotypes were found in 6.9% (2/29), with an additional 17.2% (5/29) demonstrating pharmacologic variants. Three patients were incidentally found to be carriers of recessive neurologic diseases (10.3%). Variants of unknown significance (VUSs) were identified in 34.5% (10/29). We conclude that genetic testing had at least some utility in our patient population of PDRE, that future similar larger studies in various populations are warranted, and that clinics offering such tests must be prepared to address the complicated questions raised by the results of such testing. Copyright © 2014. Published by Elsevier Inc.

  19. Use of Pregabalin - A Nationwide Pharmacoepidemiological Drug Utilization Study with Focus on Abuse Potential.

    PubMed

    Schjerning, O; Pottegård, A; Damkier, P; Rosenzweig, M; Nielsen, J

    2016-07-01

    Pregabalin is currently approved for the treatment of epilepsy, generalized anxiety disorder and neuropathic pain with a licensed dosage range of 150 mg to 600 mg/day. Growing concern about the abuse potential of pregabalin is partly based on reports of pregabalin being used in dosages that exceed the approved therapeutic range. To identify predictors of pregabalin use above recommended dosage, we conducted a pharmacoepidemological drug utilization study using the Danish nationwide registers. We deployed 4 measures of abuse: high use (≥600 mg/day) or very high use (≥1 200 mg/day) over a 6- or 12-month period, respectively. Multiple logistic regression was used to identify patient and treatment characteristics that were associated with either abuse marker. Out of 42 520 pregabalin users 4 090 (9.6%) were treated with more than 600 mg/day for 6 months and 2 765 (6.5%) for more than 12 months. Male gender and prescription of antipsychotics and benzodiazepines were associated with increased risk of use of above the recommended dosage. Use of pregabalin above recommended dosages was rare but abuse may occur in susceptible patients. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Dynamic Effects among Patients' Treatment Needs, Beliefs, and Utilization: A Prospective Study of Adolescents in Drug Treatment

    PubMed Central

    Schell, Terry L; Orlando, Maria; Morral, Andrew R

    2005-01-01

    Objective To document the prospective, reciprocal relationships among substance use problems, utilization of drug treatment, and predisposing beliefs thought to increase treatment utilization. Data Source Persistent Effects of Treatment Study-Adolescent (PETS-A), conducted by the Center on Substance Abuse Treatment. This was a longitudinal study of youths originally participating in one of two CSAT studies; one sample included 476 youths receiving residential drug treatment, and the other included 519 youths receiving outpatient treatment. Study Design This study uses five waves of data collected over a 12-month period to examine the temporal relationships among four variables: treatment dose, substance use problems, drug resistance self-efficacy, and perceived need for treatment (PNT). Data from this longitudinal study were analyzed using cross-lagged panel models, and structural equation modeling techniques were used to estimate the prospective, reciprocal relationships among these four variables in each of the two samples, while controlling for several covariates. Principal Findings Both PNT and low drug resistance self-efficacy led to higher levels of subsequent treatment. However, low self-efficacy presaged increases in drug problems while PNT predicted decreases. Conclusions Understanding the role of psychological variables in the utilization of health services is complicated for psychological disorders because beliefs that affect treatment can also influence the disorder itself. Efforts to keep adolescents in drug treatment should focus on convincing youth that treatment can help them with their problems, rather than convincing them that they cannot resist drugs on their own. While both messages increase treatment utilization, the latter belief undermines the effects of treatment. PMID:16033496

  1. Drug utilization study of systemic antifungal agents in a Brazilian tertiary care hospital.

    PubMed

    de Souza, Maria Clara Padovani; Dos Santos, Andrezza Gouvêa; Reis, Adriano Max Moreira

    2016-12-01

    Background The inappropriate use of systemic antifungal agents can result in unnecessary exposure, adverse events, increased microbial resistance and increased costs. Aim This study analysed the use of systemic antifungal agents and adherence to treatment guidelines for fungal infections. Setting A Brazilian tertiary hospital. Methods This cross-sectional study investigated 183 patients who were treated with systemic antifungals. Antifungal drugs were classified according to the fourth level of the Anatomical Therapeutic Chemical classification system. The appropriateness of treatments was analysed with respect to the indication, dose and potential drug-drug interactions. Descriptive and univariate statistical analyses were performed. The main outcome measure was the frequency of adherence to treatment guidelines for fungal infections. Results The number of established treatments was 320, with 163 (50.9 %) pre-emptive, 63 (19.7 %) targeted, 56 (17.5 %) empirical and 38 (11.9 %) prophylactic treatments. The overall adherence to the treatment guidelines was 29.4 %. The proportion of appropriate treatment considering indication, dosage and drug-drug interactions was 84.1, 67.8 and 47.2 %, respectively. The most commonly prescribed systemic antifungal agents were fluconazole in 170 (53.1 %), voriconazole in 43 (13.4 %) and amphotericin B deoxycholate in 36 (11.3 %) cases. Conclusion The study showed a low proportion of appropriate antifungal drug use; the dosage and drug-drug interactions criteria were the determining factors for the high percentage of non-adherence to treatment guidelines in the hospital. The profile of antifungal agents used showed the predominance of fluconazole as well as the use of new antifungal drugs.

  2. Management of postoperative pain in abdominal surgery in Spain. A multicentre drug utilization study

    PubMed Central

    Vallano, Antonio; Aguilera, Cristina; Arnau, Josep Maria; Baños, Josep-Eladi; Laporte, Joan-Ramon

    1999-01-01

    Participating centres: Hospital Universitario San Juan, Alicante: Maria Jesús Olaso, Javier Agulló, Clara Faura. Hospital Torrecárdenas, Almería: Carmen Fernández Sánchez, Miguel Lorenzo Campos, Juan Manuel Rodríguez Alonso. Hospital Quirúrgic Adriano, Barcelona: Carmen Alerany Pardo, Paquita Alvarez González, Teresa Martín Benito. Hospital Universitari del Mar-IMIM, Barcelona: Magí Farré, Maite Terán. Corporació Sanitària Parc Taulí, Sabadell: Montserrat Cañellas, Sergio Zavala, Josep Planell. Hospital Universitari de la Santa Creu i Sant Pau: Gonzalo Calvo, Rosa Morros, Silvia Mateo. Hospital General Vall d’Hebron, Barcelona: Carmen Bosch, María José Martínez. Hospital Universitario Virgen de la Victoria, Málaga: Maribel Lucena, José Antonio González, Gabriel Carranque. Hospital Clínico Universitario San Carlos, Madrid: Emilio Vargas, Amparo Gil López-Oliva, Míriam García Mateos. Hospital Universitario Marqués de Valdecilla, Santander: Mario González, Antonio Cuadrado. Hospital Universitario Virgen de la Macarena, Sevilla: Juan Antonio Durán, Pilar Máyquez, María Isabel Serrano. Hospital Universitario Virgen del Rocío, Sevilla: Jaume Torelló, Juan Ramón Castillo, María de las Nieves Merino. Aims Postoperative pain is common in hospital-admitted patients. Its management is determined by different therapeutic traditions and by the attitudes of health professionals in each hospital. The aim of this study was to describe the patterns of prescription and administration of analgesic drugs used for postoperative pain after abdominal surgery in Spanish hospitals, to know the prevalence and the severity of postoperative pain, and to determine the extent of variability in the management of postoperative pain among the participating centres. Methods The study was a multicentre descriptive cross-sectional drug utilization study in 12 Spanish hospitals. The subjects were an unselected sample of consecutive patients undergoing abdominal

  3. How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?

    PubMed

    Naci, Huseyin; Ioannidis, John P A

    2015-01-01

    Promising evidence from clinical studies of drug effects does not always translate to improvements in patient outcomes. In this review, we discuss why early evidence is often ill suited to the task of predicting the clinical utility of drugs. The current gap between initially described drug effects and their subsequent clinical utility results from deficits in the design, conduct, analysis, reporting, and synthesis of clinical studies-often creating conditions that generate favorable, but ultimately incorrect, conclusions regarding drug effects. There are potential solutions that could improve the relevance of clinical evidence in predicting the real-world effectiveness of drugs. What is needed is a new emphasis on clinical utility, with nonconflicted entities playing a greater role in the generation, synthesis, and interpretation of clinical evidence. Clinical studies should adopt strong design features, reflect clinical practice, and evaluate outcomes and comparisons that are meaningful to patients. Transformative changes to the research agenda may generate more meaningful and accurate evidence on drug effects to guide clinical decision making.

  4. Sequential injection affinity chromatography utilizing an albumin immobilized monolithic column to study drug-protein interactions.

    PubMed

    Zacharis, Constantinos K; Kalaitzantonakis, Eftichios A; Podgornik, Ales; Theodoridis, Georgios

    2007-03-09

    In this study, sequential injection affinity chromatography was used for drug-protein interactions studies. The analytical system used consisted of a sequential injection analysis (SIA) manifold directly connected with convective interaction media (CIM) monolithic epoxy disks modified by ligand-immobilization of protein. A non-steroidal, anti-inflammatory drug, naproxen (NAP) and bovine serum albumin (BSA) were selected as model drug and protein, respectively. The SIA system was used for sampling, introduction and propulsion of drug towards to the monolithic column. Association equilibrium constants, binding capacity at various temperatures and thermodynamic parameters (free energy DeltaG, enthalpy DeltaH) of the binding reaction of naproxen are calculated by using frontal analysis mathematics. The variation of incubation time and its effect in on-line binding mode was also studied. The results indicated that naproxen had an association equilibrium constant of 2.90 x 10(6)M(-1) at pH 7.4 and 39 degrees C for a single binding site. The associated change in enthalpy (DeltaH) was -27.36 kcal mol(-1) and the change in entropy (DeltaS) was -73 cal mol(-1)K(-1) for a single type of binding sites. The location of the binding region was examined by competitive binding experiments using a biphosphonate drug, alendronate (ALD), as a competitor agent. It was found that the two drugs occupy the same class of binding sites on BSA. All measurements were performed with fluorescence (lambda(ext)=230 nm, lambda(em)=350 nm) and spectrophotometric detection (lambda=280 nm).

  5. Study of Drug Utilization Pattern for Skin Diseases in Dermatology OPD of an Indian Tertiary Care Hospital - A Prescription Survey

    PubMed Central

    Pathak, Anuj Kumar; Kumar, Subodh; Kumar, Manish; Dikshit, Harihar

    2016-01-01

    Introduction Skin diseases are the major contributors of disease burden in society. It affects individuals of all ages, neonates to elderly. Owing to its chronic nature, it causes serious impact on quality of life and financial status of the sufferer and his family. The problem gets compounded with the inappropriate and irrational use of medicines. Periodic prescription audit in form of drug utilization study is a way to improve the quality of prescription and curb the menace of irrational prescribing which has become a global phenomenon. Aim This study aims to determine the drug utilization pattern and assess the economic burden of the patient with skin disease. Materials and Methods It was a prospective, cross-sectional study conducted over a period of three months from January to March 2015 in newly diagnosed cases attending outpatient department of Skin and VD, IGIMS, Patna. The prescriptions were analysed with the help of descriptive statistics and results were expressed in percentage. Results Total 752 prescriptions were analysed during the study. Male patients were lesser as compared to female as male to female ratio was 0.88. Over 50% of patients were in adolescent age group i.e. 21-40 years. Acne (17.95%) was most common disease in the study population followed by eczema and Dermatophytosis. Among the drugs, antihistaminics (24.13%) were prescribed most frequently followed by antifungals and antibiotics. Topical agents constituted almost 60% of the total prescription and average number of drugs per prescription was 5.13, irrespective of the dosage forms prescribed. Conclusion This drug utilization study provides an insight to the prescriber regarding various issues related to polypharmacy, cost analysis and prevalent disease pattern in the region. This study also suggests periodic evaluation of prescription pattern to monitor and improve quality of prescription in other departments of the hospital. PMID:27042479

  6. [PHOLY: A pilot study of drug utilization in civil hospices in Lyon - methodology and difficulties].

    PubMed

    Dubois, V; Rachet, F; Aulagner, G; Boissel, J P

    1998-01-01

    PHOLY is a study of drug Prescription in Hospices civils of LYon by a transverse and descriptive survey. It aims at studying the methodology of such an investigation in a large university medical centre, elaborating a methodology for continuous assessment of prescribing, comparing prescriptions with scientific knowledge and identifying specific therapies. We collected 1525 questionnaires from 4333 hospitalized patients in 11 hospitals (prescriptions and indications). The main difficulties we encountered concerned communications (4 letters), fewer questionnaires collected than expected (1525/3018), many missing data, and the lack of a specific budget, thus allowing only partial data exploitation and control. This study revealed many problems such as relevant information for physicians, training and management of investigators, control, data capture and analysis. However, a prescription study may be possible with limited means.

  7. Use of antibiotics in children: a Danish nationwide drug utilization study.

    PubMed

    Pottegård, Anton; Broe, Anne; Aabenhus, Rune; Bjerrum, Lars; Hallas, Jesper; Damkier, Per

    2015-02-01

    We aimed to describe the use of systemic antibiotics among children in Denmark. National data on drug use in Denmark were extracted from the Danish National Prescription Database. We used prescription data for all children in Denmark aged 0 to 11 years from January 1, 2000 to December 31, 2012. We obtained data on 5,884,301 prescriptions for systemic antibiotics issued to 1,206,107 children. The most used single substances were phenoxymethylpenicillin (45%), amoxicillin (34%) and erythromycin (6%). The highest incidence rate of antibiotic treatment episodes was observed among children younger than 2 at 827 per 1000 children in 2012. Incidence rates were relatively stable throughout the study period. One-year prevalences in 2012 were 485, 363 and 190 per 1000 children among children aged 0-1, 2-4 and 5-11, respectively. A gradual shift from narrow-spectrum penicillin V to the broader-spectrum amoxicillin was found among children younger than 5. The use of macrolides decreased slightly, especially among those aged 0-1. Minor regional differences were noted, with somewhat higher use in the Capital Region. Skewness in use was most notable among those aged 0-1. There was little evidence of heavy users. Prescribing rate of antibiotics to children in Denmark remained stable at a high level from 2000 to 2012. An increase in the use of broad-spectrum beta-lactam penicillin was noted, but otherwise the prescribing pattern adhered well to National guidelines with respect to choice of antibiotics.

  8. Deviant patterns of methylphenidate use in adults: a Danish nationwide registry-based drug utilization study.

    PubMed

    Rasmussen, Lotte; Zoëga, Helga; Hallas, Jesper; Pottegård, Anton

    2015-11-01

    Several survey studies have documented misuse of methylphenidate defined as the use of non-prescribed methylphenidate or use different from what was prescribed. We aimed to identify and characterize adults with deviant patterns of methylphenidate use in Denmark during 2007-2012. Further, we aimed to identify risk factors associated with deviant patterns of use. Based on individual-level prescription data, new users of methylphenidate were followed for one year after filling their first prescription on methylphenidate. Adult patients were identified with deviant patterns of use if they had ≥4 different prescribers and filled ≥1095 defined daily doses of methylphenidate during the year of follow-up. Risk factors were estimated by using logistic regression. Among 20 829 new users of methylphenidate, we identified 82 (0.39%) patients displaying deviant patterns of use. Characteristics associated with deviant patterns of use included an initial prescription for extended-release methylphenidate (OR2 4.35), age 25-49 years at first prescription (OR2 2.49), general practitioners or hospital doctors as initial prescribers (OR2 3.06 and OR2 4.07) and prior use of drugs used in addictive disorders (OR2 2.08) or opioids (OR2 1.75). Sensitivity analyses revealed that the number of different prescribers alone does not seem to effectively identify deviant users of methylphenidate. We have identified characteristics associated with deviant patterns of methylphenidate use. Our results do not allow us to conclude if deviant users truly represent medical misusers. Copyright © 2015 John Wiley & Sons, Ltd.

  9. A retrospective, matched cohort study of potential drug-drug interaction prevalence and opioid utilization in a diabetic peripheral neuropathy population initiated on pregabalin or duloxetine.

    PubMed

    Ellis, Jeffrey J; Sadosky, Alesia B; Ten Eyck, Laura L; Mudumby, Pallavi; Cappelleri, Joseph C; Ndehi, Lilian; Suehs, Brandon T; Parsons, Bruce

    2015-04-15

    Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization. Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/2012, and ≥12 months pre- and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims. No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of

  10. Sociodemographic and access-related correlates of health-care utilization among African American injection drug users: The BESURE study.

    PubMed

    Maragh-Bass, Allysha C; Powell, Christine; Park, Ju; Flynn, Colin; German, Danielle

    2017-01-01

    Persons who inject drugs (PWID) may have less access to, and utilization of, health-care services, and African American PWID may be less likely than other racial groups to utilize health care in the United States. The present study evaluated the prevalence of health-care utilization (HCU) among a cohort of African American PWID in Baltimore. Data were from the 2012 Baltimore National HIV Behavioral Surveillance study. Participants were adult PWID and recruited using respondent-driven sampling (RDS). They completed a comprehensive sociobehavioral survey and voluntary HIV test with trained study interviewers. Analyses included descriptive and bivariate statistics to examine the prevalence of HCU, defined as seeing a health-care provider in the past year. Poisson regression assessed correlates of HCU. Participants were 61% male; 23% self-reported HIV seropositivity. Nearly 90% reported unemployment and/or disability; HCU prevalence was 85%. Significant negative correlates of HCU included age and higher injection frequency; positive correlates included previous incarceration and moderate financial stability. Interaction analyses showed unemployed publicly insured individuals had 30% higher HCU than unemployed and uninsured individuals (χ(2) = 2.52; p < .05). There is a need to improve health-care utilization among PWID. High prevalence of disability was still found, despite insurance coverage and access to care in this population. While the recent Affordable Care Act has increased health-care coverage and access, our results suggest that is only a first step to improving health outcomes among PWID; targeted intervention to integrate these individuals is still needed.

  11. Effect of drug utilization reviews on the quality of in-hospital prescribing: a quasi-experimental study

    PubMed Central

    Grégoire, Jean-Pierre; Moisan, Jocelyne; Potvin, Louise; Chabot, Isabelle; Verreault, René; Milot, Alain

    2006-01-01

    Background Drug utilization review (DUR) programs are being conducted in Canadian hospitals with the aim of improving the appropriateness of prescriptions. However, there is little evidence of their effectiveness. The objective of this study was to assess the impact of both a retrospective and a concurrent DUR programs on the quality of in-hospital prescribing. Methods We conducted an interrupted time series quasi-experimental study. Using explicit criteria for quality of prescribing, the natural history of cisapride prescription was established retrospectively in three university-affiliated hospitals. A retrospective DUR was implemented in one of the hospitals, a concurrent DUR in another, whereas the third hospital served as a control. An archivist abstracted records of all patients who were prescribed cisapride during the observation period. The effect of DURs relative to the control hospital was determined by comparing estimated regression coefficients from the time series models and by testing the statistical significance using a 2-tailed Student's t test. Results The concurrent DUR program significantly improved the appropriateness of prescriptions for the indication for use whereas the retrospective DUR brought about no significant effect on the quality of prescribing. Conclusion Results suggest a retrospective DUR approach may not be sufficient to improve the quality of prescribing. However, a concurrent DUR strategy, with direct feedback to prescribers seems effective and should be tested in other settings with other drugs. PMID:16536865

  12. An investigation of the representativity of neuropsychiatrists and their patients in a drug utilization observation study on fluoxetine.

    PubMed

    Schaaf, B; Linden, M; Weber, H J

    1997-01-01

    This study presents a methodological approach to an expost facto investigation of sample bias in drug utilization observation (DUO) studies using the example of a DUO with the nontricyclic antidepressant fluoxetine. A total of 479 psychiatrists and neurologists and 2,401 patients were investigated. The purpose of the study was to judge the representativeness of our DUO sample for two populations: first, for all psychiatrics and neurologists prescribing fluoxetine or all patients being treated with fluoxetine in Germany and, second, for all psychiatrists and neurologists prescribing antidepressants or all patients being treated with antidepressants in Germany. Criteria for the representativeness test were physician variables (gender, size of community where practicing, federal state, age, volume of prescriptions) and patient variables (gender, age, prescription-related diagnosis, concurrent illnesses, concomitant medications). The study shows that the DUO sample can rightfully claim representativeness in the majority of parameters for the psychiatrists and neurologists prescribing fluoxetine and for the patients being treated with fluoxetine. There are more noticeable discrepancies with regard to the psychiatrists and neurologists in general and to the patients being treated with antidepressants in general. The methodological problems of pharmacoepidemiological investigation of representativeness are discussed.

  13. Patterns of finasteride use in the male populations of four Nordic countries: A cross-national drug utilization study.

    PubMed

    Kjærulff, T M; Ersbøll, A K; Green, A; Emneus, M; Pukkala, E; Bolin, K; Stavem, K; Iversen, P; Brasso, K; Hallas, J; Thygesen, L C

    2016-06-01

    Objective Finasteride 5 mg is a drug used to treat prostate hyperplasia. Little is known about its pattern of usage. This cross-national analysis of individual-level data from Denmark, Finland, Norway and Sweden was undertaken to appraise its usage and describe cross-national differences. Materials and methods Individual-level data from nationwide prescription registers in Denmark (1995-2009), Finland (1997-2010), Norway (2004-2009) and Sweden (July 2005-2011) were used to examine cross-national finasteride utilization patterns in the adult male population (≥15 years). The study presents period prevalences, incidence rates, waiting time distributions and Lorenz curves. Results During the study period, 295,620 men had at least one prescription redemption of finasteride 5 mg, and there were approximately 3 million dispensing events of finasteride prescriptions in the four Nordic countries. Different patterns of finasteride use were observed among the four Nordic countries. The period prevalence was markedly higher in Finland and Sweden than in Denmark and Norway. In 2009, period prevalences were 18.2/1000 males in Finland and 12.0/1000 males in Sweden compared to 6.7/1000 males in Norway and 4.9/1000 males in Denmark. Incidence rates of finasteride use for Finland, Norway and Sweden were about three times that for Denmark in 2008-2009. Long-term use of finasteride was found in all four Nordic countries with a high ratio between prevalent and incident users. Conclusion Despite resemblances regarding political systems and healthcare services in the Nordic countries, differences in finasteride utilization were found across Denmark, Finland, Norway and Sweden.

  14. Rural drug users: factors associated with substance abuse treatment utilization.

    PubMed

    Oser, Carrie B; Leukefeld, Carl G; Tindall, Michele Staton; Garrity, Thomas F; Carlson, Robert G; Falck, Russel; Wang, Jichuan; Booth, Brenda M

    2011-06-01

    The purpose of this study is to use a modified version of Andersen's Behavioral Model of Health Services Use to identify the correlates of the number of substance abuse treatment episodes received by rural drug users. Data were collected from face-to-face interviews with 711 drug users in rural areas of Ohio, Arkansas, and Kentucky. Descriptive analyses examine rural drug users' substance use histories and retrospective substance abuse treatment service utilization patterns. A negative binomial regression model indicated that selected predisposing, historical health, and enabling factors were significantly associated with the utilization of substance abuse treatment among rural drug users. Despite high levels of recent and lifetime self-reported substance use among these rural drug users, treatment services were underutilized. Future studies are needed to examine the impact of the health care system and characteristics of the external environment associated with rural substance abuse treatment in order to increase utilization among drug users.

  15. Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents).

    PubMed

    Brent, Robert L

    2004-04-01

    Toxicology studies using animals and in vitro cellular or tissue preparations have been used to study the toxic effects and mechanism of action of drugs and chemicals and to determine the effective and safe dose of drugs in humans and the risk of toxicity from chemical exposures. Studies in pregnant animals are used to determine the risk of birth defects and other reproductive effects. There is no question that whole animal teratology studies are helpful in raising concerns about the reproductive effects of drugs and chemicals, but negative animal studies do not guarantee that these agents are free from reproductive effects. There are examples in which drug testing was negative in animals (rat and mouse) but was teratogenic in the human (thalidomide), and there are examples in which a drug was teratogenic in an animal model but not in the human (diflunisal). Testing in animals could be improved if animal dosing using the mg/kg basis were abandoned and drugs and chemicals were administered to achieve pharmacokinetically equivalent serum levels in the animal and the human. Because most human teratogens have been discovered by alert physicians or epidemiology studies, not animal studies, animal studies play a minor role in discovering teratogens. In vitro studies play an even less important role, although they are helpful in describing the cellular or tissue effects of the drugs or chemicals. One cannot determine the magnitude of human risks from these in vitro studies. Performing toxicology studies on adult animals is performed by pharmaceutical companies, chemical companies, the Food and Drug Administration, many laboratories at the National Institutes of Health, and scientific investigators in laboratories throughout the world. Although a vast amount of animal toxicology studies are performed on pregnant animals and numerous toxicology studies are performed on adult animals, there is a paucity of animal studies using newborn, infant, and juvenile animals. This

  16. Utilization of psychotropic drugs by patients consulting for sleeping disorders in homeopathic and conventional primary care settings: the EPI3 cohort study.

    PubMed

    Grimaldi-Bensouda, Lamiae; Abenhaim, Lucien; Massol, Jacques; Guillemot, Didier; Avouac, Bernard; Duru, Gerard; Lert, France; Magnier, Anne-Marie; Rossignol, Michel; Rouillon, Frederic; Begaud, Bernard

    2015-07-01

    Utilization of sedative hypnotic drugs for sleeping disorders (SD) raises concerns, particularly among older people. This study compared utilization of conventional psychotropic drugs for SD among patients seeking care from general practitioners (GPs) who strictly prescribe conventional medications (GP-CM), regularly prescribe homeopathy in a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho). This was a French population-based cohort study of GPs and their patients consulting for SD, informed through the Pittsburgh sleep quality index (PSQI) questionnaire. Information on psychotropic drugs utilization was obtained from a standardized telephone interview at inclusion, one, three and 12 months. 346 patients consulting for SD were included. Patients in the GP-Ho group experienced more often severe SD (41.3%) than patients in the GP-CM group (24.3%). Adjusted multivariate analyses showed that patients who chose to be managed by GP-Ho were less likely to use psychotropic drugs over 12 months as opposed to the GP-CM group, with Odds ratio (OR) = 0.25; 95% confidence interval (CI): 0.14 to 0.42. Patients in the GP-Mx group also used less psychotropic drugs but the result was not statistically significant (OR = 0.67; 95% CI: 0.39-1.16). Rates of clinical improvement of the SD did not differ between groups. Patients with SD who chose to consult GPs certified in homeopathy consumed less psychotropic drugs and had a similar evolution of their condition to patients treated with conventional medical management. This result may translate in a net advantage with reduction of adverse events related to psychotropic drugs. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  17. Age- and Sex-related Prevalence and Drug Utilization Pattern in the Management of Type 2 Diabetes Mellitus and its Comorbidity with Cardiovascular Diseases: A Comparative Study.

    PubMed

    Das, S; Haroled Peter, P L; Bhavani, M Lakshmi; Naresh, P; Ramana, M V

    2015-01-01

    A cross-sectional study of 250 cases of type 2 diabetes management was conducted in a governmental tertiary care hospital of urban south India to determine the comparative prevalence of type 2 diabetes and its comorbidity with cardiovascular diseases in diabetic population, core drug use indicators and drug utilization pattern in the management of diabetics entirely and with cardiovascular diseases. Highest prevalent age group for type 2 diabetes/cardiovascular diseases (greater incidence in female than male) was 51-60 years. The 62.8% prevalence of cardiovascular diseases in the diabetic population ascertained in the study could provide an evidence-based rationale for the World Health Organization guidelines for the management of hypertension in type 2 diabetics. Incidence of polypharmacy (6.06, the mean number of total drug products prescribed); 59.26% of encounters prescribed antibiotics; 17.6 and 18.5 min of average consultation and dispensing time, respectively; 100% of drugs actually dispensed and adequately labeled; 81.26% of patients having knowledge of correct dosage and average drug cost of Indian Rupees 145.54 per prescription were the core drug use indicators found mainly. Moreover, drugs prescribed from the Essential Drug List were more than 90% and thereby indicated the drug use in this set-up quite rational. Around 71.09% of cardiovascular agents prescribed by generic name revealed the cost effective medical care. Among the agents in type 2 diabetes management, Actrapid(®) (35.43%) was the highest. Among the cardiovascular agents prescribed, lasix (19.37%) was the highest. Cardiovascular agents prescribed orally by 76.48% signified the good prescription habit indicating the improved patients' adherence to the treatment. The present study emphasizes the need of early detection of hypertension as a preliminary diagnostic parameter of cardiovascular diseases in diabetics and appropriate management through concomitant therapy of cardiovascular drugs to

  18. 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

  19. An examination of the effect of cytochrome P450 drug interactions of hydroxymethylglutaryl-coenzyme A reductase inhibitors on health care utilization: a Canadian population-based study.

    PubMed

    Einarson, Thomas R; Metge, Colleen J; Iskedjian, Michael; Mukherjee, Jayanti

    2002-12-01

    Cytochrome P450-related drug interactions can lead to adverse effects that may affect health care resource utilization. The purpose of this study was to quantify the impact of drug interactions involving hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) on health care resource utilization. Using the Manitoba Health Research database, we identified patients who had used statins between January 1, 1995, and March 31, 1998. New statin users (NSUs) were those who received a first prescription for a statin after April 30, 1995; old statin users (OSUs) were those who had a statin prescription before January 1, 1995. The number of hospitalizations, physician visits, and prescriptions, and their associated costs to the Manitoba health care system were calculated. Statin interacters were defined as users with >1 prescription for an interacting drug while receiving a statin. Interacting drugs were classified into 2 groups: group A included drugs whose levels increased as a result of the statin prescription; drugs in group B increased statin levels. The Wilcoxon rank-sum test was used to analyze differences by statin on health care resource use. A total of 28,705 statin users (18, 181 NSUs and 10,524 OSUs) were identified. During the study period, 24,496 (85.3%) individuals took 1 statin, 3751 (13.1%) took 2 statins, and 458 (1.6%) took 3 to 5 statins. The most common coadministered group A interacting drugs were diclofenac (5.8%), amitriptyline (4.9%), warfarin (4.5%), and ibuprofen (1.8%). The most common group B interacting drugs were erythromycin (8.2%), omeprazole (5.5%), cimetidine (3.6%), and clarithromycin (3.5%). Statin interacters consumed significantly more health care resources than did noninteracters for both incident and prevalent analyses (P < 0.001). In the prevalent analysis (NSUs + OSUs), pravastatin users taking interacting drugs had significantly fewer hospitalizations (mean, 1.3), fewer physician visits (mean, 24.2), and lower health care

  20. Low-dose naltrexone and opioid consumption: a drug utilization cohort study based on data from the Norwegian prescription database.

    PubMed

    Raknes, Guttorm; Småbrekke, Lars

    2017-06-01

    Low-dose naltrexone (LDN) is used in a wide range of conditions, including chronic pain and fibromyalgia. Because of the opioid antagonism of naltrexone, LDN users are probably often warned against concomitant use with opioids. In this study, based on data from the Norwegian prescription database, we examine changes in opioid consumption after starting LDN therapy. We included all Norwegian patients (N = 3775) with at least one recorded LDN prescription in 2013 and at least one dispensed opioid prescription during the 365 days preceding the first LDN prescription. We allocated the patients into three subgroups depending on the number of collected LDN prescriptions and recorded the number of defined daily doses (DDDs) on collected prescriptions on opioids, nonsteroidal anti-inflammatory drugs and other analgesics and antipyretics from the same patients. Among the patients collecting ≥4 LDN prescriptions, annual average opioid consumption was reduced by 41 DDDs per person (46%) compared with that of the previous year. The reduction was 12 DDDs per person (15%) among users collecting two to three prescriptions and no change among those collecting only one LDN prescription. We observed no increase in the number of DDDs in nonsteroidal anti-inflammatory drugs or other analgesics and antipyretics corresponding to the decrease in opioid use. Possibly, LDN users avoided opioids because of warnings on concomitant use or the patients continuing on LDN were less opioid dependent than those terminating LDN. Therapeutic effects of LDN contributing to lower opioid consumption cannot be ruled out. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

  1. The history of the Drug Utilization Research Group in Europe.

    PubMed

    Bergman, Ulf

    2006-02-01

    Following the recommendations from a World Health Organization (WHO)/Euro symposium Consumption of drugs in 1969, a common classification system for drugs was developed, the Anatomical Therapeutic Chemical (ATC), and a technical unit of comparison, the Defined Daily Dose (DDD), as a comparative unit of drug use. This was found to be robust across therapeutic classifications, dosing forms and diverse populations. To maintain and develop the ATC/DDD system a WHO-Collaborating Centre was established in Oslo. As this was found to be of global interest the centre now reports to the WHO headquarters in Geneva. An informal WHO Drug Utilization Research Group (WHO-DURG), later the EuroDURG, has by now met 28 times in Europe. Since 1994 in Stockholm all these meetings have been with ISPE (International Society for Pharmacoepidemiology) when meeting in Europe. The main focus was initially to improve drug utilization through cross-national drug utilization studies based on the ATC/DDD methodology as they revealed large differences between and within countries that could not easily be explained by morbidity differences alone. These observed differences have led to the expansion of the area to include social, economic and qualitative methods with a more generalized public health focus. One of the most recent contributions was the development of drug use quality indicators.

  2. Low‐dose naltrexone and opioid consumption: a drug utilization cohort study based on data from the Norwegian prescription database

    PubMed Central

    Småbrekke, Lars

    2017-01-01

    Abstract Purpose Low‐dose naltrexone (LDN) is used in a wide range of conditions, including chronic pain and fibromyalgia. Because of the opioid antagonism of naltrexone, LDN users are probably often warned against concomitant use with opioids. In this study, based on data from the Norwegian prescription database, we examine changes in opioid consumption after starting LDN therapy. Methods We included all Norwegian patients (N = 3775) with at least one recorded LDN prescription in 2013 and at least one dispensed opioid prescription during the 365 days preceding the first LDN prescription. We allocated the patients into three subgroups depending on the number of collected LDN prescriptions and recorded the number of defined daily doses (DDDs) on collected prescriptions on opioids, nonsteroidal anti‐inflammatory drugs and other analgesics and antipyretics from the same patients. Results Among the patients collecting ≥4 LDN prescriptions, annual average opioid consumption was reduced by 41 DDDs per person (46%) compared with that of the previous year. The reduction was 12 DDDs per person (15%) among users collecting two to three prescriptions and no change among those collecting only one LDN prescription. We observed no increase in the number of DDDs in nonsteroidal anti‐inflammatory drugs or other analgesics and antipyretics corresponding to the decrease in opioid use. Conclusions Possibly, LDN users avoided opioids because of warnings on concomitant use or the patients continuing on LDN were less opioid dependent than those terminating LDN. Therapeutic effects of LDN contributing to lower opioid consumption cannot be ruled out. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. PMID:28370746

  3. Assessment of function and clinical utility of alcohol and other drug web sites: An observational, qualitative study

    PubMed Central

    2011-01-01

    Background The increasing popularity and use of the internet makes it an attractive option for providing health information and treatment, including alcohol/other drug use. There is limited research examining how people identify and access information about alcohol or other drug (AOD) use online, or how they assess the usefulness of the information presented. This study examined the strategies that individuals used to identify and navigate a range of AOD websites, along with the attitudes concerning presentation and content. Methods Members of the general community in Brisbane and Roma (Queensland, Australia) were invited to participate in a 30-minute search of the internet for sites related to AOD use, followed by a focus group discussion. Fifty one subjects participated in the study across nine focus groups. Results Participants spent a maximum of 6.5 minutes on any one website, and less if the user was under 25 years of age. Time spent was as little as 2 minutes if the website was not the first accessed. Participants recommended that AOD-related websites should have an engaging home or index page, which quickly and accurately portrayed the site's objectives, and provided clear site navigation options. Website content should clearly match the title and description of the site that is used by internet search engines. Participants supported the development of a portal for AOD websites, suggesting that it would greatly facilitate access and navigation. Treatment programs delivered online were initially viewed with caution. This appeared to be due to limited understanding of what constituted online treatment, including its potential efficacy. Conclusions A range of recommendations arise from this study regarding the design and development of websites, particularly those related to AOD use. These include prudent use of text and information on any one webpage, the use of graphics and colours, and clear, uncluttered navigation options. Implications for future website

  4. Drug Utilization and Inappropriate Prescribing in Centenarians.

    PubMed

    Hazra, Nisha C; Dregan, Alex; Jackson, Stephen; Gulliford, Martin C

    2016-05-01

    To use primary care electronic health records (EHRs) to evaluate prescriptions and inappropriate prescribing in men and women at age 100. Population-based cohort study. Primary care database in the United Kingdom, 1990 to 2013. Individuals reaching the age of 100 between 1990 and 2013 (N = 11,084; n = 8,982 women, n = 2,102 men). Main drug classes prescribed and potentially inappropriate prescribing according to the 2012 American Geriatrics Society Beers Criteria. At the age of 100, 73% of individuals (79% of women, 54% of men) had received one or more prescription drugs, with a median of 7 (interquartile range 0-12) prescription items. The most frequently prescribed drug classes were cardiovascular (53%), central nervous system (CNS) (53%), and gastrointestinal (47%). Overall, 32% of participants (28% of men, 32% of women) who received drug prescriptions may have received one or more potentially inappropriate prescriptions, with temazepam and amitriptyline being the most frequent. CNS prescriptions were potentially inappropriate in 23% of individuals, and anticholinergic prescriptions were potentially inappropriate in 18% of individuals. The majority of centenarians are prescribed one or more drug therapies, and the prescription may be inappropriate for up to one-third of these individuals. Research using EHRs offers opportunities to understand prescribing trends and improve pharmacological care of the oldest adults. © 2016 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

  5. Study Drugs

    MedlinePlus

    ... think clearly, and be alert. Doctors recommend that teens get about 9 hours of sleep per night. Exercise . Get blood pumping the natural ... Date reviewed: July 2015 previous 1 • 2 For Teens For Kids For Parents MORE ON THIS TOPIC Homework Help How Much Sleep Do I Need? Prescription Drug Abuse How to ...

  6. Novel Strategy Utilizing Extracellular Cysteine-Rich Domain of Membrane Receptor for Constructing d-Peptide Mediated Targeted Drug Delivery Systems: A Case Study on Fn14.

    PubMed

    Li, Zhuoxuan; Xie, Jing; Peng, Shan; Liu, Sha; Wang, Ying; Lu, Weiyue; Shen, Jie; Li, Chong

    2017-08-16

    The development of proteolysis-resistant d-peptide ligands for targeted drug/gene delivery has been greatly limited, due to the challenge that lies in the chemical synthesis of membrane receptors without altering their structures. In the present research, a novel strategy utilizing self-stabilized extracellular CRD of the membrane receptor was developed to construct d-peptide ligands and their mediated targeted drug delivery systems. Fn14, a cell surface receptor overexpressed in many cancers including pancreatic and triple-negative breast cancers, was selected as the model receptor. Fn14 CRD was synthesized and folded, and used to screen Fn14 binding peptides using phage display (l-peptide) and mirror-image phage display (d-peptide) techniques, respectively. The d-peptide ligand successfully mediated targeted drug delivery to Fn14 positive tumor cells. In addition, the d-peptide possessed better target-binding affinity, stromal barrier permeability, and tumor targeting ability in vivo when conjugated with liposomes. More importantly, d-peptide mediated liposomal paclitaxel delivery significantly inhibited pancreatic tumor growth in a subcutaneous xenograft model and drastically prolonged survival in a lung metastasis of breast cancer mouse model. This study demonstrated that mirror-image phage display based on the CRD of membrane receptor can be a promising strategy to advance active targeted drug delivery via biostable d-peptides.

  7. Utility of serum lactate to predict drug-overdose fatality

    PubMed Central

    MANINI, ALEX F.; KUMAR, ASHISH; OLSEN, DEAN; VLAHOV, DAVID; HOFFMAN, ROBERT S.

    2014-01-01

    Context Poisoning is the second leading cause of injury-related fatality in the United States. An elevated serum lactate concentration identifies medical and surgical patients at risk for death; however, its utility in predicting death in drug overdose is controversial and unclear. Objective We aimed to evaluate the prognostic utility of serum lactate concentration for fatality in emergency department (ED) patients with acute drug overdose. Materials and Methods This was a case–control study at two urban university teaching hospitals affiliated with a regional poison control center. Data were obtained from electronic medical records, poison center data, and the office of the chief medical examiner. Controls were consecutive acute drug overdoses over a 1-year period surviving to hospital discharge. Cases were subjects over a 7-year period with fatality because of drug overdose. Serum lactate concentration was obtained from the initial blood draw in the ED and correlated with fatality. Results During the study period, 873 subjects were screened with 50 cases and 100 controls included. Drug exposures and baseline characteristics were similar between groups. Mean lactate concentration (mmol/L) was 9.88 ± 6.7 for cases and 2.76 ± 2.9 for controls (p < 0.001). The receiver operating characteristic area under the curve for prediction of fatality was 0.87 (95% CI: 0.81–0.94). The optimal lactate cutpoint was 3.0 mmol/L (84% sensitivity, 75% specificity), which conferred a 15.8-fold increase in odds of fatality (p < 0.001). Conclusion In this derivation study, serum lactate concentration had excellent prognostic utility to predict drug-overdose fatality. Prospective validation in the ED evaluation of drug overdoses is warranted. PMID:20704455

  8. Utility of Phenotypic and Genotypic Testing in the Study of Mycobacterium tuberculosis Resistance to First-Line Anti-Tuberculosis drugs.

    PubMed

    Alba Álvarez, Luz María; García García, José María; Pérez Hernández, M Dolores; Martínez González, Susana; Palacios Gutiérrez, Juan José

    2017-04-01

    To determine the utility of molecular techniques in the diagnosis of resistance and the extent of resistance to first-line drugs in our region. From 2004 to 2013, 1,889 strains of Mycobacterium tuberculosis complex isolated in Asturias, Spain, were studied using phenotypic (Clinical and Laboratory Standards Institute guidelines) and molecular (INNOLiPA RIF-TB(©); GenotypeMDRplus(©); GenotypeMDRsl(©)) sensitivity tests. 1,759 strains (94.52%) were sensitive to all first-line drugs, and 102 strains (5.48%) showed some resistance: 81 strains (4.35%) were resistant to 1 single drug, 14 (0.75%) were polyresistant, and 7 (0.37%) were multiresistant (resistant to rifampicin and isoniazid). In total, 137 resistances were identified: 60 to isoniazid (3.22%), 7 to rifampicin (0.37%), 9 to pyrazinamide (0.48%), 11 to ethambutol (0.59%), and 50 to streptomycin (2.68%). Of the mutations detected, 75.9% (63/83) correlated with resistance, while 24.09% of mutations detected (20/83) were not associated with resistance; 16 of these involved a silent mutation at codon 514 of the rpoB gene. Between 0 and 90% of strains, depending on the drug under consideration, were resistant even when no gene mutations were detected using marketed systems. Molecular techniques are very useful, particularly for obtaining rapid results, but these must be confirmed with standard phenotypic sensitivity testing. The rate of resistance in our region is low and multi-drug resistantcases (0.37%) are sporadic. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. EQ-5D utility, response and drug survival in rheumatoid arthritis patients on biologic monotherapy: A prospective observational study of patients registered in the south Swedish SSATG registry

    PubMed Central

    Jørgensen, Tanja Schjødt; Turesson, Carl; Kapetanovic, Meliha; Englund, Martin; Turkiewicz, Aleksandra; Christensen, Robin; Bliddal, Henning; Geborek, Pierre; Kristensen, Lars Erik

    2017-01-01

    Objectives Biologic agents have dramatically changed treatment of rheumatoid arthritis (RA). To date only scarce head-to-head data exist especially when the biological therapies are given as monotherapy without concomitant disease modifying drugs (DMARDs). Thus the objective of the current study is to evaluate treatment response of all available biological therapies with special focus on utility (EQ-5D-3L) and drug survival of biologic DMARDs (bDMARDs) prescribed as monotherapy in RA patients in southern Sweden. Materials and methods All RA patients registered in a regional database as initiating bDMARD as monotherapy, i.e. without concomitant conventional synthetic DMARDs (csDMARDs), from 1st of January 2006 through 31st of December 2012, were included. Patients were followed from initiation of the first dose of bDMARD monotherapy treatment until withdrawal from treatment, loss of follow-up or 31st of December 2012. Descriptive statistics for utility (EQ-5D-3L), effectiveness, and drug survival of bDMARD monotherapy were calculated. Results During the study period, a total of 554 patients were registered in SSATG as initiating bDMARD monotherapy. Most of the patients were women (81%), with a mean age of 57 years. The average disease duration was more than 12 years, and on average the patients had previously been treated with approximately four different csDMARDs. Fifty-five percent of the patients were initiating their first bDMARD, 26% their second, and 19% their third or more. At baseline the average EQ-5D-3L was 0.34. Most patients had moderate to high disease activity, with a mean DAS28 of 5.0, and were substantially disabled, with an average HAQ score of 1.4. At 6 months´ follow-up, the EQ-5D-3L in patients still on the biologic drug had increased by mean 0.23 (SD 0.4) with no differences between type of bDMARD (p = 0.49). The mean change in EQ-5D-3L ranged from 0.11 (rituximab and infliximab) to 0.42 (tocilizumab). Although the changes were numerically

  10. Drug utilization evaluation of third generation cephalosporins using core drug use indicators.

    PubMed

    Kaliamoorthy, Kousalya; Sankaralingam, Ramalakshmi; Punniyakotti, Saranya; Janardhan, Vasantha; Cheekala, Umamaheswara Reddy

    2012-04-01

    To evaluate the drug utilization of third generation cephalosporins using core drug use indicators in various wards of Sri Ramachandra Hospital. Third generation cephalosporins are the most commonly prescribed broad spectrum antibiotic even before the culture sensitivity results arrives. Hence this study was undertaken to study the drug utilization evaluation of third generation cephalosporins in the inpatient department of various wards of Sri Ramachandra Hospital. A prospective study was conducted between July 2009 and February 2010. Prescriptions of 364 patients containing third generation cephalosporins admitted in inpatient department of various wards of Sri Ramachandra Hospital, Chennai were collected and using WHO basic drug indicators, the utilization pattern were analyzed. The average number of drugs per prescription was found to be 7.89 on prescription analysis. Cefixime was the most frequently prescribed (32.69%) oral third generation cephalosporins, followed by cefotaxime (31.32%). Among IV third generation cephalosporins, cefotaxime was the most frequently prescribed injections (35.4%). Only 28.02% of drugs were prescribed by generic name. The results obtained represent the over all prescribing pattern of third generation cephalosporins in the Tertiary Care Teaching Hospital, Chennai.

  11. Ten-Year Trends in the Morbidity of Diabetes Mellitus and Antidiabetic Drug Utilization in Croatia: A Study Based on Routinely Collected Data

    PubMed Central

    Topličan, Ivančica; Vrcić Keglević, Mladenka

    2016-01-01

    Objectives. To investigate trends of diabetes mellitus (DM) morbidity and antidiabetic drug utilization in Croatian primary health care (PHC) from 2005 to 2014. Method. Routinely collected morbidity data from all PHC units, presented in Croatian health-statistics yearbooks, were retrieved. Data on drug utilization were retrieved from the Annual Reports of the Croatian Agency for Medicinal Products and Medical Devices (ATC/DDD, antidiabetic, A10). Results. Total morbidity increased by 33.3% and DM increased by 65.6%, mostly in patients over age 65 (from 50% to 57%). Estimated DM prevalence in adults increased from 3.9% to 6.4%. Increased morbidity was followed by an even higher increase in drug utilization (120%). Metformin was first, with a constant increase (from 18% to 39%), followed by glimepiride, while glibenclamide use decreased. Total utilization of insulin increased even more, mostly for aspart (600%) and newly introduced glargine and detemir, while human insulin usage sharply decreased. Spending also increased, mostly for aspart (from 21% to 61% of total). Conclusions. Increased DM is followed by a higher increase in antidiabetic drug utilization; this trend will continue in the future. In Croatian PHC, metformin has primacy along with insulin analogues. PMID:27462470

  12. Ten-Year Trends in the Morbidity of Diabetes Mellitus and Antidiabetic Drug Utilization in Croatia: A Study Based on Routinely Collected Data.

    PubMed

    Pavlov, Renata; Topličan, Ivančica; Vrcić Keglević, Mladenka

    2016-01-01

    Objectives. To investigate trends of diabetes mellitus (DM) morbidity and antidiabetic drug utilization in Croatian primary health care (PHC) from 2005 to 2014. Method. Routinely collected morbidity data from all PHC units, presented in Croatian health-statistics yearbooks, were retrieved. Data on drug utilization were retrieved from the Annual Reports of the Croatian Agency for Medicinal Products and Medical Devices (ATC/DDD, antidiabetic, A10). Results. Total morbidity increased by 33.3% and DM increased by 65.6%, mostly in patients over age 65 (from 50% to 57%). Estimated DM prevalence in adults increased from 3.9% to 6.4%. Increased morbidity was followed by an even higher increase in drug utilization (120%). Metformin was first, with a constant increase (from 18% to 39%), followed by glimepiride, while glibenclamide use decreased. Total utilization of insulin increased even more, mostly for aspart (600%) and newly introduced glargine and detemir, while human insulin usage sharply decreased. Spending also increased, mostly for aspart (from 21% to 61% of total). Conclusions. Increased DM is followed by a higher increase in antidiabetic drug utilization; this trend will continue in the future. In Croatian PHC, metformin has primacy along with insulin analogues.

  13. A multinational, drug utilization study to investigate the use of dexmedetomidine (Dexdor®) in clinical practice in the EU

    PubMed Central

    Weatherall, Mary; Aantaa, Riku; Conti, Giorgio; Garratt, Chris; Pohjanjousi, Pasi; Lewis, Michael A.; Moore, Nicholas

    2017-01-01

    Aims Dexmedetomidine (dexdor®) is approved in the European Union (EU) for sedation of adults in the intensive care unit (ICU). The present observational, retrospective study was requested by the European Medicines Agency to investigate dexmedetomidine use in clinical practice, with a particular focus on off‐label use, including the paediatric population. Methods Study countries and sites were chosen from those with highest dexmedetomidine use, based on sales. Site selection (blind) was conducted by a multispecialist, independent group. Anonymized data on demographics, treatment indication, dexmedetomidine dosing, concomitant medications and treatment effectiveness were collected retrospectively from records of all dexmedetomidine‐treated patients at the site during the enrolment period. Informed consent was waived, to avoid influencing the prescribing of dexmedetomidine. Recruitment was completed within 18 months of first site initiation. Results Data from 2000 patients were collected from 16 hospitals in four EU countries (Finland 750, Poland 505, Germany 470, Austria 275). The median age was 62 years, with more males (70.2%) than females. Dexmedetomidine was primarily used in the adult ICU (86.0%) for ICU sedation (78.6%) and mostly dosed according the product label. The intended sedative effect was obtained in 84.9% of administrations. Paediatric use (5.9% of patients, mostly in Austria and Finland) occurred mainly in the adult or paediatric ICU (75.6%) for sedation (67.2%). Conclusions Overall, most patients were treated with dexmedetomidine according to the product labelling. Use in children was limited but significant and similar in scope to that in adults. Administrations not fully according to the product labelling usually occurred in an ICU environment and reflected extensively investigated clinical uses of dexmedetomidine. PMID:28345249

  14. Tribal Utility Feasibility Study

    SciTech Connect

    Engel, R. A.; Zoellick, J. J.

    2007-06-30

    The Schatz Energy Research Center (SERC) assisted the Yurok Tribe in investigating the feasibility of creating a permanent energy services program for the Tribe. The original purpose of the DOE grant that funded this project was to determine the feasibility of creating a full-blown Yurok Tribal electric utility to buy and sell electric power and own and maintain all electric power infrastructure on the Reservation. The original project consultant found this opportunity to be infeasible for the Tribe. When SERC took over as project consultant, we took a different approach. We explored opportunities for the Tribe to develop its own renewable energy resources for use on the Reservation and/or off-Reservation sales as a means of generating revenue for the Tribe. We also looked at ways the Tribe can provide energy services to its members and how to fund such efforts. We identified opportunities for the development of renewable energy resources and energy services on the Yurok Reservation that fall into five basic categories: • Demand-side management – This refers to efforts to reduce energy use through energy efficiency and conservation measures. • Off-grid, facility and household scale renewable energy systems – These systems can provide electricity to individual homes and Tribal facilities in areas of the Reservation that do not currently have access to the electric utility grid. • Village scale, micro-grid renewable energy systems - These are larger scale systems that can provide electricity to interconnected groups of homes and Tribal facilities in areas of the Reservation that do not have access to the conventional electric grid. This will require the development of miniature electric grids to serve these interconnected facilities. • Medium to large scale renewable energy development for sale to the grid – In areas where viable renewable energy resources exist and there is access to the conventional electric utility grid, these resources can be

  15. Multicentre hospital drug utilization study on the prophylaxis of venous thromboembolism. The Venous Thromboembolism Study Group of the Spanish Society of Clinical Pharmacology.

    PubMed Central

    Vallès, J A; Vallano, A; Torres, F; Arnau, J M; Laporte, J R

    1994-01-01

    1. Thromboembolic disease (TED) is an important cause of in-hospital morbidity and mortality. Although different prophylactic approaches have been shown to be effective and cost-effective, surveys have suggested that they are underused. The aim of this study was to estimate the prevalence of use of TED prophylaxis in our hospitals. 2. All patients admitted on a specified day to the Internal Medicine and General Surgery wards of seven Spanish university hospitals were included in the study. They were identified cross-sectionally and followed up until discharge or for 15 days. Information about the following variables was collected: risk factors for venous thromboembolism, prophylactic measures used (if any), contraindications to the use of each specific drug or other prophylactic measure, and dosage schedule of the drug used, if any. 3. Nine hundred and thirty-nine patients (53% men) were studied. The most common risk factors for venous thromboembolism were: age > or = 40 years (802; 85%), major surgery (298; 32%), immobilization > or = 6 days (285; 30%), obesity (241; 26%), and cancer (202; 22%). 4. Prophylactic measures were used in 320 patients (34%). Of these, 297 (93%) received heparin, mainly as low molecular weight heparins (248, 78%); physical measures were rarely used. 5. Five hundred and eighty-three patients (62%) fulfilled criteria for moderate or high risk of venous thromboembolism; only 275 (47%) of them received any form of prophylaxis.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8198934

  16. Teaching exercise of drug utilization by medical students.

    PubMed

    Das, B P; Sethi, A; Nutan, K; Gunjan

    2005-01-01

    The prescription is a vital written document communicating between the physician, the patient and the pharmacist. The audit of prescribing pattern is a component of medical audit, which seeks monitoring, evaluation and necessary modifications in the prescribing practices of prescribers to achieve rational and cost effective medical care for the patients, The present drug utilization study was conducted by fourth year MBBs students during their research posting in the department of Pharmacology at B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan. The prescriptions were randomly collected from BPKIHS pharmacy over a period of 3 weeks. The auditing was done in the form of a semi structured performa containing the patients particulars with regard to age, sex, and residence, the details of the illness and prescribed drug information. The data was analyzed at the end of the study. The study points out that the maximum (27.5%) prescriptions were from General Outpatient Department (GOPD) followed by ENT (16.5%), Internal medicine (15.5%) and General surgery (10%). This indicates the distribution of patient load in hospital and the dominant areas to be targeted for intervention. Further, the proportion of antimicrobial agents (AMAs) i.e. 26.03% use was low and was prescribed empirically in most of the cases. There was use of expensive AMAs and irrational prescribing of combinations of AMAs in some prescriptions. Other prevailing drugs which were prescribed were analgesics. The usage of nimesulide and rofecoxib. withdrawn by FDA were used recurrently in this setup. There was greater use of dubious drugs of unproven benefit like vitamins, calcium etc. The diagnosis of the disease were not mentioned in 32.5% of prescriptions, The dose, frequency and duration of drugs were unascertained in majority of prescriptions that might lead to health hazards. This exercise might change the behavior of existing prescribers and also of the future doctors.

  17. Utilization of human nuclear receptors as an early counter screen for off-target activity: a case study with a compendium of 615 known drugs.

    PubMed

    Fan, Fan; Hu, Rong; Munzli, Anke; Chen, Yuan; Dunn, Robert T; Weikl, Kerstin; Strauch, Simone; Schwandner, Ralf; Afshari, Cynthia A; Hamadeh, Hisham; Nioi, Paul

    2015-06-01

    Off-target effects of drugs on nuclear hormone receptors (NHRs) may result in adverse effects in multiple organs/physiological processes. Reliable assessments of the NHR activities for drug candidates are therefore crucial for drug development. However, the highly permissive structures of NHRs for vastly different ligands make it challenging to predict interactions by examining the chemical structures of the ligands. Here, we report a detailed investigation on the agonistic and antagonistic activities of 615 known drugs or drug candidates against a panel of 6 NHRs: androgen, progesterone, estrogen α/β, and thyroid hormone α/β receptors. Our study revealed that 4.7 and 12.4% compounds have agonistic and antagonistic activities, respectively, against this panel of NHRs. Nonetheless, potent, unintended NHR hits are relatively rare among the known drugs, indicating that such interactions are perhaps not tolerated during drug development. However, we uncovered examples of compounds that unintentionally agonize or antagonize NHRs. In addition, a number of compounds showed multi-NHR activities, suggesting that the cross-talk between multiple NHRs co-operate to elicit in vivo effects. These data highlight the merits of counter screening drug candidate against NHRs during drug discovery/development.

  18. The Utility of a Population Approach in Drug-Drug Interaction Assessments: A Simulation Evaluation.

    PubMed

    Wang, Diane D; Yu, Yanke; Kassir, Nastya; Zhu, Min; Hanley, William D; Earp, Justin C; Chow, Andrew T; Gupta, Manish; Hu, Chuanpu

    2017-10-01

    This study aims at evaluating the utility of the population pharmacokinetics approach in therapeutic protein drug-drug-interaction (DDI) assessment. Simulations were conducted for 2 representative victim drugs, methotrexate and trastuzumab, using a parallel-group design with and without the interaction drug. The effect of a perpetrator on the exposure of the victim drug is described as the ratio of clearance/apparent clearance of the victim drug given with or without the perpetrator. The power of DDI assessment was calculated as the percentage of runs with 90% confidence interval of the estimated DDI effect within 80% to 125% for the scenarios of no DDI, benchmarked with the noncompartmental approach with intensive sampling. The impact of the number of subjects, the number of sampling points per subject, sampling time error, and model misspecification on the power of DDI determination were evaluated. Results showed that with equal numbers of subjects in each arm, the population pharmacokinetics approach with sparse sampling may need about the same or a higher number of subjects compared to a noncompartmental approach in order to achieve similar power. Increasing the number of subjects, even if only in the study drug alone arm, can increase the power. Sampling or dosing time error had notable impacts on the power for methotrexate but not for trastuzumab. Model misspecification had no notable impacts on the power for trastuzumab. Overall, the population pharmacokinetics approach with sparse sampling built in phase 2/3 studies allows appropriate DDI assessment with adequate study design and analysis and can be considered as an alternative to dedicated DDI studies. © 2017, The American College of Clinical Pharmacology.

  19. Effects of changes in patient cost sharing and drug sample policies on prescription drug costs and utilization in a safety-net-provider setting.

    PubMed

    Lurk, Jared T; DeJong, Douglas J; Woods, T Mark; Knell, Maureen E; Carroll, Cathryn A

    2004-02-01

    The impact of cost-containment strategies on prescription drug utilization and costs in an ambulatory care safety-net-provider setting was studied, along with the impact of these strategies on patient out-of-pocket expenditures. Aggregate monthly prescription drug cost and utilization data were obtained from a health system's outpatient pharmacy computer system for the targeted clinic. The data represented approximately 42,000 patient visits over 38 months. Univariate and multivariate statistics were used to evaluate the influence of copayment increases and changes in prescription drug sample policies on prescription drug costs, prescription drug utilization, and patient expenditures. Prescription drug copayment increases were associated with significant decreases in prescription drug utilization and costs. An average per visit prescription drug copayment increase of $5 was associated with a significant reduction in prescription drug utilization per visit and a $26.07 reduction in prescription drug expenditures per visit per month. Removal of samples from the clinic did not result in a significant decrease in either prescription drug costs or utilization. The presence of samples, however, was associated with a significant reduction in per visit patient expenditures by an amount similar to the copayment for one brand-name prescription drug per visit. An increase in patient copayments was associated with reductions in a clinic's drug expenditures and prescription drug utilization per visit. Removal of prescription drug samples had no effect except increasing patients' out-of-pocket drug costs.

  20. Utilization of antihypertensive drugs in obesity-related hypertension: a retrospective observational study in a cohort of patients from Southern Italy.

    PubMed

    Cataldi, Mauro; di Geronimo, Ornella; Trio, Rossella; Scotti, Antonella; Memoli, Andrea; Capone, Domenico; Guida, Bruna

    2016-03-16

    Although the pathophysiological mechanisms of arterial hypertension are different in obese and lean patients, hypertension guidelines do not include specific recommendations for obesity-related hypertension and, therefore, there is a considerable uncertainty on which antihypertensive drugs should be used in this condition. Moreover, studies performed in general population suggested that some antihypertensive drugs may increase body weight, glycemia and LDL-cholesterol but it is unclear how this impact on drug choice in clinical practice in the treatment of obese hypertensive patients. Therefore, in order to identify current preferences of practitioners for obesity-related hypertension, in the present work we evaluated antihypertensive drug therapy in a cohort of 129 pharmacologically treated obese hypertensive patients (46 males and 83 females, aged 51.95 ± 10.1 years) that came to our observation for a nutritional consultation. Study design was retrospective observational. Differences in the prevalence of use of the different antihypertensive drug classes among groups were evaluated with χ(2) square analysis. Threshold for statistical significance was set at p < 0.05. 41.1 % of the study sample was treated with one, 36.4 % with two and the remaining 22.5 % with three or more antihypertensive drugs. In patients under single drug therapy, β-blockers, ACEIs and ARBs accounted each for about 25 % of prescriptions. The prevalence of use of β-blockers was about sixfold higher in females than males. Diuretics were virtually never used in monotherapy regimens but were used in more than 60 % of patients on dual antihypertensive therapy and in all patients assuming three or more drugs. There was no significant difference in the prevalence of use of any of the aforementioned drugs among patients with obesity of type I, II and III or between patients with or without metabolic syndrome. Our data show that no first choice protocol seems to be adopted in clinical

  1. Emergency department utilization and subsequent prescription drug overdose death

    PubMed Central

    Brady, Joanne E.; DiMaggio, Charles J.; Keyes, Katherine M.; Doyle, John J.; Richardson, Lynne D.; Li, Guohua

    2015-01-01

    Purpose Prescription drug overdose (PDO) deaths are a critical public health problem in the United States. This study aims to assess the association between emergency department (ED) utilization patterns in a cohort of ED patients and the risk of subsequent unintentional PDO mortality. Methods Using data from the New York Statewide Planning and Research Cooperative System for 2006–2010, a nested case-control design was used to examine the relationship between ED utilization patterns in New York State residents of age 18–64 years and subsequent PDO death. Results The study sample consisted of 2732 case patients who died of PDO and 2732 control ED patients who were selected through incidence density sampling. With adjustment for demographic characteristics, and diagnoses of pain, substance abuse, and psychiatric disorders, the estimated odds ratios of PDO death relative to one ED visit or less in the previous year were 4.90 (95% confidence interval [CI]: 4.50–5.34) for those with two ED visits, 16.61 (95% CI: 14.72–18.75) for those with three ED visits, and 48.24 (95% CI: 43.23–53.83) for those with four ED visits or more. Conclusions Frequency of ED visits is strongly associated with the risk of subsequent PDO death. Intervention programs targeting frequent ED users are warranted to reduce PDO mortality. PMID:25935710

  2. The influence of prescription drug insurance on psychotropic and non-psychotropic drug utilization in Canada.

    PubMed

    Sarma, Sisira; Basu, Kisalaya; Gupta, Anil

    2007-12-01

    Using 2002 Canadian Community Health Survey data, this paper examines the effect of public and private prescription drug insurance on the utilization of psychotropic and non-psychotropic drugs. It is found that prescription drug utilization is characterized by two stochastic regimes requiring use of latent class modelling framework. In many instances, results differ for the classes of high and low users of prescription drugs. After accounting for the unobserved individual heterogeneity and a number of socio-demographic factors, health status, and province fixed effects, we find that having prescription drug insurance (public or private) increases the expected number of non-psychotropic medications for both low and high users. Public insurance affects psychotropic drug utilization positively for the low-user group only. The statistical insignificance of insurance for the high-user psychotropic drugs or lower magnitude of insurance coefficients on high-user non-psychotropic drugs seems to stem from high inelastic demand for prescription drugs in the concerned groups. In addition, we find that age, self-reported health status, and long-term mental and physical health problem diagnosed by a health professional are important determinants of prescription drug utilization for both classes of users.

  3. “Brown Bag” Simulations to Teach Drug Utilization Review

    PubMed Central

    Begley, Kimberley; Hoie, Eric; Elsasser, Gary; Augustine, Sam

    2014-01-01

    Objective. To teach drug utilization review (DUR) skills to pharmacy students and assess their abilities and confidence before and after training. Design. Profile reviews and online and live drug-utilization-review activities of increasing difficulty were incorporated into the first (P1), second (P2), and third (P3) years of the Pharmacy Skills Training Laboratory sequence in a doctor of pharmacy (PharmD) curriculum. Assessment. An online survey instrument was administered to gauge how comfortable students were with specific DUR skills before and after the activities. Students’ confidence in performing specific DUR skills improved after completing the activities. Conclusion. Profile reviews, as well as online and live medication reviews, gave students numerous opportunities to practice drug utilization review skills throughout the first 3 years of the pharmacy curriculum. Students’ confidence in performing specific drug utilization review skills improved after the activities. Students’ ability to perform the skills also improved as measured with the developed checklist in section V and VI of the Pharmacy Skills Laboratory sequence. PMID:24672073

  4. Drug utilization in selected health facilities of South West Shoa Zone, Oromia Region, Ethiopia

    PubMed Central

    Kebede, Mengistu; Kebebe Borga, Dereje; Mulisa Bobasa, Eshetu

    2015-01-01

    Background Sustaining the availability and rational use of safe and effective drugs is a major problem in developing countries. Irrational drug use affects quality of health care more than accessibility of drugs. Objective To assess drug utilization in selected health facilities of South West Shoa Zone, Oromia Region, Ethiopia. Methods A cross-sectional study was conducted in selected health facilities of South West Shoa Zone from January 21–28, 2012 by using structured questionnaires. Results Of 50 prescribers and 30 dispensers, 58% and 83.3% were males, respectively. The result showed that majority of prescribers agreed on availability of essential drugs (72%) and had access to up-to-date drug information (76%). However, 43.3% of dispensers didn’t get access to up-to-date drug information. 86% and 88% of prescribers note cost of drugs and stick to standard treatment guidelines of Ethiopia during prescription, respectively. All drug dispensers check the name of the drug (100%), age of the patient (90%), the dosage form of drug (96.7%), the route of administration (90%), the duration of therapy (86.7%), and frequency of administration (86.7%) for prescription papers. Conclusion In general, drug utilization at the study sites was found to be good, although there are major deviations from the concept of rational drug use. PMID:26229506

  5. Can Walmart make us healthier? Prescription drug prices and health care utilization.

    PubMed

    Borrescio-Higa, Florencia

    2015-12-01

    This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent. Copyright © 2015 Elsevier B.V. All rights reserved.

  6. Forecasting drug utilization and expenditure in a metropolitan health region

    PubMed Central

    2010-01-01

    Background New pharmacological therapies are challenging the healthcare systems, and there is an increasing need to assess their therapeutic value in relation to existing alternatives as well as their potential budget impact. Consequently, new models to introduce drugs in healthcare are urgently needed. In the metropolitan health region of Stockholm, Sweden, a model has been developed including early warning (horizon scanning), forecasting of drug utilization and expenditure, critical drug evaluation as well as structured programs for the introduction and follow-up of new drugs. The aim of this paper is to present the forecasting model and the predicted growth in all therapeutic areas in 2010 and 2011. Methods Linear regression analysis was applied to aggregate sales data on hospital sales and dispensed drugs in ambulatory care, including both reimbursed expenditure and patient co-payment. The linear regression was applied on each pharmacological group based on four observations 2006-2009, and the crude predictions estimated for the coming two years 2010-2011. The crude predictions were then adjusted for factors likely to increase or decrease future utilization and expenditure, such as patent expiries, new drugs to be launched or new guidelines from national bodies or the regional Drug and Therapeutics Committee. The assessment included a close collaboration with clinical, clinical pharmacological and pharmaceutical experts from the regional Drug and Therapeutics Committee. Results The annual increase in total expenditure for prescription and hospital drugs was predicted to be 2.0% in 2010 and 4.0% in 2011. Expenditures will increase in most therapeutic areas, but most predominantly for antineoplastic and immune modulating agents as well as drugs for the nervous system, infectious diseases, and blood and blood-forming organs. Conclusions The utilisation and expenditure of drugs is difficult to forecast due to uncertainties about the rate of adoption of new

  7. Out-of-pocket drug costs and drug utilization patterns of postmenopausal Medicare beneficiaries with osteoporosis.

    PubMed

    Conwell, Leslie Jackson; Esposito, Dominick; Garavaglia, Susan; Meadows, Eric S; Colby, Margaret; Herrera, Vivian; Goldfarb, Seth; Ball, Daniel; Marciniak, Martin

    2011-08-01

    The Medicare Part D coverage gap has been associated with lower adherence and drug utilization and higher discontinuation. Because osteoporosis has a relatively high prevalence among Medicare-eligible postmenopausal women, we examined changes in utilization of osteoporosis medications during this coverage gap. The purpose of this study was to investigate changes in out-of-pocket (OOP) drug costs and utilization associated with the Medicare Part D coverage gap among postmenopausal beneficiaries with osteoporosis. This retrospective analysis of 2007 pharmacy claims focuses on postmenopausal female Medicare beneficiaries enrolled in full-, partial-, or no-gap exposure standard or Medicare Advantage prescription drug plans (PDPs), retiree drug subsidy (RDS) plans, or the low-income subsidy program. We compared beneficiaries with osteoporosis who were taking teriparatide (Eli Lilly and Company, Indianapolis, Indiana) (n = 5657) with matched samples of beneficiaries who were taking nonteriparatide osteoporosis medications (NTO; n = 16,971) or who had other chronic conditions (OCC; n = 16,971). We measured average monthly prescription drug fills and OOP costs, medication discontinuation, and skipping. More than half the sample reached the coverage gap; OOP costs then rose for teriparatide users enrolled in partial- or full-gap exposure plans (increase of 121% and 186%; $300 and $349) but fell for those in no-gap exposure PDPs or RDS plans (decrease of 49% and 30%; $131 and $40). OOP costs for beneficiaries in partial- or full-gap exposure PDPs increased >120% (increase of $144 and $176) in the NTO group and nearly doubled for the OCC group (increase of $124 and $151); these OOP costs were substantially lower than those for teriparatide users. Both teriparatide users and NTO group members discontinued or skipped medications more often than persons in the OCC group, regardless of plan or benefit design. Medication discontinuation and OOP costs among beneficiaries with

  8. Drug use and service utilization among Hispanics in the United States.

    PubMed

    Mancini, Michael A; Salas-Wright, Christopher P; Vaughn, Michael G

    2015-11-01

    To examine illicit drug use and service utilization patterns of US-born and foreign-born Hispanics in the United States. Hispanic respondents 18 years and older in the NESARC were categorized as being of Mexican (n = 3,556), Puerto Rican (n = 785), Cuban (n = 346), Central American (n = 513), or South American (n = 381) origin. We examined lifetime prevalence of drug use and substance abuse treatment utilization patterns for US-born and Hispanic immigrants across subgroups. Lifetime prevalence of drug use was greater among US-born Hispanics than Hispanic immigrants after controlling for age, gender, income, education, urbanicity, parental history of drug use problems and lifetime DSM-IV mood/anxiety disorders. Both US-born and immigrant Hispanic drug users were less likely than non-Hispanic white drug users to have utilized any form of substance abuse treatment (US-born AOR = 0.89, immigrant AOR = 0.64) and more likely to have utilized family or social services (US-born AOR = 1.17, immigrant AOR = 1.19). Compared to US-born Hispanic drug users, Hispanic immigrant drug users were less likely to have used any form of substance abuse treatment (AOR = 0.81) and were more likely to have utilized family or social services (AOR = 1.22). Strategies to increase engagement and retention of Hispanic drug users in substance abuse treatment include increasing access to linguistically and culturally competent programs that address unmet family and social needs. Further studies examining differences in drug use and service utilization patterns within Hispanic subgroups are needed.

  9. Drug utilization, prescription errors and potential drug-drug interactions: an experience in rural Sri Lanka.

    PubMed

    Rathish, Devarajan; Bahini, Sivaswamy; Sivakumar, Thanikai; Thiranagama, Thilani; Abarajithan, Tharmarajah; Wijerathne, Buddhika; Jayasumana, Channa; Siribaddana, Sisira

    2016-06-25

    Prescription writing is a process which transfers the therapeutic message from the prescriber to the patient through the pharmacist. Prescribing errors, drug duplication and potential drug-drug interactions (pDDI) in prescriptions lead to medication error. Assessment of the above was made in prescriptions dispensed at State Pharmaceutical Corporation (SPC), Anuradhapura, Sri Lanka. A cross sectional study was conducted. Drugs were classified according to the WHO anatomical, therapeutic chemical classification system. A three point Likert scale, a checklist and Medscape online drug interaction checker were used to assess legibility, completeness and pDDIs respectively. Thousand prescriptions were collected. Majority were hand written (99.8 %) and from the private sector (73 %). The most frequently prescribed substance and subgroup were atorvastatin (4 %, n = 3668) and proton pump inhibitors (7 %, n = 3668) respectively. Out of the substances prescribed from the government and private sectors, 59 and 50 % respectively were available in the national list of essential medicines, Sri Lanka. Patients address (5 %), Sri Lanka Medical Council (SLMC) registration number (35 %), route (7 %), generic name (16 %), treatment symbol (48 %), diagnosis (41 %) and refill information (6 %) were seen in less than half of the prescriptions. Most were legible with effort (65 %) and illegibility was seen in 9 %. There was significant difference in omission and/or errors of generic name (P = 0.000), dose (P = 0.000), SLMC registration number (P = 0.000), and in evidence of pDDI (P = 0.009) with regards to the sector of prescribing. The commonest subgroup involved in duplication was non-steroidal anti-inflammatory drugs (NSAIDs) (43 %; 56/130). There were 1376 potential drug interactions (466/887 prescriptions). Most common pair causing pDDI was aspirin with losartan (4 %, n = 1376). Atorvastatin was the most frequently prescribed substance

  10. Medical cost offsets from prescription drug utilization among Medicare beneficiaries.

    PubMed

    Roebuck, M Christopher

    2014-10-01

    This brief commentary extends earlier work on the value of adherence to derive medical cost offset estimates from prescription drug utilization. Among seniors with chronic vascular disease, 1% increases in condition-specific medication use were associated with significant (P  less than  0.001) reductions in gross nonpharmacy medical costs in the amounts of 0.63% for dyslipidemia, 0.77% for congestive heart failure, 0.83% for diabetes, and 1.17% for hypertension.

  11. Microemulsion utility in pharmaceuticals: Implications for multi-drug delivery.

    PubMed

    Callender, Shannon P; Mathews, Jessica A; Kobernyk, Katherine; Wettig, Shawn D

    2017-06-30

    Emulsion technology has been utilized extensively in the pharmaceutical industry. This article presents a comprehensive review of the literature on an important subcategory of emulsions, microemulsions. Microemulsions are optically transparent, thermodynamically stable colloidal systems, 10-100nm diameter, that form spontaneously upon mixing of oil, water and emulsifier. This review is the first to address advantages and disadvantages, as well as considerations and challenges in multi-drug delivery. For the period 1 January 2011-30 April 2016, 431 publications related to microemulsion drug delivery were identified and screened according to microemulsion, drug classification, and surfactant types. Results indicate the use of microemulsions predominantly in lipophilic drug delivery (79.4%) via oil-in-water microemulsions and non-ionic surfactants (90%) for oral or topical administration. Cancer is the disease state most targeted followed by inflammatory diseases, microbial infections and cardiovascular disease. Key generalizations from this analysis include: 1) microemulsion formulation is largely based on trial-and-error despite over 1200 publications related to microemulsion drug delivery since their discovery in 1943; 2) characterization using methods including interfacial tension, droplet size, electrical conductivity, turbidity and viscosity may provide additional information for greater predictability; 3) microemulsion drug delivery publications arise primarily from China (27%) and India (21%) suggesting additional research opportunities elsewhere. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Space platform utilities distribution study

    NASA Technical Reports Server (NTRS)

    Lefever, A. E.

    1980-01-01

    Generic concepts for the installation of power data and thermal fluid distribution lines on large space platforms were discussed. Connections with central utility subsystem modules and pallet interfaces were also considered. Three system concept study platforms were used as basepoints for the detail development. The tradeoff of high voltage low voltage power distribution and the impact of fiber optics as a data distribution mechanism were analyzed. Thermal expansion and temperature control of utility lines and ducts were considered. Technology developments required for implementation of the generic distribution concepts were identified.

  13. Administrative Utility Analysis: Study Summary.

    ERIC Educational Resources Information Center

    Peat, Marwick, Mitchell and Co., San Juan, Puerto Rico.

    This document summarizes the recommendations made as a result of a study on administrative utility analysis and vocational education programs for Puerto Rico. The major recommendation was that the Area of Vocational and Technical Education (AVTE) in the Puerto Rico Department of Education be restructured at the central organizational level, for…

  14. Gated myocardial perfusion single photon emission computed tomography in the clinical outcomes utilizing revascularization and aggressive drug evaluation (COURAGE) trial, Veterans Administration Cooperative study no. 424.

    PubMed

    Shaw, Leslee J; Heller, Gary V; Casperson, Paul; Miranda-Peats, Romalisa; Slomka, Piotr; Friedman, John; Hayes, Sean W; Schwartz, Ronald; Weintraub, William S; Maron, David J; Dada, Marcin; King, Spencer; Teo, Koon; Hartigan, Pamela; Boden, William E; O'Rourke, Robert A; Berman, Daniel S

    2006-09-01

    Stress gated myocardial perfusion single photon emission computed tomography (gSPECT) is increasingly used before and after intercurrent therapeutic intervention and is the basis for ongoing evaluation in the Department of Veterans Affairs clinical outcomes utilizing revascularization and aggressive drug evaluation (COURAGE) trial. The COURAGE trial is a North American multicenter randomized clinical trial that enrolled 2287 patients to aggressive medical therapy vs percutaneous coronary intervention plus aggressive medical therapy. Three COURAGE nuclear substudies have been designed. The goals of substudy 0 are to examine the diagnostic accuracy of the extent and severity of inducible ischemia at baseline in COURAGE patients compared with patient symptoms and quantitative coronary angiography and to explore the relationship between inducible ischemia and the benefit from revascularization when added to medical therapy. Substudy 1 will correlate the extent and severity of provocative ischemia with the frequency, quality, and instability of recurrent symptoms in postcatheterization patients. Substudy 2 (n = 300) will examine the usefulness of sequential gSPECT monitoring 6 to 18 months after therapeutic intervention. Together, these nuclear substudies will evaluate the role of gSPECT to determine the effectiveness of aggressive risk-factor modifications, lifestyle interventions, and anti-ischemic medical therapies with or without revascularization in reducing patients' ischemic burdens. The unfolding of evidence on the application of gSPECT in trials such as COURAGE defines a new era for nuclear cardiology. We hope the evidence that emerges from the COURAGE trial will further establish the role of nuclear imaging in the evidence-based management of patients with stable coronary disease.

  15. Patterns of prescription drug utilization in elder Mexican Americans: results from the Hispanic EPESE Study. Established Population for the Epidemiologic Study of the Elderly.

    PubMed

    Espino, D V; Palmer, R F; Mouton, C P; Miles, T P; Bayne, N S; Markides, K S

    2000-01-01

    The objective of this study was to determine the patterns of prescription medication usage among community-dwelling Mexican-American elders. This was a cross-sectional survey of a regional probability sample of 2,895 community-dwelling Mexican Americans, aged 65 and over. Of the sample, 58.1% used at least one prescribed medication within the two weeks prior to their participation in the study. Women were significantly more likely than men to use analgesics, non-steroidal anti-inflammatory agents, prescription nutritional supplements, and other central nervous system and endocrine medications. Subjects aged 75 and over were more likely to use cardiovascular medications, nutritional supplements, ophthalmic preparations and antihistamines, while those in the age groups 65-69 and 70-74 were more likely to use hypoglycemic and endocrine medications. Interestingly, there was a significantly decreased usage of hypoglycemic medications in the older age group (aged 75 and over) as compared with the younger age groups (65-69 and 69-74). This may indicate that Mexican American elders are dying at younger ages from complications related to diabetes mellitus and are not alive to use hypoglycemic medications at ages 75 and over. Also, men used more hypoglycemic medication than women (77% vs 70%). There was no relationship between use of medication and severity of diabetic illness.

  16. Changes in drug utilization following the outpatient prescription drug cost-sharing program--evidence from Taiwan's elderly.

    PubMed

    Liu, Shuen-Zen; Romeis, James C

    2004-06-01

    This paper examines changes in drug utilization following Taiwan's newly implemented National Health Insurance (NHI) outpatient prescription drug cost-sharing program for persons over 65 years old. The study is a hospital outpatient prescription level analysis that adopts a pretest-posttest control group experiment design. Selected measures of outpatient prescription drug utilization are examined for cost-sharing and non cost-sharing groups in cost-sharing periods and pre cost-sharing periods. Additional analyses were conducted comparing older patients with and without chronic diseases and differences for essential and non-essential drugs. Patients over age 65 were drawn from 21 hospitals in the Taipei area using a stratified random sampling method. This paper yields several interesting findings. First, average prescription cost and prescription period increased for both the cost-sharing and non cost-sharing groups. However, the rate of increase was significantly less in the cost-sharing group when compared with the non cost-sharing group. Second, the elderly with non-chronic diseases were more sensitive (i.e., reducing drug utilization) to the drug cost-sharing program when compared with those with chronic diseases. Third, for the elderly with non-chronic diseases average drug cost per prescription experienced a smaller decrease in essential drugs but a moderate increase in non-essential drugs for the cost-sharing group. By contrast, for the non cost-sharing group, average drug cost per prescription increased sharply in non-essential drugs as well as essential drugs. Finally, there was a significant increase in the number of prescriptions as well as drug costs above the upper bound of the cost-sharing schedule. The outpatient drug cost-sharing program implemented by the NHI in Taiwan did not reverse the trend of prescription drug cost increases in hospitals. The significant increase in the number of prescriptions above the upper bound of the cost-sharing schedule

  17. A sudden and unprecedented increase in low dose naltrexone (LDN) prescribing in Norway. Patient and prescriber characteristics, and dispense patterns. A drug utilization cohort study.

    PubMed

    Raknes, Guttorm; Småbrekke, Lars

    2017-02-01

    Following a TV documentary in 2013, there was a tremendous increase in low dose naltrexone (LDN) use in a wide range of unapproved indications in Norway. We aim to describe the extent of this sudden and unprecedented increase in LDN prescribing, to characterize patients and LDN prescribers, and to estimate LDN dose sizes. LDN prescriptions recorded in the Norwegian Prescription Database (NorPD) in 2013 and 2014, and sales data not recorded in NorPD from the only Norwegian LDN manufacturer were included in the study. According to NorPD, 15 297 patients (0.3% of population) collected at least one LDN prescription. The actual number of users was higher as at least 23% of total sales were not recorded in NorPD. After an initial wave, there was a steady stream of new and persistent users throughout the study period. Median patient age was 52 years, and 74% of patients were female. Median daily dose was 3.7 mg. Twenty percent of all doctors and 71% of general medicine practitioners registered in Norway in 2014 prescribed LDN at least once. The TV documentary on LDN in Norway was followed by a large increase in LDN prescribing, and the proportion of LDN users went from an insignificant number to 0.3% of the population. There was a high willingness to use and prescribe off label despite limited evidence. Observed median LDN dose, and age and gender distribution were as expected in typical LDN using patients. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  18. Relationship Between Service Utilization and Runaway Youths' Alcohol and Other Drug Use.

    PubMed

    Slesnick, Natasha; Meade, Melissa; Tonigan, J Scott

    2001-01-01

    Runaway youths represent a vulnerable, high-risk population that has received little societal attention. Studies show that youths at greatest need are the least likely to access mental health, medical, and other social services. This study evaluated service utilization, including medical visits, psychological, alcohol and drug counseling and 12-step attendance, and substance use. Runaway youths (n = 51) between the ages of 12 and 17 with a diagnosis of alcohol abuse or dependence were recruited from two southwestern runaway shelters. Results showed that psychological counseling and medical visits were associated with less alcohol use while 12-step attendance was associated with more alcohol use at pretreatment. Service utilization was not associated with illicit drug use. The findings suggest that alcohol and other drug use are affected differently by service utilization in this sample of youths. More research is required to evaluate and develop treatments which can effectively intervene with this high-risk group.

  19. [Analysis of utilization situation of harm reduction services among drug users and its impact factors].

    PubMed

    Sun, Yu-ying; Yu, Xiao-ming; Sun, Jiang-ping; Xue, Hui; Wang, Geng; Wang, Jia; Wang, Lu

    2013-06-18

    To study the utilization situation of harm reduction services among drug users and to analyze the reasons of the drug users' absence in the services as well as their evaluation of the services quality based on the gender perspective, and then to provide advice on the improvement of harm reduction services in the future. Cross-sectional surveys were carried out in four cities of Yunnan Province. The information was collected from the drug users in the drug rehabilitation centers and communities through outreach workers. The utilization of methadone maintenance treatment (MMT) and needle exchange service, the reason of the drug users' absence in the services and the evaluation towards the convenience, acceptability, as well as services quality were all surveyed. The valid samples were 579 with sex ratio 50.8% (male) and 49.2% (female). Most of the respondents (56.3%) had an educational level of junior high school and 44.0% were single. There were 61.8% (358/579) of respondents who used to utilize MMT service with female participation rate being 57.5%, which was lower than the male one (P<0.05). And there were 58.2% (223/383) of the respondents who used to exchange needles from the outreach workers or needle exchange points with female participation rate being 52.9%, which was lower than the male one (P<0.05). The leading cause of the drug users' absence in the services was their lack of understanding about the services. Among the people who used to utilize the services, the evaluations of women were better than those of men. Drug users have a low awareness of harm reduction services and female drug users are lack of the utilization towards services. More publicity and concern on harm reduction services in the future as well as exploration of the services which better fit the traits of women and privacy protection are suggested.

  20. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations.

    PubMed

    Jandoc, Racquel; Burden, Andrea M; Mamdani, Muhammad; Lévesque, Linda E; Cadarette, Suzanne M

    2015-08-01

    To describe the use and reporting of interrupted time series methods in drug utilization research. We completed a systematic search of MEDLINE, Web of Science, and reference lists to identify English language articles through to December 2013 that used interrupted time series methods in drug utilization research. We tabulated the number of studies by publication year and summarized methodological detail. We identified 220 eligible empirical applications since 1984. Only 17 (8%) were published before 2000, and 90 (41%) were published since 2010. Segmented regression was the most commonly applied interrupted time series method (67%). Most studies assessed drug policy changes (51%, n = 112); 22% (n = 48) examined the impact of new evidence, 18% (n = 39) examined safety advisories, and 16% (n = 35) examined quality improvement interventions. Autocorrelation was considered in 66% of studies, 31% reported adjusting for seasonality, and 15% accounted for nonstationarity. Use of interrupted time series methods in drug utilization research has increased, particularly in recent years. Despite methodological recommendations, there is large variation in reporting of analytic methods. Developing methodological and reporting standards for interrupted time series analysis is important to improve its application in drug utilization research, and we provide recommendations for consideration. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  1. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  2. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  3. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Drug utilization management, quality assurance, and... Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a... D plan, a drug utilization management program, quality assurance measures and systems, and an...

  4. Internalized HIV and Drug Stigmas: Interacting Forces Threatening Health Status and Health Service Utilization Among People with HIV Who Inject Drugs in St. Petersburg, Russia

    PubMed Central

    Burke, Sara E.; Dovidio, John F.; Levina, Olga S.; Uusküla, Anneli; Niccolai, Linda M.; Heimer, Robert

    2016-01-01

    Marked overlap between the HIV and injection drug use epidemics in St. Petersburg, Russia, puts many people in need of health services at risk for stigmatization based on both characteristics simultaneously. The current study examined the independent and interactive effects of internalized HIV and drug stigmas on health status and health service utilization among 383 people with HIV who inject drugs in St. Petersburg. Participants self-reported internalized HIV stigma, internalized drug stigma, health status (subjective rating and symptom count), health service utilization (HIV care and drug treatment), sociodemographic characteristics, and health/behavioral history. For both forms of internalized stigma, greater stigma was correlated with poorer health and lower likelihood of service utilization. HIV and drug stigmas interacted to predict symptom count, HIV care, and drug treatment such that individuals internalizing high levels of both stigmas were at elevated risk for experiencing poor health and less likely to access health services. PMID:26050155

  5. Internalized HIV and Drug Stigmas: Interacting Forces Threatening Health Status and Health Service Utilization Among People with HIV Who Inject Drugs in St. Petersburg, Russia.

    PubMed

    Calabrese, Sarah K; Burke, Sara E; Dovidio, John F; Levina, Olga S; Uusküla, Anneli; Niccolai, Linda M; Heimer, Robert

    2016-01-01

    Marked overlap between the HIV and injection drug use epidemics in St. Petersburg, Russia, puts many people in need of health services at risk for stigmatization based on both characteristics simultaneously. The current study examined the independent and interactive effects of internalized HIV and drug stigmas on health status and health service utilization among 383 people with HIV who inject drugs in St. Petersburg. Participants self-reported internalized HIV stigma, internalized drug stigma, health status (subjective rating and symptom count), health service utilization (HIV care and drug treatment), sociodemographic characteristics, and health/behavioral history. For both forms of internalized stigma, greater stigma was correlated with poorer health and lower likelihood of service utilization. HIV and drug stigmas interacted to predict symptom count, HIV care, and drug treatment such that individuals internalizing high levels of both stigmas were at elevated risk for experiencing poor health and less likely to access health services.

  6. Impact of income-based deductibles on drug use and health care utilization among older adults

    PubMed Central

    Law, Michael R.; Cheng, Lucy; Worthington, Heather; Mamdani, Muhammad; McGrail, Kimberlyn M.; Chan, Fiona K.I.; Majumdar, Sumit R.

    2017-01-01

    BACKGROUND: Income-based deductibles are present in several provincial public drug plans in Canada and have been the subject of extensive debate. We studied the impact of such deductibles in British Columbia’s Fair PharmaCare plan on drug and health care utilization among older adults. METHODS: We used a quasi-experimental regression discontinuity design to compare the impact of deductibles in BC’s PharmaCare plan between older community-dwelling adults registered for the plan who were born in 1928 through 1939 (no deductible) and those born in 1940 through 1951 (deductible equivalent to 2% of household income). We used 1.2 million person-years of data between 2003 and 2015 to study public drug plan expenditures, overall drug use, and physician and hospital resource utilization in these 2 groups. RESULTS: The income-based deductible led to a 28.6% decrease in person-years in which public drug plan benefits were received (95% confidence interval [CI] −29.7% to −27.5%) and to a reduction in the per capita extent of annual benefits by $205.59 (95% CI −$247.81 to −$163.37). Despite this difference in public subsidy, we found no difference in the number of drugs received or in total drug spending once privately paid amounts were accounted for (p = 0.4 and 0.8, respectively). Further, we found only small or nonexistent changes in health care resource utilization at the 1939 threshold. INTERPRETATION: A modest income-based deductible had a considerable impact on the extent of public subsidy for prescription drugs. However, it had only a trivial impact on overall access to medicines and use of other health services. Unlike copayments, modest income-based deductibles may safely reduce public spending on drugs for some population groups. PMID:28507088

  7. Perceived discrimination among racial and ethnic minority drug users and the association with health care utilization.

    PubMed

    McKnight, Courtney; Shumway, Martha; Masson, Carmen L; Pouget, Enrique R; Jordan, Ashly E; Des Jarlais, Don C; Sorensen, James L; Perlman, David C

    2017-03-17

    People who use drugs (PWUDs) are at increased risk for several medical conditions, yet they delay seeking medical care and utilize emergency departments (EDs) as their primary source of care. Limited research regarding perceived discrimination and PWUDs' use of health care services exists. This study explores the association between interpersonal and institutional racial/ethnic and drug use discrimination in health care settings and health care utilization among respondents (N = 192) recruited from methadone maintenance treatment programs (36%), HIV primary care clinics (35%), and syringe exchange programs (29%) in New York City (n = 88) and San Francisco (n = 104). The Kaiser Family Foundation Survey of Race, Ethnicity, and Medical Care questionnaire was utilized to assess perceived institutional racial/ethnic and drug use discrimination. Perceived institutional discrimination was examined across race/ethnicity and by regular use of ERs, having a regular doctor, and consistent health insurance. Perceived interpersonal discrimination was examined by race/ethnicity. Perceived interpersonal drug use discrimination was the most common type of discrimination experienced in health care settings. Perceptions of institutional discrimination related to race/ethnicity and drug use among non-Hispanic Whites did not significantly differ from those among non-Hispanic Blacks or Hispanics. A perception of less frequent institutional racial/ethnic and drug use discrimination in health care settings was associated with increased odds of having a regular doctor. Awareness of perceived interpersonal and institutional discrimination in certain populations and the effect on health care service utilization should inform future intervention development to help reduce discrimination and improve health care utilization among PWUDs.

  8. Utility robotic planning: case studies

    SciTech Connect

    Roman, H.T.; Travato, S.A.; Irving, T.L.; Patnaude, L.G.

    1986-03-01

    Currently, the utility use of robotic devices is most appropriate in nuclear power plants. Four utilities are currently approaching the task of robotic applications. The planning program of each of the utilities is discussed. The following similarities of approach are noted: Plant operating personnel are surveyed for application ideas, and a company task force is established involving these personnel to determine specific application needs and cost-benefit. The state-of-the-art of various robotic devices is evaluated and selected equipment is tested in existing plants. The robotic experience gained from nuclear plant applications is extended to other non-nuclear areas. 2 figures, 1 table.

  9. Patterns of antihypertensive drug utilization in primary care.

    PubMed

    Pittrow, D; Kirch, W; Bramlage, P; Lehnert, H; Höfler, M; Unger, T; Sharma, A M; Wittchen, H-U

    2004-04-01

    In the treatment of hypertension, physicians' attitudes and practice patterns are receiving increased attention as contributors to poor blood pressure (BP) control. Thus, current use of antihypertensive drugs in primary care was analyzed and the association with selected physician and patient characteristics was assessed. The Hypertension and Diabetes Risk Screening and Awareness (HYDRA) study is a cross-sectional point prevalence study of 45,125 primary care attendees recruited from a representative nationwide sample of 1912 primary care practices in Germany. Prescription frequencies of the various antihypertensive drugs in the individual patients were recorded by the physicians using standardized questionnaires. We assessed the association of patient variables [age, gender; co-morbidities such as diabetes, nephropathy or coronary heart disease (CHD)] and physician variables (general practitioner vs internist, guideline adherence, etc.) with drug treatment intensity and prescription patterns. Of all 43,549 patients for whom a physician diagnosis on hypertension or diabetes was available, 17,485 (40.1%) had hypertension. Of these hypertensive patients, 1647 (9.4%) received no treatment at all, 1191 (6.8%) received non-pharmacological measures only, and 14,647 (83.8%) were given one or more antihypertensive drugs. Drug treatment rates were lower in young patients (16-40 years: 57.4%). BP control was poor: 70.6% of all patients were not normalized, i.e., had BP >/=140/90 mmHg. Antihypertensive treatment was generally intensified with increasing age, or if complications or comorbidities were present. The use of the different drug classes was rather uniform across the various patient subgroups (e.g., by age and gender). Individualized treatment with regard to co-morbidities as recommended in guidelines was not the rule. Adherence to guidelines as self-reported by physicians as well as other physician characteristics (region, training etc.) did not result in more

  10. An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system.

    PubMed

    Zuppa, Athena; Vijayakumar, Sundararajan; Jayaraman, Bhuvana; Patel, Dimple; Narayan, Mahesh; Vijayakumar, Kalpana; Mondick, John T; Barrett, Jeffrey S

    2007-09-01

    Drug utilization in the inpatient setting can provide a mechanism to assess drug prescribing trends, efficiency, and cost-effectiveness of hospital formularies and examine subpopulations for which prescribing habits may be different. Such data can be used to correlate trends with time-dependent or seasonal changes in clinical event rates or the introduction of new pharmaceuticals. It is now possible to provide a robust, dynamic analysis of drug utilization in a large pediatric inpatient setting through the creation of a Web-based hospital drug utilization system that retrieves source data from our accounting database. The production implementation provides a dynamic and historical account of drug utilization at the authors' institution. The existing application can easily be extended to accommodate a multi-institution environment. The creation of a national or even global drug utilization network would facilitate the examination of geographical and/or socioeconomic influences in drug utilization and prescribing practices in general.

  11. Longitudinal Analysis of Changes in Illicit Drug Use and Health Services Utilization

    PubMed Central

    French, Michael T; Fang, Hai; Balsa, Ana I

    2011-01-01

    Objective To analyze the relationships between illicit drug use and three types of health services utilization: emergency room utilization, hospitalization, and medical attention required due to injury(s). Data Waves 1 and 2 (11,253 males and 13,059 females) from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Study Design We derive benchmark estimates by employing standard cross-sectional data models to pooled waves of NESARC data. To control for potential bias due to time-invariant unobserved individual heterogeneity, we reestimate the relationships with fixed-effects models. Principal Findings The cross-sectional data models suggest that illicit drug use is positively and significantly related to health services utilization in almost all specifications. Conversely, the only significant (p<.05) relationships in the fixed-effects models are the odds of receiving medical attention for an injury and the number of injuries requiring medical attention for men, and the number of times hospitalized for men and women. Conclusions Failing to control for time-invariant individual heterogeneity could lead to biased coefficients when estimating the effects of illicit drug use on health services utilization. Moreover, it is important to distinguish between types of drug user (casual versus heavy) and estimate gender-specific models. PMID:21143479

  12. [Comparative study of drug efficacy and drug additives between generic drugs and original drugs].

    PubMed

    Katoh, Hiromi; Yoshii, Michiko; Ozawa, Koichiro

    2007-12-01

    In the present study, we tested three kinds of sleeping drugs, consisting mainly of triazolam, brotizolam, and flunitrazepam, to compare the drug efficacy of generic drugs with that of original drugs. After these drugs were administered orally to mice, drug efficacy was evaluated in terms of ambulation, onset time of sleep, and duration of sleep in the open field test. For all kinds of sleep-inducing drugs, the drug efficacy of most generic drugs is not necessarily equal to that of the original drug. The main reason for the difference appears to be due to differences in the rate of absorption of the main drug. Any other differences between an original drug and a generic drug are caused by drug additives, the crystal form of the main drug, the formulation, and so on. In this study, the formulation was not the reason for the differences because all of the drugs were pulverized in a mortar and had no special coating. The drug additives for all the drugs are listed and the drug efficacy compared. Unfortunately, the information was not sufficient to shed any light on the differences in drug efficacy. For effective drug therapy, more information on drug additives should be provided.

  13. Health care utilization among drug-using and non-drug-using women.

    PubMed

    Sterk, Claire E; Theall, Katherine P; Elifson, Kirk W

    2002-12-01

    This article explores patterns of health care utilization among urban female illegal drug users and nonusers. Interviews were conducted between August 1997 and August 2000 in Atlanta, Georgia, among current drug-using and nonusing women aged 18 to 71 years (n = 235). Women were recruited using outreach and targeted sampling. Data were examined with multivariate and bivariate methods. Compared to nonusers, the most frequent users were significantly more likely to fail to seek needed health care (adjusted odds ratio [aOR] = 3.31, 95% confidence interval [CI] = 1.18, 9.29) and to use a hospital emergency room as their primary source for care (aOR = 6.04, 95% CI = 1.97, 18.56). Multivariate results also suggest that age, self-rated health, alcohol use, insurance coverage, financial strain, and the presence of minor children are associated with health service utilization. Future health policy and research among similar populations must continue to address individual and sociodemographic factors that influence service utilization and seek to incorporate preventive care for vulnerable populations within emergency room settings.

  14. Oseltamivir Prescription and Regulatory Actions Vis-à-Vis Abnormal Behavior Risk in Japan: Drug Utilization Study Using a Nationwide Pharmacy Database

    PubMed Central

    Urushihara, Hisashi; Doi, Yuko; Arai, Masaru; Matsunaga, Toshiyuki; Fujii, Yosuke; Iino, Naoko; Kawamura, Takashi; Kawakami, Koji

    2011-01-01

    Background In March 2007, a regulatory advisory was issued in Japan to restrict oseltamivir use in children aged 10-19 years because of safety concerns over abnormal behavior. The effectiveness and validity of regulatory risk minimization actions remain to be reviewed, despite their significant public health implications. To assess the impact of the regulatory actions on prescribing practices and safety reporting. Methodoloy/Prinicpal Findings In this retrospective review of a nationwide pharmacy database, we analyzed 100,344 dispensation records for oseltamivir and zanamivir for the period from November 2006 to March 2009. The time trend in dispensations for these antiviral agents was presented before and after the regulatory actions, contrasted with intensity of media coverage and the numbers of spontaneous adverse reaction reports with regard to antivirals. The 2007 regulatory actions, together with its intense media coverage, reduced oseltamivir dispensation in targeted patients in fiscal year 2008 to 20.4% of that in fiscal year 2006, although influenza activities were comparable between these fiscal years. In contrast, zanamivir dispensation increased approximately nine-fold across all age groups. The number of abnormal behavior reports associated with oseltamivir in children aged 10-19 years decreased from fiscal year 2006 to 2008 (24 to 9 cases); this decline was offset by the increased number of reports of abnormal behavior in children under age 10 (12 to 28 cases). The number of reports associated with zanamivir increased in proportion to increased dispensation of this drug (11 to 114 cases). Conclusions/Significance The 2007 actions effectively reduced oseltamivir prescriptions and the number of reports of abnormal behavior in the targeted group. The observed increase in abnormal behavior reports in oseltamivir patients under age 10 and in zanamivir patients suggests that these patient groups may also be at risk, calling into question the validity of the

  15. Thermodynamic Studies for Drug Design and Screening

    PubMed Central

    Garbett, Nichola C.; Chaires, Jonathan B.

    2012-01-01

    Introduction A key part of drug design and development is the optimization of molecular interactions between an engineered drug candidate and its binding target. Thermodynamic characterization provides information about the balance of energetic forces driving binding interactions and is essential for understanding and optimizing molecular interactions. Areas covered This review discusses the information that can be obtained from thermodynamic measurements and how this can be applied to the drug development process. Current approaches for the measurement and optimization of thermodynamic parameters are presented, specifically higher throughput and calorimetric methods. Relevant literature for this review was identified in part by bibliographic searches for the period 2004 – 2011 using the Science Citation Index and PUBMED and the keywords listed below. Expert opinion The most effective drug design and development platform comes from an integrated process utilizing all available information from structural, thermodynamic and biological studies. Continuing evolution in our understanding of the energetic basis of molecular interactions and advances in thermodynamic methods for widespread application are essential to realize the goal of thermodynamically-driven drug design. Comprehensive thermodynamic evaluation is vital early in the drug development process to speed drug development towards an optimal energetic interaction profile while retaining good pharmacological properties. Practical thermodynamic approaches, such as enthalpic optimization, thermodynamic optimization plots and the enthalpic efficiency index, have now matured to provide proven utility in design process. Improved throughput in calorimetric methods remains essential for even greater integration of thermodynamics into drug design. PMID:22458502

  16. Utilizing the protein corona around silica nanoparticles for dual drug loading and release

    NASA Astrophysics Data System (ADS)

    Shahabi, Shakiba; Treccani, Laura; Dringen, Ralf; Rezwan, Kurosch

    2015-10-01

    A protein corona forms spontaneously around silica nanoparticles (SNPs) in serum-containing media. To test whether this protein corona can be utilized for the loading and release of anticancer drugs we incorporated the hydrophilic doxorubicin, the hydrophobic meloxicam as well as their combination in the corona around SNPs. The application of corona-covered SNPs to osteosarcoma cells revealed that drug-free particles did not affect the cell viability. In contrast, SNPs carrying a protein corona with doxorubicin or meloxicam lowered the cell proliferation in a concentration-dependent manner. In addition, these particles had an even greater antiproliferative potential than the respective concentrations of free drugs. The best antiproliferative effects were observed for SNPs containing both doxorubicin and meloxicam in their corona. Co-localization studies revealed the presence of doxorubicin fluorescence in the nucleus and lysosomes of cells exposed to doxorubicin-containing coated SNPs, suggesting that endocytotic uptake of the SNPs facilitates the cellular accumulation of the drug. Our data demonstrate that the protein corona, which spontaneously forms around nanoparticles, can be efficiently exploited for loading the particles with multiple drugs for therapeutic purposes. As drugs are efficiently released from such particles they may have a great potential for nanomedical applications.A protein corona forms spontaneously around silica nanoparticles (SNPs) in serum-containing media. To test whether this protein corona can be utilized for the loading and release of anticancer drugs we incorporated the hydrophilic doxorubicin, the hydrophobic meloxicam as well as their combination in the corona around SNPs. The application of corona-covered SNPs to osteosarcoma cells revealed that drug-free particles did not affect the cell viability. In contrast, SNPs carrying a protein corona with doxorubicin or meloxicam lowered the cell proliferation in a concentration

  17. The Valium Project: Diagnostic restrictions as a utilization control in a Medicaid drug program

    PubMed Central

    Boisseree, Victor R.; Keith, John C.; Little, Daniel L.

    1984-01-01

    This study examines the effectiveness of diagnosis restrictions as a drug utilization control in California's Medi-Cal (Medicaid) program. The numbers of Valium prescriptions dispensed, the numbers of Medi-Cal beneficiaries using Valium and the expenditures represented by those prescriptions were measured during application of a diagnosis restriction for a 33-month base period, followed by removal of the diagnosis restriction for a 14-month period. PMID:10310598

  18. Utilization of self-medication and prescription drugs among 15-year-old children from the German GINIplus birth cohort.

    PubMed

    Italia, Salvatore; Brand, Helmut; Heinrich, Joachim; Berdel, Dietrich; von Berg, Andrea; Wolfenstetter, Silke Britta

    2015-11-01

    The objective was to analyse paediatric drug utilization in relation to self-medication, prescription drugs, and the most reported therapeutic drug categories. Data were collected for 3013 children on their utilization of drugs (4-week prevalence) from a German birth cohort study (GINIplus, 15-year follow-up) using a self-administered questionnaire. The drugs were grouped into over-the-counter drugs and prescription drugs, and were classified according to the anatomical therapeutic chemical classification system. Predictors were analysed using a logistic regression model with four independent variables (gender, study area, maternal education, and parental income). Some 69% of the reported 2489 drugs were over-the-counter drugs, and 31% were prescription drugs. The 4-week prevalence for using any type of drug was 41.0%. Drug categories with high prevalence rates of use were antiinflammatory drugs (10.3%), analgesics (7.1%), and antiallergics (5.0%). Factors associated with higher use of over-the-counter drugs were female gender (OR = 1.56, p < 0.0001) and higher maternal education (OR = 1.60, p = 0.0021; university degree vs. secondary high school). Maternal education was correlated with the use of prescribed or self-medicated antiallergics (positive association) and contraceptives (negative association). The use of antibiotics, methylphenidate, and drugs for thyroid therapy was associated with lower parental income. The use of over-the-counter drugs in 15-year-old children from the GINIplus birth cohort is very common and is predicted by socioeconomic factors such as maternal education. This has to be considered by health care managers when deciding about the exclusion of over-the-counter drugs (normally used for self-medication) from reimbursement or the deregulation of drug sales. Copyright © 2015 John Wiley & Sons, Ltd.

  19. Medical and psychosocial services in drug abuse treatment: do stronger linkages promote client utilization?

    PubMed Central

    Friedmann, P D; D'Aunno, T A; Jin, L; Alexander, J A

    2000-01-01

    OBJECTIVE: To examine the extent to which linkage mechanisms (on-site delivery, external arrangements, case management, and transportation assistance) are associated with increased utilization of medical and psychosocial services in outpatient drug abuse treatment units. DATA SOURCES: Survey of administrative directors and clinical supervisors from a nationally representative sample of 597 outpatient drug abuse treatment units in 1995. STUDY DESIGN: We generated separate two-stage multivariate generalized linear models to evaluate the correlation of on-site service delivery, formal external arrangements (joint program/venture or contract), referral agreements, case management, and transportation with the percentage of clients reported to have utilized eight services: physical examinations, routine medical care, tuberculosis screening, HIV treatment, mental health care, employment counseling, housing assistance, and financial counseling services. PRINCIPAL FINDINGS: On-site service delivery and transportation assistance were significantly associated with higher levels of client utilization of ancillary services. Referral agreements and formal external arrangements had no detectable relationship to most service utilization. On-site case management was related to increased clients' use of routine medical care, financial counseling, and housing assistance, but off-site case management was not correlated with utilization of most services. CONCLUSIONS: On-site service delivery appears to be the most reliable mechanism to link drug abuse treatment clients to ancillary services, while referral agreements and formal external mechanisms offer little detectable advantage over ad hoc referral. On-site case management might facilitate utilization of some services, but transportation seems a more important linkage mechanism overall. These findings imply that initiatives and policies to promote linkage of such clients to medical and psychosocial services should emphasize on

  20. [Trends in the utilization of antidepressant drugs in the Rioja and Zamora health districts throughout the 1997-2001 period].

    PubMed

    Sainz de Rozas Aparicio, Carlos; Ruiz Clavijo Díez, Maria Teresa; Díaz Madero, Alfonso

    2004-01-01

    Due to the high increase in the utilization of antidepressant drugs and the change in the prescription profile within this group, this study is aimed at discovering the evolution of the utilization of antidepressant drugs (NO6A subgroup) outside of the hospital setting in the Rioja and Zamora health districts throughout the 1997-2001 period and to evaluate the impact of the new drugs. A study was made of the utilization of drugs included in the NO6A treatment subgroup under the Anatomical Therapeutic Chemical (ATC) classification. The data on the utilization of each specialty was taken from the pharmacy management (SIFAR) software applications and has been stated for each active ingredient in Daily Dose per Inhabitant (DDI). In the period under study, there was an increase in the total utilization of antidepressants in the two areas (Zamora 55% and Rioja 93%) due mainly to the increase in selective serotonin reuptake inhibitors (SSRI) (Zamora 80% and Rioja 143%) and in the new heterocyclic antidepressants (Zamora 82% and Rioja 78%). There has been an increase in the utilization of antidepressants, all of which has taken place in conjunction with a change in the prescription profile. There is a clear shift toward the utilization of the SSRI's and some heterocyclic antidepressants (venlafaxine, trazodone, reboxetine), the utilization of tricyclic antidepressants and IMAO's having decreased.

  1. Utility of patch testing for patients with drug eruption.

    PubMed

    Ohtoshi, S; Kitami, Y; Sueki, H; Nakada, T

    2014-04-01

    Patch testing is less dangerous than oral provocation testing for identification of the causative drug for patients with drug eruption; however, its usefulness for such identification is controversial. To clarify the rates of positive patch testing for patients with drug eruption, classified by causative drugs and clinical features. We analysed results during the period 1990-2010 for 444 patients (151 men, 293 women; mean ± SD age 49.9 ± 18.6 years) who were tested for drug eruption. In the patient group, there were 309 people (69.1%) with maculopapular eruption and 31 (6.9%) with severe drug eruption. The test materials were applied to the back and left for 2 days under occlusion, then results were assessed by the International Contact Dermatitis Research Group (ICDRG) scoring system 3 days after application. Reactions of + to +++ were regarded as positive. Of the 444 patients, 100 (22.4%) had a positive patch test result to a suspected drug. Positive rates were 23.6% and 20.0% for maculopapular eruption and fixed drug eruption, respectively. The class of materials to which most patients reacted positively was contrast medium (n = 53; 41.1%), followed by drugs acting on the central nervous system (n = 18; 28.6%). In the latter group, 16 of the 18 patients were positive to antiepileptics. Positive rates depend on the causative drug rather than the clinical features of the drug eruption. Patch testing is useful when contrast medium or antiepileptics are suspected to be the causative drugs. However, standardization of patch test materials and method of reading is needed, as well as guidelines regarding when testing should be performed. Although patch testing for drug eruption has significant potential, it requires further validation. © 2014 The Authors. Clinical and Experimental Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  2. Prescription Drug Utilization and Reimbursement Increased Following State Medicaid Expansion in 2014.

    PubMed

    Mahendraratnam, Nirosha; Dusetzina, Stacie B; Farley, Joel F

    2017-03-01

    The Affordable Care Act (ACA) expanded health care and medication insurance coverage through Medicaid expansion in select states. Expansion has the potential to increase the availability of health services to patients, including prescription medications. However, limited studies have examined how expansion affected prescription drug utilization and reimbursement. To compare prescription drug utilization (number of prescriptions filled) and reimbursement trends between states that did and did not expand Medicaid coverage in 2014, while accounting for known effects of expansion on Medicaid enrollment. We conducted a comparative interrupted time series using retrospective Medicaid state drug utilization data from 2011 to 2014. After inclusion/exclusion criteria, 8 states that expanded Medicaid in 2014 and 10 states that did not expand Medicaid were studied. Primary outcomes were changes in quarterly prescription drug utilization and quarterly total prescription drug reimbursement before and after expansion. To account for increases in enrollment in expansion states, secondary outcomes were per-member-per-quarter (PMPQ) utilization and reimbursement before and after expansion. Expansion states experienced a 1.4 million prescriptions per quarter and $163 million per quarter increase in utilization and reimbursement above the change in rates observed in nonexpansion states after expansion (P < 0.001). Specifically, 1 year after ACA implementation, expansion states used 17.0% more prescriptions and spent 36.1% more in reimbursement than the quarter preceding expansion. Expansion and nonexpansion states experienced significant drops in PMPQ prescriptions immediately after expansion (P < 0.001), but PMPQ prescriptions and reimbursement trends increased by the end of the postexpansion period in expansion states (P < 0.029 and P < 0.001, respectively). Study results suggest that Medicaid expansion offers vulnerable patients who were previously uninsured increased access to

  3. [Oxazaphosphorinane drugs. New analogues, metabolic studies, and therapeutic approaches].

    PubMed

    Misiura, Konrad

    2004-01-01

    Recent studies on oxazaphosphorinane drugs, with the main focus on those carried out in Poland, are briefly reviewed. Research leading to the introduction of the new antitumor drug (S)-(-)-bromofosfamide are presented. The utility of phosphorus nuclear magnetic resonance in studies of ifosfamide metabolism and an application of analogues of the final, active metabolite of this drug in gene therapy are shown.

  4. Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions.

    PubMed

    Chow, Andrew T; Earp, Justin C; Gupta, Manish; Hanley, William; Hu, Chuanpu; Wang, Diane D; Zajic, Stefan; Zhu, Min

    2014-05-01

    Assessment of pharmacokinetic (PK) based drug-drug interactions (DDI) is essential for ensuring patient safety and drug efficacy. With the substantial increase in therapeutic proteins (TP) entering the market and drug development, evaluation of TP-drug interaction (TPDI) has become increasingly important. Unlike for small molecule (e.g., chemical-based) drugs, conducting TPDI studies often presents logistical challenges, while the population PK (PPK) modeling may be a viable approach dealing with the issues. A working group was formed with members from the pharmaceutical industry and the FDA to assess the utility of PPK-based TPDI assessment including study designs, data analysis methods, and implementation strategy. This paper summarizes key issues for consideration as well as a proposed strategy with focuses on (1) PPK approach for exploratory assessment; (2) PPK approach for confirmatory assessment; (3) importance of data quality; (4) implementation strategy; and (5) potential regulatory implications. Advantages and limitations of the approach are also discussed. © 2013, The American College of Clinical Pharmacology.

  5. Randomized controlled trial of the effect on Quality of Life of second- vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1).

    PubMed

    Jones, Peter B; Barnes, Thomas R E; Davies, Linda; Dunn, Graham; Lloyd, Helen; Hayhurst, Karen P; Murray, Robin M; Markwick, Alison; Lewis, Shôn W

    2006-10-01

    Second-generation (atypical) antipsychotics (SGAs) are more expensive than first-generation (typical) antipsychotics (FGAs) but are perceived to be more effective, with fewer adverse effects, and preferable to patients. Most evidence comes from short-term efficacy trials of symptoms. To test the hypothesis that in people with schizophrenia requiring a change in treatment, SGAs other than clozapine are associated with improved quality of life across 1 year compared with FGAs. A noncommercially funded, pragmatic, multisite, randomized controlled trial of antipsychotic drug classes, with blind assessments at 12, 26, and 56 weeks using intention-to-treat analysis. Fourteen community psychiatric services in the English National Health Service. Two hundred twenty-seven people aged 18 to 65 years with DSM-IV schizophrenia and related disorders assessed for medication review because of inadequate response or adverse effects. Randomized prescription of either FGAs or SGAs (other than clozapine), with the choice of individual drug made by the managing psychiatrist. Quality of Life Scale scores, symptoms, adverse effects, participant satisfaction, and costs of care. The primary hypothesis of significant improvement in Quality of Life Scale scores during the year after commencement of SGAs vs FGAs was excluded. Participants in the FGA arm showed a trend toward greater improvements in Quality of Life Scale and symptom scores. Participants reported no clear preference for either drug group; costs were similar. In people with schizophrenia whose medication is changed for clinical reasons, there is no disadvantage across 1 year in terms of quality of life, symptoms, or associated costs of care in using FGAs rather than nonclozapine SGAs. Neither inadequate power nor patterns of drug discontinuation accounted for the result.

  6. Association between unemployment rates and prescription drug utilization in the United States, 2007–2010

    PubMed Central

    2012-01-01

    Background While extensive evidence suggests that the economic recession has had far reaching effects on many economic sectors, little is known regarding its impact on prescription drug utilization. The purpose of this study is to describe the association between state-level unemployment rates and retail sales of seven therapeutic classes (statins, antidepressants, antipsychotics, angiotensin-converting enzyme [ACE] inhibitors, opiates, phosphodiesterase [PDE] inhibitors and oral contraceptives) in the United States. Methods Using a retrospective mixed ecological design, we examined retail prescription sales using IMS Health Xponent™ from September 2007 through July 2010, and we used the Bureau of Labor Statistics to derive population-based rates and mixed-effects modeling with state-level controls to examine the association between unemployment and utilization. Our main outcome measure was state-level utilization per 100,000 people for each class. Results Monthly unemployment levels and rates of use of each class varied substantially across the states. There were no statistically significant associations between use of ACE inhibitors or SSRIs/SNRIs and average unemployment in analyses across states, while for opioids and PDE inhibitors there were small statistically significant direct associations, and for the remaining classes inverse associations. Analyses using each state as its own control collectively exhibited statistically significant positive associations between increases in unemployment and prescription drug utilization for five of seven areas examined. This relationship was greatest for statins (on average, a 4% increase in utilization per 1% increased unemployment) and PDE inhibitors (3% increase in utilization per 1% increased unemployment), and lower for oral contraceptives and atypical antipsychotics. Conclusion We found no evidence of an association between increasing unemployment and decreasing prescription utilization, suggesting that any

  7. Profile of drug utilization in the elderly living in Porto Alegre, Brazil

    PubMed Central

    Tôrres Faggiani, Fabiana; Schroeter, Guilherme; Luz Pacheco, Sandro; Araújo De Souza, Antônio Carlos; Werlang, Maria Cristina; Attílio De Carli, Geraldo; Bueno Morrone, Fernanda

    The elderly population is one of the most rapidly increasing populations in the world. Physiological alterations induced by the aging process make these individuals more susceptible to chronic diseases and, consequently, to increased drug utilization. Objective To describe the profile of drug utilization in the elderly living in Porto Alegre, RS, Brazil. Methods An observational and cross-sectional population-based study to investigate the characteristics of the population, sources of information and types of drugs used by the elderly was performed. Four hundred and eighty patients were recruited from data supplied by the City Hall of Porto Alegre. The elderly were interviewed individually during the period from January to May 2006 by trained interviewers. A validated pharmacotherapy questionnaire was used for data collection and data were tabulated and analyzed by the SPSS 11.5 computer program. Results Of the 480 patients interviewed, 13.8% did not use any medication. Cardiovascular system drugs represented the pharmacological class most used by the elderly (64.0%). When ill, 71.9% of these individuals visited the doctor, while 36.9% self-medicated. For the majority (50.2%), drugs were identified by their labels. Only 41.2% of the elderly understood medical prescriptions and 68.3% of the patients studied obtained the necessary information for the appropriate use of therapy from their doctors. Conclusions The present study suggests that a pharmaceutical care program for the treatment, prevention, and use of medications may provide a higher efficiency to elderly drug therapy. PMID:25170356

  8. Utility of Ion Mobility Mass Spectrometry for Drug-to-Antibody Ratio Measurements in Antibody-Drug Conjugates

    NASA Astrophysics Data System (ADS)

    Huang, Richard Y.-C.; Deyanova, Ekaterina G.; Passmore, David; Rangan, Vangipuram; Deshpande, Shrikant; Tymiak, Adrienne A.; Chen, Guodong

    2015-06-01

    Antibody-drug conjugates (ADCs) are emerging modalities in the pharmaceutical industry. Characterization of ADC's drug-to-antibody ratio (DAR) becomes a key assessment because of its importance in ADC efficacy and safety. DAR characterization by conventional intact protein MS analysis, however, is challenging because of high heterogeneity of ADC samples. The analysis often requires protein deglycosylation, disulfide-bond reduction, or partial fragmentation. In this study, we illustrate the practical utility of ion mobility mass spectrometry (IM-MS) in a routine LC/MS workflow for DAR measurements. This strategy allows analyte "cleanup" in the gas phase, providing significant improvement of signal-to-noise ratios of ADC intact mass spectra for accurate DAR measurements. In addition, protein drift time analysis offers a new dimension in monitoring the changes of DAR in lot-to-lot analysis.

  9. Utility of Ion Mobility Mass Spectrometry for Drug-to-Antibody Ratio Measurements in Antibody-Drug Conjugates.

    PubMed

    Huang, Richard Y-C; Deyanova, Ekaterina G; Passmore, David; Rangan, Vangipuram; Deshpande, Shrikant; Tymiak, Adrienne A; Chen, Guodong

    2015-10-01

    Antibody-drug conjugates (ADCs) are emerging modalities in the pharmaceutical industry. Characterization of ADC's drug-to-antibody ratio (DAR) becomes a key assessment because of its importance in ADC efficacy and safety. DAR characterization by conventional intact protein MS analysis, however, is challenging because of high heterogeneity of ADC samples. The analysis often requires protein deglycosylation, disulfide-bond reduction, or partial fragmentation. In this study, we illustrate the practical utility of ion mobility mass spectrometry (IM-MS) in a routine LC/MS workflow for DAR measurements. This strategy allows analyte "cleanup" in the gas phase, providing significant improvement of signal-to-noise ratios of ADC intact mass spectra for accurate DAR measurements. In addition, protein drift time analysis offers a new dimension in monitoring the changes of DAR in lot-to-lot analysis.

  10. Utilizing the protein corona around silica nanoparticles for dual drug loading and release.

    PubMed

    Shahabi, Shakiba; Treccani, Laura; Dringen, Ralf; Rezwan, Kurosch

    2015-10-21

    A protein corona forms spontaneously around silica nanoparticles (SNPs) in serum-containing media. To test whether this protein corona can be utilized for the loading and release of anticancer drugs we incorporated the hydrophilic doxorubicin, the hydrophobic meloxicam as well as their combination in the corona around SNPs. The application of corona-covered SNPs to osteosarcoma cells revealed that drug-free particles did not affect the cell viability. In contrast, SNPs carrying a protein corona with doxorubicin or meloxicam lowered the cell proliferation in a concentration-dependent manner. In addition, these particles had an even greater antiproliferative potential than the respective concentrations of free drugs. The best antiproliferative effects were observed for SNPs containing both doxorubicin and meloxicam in their corona. Co-localization studies revealed the presence of doxorubicin fluorescence in the nucleus and lysosomes of cells exposed to doxorubicin-containing coated SNPs, suggesting that endocytotic uptake of the SNPs facilitates the cellular accumulation of the drug. Our data demonstrate that the protein corona, which spontaneously forms around nanoparticles, can be efficiently exploited for loading the particles with multiple drugs for therapeutic purposes. As drugs are efficiently released from such particles they may have a great potential for nanomedical applications.

  11. State Network Utilization Study: Mississippi Educational Television.

    ERIC Educational Resources Information Center

    Wilson, Savan; And Others

    This document is the result of a utilization study of Mississippi Educational Television where 27 target audiences were identified and surveyed. The following information is included: a draft of and updated state network utilization studies; planning and management strategies; a profile of the survey populations; a distance learning survey report;…

  12. [Prescribing and drug utilization at community health centers].

    PubMed

    Diawara, A; Sangho, H; Maiga, D; Kone, A B D; Maiga, M D; Simaga, S Y

    2007-01-01

    The rationalization of the prescription and the good use of the drugs generally constitute a major problem in the health facilities. The present survey led in November 2002 in Mali assessed the practices of prescription and the use of the drugs by the populations. The indicators of drugs use rational have been measured from 600 drawn prescriptions randomly select at the level of 20 community health center (CSCOM) retained at random in the regions of Ségou, Sikasso, Mopti and the District of Bamako. The means of drugs by order (2.8), the percentages of prescription with antibiotic (61.6%) and injectable drugs (35%) are raised in relation to the normative values of WHO (Wold Health Organization). The rate of conformity to the treatments standardized estimated on exploitation of consultations registers in the centers is estimated to 0.5% for the simple diarrhoea, 13.5% for the acute respiratory infections (ARI) without pneumonia and 60.5% for the pneumonia. On 293 patients in the households our survey permitted to estimate to 84.6% the observance of the treatment by the persons having bought the prescribed drugs totality. The percentage of antibiotics prescription and injectable drugs, and the big insufficiency in the non respect of the treatment standard constitutes some practices potentially to high risk justifying the necessity of an urgent training to the rational prescription.

  13. PHOTOLYSIS STUDIES UTILIZING RADIOACTIVE TRACERS.

    DTIC Science & Technology

    PHOTOLYSIS, *TRACER STUDIES), (* TRITIATED COMPOUNDS, PHOTOLYSIS), (*GAS CHROMATOGRAPHY, LABELED SUBSTANCES), ALKENES, KETENES, TRITIUM, ATOMIC ENERGY LEVELS, ALKANES, METHANE , ISOTOPES, ETHYLENES, MOLECULAR ORBITALS

  14. Reservoir-Based Drug Delivery Systems Utilizing Microtechnology

    PubMed Central

    Stevenson, Cynthia L.; Santini, John T.; Langer, Robert

    2012-01-01

    This review covers reservoir-based drug delivery systems that incorporate microtechnology, with an emphasis on oral, dermal, and implantable systems. Key features of each technology are highlighted such as working principles, fabrication methods, dimensional constraints, and performance criteria. Reservoir-based systems include a subset of microfabricated drug delivery systems and provide unique advantages. Reservoirs, whether external to the body or implanted, provide a well-controlled environment for a drug formulation, allowing increased drug stability and prolonged delivery times. Reservoir systems have the flexibility to accommodate various delivery schemes, including zero order, pulsatile, and on demand dosing, as opposed to a standard sustained release profile. Furthermore, the development of reservoir-based systems for targeted delivery for difficult to treat applications (e.g., ocular) has resulted in potential platforms for patient therapy. PMID:22465783

  15. Prescription drug monitoring program utilization in Kentucky community pharmacies.

    PubMed

    Wixson, Sarah E; Blumenschein, Karen; Goodin, Amie J; Talbert, Jeffery; Freeman, Patricia R

    2015-01-01

    Identify characteristics of Kentucky community pharmacists and community pharmacists' practice environment associated with utilization of the Kentucky All Schedule Prescription Electronic Reporting Program (KASPER). Surveys were mailed to all 1,018 Kentucky pharmacists with a KASPER account and an additional 1,000 licensed pharmacists without an account. Bivariate analyses examined the association between KASPER utilization and practice type (independent or chain) and practice location (rural or urban). A multivariate Poisson regression model with robust error variance estimated risk ratios (RR) of KASPER utilization by characteristics of pharmacists' practice environment. Responses were received from 563 pharmacists (response rate 27.9%). Of these, 402 responses from community pharmacists were included in the analyses. A majority of responding pharmacists (84%) indicated they or someone in their pharmacy had requested a patient's controlled substance history since KASPER's inception. Bivariate results showed that pharmacists who practiced in independent pharmacies reported greater KASPER utilization (94%) than pharmacists in chain pharmacies (75%; p<0.001). Multivariate regression results found utilization of KASPER varied significantly among practice environments of community pharmacists with those who practiced in an urban location (RR: 1.11; [1.01-1.21]) or at an independent pharmacy (RR: 1.27; [1.14-1.40]) having an increased likelihood of KASPER utilization. Utilization of KASPER differs by community pharmacists' practice environment, predominantly by practice type and location. Understanding characteristics of community pharmacists and community pharmacists' practice environment associated with PDMP use is necessary to remove barriers to access and increase utilization thereby increasing PDMP effectiveness.

  16. Studies of food drug interactions.

    PubMed

    Aman, Syed Faisal; Hassan, Fouzia; Naqvi, Baqar S; Hasan, Syed Muhammmad Farid

    2010-07-01

    Medicines can treat and alleviate many diseases provided that they must be taken properly to ensure that they are safe and useful. One issue related with the medicines is that whether to take on empty stomach or with food. The present work gives information regarding food-drug interactions that were studied by collecting seventy five prescriptions from various hospitals. In most of the collected prescriptions, food-drug interactions were detected using the literature available. It was also found that only few studies have been carried out so far on the effect of food on drug disposition in the Asian population. Thus more studies on food-drug interactions particularly in the local population is recommended in order to determine the effect of food and food components on drug disposition and to the kinetics of the drugs which has not yet well highlighted in this part of the world.

  17. Antihypertensive drug utilization and conformity to guidelines in a sub-Saharan African hypertensive population.

    PubMed

    Olanrewaju, T O; Aderibigbe, A; Busari, O A; Sanya, E O

    2010-01-01

    Despite availability and usage of wide array of antihypertensive drugs, blood pressure has remained poorly controlled in most health care settings particularly in Africa. The cost of these drugs among other factors strongly determines the prescription and usage pattern which ultimately affects control of blood pressure particularly in sub-Saharan Africa. The aim of this study was to describe the current utilization pattern of antihypertensive drugs in a tertiary hospital in Nigeria in line with the regional and international guidelines for hypertension management and to compare with similar studies in other parts of the country to generate the national outlook. This is a cross sectional study of 805 adult hypertensive patients who were on treatment at the Medical Out-Patient Department of University of Ilorin Teaching Hospital in Nigeria, a country with the most populous black hypertensive patients. Data were collated from the patients' records and evaluated according to drug classifications. 787 patients out of the 805 evaluated were eventually included in the analysis. Mean age was 57.88 + or - 12.59 years with 490 (62.3%) females. Frequency of use of classes of antihypertensive was: diuretics (D, 84%), calcium channel blockers (CCB, 66%), angiotensin converting enzyme inhibitors (ACEI, 65%), a-methyldopa (ALD, 26%), beta-blockers (BB, 11.9%) and angiotensin receptor blockers (3.8%). Proportions of number of drugs usage per patient were: 0 (2.2%), 1 (9.1%), 2 (37.1%), 3 (35.8%), 4 (15.6%), and 5 (0.1%). The most commonly used combinations of drugs were ACEI + CCB + D (21.6%), followed by CCB + D (14.5%), ACE + D (11.4%) and ACEI + D + ALD (9.8%). Other recent studies in Nigeria revealed diuretics and multiple agents as the prevalent prescription pattern. Antihypertensive utilization in Ilorin, Nigeria like some parts of the country conforms to the guidelines for the management of hypertension in blacks with majority of patients on diuretics particularly in

  18. Utilizing Data from Cancer Patient & Survivor Studies

    Cancer.gov

    Utilizing Data from Cancer Patient & Survivor Studies and Understanding the Current State of Knowledge and Developing Future Research Priorities, a 2011 workshop sponsored by the Epidemiology and Genomics Research Program.

  19. North Carolina harvest and utilization study, 2002

    Treesearch

    James W. Bentley; Tony G. Johnson

    2006-01-01

    In 2002, a harvest and utilization study was conducted on 108 operations throughout North Carolina. There were 2,926 total trees measured; 1,693, or 58 percent, were softwood, while 1,233, or 42 percent, were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging...

  20. South Carolina harvest and utilization study, 2011

    Treesearch

    Kerry J.W. Dooley; Jason A. Cooper; James W. Bentley

    2015-01-01

    In 2011, a harvest and utilization study was conducted on 80 operations throughout South Carolina. There were 1,974 total trees measured; 1,317 or 67 percent were softwood, while 657 or 33 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, and 14 percent was left as logging residue....

  1. Georgia harvest and utilization study, 2009

    Treesearch

    James W. Bentley

    2011-01-01

    In 2009, a harvest and utilization study was conducted on 80 operations throughout Georgia. There were 1,981 total trees measured: 1,453 or 73 percent were softwood, while 528 or 27 percent were hardwood. Results from this study showed that 88 percent of the total softwood volume measured was utilized for a product, and 12 percent was left as logging residue. Seventy-...

  2. South Carolina harvest and utilization study, 2006

    Treesearch

    James W. Bentley; Tony G. Johnson

    2008-01-01

    In 2006, a harvest and utilization study was conducted on 99 operations throughout South Carolina. There were 2,904 total trees measured; 1,763 or 61 percent were softwood, while 1,141 or 39 percent were hardwood. Results from this study showed that 87 percent of the total softwood volume measured was utilized for a product, and 13 percent was left as logging residue....

  3. Kentucky harvest and utilization study, 2007

    Treesearch

    Jason A. Cooper; James W. Bentley

    2013-01-01

    In 2007, a harvest and utilization study was conducted on 53 operations in Kentucky. There were 1,310 total trees measured: 263 or 20 percent were softwood, while 1,047 or 80 percent were hardwood. Results from this study showed that 82 percent of the total softwood volume measured was utilized for a product, and 18 percent was left as logging residue. Seventy-two...

  4. North Carolina harvest and utilization study, 2007

    Treesearch

    James W. Bentley; Tony G. Johnson

    2010-01-01

    In 2007, a harvest and utilization study was conducted on 83 operations throughout North Carolina. There were 2,119 total trees measured: 1,323 or 62 percent were softwood, while 796 or 38 percent were hardwood. Results from this study showed that 85 percent of the total softwood volume measured was utilized for a product, and 15 percent was left as logging residue....

  5. Alabama harvest and utilization study, 2008

    Treesearch

    James W. Bentley; Tony G. Johnson

    2008-01-01

    In 2008, a harvest and utilization study was conducted on 80 operations throughout Alabama. There were 2,100 total trees measured; 1,433 or 68 percent were softwood, while 667 or 32 percent were hardwood. Results from this study showed that 88 percent of the total softwood volume measured was utilized for a product, and 12 percent was left as logging residue. Seventy-...

  6. Georgia harvest and utilization study, 2004

    Treesearch

    James W. Bentley; Richard a. Harper

    2006-01-01

    In 2004, a harvest and utilization study was conducted on 96 operations throughout Georgia. There were 2,368 total trees measured, 1,581 or 67 percent were softwood, while 787 or 33 percent were hardwood. Results from this study showed that 86 percent of the total softwood volume measured was utilized for a product, while the other 14 percent was left as logging...

  7. Eastern Texas harvest and utilization study, 2003

    Treesearch

    James W. Bentley; Tony G. Johnson

    2004-01-01

    In 2003, a harvest and utilization study was conducted on 81 operations throughout eastern Texas. There were 2,072 total trees measured, 1,557 or 75 percent were softwood, while 515 or 25 percent were hardwood. Results from this study showed that 87 percent of the total softwood volume measured was utilized for a product, while the other 13 percent was left as logging...

  8. Contingency management: utility in the treatment of drug abuse disorders.

    PubMed

    Stitzer, M L; Vandrey, R

    2008-04-01

    Contingency management (CM) is a strategy that uses positive reinforcement to improve the clinical outcomes of substance abusers in treatment, especially sustained abstinence from drugs of abuse. Further, CM has been adopted to improve methodology and interpretation of outcomes in clinical trials testing new pharmacotherapies and to improve adherence to efficacious medications in substance abuse patients. Thus, CM has proven to be widely useful as a direct therapeutic intervention and as a tool in treatment development.

  9. Prescription Drugs: HCFA’s Proposed Drug Utilization Review System Ignores Quality of Care Issues

    DTIC Science & Technology

    1989-07-13

    Parkinsonism , 32,000 with hip fractures attributable to dOfg-induced falls, 163,000 with drug-induced memory loss or impaired thinking, and 243,000...year there are approximately 61,000 older adults with drug-induced Parkinsonism , 32,000 with hip fractures attributable to drug-induced falls, 163,000...particu- larly phenytoin and warfarin). A drug in one category may interact with a drug in another category to raise the concentration of the drugs in the

  10. From bench to bedside: utilization of an in vitro model to predict potential drug-drug interactions in the kidney: the digoxin-mifepristone example.

    PubMed

    Woodland, Cindy; Koren, Gideon; Ito, Shinya

    2003-07-01

    Drug interactions are a common source of drug-induced toxicity. For drugs with narrow therapeutic windows, such as digoxin, an understanding of the potential mechanisms by which drugs might interact is essential to clinical practice. This article describes the utility of a renal tubular cell culture model in the prediction of drug interactions involving P-glycoprotein. Digoxin is a cardiac glycoside that undergoes active secretion in the renal tubules by the MDR1 (P-glycoprotein) drug efflux pump. Mifepristone (RU486) is a recently introduced abortifacient that is largely unstudied in terms of drug-drug interactions. The authors used an in vitro model to study the effects of mifepristone on the renal tubular secretion and cellular uptake of digoxin by Madin-Darby canine kidney (MDCK) cells. Mifepristone significantly inhibited the renal tubular secretion of digoxin (p = 0.0005), without interfering with its ability to enter the renal tubular cell. Similar results were found with the P-glycoprotein substrate vinblastine. The findings suggest that drug interactions may result if mifepristone is administered with P-glycoprotein substrates, highlighting the usefulness of this model in the study of not only common but also rare combinations of drugs.

  11. Determinants of U.S. Prescription Drug Utilization using County Level Data.

    PubMed

    Nianogo, Thierry; Okunade, Albert; Fofana, Demba; Chen, Weiwei

    2016-05-01

    Prescription drugs are the third largest component of U.S. healthcare expenditures. The 2006 Medicare Part D and the 2010 Affordable Care Act are catalysts for further growths in utilization becuase of insurance expansion effects. This research investigating the determinants of prescription drug utilization is timely, methodologically novel, and policy relevant. Differences in population health status, access to care, socioeconomics, demographics, and variations in per capita number of scripts filled at retail pharmacies across the U.S.A. justify fitting separate econometric models to county data of the states partitioned into low, medium, and high prescription drug users. Given the skewed distribution of per capita number of filled prescriptions (response variable), we fit the variance stabilizing Box-Cox power transformation regression models to 2011 county level data for investigating the correlates of prescription drug utilization separately for low, medium, and high utilization states. Maximum likelihood regression parameter estimates, including the optimal Box-Cox λ power transformations, differ across high (λ = 0.214), medium (λ = 0.942), and low (λ = 0.302) prescription drug utilization models. The estimated income elasticities of -0.634, 0.031, and -0.532 in high, medium, and low utilization models suggest that the economic behavior of prescriptions is not invariant across different utilization levels. Copyright © 2015 John Wiley & Sons, Ltd.

  12. Changes in drug utilization and out-of-pocket costs associated with Medicare Part D implementation: a systematic review

    PubMed Central

    Polinski, Jennifer M.; Kilabuk, Elaine; Schneeweiss, Sebastian; Brennan, Troyen; Shrank, William H.

    2010-01-01

    Medicare Part D was implemented 4 years ago. Despite the fact that public-use Part D data were unavailable until late 2008, researchers have used alternate data to examine Part D's impact on drug utilization and out-of-pocket costs. In a systematic review of Medline from 2006 – October 2009, we sought to summarize the literature about drug use and costs after implementation and during the transition period and coverage gap. We included studies presenting original results regarding drug utilization and costs following Part D implementation. Case reports and series and simulation studies were excluded. Of 552 originally identified articles, 26 met selection criteria: 13 regarding Part D's overall impact in the year(s) following implementation, 7 describing the Part D transition period, and 6 concerning the coverage gap. Part D implementation was associated with a 6-13% increase in drug utilization and a 13-18% decrease in patients' costs. The transition period was associated with no significant changes in utilization or costs for elderly dual-eligible beneficiaries, but effects in other populations were mixed. Entry into the coverage gap was associated with a 9-16% decrease in drug utilization and increases in costs of up to 89%. In summary, studies examining disparate data associated Part D's implementation found consistent positive effects on drug utilization and costs but revealed unfavorable trends in the coverage gap. The effect of the Part D transition period remains unclear. While public-use data will validate these results, policymakers can use the existing evidence to inform changes and enhancements to Part D immediately. PMID:20863336

  13. Impact of cost sharing on specialty drug utilization and outcomes: a review of the evidence and future directions.

    PubMed

    Doshi, Jalpa A; Li, Pengxiang; Ladage, Vrushabh P; Pettit, Amy R; Taylor, Erin A

    2016-03-01

    Specialty drugs often represent major medical advances for patients with few other effective options available, but high costs have attracted the attention of both payers and policy makers. We reviewed the evidence regarding the impact of cost sharing on utilization of specialty drugs indicated for rheumatoid arthritis (RA), multiple sclerosis (MS), and cancer, and on the use of nondrug medical services, health outcomes, and spending. Systematic review of Medline-indexed studies identified via an OVID search for articles published in English from 1995 to 2014, using combinations of terms for cost sharing and specialty drugs, and/or our 3 conditions of interest. We identified additional studies from reference lists. We identified 19 articles focusing on specialty drugs indicated for MS (n = 9), cancer (n = 8), and RA (n = 8). Studies examined prescription abandonment (n = 3), initiation or any utilization (n = 8), adherence (n = 9), persistence/discontinuation (n = 7), number of claims (n = 1), and drug spending (n = 1). Findings varied by disease, but generally indicated stronger effects for noninitiation or abandonment of a prescription at the pharmacy and somewhat smaller effects for refill behavior and drug spending once patients initiated therapy. Studies have not examined specialty tier cost sharing seen under Medicare Part D or health insurance exchanges, nor effects on medical utilization, spending, or health outcomes. Evidence to date generally indicates reductions in specialty drug utilization associated with higher cost sharing; effects have varied by type of disease and specialty drug use outcome. We draw upon our findings and the gaps in evidence to summarize future directions for research and policy.

  14. Health care utilization among young adult injection drug users in Harlem, New York.

    PubMed

    Cronquist, A; Edwards, V; Galea, S; Latka, M; Vlahov, D

    2001-01-01

    This cross-sectional study investigated the predictors for and patterns of health care utilization among young adult injection drug users (IDUs). The subjects were 206 IDUs, ages 18-29, who were street-recruited from Harlem, New York. Participants were interviewed about their drug use, health conditions, and use of services such as health care, needle exchange programs (NEPs), and drug treatment in the preceding 6 months. Data were analyzed using logistic regression. Health insurance was associated with use of health care both among NEP users [AOR (adjusted odds ratio) 10.66] and non-NEP users (AOR 2.45). Use of health care was independently associated with drug treatment (AOR 2.58), being gay/bisexual (AOR 3.86), and negatively associated with injecting cocaine (AOR 0.56). Half the participants (49%) had used health care in the previous 6 months; 48% were uninsured. Many participants who did not use health services reported a condition that would have warranted medical care. Health insurance was strongly associated with use of health care, particularly among those who attend NEPs. Young adult IDUs may benefit from increased efforts to help them arrange and maintain health insurance coverage, potentially at NEPs. NEPs may be connecting young IDUs with health insurance to medical care through referrals.

  15. Recent Advances in Ligand-Based Drug Design: Relevance and Utility of the Conformationally Sampled Pharmacophore Approach

    PubMed Central

    Acharya, Chayan; Coop, Andrew; Polli, James E.; MacKerell, Alexander D.

    2010-01-01

    In the absence of three-dimensional (3D) structures of potential drug targets, ligand-based drug design is one of the popular approaches for drug discovery and lead optimization. 3D structure-activity relationships (3D QSAR) and pharmacophore modeling are the most important and widely used tools in ligand-based drug design that can provide crucial insights into the nature of the interactions between drug target and ligand molecule and provide predictive models suitable for lead compound optimization. This review article will briefly discuss the features and potential application of recent advances in ligand-based drug design, with emphasis on a detailed description of a novel 3D QSAR method based on the conformationally sample pharmacophore (CSP) approach (denoted CSP-SAR). In addition, data from a published study is used to compare the CSP-SAR approach to the Catalyst method, emphasizing the utility of the CSP approach for ligand-based model development. PMID:20807187

  16. Utility of coloured hair for the detection of drugs and alcohol.

    PubMed

    Agius, Ronald

    2014-06-01

    The aim of this paper is to assess the utility of coloured hair for the detection of drugs and alcohol in a large statistically significant population. The positivity rate, the 1st, 5th, 50th, 95th, and 99th percentiles of five amphetamines, cannabinoids, cocaine, four opiates, methadone, buprenorphine, seven benzodiazepines, and ethyl glucuronide (EtG) in 9488 non-treated and 1026 cosmetically treated (dyed or bleached) authentic hair samples was compared. Analytical methods used were accredited for forensic purposes at the cut-offs defined by the German driving licence re-granting medical and psychological assessment (MPA) guidelines. Considering only the drug classes for which at least 10 positive samples were detected, the positivity rate in non-treated hair was highest for alcohol (4.50%; measured using EtG at concentrations ≥ 7 pg/mg hair), followed by THC (2.00%), cocaine (1.75%), and amphetamine (0.59%). While the 1st to 99th percentile range was significantly lower for drugs in treated, compared to non-treated hair, no significant change was observed for EtG. Additionally, no significant difference in the positivity rate was observed between treated hair and non-treated hair for both drugs and EtG. This study is the first attempt to evaluate the influence of cosmetic treatment, mainly dying, on the positivity rate for both drugs and EtG in hair samples submitted routinely for abstinence testing and the first to indicate that dyed and eventually bleached hair is not necessarily useless in detecting drugs and/or alcohol consumption, thus making coloured hair analysis still useful, often being the only possibility to prove such misuse.

  17. Impact of reference-based pricing for angiotensin-converting enzyme inhibitors on drug utilization.

    PubMed

    Schneeweiss, Sebastian; Soumerai, Stephen B; Glynn, Robert J; Maclure, Malcolm; Dormuth, Colin; Walker, Alexander M

    2002-03-19

    Increasing copayments for higher-priced prescription medications has been suggested as a means to help finance drug coverage for elderly patients, but evaluations of the impact of such policies are rare. The objective of this study was to analyze the effect of reference-based pricing of angiotensin-converting enzyme (ACE) inhibitors on drug utilization, cost savings and potential substitution with other medication classes. We analyzed 36 months of claims data from British Columbia for 2 years before and 1 year after implementation of reference-based pricing (in January 1997). The 119,074 patients were community-living Pharmacare beneficiaries 65 years of age or older who used ACE inhibitors during the study period. The main outcomes were changes over time in use of ACE inhibitors, use of antihypertensive drugs and expenditures for antihypertensive drugs, as well as predictors of medication switching related to reference-based pricing. We observed a sharp decline (29%) in the use of higher-priced cost-shared ACE inhibitors immediately after implementation of the policy (p < 0.001). After a transition period, the post-implementation utilization rate for all ACE inhibitors was 11% lower than projected from pre-implementation data. However, overall utilization of antihypertensives was unchanged (p = 0.40). The policy saved $6.7 million in pharmaceutical expenditures during its first 12 months. Patients with heart failure or diabetes mellitus who were taking a cost-shared ACE inhibitor were more likely to remain on the same medication after implementation of reference-based pricing (OR 1.12 [95% confidence interval, CI, 1.06-1.19] and 1.28 [95% CI 1.20-1.36] respectively). Patients with low-income status were more likely than those with high-income status to stop all antihypertensive therapy (OR 1.65 [95% CI 1.43-1.89]), which reflects a general trend toward discontinuation of therapy among these patients even before implementation of reference-based pricing. Reference

  18. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  19. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Drug utilization management, quality assurance, and... management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each... utilization management program, quality assurance measures and systems, and an MTMP as described in...

  20. An educational intervention on drug use in nursing homes improves health outcomes resource utilization and reduces inappropriate drug prescription.

    PubMed

    García-Gollarte, Fermín; Baleriola-Júlvez, José; Ferrero-López, Isabel; Cuenllas-Díaz, Álvaro; Cruz-Jentoft, Alfonso J

    2014-12-01

    Inappropriate drug prescription is a common problem in people living in nursing homes and is linked to adverse health outcomes. This study assessed the effect of an educational intervention directed to nursing home physicians in reducing inappropriate prescription and improving health outcomes and resource utilization. Prospective, randomized, multicenter study. A private organization of nursing homes in Spain. Sixty nursing home physicians caring for approximately 3900 nursing home residents in 37 centers were randomized to receive an educational intervention (30) or as a control group (30). 10 hours educational program, followed by on demand support by phone. Outcomes were assessed in 1018 randomly selected nursing home residents. Appropriateness of drug use [measured by the Screening Tool of Older Persons Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) criteria], incidence of selected geriatric syndromes (falls, delirium) and health resource utilization (visits to physicians and nursing homes, visits to the emergency room, days of hospitalization) were recorded for 3 months before the intervention started and 3 months after the intervention finished. O total of 716 residents finished the study (344 cared for by the intervention group physicians, 372 cared for by control physicians). Mean age was 84.4 ± 12.7 years; 73% were women. The mean number of inappropriate drugs (STOPP criteria) was higher at the end of the study in the control than in the intervention group (1.29 ± 1.56 vs 0.81 ± 1.13), as was the number of residents on 6 or more drugs (76.5% vs.67.0%), using antipsychotics (9.1% vs 3.2%) or duplicate medications (32.5% vs 9.2%). The number of fallers increased in the control group (from 19.3% to 28%) and did not significantly change in the intervention group (from 25.3% to 23.9%); the number of residents with delirium increased in the control group (from 3.8% to 9.1%) and decreased in the intervention group (from 6

  1. West Virginia harvest and utilization study, 2008

    Treesearch

    Jan Wiedenbeck; Shawn. Grushecky

    2014-01-01

    Thirty active harvesting operations were part of a harvest and utilization study conducted in West Virginia in 2008. Data were collected on roundwood product and residue yields obtained from trees of different sizes, species, and qualities. This study was modeled after studies conducted on a regular and frequent basis by the Forest Inventory and Analysis unit in the...

  2. The utilization of Arabic online drug information among adults in Saudi Arabia.

    PubMed

    Abanmy, Norah O; Al-Quait, Nouf A; Alami, Amani H; Al-Juhani, Meshaal H; Al-Aqeel, Sinaa

    2012-10-01

    In Saudi Arabia, the utilization of the world wide web has become increasingly popular. However, the exact figure of such use is unknown. This study aimed to determine the percentage of, and experience with, online Arabic drug information by Arabic-speaking adults in Saudi Arabia. A web based questionnaire was used. The questionnaire language was Arabic. Public were invited to participate in the survey through e-mails, Twitter, WhatsApp and Facebook in March 2012. The survey included 17 items examining the types of accessed Arabic drug information, the respondent's demographics, their ability to easily find and understand Arabic drug-related information, and their trustfulness and dependency on such information websites. Of the 422 Arabic speaking adults who answered the questionnaire, 88% stated that they used Arabic websites to answer drug-related questions. Of the respondents, 50% had a bachelor's degree, 44% were young adults, over half were female (60%), and 72% of them have a chronic disease. The ease of retrieving online information was the most common reason (69%) for consulting such websites. Google as a search engine was the most frequently (86%) accessible website. Although respondents reported different drug-related topics in their online searching, the search for adverse effects was the most common (68%). Respondents claimed that they could easily find (65%) and understand (49%) the drug-related information. Although a good number of respondents qualified this type of information as good, double-checking of information on other websites was highly recommended. Trustfulness was one of the important parameters to measure and 205 respondents (55%) claimed that they only trusted half of the information cited. Moreover, around 48% of respondents considered that finding the same information on more than one website increased its trustfulness. Surprisingly, 54% of respondents did not depend on Arabic information websites when making decisions on drug use

  3. The utilization of Arabic online drug information among adults in Saudi Arabia

    PubMed Central

    Abanmy, Norah O.; Al-quait, Nouf A.; Alami, Amani H.; Al-Juhani, Meshaal H.; Al-Aqeel, Sinaa

    2012-01-01

    In Saudi Arabia, the utilization of the world wide web has become increasingly popular. However, the exact figure of such use is unknown. This study aimed to determine the percentage of, and experience with, online Arabic drug information by Arabic-speaking adults in Saudi Arabia. A web based questionnaire was used. The questionnaire language was Arabic. Public were invited to participate in the survey through e-mails, Twitter, WhatsApp and Facebook in March 2012. The survey included 17 items examining the types of accessed Arabic drug information, the respondent’s demographics, their ability to easily find and understand Arabic drug-related information, and their trustfulness and dependency on such information websites. Of the 422 Arabic speaking adults who answered the questionnaire, 88% stated that they used Arabic websites to answer drug-related questions. Of the respondents, 50% had a bachelor’s degree, 44% were young adults, over half were female (60%), and 72% of them have a chronic disease. The ease of retrieving online information was the most common reason (69%) for consulting such websites. Google as a search engine was the most frequently (86%) accessible website. Although respondents reported different drug-related topics in their online searching, the search for adverse effects was the most common (68%). Respondents claimed that they could easily find (65%) and understand (49%) the drug-related information. Although a good number of respondents qualified this type of information as good, double-checking of information on other websites was highly recommended. Trustfulness was one of the important parameters to measure and 205 respondents (55%) claimed that they only trusted half of the information cited. Moreover, around 48% of respondents considered that finding the same information on more than one website increased its trustfulness. Surprisingly, 54% of respondents did not depend on Arabic information websites when making decisions on drug use

  4. Utilizing diversity-oriented synthesis in antimicrobial drug discovery.

    PubMed

    Comer, Eamon; Duvall, Jeremy R; duPont Lee, Maurice

    2014-01-01

    The development of resistance to existing antimicrobials has created a threat to human health that is not being addressed through our current drug pipeline. Limitations with the use of commercial vendor libraries and natural products have created a need for new types of small molecules to be screened in antimicrobial assays. Diversity oriented synthesis (DOS) is a strategy for the efficient generation of compound collections with a high degree of structural diversity. Diversity-oriented synthesis molecules occupy the middle ground of both complexity and efficiency of synthesis between natural products and commercial libraries. In this review we focus upon the use of diversity-oriented synthesis compound collections for the discovery of new antimicrobial agents.

  5. Florida harvest and utilization study, 2008

    Treesearch

    James W. Bentley; Tony G. Johnson

    2009-01-01

    In 2008, a harvest and utilization study was conducted on 82 operationsthroughout Florida. There were 2,114 total trees measured: 1,670 or79 percent were softwood, while 444 or 21 percent were hardwood. Resultsfrom this study showed that 85 percent of the total softwood volumemeasured was...

  6. Virginia harvest and utilization study, 2007

    Treesearch

    James W. Bentley; Tony G. Johnson

    2009-01-01

    In 2007, a harvest and utilization study was conducted on 81 operationsthroughout Virginia. There were 2,016 total trees measured; 1,086 or54 percent were softwood, while 930 or 46 percent were hardwood. Resultsfrom this study showed that 86 percent of the total softwood volumemeasured was...

  7. Drug utilization in a hospital general medical outpatient clinic with particular reference to antihypertensive and antidiabetic drugs.

    PubMed

    Yuen, Y H; Chang, S; Chong, C K; Lee, S C; Critchley, J A; Chan, J C

    1998-08-01

    To examine the prescribing patterns, particularly antihypertensive and antidiabetic drugs, in a hospital outpatient clinic and to evaluate the expenditure incurred. Prescriptions from a general medical outpatient clinic in a teaching hospital were collected for 4 weeks. Drug expenditures were calculated. A total of 622 prescriptions containing 1903 items were collected. Antihypertensive and antidiabetic drugs accounted for 25.9 and 9.1% usage, respectively. Calcium channel blocking agents, angiotensin converting enzyme inhibitors and beta-blocking agents were the most popular antihypertensive drugs used. Sulphonylureas were the most frequently prescribed antidiabetic agents. Amlodipine, doxazosin and sotalol accounted for 4.5% of all prescription items but 27.8% of the total drug expenditure. The use of antihypertensive and antidiabetic drugs accounted for most of the drug usage in this study. Use of newer and more expensive agents has further increased drug expenditure. Monitoring drug usage and their correlations with clinical outcomes are warranted.

  8. Liquefaction chemistry and kinetics: Hydrogen utilization studies

    SciTech Connect

    Rothenberger, K.S.; Warzinski, R.P.; Cugini, A.V.

    1995-12-31

    The objectives of this project are to investigate the chemistry and kinetics that occur in the initial stages of coal liquefaction and to determine the effects of hydrogen pressure, catalyst activity, and solvent type on the quantity and quality of the products produced. The project comprises three tasks: (1) preconversion chemistry and kinetics, (2) hydrogen utilization studies, and (3) assessment of kinetic models for liquefaction. The hydrogen utilization studies work will be the main topic of this report. However, the other tasks are briefly described.

  9. Mental Health Service and Drug Treatment Utilization: Adolescents with Substance Use/Mental Disorders and Dual Diagnosis

    ERIC Educational Resources Information Center

    Cheng, Tyrone C.; Lo, Celia C.

    2010-01-01

    This research is a secondary data analysis of the impact of adolescents' mental/substance-use disorders and dual diagnosis on their utilization of drug treatment and mental health services. By analyzing the same teenagers who participated in the NIMH Methods for the Epidemiology of Child and Adolescent Mental Disorders (MECA) study, logistic…

  10. Mental Health Service and Drug Treatment Utilization: Adolescents with Substance Use/Mental Disorders and Dual Diagnosis

    ERIC Educational Resources Information Center

    Cheng, Tyrone C.; Lo, Celia C.

    2010-01-01

    This research is a secondary data analysis of the impact of adolescents' mental/substance-use disorders and dual diagnosis on their utilization of drug treatment and mental health services. By analyzing the same teenagers who participated in the NIMH Methods for the Epidemiology of Child and Adolescent Mental Disorders (MECA) study, logistic…

  11. Substance abuse treatment utilization among adults living with HIV/AIDS and alcohol or drug problems.

    PubMed

    Orwat, John; Saitz, Richard; Tompkins, Christopher P; Cheng, Debbie M; Dentato, Michael P; Samet, Jeffrey H

    2011-10-01

    This is a prospective cohort study to identify factors associated with receipt of substance abuse treatment (SAT) among adults with alcohol problems and HIV/AIDS. Data from the HIV Longitudinal Interrelationships of Viruses and Ethanol study were analyzed. Generalized estimating equation logistic regression models were fit to identify factors associated with any service utilization. An alcohol dependence diagnosis had a negative association with SAT (adjusted odds ratio [AOR] = 0.36, 95% confidence interval [95% CI] = 0.19-0.67), as did identifying sexual orientation other than heterosexual (AOR = 0.46, CI = 0.29-0.72) and having social supports that use alcohol/drugs (AOR = 0.62, CI = 0.45-0.83). Positive associations with SAT include presence of hepatitis C antibody (AOR = 3.37, CI = 2.24-5.06), physical or sexual abuse (AOR = 2.12, CI = 1.22-3.69), social supports that help with sobriety (AOR = 1.92, CI = 1.28-2.87), homelessness (AOR = 2.40, CI = 1.60-3.62), drug dependence diagnosis (AOR = 2.64, CI = 1.88-3.70), and clinically important depressive symptoms (AOR = 1.52, CI = 1.08-2.15). While reassuring that factors indicating need for SAT among people with HIV and alcohol problems (e.g., drug dependence) are associated with receipt, nonneed factors (e.g., sexual orientation, age) that should not decrease likelihood of receipt of treatment were identified.

  12. Quantification of cell viability and rapid screening anti-cancer drug utilizing nanomechanical fluctuation.

    PubMed

    Wu, Shangquan; Liu, Xiaoli; Zhou, Xiarong; Liang, Xin M; Gao, Dayong; Liu, Hong; Zhao, Gang; Zhang, Qingchuan; Wu, Xiaoping

    2016-03-15

    Cancer is a serious threat to human health. Although numerous anti-cancer drugs are available clinically, many have shown toxic side effects due to poor tumor-selectivity, and reduced effectiveness due to cancers rapid development of resistance to treatment. The development of new highly efficient and practical methods to quantify cell viability and its change under drug treatment is thus of significant importance in both understanding of anti-cancer mechanism and anti-cancer drug screening. Here, we present an approach of utilizing a nanomechanical fluctuation based highly sensitive microcantilever sensor, which is capable of characterizing the viability of cells and quantitatively screening (within tens of minutes) their responses to a drug with the obvious advantages of a rapid, label-free, quantitative, noninvasive, real-time and in-situ assay. The microcantilever sensor operated in fluctuation mode was used in evaluating the paclitaxel effectiveness on breast cancer cell line MCF-7. This study demonstrated that the nanomechanical fluctuations of the microcantilever sensor are sensitive enough to detect the dynamic variation in cellular force which is provided by the cytoskeleton, using cell metabolism as its energy source, and the dynamic instability of microtubules plays an important role in the generation of the force. We propose that cell viability consists of two parts: biological viability and mechanical viability. Our experimental results suggest that paclitaxel has little effect on biological viability, but has a significant effect on mechanical viability. This new method provides a new concept and strategy for the evaluation of cell viability and the screening of anti-cancer drugs.

  13. Stadium Site Utilization Study. University of Cincinnati.

    ERIC Educational Resources Information Center

    Caudill, Rowlett, and Scott, New York, NY.

    An evaluative study of the University of Cincinnati stadium site shows its potential with relation to the existing campus. Conclusions and recommendations concerning its future utilization are presented, based upon consideration of the following--(1) basic university planning policies, (2) assets and liabilities of the site, (3) the decision to…

  14. Pediatric asthma mortality and hospitalization trends across Asia pacific: relationship with asthma drug utilization patterns.

    PubMed

    Chua, Kun Lin; Soh, Shu E; Ma, Stefan; Lee, Bee Wah

    2009-05-01

    : The wide variability in prevalence of childhood asthma across Asia Pacific is well documented, but less is known about its trends in mortality and hospitalization. : To examine pediatric asthma mortality and hospitalization trends of selected countries across Asia Pacific, and also patterns of asthma drug utilization. : Mortality and population data were sourced from the World Health Organization's mortality database. Data on hospitalization were obtained by direct inquiry and from government and scientific publications. Drug use for asthma was expressed as a controller-to-reliever (C:R) ratio (ie, units of inhaled corticosteroids/units of short-acting β-agonists, sold in each country). Time-series regression analyses were used to examine temporal patterns and study association between deaths, hospitalizations, and drug use. : Japan showed a decreasing trend in pediatric asthma mortality whereas an increase was observed in Thailand. Hospitalizations decreased in Australia and Singapore but increased in Taiwan, Republic of China. C:R ratios increased significantly across the countries. : Mixed trends in pediatric asthma mortality and hospitalization rates were observed, which coincided with a uniform increase in C:R ratios. This may reflect importance of other aspects of asthma management besides pharmacotherapy.

  15. Pediatric Asthma Mortality and Hospitalization Trends Across Asia Pacific Relationship With Asthma Drug Utilization Patterns

    PubMed Central

    2009-01-01

    Background The wide variability in prevalence of childhood asthma across Asia Pacific is well documented, but less is known about its trends in mortality and hospitalization. Objectives To examine pediatric asthma mortality and hospitalization trends of selected countries across Asia Pacific, and also patterns of asthma drug utilization. Materials and Methods Mortality and population data were sourced from the World Health Organization's mortality database. Data on hospitalization were obtained by direct inquiry and from government and scientific publications. Drug use for asthma was expressed as a controller-to-reliever (C:R) ratio (ie, units of inhaled corticosteroids/units of short-acting β-agonists, sold in each country). Time-series regression analyses were used to examine temporal patterns and study association between deaths, hospitalizations, and drug use. Results Japan showed a decreasing trend in pediatric asthma mortality whereas an increase was observed in Thailand. Hospitalizations decreased in Australia and Singapore but increased in Taiwan, Republic of China. C:R ratios increased significantly across the countries. Conclusions Mixed trends in pediatric asthma mortality and hospitalization rates were observed, which coincided with a uniform increase in C:R ratios. This may reflect importance of other aspects of asthma management besides pharmacotherapy. PMID:23283014

  16. Posaconazole exposure-response relationship: evaluating the utility of therapeutic drug monitoring.

    PubMed

    Dolton, Michael J; Ray, John E; Marriott, Deborah; McLachlan, Andrew J

    2012-06-01

    Posaconazole has become an important part of the antifungal armamentarium in the prophylaxis and salvage treatment of invasive fungal infections (IFIs). Structurally related to itraconazole, posaconazole displays low oral bioavailability due to poor solubility, with significant drug interactions and gastrointestinal disease also contributing to the generally low posaconazole plasma concentrations observed in patients. While therapeutic drug monitoring (TDM) of plasma concentrations is widely accepted for other triazole antifungal agents such as voriconazole, the utility of TDM for posaconazole is controversial due to debate over the relationship between posaconazole exposure in plasma and clinical response to therapy. This review examines the available evidence for a relationship between plasma concentration and clinical efficacy for posaconazole, as well as evaluating the utility of TDM and providing provisional target concentrations for posaconazole therapy. Increasing evidence supports an exposure-response relationship for plasma posaconazole concentrations for prophylaxis and treatment of IFIs; a clear relationship has not been identified between posaconazole concentration and toxicity. Intracellular and intrapulmonary concentrations have been studied for posaconazole but have not been correlated to clinical outcomes. In view of the high mortality and cost associated with the treatment of IFIs, increasing evidence of an exposure-response relationship for posaconazole efficacy in the prevention and treatment of IFIs, and the common finding of low posaconazole concentrations in patients, TDM for posaconazole is likely to be of significant clinical utility. In patients with subtherapeutic posaconazole concentrations, increased dose frequency, administration with high-fat meals, and withdrawal of interacting medications from therapy are useful strategies to improve systemic absorption.

  17. Methods for comparing drug policies--the utility of composite drug harm indexes.

    PubMed

    Ritter, Alison

    2009-11-01

    One of the challenges for drug policy research is being able to compare policy options and outcomes. The development of indexes, such as the UK Drug Harm Index or the UNODC Illicit Drug Index is a way to systematically enable such comparisons. An Index is a single common metric that represents the diverse outcomes or consequences of drug use. An Index may be used for performance monitoring within one country/region over time; to establish societal benefit of drug policies as expressed in social costs saved; to compare countries or regions; or for comparative policy analysis. Clarity of purpose is important in how an Index is used. The consequences or outcomes that can be combined into a single Index include health consequences, crime consequences, public amenity, pain and suffering, labour market outcomes, and drug manufacture and trafficking activity. The choice of outcomes for inclusion is driven by the purpose but also often by practical considerations, such as data availability. The weighting of the consequences is an important consideration in translating the outcomes into a common metric. A monetary unit has a number of advantages: it is a unit that can be measured across diverse impacts; it gives implicit "weighting" of harms; and it is intuitive for policy makers and community. On the other hand, it represents an economic perspective. No one Index will be regarded as suitable and appropriate by every stakeholder and ongoing research effort on Indexes is an important foundational research activity to advance illicit drug policy.

  18. Experimental study and evaluation of radioprotective drugs

    NASA Technical Reports Server (NTRS)

    Smith, D. E.; Thomson, J. F.

    1968-01-01

    Experimental study evaluates radioprotective drugs administered before exposure either orally or intravenously. Specifically studied are the sources of radiation, choice of radiation dose, choice of animals, administration of drugs, the toxicity of protective agents and types of protective drug.

  19. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

    SciTech Connect

    Radford, L.R.; Rankin, W.L.; Barnes, V.; McGuire, M.V.; Hope, A.M.

    1983-07-01

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclear utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.

  20. Chemical and genetic validation of thiamine utilization as an antimalarial drug target.

    PubMed

    Chan, Xie Wah Audrey; Wrenger, Carsten; Stahl, Katharina; Bergmann, Bärbel; Winterberg, Markus; Müller, Ingrid B; Saliba, Kevin J

    2013-01-01

    Thiamine is metabolized into an essential cofactor for several enzymes. Here we show that oxythiamine, a thiamine analog, inhibits proliferation of the malaria parasite Plasmodium falciparum in vitro via a thiamine-related pathway and significantly reduces parasite growth in a mouse malaria model. Overexpression of thiamine pyrophosphokinase (the enzyme that converts thiamine into its active form, thiamine pyrophosphate) hypersensitizes parasites to oxythiamine by up to 1,700-fold, consistent with oxythiamine being a substrate for thiamine pyrophosphokinase and its conversion into an antimetabolite. We show that parasites overexpressing the thiamine pyrophosphate-dependent enzymes oxoglutarate dehydrogenase and pyruvate dehydrogenase are up to 15-fold more resistant to oxythiamine, consistent with the antimetabolite inactivating thiamine pyrophosphate-dependent enzymes. Our studies therefore validate thiamine utilization as an antimalarial drug target and demonstrate that a single antimalarial can simultaneously target several enzymes located within distinct organelles.

  1. Drug utilization review of cephalosporins in a secondary care hospital in United Arab Emirates.

    PubMed

    Abou-Shaaban, Mohammad; Ali, Areeg Anwer; Rao, Padma G M; Majid, Asif

    2016-12-01

    Background Cephalosporins are one of the most commonly used antibiotics in United Arab Emirates (UAE). Few studies have been carried out to evaluate the antibiotic utilization pattern in UAE in spite of the obvious increase in cephalosporins resistance during the past decade. Objective To assess the prescriptions pattern of cephalosporins among physicians at a secondary care hospital in Ras Al Khaimah, UAE. Method This observational prospective study was carried out during October 2013 to April 2014. The data of in patients were documented in the predesigned patient profile form and was analyzed for patient's, drug's and drug's therapy related parameters. Results The 3rd generation cephalosporins constituted 83.6 % of the prescriptions, with ceftriaxone being the most commonly used one (81.1 %). They were mainly prescribed for the treatment of the lower respiratory tract infections (60.2 %). Seven (3.5 %) different ADRs linked to cephalosporin use were observed ranging from oral thrush to clostridium difficile infection. A total of 1039 antimicrobial and nonantimicrobial medications were prescribed concomitantly with cephalosporins. Conclusion The 3rd generation cephalosporins were commonly prescribed by parenteral route. Thus, there is a strong need for rationalizing their use to preserve their efficacy and prevent the development of resistance in the region.

  2. The Utilization of the Monte Carlo Technique for Rational Drug Discovery.

    PubMed

    Toropova, Mariya A; Raška, Ivan; Toropov, Andrey A; Rašková, Mária

    2016-01-01

    Quantitative structure - activity relationships (QSARs) are built up for three endpoints (i) blood-brain barrier permeability; (ii) butyrylcholinesterase (BChE) inhibitory activity; and (iii) for biological effect of antibacterial drugs. The models are based on utilization of the Monte Carlo technique. The CORAL software available on the Internet has been utilized for the calculations. The principles of validation of models together with principles of selection of potential therapeutic agents are suggested. An original version of the definition for the domain of applicability as well as the mechanistic interpretation of model calculated with the Monte Carlo technique are described. Advantages and disadvantages of the utilized approach are discussed.

  3. Utility of cerebrospinal fluid drug concentration as a surrogate for unbound brain concentration in nonhuman primates.

    PubMed

    Nagaya, Yoko; Nozaki, Yoshitane; Kobayashi, Kazumasa; Takenaka, Osamu; Nakatani, Yosuke; Kusano, Kazutomi; Yoshimura, Tsutomu; Kusuhara, Hiroyuki

    2014-01-01

    In central nervous system drug discovery, cerebrospinal fluid (CSF) drug concentration (C(CSF)) has been widely used as a surrogate for unbound brain concentrations (C(u,brain)). However, previous rodent studies demonstrated that when drugs undergo active efflux by transporters, such as P-glycoprotein (P-gp), at the blood-brain barrier, the C(CSF) overestimates the corresponding C(u,brain). To investigate the utility of C(CSF) as a surrogate for interstitial fluid (ISF) concentration (C(ISF)) in nonhuman primates, this study simultaneously determined the C(CSF) and C(ISF) of 12 compounds, including P-gp substrates, under steady-state conditions in cynomolgus monkeys using intracerebral microdialysis coupled with cisternal CSF sampling. Unbound plasma concentrations of non- or weak P-gp substrates were within 2.2-fold of the C(ISF) or C(CSF), whereas typical P-gp substrates (risperidone, verapamil, desloratadine, and quinidine) showed ISF-to-plasma unbound (K(p,uu,ISF)) and CSF-to-plasma unbound concentration ratios (K(p,uu,CSF)) that were appreciably lower than unity. Although the K(p,uu,CSF) of quinidine, verapamil, and desloratadine showed a trend of overestimating the K(p,uu,ISF), K(p,uu,CSF) showed a good agreement with K(p,uu,ISF) within 3-fold variations for all compounds examined. C(u,brain) of some basic compounds, as determined using brain homogenates, overestimated the C(ISF) and C(CSF). Therefore, C(CSF) could be used as a surrogate for C(ISF) in nonhuman primates.

  4. Effects of gamma-aminobutyric acid agonist and antagonist drugs on local cerebral glucose utilization

    SciTech Connect

    Palacios, J.M.; Kuhar, M.J.; Rapoport, S.I.; London, E.D.

    1982-07-01

    The (/sup 14/C)2-deoxy-D-glucose method of Sokoloff et al. was used to study local cerebral glucose utilization (LCGU) in rats treated with gamma-aminobutyric acid (GABA) agonist (muscimol and 4,5,6,7-tetrahydroisoxazolo(5,4-C)pyridin-3-ol, THIP) and antagonist (bicuculline) drugs. It was of interest to determine if the pattern of LCGU responses to GABA agonists and antagonists administered systemically in vivo would reflect the known distributions of markers for central GABAergic synapses. The patterns of LCGU responses to muscimol and THIP generally were similar. Most brain regions showed dose-dependent decreases in LCGU; others showed no effects; but the red nucleus showed an increase. The GABA antagonist bicuculline produced convulsions and variable LCGU responses, depending on the time of administration. Bicuculline also partially antagonized the depressant effects of muscimol of LCGU. The magnitudes and distribution of in vivo cerebral metabolic responses to specific GABA agonists were not correlated simply with markers for GABAergic synapses. This lack of correlation indicates that additional factors, such as neural circuitry, regulate the LCGU responses to GABAergic drugs.

  5. Polypharmacy in HIV: impact of data source and gender on reported drug utilization.

    PubMed

    Furler, Michelle D; Einarson, Thomas R; Walmsley, Sharon; Millson, Margaret; Bendayan, Reina

    2004-10-01

    Drug use in HIV is complex and may involve multiple therapeutic and nontherapeutic agents including prescription, over-the-counter, complementary and alternative medicine, and social/recreational drugs. This study was designed to assess the extent of such drug use in HIV-infected men and women. One hundred four adults were recruited through the HIV Ontario Observational Database from HIV outpatient clinics throughout Ontario, Canada. Patient demographics and data on drug use and physician awareness of drug use were collected through in-person interviews and medical chart review. All patient interviews and 96% of medical charts revealed the use of at least one drug. Eighty-five percent of patients reported use of antiretroviral medications; nearly 70% used highly active antiretroviral therapy. Patients used significantly more drugs by patient report (15.7 +/- 7.7) than by medical chart review (8.4 +/- 5.0) reporting up to 39 drugs per person. Pill burden was substantial, averaging 20.7 +/- 12.5 and ranged up to 69 "pills-per-day." Patient-reported physician awareness of drug use was highest for prescription drugs and lowest for social/recreational drugs; correspondingly agreement between medical chart and patient report ranged from 80% for antiretrovirals to 10% for non-prescribed drugs. The drug and pill burden faced by patients with HIV is considerable. Prevalence of use for specific drug classes varied with both data source and gender while number of drugs used differed only by data source. Our findings emphasize the complexity of pharmacotherapy in HIV and the need for comprehensive drug assessment, particularly because of the risks of drug-drug interactions and decreased adherence secondary to therapeutic complexity.

  6. ChEMBL web services: streamlining access to drug discovery data and utilities

    PubMed Central

    Davies, Mark; Nowotka, Michał; Papadatos, George; Dedman, Nathan; Gaulton, Anna; Atkinson, Francis; Bellis, Louisa; Overington, John P.

    2015-01-01

    ChEMBL is now a well-established resource in the fields of drug discovery and medicinal chemistry research. The ChEMBL database curates and stores standardized bioactivity, molecule, target and drug data extracted from multiple sources, including the primary medicinal chemistry literature. Programmatic access to ChEMBL data has been improved by a recent update to the ChEMBL web services (version 2.0.x, https://www.ebi.ac.uk/chembl/api/data/docs), which exposes significantly more data from the underlying database and introduces new functionality. To complement the data-focused services, a utility service (version 1.0.x, https://www.ebi.ac.uk/chembl/api/utils/docs), which provides RESTful access to commonly used cheminformatics methods, has also been concurrently developed. The ChEMBL web services can be used together or independently to build applications and data processing workflows relevant to drug discovery and chemical biology. PMID:25883136

  7. Case studies in electric utility competition litigation

    SciTech Connect

    Orr, J.A.; Hawks, B.K.

    1994-12-31

    Although electric utilities in the US in many ways operate as highly regulated monopolies, federal and state regulation has not eliminated competition in the electric utility industry. This article describes trends in utility competition litigation as they have evolved in Georgia and other parts of the country.

  8. Using the theory of planned behavior to examine pharmacists' intention to utilize a prescription drug monitoring program database.

    PubMed

    Fleming, Marc L; Barner, Jamie C; Brown, Carolyn M; Shepherd, Marvin D; Strassels, Scott; Novak, Suzanne

    2014-01-01

    Prescription drug monitoring programs (PDMPs) are state-operated electronic databases that contain patients' controlled drug histories. Most states provide these data to pharmacists via online web portals to combat prescription drug abuse and diversion. The objectives of this study were to: 1) explore the theory of planned behavior's (TPB) utility in predicting Texas pharmacists' intention to utilize an online accessible PDMP; 2) to determine the contribution of each construct, attitude (A), subjective norm (SN) and perceived behavioral control (PBC) in predicting pharmacists' intention; and 3) test whether the addition of perceived obligation (PO) is significantly related to pharmacists' intention. A cross-sectional, 36-item questionnaire was developed from focus groups and literature of pharmacists' views regarding prescription drug abuse. A total of 998 practicing Texas community pharmacists were surveyed to collect data on their intention to utilize a PDMP database. Descriptive statistics, multivariate and hierarchical logistic regression analyses were used to address the study objectives. The response rate was 26.2% (261/998). TPB constructs were significant predictors of pharmacists' high intention to utilize the PDMP. Pharmacists with positive attitudes were almost twice as likely to have high intention (odds ratio [OR] = 1.8, 95% confidence interval [CI] = 1.2-2.8). SN was the strongest predictor of pharmacists' high intention (OR = 2.2, 95% CI = 1.4-3.3). Pharmacists with high PBC were also twice as likely to have high intention (OR = 1.9, 95% CI = 1.2-3.0). Additionally, pharmacists' PO contributed to the prediction of high intention (OR = 1.8, 95% CI = 1.0-3.1) above that explained by the TPB model constructs (X(2) = 4.14, P < 0.05). TPB with the addition of PO was useful in predicting pharmacists' high intention to utilize a PDMP database. Interventions that address pharmacists' A, SN, PBC, and PO may be valuable to increase pharmacists' high intention

  9. Cost-utility analyses of drug therapies in breast cancer: a systematic review.

    PubMed

    Nerich, Virginie; Saing, Sopany; Gamper, Eva Maria; Kemmler, Georg; Daval, Franck; Pivot, Xavier; Holzner, Bernhard

    2016-10-01

    The economic evaluation (EE) of health care products has become a necessity. Their quality must be high in order to trust the results and make informed decisions. While cost-utility analyses (CUAs) should be preferred to cost-effectiveness analyses in the oncology area, the quality of breast cancer (BC)-related CUA has been given little attention so far. Thus, firstly, a systematic review of published CUA related to drug therapies for BC, gene expression profiling, and HER2 status testing was performed. Secondly, the quality of selected CUA was assessed and the factors associated with a high-quality CUA identified. The systematic literature search was conducted in PubMed, MEDLINE/EMBASE, and Cochrane to identify published CUA between 2000 and 2014. After screening and data extraction, the quality of each selected CUA was assessed by two independent reviewers, using the checklist proposed by Drummond et al. The analysis of factors associated with a high-quality CUA (defined as a Drummond score ≥7) was performed using a two-step approach. Our systematic review was based on 140 CUAs and showed a wide variety of methodological approaches, including differences in the perspective adopted, the time horizon, measurement of cost and effectiveness, and more specially health-state utility values (HSUVs). The median Drummond score was 7 [range 3-10]. Only one in two of the CUA (n = 74) had a Drummond score ≥7, synonymous of "high quality." The statistically significant predictors of a high-quality CUA were article with "gene expression profiling" topic (p = 0.001), consulting or pharmaceutical company as main location of first author (p = 0.004), and articles with both incremental cost-utility ratio and incremental cost-effectiveness ratio as outcomes of EE (p = 0.02). Our systematic review identified only 140 CUAs published over the past 15 years with one in two of high quality. It showed a wide variety of methodological approaches, especially focused on HSUVs. A

  10. Applicability, Commercial Utility and Recent Patents on Starch and Starch Derivative as Pharmaceutical Drug Delivery Carrier.

    PubMed

    Pandey, Shreya; Malviya, Rishabha; Sharma, Pramod K

    2015-01-01

    Natural polymers are widely utilized in pharmaceutical and food industries. Starch, a major carbohydrate is a staple food in human and animal diets which is simply extractable from various sources, like potato, maize, corn, wheat, etc. It is widely used as a raw material in various food and non food industries as well as in paper, textile and other industries. This article summarizes the starch and modification of starch and to produce a novel molecule with various applications in industries including number of advances in pharmaceutical industry. The unique characteristics of starch and their modified form can be successfully used as drug delivery carriers in various pharmaceutical preparations. It is widely used as controlled and sustained release polymer, tablet disintegrant, drug delivery carrier, plasma volume expander and also finds its applicability in bone tissue engineering and in artificial red cells. It also includes the patents related to starch and modified starch based products and their commercial utility.

  11. [Utilization of Genomic Biomarkers for Post-marketing Safety of Drugs].

    PubMed

    Kaniwa, Nahoko

    2015-01-01

    To prevent adverse drug reactions in the post-marketing phase, therapeutic drug monitoring and various laboratory tests have been used for decades. Recently, data on associations between drug adverse reactions and biomarkers based on "omics" technologies/studies have been increasing. Using genomic biomarkers, patients at high risk for developing side effects can be distinguished before initiating medical treatment, allowing the choice of an appropriate drug/initial dosage regimen. Biomarkers based on proteomics or metabolomics can detect the onset of adverse reactions at an earlier stage than can be accomplished with classical laboratory tests. However, the clinical use of drug safety-related biomarkers is still limited compared with biomarkers that predict drug efficacy of, for example, molecular-targeted drugs. In this symposium, genomic biomarkers associated with the safety of anticancer drugs and idiosyncratic adverse reactions are introduced and compared between Japan and other countries. Prospective studies evaluating the application of screening tests to prevent adverse drug reactions are also shown, and steps necessary to accelerate the use of drug safety-related biomarkers are discussed.

  12. Moving on From Representativeness: Testing the Utility of the Global Drug Survey

    PubMed Central

    Barratt, Monica J; Ferris, Jason A; Zahnow, Renee; Palamar, Joseph J; Maier, Larissa J; Winstock, Adam R

    2017-01-01

    A decline in response rates in traditional household surveys, combined with increased internet coverage and decreased research budgets, has resulted in increased attractiveness of web survey research designs based on purposive and voluntary opt-in sampling strategies. In the study of hidden or stigmatised behaviours, such as cannabis use, web survey methods are increasingly common. However, opt-in web surveys are often heavily criticised due to their lack of sampling frame and unknown representativeness. In this article, we outline the current state of the debate about the relevance of pursuing representativeness, the state of probability sampling methods, and the utility of non-probability, web survey methods especially for accessing hidden or minority populations. Our article has two aims: (1) to present a comprehensive description of the methodology we use at Global Drug Survey (GDS), an annual cross-sectional web survey and (2) to compare the age and sex distributions of cannabis users who voluntarily completed (a) a household survey or (b) a large web-based purposive survey (GDS), across three countries: Australia, the United States, and Switzerland. We find that within each set of country comparisons, the demographic distributions among recent cannabis users are broadly similar, demonstrating that the age and sex distributions of those who volunteer to be surveyed are not vastly different between these non-probability and probability methods. We conclude that opt-in web surveys of hard-to-reach populations are an efficient way of gaining in-depth understanding of stigmatised behaviours and are appropriate, as long as they are not used to estimate drug use prevalence of the general population. PMID:28924351

  13. Legitimacy and modernity via policy transfer: the utility of the 2003 Afghan National Drug Control Strategy.

    PubMed

    Bewley-Taylor, David R

    2014-09-01

    Very much an exercise in historical reconstruction, this article is concerned with the development of the first version of the Afghan NDCS. It is hoped that this domain of enquiry will contribute to discussions around the 'governance of drug policy' in this special issue of the International Journal of Drug Policy by focusing on how different policy actors operate in influencing the policy process; or parts thereof. More specifically, exploration of the formulation of the Strategy does much to help us understand not only the origins and shifting nature of ownership of drug policy within Afghanistan but also the relationship between the NDCS and the broader normative expectations of what has been referred to as the global drug prohibition regime (Andreas & Nadelmann, 2006, p. 38). As will be discussed, while indisputably the product of a process of policy transfer involving a number of non-Afghan actors - and as such arguably not always appropriate to the peculiarities of the drug market within the country - it can be argued that the 2003 National Drug Control Strategy fulfilled a useful functional role that in many ways exceeded its utility as a guiding document beyond the confines of Kabul. Copyright © 2014 Elsevier B.V. All rights reserved.

  14. A Conceptual Framework for Studying Knowledge Utilization.

    ERIC Educational Resources Information Center

    Paul, Douglas

    This paper, written from an organizational perspective, begins with an examination of the deficiencies of knowledge utilization and educational change literature. It suggests the explication of descriptive and heuristic conceptual dimensions as one approach for facilitating a descriptive perspective of knowldge utilization. The efficacy of three…

  15. Photovoltaic utility/customer interface study

    NASA Astrophysics Data System (ADS)

    Eichler, C. H.; Hayes, T. P.; Matthews, M. M.; Wilraker, V. F.

    1980-12-01

    The technical, economic, and legal and regulatory issues of interconnecting small, privately-owned, on-site photovoltaic generating systems to an electric utility are addressed. Baseline residential, commercial and industrial class photovoltaic systems were developed. Technical issues of concern affecting this interconnection were identified and included fault protection, undervoltage protection, lamp flicker, revenue metering, loss of synchromism, electrical safety, prevention of backfeeding a de-energized utility feeder, effects of on-site generation on utility relaying schemes, effects of power conditioner harmonic distortion on the electric utility, system isolation, electromagnetic interference and site power factor as seen by the utility. Typical interconnection wiring diagrams were developed for interconnecting each class of baseline photovoltaic generating system.

  16. Watching the monitors: "PAID" prescriptions, fiscal intermediaries and drug-utilization review.

    PubMed

    Morgan, J P

    1977-02-03

    Prescription monitoring evolved from the need of drug firms to obtain marketing information. Today, extensive monitoring is also done by fiscal intermediaries who administer prepaid drug benefit plans, both private and governmental, particularly Medicaid. The most important such agent is PAID Prescriptions. Under various contracts, PAID monitors physician, pharmacy, and patient behavior related to prescriptions and uses review processes that evaluate certain kinds of behavior for appropriateness. The criteria of appropriateness are essentially those that save money. PAID negotiates a program fee with the insurer (public or private) and applies constraints so that prescription and administrative costs do not overrun that fee. PAID and other monitors have contemplated expansion into the realm of defining and encouraging appropriate prescribing under the concept of "drugutilization review." The actual practices of PAID, particularly the background of fiscal enforcement, may impede the development of an actual drug-utilization review process.

  17. Utilization of purified cellulose in fiber studies.

    PubMed

    Penner, M H; Liaw, E T

    1990-01-01

    Purified cellulose-type fiber products are widely used in experimental nutrition. Their use in a broad spectrum of studies may potentially lead to the acceptance of the misconception that the various commercially available cellulose products are equivalent. In this paper we have attempted to show that this is not the case. The comparative structural data of Table 2 and the compositional data of Olsen et al provide examples which indicate that purified cellulose preparations should not necessarily be considered equivalent. Unfortunately, our current lack of understanding of how fibers are metabolized and how they may affect specific physiological parameters makes it difficult to determine which, if any, of the measurable structural and chemical properties will be of relevance for a given in vivo study. At present, it appears that researchers utilizing/evaluating the consequences of consuming a purified cellulose-type fiber would be prudent to provide at least a limited amount of data on the properties of the cellulose preparation used in their studies. The characterization of the cellulose product may be done by a variety of methods depending on the expertise of the laboratory. The methods and results discussed in this paper provide an example of the type of information which may be obtained from an in vitro characterization of cellulose products.

  18. Medication assisted treatment of drug abuse and dependence: global availability and utilization.

    PubMed

    Kresina, Thomas F

    2007-01-01

    Clinical trials and clinical studies, using patented drugs and drugs off patent, provide data that impact the best treatment practices for substance abuse and dependence. In the United States, medications have been approved for use in the treatment of both alcohol and opioid dependence. Medications are used in the detoxification from drug abuse and dependence in the symptomatic relief of withdrawal. For long term treatment or medical maintenance treatment, medications eliminate the physiological effects of drug use by blocking drug-receptor binding in the brain. Therefore, patented drugs showing interactions with neurotransmitters in the brain, are attractive candidates for treatment efficacy trials. An effective long term treatment paradigm for reducing drug dependence is the combinatorial use of medications that block the effects of drug use with behavior change counseling and psychotherapy. Medications used for the long term treatment of opioid dependence are methadone, buprenorphine, and naltrexone. Pharmacotherapies used in the treatment of alcohol dependence include acamprosate, antabuse and naltrexone. A reliable indicator for successful treatment of drug dependence is time in treatment. Patients remain in long term treatment when they perceive that their health care environment is supportive and non-stigmatizing and with a good patient-provider relationship where their needs are identified and met. Additional medications are needed for individual comprehensive substance abuse treatment plans, particularly for individuals who abuse stimulants. Patented drugs remain an important source of candidate pharmacotherapies comprising medication assistant treatment, part of a comprehensive treatment plan for drug dependence that addresses the medical, social, and psychological needs of the patient. Adapting this drug treatment paradigm globally requires identifying and testing new drug candidates while building and changing programs to patient centered treatment

  19. The Impact of Medicare Part D on Out-of-Pocket Costs for Prescription Drugs, Medication Utilization, Health Resource Utilization, and Preference-Based Health Utility

    PubMed Central

    Liu, Frank Xiaoqing; Alexander, G Caleb; Crawford, Stephanie Y; Pickard, A Simon; Hedeker, Donald; Walton, Surrey M

    2011-01-01

    Objectives To quantify the impact of Medicare Part D eligibility on medication utilization, emergency department use, hospitalization, and preference-based health utility among civilian noninstitutionalized Medicare beneficiaries. Study Design Difference-in-differences analyses were used to estimate the effects of Part D eligibility on health outcomes by comparing a 12-month period before and after Part D implementation using the Medical Expenditure Panel Survey. Models adjusted for sociodemographic characteristics and health status and compared Medicare beneficiaries aged 65 and older with near elderly aged 55–63 years old. Principal Findings Five hundred and fifty-six elderly and 549 near elderly were included. After adjustment, Part D was associated with a U.S.$179.86 (p = .034) reduction in out-of-pocket costs and an increase of 2.05 prescriptions (p = .081) per patient year. The associations between Part D and emergency department use, hospitalizations, and preference-based health utility did not suggest cost offsets and were not statistically significant. Conclusions Although there was a substantial reduction in out-of-pocket costs and a moderate increase in medication utilization among Medicare beneficiaries during the first year after Part D, there was no evidence of improvement in emergency department use, hospitalizations, or preference-based health utility for those eligible for Part D during its first year of implementation. PMID:21609328

  20. Drug therapy problems and medication discrepancies during care transitions in super-utilizers.

    PubMed

    Surbhi, Satya; Munshi, Kiraat D; Bell, Paula C; Bailey, James E

    First, to investigate the prevalence and types of drug therapy problems and medication discrepancies among super-utilizers, and associated patient characteristics. Second, to examine the outcomes of pharmacist recommendations and estimated cost avoidance through care transitions support focused on medication management. Retrospective analysis of the pharmacist-led interventions as part of the SafeMed Program. A large nonprofit health care system serving the major medically underserved areas in Memphis, Tennessee. Three hundred seventy-four super-utilizing SafeMed participants with multiple chronic conditions and polypharmacy. Comprehensive medication review, medication therapy management, enhanced discharge planning, home visits, telephone follow-up, postdischarge medication reconciliation, and care coordination with physicians. Types of drug therapy problems, outcomes of pharmacist recommendations, estimated cost avoided, medication discrepancies, and self-reported medication adherence. Prevalence of drug therapy problems and postdischarge medication discrepancies was 80.7% and 75.4%, respectively. The most frequently occurring drug therapy problems were enrollee not receiving needed medications (33.4%), underuse of medications (16.9%), and insufficient dose or duration (11.2%). Overall 50.8% of the pharmacist recommendations were accepted by physicians and patients, resulting in an estimated cost avoidance of $293.30 per drug therapy problem identified. Multivariate analysis indicated that participants with a higher number of comorbidities were more likely to have medication discrepancies (odds ratio 1.23 [95% CI 1.05-1.44]). Additional contributors to postdischarge medication discrepancies were difficulty picking up and paying for medications and not being given necessary prescriptions before discharge. Drug therapy problems and medication discrepancies are common in super-utilizers with multiple chronic conditions and polypharmacy during transitions of care

  1. A Bayesian approach to utilizing prior data in new drug development.

    PubMed

    Shen, Larry Z; Coffey, Todd; Deng, Wei

    2008-01-01

    In this paper we propose a Bayesian method to combine safety data collected from two separate drug development programs using the same active drug substance but for different indications, formulations, or patient populations. The objective of combining the data across the programs is to better define the level of safety risk associated with the new indication or target population. There may be adverse events (AEs) observed in the new program that represent new safety signals. Our method is to explore the AEs using data from both development programs. Our approach utilizes data collected previously to assist in analyzing safety data from the new program. It is assumed that the frequency of a certain AE follows a distribution with a parameter that characterizes the safety risk level. The parameter is assumed to follow a distribution function. In the Bayesian framework, this distribution function is called a prior distribution in the absence of data and posterior distribution when updated by real data. The key concept behind our method is to use data from the previous program to construct a posterior distribution that will in turn serve as a prior distribution for the new program. The construction of this updated prior down weights data from the previous program to emphasize the new program and thus avoids simple pooling of the data across programs. Such "soft use" of previous information minimizes the potential for undue influence of previous data on the analysis. Data from the new program are used to update the prior distribution and compute the posterior distribution for the new program. Key statistics are then calculated from the posterior distribution to quantify the risk level for the new program. We have tested the proposed approach using data from a real Phase 2 study that was conducted as part of a clinical development program for a new indication of an approved drug. The results indicate that the estimated risk level was affected both by the observed event

  2. Utility of hydroxypropylmethylcellulose acetate succinate (HPMCAS) for initiation and maintenance of drug supersaturation in the GI milieu.

    PubMed

    Curatolo, William; Nightingale, James A; Herbig, Scott M

    2009-06-01

    To identify materials and processes which effect supersaturation of the GI milieu for low solubility drugs in order to increase oral bioavailability. A variety of small and polymeric molecules were screened for their ability to inhibit drug precipitation in supersaturated solutions. The best polymeric materials were utilized to create spray-dried dispersions (SDDs) of drug and polymer, and these were tested for drug form and homogeneity. Dispersions were tested in vitro for their ability to achieve and maintain drug supersaturation, for a variety of drug structures. Of the 41 materials tested, HPMCAS was the most effective at maintaining drug supersaturation. Drug/HPMCAS SDDs were consistently more effective at achieving and maintaining drug supersaturation in vitro than were SDDs prepared with other polymers. Drug/HPMCAS SDDs were effective in vitro for eight low solubility drugs of widely varying structure. Drug/HPMCAS SDDs were more effective at achieving and maintaining supersaturation than were rotoevaporated Drug/HPMCAS dispersions or physical mixtures of Drug and HPMCAS. The degree of achievable drug supersaturation increased with increasing polymer content in the SDD. The drug in Drug /HPMCAS SDDs was amorphous, and the dispersions were demonstrated to have a single glass transition and were thus homogeneous. HPMCAS has been identified as a uniquely effective polymer for use in SDDs of low solubility drugs, with broad applicability across a variety of drug structures and properties.

  3. An overview of herbal supplement utilization with particular emphasis on possible interactions with dental drugs and oral manifestations.

    PubMed

    Abebe, Worku

    2003-01-01

    Herbal medication in the United States is a popular form of therapy. This paper provides an overview of the utilization of herbal supplements with particular emphasis on possible interactions with oral health drugs and oral manifestations. Herbal supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA), which limits their regulation by the U.S Food and Drug Administration (FDA). A number of studies indicate that there is a progressive increase in the utilization of herbal supplements. The majority of consumers of these products are white, middle-aged women who have some college education. Many of the consumers use pharmaceutical drugs concurrently, but most do not inform their health-care providers about their use of herbal supplements. Various herbal supplements have been reported or are suspected to interact with certain oral health drugs, the most important one being 1) bromelain, cayenne, chamomile, feverfew, dong quai, eleuthro/Seberian ginseng, garlic, ginkgo, ginger, ginseng and licorice interacting with aspirin; 2) aloe latex, ephedra, ginseng, rhubarb, cascara sagrada, licorice, and senna interacting with corticosteriods; 3) kava, St. John's wort, chamomile, and valerian interacting with central nervous system (CNS) depressant drugs; and 4) herbs acting on the gastrointestinal system, altering the absorption of several orally administered drugs. Further, the use of some herbal supplements has been reported to be associated with oral manifestations, including aphthous ulcers, lip and tongue irritation, and swelling with feverfew; gingival bleeding with feverfew and ginkgo; tongue numbness with echinacea; xerostomia with St. John's wort; oral and lingual dyskinesia with kava; and salivation with yohimbe. These potential effects of herbal supplements in conjunction with factors related to regulation restrictions suggest that the use of these products may be associated with various adverse reactions that can affect oral health and

  4. Toxicologic Studies for Investigational New Drugs.

    DTIC Science & Technology

    This annual report presents the results of three toxicological studies on an investigational new drug completed from 15 September 1981 through 30...Investigational New Drug Applications for Phase I and early Phase II clinical studies. One drug (WR 6026-2HCl) has been tested for Walter Reed Army

  5. Iron utilization studies in Citrobacter species.

    PubMed

    Khashe, S; Janda, J M

    1996-04-01

    Seventy-one strains of Citrobacter were screened for iron scavenging mechanisms by biologic and chemical assays. Essentially all citrobacteria (70/71) were found to elaborate enterobactin-like siderophores by both biologic and chemical assays, however only c. koseri (C. diversus) was found to produce aerobactin. The concentration of ethylenediamine di(o-hydroxyphenylacetic acid) (EDDA) required to inhibit the growth of individual Citrobacter strains by depleting free iron ranged from 250 micrograms/ml to 100 micrograms/ml. Iron utilization studies of selected citrobacter isolates indicated that hemin and hematin could reverse the effects of iron limitation on growth under iron-stressed conditions (1000 micrograms/ml of EDDA). Two C. koseri strains grown under iron-restricted conditions showed similar changes in their whole cell protein profiles including induction of high molecular mass proteins (72-83 kDa) which may play a role in iron acquisition under iron-stressed conditions. The collective results support an additional virulence-associated mechanism for C. koseri strains which may help explain the greater pathogenic potential this group has for causing serious extraintestinal disease in humans.

  6. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or... outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough... CFR part 341, ``Cold, Cough, Allergy, Bronchodilator, and Antihistamine Drug Products for...

  7. Trends in prescribing and utilization of statins and other lipid lowering drugs across Europe 1997–2003

    PubMed Central

    Walley, T; Folino-Gallo, P; Stephens, P; Van Ganse, E

    2005-01-01

    Aims To describe trends in utilization and prescribing of statins and other lipid lowering drugs across Europe from data in routine administrative databases. Methods Observational study in EU member states and Norway. Comparison of annual utilization data for lipid lowering agents by class and drug from national administrative databases for reimbursement over the period 1997–2003, measured in DDDs per 1000 inhabitants/day. Prescribed daily doses (PDD) of statins obtained from a commercial database (IMS Health) for 2000 and 2003, and used to calculate numbers of ‘patient treatment days’ (PTD) in each country in each year. Analysis of PTD to explain increased utilization of statins. Results Use of lipid lowering agents varied among countries (in 2003, highest in Ireland and Norway, and lowest in Italy), but increased in all countries studied (between 2000 and 2003 by 274%in Ireland and by 56%in France). This increase was entirely due to increases in statin use. Prescribed daily doses of statins increased in all countries for which data was available between 2000 and 2003, but still usually fell below the doses used in the major trials of statins. As a result, the numbers of PTDs increased to a lesser extent than suggested by utilization (e.g. by 192% in Ireland and by 35% in France). One-third of the total rise in utilization was explained by increased PDD, and two-thirds by an increase in numbers of PTDs. Statins dominated the markets in all countries, although fibrates remained strong in France and Belgium (approximately 25% of all lipid lowering agents) and to a lesser extent Germany (10%). Conclusions Use of statins across Europe has increased hugely over the study period. Some of the increase in use is due to higher prescribed daily doses, but two-thirds is due to increases in numbers of patient days of treatment, either due to more patients treated or less likely to better compliance. PMID:16236045

  8. Utilization of pharmacogenomics and therapeutic drug monitoring for opioid pain management.

    PubMed

    Jannetto, Paul J; Bratanow, Nancy C

    2009-07-01

    The use of medication in pain management currently involves empirical adjustment based on observed clinical outcome and the presence of adverse drug reactions. In this study, pharmacogenomics and therapeutic drug monitoring were used to evaluate the clinical effectiveness of genotyping chronic pain patients on analgesic therapy. It was hypothesized that patients who have inherited polymorphisms in CYP2D6 that make them poor or intermediate metabolizers of opioid medications would have higher steady-state concentrations of those opioids and may be more likely to experience adverse drug reactions. In an attempt to investigate the relationship between the polymorphic enzymes, steady-state drug concentrations, therapeutic effects and side effects, 61 patients were clinically evaluated and genotyped, and drug concentrations were measured and outcomes analyzed. Samples were collected and DNA extracted from whole blood using a Puregene DNA isolation kit. CYP2D6 genotyping (*3, *4, *5, *6, *7, *8 and gene duplication) were carried out using Pyrosequencing. Steady-state plasma concentrations of methadone, oxycodone, hydrocodone and tramadol were determined by HPLC tandem mass spectrometry. The results demonstrated the prevalence of CYP2D6 polymorphisms in the population undergoing pain management was not statistically different from the general population. The majority of the pain patients (54%) were extensive metabolizers; 41% were intermediate metabolizers and 5% poor metabolizers. Poor metabolizers in general tended to have the highest steady-state drug concentrations compared with extensive metabolizers (poor metabolizers > intermediate metabolizers > extensive metabolizers) although this wasn't statistically significant. Also, a relationship between oxycodone steady-state drug concentrations and pain relief was found. A total of 80% of patients reporting adverse drug reactions also had impaired CYP2D6 metabolism. The remaining 20% with adverse drug reactions had other

  9. Effect of questionnaire structure on recall of drug utilization in a population of university students

    PubMed Central

    2009-01-01

    Background Self-reported data are a common source of information about drug exposure. Modes of data collection differ considerably and the questionnaire's structure may affect prevalence estimates. We compared the recall of medication use evaluated by means of two questionnaires differing in structure and length. Methods Drug utilization was assessed by two alternative versions of a questionnaire (A – 4 pages, including specific questions for 12 indications/pharmacological groups and one question for "other medicines"; B – 1 page, including 1 open-ended question to cover overall drug consumption). Each of 32 classes in a private University in Maputo, Mozambique, was randomly assigned questionnaire A (233 participants) or B (276 participants). Logistic regression (allowing for clustering by classroom) was used to compare the two groups in terms of socio-demographic characteristics and medication used during the previous month. Results Overall, 67.4% of the subjects had used at least one drug during the previous month. The following prevalences were greater among participants completing questionnaire A: use of drugs from two or more pharmacological groups (60.5% vs. 34.4%, p < 0.001), use of two or more drugs (66.2% vs. 43.0%, p < 0.001), and use of antibiotics (14.6% vs. 6.9%, p = 0.001), antifungals (9.4% vs. 4.0%, p = 0.013), antiparasitics (5.6% vs. 1.8%, p = 0.031) and antacids (8.6% vs. 3.6%, p = 0.024). Information about duration of treatment and medical advice was more complete with version A. Conclusion The indication/drug-specific questions (questionnaire A) revealed a significantly higher prevalence of use of medicines – antibiotics, antifungals, antiparasitics and antacids – without compromising the completeness of the information. PMID:19563651

  10. Drugs foresight 2020: a Delphi expert panel study

    PubMed Central

    2014-01-01

    Background Historically substance misuse has been relatively common in western countries, but comparatively few Finns report drug use. The Drugs 2020 study aimed at foreseeing changes in the drug situation in Finland by the year 2020. Methods The Delphi method was used, utilizing drug experts of the EU national network in Finland. Results Marked growth was foreseen in drug use, especially in synthetic designer drugs and misuse of medicinal drugs. Significant increase was also expected in growing cannabis at home. However, the control of drug market was expected to shift more into the hands of organized crime. No consensus was reached on how drug prices will develop in the time period. Drug use is likely to remain punishable although the use and possession of cannabis may be treated less severely. It seems likely that health and social services resources will be directed towards medicinal treatment. Conclusions Foresight can be utilized in preparing for the future; desirable developments can be fostered, and measures can be taken to curb probable but undesirable lines of development. Based on the results of this study, the experts’ view is that it is highly likely that the Finnish society will have to prepare for an increase in the demand for drug-related care, both in terms of content of the care and financing the services. Also, the forecasted increase in the role of legal prescription medicine used as intoxicants will call for efforts not only in changing prescription practices but in border and police control measures, as well. Parallel developments have been foreseen in the UK and Sweden, and it is likely that similar trends will actualize also in other western countries. PMID:24885142

  11. Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

    PubMed

    Luciano, Juan V; D'Amico, Francesco; Feliu-Soler, Albert; McCracken, Lance M; Aguado, Jaume; Peñarrubia-María, María T; Knapp, Martin; Serrano-Blanco, Antoni; García-Campayo, Javier

    2017-07-01

    The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

  12. Utility of AIRS Retrievals for Climate Studies

    NASA Technical Reports Server (NTRS)

    Molnar, Guyla I.; Susskind, Joel

    2007-01-01

    Satellites provide an ideal platform to study the Earth-atmosphere system on practically all spatial and temporal scales. Thus, one may expect that their rapidly growing datasets could provide crucial insights not only for short-term weather processes/predictions but into ongoing and future climate change processes as well. Though Earth-observing satellites have been around for decades, extracting climatically reliable information from their widely varying datasets faces rather formidable challenges. AIRS/AMSU is a state of the art infrared/microwave sounding system that was launched on the EOS Aqua platform on May 4, 2002, and has been providing operational quality measurements since September 2002. In addition to temperature and atmospheric constituent profiles, outgoing longwave radiation and basic cloud parameters are also derived from the AIRS/AMSU observations. However, so far the AIRS products have not been rigorously evaluated and/or validated on a large scale. Here we present preliminary assessments of monthly and 8-day mean AIRS "Version 4.0" retrieved products (available to the public through the DAAC at NASA/GSFC) to assess their utility for climate studies. First we present "consistency checks" by evaluating the time series of means, and "anomalies" (relative to the first 4 full years' worth of AIRS "climate statistics") of several climatically important retrieved parameters. Finally, we also present preliminary results regarding interrelationships of some of these geophysical variables, to assess to what extent they are consistent with the known physics of climate variability/change. In particular, we find at least one observed relationship which contradicts current general circulation climate (GCM) model results: the global water vapor climate feedback which is expected to be strongly positive is deduced to be slightly negative (shades of the "Lindzen effect"?). Though the current AIRS climatology covers only -4.5 years, it will hopefully extend much

  13. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.

    PubMed

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year. © 2014.

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

    PubMed Central

    2014-01-01

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

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

    PubMed

    Tantai, Narisa; Chaikledkaew, Usa; Tanwandee, Tawesak; Werayingyong, Pitsaphun; Teerawattananon, Yot

    2014-04-14

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

  16. Race/ethnic disparities in the utilization of treatment for drug dependent inmates in U.S. state correctional facilities.

    PubMed

    Nowotny, Kathryn M

    2015-01-01

    Research has documented racial and ethnic disparities in utilization, access, continuity, and quality of care for psychiatric disorders including treatment for substance use disorders among those with similar need in the general community. Currently, the extent of racial and ethnic disparities in treatment within U.S. correctional facilities is unknown. This study examines race/ethnic disparities in treatment for drug dependent inmates using the 2004 Survey of Inmates in State Correctional Facilities. Fixed effects logistic regression is used to analyze treatment outcomes for 5180 inmates housed within 286 prisons. The analysis accounts for differences in background characteristics (i.e., age, gender, marital status, foreign born status, veteran status), socioeconomic characteristics (i.e., education, employment prior to incarceration), mental health (i.e., diagnosis with a serious mental illness), and incarceration experiences (i.e., current conviction, previous incarceration episodes, time served, additional sentencing requirements, external social support, disciplinary violations). The findings identify a remarkable unmet need among drug dependent inmates in that less than one-half of drug dependent inmates had received any type of treatment in prison at the time of the interview with the most common treatment type being self-help groups. Compared to whites, drug dependent Latino inmates have significantly lower odds of utilizing treatment, yet there are no significant black--white disparities found. The current study suggests that treatment for drug dependent inmates needs to be expanded to include clinically or medically based treatment since the failure to address addictions in the criminal legal system has been identified as the single most significant reason for rearrest and recidivism once released. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Race/Ethnic Disparities in the Utilization of Treatment for Drug Dependent Inmates in U.S. State Correctional Facilities

    PubMed Central

    Nowotny, Kathryn M.

    2014-01-01

    This study examines race/ethnic disparities in treatment for drug dependent inmates in state correctional facilities. The data come from the 2004 Survey of Inmates in State Correctional Facilities. Fixed effects logistic regression is used to analyze treatment outcomes for 5,180 inmates housed within 286 prisons. The analysis accounts for differences in background characteristics (i.e., age, gender, marital status, foreign born status, veteran status), socioeconomic characteristics (i.e., education, employment prior to incarceration), mental health (i.e., diagnosis with a serious mental illness), and incarceration experiences (i.e., current conviction, previous incarceration episodes, time served, additional sentencing requirements, external social support, disciplinary violations). The findings identify a remarkable unmet need among drug dependent inmates in that less than one-half of drug dependent inmates had received any type of treatment in prison at the time of the interview with the most common treatment type being self-help groups. Compared to whites, drug dependent Latino inmates have significantly lower odds of utilizing treatment, yet there are no significant black-white disparities found. Implications for drug treatment within prisons are discussed. PMID:25270722

  18. Mechanistic and inhibition studies of chorismate-utilizing enzymes.

    PubMed

    Kerbarh, O; Bulloch, E M M; Payne, R J; Sahr, T; Rébeillé, F; Abell, C

    2005-08-01

    The shikimate biosynthetic pathway is utilized in algae, higher plants, bacteria, fungi and apicomplexan parasites; it involves seven enzymatic steps in which phosphoenolpyruvate and erythrose 4-phosphate are converted into chorismate. In Escherichia coli, five chorismate-utilizing enzymes catalyse the synthesis of aromatic compounds such as L-phenylalanine, L-tyrosine, L-tryptophan, folate, ubiquinone and siderophores such as yersiniabactin and enterobactin. As mammals do not possess such a biosynthetic system, the enzymes involved in the pathway have aroused considerable interest as potential targets for the development of antimicrobial drugs and herbicides. As an initiative to investigate the mechanism of some of these enzymes, we showed that the antimicrobial effect of (6S)-6-fluoroshikimate is the result of irreversible inhibition of 4-amino-4-deoxychorismate synthase by 2-fluorochorismate. Based on this study, a catalytic mechanism for this enzyme was proposed, in which the residue Lys-274 is involved in the formation of a covalent intermediate. In another study, Yersinia enterocolitica Irp9, which is involved in the biosynthesis of the siderophore yersiniabactin, was for the first time biochemically characterized and shown to catalyse the formation of salicylate from chorismate via isochorismate as a reaction intermediate. A three-dimensional model for this enzyme was constructed that will guide the search for potent inhibitors of salicylate formation, and hence of bacterial iron uptake.

  19. Estimation of drug solubility in polymers via differential scanning calorimetry and utilization of the fox equation.

    PubMed

    Haddadin, Raja; Qian, Feng; Desikan, Sridhar; Hussain, Munir; Smith, Ronald L

    2009-01-01

    The solubility of drugs in polyethylene glycol 400 (PEG 400) was estimated and rank ordered using a differential scanning calorimetry (DSC) method and the Fox Equation. Drug-polymer binary mixtures of six compounds (Ibuprofen, Indomethacin, Naproxen, and three proprietary compounds: PC-1 through PC-3) with PEG 400 were heat treated using a three-cycle DSC method to establish a correlation between equilibrium solubility and temperature. Thermal events such as heat of fusion, heat of recrystallization and glass transition temperature, T(g), were used to calculate the drug solubility at multiple higher temperatures through the Fox Equation. Subsequently, a van't Hoff plot was constructed to estimate the drug solubility at room temperature, and the values were compared with those measured by HPLC. With the exception of Naproxen, room temperature solubilities of the remaining drug compounds in PEG 400 were determined by this thermal method approach, and compared with those measured by HPLC: 26.7% vs. 24.7% for Ibuprofen, 5.8% vs. 9.6% for Indomethacin, 3.1 % vs. 1.5% for PC-1, 2.3% vs. 1.3% for PC-2, and 1.4% vs. 0.2% for PC-3 in PEG 400. There was good concordance in solubility rank order estimates between the two methods. These collective results support the potential utility of the thermal method as an alternative to other methods for estimation of drug solubility in polymers which is an important determinant in the design of physically-stable amorphous systems.

  20. Drug discrimination studies with ibogaine.

    PubMed

    Helsley, S; Rabin, R A; Winter, J C

    2001-01-01

    The results of the studies described here support the hypothesis that ibogaine produces its effects via selective interactions with multiple receptors. It appears that 5-HT2A, 5-HT2C, and sigma 2 receptors are involved in mediating the stimulus effects of ibogaine. In addition, opiate receptors may also be involved. In contrast, sigma 1, PCP/MK-801, 5-HT3, and 5-HT1A receptors do not appear to play a major role. Ibogaine's hallucinogenic effects may be explained by its interactions with 5-HT2A and 5-HT2C receptors, while its putative antiaddictive properties may result from its interactions with sigma 2 and opiate receptors. Alternatively, the possibility that ibogaine's hallucinogenic properties underlie its antiaddictive effects, as previously suggested (34), would support a role for 5-HT2 receptors in mediating the reported therapeutic effects of ibogaine. Certainly many questions remain regarding ibogaine's mechanism of action. Although drug discrimination will be useful for answering some of those questions, the true potential of this technique is realized whin it is combined with other techniques. The next few years promise to be fruitful with respect to our understanding of this agent. Reasons supporting this belief include advances in the study of sigma receptors, interest in ibogaine's effects on second messenger systems, and the development of ibogaine congeners such as 18-methoxycoronaridine (35). In conclusion, the aforementioned studies should serve to guide further endeavors. Pertinent questions have been generated: What is the role of sigma receptors in the effects of ibogaine, especially with regard to addiction? How does ibogaine affect opiate neurotransmission? What effects, if any, do the Harmala alkaloids have on addiction phenomena? What is the mechanism of action of harmaline? Can 10-hydroxyibogamine serve as a discriminative stimulus and, if so, what receptor interactions mediate its stimulus effects? Does the ibogaine-trained stimulus

  1. Kauai Island Utility Cooperative energy storage study.

    SciTech Connect

    Akhil, Abbas Ali; Yamane, Mike; Murray, Aaron T.

    2009-06-01

    Sandia National Laboratories performed an assessment of the benefits of energy storage for the Kauai Island Utility Cooperative. This report documents the methodology and results of this study from a generation and production-side benefits perspective only. The KIUC energy storage study focused on the economic impact of using energy storage to shave the system peak, which reduces generator run time and consequently reduces fuel and operation and maintenance (O&M) costs. It was determined that a 16-MWh energy storage system would suit KIUC's needs, taking into account the size of the 13 individual generation units in the KIUC system and a system peak of 78 MW. The analysis shows that an energy storage system substantially reduces the run time of Units D1, D2, D3, and D5 - the four smallest and oldest diesel generators at the Port Allen generating plant. The availability of stored energy also evens the diurnal variability of the remaining generation units during the off- and on-peak periods. However, the net economic benefit is insufficient to justify a load-leveling type of energy storage system at this time. While the presence of storage helps reduce the run time of the smaller and older units, the economic dispatch changes and the largest most efficient unit in the KIUC system, the 27.5-MW steam-injected combustion turbine at Kapaia, is run for extra hours to provide the recharge energy for the storage system. The economic benefits of the storage is significantly reduced because the charging energy for the storage is derived from the same fuel source as the peak generation source it displaces. This situation would be substantially different if there were a renewable energy source available to charge the storage. Especially, if there is a wind generation resource introduced in the KIUC system, there may be a potential of capturing the load-leveling benefits as well as using the storage to dampen the dynamic instability that the wind generation could introduce into

  2. Drug dispensing systems in Gaza hospitals: a comparative study.

    PubMed

    Al Adham, M; Abu Hamad, B

    2011-10-01

    Implementing an appropriate drug dispensing system in hospitals is essential to ensure the safe and rational use of drugs. This study aimed to assess the unit-dose drug dispensing system (DDS) and the ward-stock DDS utilized in Gaza hospitals to ascertain which system is more beneficial. The quantitative, comparative cross-sectional design utilized structured interviews with pharmacists and head nurses, missing drug registration sheets and drug administration observation checklists. The number of missing units per drug item dispensed (mean 3.4 and 1.8 respectively) and medication administration errors per patient (mean 1.8 and 0.9 respectively) were statistically significantly lower in the hospital using the unit-dose DDS than the ward-stock DDS. The unit-dose DDS appeared to be safer, with fewer missing drugs, was more positively perceived by staff and was more supportive of good clinical pharmacy practice. Its use in other hospitals in the Gaza Strip is recommended.

  3. Impact of 3-tier pharmacy benefit design and increased consumer cost-sharing on drug utilization.

    PubMed

    Landsman, Pamela B; Yu, Winnie; Liu, XiaoFeng; Teutsch, Steven M; Berger, Marc L

    2005-10-01

    To estimate responsiveness of prescription demand within 9 therapeutic classes to increased cost-sharing compared with constant cost-sharing. Retrospective prescription claims analysis. Between 1999 and 2001, 3 benefit plans changed from a 2-tier to a 3-tier design (cases); 1 plan kept a 2-tier design (controls). Study subjects needed 24 months of continuous coverage and a prescription filled < OR = 3 months before the benefit change for a nonsteroidal anti-inflammatory agent (NSAID), a cyclooxygenase (COX-2) inhibitor, a selective serotonin reuptake inhibitor (SSRI), a tricyclic antidepressant (TCA), an angiotensin-converting enzyme (ACE) inhibitor, a calcium-channel blocker (CCB), an angiotensin-receptor blocker (ARB), a statin, or a triptan. Changes in use were compared with the Wilcoxon signed rank test. Elasticity of demand among cases was calculated. Generally, medication possession ratios decreased for cases and increased for controls between 1999 and 2000. Switch rates increased for cases and decreased for controls for all classes but CCBs. Switches to lower copayments for ACE inhibitors, statins, and triptans occurred more often for cases. Discontinuation-rate changes for cases were 2 to 8 times those for controls. Generic-substitution rates depended on availability and initial generic utilization. Elasticity of demand for drugs was generally low, -0.16 to -0.10, for asymptomatic conditions (ACE inhibitors, ARBs, CCBs, statins), and moderate, -0.60 to -0.24, for symptomatic conditions (COX-2 inhibitors, NSAIDs, triptans, SSRIs). Use of retail prescription medications within 9 specific therapeutic classes decreased as copayment increased. Demand for pharmaceuticals was relatively inelastic with these copayment increases.

  4. Evaluation of algorithms to identify delirium in administrative claims and drug utilization database.

    PubMed

    Kim, Dae Hyun; Lee, Jung; Kim, Caroline A; Huybrechts, Krista F; Bateman, Brian T; Patorno, Elisabetta; Marcantonio, Edward R

    2017-08-01

    To evaluate the performance of delirium-identification algorithms in administrative claims and drug utilization data. We used data from a prospective study of 184 older adults who underwent aortic valve replacement at a single academic medical center to evaluate the following delirium-identification algorithms: (1) International Classification of Diseases (ICD) diagnosis codes for delirium; (2) antipsychotics use; (3) either ICD diagnosis codes or antipsychotics use; and (4) both ICD diagnosis codes and antipsychotics use. These algorithms were evaluated against a validated bedside assessment, the Confusion Assessment Method, and a validated delirium severity scale, the CAM-S. Delirium occurred in 66 patients (36%), of which 14 (21%) had hyperactive or mixed features and 15 (23%) had severe delirium. ICD diagnosis codes for delirium were present in 15 patients (8%). Antipsychotics were used in 13 patients (7%). ICD diagnosis codes alone and antipsychotics use alone had comparable sensitivity (18% vs. 18%) and specificity (98% vs. 99%). Defining delirium using either ICD diagnosis codes or antipsychotics use, sensitivity improved to 30% with little change in specificity (97%). This algorithm showed higher sensitivity for hyperactive or mixed delirium (64%) and severe delirium (73%). Requiring both ICD diagnosis codes and antipsychotics use resulted in perfect specificity but low sensitivity (6%). Delirium-identification algorithms in claims data have low sensitivity and high specificity. Defining delirium using ICD diagnosis codes or antipsychotics use performs better than considering either type of information alone. This information should inform the design and interpretation of claims-based comparative effectiveness and safety research. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  5. The DoD Laboratory Utilization Study

    DTIC Science & Technology

    1975-04-28

    ODDR&E view of the Navy laboratories was that: (1) they are well integrated into many of the Navy programs , including fleet support, (2) they possess...an innovative, well structured Tech- nology Base program ; (2) they utilize military personnel in the labora- tories effectively; (3) they specialize...education, an early 4•-,- tour in a Laboratory as a "bench-level" engineer or scientist and usually includes duty in program management as well as

  6. Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag.

    PubMed

    Kogure, Seiji; Koyama, Nobuyuki; Hidaka, Shinji

    2017-06-19

    Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies. © 2017, The American College of Clinical Pharmacology.

  7. Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

    PubMed

    Kales, A; Scharf, M B; Soldatos, C R; Bixler, E O

    1979-07-01

    The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

  8. The effect of the Rx-to-OTC switch of loratadine and changes in prescription drug benefits on utilization and cost of therapy.

    PubMed

    Sullivan, Patrick W; Nair, Kavita V; Patel, Bimal V

    2005-06-01

    Numerous prescription products have become available over the counter (OTC) in recent years. Previous simulation models have shown the Rx-to-OTC switch of loratadine to be cost effective. To empirically assess the overall effect of the Rx-to-OTC switch of loratadine and the specific effect of different pharmacy benefit structures on prescription drug utilization and cost among different plan sponsors. Data from a national pharmacy benefit management organization covering lives throughout the United States were used. The analysis included a comparison of the before and after change in prescription utilization and cost for plan sponsors that instituted 1 of 3 second-generation antihistamine (SGA) benefit responses: made no change, moved SGAs to the third tier, or restricted SGA benefits through a requirement for prior authorization. Multivariate regression analysis was used to control for differences across the study groups. There was a substantial decrease in utilization and cost of all prescription drugs and combinations of drug classes. Patients with allergic rhinitis facing restricted prescription benefits for SGAs did not appear to increase utilization of other allergic rhinitis medications or other medications used to treat comorbid conditions such as asthma, sinusitis, and otitis media. Utilization and cost decreased substantially for all types of medications and all pharmacy benefit structures. Future studies need to examine the effect of the Rx-to-OTC switch of loratadine and resultant prescription benefit policies on medical utilization and OTC antihistamine utilization.

  9. Ophthalmic drug delivery utilizing two-photon absorption: a novel approach to treat posterior capsule opacification

    NASA Astrophysics Data System (ADS)

    Kim, H.-C.; Träger, J.; Zorn, M.; Haberkorn, N.; Hampp, N.

    2007-07-01

    Intraocular lens (IOL) implantation is the standard technique to treat cataract. Despite recent progress in surgical procedures, posterior capsule opacification is one of the sill remaining postoperative complications of cataract surgery. We present a novel strategy to reduce the incidence of posterior capsule opacification. A drug delivery polymer suitable for manufacturing intraocular lenses has been developed which enables repeated drug release in a non-invasive and controlled manner. The therapeutic molecules are attached through a UV light sensitive linkage to the polymer backbone which is mainly responsible for the optical properties of the intraocular lenses. However, UV light can not trigger the release of drug from the polymer due to the high absorption of the cornea. We developed linkers which enable drug release by two-photon absorption induced cleavage of the linker structure. Since the two-photon absorption requires high photon densities, this does not occur in ambient light conditions in daily life, but is easily triggered by focused laser beams from a pulsed laser. In this proof-of-principle study we have employed a cyclobutane type linker and investigated the properties of the therapeutic system with the approved drugs 5-fluorouracil and chlorambucil. The controlled drug delivery was successfully demonstrated in vitro and additional cell tests confirmed that the device itself shows no cytotoxicity until photochemical activation. This presented concept can provide a powerful method in ophthalmic drug delivery.

  10. Targeted drug delivery system to neural cells utilizes the nicotinic acetylcholine receptor.

    PubMed

    Huey, Rachel; O'Hagan, Barry; McCarron, Paul; Hawthorne, Susan

    2017-06-15

    Drug delivery to the brain is still a major challenge in the field of therapeutics, especially for large and hydrophilic compounds. In order to achieve drug delivery of therapeutic concentration in the central nervous system, the problematic blood brain barrier (BBB) must be overcome. This work presents the formulation of a targeted nanoparticle-based drug delivery system using a specific neural cell targeting ligand, rabies virus derived peptide (RDP). Characterization studies revealed that RDP could be conjugated to drug-loaded PLGA nanoparticles of average diameter 257.10±22.39nm and zeta potential of -5.51±0.73mV. In vitro studies showed that addition of RDP to nanoparticles enhanced drug accumulation in a neural cell line specifically as opposed to non-neural cell lines. It was revealed that this drug delivery system is reliant upon nicotinic acetylcholine receptor (nAChR) function for RDP-facilitated effects, supporting a cellular uptake mechanism of action. The specific neural cell targeting capabilities of RDP via the nAChR offers a non-toxic, non-invasive and promising approach to the delivery of therapeutics to the brain. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

  11. Drug utilisation study in patients receiving antiepileptic drugs in Colombia.

    PubMed

    Machado-Alba, J E; Calvo-Torres, L F; García-Betancur, S; Aguirre-Novoa, A; Bañol-Giraldo, A M

    2016-03-01

    This study examines the indications according to which antiepileptic drugs are prescribed and used in a population of patients enrolled in the Colombian national health system (SGSSS). Retrospective cross-sectional study. From the pool of individuals in 34 Colombian cities who used antiepileptic drugs between 18 July, 2013 and 31 August, 2014 during a period of no less than 12 months, we obtained a random sample stratified by city. Socio-demographic, pharmacological and comorbidity variables were analysed. Continuous and categorical variables were compared, and logistic regression models were used. Our patient total was 373 patients, with 197 women (52.1%) and a mean age of 41.9 ± 21.7 years; 65.4% of the patients were treated with monotherapy. The most frequently used drugs were valproic acid (53.1%) and carbamazepine (33.2%). Epilepsy was the most frequent indication (n=178; 47.7%); however, 52.3% of the patients were prescribed antiepileptics for different indications, especially neuropathic pain (26.8%), affective disorders (14.2%) and migraine prophylaxis (12.3%). A total of 81 patients with epilepsy (46.6%) displayed good seizure control while another 25 (14.4%) had drug-resistant epilepsy. In the multivariate analysis, medication adherence was associated with a lower risk of treatment failure in patients with epilepsy (OR: 0.27; 95%CI, 0.11-0.67). In Colombia, antiepileptic drugs are being used for indications other than those originally intended. Monotherapy is the most commonly used treatment approach, together with the use of classic antiepileptic drugs. Copyright © 2015 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  12. Effects of managerial intervention on drug utilization pattern at King Chulalongkorn Memorial Hospital.

    PubMed

    Limpanasithikul, Wacharee; Wangsaturaka, Danai; Nantawan, Patra; Itthipanichapong, Chandhanee; Thamaree, Sopit; Wittayalertpanya, Supeecha; Ketcharoen, Aurawan; Taworn, Nongnuch; Kemsri, Wandee; Kusolsomboon, Thammarat; Tangphao, Oranee

    2002-06-01

    The economic crisis in Thailand since 1997 has a major impact on all sections of the country including health care. There were several suggestions for reducing the drug expenditure budget including restriction of hospital formulary, generic prescribing and generic dispensing. At King Chulalongkorn Memorial hospital, the new hospital formulary was established and implemented in March 1998. The generic dispensing policy was also in place at the same time. This study aimed to evaluate the impact of the new implementation by comparing the prescription patterns in out patient departments (OPDs) of the hospital before and after the new hospital formulary implementation. The prescriptions from several OPDs were systematically stratified samplings 5 weeks before and 5 weeks after March 1st, 1998. The information from the prescriptions including drug category, drug name, amount of dispensed drug, drug cost, etc. was collected and analyzed. The total number of prescriptions and the average number of drug items/prescription before and after the implementation were similar (2,049 vs 2,052, and 2.52 +/- 0.048 vs 2.45 +/- 0.03 respectively). The total cost of the prescription, the cost/prescription and the cost/item seemed to be different (1,690,484 baht vs 1,282,343 baht, 844 +/- 54.04 vs 633 +/- 41.11 and 332.58 +/- 29.59 vs 255.29 +/- 19.98 respectively). After the implementation, physicians in the hospital increasingly prescribed drugs by generic name (37.1% vs 44.85%). Locally made drugs were also prescribed by physicians and received by patients more than before (9.56% vs 84.27% and 28.15% vs 60.72%, respectively). Anti-infective agents were studied in depth as they contribute to significant amount of drug expenditure. The total cost of prescribed anti-infective agents and the cost/prescription were increased after the implementation (223,529 vs 274,435 Baht and 585.38 +/- 102.84 vs 772.71 +/- 147.59). The increased cost mainly came from the cost of anti-HIV drugs. Our

  13. Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

    PubMed Central

    Raschi, Emanuel; Poluzzi, Elisabetta; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Bennie, Marion; Barbui, Corrado; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2013-01-01

    Background Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. Methods FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID). Results Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia). Conclusions This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  14. Mining severe drug-drug interaction adverse events using Semantic Web technologies: a case study.

    PubMed

    Jiang, Guoqian; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2015-01-01

    Drug-drug interactions (DDIs) are a major contributing factor for unexpected adverse drug events (ADEs). However, few of knowledge resources cover the severity information of ADEs that is critical for prioritizing the medical need. The objective of the study is to develop and evaluate a Semantic Web-based approach for mining severe DDI-induced ADEs. We utilized a normalized FDA Adverse Event Report System (AERS) dataset and performed a case study of three frequently prescribed cardiovascular drugs: Warfarin, Clopidogrel and Simvastatin. We extracted putative DDI-ADE pairs and their associated outcome codes. We developed a pipeline to filter the associations using ADE datasets from SIDER and PharmGKB. We also performed a signal enrichment using electronic medical records (EMR) data. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the DDI-induced ADEs into the CTCAE in the Web Ontology Language (OWL). We identified 601 DDI-ADE pairs for the three drugs using the filtering pipeline, of which 61 pairs are in Grade 5, 56 pairs in Grade 4 and 484 pairs in Grade 3. Among 601 pairs, the signals of 59 DDI-ADE pairs were identified from the EMR data. The approach developed could be generalized to detect the signals of putative severe ADEs induced by DDIs in other drug domains and would be useful for supporting translational and pharmacovigilance study of severe ADEs.

  15. Trends in prescription drug utilization and spending for the Department of Defense, 2002-2007.

    PubMed

    Devine, Joshua W; Trice, Shana; Spridgen, Stacia L; Bacon, Thomas A

    2009-09-01

    Examine trends in U.S. Department of Defense (DoD) outpatient drug spending and utilization between 2002 and 2007. We analyzed pharmacy claims data from the U.S. Military Health System (MHS), using a cross-sectional analysis at the prescription and patient-year level and measuring utilization in 30-day equivalent prescriptions and expenditures in dollars. Pharmaceutical spending more than doubled in DoD, from $3 billion in FY02 to $6.5 billion in FY07. The largest increase occurred in the DoD community pharmacy network, where utilization grew from 6 million 30-day equivalent prescriptions in the first quarter of FY02 to more than 16 million in the last quarter of FY07. The smallest increase in annual spending occurred in FY07 (5.5%), down from a high of 27.5% in FY03. The MHS has experienced rapid growth in pharmaceutical spending since FY02. However, there are signs that growth in pharmaceutical spending may be slowing.

  16. Patterns of prescription antihypertensive drug utilization and adherence to treatment guidelines in the city of Novi Sad.

    PubMed

    Tomas, Ana; Tomić, Zdenko; Milijasević, Boris; Ban, Milica; Horvat, Olga; Vukmirović, Sasa; Sabo, Ana

    2016-06-01

    Hypertension is one of the leading causes of cardiovascular morbidity and mortality and more than a half of all health insurance expenditures for reimbursed medicines are allocated to antihypertensive drugs in Serbia. The aim of this study was to identify the antihypertensive drug utilization patterns among hypertensive outpatients in the city of Novi Sad, Serbia, determine the adherence to clinical guidelines and address the economic aspects of current prescribing practices. This retrospective observational study was conducted in Novi Sad over a period of six months. The data on the number of packages, size their, and retail price of antihypertensives issued on prescription in outpatients with the diagnosis of essential arterial hypertension was collected from all state-owned pharmacies in Novi Sad. Drug consumption was analyzed using the Anatomical Therapeutic Chemical (ATC)/ defined daily dose (DDD) methodology. Total consumption of antihypertensives issued on prescription over a 6-month period in the city of Novi sad, Serbia was 283.48 DDD per 1,000 inhabitans per day (DID). Angiotensin converting enzyme inhibitors (ACEi) were most commonly prescribed drugs, and were used 3 times more often than calcium channel blockers and 5 times more than beta-blockers. The consumption of diuretics and angiotensin receptor antagonists was low within all the groups of outpatients. Both national and international guidelines state superiority and effectiveness of diuretics in treatment of hypertension in the elderly, but their consumption was unreasonable low despite the fact that over 70% of all antihypertensive drugs in the city of Novi Sad were dispensed in people aged > 60. The use of more expensive ACEi was observed despite the guidelines deeming all the drugs of this class equally effective in treatment of hypertension. Large differences in utilization of different groups of antihypertensive agents were noted in this study. Underutilization of valuable, efficacious, and

  17. Toward a standard definition and measurement of persistence with drug therapy: Examples from research on statin and antihypertensive utilization.

    PubMed

    Caetano, Patricia A; Lam, Jonathan M C; Morgan, Steven G

    2006-09-01

    Long-term utilization of prescription drugs for chronic conditions such as hypertension and/or hypercholesterolemia is a reality for millions of individuals, yet therapies may be discontinued before they can exert their beneficial effect. Several studies have measured the mean duration of therapy (ie, persistence) using administrative health databases. However, the terminology and methodology used for measuring persistence varied across studies, making it difficult to compare persistence rates. The objectives of this study were to identify currently used measures of persistence and to propose a standard operational definition for use in administrative database analyses of drug utilization. MEDLINE was searched for English-language articles published between January 1997 and June 2005 that quantified the concepts of persistence, adherence, compliance, or continuity with statin or antihypertensive therapy using administrative prescription claims databases. The conceptual and operational definitions of persistence used in the identified studies were categorized and applied to prescription-refill data for a hypothetical patient to compare the durations of persistence resulting from each method. Thirty-one articles were identified and reviewed. Few of the studies explicitly stated the conceptual definition of persistence used. Five methods of measuring persistence were identified: anniversary models, minimum-refills models, refill-sequence models, proportion-of-days-covered models, and hybrid models. When these models were applied to data for the hypothetical patient, total persistence with drug therapy ranged from 7 days to >1 year. There continue to be inconsistencies in the definition of persistence and the methods by which it is measured. A standard operational definition of persistence should be 2-dimensional, quantifying not only the total duration of therapy, but also the intensity of medication-taking within this interval.

  18. Erosive Burning Study Utilizing Ultrasonic Measurement Techniques

    NASA Technical Reports Server (NTRS)

    Furfaro, James A.

    2003-01-01

    A 6-segment subscale motor was developed to generate a range of internal environments from which multiple propellants could be characterized for erosive burning. The motor test bed was designed to provide a high Mach number, high mass flux environment. Propellant regression rates were monitored for each segment utilizing ultrasonic measurement techniques. These data were obtained for three propellants RSRM, ETM- 03, and Castor@ IVA, which span two propellant types, PBAN (polybutadiene acrylonitrile) and HTPB (hydroxyl terminated polybutadiene). The characterization of these propellants indicates a remarkably similar erosive burning response to the induced flow environment. Propellant burnrates for each type had a conventional response with respect to pressure up to a bulk flow velocity threshold. Each propellant, however, had a unique threshold at which it would experience an increase in observed propellant burn rate. Above the observed threshold each propellant again demonstrated a similar enhanced burn rate response corresponding to the local flow environment.

  19. Utilizing Chemical Genomics to Identify Cytochrome b as a Novel Drug Target for Chagas Disease

    PubMed Central

    Khare, Shilpi; Roach, Steven L.; Barnes, S. Whitney; Hoepfner, Dominic; Walker, John R.; Chatterjee, Arnab K.; Neitz, R. Jeffrey; Arkin, Michelle R.; McNamara, Case W.; Ballard, Jaime; Lai, Yin; Fu, Yue; Molteni, Valentina; Yeh, Vince; McKerrow, James H.; Glynne, Richard J.; Supek, Frantisek

    2015-01-01

    Unbiased phenotypic screens enable identification of small molecules that inhibit pathogen growth by unanticipated mechanisms. These small molecules can be used as starting points for drug discovery programs that target such mechanisms. A major challenge of the approach is the identification of the cellular targets. Here we report GNF7686, a small molecule inhibitor of Trypanosoma cruzi, the causative agent of Chagas disease, and identification of cytochrome b as its target. Following discovery of GNF7686 in a parasite growth inhibition high throughput screen, we were able to evolve a GNF7686-resistant culture of T. cruzi epimastigotes. Clones from this culture bore a mutation coding for a substitution of leucine by phenylalanine at amino acid position 197 in cytochrome b. Cytochrome b is a component of complex III (cytochrome bc1) in the mitochondrial electron transport chain and catalyzes the transfer of electrons from ubiquinol to cytochrome c by a mechanism that utilizes two distinct catalytic sites, QN and QP. The L197F mutation is located in the QN site and confers resistance to GNF7686 in both parasite cell growth and biochemical cytochrome b assays. Additionally, the mutant cytochrome b confers resistance to antimycin A, another QN site inhibitor, but not to strobilurin or myxothiazol, which target the QP site. GNF7686 represents a promising starting point for Chagas disease drug discovery as it potently inhibits growth of intracellular T. cruzi amastigotes with a half maximal effective concentration (EC50) of 0.15 µM, and is highly specific for T. cruzi cytochrome b. No effect on the mammalian respiratory chain or mammalian cell proliferation was observed with up to 25 µM of GNF7686. Our approach, which combines T. cruzi chemical genetics with biochemical target validation, can be broadly applied to the discovery of additional novel drug targets and drug leads for Chagas disease. PMID:26186534

  20. Physician drug dispensing in Switzerland: association on health care expenditures and utilization.

    PubMed

    Trottmann, Maria; Frueh, Mathias; Telser, Harry; Reich, Oliver

    2016-07-08

    Several countries recently reassessed the roles of drug prescribing and dispensing, either by enlarging pharmacists' rights to prescribe (e.g. the US and the United Kingdom) or by limiting physicians' rights to dispense (e.g. Taiwan and South Korea). While integrating the two roles might increase supply and be convenient for patients, concern is that drug mark-ups incite providers to prescribe unnecessary drugs. We aimed to assess the association of physician dispensing (PD) in Switzerland on various outcomes. We performed a retrospective cohort study, using health care claims data for patients in the year 2013. The analysis of the association of PD was perfomed using a large patient level dataset and several target variables, including the number of different chemical agents, share of generic drugs, number of visits to physicians and expenditures. Different multivariate econometric models were applied in order to capture the association PD on the target variables. A total of 101'784 patients were enrolled in 2013, whereas 54 % were PD patients. We find that PD is associated with lower pharmaceutical expenditure per patient, which can be explained by an increased use of generic drugs. The decrease is compensated by higher use of physician services. We find no significant impact of physician dispensing on total health care expenditure. Our study offers insights for policy makers who are (re-)considering the separation between drug prescribing and dispensing, either by allowing physicians to dispense or pharmacists to prescribe certain drugs. In terms of total health care expenditures, we find no difference between the two systems, so we are doubtful that changing dispensing rights are a good measure to contain cost, at least in Switzerland.

  1. Drug-induced Parkinsonism versus Idiopathic Parkinson Disease: Utility of Nigrosome 1 with 3-T Imaging.

    PubMed

    Sung, Young Hee; Noh, Young; Lee, Jongho; Kim, Eung Yeop

    2016-06-01

    Purpose To explore the utility of nigrosome 1 with 3-T magnetic resonance (MR) imaging to differentiate idiopathic Parkinson disease (IPD) from drug-induced parkinsonism (DIP). Materials and Methods The institutional review board approved this study, and participants gave informed consent. This study enrolled patients with DIP (n = 20) and IPD (n = 29) who underwent N-3-fluoropropyl-2-β-carbomethoxy-3-β-(4-iodophenyl)nortropane ((18)F-FP-CIT) positron emission tomography (PET) and healthy participants (n = 20). All participants underwent 0.5 × 0.5 × 1.0 mm(3) oblique axial three-dimensional multiecho-data image combination imaging to view the nigrosome 1 with 3-T imaging. Two reviewers independently assessed the nigrosome 1 without clinical information. DIP was diagnosed when no abnormality was seen at (18)F-FP-CIT PET. Diagnostic sensitivity, specificity, and accuracy of the nigrosome 1 imaging were evaluated between the IPD and DIP patients and between the IPD patients and healthy participants. Interrater agreement was assessed with Cohen κ. Results Both reviewers agreed in 63 of 69 participants (91.3%) for the presence of any abnormality on either side of the nigrosome 1 (κ = 0.825). Findings in all 29 IPD patients (100%) and three of 20 DIP patients (15%) were rated as abnormal and in 17 of 20 DIP patients (85%) they were interpreted as normal on the basis of imaging of the nitgrosome 1 (sensitivity, 100% (29 of 29); specificity, 85.0% (17 of 20); accuracy, 93.9% (46 of 49) between IPD and DIP patients). Findings in 3 of 20 healthy participants (15.0%) were interpreted as abnormal on the basis of imaging the nigrosome 1 while in the other 17 of 20 healthy participants (85.0%) they were rated as normal (sensitivity, 100% [29 of 29]; specificity, 85.0% [17 of 20]; accuracy, 93.9% [46 of 49] between IPD patients and healthy participants [κ = 0.831]). Conclusion The imaging of nigrosome 1 with 3-T imaging can differentiate DIP from IPD with high accuracy and

  2. Market feasibility study of utility battery applications: Penetration of battery energy storage into regulated electric utilities

    SciTech Connect

    Akhil, A.; Kraft, S.; Symons, P.C.

    1997-12-01

    Although recent studies indicate there could be significant opportunities for battery systems in electric utility applications, markets for this and other dispersed energy storage technologies have been slow to develop. Prior analyses had suggested that the slow market development has resulted from reluctance to make the necessary investments on the part of both suppliers and customers. In order to confirm this and other concerns over the utility energy storage market, an assessment has been performed to estimate the potential penetration of batteries into regulated electric utilities. The estimates thus obtained confirm that the possible market for batteries on the utility side of the meter, approximately $280 million annually in 2010, is indeed smaller than indicated by the assessment of potential opportunities had suggested it might be. On the other hand, the estimates for possible market penetration on the customer side of the meter are greater than on the utility-side, particularly in the nearer-term. Of more importance than the numeric results, however, are the comments given by potential customers of utility battery energy storage, and the conclusions regarding ways to increase the attractiveness of utility battery energy storage that result from analyses of these comments.

  3. Indications of success: Strategies for utilizing neuroimaging biomarkers in CNS drug discovery and development: CINP/JSNP working group report.

    PubMed

    Suhara, Tetsuya; Chaki, Shigeyuki; Kimura, Haruhide; Furusawa, Makoto; Matsumoto, Mitsuyuki; Ogura, Hiroo; Negishi, Takaaki; Saijo, Takeaki; Higuchi, Makoto; Omura, Tomohiro; Watanabe, Rira; Miyoshi, Sosuke; Nakatani, Noriaki; Yamamoto, Noboru; Liou, Shyh-Yuh; Takado, Yuhei; Maeda, Jun; Okamoto, Yasumasa; Okubo, Yoshiaki; Yamada, Makiko; Ito, Hiroshi; Walton, Noah M; Yamawaki, Shigeto

    2016-12-28

    Despite large unmet medical needs in the field for several decades, central nervous system (CNS) drug discovery and development has been largely unsuccessful. Biomarkers, particularly those utilizing neuroimaging, have played important roles in aiding CNS drug development, including dosing determination of investigational new drugs (INDs). The utility of biomarkers as tools to overcome issues of CNS drug development is the subject for this review.In this review aimed at employing biomarkers as tools to overcome issues surrounding CNS drug development, we first analyzed problems in utilizing biomarkers in processes of drug discovery and development for CNS disorders. Based on this analysis, we propose a new paradigm containing five distinct tiers to further clarify the use of biomarkers and establish new strategies for decision-making in the context of clinical drug development. Specifically, we discuss more rational ways to determine optimal dose for INDs with novel mechanisms and targets, and propose additional categorization criteria to further the use of biomarkers in patient stratification and efficacy prediction. Finally, we propose validation and development of new neuroimaging biomarkers through Public-Private-Partnerships to realize rational and successful drug discovery and development for CNS disorders.

  4. Specific systems studies of battery energy storage for electric utilities

    SciTech Connect

    Akhil, A.A.; Lachenmeyer, L.; Jabbour, S.J.; Clark, H.K.

    1993-08-01

    Sandia National Laboratories, New Mexico, conducts the Utility Battery Storage Systems Program, which is sponsored by the US Department of Energy`s Office of Energy Management. As a part of this program, four utility-specific systems studies were conducted to identify potential battery energy storage applications within each utility network and estimate the related benefits. This report contains the results of these systems studies.

  5. A study of critical thinking and research utilization among nurses.

    PubMed

    Profetto-McGrath, Joanne; Hesketh, Kathryn L; Lang, Sarah; Estabrooks, Carole A

    2003-04-01

    Previous studies have suggested that critical thinking influences research utilization; however, empirical support for the link between critical thinking dispositions and research utilization is nonexistent. In this article, critical thinking dispositions and research utilization habits are detailed, and the relationship of critical thinking dispositions to research utilization in a sample of 141 nurses working on two acute surgical units and five pediatric units in four tertiary care hospitals are examined. Results indicate a significant positive correlation between the total critical thinking disposition score and overall research utilization. Overall critical thinking disposition correlates significantly with all forms of research utilization, with the exception of symbolic research utilization. These findings indicate a need to foster critical thinking in both nursing education and the work environment.

  6. Sale of drugs and health care utilization in a health care district in Zaire.

    PubMed

    Courtois, X; Dumoulin, J

    1995-06-01

    Health centres of Idjwi district (Zaire) have been self-financed through the selling of drugs since 1985. Medical care is expensive and its use is low (24 visits per year per 100 inhabitants). In 1989 the medical team tried to reduce the cost of visits by changing the prices of drugs and prescriptions. A limited control was set up to assess this intervention. The study showed that although prescribed drug costs were stabilized compared to inflation, there was no increase in the use of medical care. Moreover, the reduction of drug profit margins for health centres seriously affected the health care institution by causing a drop in income. Six months after the intervention the monthly accounts showed a deficit in 6 centres out of 8. The need for health care centres to be self-financing is a major limiting factor in the use of health care in Idjwi district. There are no easy solutions for health centre managers that satisfy both low-cost access to care and health care self-financing. Some minimal financial participation from the state is required. Only then can the concept of financing health care through the selling of drugs be operational.

  7. Utility of preclinical drug versus food choice procedures to evaluate candidate medications for methamphetamine use disorder.

    PubMed

    Banks, Matthew L

    2017-04-01

    Substance use disorders are diagnosed as a manifestation of inappropriate behavioral allocation toward abused drugs and away from other behaviors maintained by more adaptive nondrug reinforcers (e.g., money and social relationships). Substance use disorder treatment goals include not only decreasing drug-maintained behavior but also promoting behavioral reallocation toward these socially adaptive alternative reinforcers. Preclinical drug self-administration procedures that offer concurrent access to both drug and nondrug reinforcers provide a translationally relevant dependent measure of behavioral allocation that may be useful for candidate medication evaluation. In contrast to other abused drugs, such as heroin or cocaine, preclinical methamphetamine versus food choice procedures have been a more recent development. We hypothesize that preclinical to clinical translatability would be improved by the evaluation of repeated pharmacological treatment effects on methamphetamine self-administration under a methamphetamine versus food choice procedure. In support of this hypothesis, a literature review suggests strong concordance between preclinical pharmacological treatment effects on methamphetamine versus food choice in nonhuman primates and clinical medication treatment effects on methamphetamine self-administration in human laboratory studies or methamphetamine abuse metrics in clinical trials. In conclusion, this literature suggests preclinical methamphetamine versus food choice procedures may be useful in developing innovative pharmacotherapies for methamphetamine use disorder. © 2016 New York Academy of Sciences.

  8. The Affordable Care Act, health care reform, prescription drug formularies and utilization management tools.

    PubMed

    Ung, Brian L; Mullins, C Daniel

    2015-01-01

    The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability.

  9. The utility of modeling and simulation in drug development and regulatory review.

    PubMed

    Huang, Shiew-Mei; Abernethy, Darrell R; Wang, Yaning; Zhao, Ping; Zineh, Issam

    2013-09-01

    US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. Published 2013. This article is a U.S. Government work and is in the public domain in the USA. 102:2912-2923, 2013.

  10. An Oral Contraceptive Drug Interaction Study

    ERIC Educational Resources Information Center

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  11. An Oral Contraceptive Drug Interaction Study

    ERIC Educational Resources Information Center

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  12. A Case Report of Clonazepam Dependence: Utilization of Therapeutic Drug Monitoring During Withdrawal Period.

    PubMed

    Kacirova, Ivana; Grundmann, Milan; Silhan, Petr; Brozmanova, Hana

    2016-03-01

    Clonazepam is long-acting benzodiazepine agonist used in short-acting benzodiazepine withdrawal; however, recent observations suggest the existence of its abuse. We demonstrate a 40-year-old man with a 20-year history of psychiatric care with recently benzodiazepine dependence (daily intake of ∼60 mg of clonazepam and 10 mg of alprazolam). High serum levels of both drugs were analyzed 3 weeks before admission to hospitalization (clonazepam 543.9 ng/mL, alprazolam 110 ng/mL) and at the time of admission (clonazepam 286.2 ng/mL, alprazolam 140 ng/mL) without any signs of benzodiazepine intoxication. Gradual withdrawal of clonazepam with monitoring of its serum levels and increase of gabapentin dose were used to minimize physical signs and symptoms of clonazepam withdrawal. Alprazolam was discontinued promptly. Clinical consequences of the treatment were controllable tension, intermittent headache, and rarely insomia. It is the first case report showing utilization of therapeutic drug monitoring during withdrawal period in the patient with extreme toleration to severe benzodiazepine dependence.

  13. Utilization of the Arkansas Prescription Monitoring Program to combat prescription drug abuse

    PubMed Central

    Rittenhouse, Rebecca; Wei, Feifei; Robertson, Denise; Ryan, Kevin

    2015-01-01

    Objective The Arkansas Prescription Monitoring Program (AR PMP) was implemented in 2013 to combat prescription drug abuse. All enrollees were invited to participate in a user survey available in February 2014, to identify makeup of users, utilization of the program, and changes made to health care practices after implementation of the program. Methods Of the 3694 individual enrollees invited to participate, 1541 (41.7%) completed the survey. Data collected were analyzed to identify changes in health care practices by program frequency of use and user profession. Results Medical doctors, advanced practice nurses, and pharmacists are the professions who use the program most frequently. Daily AR PMP users are considerably more likely than infrequent users to be prompted to access the program by the involvement of a controlled substance (CS) prescription or by office/facility policy requirements. Increased frequency of use of the AR PMP results in positive impacts on CS prescribing and dispensing practices. Conclusion Compelling more users of the AR PMP to be prompted to access the program by the involvement of a CS prescription or by requirements per office/facility policy may increase frequency of use of the program and thereby changes in health care practices to combat prescription drug abuse. PMID:26191489

  14. Impact of China's Public Hospital Reform on Healthcare Expenditures and Utilization: A Case Study in ZJ Province.

    PubMed

    Zhang, Hao; Hu, Huimei; Wu, Christina; Yu, Hai; Dong, Hengjin

    2015-01-01

    High drug costs due to supplier-induced demand (SID) obstruct healthcare accessibility in China. Drug prescriptions can generate markup-related profits, and the low prices of other medical services can lead to labor-force underestimations; therefore, physicians are keen to prescribe drugs rather than services. Thus, in China, a public hospital reform has been instituted to cancel markups and increase service prices. A retrospective pre/post-reform study was conducted in ZJ province to assess the impact of the reform on healthcare expenditures and utilization, ultimately to inform policy development and decision-making. The main indicators are healthcare expenditures and utilization. Post-reform, drug expenditures per visit decreased by 8.2% and 15.36% in outpatient and inpatient care, respectively; service expenditures per visit increased by 23.03% and 27.69% in outpatient and inpatient care, respectively. Drug utilization per visit increased by 5.58% in outpatient care and underwent no significant change in inpatient care. Both were lower than the theoretical drug-utilization level, which may move along the demand curve because of patient-initiated demand (PID); this indicates that SID-promoted drug utilization may decrease. Finally, service utilization per visit increased by 6% in outpatient care and by 13.10% in inpatient care; both were higher than the theoretical level moving along the demand curve, and this indicates that SID-promoted service utilization may increase. The reform reduces drug-prescription profits by eliminating drug markups; additionally, it compensates for service costs by increasing service prices. Post-reform, the SID of drug prescriptions decreased, which may reduce drug-resource waste. The SID of services increased, with potentially positive and negative effects: accessibility to services may be promoted when physicians provide more services, but the risk of resource waste may also increase. This warrants further research. It is

  15. Epidemiological study of epilepsy by monitoring prescriptions of antiepileptic drugs.

    PubMed

    Banfi, R; Borselli, G; Marinai, C; Borgheresi, A; Cavalieri, A

    1995-07-28

    The aim of this study is to evaluate a simple and effective method of acquiring epidemiological information about epilepsy. Data on antiepileptic drug prescriptions was collected, the utilization pattern being based on defined daily doses (DDDs). Antiepileptic drugs are epidemiological tracers of epilepsy due to their chronic and highly specific usage. Consequently, a prevalence rate for the whole population may be obtained by using DDDs. Data on antiepileptic drug prescriptions for a period of 6 months in 1992 and 6 months in 1993 indicate a utilization of approximately 7 DDDs of antiepileptic drugs per 1,000 inhabitants. The prevalence of epilepsy was estimated by correcting the exposure calculated in DDDs by a factor of 0.68. In our sample, the prevalence of the disease was 5.2 per 1,000 inhabitants in 1992 and 4.9 per 1,000 in 1993. Physician prescriptions were concentrated on four compounds, namely phenobarbital, carbamazepine, valproic acid and phenytoin, which together represented 90% of total antiepileptic drug prescriptions.

  16. Biologic Disease-Modifying Antirheumatic Drugs in a National, Privately Insured Population: Utilization, Expenditures, and Price Trends.

    PubMed

    Atzinger, Christopher B; Guo, Jeff J

    2017-02-01

    Spending on biologic drugs is a significant driver of drug expenditures for payers in private health plans. Biologic disease-modifying antirheumatic drugs (DMARDs) are some of the most effective and costly treatments in a physician's arsenal. Understanding the total annual expenditure, the average cost per prescription, and the impact of cost-sharing is important for drug benefit managers. To assess drug utilization, expenditures, out-of-pocket (OOP) cost, and price trends of biologic DMARDs in patients with rheumatoid arthritis (RA) in a large managed care organization. We conducted a retrospective database analysis of pharmacy claims data from January 2004 to December 2013 using the Optum Clinformatics Data Mart database, which covers 13.3 million lives. Pharmacy claims for 40,373 patients with RA were identified during the study period. In all, 9 biologic DMARDs approved for the treatment of RA, including infliximab, etanercept, adalimumab, certoizumab, golimumab, tocilizumab, anakinra, abatacept, and rituximab, and 1 nonbiologic oral, small molecule-targeted synthetic drug, tofacitinib, were included in this study. Descriptive statistics were used to analyze the total annual number of prescriptions, the total annual expenditures, the average annual cost per drug (a proxy of drug price), and the average OOP cost (copay plus deductible and coinsurance). All measurements were also stratified by study drugs and by insurance type. Of the 40,373 patients with RA included in the study, approximately 76% were female (mean age, 55 years at diagnosis). Approximately 77% of the patients were white, and almost 48% lived in the South or Midwest region of the United States. Approximately 62% of patients had a point of service insurance plan. Expenditures on biologic DMARDs increased from $166 million in 2004 to $243 million in 2013, and the number of prescriptions and refills increased from 59,960 in 2004 to 105,295 in 2013. Prescriptions for biologic DMARDs increased more

  17. Paralegal Studies Program. Curriculum Utilization. Final Report.

    ERIC Educational Resources Information Center

    Humphrey, Doris D.

    A program developed a paralegal studies program for Delaware County Community College in the Philadelphia (Pennsylvania) metropolitan area. Activities included gathering of information on paralegal studies as it related to curriculum content; advisory group establishment; curriculum development; training/educational material development; and…

  18. Impact of drug price adjustments on utilization of and expenditures on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in Taiwan.

    PubMed

    Huang, Shiou-Huei; Hsu, Chien-Ning; Yu, Shu-Hui; Cham, Thau-Ming

    2012-05-31

    A previous study has suggested that drug price adjustments allow physicians in Taiwan to gain greater profit by prescribing generic drugs. To better understand the effect of price adjustments on physician choice, this study used renin-angiotensin drugs (including angiotensin-converting enzyme inhibitors [ACEIs] and angiotensin receptor blockers [ARBs]) to examine the impact of price adjustments on utilization of and expenditures on patented and off-patent drugs with the same therapeutic indication. Using the Taiwan's Longitudinal Health Insurance Database (2005), we identified 147,157 patients received ACEIs and/or ARBs between 1997 and 2008. The annual incident and prevalent users of ACEIs, ARBs and overall renin-angiotensin drugs were examined. Box-Tiao intervention analysis was applied to assess the impact of price adjustments on monthly utilization of and expenditures on these drugs. ACEIs were divided into patented and off-patent drugs, off-patent ACEIs were further divided into original brands and generics, and subgroup analyses were performed. The number of incident renin-angiotensin drug users decreased over the study period. The number of prevalent ARB users increased and exceeded the cumulative number of first-time renin-angiotensin drug users starting on ARBs, implying that some patients switched from ACEIs to ARBs. After price adjustments, long term trend increases in utilization were observed for patented ACEIs and ARBs; a long-term trend decrease was observed for off-patent ACEIs; long-term trend change was not significant for overall renin-angiotensin drugs. Significant long-term trend increases in expenditures were observed for patented ACEIs after price adjustment in 2007 (200.9%, p = 0.0088) and in ARBs after price adjustments in 2001 (173.4%, p < 0.0001) and 2007 (146.3%, p < 0.0001). A significant long-term trend decrease in expenditures was observed for off-patent ACEIs after 2004 price adjustment (-156.9%, p < 0

  19. Impact of drug price adjustments on utilization of and expenditures on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in Taiwan

    PubMed Central

    2012-01-01

    Background A previous study has suggested that drug price adjustments allow physicians in Taiwan to gain greater profit by prescribing generic drugs. To better understand the effect of price adjustments on physician choice, this study used renin-angiotensin drugs (including angiotensin-converting enzyme inhibitors [ACEIs] and angiotensin receptor blockers [ARBs]) to examine the impact of price adjustments on utilization of and expenditures on patented and off-patent drugs with the same therapeutic indication. Methods Using the Taiwan’s Longitudinal Health Insurance Database (2005), we identified 147,157 patients received ACEIs and/or ARBs between 1997 and 2008. The annual incident and prevalent users of ACEIs, ARBs and overall renin-angiotensin drugs were examined. Box-Tiao intervention analysis was applied to assess the impact of price adjustments on monthly utilization of and expenditures on these drugs. ACEIs were divided into patented and off-patent drugs, off-patent ACEIs were further divided into original brands and generics, and subgroup analyses were performed. Results The number of incident renin-angiotensin drug users decreased over the study period. The number of prevalent ARB users increased and exceeded the cumulative number of first-time renin-angiotensin drug users starting on ARBs, implying that some patients switched from ACEIs to ARBs. After price adjustments, long term trend increases in utilization were observed for patented ACEIs and ARBs; a long-term trend decrease was observed for off-patent ACEIs; long-term trend change was not significant for overall renin-angiotensin drugs. Significant long-term trend increases in expenditures were observed for patented ACEIs after price adjustment in 2007 (200.9%, p = 0.0088) and in ARBs after price adjustments in 2001 (173.4%, p < 0.0001) and 2007 (146.3%, p < 0.0001). A significant long-term trend decrease in expenditures was observed for off-patent ACEIs after 2004 price adjustment (

  20. Impact of hospital and sociodemographic factors on utilization of drug-eluting stents in 2011–2012 Medicare cohort

    PubMed Central

    Tuliani, Tushar A.; Shenoy, Maithili; Parikh, Milind; Cohen, Mauricio G.; Grines, Cindy; Jutzy, Kenneth; Hilliard, Anthony

    2017-01-01

    Objective: Insurance status is a predictor of drug-eluting stent (DES) usage. Our study sought to determine the effect of hospital and sociodemographic characteristics on utilization of DES in nationwide inpatient discharges with uniform insurance (Medicare). Methods: We linked data from the 2011 to 2012 Medicare discharges, 2011 Medicare hospital referral region (HRR) report (racial composition of each HRR), American Hospital Association (number of beds, rural/urban location, public/private status, and academic affiliation of hospitals), and American Community Survey 2011 (median income using zip code). We analyzed diagnosis-related group (DRG) codes 249 (bare metal stent without complications), 246, and 247 (DES with and without complications, respectively). Univariate and multivariable logistic regression was conducted to determine odds ratios (OR) for utilization of DES. Results: There were 322,002 discharges with DRG codes 246 (54,279), 247 (209,365), and 249 (58,358) in our database. Higher odds of DES usage was observed in Hispanic dominant HRR(s) (OR: 1.37, 95% confidence interval [CI]: 1.33–1.42, P < 0.001) compared to Caucasian dominant HRR(s). DES utilization was similar in African-American and Caucasian dominant HRR (s). Higher odds of DES use was observed in median household income groups ≥$20,001 (OR: 1.07, 95% CI: 1.01–1.13, P - 0.03). Lower DES usage was observed in hospitals with higher total stent volume (quartile 4 vs. quartile 1: OR: 0.66, 95% CI: 0.63–0.69, P < 0.001) and for-profit hospitals (OR: 0.88, 95% CI: 0.85–0.92, P < 0.001). Conclusions: Our study findings suggest that there are significant differences in DES utilization in a national cohort of individuals with uniform insurance. PMID:28182024

  1. Utilization of date syrup as a tablet binder, comparative study

    PubMed Central

    Alanazi, Fars Kaed

    2010-01-01

    The aim of this study was to investigate the possibility of using dates syrup as a tablet binder. Dates syrup (40%, 50%, 60% w/w dates syrup:water) was utilized for the granulation of sodium bicarbonate and calcium carbonate as examples for water-soluble and water-insoluble materials; correspondingly. Those two materials represent examples of bulky drugs as well. Starch paste (10% w/w starch in water) and sucrose syrup (50% w/w sucrose in water), the well-known tablet binders, were used in the granulation of the same materials for the sake of comparison. The granulations were evaluated with regard to particle size and particle size distribution, granule strength, bulk density, flowability, moisture content and compression behavior. In addition, tablets prepared and evaluated from these granules. Taste and flavor of the prepared tablet have been tested by seven healthy volunteers. Within the scope of this work, dates syrup showed excellent properties as a tablet binder in comparison to starch paste or sucrose syrup for the granulation of both water-soluble and water-insoluble materials. Also, better flavoring and masking taste have been noticed from an evaluation by human volunteers demonstrating the usefulness of the date syrup as sweetener and flavoring the tablets in addition to its use as binder. PMID:23960724

  2. Dynamic SIMS utilizing SF 5+ polyatomic primary ion beams for drug delivery applications

    NASA Astrophysics Data System (ADS)

    Mahoney, Christine M.; Roberson, Sonya; Gillen, Greg

    2004-06-01

    The behavior of various biodegradable polymer films (e.g. polylactic acid, polyglycolic acid and polycaprolactone) as well as some model drugs (theophylline and 4-acetamidophenol) under dynamic SF 5+ primary ion bombardment is explored. A series of polylactic acid films containing varying concentrations of 4-acetamidophenol are also analyzed under similar conditions. The resultant molecular depth profiles obtained from these polymer films doped with drug show very little degradation in molecular signal as a function of SF 5+ primary ion dose, and it was found that the molecular ion signals of both polymer and drug remained constant for ion doses up to ˜5×10 15 ions/cm 2. In addition, the polymer film/Si interface was well defined which may imply that sputter-induced topography formation was not a significant limitation. These results suggest that the structure of the biodegradable polymers studied here which all have the common main chain structural unit, RCOOR, allows for a greater ability to depth profile due to ease of bond cleavage. Most importantly, however, these results indicate that in these particular polymer systems, the distribution of the drug as a function of depth can be monitored.

  3. Space Station RT and E Utilization Study

    NASA Technical Reports Server (NTRS)

    Wunsch, P. K.; Anderson, P. H.

    1989-01-01

    Descriptive information on a set of 241 mission concepts was reviewed to establish preliminary Space Station outfitting needs for technology development missions. The missions studied covered the full range of in-space technology development activities envisioned for early Space Station operations and included both pressurized volume and attached payload requirements. Equipment needs were compared with outfitting plans for the life sciences and microgravity user communities, and a number of potential outfitting additions were identified. Outfitting implementation was addressed by selecting a strawman mission complement for each of seven technical themes, by organizing the missions into flight scenarios, and by assessing the associated outfitting buildup for planning impacts.

  4. Differential effects of ibogaine on local cerebral glucose utilization in drug-naive and morphine-dependent rats.

    PubMed

    Levant, Beth; Pazdernik, Thomas L

    2004-04-02

    Ibogaine, a hallucinogenic indole alkaloid, has been proposed as a treatment for addiction to opioids and other drugs of abuse. The mechanism for its putative anti-addictive effects is unknown. In this study, the effects of ibogaine on local cerebral glucose utilization (LCGU) were determined in freely moving, drug-naive, or morphine-dependent adult, male, Sprague-Dawley rats using the [(14)C]2-deoxyglucose (2-DG) method. Morphine-dependent rats were treated with increasing doses of morphine (5-25 mg/kg, s.c., b.i.d.) and then maintained at 25 mg/kg (b.i.d.) for 4-7 days. For the 2-DG procedure, rats were injected with saline or ibogaine (40 mg/kg, i.p.). 2-DG was administered 1 h after administration of ibogaine. The rate of LCGU was determined by quantitative autoradiography in 46 brain regions. In drug-naive animals, ibogaine produced significant increases in LCGU in the parietal, cingulate, and occipital cortices and cerebellum compared to controls consistent with its activity as a hallucinogen and a tremorogen. Morphine-dependent rats had only minor alterations in LCGU at the time assessed in this experiment. However, in morphine-dependent animals, ibogaine produced a global decrease in LCGU that was greatest in brain regions such as the lateral and medial preoptic areas, nucleus of the diagonal band, nucleus accumbens shell, inferior colliculus, locus coeruleus, and flocculus compared to morphine-dependent animals treated with saline. These findings indicate that ibogaine produces distinctly different effects on LCGU in drug-naive and morphine-dependent rats. This suggests that different mechanisms may underlie ibogaine's hallucinogenic and anti-addictive effects.

  5. Predictions instead of panics: the framework and utility of systematic forecasting of novel psychoactive drug trends.

    PubMed

    Stogner, John M

    2015-01-01

    Countless novel psychoactive substances have been sensationally described in the last 15 years by the media and academia. Though some become significant issues, most fail to become a substantial threat. The diversity and breadth of these potential problem substances has led policymakers, law enforcement officers, and healthcare providers alike to feel overwhelmed and underprepared for dealing with novel drugs. Inadequacies in training and preparation may be remedied by a response that is more selective and more proactive. The current manuscript seeks to clarify how to most efficiently forecast the "success" of each newly introduced novel psychoactive substance in order to allow for more efficient decision making and proactive resource allocation. A review of literature, published case reports, and legal studies was used to determine which factors were most closely linked to use of a novel drug spreading. Following the development of a forecasting framework, examples of its use are provided. The resulting five-step forecast method relies on assessments of the availability of a potential user base, the costs--legal and otherwise--of the drug relative to existent analogues, the subjective experience, the substance's dependence potential and that of any existent analogue, and ease of acquisition. These five factors should serve to forecast the prevalence of novel drug use, but reaction should be conditioned by the potential for harm. The five-step forecast method predicts that use of acetyl fentanyl, kratom, Leonotis leonurus, and e-cigarettes will grow, but that use of dragonfly and similar substances will not. While this forecasting approach should not be used as a replacement for monitoring, the use of the five-step method will allow policymakers, law enforcement and practitioners to quickly begin targeted evaluative, intervention, and treatment initiatives only for those drugs with predicted harm.

  6. Inpatient drug utilization in Europe: nationwide data sources and a review of publications on a selected group of medicines (PROTECT project).

    PubMed

    Sabaté, Mònica; Ferrer, Pili; Ballarín, Elena; Rottenkolber, Marietta; Amelio, Justyne; Schmiedl, Sven; Reynolds, Robert; Klungel, Olaf; Ibáñez, Luisa

    2015-03-01

    Drug utilization (DU) studies in inpatient settings at a national level are rarely conducted. The main objective of this study was to review the general information on hospital medicine management in Europe and to report on the availability and characteristics of nationwide administrative drug consumption databases. A secondary objective was to perform a review of published studies on hospital DU of a group of selected drugs, focusing on methodological characteristics (ATC/DDD). General information on hospital drug management was retrieved from several websites, nationwide administrative drug consumption databases and reports published by governmental organizations. A PubMed search was conducted using keywords related to the selected group of drugs AND 'hospital drug utilization'. The data sources for hospital DU information varied widely and included 14 databases from 25 reviewed countries. Bulgaria, Croatia, Denmark, Estonia, Finland, France, Hungary, Iceland, Latvia, Norway and Sweden obtain information on inpatient DU at a national level from wholesalers/manufacturers. In Belgium, Italy and Portugal, drugs dispensed to patients in hospitals are registered at a national level. Data are freely available online only for Denmark and Iceland. From the PubMed search, of a total of 868 retrieved studies, only 13 studies used the ATC/DDD methodology. Although the number of DDD/100 bed-days was used in four studies, other units of measure were also used. The type of information provided for the inpatient sector allowed primarily for conducting DU research at an aggregated data level. The existence of national administrative structures to monitor hospital DU would contribute to promoting the rational use of medicines and improving the safety and quality of prescribing. © 2014 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  7. Vaccine and Drug Ontology Studies (VDOS 2014).

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2016-01-01

    The "Vaccine and Drug Ontology Studies" (VDOS) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, developing new models such as the Vaccine Ontology (VO) and Ontology of Adverse Events (OAE), vernacular medical terminologies such as the Consumer Health Vocabulary (CHV). The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The five full-length papers included in this 2014 thematic issue focus on two main themes: (i) General vaccine/drug-related ontology development and exploration, and (ii) Interaction and network-related ontology studies.

  8. Utilization of iPSC-derived human neurons for high-throughput drug-induced peripheral neuropathy screening.

    PubMed

    Rana, Payal; Luerman, Gregory; Hess, Dietmar; Rubitski, Elizabeth; Adkins, Karissa; Somps, Christopher

    2017-08-24

    As the number of cancer survivors continues to grow, awareness of long-term toxicities and impact on quality of life after chemotherapy treatment in cancer survivors has intensified. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of modern chemotherapy. Animal models are used to study peripheral neuropathy and predict human risk; however, such models are labor-intensive and limited translatability between species has become a major challenge. Moreover, the mechanisms underlying CIPN have not been precisely determined and few human neuronal models to study CIPN exist. Here, we have developed a high-throughput drug-induced neurotoxicity screening model using human iPSC-derived peripheral-like neurons to study the effect of chemotherapy agents on neuronal health and morphology using high content imaging measurements (neurite length and neuronal cell viability). We utilized this model to test various classes of chemotherapeutic agents with known clinical liability to cause peripheral neuropathy such as platinum agents, taxanes, vinca alkaloids, proteasome inhibitors, and anti-angiogenic compounds. The model was sensitive to compounds that cause interference in microtubule dynamics, especially the taxane, epothilone, and vinca alkaloids. Conversely, the model was not sensitive to platinum and anti-angiogenic chemotherapeutics; compounds that are not reported to act directly on neuronal processes. In summary, we believe this model has utility for high-throughput screening and prediction of human risk for CIPN for novel chemotherapeutics. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Investigation of utilization of nanosuspension formulation to enhance exposure of 1,3-dicyclohexylurea in rats: Preparation for PK/PD study via subcutaneous route of nanosuspension drug delivery

    NASA Astrophysics Data System (ADS)

    Chiang, Po-Chang; Ran, Yingqing; Chou, Kang-Jye; Cui, Yong; Wong, Harvey

    2011-06-01

    1,3-Dicyclohexylurea (DCU), a potent soluble epoxide hydrolase (sEH) inhibitor has been reported to lower systemic blood pressure in spontaneously hypertensive rats. One limitation of continual administration of DCU for in vivo studies is the compound's poor oral bioavailability. This phenomenon is mainly attributed to its poor dissolution rate and low aqueous solubility. Previously, wet-milled DCU nanosuspension has been reported to enhance the bioavailability of DCU. However, the prosperities and limitations of wet-milled nanosuspension have not been fully evaluated. Furthermore, the oral pharmacokinetics of DCU in rodent are such that the use of DCU to understand PK/PD relationships of sEH inhibitors in preclinical efficacy model is less than ideal. In this study, the limitation of orally delivered DCU nanosuspension was assessed by a surface area sensitive absorption model and pharmacokinetic modeling. It was found that dosing DCU nanosuspension did not provide the desired plasma profile needed for PK/PD investigation. Based on the model and in vivo data, a subcutaneous route of delivery of nanosuspension of DCU was evaluated and demonstrated to be appropriate for future PK/PD studies.

  10. Investigation of utilization of nanosuspension formulation to enhance exposure of 1,3-dicyclohexylurea in rats: Preparation for PK/PD study via subcutaneous route of nanosuspension drug delivery.

    PubMed

    Chiang, Po-Chang; Ran, Yingqing; Chou, Kang-Jye; Cui, Yong; Wong, Harvey

    2011-06-07

    1,3-Dicyclohexylurea (DCU), a potent soluble epoxide hydrolase (sEH) inhibitor has been reported to lower systemic blood pressure in spontaneously hypertensive rats. One limitation of continual administration of DCU for in vivo studies is the compound's poor oral bioavailability. This phenomenon is mainly attributed to its poor dissolution rate and low aqueous solubility. Previously, wet-milled DCU nanosuspension has been reported to enhance the bioavailability of DCU. However, the prosperities and limitations of wet-milled nanosuspension have not been fully evaluated. Furthermore, the oral pharmacokinetics of DCU in rodent are such that the use of DCU to understand PK/PD relationships of sEH inhibitors in preclinical efficacy model is less than ideal. In this study, the limitation of orally delivered DCU nanosuspension was assessed by a surface area sensitive absorption model and pharmacokinetic modeling. It was found that dosing DCU nanosuspension did not provide the desired plasma profile needed for PK/PD investigation. Based on the model and in vivo data, a subcutaneous route of delivery of nanosuspension of DCU was evaluated and demonstrated to be appropriate for future PK/PD studies.

  11. Physicians' and pharmacists' perceptions on real-time drug utilization review system: a nationwide survey.

    PubMed

    Lee, Seung-Mi; Lee, Soo-Ok; Kim, Dong-Sook

    2017-10-01

    To identify healthcare providers' experience and satisfaction for the drug utilization review (DUR) system, their impact on prescription changes following alerts, and difficulties experienced in the system by surveying primary healthcare centers and pharmacies. A cross-sectional nationwide survey. Approximately 2000 institutions were selected for the survey by a simple random sampling of nationwide primary healthcare centers and community pharmacy approximately practices, and 358 replied. The questionnaire included questions on experience and recognition of DUR alerts, personal attitude and respondents' biographical information. Space was included for respondents to suggest improvements of the DUR system. The DUR system scored 71.5 out of 100 points for satisfaction by physicians and pharmacists, who reported that the alerts prevent medication-related errors; most respondents (96.6%) received the alerts. Several respondents (10.9%) replied that they prescribe or dispense prescriptions as they are without following the alerts. Physicians (adjusted odds ratio, 8.334; 95% confidence interval, 3.449-20.139) are more likely to change the prescription than pharmacists and persons with alert experience (4.605; 1.080-19.638). However, current practice in metropolitan areas (0.478; 0.228-1.000) and frequent alerts regarding co-administration incompatibilities within prescriptions (0.135; 0.031-0.589) negatively influence adherence to DUR alerts. Although most surveyed physicians and pharmacists receive the alerts, some do not or reported that they would not follow the alerts. To increase adherence, the DUR system should be improved to ensure a preferential and intensive approach to detecting potentially high-risk drug combinations.

  12. Drug utilization review of mupirocin ointment in a Korean university-affiliated hospital

    PubMed Central

    Youn, Sung Hee; Kim, Sukyeon; Lee, Jeong-a; Kim, Bum Joon; Kim, Jounghee; Han, Hye-kyung; Kim, Jae-Seok

    2015-01-01

    Background/Aims Intranasal mupirocin and chlorhexidine bathing are candidate strategies to prevent healthcare-associated infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In Korea, intranasal mupirocin is not available, and mupirocin ointment, an over-the-counter drug, has been used indiscriminately. Furthermore, because it is covered by health insurance, mupirocin is easy to prescribe within hospitals. Methods We performed a mupirocin drug utilization review (DUR) within Hallym University Sacred Heart Hospital. Annual use of mupirocin was investigated between 2003 and 2013, and monthly consumption of mupirocin was assessed during the final 2-year period. The DUR focused on August 2012, the period of highest use of mupirocin. Also, we investigated trends in mupirocin resistance in MRSA between 2011 and 2013. Results Annual consumption of mupirocin increased from 3,529 tubes in 2003 to 6,475 tubes in 2013. During August 2012, 817 tubes were prescribed to 598 patients; of these, 84.9% were prescribed to outpatients, and 77.6% at the dermatology department. The most common indication was prevention of skin infections (84.9%), and the ointment was combined with systemic antibiotics in 62.9% of cases. The average duration of systemic antibiotic administration was about 7.8 days. The rate of low-level mupirocin resistance in MRSA increased from 8.0% to 22.0%, and that of high-level mupirocin resistance increased from about 4.0% to about 7.5%. Conclusions Inappropriate use of mupirocin is prevalent. Considering the increase in resistance and the future application of intranasal mupirocin, prophylactic use of mupirocin in dermatology departments should be reconsidered. PMID:26161018

  13. Kidney function assessment and its role in drug development, review and utilization.

    PubMed

    Tortorici, Michael A; Nolin, Thomas D

    2014-07-01

    A key regulatory requirement pertaining to drug development is characterization of the role of kidney function in drug disposition and response, along with provision of corresponding renal dose adjustment recommendations. Traditionally, this information has been derived from Phase I pharmacokinetic studies in which regulatory guidance exists for pharmaceutical manufacturers on the design, conduct, analysis, and interpretation of data. Categorization and stratification of subjects into kidney function groups and dosing recommendations have historically been based on creatinine clearance estimates using the Cockcroft-Gault equation. As new estimating equations have emerged, the choice of equation for assessment of kidney function has become an area of debate. This review highlights these equations and provides recent examples of the use of quantitative models, incorporating efficacy and safety to make rational dose recommendations in subjects with impaired kidney function.

  14. Utilization

    NASA Astrophysics Data System (ADS)

    Lu, Guozhi; Zhang, Ting-An; Zhu, Xiaofeng; Liu, Yan; Wang, Yanxiu; Guo, Fangfang; Zhao, Qiuyue; Zheng, Chaozhen

    2014-09-01

    In this study, a calcification-carbonation method is proposed to change the equilibrium structure of red mud produced from the Bayer process. The thermodynamics of both calcification and carbonation processes has been elucidated. In addition, the non-isothermal kinetics involved in the calcification process and the effects of different parameters on the hydrogarnet synthesis and carbonation decomposition are experimentally investigated using pure reagents. The results indicate that through a two-step carbonation treatment of calcified slag by the new method, the mass ratio of alumina to silica ( A/S) of the modified red mud has decreased to 0.44 and the Na2O content drops to 0.12 wt.% at the carbonation temperature of 120°C under the CO2 pressure of 1.2 MPa. The newly modified red mud could be directly used in the cement industry.

  15. Selection and utilization of assessment instruments in substance abuse treatment trials: the National Drug Abuse Treatment Clinical Trials Network experience

    PubMed Central

    Rosa, Carmen; Ghitza, Udi; Tai, Betty

    2012-01-01

    Based on recommendations from a US Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999, to accelerate the translation of science-based addiction treatment research into community-based practice, and to improve the quality of addiction treatment, using science as the vehicle. One of the CTN’s primary tasks is to serve as a platform to forge bi-directional communications and collaborations between providers and scientists, to enhance the relevance of research, which generates empirical results that impact practice. Among many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with focus on how the CTN study teams select and utilize assessment instruments, which can reasonably balance the interests of both research scientists and practicing providers when applied in CTN trials. This commentary also discusses the process by which the CTN further selects a core set of common assessment instruments that may be applied across all trials, to allow easier cross-study analyses of comparable data. PMID:22904649

  16. [Research on drug utilization in primary health care in national journals].

    PubMed

    Arnau, J M; Vallano, A; Artigas, R; Vallés, J A; Agustí, A; Colomé, E; Pontes, C; Diogene, E

    1991-12-01

    In order to discover the present state of research into the use of medication (UM) in primary care, articles published in the "Original Articles" sections of Medicina Clínica (MC) (Clinical Medicine) and Atención Primaria (AP) (Primary Care) between 1983 and 1990, were studied. A total of 130 articles that meet the definition of the WHO for studies into the use of Medications (SUM) were identified. The instigator and organiser of the research, the drugs included, the kind of study, the source of the data, the main variables used and the qualitative analysis made, were all studied. In conclusion we were able to point out that the characteristics of UM were met in the majority of the studies; although they are the main objective of the study in only a minority of cases. The people who undertook most of the research were those who themselves prescribed the drugs or dealt with very common pathologies. In general, the studies are only descriptive and have a poor level of assessment of the results.

  17. Utilizing Functional Genomics Screening to Identify Potentially Novel Drug Targets in Cancer Cell Spheroid Cultures

    PubMed Central

    Morrison, Eamonn; Wai, Patty; Leonidou, Andri; Bland, Philip; Khalique, Saira; Farnie, Gillian; Daley, Frances; Peck, Barrie; Natrajan, Rachael

    2016-01-01

    The identification of functional driver events in cancer is central to furthering our understanding of cancer biology and indispensable for the discovery of the next generation of novel drug targets. It is becoming apparent that more complex models of cancer are required to fully appreciate the contributing factors that drive tumorigenesis in vivo and increase the efficacy of novel therapies that make the transition from pre-clinical models to clinical trials. Here we present a methodology for generating uniform and reproducible tumor spheroids that can be subjected to siRNA functional screening. These spheroids display many characteristics that are found in solid tumors that are not present in traditional two-dimension culture. We show that several commonly used breast cancer cell lines are amenable to this protocol. Furthermore, we provide proof-of-principle data utilizing the breast cancer cell line BT474, confirming their dependency on amplification of the epidermal growth factor receptor HER2 and mutation of phosphatidylinositol-4,5-biphosphate 3-kinase (PIK3CA) when grown as tumor spheroids. Finally, we are able to further investigate and confirm the spatial impact of these dependencies using immunohistochemistry. PMID:28060271

  18. Drug utilization pattern and cost for the treatment of severe sepsis and septic shock in critically ill cancer patients.

    PubMed

    Nazer, Lama; Al-Shaer, Mohammad; Hawari, Feras

    2013-12-01

    Cancer patients are at high risk for developing sepsis. To our knowledge, there are no studies that evaluated the type of medications utilized and the associated cost in cancer patients with severe sepsis and septic shock. To describe the drug utilization pattern and drug cost in the treatment of cancer patients with severe sepsis and septic shock. 12-bed medical/surgical intensive care unit (ICU) of a comprehensive teaching cancer center. A retrospective cohort study of cancer patients with severe sepsis or septic shock who were treated in the ICU between January and December, 2010. The ICU sepsis database was used to identify patients. The patient demographics and characteristics were recorded. In addition, the number and type of prescribed medications, total cost for each medication, type of infection, and culture results were determined. The main outcomes were the type of medication classes utilized and the cost of the medications. During the study period, 116 cases were identified. Upon presentation, the mean Acute Physiology and Chronic Health Evaluation II (APACHE II) score was 21.8 (SD ± 7.8), 30 (25.9 %) patients had neutropenia, and 94 (81 %) had positive cultures. The total cost of the medications prescribed for this cohort of patients was 291,030 Euro. The mean number of medications prescribed per patient and the mean total cost per patient were 11.7 (SD ± 4.7) and 2,509 Euro (SD ± 2,844), respectively. The most commonly prescribed medication classes were acid suppressive therapy, glycopeptides, penicillins/cephalosporins and vasopressors prescribed in 113 (97 %), 104 (89.7 %), 103 (88.9 %), and 102 (88 %) patients, respectively. The highest medication costs were associated with antifungals (mean 1,288 Euro/patient) and colony stimulating factors (mean 829 Euro/patient), prescribed in 55 (47.4 %) and 37 (31.9 %) patients, respectively. Medication costs were higher in non-survivors, compared to survivors (3,664 Euro vs. 1,430 Euro, p = 0.0001), and in

  19. The Michigan regulatory incentives study for electric utilities

    SciTech Connect

    Reid, M.W.; Weaver, E.M. )

    1991-06-17

    This is the final report of Phase I of the Michigan Regulatory Incentives Study for Electric Utilities, a three-phase review of Michigan's regulatory system and its effects on resource selection by electric utilities. The goal of Phase I is to identify and analyze financial incentive mechanisms that encourage selection of resources in accord with the principles of integrated resource planning (IRP) or least-cost planning (LCP). Subsequent study phases will involve further analysis of options and possibly a collaborative formal effort to propose regulatory changes. The Phase I analysis proceeded in three steps: (1) identification and review of existing regulatory practices that affect utilities; selection of resources, particularly DSM; (2) preliminary analysis of ten financial mechanisms, and selection of three for further study; (3) detailed analysis of the three mechanisms, including consideration of how they could be implemented in Michigan and financial modeling of their likely impacts on utilities and ratepayers.

  20. PTSD, depression, prescription drug use, and health care utilization of Chinese workers affected by the WTC attacks.

    PubMed

    de Bocanegra, Heike Thiel; Moskalenko, Sophia; Kramer, Elizabeth J

    2006-07-01

    This study assessed the impact of the World Trade Center (WTC) attacks on emotional problems, prescription drug usage, and utilization of medical and mental health services within the Chinese community in lower Manhattan. We administered a survey to 148 randomly selected Chinese workers affected by the WTC attacks in March 2003. Although nearly half of the respondents had elevated PTSD and/or elevated depression scores, only a few (4.4%) had talked to a counselor. However, nearly all (86%) reported having visited a physician at least once since September 11, 2001. Individuals with elevated PTSD scores were significantly more likely to have gone to a physician after 9/11. They were also more likely to have received prescription drugs and to indicate an interest in counseling after 9/11 than individuals with low PTSD scores. The findings highlight the role of the primary care physician as gatekeeper for mental health symptoms after a disaster. They further suggest that primary care physicians should use screening tools for depression and posttraumatic stress after a major disaster and that they should be sensitive to potential emotional problems that are associated with somatic complaints.

  1. A cost-utility analysis of alternative drug regimens for newly diagnosed severe lupus nephritis patients in Thailand.

    PubMed

    Mohara, Adun; Pérez Velasco, Román; Praditsitthikorn, Naiyana; Avihingsanon, Yingyos; Teerawattananon, Yot

    2014-01-01

    The aim of this study was to assess the value of four drug regimens for newly diagnosed severe LN from a societal perspective. A model-based cost-utility analysis was devised to measure lifetime costs and health outcomes. Current treatment options consisting of different combinations of i.v. CYC, AZA and MMF were compared with a baseline regimen of i.v. CYC in both the induction and maintenance phases. Resource use and costs were derived from medical records reviews and databases. Event rates were elicited from randomized controlled trials. Relative treatment effects were obtained from meta-analyses. Health utilities were obtained from a real cohort of patients to estimate the outcome of quality-adjusted life years. It was found that a treatment regimen that combined i.v. CYC in the induction phase with AZA in the maintenance phase was cost saving compared with the baseline regimen. Treatment with i.v. CYC in the induction phase and MMF in the maintenance phase and treatment with MMF in the induction phase and a reduced dose of the same in the maintenance phase turned out to be a negatively dominated regimen. In the Thai context, the combination of i.v. CYC for the induction phase followed by AZA for the maintenance phase should be considered as the first-line therapy for newly diagnosed severe LN, as it seems to be the most cost-saving regimen.

  2. Unique and potent effects of acute ibogaine on zebrafish: the developing utility of novel aquatic models for hallucinogenic drug research.

    PubMed

    Cachat, Jonathan; Kyzar, Evan J; Collins, Christopher; Gaikwad, Siddharth; Green, Jeremy; Roth, Andrew; El-Ounsi, Mohamed; Davis, Ari; Pham, Mimi; Landsman, Samuel; Stewart, Adam Michael; Kalueff, Allan V

    2013-01-01

    An indole alkaloid, ibogaine is the principal psychoactive component of the iboga plant, used by indigenous peoples in West Africa for centuries. Modulating multiple neurotransmitter systems, the drug is a potent hallucinogen in humans, although its psychotropic effects remain poorly understood. Expanding the range of model species is an important strategy for translational neuroscience research. Here we exposed adult zebrafish (Danio rerio) to 10 and 20mg/L of ibogaine, testing them in the novel tank, light-dark box, open field, mirror stimulation, social preference and shoaling tests. In the novel tank test, the zebrafish natural diving response (geotaxis) was reversed by ibogaine, inducing initial top swimming followed by bottom dwelling. Ibogaine also attenuated the innate preference for dark environments (scototaxis) in the light-dark box test. While it did not exert overt locomotor or thigmotaxic responses in the open field test, the drug altered spatiotemporal exploration of novel environment, inducing clear preference of some areas over others. Ibogaine also promoted 'mirror' exploration in the mirror stimulation test, disrupted group cohesion in the shoaling test, and evoked strong coloration responses due to melanophore aggregation, but did not alter brain c-fos expression or whole-body cortisol levels. Overall, our results support the complex pharmacological profile of ibogaine and its high sensitivity in zebrafish models, dose-dependently affecting multiple behavioral domains. While future investigations in zebrafish may help elucidate the mechanisms underlying these unique behavioral effects, our study strongly supports the developing utility of aquatic models in hallucinogenic drug research. High sensitivity of three-dimensional phenotyping approaches applied here to behavioral effects of ibogaine in zebrafish provides further evidence of how 3D reconstructions of zebrafish swimming paths may be useful for high-throughput pharmacological screening.

  3. Temporal Changes in Prescription of Neuropharmacologic Drugs and Utilization of Resources Related to Neurologic Morbidity in Mechanically Ventilated Children With Bronchiolitis.

    PubMed

    Shein, Steven L; Slain, Katherine; Wilson-Costello, Deanne; McKee, Bryan; Rotta, Alexandre T

    2017-09-19

    Critically ill children with bronchiolitis may require neuropharmacologic medications and support for neuro-functional sequelae, but current practices are not well described. We aimed to describe recent trends in neuropharmacology and utilization of neuro-rehabilitation resources in mechanically ventilated children with bronchiolitis. Analysis of the multicenter Pediatric Health Information System database. Forty-seven U.S. children's hospitals. PICU patients less than 2 years old with bronchiolitis undergoing mechanical ventilation between 2006 and 2015. None. Annual rates of utilization of neuropharmacologic medications (sedatives, analgesics, etc) and of neuro-rehabilitation services (physical therapy, neurologic consultation, etc) over the 10-year study period were compared. Neuropharmacologic medications prescribed on greater than or equal to 2 days were extracted. Utilization of MRI of the brain, neurologic consultation, swallow evaluation, occupational therapy, and physical therapy was also extracted. Among 12,508 subjects, the median age was 2.8 months, ~50% had comorbid conditions, and the median duration of mechanical ventilation was 7 days. The percentage of children prescribed greater than or equal to five drugs/drug classes increased over the study period from 36.5% to 55.8% (p < 0.001). There were significant increases over time in utilization of 10 of the 15 individual drugs/drug classes analyzed. More than half of subjects (6,294 [50.3%]) received at least one service that evaluates/treats neurologic morbidity. There were significant increases in the use of greater than or equal to one service (36.3% in 2006 to 59.6% in 2015; p < 0.001) and in the use of greater than or equal to two services (20.8% to 34.8%; p < 0.001). Utilization of each of the five individual resources increased significantly during the study period, but use of vasoactive medications and mortality did not. Prescription of neuropharmacologic agents increased over time using

  4. Utility of humanized BLT mice for analysis of dengue virus infection and antiviral drug testing.

    PubMed

    Frias-Staheli, Natalia; Dorner, Marcus; Marukian, Svetlana; Billerbeck, Eva; Labitt, Rachael N; Rice, Charles M; Ploss, Alexander

    2014-02-01

    Dengue virus (DENV) is the cause of a potentially life-threatening disease that affects millions of people worldwide. The lack of a small animal model that mimics the symptoms of DENV infection in humans has slowed the understanding of viral pathogenesis and the development of therapies and vaccines. Here, we investigated the use of humanized "bone marrow liver thymus" (BLT) mice as a model for immunological studies and assayed their applicability for preclinical testing of antiviral compounds. Human immune system (HIS) BLT-NOD/SCID mice were inoculated intravenously with a low-passage, clinical isolate of DENV-2, and this resulted in sustained viremia and infection of leukocytes in lymphoid and nonlymphoid organs. In addition, DENV infection increased serum cytokine levels and elicited DENV-2-neutralizing human IgM antibodies. Following restimulation with DENV-infected dendritic cells, in vivo-primed T cells became activated and acquired effector function. An adenosine nucleoside inhibitor of DENV decreased the circulating viral RNA when administered simultaneously or 2 days postinfection, simulating a potential treatment protocol for DENV infection in humans. In summary, we demonstrate that BLT mice are susceptible to infection with clinical DENV isolates, mount virus-specific adaptive immune responses, and respond to antiviral drug treatment. Although additional refinements to the model are required, BLT mice are a suitable platform to study aspects of DENV infection and pathogenesis and for preclinical testing of drug and vaccine candidates. IMPORTANCE Infection with dengue virus remains a major medical problem. Progress in our understanding of the disease and development of therapeutics has been hampered by the scarcity of small animal models. Here, we show that humanized mice, i.e., animals engrafted with components of a human immune system, that were infected with a patient-derived dengue virus strain developed clinical symptoms of the disease and mounted

  5. L-type amino acid transporter 1 utilizing prodrugs: How to achieve effective brain delivery and low systemic exposure of drugs.

    PubMed

    Puris, Elena; Gynther, Mikko; Huttunen, Johanna; Petsalo, Aleksanteri; Huttunen, Kristiina M

    2017-09-10

    L-type amino acid transporter 1 (LAT1) is selectively expressed in the blood-brain barrier (BBB) and brain parenchyma. This transporter can facilitate brain delivery of neuroprotective agents and additionally give opportunity to minimize systemic exposure. Here, we investigated structure-pharmacokinetics relationship of five newly synthesized LAT1-utilizing prodrugs of the cyclooxygenase inhibitor, ketoprofen, in order to identify beneficial structural features of prodrugs to achieve both targeted brain delivery and low peripheral distribution of the parent drug. Besides, we studied whether pharmacokinetics and bioconversion of LAT1-utilizing prodrugs in vivo can be predicted in early stage experiments. To achieve these goals, we compared the in vitro brain uptake mechanism of prodrugs, rate of BBB permeation of compounds using in situ perfusion technique, their systemic pharmacokinetics and release of parent drug in brain, plasma and liver of mice. The results revealed that both excellent LAT1-binding ability and transporter utilization in vitro can be achieved by conjugating the parent drug to aromatic amino acids such as phenylalanine in comparison to prodrugs with an aliphatic promoiety. The presence of an aromatic promoiety directly conjugated in meta- or para-position to ketoprofen led to LAT1-utilizing prodrugs capable of delivering the parent drug into the brain with higher unbound brain to plasma ratio and reduced liver exposure than with ketoprofen itself. In contrast, the prodrugs with aliphatic promoieties and with an additional carbon attached between the parent drug and phenylalanine aromatic ring did not enhance brain delivery of ketoprofen. Furthermore, we have devised a screening strategy to pinpoint successful candidates at an early stage of development of LAT1-utilizing prodrugs. The screening approach demonstrated that early stage experiments could not replace pharmacokinetic studies in vivo due to the lack of prediction of the intra

  6. Youth and Drugs. Internships in Drug Education: A Feasibility Study.

    ERIC Educational Resources Information Center

    Cheaney, Lee

    New statistics indicate that drug use is prevalent among today's youth for reasons of alienation, affluency, a philosophy of experimentation, peer pressure of social acceptance, availability of drugs, and changing values. The solution lies not in punitive measures but in education as a practical approach. Although much is being done toward drug…

  7. Defining personal utility in genomics: A Delphi study.

    PubMed

    Kohler, J; Turbitt, E; Lewis, K L; Wilfond, B S; Jamal, L; Peay, H L; Biesecker, L G; Biesecker, B B

    2017-02-20

    Individual genome sequencing results are valued by patients in ways distinct from clinical utility. Such outcomes have been described as components of "personal utility," a concept that broadly encompasses patient-endorsed benefits, that is operationally defined as non-clinical outcomes. No empirical delineation of these outcomes has been reported. To address this gap, we administered a Delphi survey to adult participants in a NIH clinical exome study to extract the most highly endorsed outcomes constituting personal utility. Forty research participants responded to a Delphi survey to rate 35 items identified by a systematic literature review of personal utility. Two rounds of ranking resulted in 24 items that represented 14 distinct elements of personal utility. Elements most highly endorsed by participants were: increased self-knowledge, knowledge of "the condition," altruism, and anticipated coping. Our findings represent the first systematic effort to delineate elements of personal utility that may be used to anticipate participant expectation and inform genetic counseling prior to sequencing. The 24 items reported need to be studied further in additional clinical genome sequencing studies to assess generalizability in other populations. Further research will help to understand motivations and to predict the meaning and use of results.

  8. Relating Translational Neuroimaging and Amperometric Endpoints: Utility for Neuropsychiatric Drug Discovery.

    PubMed

    Li, Jennifer; Schwarz, Adam J; Gilmour, Gary

    Measures of neuronal activation are a natural and parsimonious translational biomarker to consider in the context of neuropsychiatric drug discovery studies. In this regard, functional neuroimaging using the BOLD fMRI technique is becoming more frequently employed to not only probe aberrant brain regions and circuits in disease, but also to assess the effects of novel pharmacological agents on these processes. In the ideal situation, these types of studies would first be conducted pre-clinically in rodents to confirm a measurable functional response on relevant brain circuits before seeking to replicate the findings in an analogous fMRI paradigm in humans. However, the need for animal immobilization during the scanning procedure precludes all but the simplest behavioural task-based paradigms in rodent BOLD fMRI. This chapter considers how in vivo oxygen amperometry may represent a viable and valid proxy for BOLD fMRI in freely moving rodents engaged in behavioural tasks. The amperometric technique and several examples of emerging evidence are described to show how the technique can deliver results that translate to pharmacological, event-related and functional connectivity variants of fMRI. In vivo oxygen amperometry holds great promise as a technique that may help to bridge the gap between basic drug discovery research in rodents and applied efficacy testing in humans.

  9. Amorphous Solid Dispersions: Utilization and Challenges in Drug Discovery and Development.

    PubMed

    He, Yan; Ho, Chris

    2015-10-01

    Amorphous solid dispersion (ASD) can accelerate a project by improving dissolution rate and solubility, offering dose escalation flexibility and excipient acceptance for toxicology studies, as well as providing adequate preclinical and clinical exposure. The prerequisite physicochemical properties for a compound to form a stable ASD are glass-forming ability and low-crystallization tendency, which can be assessed using computational tools and experimental methods. Polymer excipient screening by in silico miscibility prediction and experimental screening techniques is discussed. Improved technologies for polymer screening with minimal quantity of drug substance, and the scalability of ASD from bench to commercial are reviewed. Considerations of in vitro evaluations, preclinical animal selection, and the translation of the preclinical results to clinical studies are also discussed. Better understanding of how polymers improve the stability of the amorphous phase in the solid state and how ASD improves bioavailability have facilitated the applications of ASD ranging from discovery research to preclinical development and further to commercialization. With the understanding of how ASDs are currently used in the pharmaceutical industry and what challenges remain to be solved, ASD can be applied to solve drug formulation problems at given research and development stages.

  10. Pro-Arrhythmic Potential of Oral Antihistamines (H1): Combining Adverse Event Reports with Drug Utilization Data across Europe

    PubMed Central

    Poluzzi, Elisabetta; Raschi, Emanuel; Godman, Brian; Koci, Ariola; Moretti, Ugo; Kalaba, Marija; Wettermark, Bjorn; Sturkenboom, Miriam; De Ponti, Fabrizio

    2015-01-01

    Background There is appreciable utilisation of antihistamines (H1) in European countries, either prescribed by physician and purchased by patients for self-medication. Terfenadine and astemizole underwent regulatory restrictions in ’90 because of their cardiac toxicity, but only scarce clinical data are available on other antihistamines. Aim To investigate the pro-arrhythmic potential of antihistamines by combining safety reports of the FDA Adverse Event Reporting System (FAERS) with drug utilization data from 13 European Countries. Methods We identified signals of antihistamine arrhythmogenic potential by analyzing FAERS database for all cases of Torsades de Pointes (TdP), QT abnormalities (QTabn), ventricular arrhythmia (VA) and sudden cardiac death/cardiac arrest (SCD/CA). Number of cases ≥3 and disproportionality were used to define alert signals: TdP and QTabn identified stronger signals, whereas SCD/CA identified weaker signals. Drug utilization data from 2005 to 2010 were collected from administrative databases through health authorities and insurance. Results Antihistamines were reported in 109 cases of TdP/QT prolongation, 278 VA and 610 SCD/CA. Five agents resulted in stronger signals (cetirizine, desloratadine, diphenhydramine, fexofenadine, loratadine) and 6 in weaker signals (alimemazine, carbinoxamine, cyclizine, cyproeptadine, dexchlorpheniramine and doxylamine). Exposure to antihistamines with stronger signal was markedly different across European countries and was at least 40% in each Country. Cetirizine was >29 Defined Daily Doses per 1000 inhabitants per day (DID) in Norway, desloratadine >11 DID in France and loratadine >9 DID in Sweden and Croatia. Drugs with weaker signals accounted for no more than 10% (in Sweden) and in most European countries their use was negligible. Conclusions Some second-generation antihistamines are associated with signal of torsadogenicity and largely used in most European countries. Although confirmation by

  11. Advances in drug discovery and biochemical studies.

    PubMed

    Kita, Kiyoshi; Shiomi, Kazuro; Omura, Satoshi

    2007-05-01

    Japanese researchers continue to discover new means to combat parasites and make important contributions toward developing tools for global control of parasitic diseases. Streptomyces avermectinius, the source of ivermectin, was discovered in Japan in the early 1970s and renewed and vigorous screening of microbial metabolites in recent years has led to the discovery of new antiprotozoals and anthelminthics, including antimalarial drugs. Intensive studies of parasite energy metabolism, such as NADH-fumarate reductase systems and the synthetic pathways of nucleic acids and amino acids, also contribute to the identification of novel and unique drug targets.

  12. School District Drug and Alcohol Study.

    ERIC Educational Resources Information Center

    Crabtree, Michael

    Marijuana and alcohol use by high school students has continued to increase through the latter part of the 1970's. To gain information on the extent of this problem in their area, a school district in rural western Pennsylvania approved a study of drug and alcohol usage by the school district's 2,200 students. For reasons of confidentiality, all…

  13. Analytical and Characterization Studies of Organic Chemicals, Drugs, and Drug Formulation

    DTIC Science & Technology

    2011-11-21

    of the bulk drugs, drug products, to determine their stability under defined conditions, to prepare formulations of bulk drugs for biological...testing, and to coordinate ongoing stability studies on an artesunate dosage form with a subcontractor. 15. SUBJECT TERMS Anti-Parasitic Drugs, Chemical...Defense Agents, Chemical Analyses, Stability Studies, Formulation Development 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18

  14. Utilization of gastroprotective strategies for nonsteroidal anti-inflammatory drug-induced gastrointestinal events in a major teaching hospital.

    PubMed

    Lee, Hooi Leng; Chua, Siew Siang; Mahadeva, Sanjiv

    2016-01-01

    Clinical guidelines recommend the prescribing of gastroprotective strategies in nonsteroidal anti-inflammatory drug (NSAID) users with risk factors for gastrointestinal (GI) ulcer or ulcer complications. However, these guidelines are not often translated into clinical practice. Therefore, the aim of this study was to investigate the utilization of gastroprotective strategies for NSAID-induced upper GI events in at-risk users in a major teaching hospital. A cross-sectional, observational, pharmacy-based study was conducted in a major Asian institution with both primary and secondary health care services. This study involved the screening of prescriptions for regular NSAIDs, and patients who met the inclusion criteria were recruited and interviewed using a questionnaire. Of the 409 participants recruited, 83.1% had at least one GI risk factor, of whom 70.3% did not receive appropriate gastroprotection. The most common GI risk factor was the use of high-dose NSAIDs (69.2%), followed by participants aged 65 years and older (22%) and concomitant use of low-dose aspirin (11.7%). Appropriate gastroprotective strategies utilized consisted of the use of a cyclooxygenase (COX)-2 inhibitor alone or a nonselective NSAID plus a proton pump inhibitor (PPI) in the moderate-risk group and a COX-2 inhibitor plus a PPI in the high-risk group. Gastroprotective strategies were underutilized in 67.1% of at-risk participants and overutilized in 59.4% of those without risk factors. Co-prescription of a histamine-2 receptor antagonist at lower-than-recommended doses constituted 59% of the inappropriate gastroprotective agents used. Logistic regression analysis revealed patients aged 65 years and older (odds ratio, 1.89; 95% CI =1.15-3.09) as a predictor for the prescribing of gastroprotection by the clinicians. Approximately 70% of at-risk NSAID users, mainly on high-dose NSAIDs, were not prescribed appropriate gastroprotective strategies. Further measures are warranted to improve the

  15. STUDY OF DOSHIC INVOLVEMENT IN APASMARA (EPILEPSY) AND ITS UTILITY

    PubMed Central

    Venkataraghavan, S.; Rajagopalan, V.; Srinivasan, Kanchana

    1987-01-01

    68 cases of epilepsy are studied here for assessing the doshic dominance to understand prognosis with a view to supplement the treatment with some doshahara compounds or drugs. Most of the cases studied or vata or pitta dominant cases, thereby, requiring vatahara or pittahara treatment. PMID:22557563

  16. Capacity Utilization Study for Aviation Security Cargo Inspection Queuing System

    SciTech Connect

    Allgood, Glenn O; Olama, Mohammed M; Lake, Joe E; Brumback, Daryl L

    2010-01-01

    In this paper, we conduct performance evaluation study for an aviation security cargo inspection queuing system for material flow and accountability. The queuing model employed in our study is based on discrete-event simulation and processes various types of cargo simultaneously. Onsite measurements are collected in an airport facility to validate the queuing model. The overall performance of the aviation security cargo inspection system is computed, analyzed, and optimized for the different system dynamics. Various performance measures are considered such as system capacity, residual capacity, throughput, capacity utilization, subscribed capacity utilization, resources capacity utilization, subscribed resources capacity utilization, and number of cargo pieces (or pallets) in the different queues. These metrics are performance indicators of the system s ability to service current needs and response capacity to additional requests. We studied and analyzed different scenarios by changing various model parameters such as number of pieces per pallet, number of TSA inspectors and ATS personnel, number of forklifts, number of explosives trace detection (ETD) and explosives detection system (EDS) inspection machines, inspection modality distribution, alarm rate, and cargo closeout time. The increased physical understanding resulting from execution of the queuing model utilizing these vetted performance measures should reduce the overall cost and shipping delays associated with new inspection requirements.

  17. Capacity utilization study for aviation security cargo inspection queuing system

    NASA Astrophysics Data System (ADS)

    Allgood, Glenn O.; Olama, Mohammed M.; Lake, Joe E.; Brumback, Daryl

    2010-04-01

    In this paper, we conduct performance evaluation study for an aviation security cargo inspection queuing system for material flow and accountability. The queuing model employed in our study is based on discrete-event simulation and processes various types of cargo simultaneously. Onsite measurements are collected in an airport facility to validate the queuing model. The overall performance of the aviation security cargo inspection system is computed, analyzed, and optimized for the different system dynamics. Various performance measures are considered such as system capacity, residual capacity, throughput, capacity utilization, subscribed capacity utilization, resources capacity utilization, subscribed resources capacity utilization, and number of cargo pieces (or pallets) in the different queues. These metrics are performance indicators of the system's ability to service current needs and response capacity to additional requests. We studied and analyzed different scenarios by changing various model parameters such as number of pieces per pallet, number of TSA inspectors and ATS personnel, number of forklifts, number of explosives trace detection (ETD) and explosives detection system (EDS) inspection machines, inspection modality distribution, alarm rate, and cargo closeout time. The increased physical understanding resulting from execution of the queuing model utilizing these vetted performance measures should reduce the overall cost and shipping delays associated with new inspection requirements.

  18. Feasibility Study for a Hopi Utility-Scale Wind Project

    SciTech Connect

    Kendrick Lomayestewa

    2011-05-31

    The goal of this project was to investigate the feasibility for the generation of energy from wind and to parallel this work with the development of a tribal utility organization capable of undertaking potential joint ventures in utility businesses and projects on the Hopi reservation. The goal of this project was to investigate the feasibility for the generation of energy from wind and to parallel this work with the development of a tribal utility organization capable of undertaking potential joint ventures in utility businesses and projects on the Hopi reservation. Wind resource assessments were conducted at two study sites on Hopi fee simple lands located south of the city of Winslow. Reports from the study were recently completed and have not been compared to any existing historical wind data nor have they been processed under any wind assessment models to determine the output performance and the project economics of turbines at the wind study sites. Ongoing analysis of the wind data and project modeling will determine the feasibility of a tribal utility-scale wind energy generation.

  19. Analytical lessons learned from selected therapeutic protein drug comparability studies.

    PubMed

    Federici, Marcia; Lubiniecki, Anthony; Manikwar, Prakash; Volkin, David B

    2013-05-01

    The successful implementation of process and product changes for a therapeutic protein drug, both during clinical development and after commercialization, requires a detailed evaluation of their impact on the protein's structure and biological functionality. This analysis is called a comparability exercise and includes a data driven assessment of biochemical equivalence and biological characterization using a cadre of analytical methodologies. This review focuses on describing analytical results and lessons learned from selected published therapeutic protein comparability case studies both for bulk drug substance and final drug product. An overview of the currently available analytical methodologies typically used is presented as well as a discussion of new emerging analytical techniques. The potential utility of several novel analytical approaches to comparability studies is discussed including distribution and stability of protein drugs in vivo, and enhanced evaluation of higher-order protein structure in actual formulations using hydrogen/deuterium exchange mass spectrometry, two-dimensional nuclear magnetic resonance fingerprinting or empirical phase diagrams. In addition, new methods for detecting and characterizing protein aggregates and particles are presented as these degradants are of current industry-wide concern. The critical role that analytical methodologies play in elucidating the structure-function relationships for therapeutic protein products during the overall assessment of comparability is discussed.

  20. Translatability scoring in drug development: eight case studies

    PubMed Central

    2012-01-01

    Translational medicine describes the transfer of basic in vitro and in vivo data into human applications. In the light of low rates of market approvals for new medical entities, better strategies to predict the risk of drug development should be used to increase output and reduce costs. Recently, a scoring system to assess the translatability of early drug projects has been proposed. Here eight drugs from different therapeutic areas have been subjected to a retrospective test-run in this system fictively located at the phase II-III transition. The scores gained here underline the importance of biomarker quality which is pivotal to decrease the risk of the project in all cases. This is particularly evident for gefitinib. The EGFR mutation status is a breakthrough biomarker to predict therapeutic success which made this compound clinically acceptable, and this is plausibly reflected by a considerable increase of the translatability score. For psychiatric and Alzheimer's drugs, and for a CETP-inhibitor, the lack of suitable biomarkers and animal models is reflected by a low translatability score, well correlating with the excessive translational risk in these areas. These case studies document the apparent utility of the scoring system, at least under retrospective conditions, as the scores correlate with the outcomes at the level of market approval. Prospective validation is still missing, but these case studies are encouraging. PMID:22397594

  1. Spiritual change in drug treatment: utility of the Christian Inventory of Spirituality.

    PubMed

    Windsor, Liliane Cambraia; Shorkey, Clay

    2010-07-01

    The current study used data from reliability testing of the Christian Inventory of Spirituality (CIS) to (1) assess the utility of CIS in detecting differences in level of spirituality in residents of residential Christian faith-based substance abuse programs (RCFBSAPs); (2) test the hypothesis that residents who have been in the program for longer periods of time will have significantly higher levels of spirituality after controlling for relevant demographic characteristics; and (3) test the hypothesis that residents of programs that only use unlicensed staff and place higher importance on spirituality will have significantly higher levels of spirituality. A purposive sample of the cross-sectional data from the reliability testing of the CIS was used (n = 253). Analysis supported the hypothesis. Demographic characteristics were not associated with level of spirituality. The CIS proved to be useful in discriminating levels of spirituality. Further research is needed to examine spiritual change using randomized pre-post test designs.

  2. Smarter candidate selection--utilizing microdosing in exploratory clinical studies.

    PubMed

    Buchan, P

    2007-01-01

    Microdosing offers a faster and potentially less expensive approach to obtaining human in vivo PK data in early clinical drug development. It encompasses the use of pharmacologically inactive doses of test drug in the low microgram range along with ultrasensitive assay methods (PET, AMS) to assess human exposure in order to extrapolate the PK of higher, clinically more relevant doses, assuming linear PK. This strategy allows early evaluation of systemic clearance, oral bioavailability as well as sources of intersubject variability and questions of specific metabolite formation. It does take advantage of reduced regulatory requirements of preclinical safety studies, bulk drug synthesis (CMC requirements) and easier formulation options, e.g., as part of an exploratory IND; however, this is counterbalanced by a need to synthesize radiolabeled test compound and the development of a sophisticated analytical method. Ongoing studies will determine the predictability of human PK using Microdosing methods.

  3. New developments in the treatment of drug-resistant tuberculosis: clinical utility of bedaquiline and delamanid.

    PubMed

    Brigden, Grania; Hewison, Cathy; Varaine, Francis

    2015-01-01

    The current treatment for drug-resistant tuberculosis (TB) is long, complex, and associated with severe and life-threatening side effects and poor outcomes. For the first time in nearly 50 years, there have been two new drugs registered for use in multidrug-resistant TB (MDR-TB). Bedaquiline, a diarylquinoline, and delamanid, a nitromidoxazole, have received conditional stringent regulatory approval and have World Health Organization interim policy guidance for their use. As countries improve and scale up their diagnostic services, increasing number of patients with MDR-TB and extensively drug-resistant TB are identified. These two new drugs offer a real opportunity to improve the outcomes of these patients. This article reviews the evidence for these two new drugs and discusses the clinical questions raised as they are used outside clinical trial settings. It also reviews the importance of the accompanying drugs used with these new drugs. It is important that barriers hindering the use of these two new drugs are addressed and that the existing clinical experience in using these drugs is shared, such that their routine-use programmatic conditions is scaled up, ensuring maximum benefit for patients and countries battling the MDR-TB crisis.

  4. Models for placental transfer studies of drugs.

    PubMed

    Bourget, P; Roulot, C; Fernandez, H

    1995-02-01

    Pregnancy is a specific dynamic state, and the potential usefulness of caring for a disorder in the fetus or the mother is now well established. Previously, pregnant women have been excluded from clinical trials, therefore only a few studies concerning evaluation of the pregestational metabolism or transplacental transfer (TPT) of drugs exist. Questions regarding the TPT of drugs are extensive and complex. For example, does TPT occur at a given gestational age, in the context of a particular type of pathology or when a drug is administered by a certain dosage regimen? If this is the case, what is the rapidity of penetration of the products of conception by the drug (bearing in mind its physicochemical characteristics)? Need harmful adverse effects on the child be feared? Is such penetration desirable, of no consequence, or dangerous? Does the possibility exist of accumulation in the placenta, fetal tissue or amniotic fluid? Should such findings modify the therapeutic regimens of drugs given to expectant mothers? Exchange mechanisms are complicated and models developed in vitro only partially reflect the actual equilibria that exist between mother and fetus. These include: (i) the perfused cotyledon model, which while simple, elegant and inexpensive, offers only a localised, restricted and fixed view of pregnancy; (ii) isolated anatomical fractions that are informative, but which straddle the border between physiology and pharmacology; and (iii) the necessary study, using microsomes, of placental metabolic capacity (enzyme cartography). In vivo study of TPT is based upon various multicompartmental pharmacokinetic models, some of which have been relatively validated in animals. The simplest indicator for the in vivo evaluation of TPT of a drug in the human species is determination of a feto-maternal blood concentration ratio (usually performed at the time of placental separation). However, the usefulness and limitations of this parameter are controversial, and it

  5. The limited utility of electrocardiography variables used to predict arrhythmia in psychotropic drug overdose

    PubMed Central

    Buckley, Nicholas A; Chevalier, Stephan; Leditschke, I Anne; O'Connell, Dianne L; Leitch, James; Pond, Susan M

    2003-01-01

    Objective The aim of the present study was to examine the relationship between serious arrhythmias in patients with psychotropic drug overdose and electrocardiography (ECG) findings that have been suggested previously to predict this complication. Methods Thirty-nine patients with serious arrhythmias (ventricular tachycardia, supraventricular tachycardia or cardiac arrest) after tricyclic antidepressant overdose or thioridazine overdose were compared with 117 controls with clinically significant overdose matched to each case for the drug ingested. These patients with psychotropic drug overdose had presented for treatment to the Department of Clinical Toxicology, Newcastle and to the Princess Alexandra Hospital, Brisbane. The heart rate, the QRS width, the QTc and QT intervals, the QT dispersion, and the R wave and R/S ratios in aVR on the initial ECGs were compared in cases and controls. Results The cases had taken dothiepin (16 patients), doxepin (six patients), thioridazine (five patients), amitriptyline (five patients), nortriptyline (three patients), imipramine (one patient) and a combination of dothiepin and thioridazine (three patients). In 20 of the 39 patients with arrhythmias, the arrhythmia had been a presumed ventricular tachycardia. Of the other 19 patients, 15 patients had a supraventricular tachycardia, two patients had cardiac arrests (one asystole, one without ECG monitoring) and two patients had insufficient data recorded to make classification of the arrhythmias possible. The QRS was ≥ 100 ms in 82% of cases but also in 76% of controls. QRS ≥ 160 ms had a sensitivity of only 13% and occurred in 2% of controls. QRS > 120 ms, QTc > 500 and the R/S ratio in aVR appeared to have a stronger association with the occurrence of arrhythmia: QRS > 120 ms (odds ratio [OR], 3.56; 95% confidence interval [CI], 1.46–8.68), QTc > 500 (OR, 3.07; 95% CI, 1.33–7.07), and R/S ratio in aVR > 0.7 (OR, 16; 95% CI, 3.47–74). Excluding thioridazine overdoses

  6. Antihypertensive medicines utilization: A decade-long nationwide study of octogenarians, nonagenarians and centenarians.

    PubMed

    Narayan, Sujita W; Nishtala, Prasad S

    2017-07-01

    Gaining an insight into the utilization of antihypertensive medicines against a background of evolving hypertension treatment guidelines that might not be relevant to the oldest old is important. The aim of the present study was to characterize the overall trends in the utilization of antihypertensive medicines in the oldest old by therapeutic class and chemical type, stratified by age and sex over a decade. Antihypertensive medicines utilization was examined using the therapeutic and chemical groups based on the World Health Organization Collaborating Center for Drug Statistics Mythology's Anatomical Therapeutic Chemical classification system for all individuals aged ≥80 years. Regression and repeated cross-sectional analyses was carried out, and defined daily dose was used to describe the utilization per thousand older people per day. Utilization of antihypertensive medicines increased over the decade from 187.28 in 2005 to 205.01 defined daily dose per thousand older people per day in 2014, and shifted from mainly diuretics to angiotensin-converting enzyme inhibitors. Interestingly, with the exception of diuretics, utilization of all medicines decreased gradually with increasing age. Single products use increased by 1.48-fold in 2014 compared with 2005, and for fixed-dose combinations the increase was 1.41-fold for the same period. The increased utilization of angiotensin-converting enzyme inhibitors is consistent with recommendations from cardiovascular guidelines formulated from large randomized control trials that often exclude the oldest old. Interestingly, the utilization of beta-blockers decreased and diuretics increased in centenarians. The utilization of calcium channel blockers and angiotensin-converting enzyme inhibitors across the study period increased in all age categories. Geriatr Gerontol Int 2017; 17: 1109-1117. © 2016 Japan Geriatrics Society.

  7. Part I---Evaluating Effects of Oligomer Formation on Cytochrome P450 2C9 Electron Transfer and Drug Metabolism, Part II---Utilizing Molecular Modeling Techniques to Study the Src-Interacting Proteins Actin Filament Associated Protein of 110 kDa (AFAP-110) and Cortactin

    NASA Astrophysics Data System (ADS)

    Jett, John Edward, Jr.

    The dissertation has been divided into two parts to accurately reflect the two distinct areas of interest pursued during my matriculation in the School of Pharmacy at West Virginia University. In Part I, I discuss research probing the nature of electron transfer in the Cytochrome P450 family of proteins, a group of proteins well-known for their role in drug metabolism. In Part II, I focus on in silico and in vitro work developed in concert to probe protein structure and protein-protein interactions involved in actin filament reorganization and cellular motility. Part I. Cytochrome P450s (P450s) are an important class of enzymes known to metabolize a variety of endogenous and xenobiotic compounds. P450s are most commonly found in liver and intestinal endothelial cells and are responsible for the metabolism of approximately 75% of pharmaceutical drugs on the market. CYP2C9---one of the six major P450 isoforms---is responsible for ˜20% of drug metabolism. Elucidation of the factors that affect in vitro drug metabolism is crucial to the accurate prediction of in vivo drug metabolism kinetics. Currently, the two major techniques for studying in vitro drug metabolism are solution-based. However, it is known that the results of solution-based studies can vary from in vivo drug metabolism. One reason suggested to account for this variation is the state of P450 oligomer formation in solution compared to the in vivo environment, where P450s are membrane-bound. To understand the details of how oligomer formation affects in vitro drug metabolism, it is imperative that techniques be developed which will allow for the unequivocal control of oligomer formation without altering other experimental parameters. Our long term goal of this research is to develop methods to more accurately predict in vivo drug metabolism from in vitro data. This section of the dissertation will discuss the development of a platform consisting of a doped silicon surface containing a large array of gold

  8. Health service utilization of heroin abusers: a retrospective cohort study.

    PubMed

    Chen, I-Ming; Huang, Charles Lung-Cheng; Yeh, Bao-Juan; Chien, Yi-Ling

    2015-06-01

    This study aimed to determine the patterns of medical service utilization among heroin users and to identify the factors associated with the frequency of utilization. We conducted a retrospective/prospective cohort study of 789 heroin-using adults in a catchment area, collecting data on their usage of medical care, including inpatient care, emergency visits, and outpatient care, in a 2-year observation period. We interviewed and reviewed the medical records of 789 heroin users in a methadone clinic of a general hospital in a rural area of Taiwan. The demographic data, records of service use, diagnoses, and information on viral infection status from Jan. 1, 2007 to Dec. 31, 2008 were collected. Most patients were middle-aged and unemployed, had a basic educational level, and began their first heroin use in their twenties. The health service utilization of heroin users was mostly for infectious diseases, orthopedic conditions, and gastroenterological disorders mainly due to blood-borne or local infections and traumatic injury. Heroin users utilize fewer outpatient or inpatient services, but more emergency care than the general public. The major correlates of inpatient and emergency service utilization were HIV status and education level. Our findings suggest that integrated outpatient services may help to enhance medical service accessibility and adherence, and also imply the necessity of putting more effort into promoting health management and safe behaviors in heroin users, particularly the lower-educated addicts. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children

    PubMed Central

    Chhim, Rebecca F.; Shelton, Chasity M.; Christensen, Michael L.

    2013-01-01

    The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children. PMID:23616733

  10. Hospital ownership and drug utilization under a global budget: a quantile regression analysis.

    PubMed

    Zhang, Jing Hua; Chou, Shin-Yi; Deily, Mary E; Lien, Hsien-Ming

    2014-03-01

    A global budgeting system helps control the growth of healthcare spending by setting expenditure ceilings. However, the hospital global budget implemented in Taiwan in 2002 included a special provision: drug expenditures are reimbursed at face value, while other expenditures are subject to discounting. That gives hospitals, particularly those that are for-profit, an incentive to increase drug expenditures in treating patients. We calculated monthly drug expenditures by hospital departments from January 1997 to June 2006, using a sample of 348 193 patient claims to Taiwan National Health Insurance. To allow for variation among responses by departments with differing reliance on drugs and among hospitals of different ownerships, we used quantile regression to identify the effect of the hospital global budget on drug expenditures. Although drug expenditure increased in all hospital departments after the enactment of the hospital global budget, departments in for-profit hospitals that rely more heavily on drug treatments increased drug spending more, relative to public hospitals. Our findings suggest that a global budgeting system with special reimbursement provisions for certain treatment categories may alter treatment decisions and may undermine cost-containment goals, particularly among for-profit hospitals.

  11. Utilizing a Health Behavior Model to Design Drug Education/Prevention Programs.

    ERIC Educational Resources Information Center

    Iverson, Donald C.

    1978-01-01

    The underlying philosophical and practical problems encountered when designing drug education/prevention programs are reviewed. The Health Belief Model is described and its most relevant components are outlined. The drug education material and teaching methodology which complement the model are reviewed as well. (Author)

  12. Impact of Disease Management on Utilization and Adherence With Drugs and Tests

    PubMed Central

    Thiebaud, Patrick; Demand, Michael; Wolf, Scott A.; Alipuria, Linda L.; Ye, Qin; Gutierrez, Peter R.

    2008-01-01

    OBJECTIVE—The purpose of this study was to evaluate the effect of telephonic care management within a diabetes disease management program on adherence to treatment with hypoglycemic agents, ACE inhibitors (ACEIs), angiotensin receptor blockers (ARBs), statins, and recommended laboratory tests in a Medicaid population. RESEARCH DESIGN AND METHODS—A total of 2,598 patients with diabetes enrolled for at least 2 years in Florida: A Healthy State (FAHS), a large Medicaid disease management program, who received individualized telephonic care management were selected if they were eligible for at least 12 months before and 12 months after beginning care management. Patients were matched one-to-one on all baseline characteristics to 2,598 control patients. The impact of care management on utilization and adherence rates for diabetes-related medications and tests was analyzed with the difference-in-difference estimator. RESULTS—Changes in utilization were evaluated separately for those who were characterized as adherent to treatment at baseline (“users”) and those who were not (“nonusers”). Both groups achieved significant improvement in adherence between baseline and follow-up. Nonusers increased their overall hypoglycemic use by 0.7 script (P < 0.001), by 0.7 script for ACEIs and statins (both P < 0.001), by 0.8 test for A1C (P < 0.001), and by 0.7 test for lipids (P < 0.001). Users increased hypoglycemic use by 1.5 scripts (P < 0.001) and insulin use by 0.9 script (P < 0.001). CONCLUSIONS—The FAHS telephonic care management intervention effectively induced Medicaid patients with diabetes to begin treatment and improved adherence to oral hypoglycemic agents and recommended tests. It also substantially improved adherence among baseline insulin users. PMID:18523144

  13. Utilization and costs of conventional and alternative pharmaceuticals in children: results from the German GINIplus and LISAplus birth cohort studies.

    PubMed

    Italia, Salvatore; Batscheider, Ariane; Heinrich, Joachim; Wenig, Christina; Bauer, Carl Peter; Koletzko, Sibylle; Lehmann, Irina; Herbarth, Olf; von Berg, Andrea; Berdel, Dietrich; Hoffmann, Barbara; Schaaf, Beate; Wolfenstetter, Silke B

    2012-10-01

    The socioeconomic determinants for drug utilization, especially in children, have not been investigated sufficiently so far. The study's aim was the estimation of prevalences and determinants of conventional, homeopathic and phytotherapeutic drugs and expenditures. Population-based data on drug utilization of 3,642 children in two German birth cohorts (GINIplus and LISAplus, 10-year follow-up) were collected using a self-administered questionnaire. For analysis, the reported drugs (use within the last four weeks) were classified into the therapeutic categories of 'conventional medicine', 'homeopathy', 'phytotherapy' and 'others'. Drug costs were estimated using pharmaceutical identification numbers. In all, 42.3% of the children reported drug use; 24.1% of the drugs were homeopathic and 11.5% were phytotherapeutic. The proportion of children who took at least one homeopathic remedy was 14.3%. Drugs prescribed by physicians were dominated by conventional medicine (76.5%), whereas in non-prescribed drugs, both homeopathy and conventional medicine accounted for 37% each. Boys (OR = 0.78) used less homeopathy than girls. Income showed only a weak influence. Education had a strong effect on the use of phytotherapy such that children of mothers with higher school education (>10 years vs. <10 years) used more phytotherapy (OR = 2.01). If out-of-pocket payments arose (n = 613), the mean was €20. On average, total drug expenditures summed up to €39 in 4 weeks for drug users if only clearly identifiable prices for drugs were considered (58% of all data). Utilization of homeopathy is common in children from the analyzed cohort. User profiles of homeopathy and phytotherapy differ from each other and should be analyzed separately. Copyright © 2012 John Wiley & Sons, Ltd.

  14. Biomembrane models and drug-biomembrane interaction studies: Involvement in drug design and development

    PubMed Central

    Pignatello, R.; Musumeci, T.; Basile, L.; Carbone, C.; Puglisi, G.

    2011-01-01

    Contact with many different biological membranes goes along the destiny of a drug after its systemic administration. From the circulating macrophage cells to the vessel endothelium, to more complex absorption barriers, the interaction of a biomolecule with these membranes largely affects its rate and time of biodistribution in the body and at the target sites. Therefore, investigating the phenomena occurring on the cell membranes, as well as their different interaction with drugs in the physiological or pathological conditions, is important to exploit the molecular basis of many diseases and to identify new potential therapeutic strategies. Of course, the complexity of the structure and functions of biological and cell membranes, has pushed researchers toward the proposition and validation of simpler two- and three-dimensional membrane models, whose utility and drawbacks will be discussed. This review also describes the analytical methods used to look at the interactions among bioactive compounds with biological membrane models, with a particular accent on the calorimetric techniques. These studies can be considered as a powerful tool for medicinal chemistry and pharmaceutical technology, in the steps of designing new drugs and optimizing the activity and safety profile of compounds already used in the therapy. PMID:21430952

  15. Tools for studying drug transport and metabolism in the brain.

    PubMed

    Pitcher, Meagan R; Quevedo, João

    2016-01-01

    Development of xenobiotics that cross the blood-brain barrier in therapeutically-relevant quantities is an expensive and time-consuming undertaking. However, central nervous system diseases are an under-addressed cause of high mortality and morbidity, and drug development in this field is a worthwhile venture. We aim to familiarize the reader with available methodologies for studying drug transport into the brain. Current understanding of the blood-brain barrier structure has been well-described in other manuscripts, and first we briefly review the path that xenobiotics take through the brain - from bloodstream, to endothelial cells of the blood-brain barrier, to interstitial space, to brain parenchymal cells, and then to an exit point from the central nervous system. The second half of the review discusses research tools available to determine if xenobiotics are making the journey through the brain successfully and offers commentary on the translational utility of each methodology. Theoretically, non-human mammalian and human blood-brain barriers are similar in composition; however, some findings demonstrate important differences across species. Translational methodologies may provide more reliable information about how a drug may act across species. The recent finding of lymphatic vessels within the central nervous system may provide new tools and strategies for drug delivery to the brain.

  16. A Space Utilization Study at Gaston College: Methodology and Procedures.

    ERIC Educational Resources Information Center

    Hall, Pam; Clay, Rex

    In fall 1995, North Carolina's Gaston College undertook a study of space utilization at the college's main campus. A local architectural firm was contracted to document the exact usage of space on campus, establish space requirements to meet present circumstances, and identify future needs. To determine current usage, plots of current and original…

  17. Modification and Utilization of Nanoporous Gold for Loading and Release of Drugs

    NASA Astrophysics Data System (ADS)

    Al-badri, Ibtisam

    Nanoporous gold (np-Au) is a sponge-like structure of gold, which can be created by removing the less noble element from the precursor alloy, most typically silver or copper, using different chemical or electrochemical methods. It consists of interconnected ligaments and gaps between the ligaments, whose width can range from a few nanometers to a few hundreds of nanometers, creating a high surface area-to-volume ratio. Due to its many important properties (e.g., conductivity, high surface area-to-volume ratio, plasmonic response, biocompatibility, chemically inertness, and physically robustness), np-Au is suitable for different types of applications, including as a transducer for biosensors, in catalysis, for biomolecule separation, as a substrate for enzyme immobilization, and in drug delivery. The widths of the ligaments and gaps of np-Au can be easily tuned by varying conditions during the pre- or post-production process, for example, time kept in an acid bath and post-annealing (e.g. thermal, chemical, and electrochemical), depending on the requirement of the study. Thermal annealing is a commonly used process for tuning the ligaments and pore size of np-Au. However, the effects of thermal annealing on modification of ligaments and gaps sizes are not completely understood and more research needs to be done. Herein, we have explored the effect of annealing time and thickness of the np-Au sample on modification of ligaments and gaps. Furthermore, we used the electroless plating method to cover the pores or gaps partially on the surface without modifying the interior of np-Au. As-prepared np-Au was then studied as a platform for molecular loading and releasing kinetics for the possible use in drug delivery. We have found that simply applying the electroless deposition for 1 to 5 min can drastically decrease the rate of release of the molecules, and flow cell-based loading is the preferred way to load the molecules inside np-Au compared to the static method. The

  18. PET IMAGING STUDIES IN DRUG ABUSE RESEARCH.

    SciTech Connect

    Fowler, J.S.; Volkow, N.D.; Ding, Y.S.; Logan, J.; Wang, G.J.

    2001-01-29

    . This will be followed by highlights of PET studies of the acute effects of the psychostimulant drugs cocaine and methylphenidate (ritalin) and studies of the chronic effects of cocaine and of tobacco smoke on the human brain. This chapter concludes with the description of a study which uses brain imaging coupled with a specific pharmacological challenge to address the age-old question of why some people who experiment with drugs become addicted while others do not.

  19. Ground-source heat pump case studies and utility programs

    SciTech Connect

    Lienau, P.J.; Boyd, T.L.; Rogers, R.L.

    1995-04-01

    Ground-source heat pump systems are one of the promising new energy technologies that has shown rapid increase in usage over the past ten years in the United States. These systems offer substantial benefits to consumers and utilities in energy (kWh) and demand (kW) savings. The purpose of this study was to determine what existing monitored data was available mainly from electric utilities on heat pump performance, energy savings and demand reduction for residential, school and commercial building applications. In order to verify the performance, information was collected for 253 case studies from mainly utilities throughout the United States. The case studies were compiled into a database. The database was organized into general information, system information, ground system information, system performance, and additional information. Information was developed on the status of demand-side management of ground-source heat pump programs for about 60 electric utility and rural electric cooperatives on marketing, incentive programs, barriers to market penetration, number units installed in service area, and benefits.

  20. An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

    PubMed

    Chua, S S; Tea, M H; Rahman, M H A

    2009-04-01

    Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

  1. A study on comparative efficacyof hypolipidemic drugs.

    PubMed

    Sher, A; Ullah, A; Mateen, A

    1995-01-01

    A study was carried out on the comparative efficacy of Lopid, Mevacor, Bezalip and Lasona in sixteen hyperlipidemic subjects. All the subjects were on Lopid at least for the last 15 days. Lopid therapy was discontinued after determining blood lipid profile of the subjects on day zero (day of 1st contact). The subjects were divided into three groups and after a washout period of 15 days, they were given three different drugs for the next 15 days. Subjects in group a (6), b (5) and c (5) received Mevacor, Bezalip and lasona respectively. In the present study mevacor was found to be the most potent hypolipidemic drug in lowering blood cholesterol and Low density lipoprotein (LDL) while lopid was most effective in keeping blood Triglycerides (TG) and High density lipoproteins (HDL) level within the desired limits. Bezalip and Lasona were also sufficiently effective in changing blood lipid profile, but lasona showed a negligible effect on HDL rise as compared with Bezalip or any other drug used in this study.

  2. Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department

    PubMed Central

    Genco, Emma K.; Forster, Jeri E.; Flaten, Hanna; Goss, Foster; Heard, Kennon J.; Hoppe, Jason; Monte, Andrew A.

    2016-01-01

    Study objective We examine the characteristics of clinical decision support alerts triggered when opioids are prescribed, including alert type, override rates, adverse drug events associated with opioids, and preventable adverse drug events. Methods This was a retrospective chart review study assessing adverse drug event occurrences for emergency department (ED) visits in a large urban academic medical center using a commercial electronic health record system with clinical decision support. Participants include those aged 18 to 89 years who arrived to the ED every fifth day between September 2012 and January 2013. The main outcome was characteristics of opioid drug alerts, including alert type, override rates, opioid-related adverse drug events, and adverse drug event preventability by clinical decision support. Results Opioid drug alerts were more likely to be overridden than nonopioid alerts (relative risk 1.35; 95% confidence interval [CI] 1.21 to 1.50). Opioid drug-allergy alerts were twice as likely to be overridden (relative risk 2.24; 95% CI 1.74 to 2.89). Opioid duplicate therapy alerts were 1.57 times as likely to be overridden (95% CI 1.30 to 1.89). Fourteen of 4,581 patients experienced an adverse drug event (0.31%; 95% CI 0.15% to 0.47%), and 8 were due to opioids (57.1%). None of the adverse drug events were preventable by clinical decision support. However, 46 alerts were accepted for 38 patients that averted a potential adverse drug event. Overall, 98.9% of opioid alerts did not result in an actual or averted adverse drug event, and 96.3% of opioid alerts were overridden. Conclusion Overridden opioid alerts did not result in adverse drug events. Clinical decision support successfully prevented adverse drug events at the expense of generating a large volume of inconsequential alerts. To prevent 1 adverse drug event, providers dealt with more than 123 unnecessary alerts. It is essential to refine clinical decision support alerting systems to eliminate

  3. German drug monitoring studies with nabumetone.

    PubMed

    Stroehmann, I; Fedder, M; Zeidler, H

    1990-01-01

    Although randomised controlled comparative trials concerning the efficacy of the drug tested can produce reliable results in a limited number of selected patient groups, drug monitoring studies involving 10,000 patients or more are the methods of choice to detect rare adverse events. The aim of this drug monitoring study was to evaluate the efficacy and safety of dispersible nabumetone tablets. 8865 patients (46.2% male, 53.5% female, mean age 55 years, range 14.95) were involved in the investigation carried out by 1172 general practitioners. The disease indications comprised osteoarthritis (69.8%), soft-tissue rheumatism (11.3%), rheumatoid arthritis (9.9%) and soft tissue injuries (7.7%). Most of the patients (67.3%) received a daily dose of nabumetone 1 g for up to 6 weeks. Efficacy was evaluated at baseline, and after 1 week, 3 weeks and 6 weeks of treatment. With regard to global efficacy, overall improvement (symptoms resolved or markedly improved) was assessed in 82% of the patients. Elimination or at least significant improvement of pain on movement occurred in 95%, pain on pressure in 90% and pain at rest in 89% of the patients with symptoms. In relation to swelling, morning stiffness and joint mobility, elimination or at least significant improvement occurred in 79%, 80% and 82% of patients, respectively. 1846 patients (20.8%) had frequent periods of NSAID-related symptoms before treatment with nabumetone. A total of 1174 adverse events occurred in 850 patients (9.6%), most comprising minor gastrointestinal complaints. Considering that at least 25,000 patients have been documented in 2 German drug monitoring studies, it is therefore unlikely that any unexpected side effects will occur in the future. Consequently, nabumetone can be classified as an effective and safe NSAID.

  4. Monitoring Utilization of a Large Scale Addiction Treatment System: The Drug and Alcohol Treatment Information System (DATIS)

    PubMed Central

    Rotondi, Nooshin Khobzi; Rush, Brian

    2012-01-01

    Client-based information systems can yield data to address issues of system accountability and planning, and contribute information related to changing patterns of substance use in treatment and, indirectly, general populations. The Drug and Alcohol Treatment Information System (DATIS) monitors the number/types of clients treated in approximately 170 publicly-funded addiction treatment agencies in Ontario. The purpose of this study was to estimate the caseload of addiction treatment agencies, and describe important characteristics of clients, their patterns of service utilization and trends over-time from 2005 to 2010. In 2009–2010, 47,065 individuals were admitted to treatment. Since 2005–2006, there has been an increase in adolescents/youth in treatment, and a decrease in the male-female gender ratio. Alcohol problems predominated, but an increasing proportion of clients used cannabis and prescription opioids. DATIS is an evolving system and an integral component of Ontario’s performance measurement system. Linkages with healthcare information systems will allow for longitudinal tracking of client health-related outcomes. PMID:22879755

  5. Illicit Drugs: Contaminants in the Environment and Utility in Forensic Epidemiology

    EPA Science Inventory

    The published literature surrounding the origin, occurrence, fate, and effects of illicit drug ingredients (IDIs) in the environment is examined. Similarities exist with medical pharmaceuticals, particularly with regard to the basic processes by which these ingredients enter the ...

  6. Illicit Drugs: Contaminants in the Environment and Utility in Forensic Epidemiology

    EPA Science Inventory

    The published literature surrounding the origin, occurrence, fate, and effects of illicit drug ingredients (IDIs) in the environment is examined. Similarities exist with medical pharmaceuticals, particularly with regard to the basic processes by which these ingredients enter the ...

  7. Impact of China's Public Hospital Reform on Healthcare Expenditures and Utilization: A Case Study in ZJ Province

    PubMed Central

    Zhang, Hao; Hu, Huimei; Wu, Christina; Yu, Hai; Dong, Hengjin

    2015-01-01

    Background High drug costs due to supplier-induced demand (SID) obstruct healthcare accessibility in China. Drug prescriptions can generate markup-related profits, and the low prices of other medical services can lead to labor-force underestimations; therefore, physicians are keen to prescribe drugs rather than services. Thus, in China, a public hospital reform has been instituted to cancel markups and increase service prices. Methods A retrospective pre/post-reform study was conducted in ZJ province to assess the impact of the reform on healthcare expenditures and utilization, ultimately to inform policy development and decision-making. The main indicators are healthcare expenditures and utilization. Results Post-reform, drug expenditures per visit decreased by 8.2% and 15.36% in outpatient and inpatient care, respectively; service expenditures per visit increased by 23.03% and 27.69% in outpatient and inpatient care, respectively. Drug utilization per visit increased by 5.58% in outpatient care and underwent no significant change in inpatient care. Both were lower than the theoretical drug-utilization level, which may move along the demand curve because of patient-initiated demand (PID); this indicates that SID-promoted drug utilization may decrease. Finally, service utilization per visit increased by 6% in outpatient care and by 13.10% in inpatient care; both were higher than the theoretical level moving along the demand curve, and this indicates that SID-promoted service utilization may increase. Conclusion The reform reduces drug-prescription profits by eliminating drug markups; additionally, it compensates for service costs by increasing service prices. Post-reform, the SID of drug prescriptions decreased, which may reduce drug-resource waste. The SID of services increased, with potentially positive and negative effects: accessibility to services may be promoted when physicians provide more services, but the risk of resource waste may also increase. This

  8. Studies on effective utilization of precipitates from neutralized mine drainage

    SciTech Connect

    Harada, Taneomi

    1995-12-31

    Mine drainage has high acidity and sometimes contains more than the allowable concentration of ionized iron. In such a case, mine drainage is neutralized with calcium carbonate and calcium hydroxide to separate precipitates, such as the iron hydroxide and gypsum generated. Currently, most of these precipitates are not utilized and are accumulated in tailing dams. As a result, the service life of the tailing dams is reduced. This becomes a matter of concern, since securing sites for such dams is difficult. A most effective means of solving this problem would be to promote utilization of these neutralized precipitates. This paper reports on the results of studies on neutralized precipitates produced at the old Matsuo Mine (Iwate Prefecture), which has the largest neutralization treatment facility in Japan. As a result of the studies, the following was proposed regarding application of neutralized precipitates. Utilization as ferrite: mix ferrous hydroxide and ferric hydroxide in water to synthesize magnetite-like ferrite, to be used in the manufacture of magnetic markers for a mobility support system for blind pedestrians, or in producing magnetic fluids for sink-and-float separation of nonmagnetic metals and nonmetals. Utilization as hematite: bake ferric hydroxide to produce hematite, thereby extracting metallic iron for paint pigment as well as for the manufacture of ironware by local industry. Production of aluminum sulfate: precipitate aluminum ions from water and add sulfuric acid to produce aluminum sulfate.

  9. Trends in prescription drug abuse and dependence, co-occurrence with other substance use disorders, and treatment utilization: Results from two national surveys

    PubMed Central

    McCabe, Sean Esteban; Cranford, James A.; West, Brady T.

    2011-01-01

    Objectives This study examined trends in prescription drug abuse and dependence (sedatives, tranquilizers, opioids, and stimulants), co-occurrence with other substance use disorders and substance abuse treatment utilization among those with diagnoses of prescription drug abuse and dependence in two large, nationally representative, independent samples of adults in the United States in 1991–1992 and 2001–2002. Methods Two nationally representative cross-sectional samples of civilian noninstitutionalized adults 18 years or older in the United States, of which 52% were women. Data were collected from structured diagnostic interviews using the NIAAA Alcohol Use Disorder and Associated Disabilities Interview Schedule: Diagnostic and Statistical Manual version IV (DSM-IV). National prevalence estimates were derived from the 1991–1992 National Longitudinal Alcohol Epidemiologic Survey (N = 42,862) and the 2001–2002 National Epidemiologic Survey on Alcohol and Related Conditions (N = 43,093). Results The past-year prevalence of prescription sedative abuse, sedative dependence, opioid abuse, and opioid dependence increased from 1991–1992 to 2001–2002. The majority of individuals with past-year sedative (56.8%), tranquilizer (89.0%), stimulant (67.9%) and opioid (74.2%) use disorders also met DSM-IV criteria for an additional past-year substance use disorder. The co-occurrence of several forms of prescription drug use disorders and other substance use disorders increased from 1991–1992 to 2001–2002. A minority of individuals with past-year prescription drug abuse and approximately one-half of those with past-year prescription drug dependence utilized substance abuse treatment. Conclusions The findings reinforce the importance of continued national monitoring based on the increases in prescription drug abuse and dependence, high co-occurrence with other substance use disorders, and underutilization of substance abuse treatment services. PMID:18632211

  10. Investigation of drug delivery by iontophoresis in a surgical wound utilizing microdialysis

    PubMed Central

    Holovics, Heidi J.; Anderson, Carter R.; Levine, Barry S.; Hui, Ho-Wah; Lunte, Craig E.

    2008-01-01

    Purpose: This study investigated the penetration of lidocaine around and through a sutured incision following the application of iontophoretic and passive patches in the CD Hairless rat. Methods: Concentrations in localized areas (suture, dermis, subcutaneous, and vascular) were determined using microdialysis sampling followed by analysis using liquid chromatography with UV detection. Results: Iontophoresis significantly enhanced the dermal penetration of lidocaine. In an intact skin model, dermal concentrations were 40 times greater following iontophoretic delivery compared to passive delivery. In a sutured incision model, iontophoresis enhanced localized concentrations in the dermis, suture, and subcutaneous regions by 6, 15, and 20 fold, respectively. Iontophoretic delivery to a region containing a sutured incision was focused to the incision resulting in a greater increase in the suture concentration and in the subcutaneous region directly below the incision. Conclusions: The four microdialysis probe design was successful in the determination of localized drug penetration in a sutured incision model. Iontophoresis enhanced skin penetration and allowed for site specific delivery when applied to a sutured incision. PMID:18080730

  11. Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department.

    PubMed

    Genco, Emma K; Forster, Jeri E; Flaten, Hanna; Goss, Foster; Heard, Kennon J; Hoppe, Jason; Monte, Andrew A

    2016-02-01

    We examine the characteristics of clinical decision support alerts triggered when opioids are prescribed, including alert type, override rates, adverse drug events associated with opioids, and preventable adverse drug events. This was a retrospective chart review study assessing adverse drug event occurrences for emergency department (ED) visits in a large urban academic medical center using a commercial electronic health record system with clinical decision support. Participants include those aged 18 to 89 years who arrived to the ED every fifth day between September 2012 and January 2013. The main outcome was characteristics of opioid drug alerts, including alert type, override rates, opioid-related adverse drug events, and adverse drug event preventability by clinical decision support. Opioid drug alerts were more likely to be overridden than nonopioid alerts (relative risk 1.35; 95% confidence interval [CI] 1.21 to 1.50). Opioid drug-allergy alerts were twice as likely to be overridden (relative risk 2.24; 95% CI 1.74 to 2.89). Opioid duplicate therapy alerts were 1.57 times as likely to be overridden (95% CI 1.30 to 1.89). Fourteen of 4,581 patients experienced an adverse drug event (0.31%; 95% CI 0.15% to 0.47%), and 8 were due to opioids (57.1%). None of the adverse drug events were preventable by clinical decision support. However, 46 alerts were accepted for 38 patients that averted a potential adverse drug event. Overall, 98.9% of opioid alerts did not result in an actual or averted adverse drug event, and 96.3% of opioid alerts were overridden. Overridden opioid alerts did not result in adverse drug events. Clinical decision support successfully prevented adverse drug events at the expense of generating a large volume of inconsequential alerts. To prevent 1 adverse drug event, providers dealt with more than 123 unnecessary alerts. It is essential to refine clinical decision support alerting systems to eliminate inconsequential alerts to prevent alert

  12. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    PubMed

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  13. 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.

  14. Health Services Utilization and Payments in Patients With Cancer Pain: A Comparison of Intrathecal Drug Delivery vs. Conventional Medical Management

    PubMed Central

    Stearns, Lisa J.; Hammond, Krisstin; Berryman, Eric; Janjan, Nora A.

    2016-01-01

    Introduction To compare health services utilization and payments for cancer patients who received an implantable intrathecal drug delivery (IDD) system, consisting of a pump and catheter, vs. conventional medical management (CMM) for the treatment of cancer‐related pain. Methods This retrospective claims‐data analysis compared health services utilization and payments in a population of patients receiving either IDD or CMM for treatment of cancer pain. Patients were propensity score‐matched 1:1 based on characteristics including, but not limited to, age, gender, cancer type, comorbid conditions, and health care utilization and payments. Results From a sample of 142 IDD patients and 3188 CMM patients who met all inclusion/exclusion criteria, 73 matched pairs were obtained. In the year following implant, IDD patients had a consistent trend of lower medical utilization, and total payments that were $3195 lower compared to CMM. Conclusions Despite the high initial cost of IDD, this analysis suggests that patients with IDD incur lower medical utilization and payments over the first year post‐implant. Further analysis comprised of a larger, longitudinal sample would contribute to health economics and outcomes research, and assist with future practice guideline development. PMID:26816205

  15. The Burden of Narcolepsy Disease (BOND) study: health-care utilization and cost findings.

    PubMed

    Black, Jed; Reaven, Nancy L; Funk, Susan E; McGaughey, Karen; Ohayon, Maurice; Guilleminault, Christian; Ruoff, Chad; Mignot, Emmanuel

    2014-05-01

    The aim of this study was to characterize health-care utilization, costs, and productivity in a large population of patients diagnosed with narcolepsy in the United States. This retrospective, observational study using data from the Truven Health Analytics MarketScan Research Databases assessed 5 years of claims data (2006-2010) to compare health-care utilization patterns, productivity, and associated costs among narcolepsy patients (identified by International Classification of Diseases, Ninth Revision (ICD9) narcolepsy diagnosis codes) versus matched controls. A total of 9312 narcolepsy patients (>18 years of age, continuously insured between 2006 and 2010) and 46,559 matched controls were identified. Compared with controls, narcolepsy subjects had approximately twofold higher annual rates of inpatient admissions (0.15 vs. 0.08), emergency department (ED) visits w/o admission (0.34 vs. 0.17), hospital outpatient (OP) visits (2.8 vs. 1.4), other OP services (7.0 vs. 3.2), and physician visits (11.1 vs. 5.6; all p<0.0001). The rate of total annual drug transactions was doubled in narcolepsy versus controls (26.4 vs. 13.3; p<0.0001), including a 337% and 72% higher usage rate of narcolepsy drugs and non-narcolepsy drugs, respectively (both p<0.0001). Mean yearly costs were significantly higher in narcolepsy compared with controls for medical services ($8346 vs. $4147; p<0.0001) and drugs ($3356 vs. $1114; p<0.0001). Narcolepsy was found to be associated with substantial personal and economic burdens, as indicated by significantly higher rates of health-care utilization and medical costs in this large US group of narcolepsy patients. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Physician adherence to hypertension treatment guidelines and drug acquisition costs of antihypertensive drugs at the cardiac clinic: a pilot study.

    PubMed

    Abdulameer, Shaymaa Abdalwahed; Sahib, Mohanad Naji; Aziz, Noorizan Abd; Hassan, Yahaya; Alrazzaq, Hadeer Akram Abdul; Ismail, Omar

    2012-01-01

    Prescribing pattern surveys are one of the pharmacoepidemiological techniques that provide an unbiased picture of prescribing habits. Prescription surveys permit the identification of suboptimal prescribing patterns for further evaluation. The aims of this study were to determine the prescribing trend, adherence of the prescribers to the guideline, and the impact of drug expenditure on drug utilization at the cardiac clinic of Penang Hospital, Malaysia. This was a cross-sectional study. Demographic data of the patients, diagnoses and the drugs prescribed were recorded. The average drug acquisition costs (ADAC) were calculated for each antihypertensive drug class on a daily and annual basis. Adherence to the guideline was calculated as a percentage of the total number of patients. A total of 313 individuals fulfilled the inclusion criteria. The average age of the study population was 59.30 ± 10.35 years. The mean number of drugs per prescription in the study was 2.09 ± 0.78. There were no significant differences in the demographic data. Antihypertensive drugs were used in monotherapy and polytherapy in 20.8% and 79.2% of the patients, respectively. Adherence to the guideline regarding prescription occurred in 85.30% of the patients. The lowest priced drug class was diuretics and the highest was angiotensin-receptor blockers. In conclusion, the total adherence to the guideline was good; the adherence percentage only slightly decreased with a co-existing comorbidity (such as diabetes mellitus). The use of thiazide diuretics was encouraged because they are well tolerated and inexpensive, and perindopril was still prescribed for diabetic patients since it is relatively cheap (generic drug) and its daily dosage is beneficial.

  17. Examination of psychosocial predictors of Virginia pharmacists' intention to utilize a prescription drug monitoring program using the theory of planned behavior.

    PubMed

    Gavaza, Paul; Fleming, Marc; Barner, Jamie C

    2014-01-01

    Little is known about the main drivers of pharmacists' intention to utilize prescription drug monitoring programs (PDMPs) when making care decisions and the actual contribution of these factors in explaining intention and behavior. This study examined what theory of planned behavior (TPB) model constructs (i.e., attitude, subjective norm [SN], perceived behavioral control [PBC]), past utilization behavior (PUB) and perceived moral obligation (PMO) were significant predictors of Virginia community pharmacists' intention to utilize a PDMP. A cover letter with a link to a 28-item online survey was e-mailed to 600 members of the Virginia Pharmacists Association. Multiple regression analyses were used to determine the association between pharmacists' intention to utilize the PDMP database and attitude, SN, PBC, PUB and PMO. Ninety-seven usable responses were received, for a response rate of 16.2%. A majority of the respondents were Caucasian (96.4%), female (50.5%), working in independent community pharmacies (60.4%) with an average age of 49.5 ± 13.4 years. Overall, pharmacists intended to utilize a PDMP (mean = 5.3 ± 4.6; possible range: -9 to 9), had a positive attitude toward utilizing PDMP (mean = 6.3 ± 5.3; possible range: -12 to 12), perceived that others wanted them to utilize a PDMP (SN score = 3.7 ± 2.4; range: -6 to 6), and believed that they had control over utilization behavior (PBC score = 4.5 ± 4.0; range: -9 to 9). Attitude (β = 0.723, P < 0.001), SN (β = 0.230, P = 0.014) and PBC (β = -0.215, P = 0.026) significantly predicted pharmacists' intent, accounting for 56.7% of the variance in intention to utilize the PDMP database (P < 0.001). The addition of PMO (P < 0.001) significantly contributed to explaining the variance in intention but PUB did not. Members of the Virginia Pharmacists Association who responded to the survey showed a strong positive intent to utilize PDMP database. Pharmacists' attitudes, subjective norm, perceived behavioral

  18. Boosting workplace stair utilization: a study of incremental reinforcement.

    PubMed

    Schumacher, Joseph E; Utley, Janice; Sutton, Lindsay; Horton, Trudi; Hamer, Trey; You, Zhiying; Klapow, Joshua C

    2013-02-01

    This study was designed to determine whether engagement in stair taking can be increased in a worksite setting through the provision of an employer-sponsored, behavior-based incentive system in which employees (members) accumulate points that can be redeemed for merchandise. ChipRewards implemented stair utilization in one employer as a part of a larger health incentive engagement program. Using an AB (baseline-intervention) design, members (N = 216) were observed for 6 months (6.17.10 to 12.14.10 or 129 weekdays after excluding 52 weekend days) before the intervention (baseline) and after 6 months (1.1.11 to 6.30.11 with the same number of weekdays) of implementation. Members were 84% female, 51% Caucasian, 48% African American, 3% Hispanic, and 45 years average age. The number of total stair transactions for all members for all days monitored increased from 5,070 to 38,900, and the average number of stair transactions per day rose from 39 to 301, representing over a 600% increase. The overall cost of incentives for stair utilization was $3,739.30 or $17.55 per member on average. This study supports that stair usage in the workplace is a viable way to increase physical activity. This study adds to existing research that attempted to increase stair utilization through promotion only by adding a behavioral reinforcement strategy. Finally, this study demonstrates that a physical activity among employees at the worksite can be increased with minimal relative cost.

  19. Effectiveness of a Retrospective Drug Utilization Review on Potentially Unsafe Opioid and Central Nervous System Combination Therapy.

    PubMed

    Qureshi, Nabeel; Wesolowicz, Laurie A; Liu, Chi-Mei; Tungol Lin, Alexandra

    2015-10-01

    Drug overdose deaths are the leading cause of unintentional death in the United States, and opioid-related mortality is the primary contributor (75.2%). Among opioid-related mortalities, opioids are most commonly taken with benzodiazepines (30.1%) and antidepressants (13.4%). The utility of a retrospective drug utilization review (DUR) program initiated by a commercial health plan for members taking potentially unsafe opioid and central nervous system (CNS) combination therapy is currently unknown. To determine the effectiveness of a retrospective DUR program on potentially unsafe opioid and CNS combination therapy. This research is a pre-post study utilizing pharmacy claims data from 2.6 million commercially insured members enrolled in a health plan in the Midwest. Members were required to be at least aged 18 years as of August 30, 2013, and continuously enrolled from May 2, 2013, through February 15, 2014. Members with 1 or more paid claims for an opioid at least 200 morphine equivalent dose (MED) daily and a concur- rent supply of another opioid, benzodiazepine, or antidepressant from May 2, 2013, through August 30, 2013 (120-day preintervention period) were targeted for the retrospective DUR program. These exclusion criteria were applied: members belonging to commercial groups requiring permission on claims data analyses, missing or invalid prescriber information, or presence of pharmacy claims indicating human immunodeficiency virus or acquired immunodeficiency syndrome during the 2 years prior to the pre-intervention period. Prescribers of high-dose opioids received a mailing (intervention) containing a member-specific letter, medication profile, and satisfaction survey to determine the prescriber-perceived clinical value of the program. To assess the effectiveness of the retrospective DUR program, criteria was reapplied to identify members still meeting criteria 120 days postintervention (February 15, 2014). Paired samples t-test was used to compare pre

  20. Study of Lyndon B. Johnson Space Center utility systems

    NASA Technical Reports Server (NTRS)

    Redding, T. E.; Huber, W. C.

    1977-01-01

    The results of an engineering study of potential energy saving utility system modifications for the NASA Lyndon B. Johnson Space Center are presented. The objective of the study was to define and analyze utility options that would provide facility energy savings in addition to the approximately 25 percent already achieved through an energy loads reduction program. A systems engineering approach was used to determine total system energy and cost savings resulting from each of the ten major options investigated. The results reported include detailed cost analyses and cost comparisons of various options. Cost are projected to the year 2000. Also included are a brief description of a mathematical model used for the analysis and the rationale used for a site survey to select buildings suitable for analysis.

  1. Drug Court Effectiveness: A Matched Cohort Study in the Dane County Drug Treatment Court

    ERIC Educational Resources Information Center

    Brown, Randall

    2011-01-01

    Drug treatment courts (DTCs) are widely viewed as effective diversion programs for drug-involved offenders; however, previous studies frequently used flawed comparison groups. In the current study, the author compared rates of recidivism for drug court participants to rates for a traditionally adjudicated comparison group matched on potentially…

  2. Drug Court Effectiveness: A Matched Cohort Study in the Dane County Drug Treatment Court

    ERIC Educational Resources Information Center

    Brown, Randall

    2011-01-01

    Drug treatment courts (DTCs) are widely viewed as effective diversion programs for drug-involved offenders; however, previous studies frequently used flawed comparison groups. In the current study, the author compared rates of recidivism for drug court participants to rates for a traditionally adjudicated comparison group matched on potentially…

  3. The Therapeutic Utility of Employment in Treating Drug Addiction: Science to Application

    PubMed Central

    Silverman, Kenneth; Holtyn, August F.; Morrison, Reed

    2016-01-01

    Research on a model Therapeutic Workplace has allowed for evaluation of the use of employment in the treatment of drug addiction. Under the Therapeutic Workplace intervention, adults with histories of drug addiction are hired and paid to work. To promote drug abstinence or adherence to addiction medications, participants are required to provide drug-free urine samples or take prescribed addiction medications, respectively, to gain access to the workplace and/or to maintain their maximum rate of pay. Research has shown that the Therapeutic Workplace intervention is effective in promoting and maintaining abstinence from heroin, cocaine and alcohol and in promoting adherence to naltrexone. Three models could be used to implement and maintain employment-based reinforcement in the treatment of drug addiction: A Social Business model, a Cooperative Employer model, and a Wage Supplement model. Under all models, participants initiate abstinence in a training and abstinence initiation phase (Phase 1). Under the Social Business model, Phase 1 graduates are hired as employees in a social business and required to maintain abstinence to maintain employment and/or maximum pay. Under the Cooperative Employer model, cooperating community employers hire graduates of Phase 1 and require them to maintain abstinence to maintain employment and/or maximum pay. Under the Wage Supplement Model, graduates of Phase 1 are offered abstinence-contingent wage supplements if they maintain competitive employment in a community job. Given the severity and persistence of the problem of drug addiction and the lack of treatments that can produce lasting effects, continued development of the Therapeutic Workplace is warranted. PMID:27777966

  4. The Therapeutic Utility of Employment in Treating Drug Addiction: Science to Application.

    PubMed

    Silverman, Kenneth; Holtyn, August F; Morrison, Reed

    2016-06-01

    Research on a model Therapeutic Workplace has allowed for evaluation of the use of employment in the treatment of drug addiction. Under the Therapeutic Workplace intervention, adults with histories of drug addiction are hired and paid to work. To promote drug abstinence or adherence to addiction medications, participants are required to provide drug-free urine samples or take prescribed addiction medications, respectively, to gain access to the workplace and/or to maintain their maximum rate of pay. Research has shown that the Therapeutic Workplace intervention is effective in promoting and maintaining abstinence from heroin, cocaine and alcohol and in promoting adherence to naltrexone. Three models could be used to implement and maintain employment-based reinforcement in the treatment of drug addiction: A Social Business model, a Cooperative Employer model, and a Wage Supplement model. Under all models, participants initiate abstinence in a training and abstinence initiation phase (Phase 1). Under the Social Business model, Phase 1 graduates are hired as employees in a social business and required to maintain abstinence to maintain employment and/or maximum pay. Under the Cooperative Employer model, cooperating community employers hire graduates of Phase 1 and require them to maintain abstinence to maintain employment and/or maximum pay. Under the Wage Supplement Model, graduates of Phase 1 are offered abstinence-contingent wage supplements if they maintain competitive employment in a community job. Given the severity and persistence of the problem of drug addiction and the lack of treatments that can produce lasting effects, continued development of the Therapeutic Workplace is warranted.

  5. Utilization of gastroprotective strategies for nonsteroidal anti-inflammatory drug-induced gastrointestinal events in a major teaching hospital

    PubMed Central

    Lee, Hooi Leng; Chua, Siew Siang; Mahadeva, Sanjiv

    2016-01-01

    Background and purpose Clinical guidelines recommend the prescribing of gastroprotective strategies in nonsteroidal anti-inflammatory drug (NSAID) users with risk factors for gastrointestinal (GI) ulcer or ulcer complications. However, these guidelines are not often translated into clinical practice. Therefore, the aim of this study was to investigate the utilization of gastroprotective strategies for NSAID-induced upper GI events in at-risk users in a major teaching hospital. Patients and methods A cross-sectional, observational, pharmacy-based study was conducted in a major Asian institution with both primary and secondary health care services. This study involved the screening of prescriptions for regular NSAIDs, and patients who met the inclusion criteria were recruited and interviewed using a questionnaire. Results Of the 409 participants recruited, 83.1% had at least one GI risk factor, of whom 70.3% did not receive appropriate gastroprotection. The most common GI risk factor was the use of high-dose NSAIDs (69.2%), followed by participants aged 65 years and older (22%) and concomitant use of low-dose aspirin (11.7%). Appropriate gastroprotective strategies utilized consisted of the use of a cyclooxygenase (COX)-2 inhibitor alone or a nonselective NSAID plus a proton pump inhibitor (PPI) in the moderate-risk group and a COX-2 inhibitor plus a PPI in the high-risk group. Gastroprotective strategies were underutilized in 67.1% of at-risk participants and overutilized in 59.4% of those without risk factors. Co-prescription of a histamine-2 receptor antagonist at lower-than-recommended doses constituted 59% of the inappropriate gastroprotective agents used. Logistic regression analysis revealed patients aged 65 years and older (odds ratio, 1.89; 95% CI =1.15–3.09) as a predictor for the prescribing of gastroprotection by the clinicians. Conclusion Approximately 70% of at-risk NSAID users, mainly on high-dose NSAIDs, were not prescribed appropriate

  6. Utility of spatially-resolved atmospheric pressure surface sampling and ionization techniques as alternatives to mass spectrometric imaging (MSI) in drug metabolism

    SciTech Connect

    Blatherwick, Eleanor Q.; Van Berkel, Gary J; Pickup, Kathryn; Johansson, Maria K.; Beaudoin, Marie-Eve; Cole, Roderic; Day, Jennifer M.; Iverson, Suzanne; Wilson, Ian D.; Scrivens, James H.; Weston, Daniel J.

    2011-01-01

    1. Tissue distribution studies of drug molecules play an essential role in the pharmaceutical industry and are commonly undertaken using quantitative whole body autoradiography (QWBA) methods. 2. The growing need for complementary methods to address some scientific gaps around radiography methods has led to increased use of mass spectrometric imaging (MSI) technology over the last 5 to 10 years. More recently, the development of novel mass spectrometric techniques for ambient surface sampling has redefined what can be regarded as fit-for-purpose for MSI in a drug metabolism and disposition arena. 3. Together with a review of these novel alternatives, this paper details the use of two liquid microjunction (LMJ)- based mass spectrometric surface sampling technologies. These approaches are used to provide qualitative determination of parent drug in rat liver tissue slices using liquid extraction surface analysis (LESA) and to assess the performance of a LMJ surface sampling probe (LMJ-SSP) interface for quantitative assessment of parent drug in brain, liver and muscle tissue slices. 4. An assessment of the utility of these spatially-resolved sampling methods is given, showing interdependence between mass spectrometric and QWBA methods, in particular there emerges a reason to question typical MSI workflows for drug metabolism; suggesting the expedient use of profile or region analysis may be more appropriate, rather than generating time-intensive molecular images of the entire tissue section.

  7. Analysis of nine drugs and their cytochrome P450-specific probe metabolites from urine by liquid chromatography-tandem mass spectrometry utilizing sub 2 microm particle size column.

    PubMed

    Petsalo, Aleksanteri; Turpeinen, Miia; Pelkonen, Olavi; Tolonen, Ari

    2008-12-26

    An LC/MS/MS method was developed for the analysis of twelve cytochrome P450 (CYP)-specific probe metabolites and their nine parent drugs from human urine. CYP-specific metabolites of melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19 and CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1) and midazolam (CYP3A4) were all analyzed using the same LC/MS/MS method with a single analytical run, either after a one-at-a-time dose or cocktail-type dosing of the parent drugs. Ultra performance liquid chromatography (UPLC) with a 1.7 microm particle size column was utilized, providing 1.5-3-fold increase in sensitivity, decrease of analysis time to one third and clearly better chromatographic peak shapes when comparing it with the method using traditional high performance liquid chromatography for the same metabolites. In addition, the method was applied for the analysis of the metabolites from human urine samples collected at multiple time points after single and N-in-one dosing of each of the drugs, showing that the use of both the analytical method and these probe metabolites as CYP-specific markers is feasible in in vivo drug-drug interaction or phenotyping studies.

  8. Utility of spatially-resolved atmospheric pressure surface sampling and ionization techniques as alternatives to mass spectrometric imaging (MSI) in drug metabolism.

    PubMed

    Blatherwick, Eleanor Q; Van Berkel, Gary J; Pickup, Kathryn; Johansson, Maria K; Beaudoin, Marie-Eve; Cole, Roderic O; Day, Jennifer M; Iverson, Suzanne; Wilson, Ian D; Scrivens, James H; Weston, Daniel J

    2011-08-01

    Tissue distribution studies of drug molecules play an essential role in the pharmaceutical industry and are commonly undertaken using quantitative whole body autoradiography (QWBA) methods. The growing need for complementary methods to address some scientific gaps around radiography methods has led to increased use of mass spectrometric imaging (MSI) technology over the last 5 to 10 years. More recently, the development of novel mass spectrometric techniques for ambient surface sampling has redefined what can be regarded as "fit-for-purpose" for MSI in a drug metabolism and disposition arena. Together with a review of these novel alternatives, this paper details the use of two liquid microjunction (LMJ)-based mass spectrometric surface sampling technologies. These approaches are used to provide qualitative determination of parent drug in rat liver tissue slices using liquid extraction surface analysis (LESA) and to assess the performance of a LMJ surface sampling probe (LMJ-SSP) interface for quantitative assessment of parent drug in brain, liver and muscle tissue slices. An assessment of the utility of these spatially-resolved sampling methods is given, showing interdependence between mass spectrometric and QWBA methods, in particular there emerges a reason to question typical MSI workflows for drug metabolism; suggesting the expedient use of profile or region analysis may be more appropriate, rather than generating time-intensive molecular images of the entire tissue section.

  9. 77 FR 43337 - Drugs for Human Use; Drug Efficacy Study Implementation; Certain Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... enacted in 1938, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) required that ``new drugs'' (see... commerce. To this end, the FD&C Act made it the sponsor's responsibility, before marketing a new drug, to... to be marketed without independent approval. In 1962, Congress amended the FD&C Act to require...

  10. Enterprise utilization of "always on-line" diagnostic study archive.

    PubMed

    McEnery, Kevin W; Suitor, Charles T; Thompson, Stephen K; Shepard, Jeffrey S; Murphy, William A

    2002-01-01

    To meet demands for enterprise image distribution, an "always on-line" image storage archive architecture was implemented before soft copy interpretation. It was presumed that instant availability of historical diagnostic studies would elicit a substantial utilization. Beginning November 1, 2000 an enterprise distribution archive was activated (Stentor, SanFrancisco, CA). As of August 8, 2001, 83,052 studies were available for immediate access without the need for retrieval from long-term archive. Image storage and retrieval logs for the period from June 12, 2001 to August 8, 2001 were analyzed. A total of 41,337 retrieval requests were noted for the 83,052 studies available as August 8, 2001. Computed radiography represented 16.8% of retrieval requests; digital radiography, 16.9%; computed tomography (CT), 44.5%; magnetic resonance (MR), 19.2%; and ultrasonography, 2.6%. A total of 51.5% of study retrievals were for studies less than 72 hours old. Study requests for cases greater than 100 days old represented 9.9% of all accessions, 9.7% of CT accessions, and 15.4% of MR accessions. Utilization of the archive indicates a substantial proportion of study retrievals for studies less than 72 hours after study completion. However, significant interest in historical CT and MR examinations was shown.

  11. Utilizing Business, University, and Community Resources to Target Adolescent Prescription Drug Abuse

    ERIC Educational Resources Information Center

    Wade-Mdivanian, R.; Anderson-Butcher, D.; Hale, K.; Kwiek, N.; Smock, J.; Radigan, D.; Lineberger, J.

    2012-01-01

    "Generation Rx" is a prescription drug abuse prevention strategy which includes a "toolkit" designed to be used with youth. Developed by Cardinal Health Foundation and the Ohio State University, it provides health care providers (especially pharmacists), parents, teachers, youth workers, and other community leaders with…

  12. Utilizing Business, University, and Community Resources to Target Adolescent Prescription Drug Abuse

    ERIC Educational Resources Information Center

    Wade-Mdivanian, R.; Anderson-Butcher, D.; Hale, K.; Kwiek, N.; Smock, J.; Radigan, D.; Lineberger, J.

    2012-01-01

    "Generation Rx" is a prescription drug abuse prevention strategy which includes a "toolkit" designed to be used with youth. Developed by Cardinal Health Foundation and the Ohio State University, it provides health care providers (especially pharmacists), parents, teachers, youth workers, and other community leaders with…

  13. Prevalence of multi-drug resistant Salmonella on comercial dairies utilizing a single heifer raising facility

    USDA-ARS?s Scientific Manuscript database

    The objectives of the current research were two-fold: 1) Determine the prevalence of multiple drug resistant (MDR) Salmonella in the various classes of dairy cattle; and 2) Determine if co-mingling of calves from multiple farms at a heifer feedlot serves as a transmission vector for Salmonella back ...

  14. Are we using drugs rationally? A survey study from Turkey

    PubMed Central

    Ozdinc, Serife; Sensoy, Nazli; Kurt, Rumeysa; Altas, Sevda; Altun, Ramazan

    2015-01-01

    Objectives: To investigate the rational use of drugs from patient’s perspective. Methods: This study was conducted at the Afyon Kocatepe University Training and Research Hospital between February and March 2013. Data were collected with a questionnaire. Descriptive statistics and Chi-Square test were used. Results: About 54% (n=419) of participants reported that they used drugs without the advice of a physician. The 19-24 age group, secondary and high school graduates, and students used drugs more often without consulting a physician (P < 0.05). Participants that used drugs after consulting a physician did not fully use the drugs as recommended by the physician, and physicians did not give patients adequate information about prescribed drug(s). 72% of participants stored drug(s) at home. Conclusions: Rational use of drugs is not completely achieved. Certain patient groups and even physicians are closer to being a part of the irrational use of drugs. PMID:26649005

  15. Modelling Simple Experimental Platform for In Vitro Study of Drug Elution from Drug Eluting Stents (DES)

    NASA Astrophysics Data System (ADS)

    Kalachev, L. V.

    2016-06-01

    We present a simple model of experimental setup for in vitro study of drug release from drug eluting stents and drug propagation in artificial tissue samples representing blood vessels. The model is further reduced using the assumption on vastly different characteristic diffusion times in the stent coating and in the artificial tissue. The model is used to derive a relationship between the times at which the measurements have to be taken for two experimental platforms, with corresponding artificial tissue samples made of different materials with different drug diffusion coefficients, to properly compare the drug release characteristics of drug eluting stents.

  16. Theoretical studies of anticancer drugs, lexitropsins

    SciTech Connect

    Kabir, S.

    1992-01-01

    The purpose of this research study was to gather information about the structure and activity of some anticancer drugs, leading eventually to better drug designs. The following studies were undertaken: (1) The investigation via geometry optimization of the structure of one small lexitropsin, amidinomycin, which is an oligopeptide that binds to the minor groove of B-DNA. (2) Proton affinities of some hydrogen acceptor rings that are present in some lexitropsin were studied in order to estimate their capacities to bind to GC sequences of DNA. (3) Binding power of one of the DNA bases, thymine, to either guanidinium ion as present in netropsin or aminopyrrolidinium ion moiety as is present in anthelvencin was compared in order to determine how much these two groups contributed to the overall binding of netropsin and anthelvencin to the base sequences of DNA. It was found that ab initio calculations on amidinomycin agree well with the experimental results and the proton affinities of imidazole is much higher than the one of oxazole which in turn is much higher than the one of thiazole and a methyl group substitutent increases the proton of imidazole, while a peptidic group decreases it. Also, it was found that the binding of guanidinium and aminopyrrolidinium ions to uracil as a model for thymine is very similar.

  17. Patterns of healthcare utilization by COPD severity: a pilot study.

    PubMed

    Joo, Min J; Lee, Todd A; Bartle, Brian; van de Graaff, William B; Weiss, Kevin B

    2008-01-01

    Global Initiative on Chronic Obstructive Lung Disease (GOLD) guidelines recently removed stage 0, a group with symptoms but without airways obstruction, from their severity staging. However, in practice this group may still be diagnosed and medically managed. The aim of this study was to characterize healthcare utilization patterns of chronic obstructive pulmonary disease (COPD) patients by disease severity, focusing on the possible unique attributes of patients who would have been classified as GOLD stage 0. This is a prospective cohort pilot study performed at the Hines Veterans Administration Hospital. One hundred twenty patients with a diagnosis of COPD were enrolled. The participants completed quality-of-life questionnaires and a pulmonary function test. Healthcare utilization data were obtained 1 year prior and 2 years after the enrollment date. Three disease severity groups were defined based on GOLD criteria for comparison [GOLD stage 1-2 (GS 1-2), GOLD stage 3-4 (GS 3-4), and formerly GOLD stage 0 ("at risk")]. The "at risk" group had an average of 14.4 (SD = 30.5) outpatient visits/year and 0.3 (SD = 0.8) hospitalizations/year, which were higher than the other groups, but this was not statistically significant. Respiratory medications were used by 6 (26%), 30 (59%), and 40 (91%) patients from "at risk" to GS 3-4, respectively. Patients in the "at risk" group had a decrement in health status, significant utilization of healthcare services, and were often receiving medications not consistent with guidelines.

  18. Technology Utilization House Study Report. [For Energy Conservation

    NASA Technical Reports Server (NTRS)

    1974-01-01

    The objectives of Project TECH are: (1) to construct a single family detached dwelling for demonstrating the application of advanced technology and minimizing the requirement for energy and utility services, and (2) to help influence future development in home construction by defining the interaction of integrated energy and water management systems with building configuration and construction materials. Components and methods expected to be cost effective over a 20 year span were studied. Emphasis was placed on the utilization of natural heating and cooling characteristics. Orientation and location of windows, landscaping, natural ventilation, and characteristics of the local climate and microclimate were intended to be used to best advantage. Energy conserving homes are most efficient when design for specific sites, therefore project TECH should not be considered a prototype design suitable for all locations. However, it does provide ideas and analytical methods which can be applied to some degree in all housing.

  19. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... Anti- Salmonella Chemical Food Additives in Feeds; Request for Comments AGENCY: Food and Drug... Chemical Food Additives in Feeds,'' and is seeking comments on this guidance before revisions are made... Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds...

  20. Turning the gun on cancer: Utilizing lysosomal P-glycoprotein as a new strategy to overcome multi-drug resistance.

    PubMed

    Seebacher, Nicole; Lane, Darius J R; Richardson, Des R; Jansson, Patric J

    2016-07-01

    Oxidative stress plays a role in the development of drug resistance in cancer cells. Cancer cells must constantly and rapidly adapt to changes in the tumor microenvironment, due to alterations in the availability of nutrients, such as glucose, oxygen and key transition metals (e.g., iron and copper). This nutrient flux is typically a consequence of rapid growth, poor vascularization and necrosis. It has been demonstrated that stress factors, such as hypoxia and glucose deprivation up-regulate master transcription factors, namely hypoxia inducible factor-1α (HIF-1α), which transcriptionally regulate the multi-drug resistance (MDR), transmembrane drug efflux transporter, P-glycoprotein (Pgp). Interestingly, in addition to the established role of plasma membrane Pgp in MDR, a new paradigm of intracellular resistance has emerged that is premised on the ability of lysosomal Pgp to transport cytotoxic agents into this organelle. This mechanism is enabled by the topological inversion of Pgp via endocytosis resulting in the transporter actively pumping agents into the lysosome. In this way, classical Pgp substrates, such as doxorubicin (DOX), can be actively transported into this organelle. Within the lysosome, DOX becomes protonated upon acidification of the lysosomal lumen, causing its accumulation. This mechanism efficiently traps DOX, preventing its cytotoxic interaction with nuclear DNA. This review discusses these effects and highlights a novel mechanism by which redox-active and protonatable Pgp substrates can utilize lysosomal Pgp to gain access to this compartment, resulting in catastrophic lysosomal membrane permeabilization and cell death. Hence, a key MDR mechanism that utilizes Pgp (the "gun") to sequester protonatable drug substrates safely within lysosomes can be "turned on" MDR cancer cells to destroy them from within. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Drug Induced Hearing Loss: Researchers Study Strategies to Preserve Hearing

    MedlinePlus

    ... JavaScript on. Feature: Drug-Induced Hearing Loss Researchers Study Strategies to Preserve Hearing Past Issues / Spring 2016 Table ... Read More "Drug Induced Hearing Loss" Articles Researchers Study Strategies to Preserve Hearing / What Is Ototoxicity? Spring 2016 ...

  2. Scoping study of integrated resource planning needs in the public utility sector

    SciTech Connect

    Garrick, C J; Garrick, J M; Rue, D R

    1993-06-01

    Integrated resource planning (IRP) is an approach to utility resource planning that integrates the evaluation of supply- and demand-site options for providing energy services at the least cost. Many utilities practice IRP; however, most studies about IRP focus on investor-owned utilities (IOUs). This scoping study investigates the IRP activities and needs of public utilities (not-for-profit utilities, including federal, state, municipal, and cooperative utilities). This study (1) profiles IRP-related characteristics of the public utility sector, (2) articulates the needs of public utilities in understanding and implementing IRP, and (3) identifies strategies to advance IRP principles in public utility planning.

  3. Fundamental Study of Low-Nox Combustion Fly Ash Utilization

    SciTech Connect

    E. M. Suuberg; I. Kuloats; K. Smith; N. Sabanegh; R. H. Hurt; W. D. Lilly; Y. M. Gao

    1997-11-01

    This study is principally concerned with characterizing the organic part of coal combustion fly ashes. High carbon fly ashes are becoming more common as by-products of low-NOx combustion technology, and there is need to learn more about this fraction of the fly ash. The project team consists of two universities, Brown and Princeton, and an electrical utility, New England Power. A sample suite of over forty fly ashes has been gathered from utilities across the United States, and includes ashes from a coals ranging in rank from bituminous to lignite. The characterizations of these ashes include standard tests (LOI, Foam Index), as well as more detailed characterizations of their surface areas, porosity, extractability and adsorption behavior. The ultimate goal is, by better characterizing the material, to enable broadening the range of applications for coal fly ash re-use beyond the current main market as a pozzolanic agent for concretes. The potential for high carbon-content fly ashes to substitute for activated carbons is receiving particular attention. The work performed to date has already revealed how very different the surfaces of different ashes produced by the same utility can be, with respect to polarity of the residual carbon. This can help explain the large variations in acceptability of these ashes as concrete additives.

  4. FUNDAMENTAL STUDY OF LOW-NOx COMBUSTION FLY ASH UTILIZATION

    SciTech Connect

    ERIC M. SUUBERG; ROBERT H. HURT

    1998-10-19

    This study is principally concerned with characterizing the organic part of coal combustion fly ashes. High carbon fly ashes are becoming more common as by-products of low-NOx combustion technology, and there is need to learn more about this fraction of the fly ash. The project team consists of two universities, Brown and Princeton, and an electrical utility, New England Power. A sample suite of over fifty fly ashes has been gathered from utilities across the United States, and includes ashes from a coals ranging in rank from bituminous to lignite. The characterizations of these ashes include standard tests (LOI, Foam Index), as well as more detailed characterizations of their surface areas, porosity, extractability and adsorption behavior. The ultimate goal is, by better characterizing the material, to enable broadening the range of applications for coal fly ash re-use beyond the current main market as a pozzolanic agent for concretes. The potential for high carbon-content fly ashes to substitute for activated carbons is receiving particular attention. The work performed to date has already revealed how very different the surfaces of different ashes produced by the same utility can be, with respect to polarity of the residual carbon. This can help explain the large variations in acceptability of these ashes as concrete additives.

  5. Fundamental Study of Low NOx Combustion Fly Ash Utilization

    SciTech Connect

    E. M. Suubert; I. Kuloats; K. Smith; N. Sabanegh; R.H. Hurt; W. D. Lilly; Y. M. Gao

    1997-05-01

    This study is principally concerned with characterizing the organic part of coal combustion fly ashes. High carbon fly ashes are becoming more common as by-products of low-NOx combustion technology, and there is need to learn more about this fraction of the fly ash. The project team consists of two universities, Brown and Princeton, and an electrical utility, New England Power. A sample suite of over forty fly ashes has been gathered from utilities across the United States, and includes ashes from a coals ranging in rank from bituminous to lignite. The characterizations of these ashes include standard tests (LOI, Foam Index), as well as more detailed characterizations of their surface areas, porosity, extractability and adsorption behavior. The ultimate goal is, by better characterizing the material, to enable broadening the range of applications for coal fly ash re-use beyond the current main market as a pozzolanic agent for concretes. The potential for high carbon-content fly ashes to substitute for activated carbons is receiving particular attention. The work performed to date has already revealed how very different the surfaces of different ashes produced by the same utility can be, with respect to polarity of the residual carbon. This can help explain the large variations in acceptability of these ashes as concrete additives.

  6. Emerging role of drug interaction studies in drug development: the good, the bad, and the unknown.

    PubMed

    Alfaro, C L

    2001-01-01

    Significant scientific advancements in the last decade have armed researchers with tools to assess drug metabolism and the effects of drugs on metabolic pathways; however, most of this research has focused on cytochrome P450 isozymes. Early delineation of this information aids in the prediction of potential drug-drug interactions, which may ultimately determine whether a compound is pursued in the drug development process. The recent withdrawals of medications such as terfenadine, astemizole, cisapride, and mibefradil from the market demonstrate the relevance of this a priori approach--the risk of drug interactions was largely unrecognized prior to their approval by the Food and Drug Administration (FDA). Drug interaction studies for new drug applications (NDAs) field between 1987 and 1991 were largely in vivo studies with potential coadministered drugs, whereas for NDAs field between 1992 and 1997, the majority of studies involved metabolic mechanisms and in vitro methodology. Despite current limitations in the extrapolation of in vitro drug metabolism data to the in vivo environment, in vitro studies remain the mainstay of initial evaluations in this area primarily because of the high throughput nature of these investigations and the reduced cost compared with in vivo studies. The FDA has published several guidance documents in the area of drug metabolism and drug interaction studies in drug development with suggestions for in vitro as well as in vivo approaches to these investigations. Current and future research will likely focus on in vitro models for cytochrome P450 induction, Phase II metabolism, and drug transporters, and include validation and extrapolation of these approaches in vivo.

  7. Cost-utility analysis comparing radioactive iodine, anti-thyroid drugs and total thyroidectomy for primary treatment of Graves' disease.

    PubMed

    Donovan, Peter J; McLeod, Donald S A; Little, Richard; Gordon, Louisa

    2016-12-01

    Little data is in existence about the most cost-effective primary treatment for Graves' disease. We performed a cost-utility analysis comparing radioactive iodine (RAI), anti-thyroid drugs (ATD) and total thyroidectomy (TT) as first-line therapy for Graves' disease in England and Australia. We used a Markov model to compare lifetime costs and benefits (quality-adjusted life-years (QALYs)). The model included efficacy, rates of relapse and major complications associated with each treatment, and alternative second-line therapies. Model parameters were obtained from published literature. One-way sensitivity analyses were conducted. Costs were presented in 2015£ or Australian Dollars (AUD). RAI was the least expensive therapy in both England (£5425; QALYs 34.73) and Australia (AUD5601; 30.97 QALYs). In base case results, in both countries, ATD was a cost-effective alternative to RAI (£16 866; 35.17 QALYs; incremental cost-effectiveness ratio (ICER) £26 279 per QALY gained England; AUD8924; 31.37 QALYs; ICER AUD9687 per QALY gained Australia), while RAI dominated TT (£7115; QALYs 33.93 England; AUD15 668; 30.25 QALYs Australia). In sensitivity analysis, base case results were stable to changes in most cost, transition probabilities and health-relative quality-of-life (HRQoL) weights; however, in England, the results were sensitive to changes in the HRQoL weights of hypothyroidism and euthyroidism on ATD. In this analysis, RAI is the least expensive choice for first-line treatment strategy for Graves' disease. In England and Australia, ATD is likely to be a cost-effective alternative, while TT is unlikely to be cost-effective. Further research into HRQoL in Graves' disease could improve the quality of future studies. © 2016 European Society of Endocrinology.

  8. Intravenous infusion tests have limited utility for selecting long-term drug therapy in patients with chronic pain: a systematic review.

    PubMed

    Cohen, Steven P; Kapoor, Shruti G; Rathmell, James P

    2009-08-01

    Since the first description in the early 1990s, the scope of intravenous infusions tests has expanded to encompass multiple drug classes and indications. Purported advantages of these tests include elucidating mechanisms of pain, providing temporary relief of symptoms, and usefulness as prognostic tools in guiding drug therapy. In an attempt to discern the value of these tests, the authors conducted a systematic review to explore the rationale and evidence behind the following intravenous infusion tests: lidocaine, ketamine, opioid, and phentolamine. The studies evaluating all intravenous infusion tests were characterized by lack of standardization, wide variations in outcome measures, and methodological flaws. The strongest evidence found was for the intravenous lidocaine test, with the phentolamine test characterized by the least convincing data. Whereas intravenous opioid infusions are the most conceptually appealing test, their greatest utility may be in predicting poor responders to sustained-release formulations.

  9. A comparative study of the utility of two superdisintegrants in microcrystalline cellulose pellets prepared by extrusion-spheronization.

    PubMed

    Souto, Consuelo; Rodríguez, Alberto; Parajes, Silvia; Martínez-Pacheco, Ramón

    2005-09-01

    This study evaluated the utility of including superdisintegrants (croscarmellose sodium or sodium starch glycolate) in microcrystalline cellulose extrusion-spheronization pellets as a means of increasing the dissolution rate of poorly water-soluble drugs. The model drug was hydrochlorothiazide, with water or water/ethanol as wetting agent for pellet preparation. Neither disintegrant had significant effects on pellet morphology, flow properties or mechanical resistance. Neither disintegrant caused disintegration of the pellet in drug dissolution medium. Nevertheless, the disintegrants afforded a modest increase in drug dissolution rate, attributable to the observed increase in pellet micropore volume. Drug dissolution rate was slightly higher in pellets prepared with sodium starch glycolate, probably because of this disintegrant's higher swelling capacity.

  10. Animal models of disease: pre-clinical animal models of cancer and their applications and utility in drug discovery.

    PubMed

    Ruggeri, Bruce A; Camp, Faye; Miknyoczki, Sheila

    2014-01-01

    Preclinical models of human cancers are indispensable in the drug discovery and development process for new cancer drugs, small molecules and biologics. They are however imperfect facsimiles of human cancers given the genetic and epigenetic heterogeneity of the latter and the multiplicity of dysregulated survival and growth-regulatory pathways that characterize this spectrum of diseases. This review discusses pre-clinical tumor models - traditional ectopic xenografts, orthotopic xenografts, genetically engineered tumor models, primary human tumorgrafts, and various multi-stage carcinogen-induced tumor models - their advantages, limitations, physiological and pathological relevance. Collectively, these animal models represent a portfolio of test systems that should be utilized at specific stages in the drug discovery process in a pragmatic and hierarchical manner of increasing complexity, physiological relevance, and clinical predictability of the human response. Additionally, evaluating the efficacy of novel therapeutic agents emerging from drug discovery programs in a variety of pre-clinical models can better mimic the heterogeneity of human cancers and also aid in establishing dose levels, dose regimens and drug combinations for use in clinical trials. Nonetheless, despite the sophistication and physiological relevance of these human cancer models (e.g., genetically engineered tumor models and primary human tumografts), the ultimate proof of concept for efficacy and safety of novel oncology therapeutics lies in humans. The judicious interpretation and extrapolation of data derived from these models to humans, and a correspondingly greater emphasis placed on translational medical research in early stage clinical trials, are essential to improve on the current clinical attrition rates for novel oncology therapeutic agents.

  11. Feasibility study on utilization of vitrified wastes as radiation sources

    NASA Astrophysics Data System (ADS)

    Makuuchi, K.; Yoshii, F.; Hyakutake, K.

    1995-02-01

    A feasibility study on utilization of vitrified high level waste as radiation source has been carried out. Natural rubber latex was radiation vulcanized with VW to demonstrate the feasibility. The dose rate was 0.1 kGy/hr. As a sensitizer, n-butyl acrylate was added. Negligible small activation of NR latex by neutron from the waste was observed. The residual sensitizer in the irradiated latex and physical properties of film molded from the irradiated latex were the same level with the conventional RVNRL with gamma-rays from Co-60. These results suggested that vitrified high level waste can be used as an industrial radiation source.

  12. Utility of the Electrocardiogram in Drug Overdose and Poisoning: Theoretical Considerations and Clinical Implications

    PubMed Central

    Yates, Christopher; Manini, Alex F

    2012-01-01

    The ECG is a rapidly available clinical tool that can help clinicians manage poisoned patients. Specific myocardial effects of cardiotoxic drugs have well-described electrocardiographic manifestations. In the practice of clinical toxicology, classic ECG changes may hint at blockade of ion channels, alterations of adrenergic tone, or dysfunctional metabolic activity of the myocardium. This review will offer a structured approach to ECG interpretation in poisoned patients with a focus on clinical implications and ECG-based management recommendations in the initial evaluation of patients with acute cardiotoxicity. PMID:22708912

  13. Preliminary Study of Plutonium Utilization in AP1000 Reactor

    NASA Astrophysics Data System (ADS)

    Nailatussaadah; Prastyo, Puguh A.; Waris, Abdul; Kurniadi, Rizal; Pramuditya, Syeilendra

    2017-07-01

    Preliminary study of plutonium utilization in AP1000 reactor has been conducted. This study evaluated the standard of Westinghouse AP1000 reactor and ZrB2 as Integral Fuel Burnable Absorber (IFBA). Different fuel compositions of assembly type were analyze in by using SRAC 2006 code system with JENDL 4.0 nuclear data library. This study aiming to compare the neutronics characteristics of an UO2 and an(U,Pu)O2 assembly designs. Some results of the study show that optimal criticality of the fuel assembly can be accomplished by using 5% enrichment of U-235 for UO2 fuel and 8.75% plutonium fraction for(U,Pu)O2 fuel assembly.

  14. Role of UCG in maximizing coal utilization: site specific study

    SciTech Connect

    Linn, J. K.; Love, S. L.

    1980-01-01

    The Department of Energy is sponsoring a project to develop a planning scheme for improving the utilization of coal deposits. This prototype study, called Total Economic Coal Utilization (TECU), is being applied to specific coal reserves within the Centralia-Chehalis District of Washington State. A significant aspect of the study is to determine the potential role for in situ gasification in maximizing the energy recovery and use. The results obtained indicate that UCG could be used to realize a sizeable increase in the amount of energy that can be economically recovered from the District. Since UCG technology has not reached the commercialization stage, some significant assumptions had to be made for this study. These are that the in situ process will work reliably and that product gas cleanup will proceed without major problems. However, if these conditions are met, this assessment indicates that in situ coal gasification could increase the extractable energy from Washington's Centralia-Chehalis coal deposits by a substantial amount and that this additional energy could be accessed at reasonable cost.

  15. Guidelines for Planning in Colleges and Universities. Volume 5: Physical Plant Planning, Utilities Studies.

    ERIC Educational Resources Information Center

    Pinnell, Charles; Wacholder, Michael

    The fifth and final volume of a series concerned with higher educational facilities planning expands the discussion of the utilities planning process initiated in the overview of volume one. Three major classes of utilities--energy utilities, service utilities, and communications utilities are studied. Their influences on the overall physical…

  16. 76 FR 1174 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-1981-N-0361 (formerly 81N-0391), FDA-1981-N... Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Opportunity To Affirm Outstanding Hearing Requests; Final Resolution of Dockets ACTION: Notice. SUMMARY: The Food and Drug...

  17. [National study of drug habits in Uruguay].

    PubMed

    Míguez, H; Magri, R

    1995-03-01

    The results of a prevalence study of alcohol abuse and drugs use in the general population of the República Oriental del Uruguay are showed here. A national household sample was drawn from the most important urban areas and 2500 persons, aged between 15 and 65 years, were selected and interviewed. Illicit substances use (include use of any of the following: marihuana, cocaine, inhalants, hallucinogens) reached 4.5% for the lifetime prevalence period, 1.1% in the last twelve months and 0.7% for the last thirty day. Twenty percent of the sample classified for tobacco dependence, and alcohol abuse, in the last 30 days, was 19.5%. Significant associations, by sex and age, were found.

  18. Effect of educational and policy interventions on institutional utilization of wet nebulization respiratory drugs and portable inhalers.

    PubMed

    Lowe, Donna O; Lummis, Heather; Zhang, Ying; Sketris, Ingrid S

    2008-01-01

    Asthma and chronic obstructive pulmonary disease treatment guidelines support the preferential use of portable inhalers (PIs) over wet nebulization (WN) respiratory therapy. Hospital- and community-based educational initiatives and a community-based provincial drug program policy change were previously implemented to promote the conversion of WN therapy to PI and spacer device use in Nova Scotia. To examine the effect of these interventions on salbutamol, ipratropium bromide, and spacer device (Aerochamber) use at the Queen Elizabeth II Health Sciences Centre (QEII HSC). We conducted a time-series analysis of drug utilization data from August 1998 to July 2005. We used two intervention phases compared to the pre-intervention phase to determine whether the educational and policy interventions were associated with significant changes in monthly drug and spacer device utilization rates at the QEII HSC (1000-bed teaching hospital; Halifax, Nova Scotia). Salbutamol and ipratropium bromide PI use significantly increased in both intervention phases, compared to the pre-intervention phase. Mean (SD) defined daily doses/100 bed-days for salbutamol PI increased from 30.4 (0.4) in the pre-intervention phase to 34.6 (0.9) and 37.0 (0.4) in intervention phases I and II respectively (p<0.001 for both), and ipratropium bromide PI increased from 27.3 (3.5) to 32.8 (2.5) in intervention phase I (p=0.004) and 35.6 (3.5) in intervention phase II (p<0.001). However, a significant corresponding decrease was observed with salbutamol WN only. Mean (SD) Aerochamber units/100 bed-days significantly increased. Educational and policy interventions had limited effects on converting WN to PI use at the QEII HSC.

  19. The outpatient utilization of non-steroidal anti-inflammatory drugs in South Bačka District, Serbia.

    PubMed

    Calasan, Jelena; Mijatović, Vesna; Horvat, Olga; Varga, Jan; Sabo, Ana; Stilinović, Nebojša

    2011-04-01

    To evaluate the utilization of non-steroidal anti-inflammatory drugs (NSAIDs) in South Bačka District (SBD), Serbia. State-owned and private pharmacies in SBD, a northern district of Serbia, with 605,720 inhabitants (according to the 2008 census). Data on the number of packages, size of packages, and retail price of NSAIDs (Anatomical Therapeutic Chemical (ATC) group M01A) from 1 January to 31 March 2008 were obtained from all state-owned and private pharmacies in SBD. This included NSAIDs bought without prescription and those issued by prescription (on the Health Insurance Companies List for Reimbursement). The number of defined daily doses/1000 inhabitants/day (DDD/1000 inh/day) was calculated. Within the DU90% (drug utilization 90%) segment, the proportion of high-, medium- and low-risk NSAIDs with respect to the risk of gastrointestinal (GI) bleeding was determined. Price/DDD was also calculated. Consumption of drugs expressed as DDD/1000 inh/day. The total consumption of NSAIDs over a 3-month period was 48.31 DDD/1000 inh/day. Only four drugs were within DU90%: diclofenac, ibuprofen, nimesulide and meloxicam (62.14, 19.87, 5.77, and 5.73% of total NSAID consumption, respectively). All dispensed NSAIDs within the DU90% segment except nimesulide (which was exclusively purchased without prescription) were nearly equally purchased without prescription and issued by prescription. The average price per DDD within the DU90% segment was 0.17 Euro/DDD, whereas it was 0.30 Euro/DDD for NSAIDs beyond the DU90% segment. The pattern of use of NSAIDs according to their GI risk showed that medium-risk diclofenac accounted for 66.45%, whereas low-risk ibuprofen was estimated to be 21.25% within the DU90% segment. Factors other than evidence-based medicine (such as poor health education in the past that led to long-lasting consequences on the cultural behaviour of the general population as well as on the prescribing habits of physicians) have a dominating impact on the use of

  20. Many Doctors Get Payments from Drug Companies, Study Shows

    MedlinePlus

    ... 164203.html Many Doctors Get Payments From Drug Companies, Study Shows But few patients know about financial ... News) -- Many American doctors receive payments from drug companies, but few patients know about those financial ties, ...

  1. Malaria Drug Protected Mouse Fetus from Zika: Study

    MedlinePlus

    ... 167128.html Malaria Drug Protected Mouse Fetus From Zika: Study More research is needed on effects in ... A malaria drug protected mice fetuses from the Zika virus, researchers report. In humans, Zika infection during ...

  2. The importance of drug metabolites synthesis: the case-study of cardiotoxic anticancer drugs.

    PubMed

    Hrynchak, Ivanna; Sousa, Emília; Pinto, Madalena; Costa, Vera Marisa

    2017-05-01

    Anticancer drugs are presently guarantying more survivors as a result of more powerful drugs or combinations of drugs used in therapy. Thus, it has become more crucial to study and overcome the side effects of these therapies. Cardiotoxicity is one of the most relevant side effects on the long-term cancer survivors, because of its high social and economic impact. Drug metabolism can result in active metabolites or toxic metabolites that can lead to important side effects. The metabolites of anticancer drugs are possible culprits of cardiotoxicity; however, the cardiotoxicity of many of the metabolites in several drug classes was not yet suitably studied so far. On the other hand, the use of prodrugs that are bioactivated through metabolism can be a good alternative to obtain more cardio safe drugs. In this review, the methods to obtain and study metabolites are summarized and their application to the study of a group of anticancer drugs with acknowledged cardiotoxicity is highlighted. In this group of drugs, doxorubicin (DOX, 1), mitoxantrone (MTX, 2), cyclophosphamide (CTX, 3) and 5-fluorouracil (5-FU, 4) are included, as well as the tyrosine kinase inhibitors, such as imatinib (5), sunitinib (6) and sorafenib (7). Only with the synthesis and purification of considerable amounts of the metabolites can reliable studies be performed, either in vitro or in vivo that allow accurate conclusions regarding the cardiotoxicity of anticancer drug metabolites and then pharmacological prevention or treatment of the cardiac side effects can be done.

  3. Molecular dynamics study on DNA nanotubes as drug delivery vehicle for anticancer drugs.

    PubMed

    Liang, Lijun; Shen, Jia-Wei; Wang, Qi

    2017-05-01

    In recent years, self-assembled DNA nanotubes have emerged as a type of nano-biomaterials with great potential for biomedical applications. To develop universal nanocarriers for smart and targeted drug delivery from DNA nanotubes, the understanding of interaction mechanism between DNA nanotubes and drugs is essential. In this study, the interactions between anti-cancer drugs and DNA nanotubes were investigated via molecular dynamics simulation. Our simulation results demonstrated that the DNA nanotubes could serve as a good drug delivery material by absorption of anti-cancer drugs with π-π interactions. At high concentration of anti-cancer drugs, most of the drugs could be absorbed by DNA nanotubes. Therefore, it could greatly decrease the aggregation of anti-cancer drugs in aqueous solution. In addition, the stability of DNA nanotubes could be improved with the absorption of anti-cancer drugs. These findings greatly enhance the understanding of the interaction mechanism of DNA nanotubes and anti-cancer drugs. Our study suggests that DNA nanotubes are promising delivery vehicles by strong absorption of anti-cancer drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Automated method for study of drug metabolism

    NASA Technical Reports Server (NTRS)

    Furner, R. L.; Feller, D. D.

    1973-01-01

    Commercially available equipment can be modified to provide automated system for assaying drug metabolism by continuous flow-through. System includes steps and devices for mixing drug with enzyme and cofactor in the presence of pure oxygen, dialyzing resulting metabolite against buffer, and determining amount of metabolite by colorimetric method.

  5. Active controlled studies in antibiotic drug development.

    PubMed

    Dane, Aaron

    2011-01-01

    The increasing concern of antibacterial resistance has been well documented, as has the relative lack of antibiotic development. This paradox is in part due to challenges with clinical development of antibiotics. Because of their rapid progression, untreated bacterial infections are associated with significant morbidity and mortality. As a consequence, placebo-controlled studies of new agents are unethical. Rather, pivotal development studies are mostly conducted using non-inferiority designs versus an active comparator. Further, infections because of comparator-resistant isolates must usually be excluded from the trial programme. Unfortunately, the placebo-controlled data classically used in support of non-inferiority designs are largely unavailable for antibiotics. The only available data are from the 1930s and 1940s and their use is associated with significant concerns regarding constancy and assay sensitivity. Extended public debate on this challenge has led to proposed solutions by some in which these concerns are addressed by using very conservative approaches to trial design, endpoints and non-inferiority margins, in some cases leading to potentially impractical studies. To compound this challenge, different Regulatory Authorities seem to be taking different approaches to these key issues. If harmonisation does not occur, antibiotic development will become increasingly challenging, with the risk of further decreases in the amount of antibiotic drug development. However with clarity on Regulatory requirements and an ability to feasibly conduct global development programmes, it should be possible to bring much needed additional antibiotics to patients. Copyright © 2011 John Wiley & Sons, Ltd.

  6. Cost-utility analysis of competing treatment strategies for drug-resistant epilepsy in children with Tuberous Sclerosis Complex.

    PubMed

    Fallah, Aria; Weil, Alexander G; Wang, Shelly; Lewis, Evan; Baca, Christine B; Mathern, Gary W

    2016-10-01

    The management of drug-resistant epilepsy in children with Tuberous Sclerosis Complex (TSC) is challenging because of the multitude of treatment options, wide range of associated costs, and uncertainty of seizure outcomes. The most cost-effective approach for children whose epilepsy has failed to improve with first-line medical therapy is uncertain. A review of MEDLINE from 1990 to 2015 was conducted. A cost-utility analysis, from a third-party payer perspective, was performed for children with drug-resistant epilepsy that had failed to improve with 2 antiseizure drugs (ASDs) and that was amenable to resective epilepsy surgery, across a time-horizon of 5years. Four strategies were included: (1) resective epilepsy surgery, (2) vagus nerve stimulator (VNS) implantation, (3) ketogenic diet, and (4) addition of a third ASD (specifically, carbamazepine). The incremental cost per quality-adjusted life year (QALY) gained was analyzed. Given a willingness-to-pay (WTP) of $100,000 per QALY, the addition of a third ASD ($6600 for a gain of 4.14 QALYs) was the most cost-effective treatment strategy. In a secondary analysis, if the child whose epilepsy had failed to improve with 3 ASDs, ketogenic diet, addition of a fourth ASD, and resective epilepsy surgery were incrementally cost-effective treatment strategies. Vagus nerve stimulator implantation was more expensive yet less effective than alternative strategies and should not be prioritized. The addition of a third ASD is a universally cost-effective treatment option in the management of children with drug-resistant epilepsy that has failed to improve with 2 ASDs. For children whose epilepsy has failed to improve with 3 ASDs, the most cost-effective treatment depends on the health-care resources available reflected by the WTP. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.

    PubMed

    Godman, Brian; Malmström, Rickard E; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Fürst, Jurij; Garuoliene, Kristina; Gutiérrez-Ibarluzea, Iñaki; Hviding, Krystyna; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Vončina, Luka; Vlahović-Palčevski, Vera; Wale, Janet; Wladysiuk, Magdalena; van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars L

    2014-01-01

    There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

  8. Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

    PubMed Central

    Godman, Brian; Malmström, Rickard E.; Diogene, Eduardo; Jayathissa, Sisira; McTaggart, Stuart; Cars, Thomas; Alvarez-Madrazo, Samantha; Baumgärtel, Christoph; Brzezinska, Anna; Bucsics, Anna; Campbell, Stephen; Eriksson, Irene; Finlayson, Alexander; Fürst, Jurij; Garuoliene, Kristina; Gutiérrez-Ibarluzea, Iñaki; Hviding, Krystyna; Herholz, Harald; Joppi, Roberta; Kalaba, Marija; Laius, Ott; Malinowska, Kamila; Pedersen, Hanne B.; Markovic-Pekovic, Vanda; Piessnegger, Jutta; Selke, Gisbert; Sermet, Catherine; Spillane, Susan; Tomek, Dominik; Vončina, Luka; Vlahović-Palčevski, Vera; Wale, Janet; Wladysiuk, Magdalena; van Woerkom, Menno; Zara, Corinne; Gustafsson, Lars L.

    2014-01-01

    Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies. Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding. PMID

  9. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    PubMed

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  10. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    NASA Astrophysics Data System (ADS)

    Hamlekhan, Azhang; Sinha-Ray, Suman; Takoudis, Christos; Mathew, Mathew T.; Sukotjo, Cortino; Yarin, Alexander L.; Shokuhfar, Tolou

    2015-06-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT.

  11. RS-34 Phoenix (Peacekeeper Post Boost Propulsion System) Utilization Study

    NASA Technical Reports Server (NTRS)

    Esther, Elizabeth A.; Kos, Larry; Burnside, Christopher G.; Bruno, Cy

    2013-01-01

    The Advanced Concepts Office (ACO) at the NASA Marshall Space Flight Center (MSFC) in conjunction with Pratt & Whitney Rocketdyne conducted a study to evaluate potential in-space applications for the Rocketdyne produced RS-34 propulsion system. The existing RS-34 propulsion system is a remaining asset from the de-commissioned United States Air Force Peacekeeper ICBM program, specifically the pressure-fed storable bipropellant Stage IV Post Boost Propulsion System, renamed Phoenix. MSFC gained experience with the RS-34 propulsion system on the successful Ares I-X flight test program flown in October 2009. RS-34 propulsion system components were harvested from stages supplied by the USAF and used on the Ares I-X Roll control system (RoCS). The heritage hardware proved extremely robust and reliable and sparked interest for further utilization on other potential in-space applications. MSFC is working closely with the USAF to obtain RS-34 stages for re-use opportunities. Prior to pursuit of securing the hardware, MSFC commissioned the Advanced Concepts Office to understand the capability and potential applications for the RS-34 Phoenix stage as it benefits NASA, DoD, and commercial industry. As originally designed, the RS-34 Phoenix provided in-space six-degrees-of freedom operational maneuvering to deploy multiple payloads at various orbital locations. The RS-34 Phoenix Utilization Study sought to understand how the unique capabilities of the RS-34 Phoenix and its application to six candidate missions: 1) small satellite delivery (SSD), 2) orbital debris removal (ODR), 3) ISS re-supply, 4) SLS kick stage, 5) manned GEO servicing precursor mission, and an Earth-Moon L-2 Waypoint mission. The small satellite delivery and orbital debris removal missions were found to closely mimic the heritage RS-34 mission. It is believed that this technology will enable a small, low-cost multiple satellite delivery to multiple orbital locations with a single boost. For both the small

  12. RS-34 Phoenix (Peacekeeper Post Boost Propulsion System) Utilization Study

    NASA Technical Reports Server (NTRS)

    Esther, Elizabeth A.; Kos, Larry; Bruno, Cy

    2012-01-01

    The Advanced Concepts Office (ACO) at the NASA Marshall Space Flight Center (MSFC) in conjunction with Pratt & Whitney Rocketdyne conducted a study to evaluate potential in-space applications for the Rocketdyne produced RS-34 propulsion system. The existing RS-34 propulsion system is a remaining asset from the decommissioned United States Air Force Peacekeeper ICBM program; specifically the pressure-fed storable bipropellant Stage IV Post Boost Propulsion System, renamed Phoenix. MSFC gained experience with the RS-34 propulsion system on the successful Ares I-X flight test program flown in October 2009. RS-34 propulsion system components were harvested from stages supplied by the USAF and used on the Ares I-X Roll control system (RoCS). The heritage hardware proved extremely robust and reliable and sparked interest for further utilization on other potential in-space applications. Subsequently, MSFC is working closely with the USAF to obtain all the remaining RS-34 stages for re-use opportunities. Prior to pursuit of securing the hardware, MSFC commissioned the Advanced Concepts Office to understand the capability and potential applications for the RS-34 Phoenix stage as it benefits NASA, DoD, and commercial industry. Originally designed, the RS-34 Phoenix provided in-space six-degrees-of freedom operational maneuvering to deploy multiple payloads at various orbital locations. The RS-34 Phoenix Utilization Study sought to understand how the unique capabilities of the RS-34 Phoenix and its application to six candidate missions: 1) small satellite delivery (SSD), 2) orbital debris removal (ODR), 3) ISS re-supply, 4) SLS kick stage, 5) manned GEO servicing precursor mission, and an Earth-Moon L-2 Waypoint mission. The small satellite delivery and orbital debris removal missions were found to closely mimic the heritage RS-34 mission. It is believed that this technology will enable a small, low-cost multiple satellite delivery to multiple orbital locations with a single

  13. An industry perspective on the role and utility of animal models of pain in drug discovery.

    PubMed

    Whiteside, Garth T; Pomonis, James D; Kennedy, Jeffrey D

    2013-12-17

    In recent years, animal behavioral models, particularly those used in pain research, have been increasingly scrutinized and criticized for their role in the poor translation of novel pharmacotherapies for chronic pain. This article addresses the use of animal models of pain from the perspective of industrial drug discovery research. It highlights how, when, and why animal models of pain are used as one of the many experimental tools used to gain better understanding of target mechanisms and rank-order compounds in the iterative process of establishing structure-activity relationships (SAR). Together, these models help create an 'analgesic signature' for a compound and inform the indications most likely to yield success in clinical trials. In addition, the authors discuss some often under-appreciated aspects of currently used (traditional) animal models of pain, including how industry balances efficacy with side effect measures as part of the overall conclusion of efficacy. This is provided to add perspective regarding current efforts to develop new models and endpoints both in rodents and larger animal species as well as assess cognitive and/or affective aspects of pain. Finally, the authors suggest ways in which efficacy evaluation in animal models of pain, whether traditional or new, might better align with clinical standards of analysis, citing examples where applying effect size and NNT estimations to animal model data suggest that the efficacy bar often may be set too low preclinically to allow successful translation to the clinical setting. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  14. Utilizing a novel tandem oral dosing strategy to enhance exposure of low-solubility drug candidates in a preclinical setting.

    PubMed

    Chiang, Po-Chang; South, Sarah A; Foster, Kimberly A; Daniels, J Scott; Wene, Steve P; Albin, Lesley A; Thompson, David C

    2010-07-01

    Time and resource constraints necessitate increasingly early decision making to accelerate or stop preclinical drug discovery programs. Early discovery drug candidates may be potent inhibitors of new targets, but all too often exhibit poor pharmaceutical and pharmacokinetic properties that limit the in vivo exposure. Low solubility of a drug candidate often leads to poor oral bioavailability and poor dose linearity that creates an issue for efficacy and target safety studies, where high drug exposures are desired. When solubility issues are encountered, enabling formulations are often used to improve the exposure. However, this approach often requires a substantial and lengthy investment to develop the formulation. In our study, two drug candidates with poor aqueous solubility were dosed in rats as simple suspension formulations using a novel tandem dosing strategy, which employs dosing orally in 2.5 h increments up to three times to simulate an oral infusion by avoiding saturation of absorption associated with bolus dosing. These compounds were also dosed using the same suspension formulations and a standard dosing strategy. The resulting in vivo exposures were compared. It was found that this novel tandem dosing strategy significantly improved the in vivo exposures.

  15. Alcohol and Drug Use among "Street" Adolescents: An Exploratory Study.

    ERIC Educational Resources Information Center

    McKirnan, David J.; Johnson, Tina

    Although adolescent alcohol and drug use is decreasing, many teenagers continue to use alcohol and drugs. Studies of adolescent alcohol use typically sample intact high school populations, excluding dropouts and adolescents alienated from straight high school populations. Alcohol and drug use and alcohol related attitudes were measured in 62…

  16. Potential utility of precision medicine for older adults with polypharmacy: a case series study

    PubMed Central

    Finkelstein, Joseph; Friedman, Carol; Hripcsak, George; Cabrera, Manuel

    2016-01-01

    Pharmacogenomic (PGx) testing has been increasingly used to optimize drug regimens; however, its potential in older adults with polypharmacy has not been systematically studied. In this hypothesis-generating study, we employed a case series design to explore potential utility of PGx testing in older adults with polypharmacy and to highlight barriers in implementing this methodology in routine clinical practice. Three patients with concurrent chronic heart and lung disease aged 74, 78, and 83 years and whose medication regimen comprised 26, 17, and 18 drugs, correspondingly, served as cases for this study. PGx testing identified major genetic polymorphisms in the first two cases. The first case was identified as “CYP3A4/CYP3A5 poor metabolizer”, which affected metabolism of eleven prescribed drugs. The second case had “CYP2D6 rapid metabolizer” status affecting three prescribed medications, two of which were key drugs for managing this patient’s chronic conditions. Both these patients also had VKORC1 allele *A, resulting in higher sensitivity to warfarin. All cases demonstrated a significant number of potential drug–drug interactions. Both patients with significant drug–gene interactions had a history of frequent hospitalizations (six and 23, respectively), whereas the person without impaired cytochrome P450 enzyme activity had only two acute episodes in the last 5 years, although he was older and had multiple comorbidities. Since all patients received guideline-concordant therapy from the same providers and were adherent to their drug regimen, we hypothesized that genetic polymorphism may represent an additional risk factor for higher hospitalization rates in older adults with polypharmacy. However, evidence to support or reject this hypothesis is yet to be established. Studies evaluating clinical impact of PGx testing in older adults with polypharmacy are warranted. For practical implementation of pharmacogenomics in routine clinical care, besides

  17. Clopidogrel-Paclitaxel Drug-Drug Interaction: A Pharmacoepidemiologic Study.

    PubMed

    Agergaard, K; Mau-Sørensen, M; Stage, T B; Jørgensen, T L; Hassel, R E; Steffensen, K D; Pedersen, J W; Milo, Mlh; Poulsen, S H; Pottegård, A; Hallas, J; Brøsen, K; Bergmann, T K

    2017-09-01

    Paclitaxel is mainly eliminated by CYP2C8 in the liver. CYP2C8 is strongly inhibited by the clopidogrel metabolite acyl-β-D-glucuronide. To determine if this interaction has clinical relevance, we identified 48 patients treated with clopidogrel and paclitaxel using databases and a prescription register. Peripheral sensory neuropathy was retrospectively evaluated from medical charts and compared to that of 88 age- and sex-matched controls treated with paclitaxel and low-dose aspirin. By a cumulative dose of 1,500 mg paclitaxel, 35% of the patients had developed severe neuropathy. The overall hazard ratio between clopidogrel use and severe paclitaxel neuropathy was 1.7 (95% confidence interval, 0.9-3.0). Among those receiving a high-dose paclitaxel regimen, the hazard ratio was 2.3 (95% confidence interval, 1.1-4.5). Our study indicates that clopidogrel is associated with a clinically relevant increased risk of neuropathy in patients treated with high-dose paclitaxel. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  18. Drug availability adjustments in population-based studies of prescription opioid abuse.

    PubMed

    Secora, Alex; Trinidad, James Phillip; Zhang, Rongmei; Gill, Rajdeep; Dal Pan, Gerald

    2017-02-01

    Population-based prescription opioid abuse studies in which one drug is compared to another, or drugs are compared across time, often account for the availability of those drugs in the community. The objective of this investigation is to assess consistency in the relative abuse ratios (RARs) across different approaches for adjusting for drug availability. For the years 2004 through 2010, RARs for each of four prescription opioids (hydrocodone, oxycodone, hydromorphone, and morphine) were calculated using negative binomial regression. Measures of abuse (outcome) were misuse/abuse-related emergency department visits obtained from the Drug Abuse Warning Network. Measures of drug availability (offsets) were drug utilization estimates obtained from IMS Health. Separate regression models were run using each of five measures of drug utilization: unique patients (URDD), prescriptions dispensed (RX), tablets dispensed (TD), kilograms (KGs) sold, and morphine-equivalents (MEs) of kilograms sold. These results were compared for consistency. Aside from oxycodone-combination products, across molecules, RARs adjusted by RXs, TDs, and URDDs were generally similar to each other while RARs adjusted by KGs and MEs were different. For example, compared to hydrocodone, oxycodone had statistically significantly increased RARs of 3.6 (95%CI: 2.0-6.5), 3.5 (95%CI: 1.9-6.4), and 2.7 (95%CI: 1.5-5.0) when adjusted by URDDs, RXs, and TDs, respectively, but not when adjusted by KGs or MEs. Different drug utilization adjustment approaches may yield inconsistent RAR estimates in population-based prescription opioid abuse analyses. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

  19. Longitudinal studies of drug abuse in a fifteen-year-old population. 3. Hidden drug abuse.

    PubMed

    Holmberg, M B

    1985-02-01

    The hidden drug abuse in a stratified sample of a year cohort born in 1953 was studied by measuring the difference between drug abuse stated in interviews and registered in public health and social welfare files in 1968, 1973 and 1976. Among men who had stated high-frequency drug use in a school questionnaire in 1968 hidden drug abuse comprised two thirds of the total abuse, among women from the same group one half. In groups with lower degrees of abuse hidden drug abuse was 70-90% of the total abuse. Intravenous abuse was mostly known to public health and social welfare authorities. When trying to estimate the total number of drug abusers in an area there is reason to at least double the figures presented in case-finding studies.

  20. Alternative approach for cavitation damage study utilizing repetitive laser pulses

    SciTech Connect

    Ren, Fei; Wang, Jy-An John; Wang, Hong

    2010-01-01

    Cavitation is a common phenomenon in fluid systems that can lead to dramatic degradation of solid materials surface in contact with the cavitating media. Study of cavitation damage has great significance in many engineering fields. Current techniques for cavitation damage study either require large scale equipments or tend to introduce damages from other mechanisms. In this project, we utilized the cavitation phenomenon induced by laser optical breakdown and developed a prototype apparatus for cavitation damage study. In our approach, cavitation was generated by the repetitive pressure waves induced by high-power laser pulses. As proof of principal study, stainless steel and aluminum samples were tested using the novel apparatus. Surface characterization via scanning electron microscopy revealed damages such as indentation and surface pitting, which were similar to those reported in literature using other state-of-the-art techniques. These preliminary results demonstrated the new device was capable of generating cavitation damages and could be used as an alternative method for cavitation damage study.

  1. Parent Drug Education: A Participatory Action Research Study into Effective Communication about Drugs between Parents and Unrelated Young People

    ERIC Educational Resources Information Center

    Mallick, Jane

    2007-01-01

    Parent drug education is considered a key aspect of drug prevention. Effective communication acts as protective factor for drug misuse in young people. This study is a Participatory Action Research study of "Drugsbridge", a drug education programme that has an emphasis on facilitating intergenerational communication about drugs between parents and…

  2. Parent Drug Education: A Participatory Action Research Study into Effective Communication about Drugs between Parents and Unrelated Young People

    ERIC Educational Resources Information Center

    Mallick, Jane

    2007-01-01

    Parent drug education is considered a key aspect of drug prevention. Effective communication acts as protective factor for drug misuse in young people. This study is a Participatory Action Research study of "Drugsbridge", a drug education programme that has an emphasis on facilitating intergenerational communication about drugs between parents and…

  3. Utility of NBD-Cl for the spectrophotometric determination of some skeletal muscle relaxant and antihistaminic drugs

    NASA Astrophysics Data System (ADS)

    Saleh, Hanaa M.; EL-Henawee, Magda M.; Ragab, Gamal H.; El-Hay, Soad S. Abd

    2007-08-01

    A simple, accurate, precise and sensitive colorimetric method for the determination of some skeletal muscle relaxant drugs, namely orphenadrine citrate ( I), baclofen ( II), antihistaminic drugs as acrivastine ( III) and fexofenadine hydrochloride ( IV) is described. This method is based on the formation of charge transfer complex with 4-chloro-7-nitro-2,1,3-benzoxadiazole (NBD-Cl) in non-aqueous medium. The orange color products were measured at 472, 465, 475 and 469 nm for drugs I, II, III and IV, respectively. The optimization of various experimental conditions was described. Beer's Law was obeyed in the range (2.5-17.5), (5-70), (2.5-25) and (10-50) μg/ml for drugs I, II, III and IV, respectively. The molar absorptivity ( ɛ), sandell sensitivity, detection (LOD) and quantitation limits (LOQ) are calculated. The procedure was favorably applied for determination of certain pharmaceutical dosage forms containing the studied drugs. The obtained results were compared with the official and reported methods. There were no significant differences between proposed, reported and the official methods.

  4. Drug abuse in Costa Rica: a review of several studies.

    PubMed

    Alfaro Murillo, E

    1990-01-01

    This article provides a review of drug use surveys conducted by Costa Rica's Institute on Alcoholism and Drug Dependence during the years 1983-1987. These studies dealt with a wide range of subjects--residents of marginal neighborhoods, juvenile male and adult female detainees, and high school students--as well as with the general population. Overall, the studies indicated that the most commonly used illicit drug was marijuana, that the bulk of the drug users (excluding alcohol and tobacco users) were young males, that relevant levels of cocaine use were starting to occur, and that the country's general drug abuse picture poses a problem in need of immediate attention.

  5. FEASIBILITY OF MATCHING STUDY PARTICIPANT RESIDENCE WITH SPECIFIC WATER UTILITY TRIHALOMETHANE (THM) DATA IN EPIDEMIOLOGIC STUDIES

    EPA Science Inventory

    Many epidemiologic studies concerning by-products of water disinfection use utility monitoring data to estimate exposure. Use of such data requires linkage of residence location to a specific water utility and associated monitoring data during a given exposure period. The inabil...

  6. FEASIBILITY OF MATCHING STUDY PARTICIPANT RESIDENCE WITH SPECIFIC WATER UTILITY TRIHALOMETHANE (THM) DATA IN EPIDEMIOLOGIC STUDIES

    EPA Science Inventory

    Many epidemiologic studies concerning by-products of water disinfection use utility monitoring data to estimate exposure. Use of such data requires linkage of residence location to a specific water utility and associated monitoring data during a given exposure period. The inabil...

  7. Genome-Wide Association Studies of Drug-Resistance Determinants.

    PubMed

    Volkman, Sarah K; Herman, Jonathan; Lukens, Amanda K; Hartl, Daniel L

    2017-03-01

    Population genetic strategies that leverage association, selection, and linkage have identified drug-resistant loci. However, challenges and limitations persist in identifying drug-resistance loci in malaria. In this review we discuss the genetic basis of drug resistance and the use of genome-wide association studies, complemented by selection and linkage studies, to identify and understand mechanisms of drug resistance and response. We also discuss the implications of nongenetic mechanisms of drug resistance recently reported in the literature, and present models of the interplay between nongenetic and genetic processes that contribute to the emergence of drug resistance. Throughout, we examine artemisinin resistance as an example to emphasize challenges in identifying phenotypes suitable for population genetic studies as well as complications due to multiple-factor drug resistance. Copyright © 2016. Published by Elsevier Ltd.

  8. Impact of Participatory Design for Drug-Drug Interaction Alerts. A Comparison Study Between Two Interfaces.

    PubMed

    Luna, Daniel; Otero, Carlos; Risk, Marcelo; Stanziola, Enrique; González Bernaldo de Quirós, Fernán

    2016-01-01

    Decision support systems for alert drug-drug interactions have been shown as valid strategy to reduce medical error. Even so the use of these systems has not been as expected, probably due to the lack of a suitable design. This study compares two interfaces, one of them developed using participatory design techniques (based on user centered design processes). This work showed that the use of these techniques improves satisfaction, effectiveness and efficiency in an alert system for drug-drug interactions, a fact that was evident in specific situations such as the decrease of errors to meet the specified task, the time, the workload optimization and users overall satisfaction with the system.

  9. Clinical utility of reflex studies in assessing cervical radiculopathy.

    PubMed

    Miller, T A; Pardo, R; Yaworski, R

    1999-08-01

    We prospectively studied the diagnostic utility of upper limb segmental reflexes in patients with suspected cervical radiculopathy (CR). Fifty-three patients (29 men and 24 women), referred for electrodiagnostic testing, were positive for at least one of four clinical criteria for CR: abnormal (1) history, (2) motor (myotomal) examination, (3) sensory (dermatomal) examination, and (4) changes in deep tendon reflexes (DTR). All underwent electrodiagnostic assessment, needle electrode examination (NEE), specialized segmental reflexes (heteronymous and Hoffman's reflexes [H reflexes]), and neuroimaging. The clinical diagnosis was supported in all 32 patients who entered the study with two or more clinical signs for CR. Abnormal NEE was found in 90% of subjects with three clinical signs, 59% with two signs, and only 10% of those with one sign. H reflexes demonstrated a sensitivity of 72% and specificity of 85% for detection of CR and were particularly helpful when forming conclusions in the 21 subjects with only one clinical sign for CR. Specialized segmental H-reflex studies of the upper limb were as sensitive and specific as neuroimaging (magnetic resonance imaging). Copyright 1999 John Wiley & Sons, Inc.

  10. Kauai Island Utility Co-op (KIUC) PV integration study.

    SciTech Connect

    Ellis, Abraham; Mousseau, Tom

    2011-08-01

    This report investigates the effects that increased distributed photovoltaic (PV) generation would have on the Kauai Island Utility Co-op (KIUC) system operating requirements. The study focused on determining reserve requirements needed to mitigate the impact of PV variability on system frequency, and the impact on operating costs. Scenarios of 5-MW, 10-MW, and 15-MW nameplate capacity of PV generation plants distributed across the Kauai Island were considered in this study. The analysis required synthesis of the PV solar resource data and modeling of the KIUC system inertia. Based on the results, some findings and conclusions could be drawn, including that the selection of units identified as marginal resources that are used for load following will change; PV penetration will displace energy generated by existing conventional units, thus reducing overall fuel consumption; PV penetration at any deployment level is not likely to reduce system peak load; and increasing PV penetration has little effect on load-following reserves. The study was performed by EnerNex under contract from Sandia National Laboratories with cooperation from KIUC.

  11. [Utilization of spaceflight technology on medicinal plant study].

    PubMed

    Gao, Wen-yuan; Jia, Wei; Xiao, Pei-gen

    2004-07-01

    Utilization of spaceflight technology will benefit the modernization of Traditional Chinese Medicine study. Many countries, such as USA or Russia, have conducted extensive experimental research with plants in the regenerative life-support system in space stations as well as the research on breeding or chromosomal aberration after spaceflight. The space botany is still in its preliminary stage in our country. Research has mainly been focused on breeding under space-environment. In addition, many experiments have been conducted with the spaceflown plants to investigate the growth, development, biochemical and physiological changes, as well as the inheritance and variation. Little has been done with regard to the facility development to contain the spaceflying seeds and no research has been reported on plant growth in spacecrafts. Medicinal plant study has certain characteristics and advantages in our country where small biological vessels are developed for the spaceflown seeds, which are then distinguished to microgravity group and radiation exposed group with analytical instrument. However, research has been carried out in medicinal plant breeding or inheritance. In future research, more effort should be directed to the study of medicinal plants as an important link of a future biological life support system as well as to the health care of astronauts by.

  12. Utility of transplantation in studying adipocyte biogenesis and function

    PubMed Central

    Zhang, Yiying

    2009-01-01

    Adipose tissue plays important roles in the regulation of energy homeostasis and metabolism. Two features distinguish adipose tissue from other organs - the ability to greatly expand its mass, via increases in cell size and/or number, and the wide anatomical distribution. While adipose tissue function is greatly affected by adipocyte size and anatomic location, regulations of adipocyte size, number, and body fat distribution are poorly understood. Transplantation of either mature adipose tissue or adipocyte progenitor cells has been used in studying adipocyte function and biogenesis. In this review, we will attempt to summarize methodological considerations for transplantation, including selections of donor material, transplantation site and the length of transplantation study, as well as effects of these factors and vascularization and innervation on the function of transplants. Specific studies are also reviewed to illustrate the utility of adipose tissue transplants in studying adipose tissue function and biogenesis. The focus is on studies in three areas: 1) use of transplants in demonstrating adipose tissue function, such as effects of adipose tissue transplants on metabolism and energy homeostasis of the recipient animals and depot-specific differences in adipose tissue function; 2) use of transplantation to dissect direct or cell-autonomous from indirect or non cell-autonomous effects of leptin signaling and sex on adipocyte size; 3) use of transplantation in the identification of adipocyte progenitor cells and lineage analysis. Finally, future applications of transplantation in studying depot-specific adipocyte biogenesis, and genetic and hormonal effects of sex and age on adipocyte biogenesis and function are discussed. PMID:19733623

  13. A study on drug safety monitoring program in India.

    PubMed

    Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

    2014-09-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.

  14. A Study on Drug Safety Monitoring Program in India

    PubMed Central

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  15. Pharmacogenomic study using bio- and nanobioelectrochemistry: Drug-DNA interaction.

    PubMed

    Hasanzadeh, Mohammad; Shadjou, Nasrin

    2016-04-01

    Small molecules that bind genomic DNA have proven that they can be effective anticancer, antibiotic and antiviral therapeutic agents that affect the well-being of millions of people worldwide. Drug-DNA interaction affects DNA replication and division; causes strand breaks, and mutations. Therefore, the investigation of drug-DNA interaction is needed to understand the mechanism of drug action as well as in designing DNA-targeted drugs. On the other hand, the interaction between DNA and drugs can cause chemical and conformational modifications and, thus, variation of the electrochemical properties of nucleobases. For this purpose, electrochemical methods/biosensors can be used toward detection of drug-DNA interactions. The present paper reviews the drug-DNA interactions, their types and applications of electrochemical techniques used to study interactions between DNA and drugs or small ligand molecules that are potentially of pharmaceutical interest. The results are used to determine drug binding sites and sequence preference, as well as conformational changes due to drug-DNA interactions. Also, the intention of this review is to give an overview of the present state of the drug-DNA interaction cognition. The applications of electrochemical techniques for investigation of drug-DNA interaction were reviewed and we have discussed the type of qualitative or quantitative information that can be obtained from the use of each technique. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. An Exploratory Study Examining the Spatial Dynamics of Illicit Drug Availability and Rates of Drug Use

    ERIC Educational Resources Information Center

    Freisthler, Bridget; Gruenewald, Paul J.; Johnson, Fred W.; Treno, Andrew J.; Lascala, Elizabeth A.

    2005-01-01

    This study examines the spatial relationship between drug availability and rates of drug use in neighborhood areas. Responses from 16,083 individuals were analyzed at the zip code level (n = 158) and analyses were conducted separately for youth and adults using spatial regression techniques. The dependent variable is the percentage of respondents…

  17. Solid state drug-polymer miscibility studies using the model drug ABT-102.

    PubMed

    Jog, Rajan; Gokhale, Rajeev; Burgess, Diane J

    2016-07-25

    Amorphous solid dispersions typically suffer storage stability issues due to: their amorphous nature, high drug loading, uneven drug:stabilizer ratio and plasticization effects as a result of hygroscopic excipients. An extensive solid state miscibility study was conducted to aid in understanding the mechanisms involved in drug/stabilizer interactions. ABT-102 (model drug) and nine different polymers with different molecular weights and viscosities were selected to investigate drug/polymer miscibility. Three different polymer:drug ratios (1:3, 1:1 and 3:1, w/w) were analyzed using: DSC, FTIR and PXRD. Three different techniques were used to prepare the amorphous solid dispersions: serial dilution, solvent evaporation and spray drying. Spray drying was the best method to obtain amorphous solid dispersions. However, under certain conditions amorphous formulations could be obtained using solvent evaporation. Melting point depression was used to calculate interaction parameters and free energy of mixing for the various drug polymer mixtures. The spray dried solid dispersions yielded a negative free energy of mixing which indicated strong drug-polymer miscibility compared to the solvent evaporation and serial dilution method. Soluplus was the best stabilizer compared to PVP and HPMC, which is probably a consequence of strong hydrogen bonding between the two CO moieties of soluplus and the drug NH moieities. Copyright © 2016. Published by Elsevier B.V.

  18. Decontamination trade study for the Light Duty Utility Arm

    SciTech Connect

    Rieck, R.H.

    1994-09-29

    Various methods were evaluated for decontaminating the Light Duty Utility Arm (LDUA). Physical capabilities of each method were compared with the constraints and requirements for the LDUA Decontamination System. Costs were compared and a referred alternative was chosen.

  19. Recent progress in solid-state NMR studies of drugs confined within drug delivery systems.

    PubMed

    Skorupska, Ewa; Jeziorna, Agata; Kazmierski, Slawomir; Potrzebowski, Marek J

    2014-01-01

    Recent progress in the application of solid-state NMR (SS NMR) spectroscopy in structural studies of active pharmaceutical ingredients (APIs) embedded in different drug carriers is detailed. This article is divided into sections. The first part reports short characterization of the nanoparticles and microparticles that can be used as drug delivery systems (DDSs). The second part shows the applicability of SS NMR to study non-steroidal anti-inflammatory drugs (NSAIDs). In this section, problems related to API-DDS interactions, morphology, local molecular dynamics, nature of inter- or intramolecular connections, and pore filling are reviewed for different drug carriers (e.g. mesoporous silica nanoparticles (MSNs), cyclodextrins, polymeric matrices and others). The third and fourth sections detail the recent applications of SS NMR for searching for antibiotics and anticancer drugs confined in zeolites, MSNs, amorphous calcium phosphate and other carriers.

  20. Potential utility of optogenetics in the study of depression

    PubMed Central

    Lobo, Mary Kay; Nestler, Eric J.; Covington, Herbert E.

    2013-01-01

    Novel antidepressants are needed to enhance the health and quality of life of the hundreds-of-millions of depressed individuals worldwide who remain inadequately treated with today’s approaches. In reality, no new class of antidepressant medication has been introduced in over 50 years. This insufficiency of current drug treatments is evident to those eager to pursue invasive experimental options like that of deep brain stimulation (DBS). Encouragingly, human brain imaging studies and animal work implicate strong relationships between depressive symptoms and patterns of brain activity, which are now open to more empirical assessments using optogenetics. Recent advances in optogenetics permit control over specific subtypes of neurons, or their afferent or efferent projections, and can greatly further our understanding of the neural mechanisms involved in depression and the mechanism of action of DBS and perhaps chemical antidepressants. Here, we discuss how optogenetic tools are being used to answer a broad range of molecular, cellular, and circuit-level questions pertaining to depression which, up until now, have been resistant to other experimental approaches. The emergence of optogenetic technology, when combined with the best-validated animal models of depression, will dramatically increase knowledge about the basic neurobiology of depression as well as facilitate the development of more effective antidepressant treatments. PMID:22322104

  1. Use of Serotonergic Drugs in Canada for Gastrointestinal Motility Disorders: Results of a Retrospective Cohort Study

    PubMed Central

    Manji, Farouq; Lam, Jennifer; Taylor, Brian M.

    2016-01-01

    Background. Surgery for GI dysmotility is limited to those with severe refractory disease. Though effective, use of serotonergic promotility drugs has been restricted in Canada due to adverse events. We aimed to investigate utilization of promotility serotonergic drugs in patients under consideration for surgical management. Methods. A retrospective cohort study was conducted using prospectively collected data. The study population included consecutive patients referred to a motility clinic for consideration of bowel resection at a Canadian tertiary hospital (1996–2011). Univariable tests and multivariable logistic regression analyses were used to assess predictors of serotonergic drug use. Results. Of 128 patients, the majority (n = 98, 76.6%) had constipation-dominant symptoms. Only 25% (n = 32) had tried serotonergic promotility drugs. There was no association between use of these drugs and severity of constipation nor was there an association between serotonergic drug use and presence of diffuse dysmotility (all p > 0.05). The majority of patients (n = 97, 75.8%) underwent some type of surgical resection, which was associated with considerable morbidity (n = 13, 13.4%). Conclusions. Surgical management of GI dysmotility results in serious morbidity. Serotonergic promotility drugs may allow patients to avoid surgery but disease severity does not predict use of these drugs. PMID:27313955

  2. Utilizing Social Action Theory as a framework to determine correlates of illicit drug use among young men who have sex with men.

    PubMed

    Traube, Dorian E; Holloway, Ian W; Schrager, Sheree M; Kipke, Michele D

    2012-03-01

    Young men who have sex with men (YMSM) continue to be at elevated risk for substance use; however, models explaining this phenomenon have often focused on a limited array of explanatory constructs. This study utilizes Social Action Theory (SAT) as a framework to address gaps in research by documenting the social, behavioral, and demographic risk factors associated with illicit drug use among YMSM. Structural equation modeling was used to apply SAT to a cross-sectional sample of 526 men from the Healthy Young Men Study, a longitudinal study of substance use and sexual risk behavior among YMSM in Los Angeles. The final model possessed very good fit statistics (Comparative Fit Index (CFI) = 0.936, Tucker-Lewis Index (TLI) = 0.925, Root Mean Square Error of Approximation (RMSEA) = 0.040) indicating that SAT is appropriate for use with YMSM. Substance use interventions for YMSM could be enhanced by employing SAT as conceptualized in this study and using a multitargeted strategy for impacting illicit drug use.

  3. Utilizing Social Action Theory as a Framework to Determine Correlates of Illicit Drug Use Among Young Men Who Have Sex with Men

    PubMed Central

    Traube, Dorian E.; Holloway, Ian W.; Schrager, Sheree M.; Kipke, Michele D.

    2011-01-01

    Background Young men who have sex with men (YMSM) continue to be at elevated risk for substance use; however, models explaining this phenomenon have often focused on a limited array of explanatory constructs. Purpose This study utilizes Social Action Theory (SAT) as a framework to address gaps in research by documenting the social, behavioral, and demographic risk factors associated with illicit drug use among YMSM. Methods Structural equation modeling was used to apply SAT to a cross-sectional sample of 526 men from the Healthy Young Men Study, a longitudinal study of substance use and sexual risk behavior among YMSM in Los Angeles. Results The final model possessed very good fit statistics (CFI = 0.936, TLI = 0.925, RMSEA = 0.040) indicating that SAT is appropriate for use with YMSM. Conclusions Substance use interventions for YMSM could be enhanced by employing SAT as conceptualized in this study and using a multi-targeted strategy for impacting illicit drug use. PMID:21644802

  4. Turbidity study of solar ponds utilizing seawater as salt source

    SciTech Connect

    Li, Nan; Sun, Wence; Shi, Yufeng; Yin, Fang; Zhang, Caihong

    2010-02-15

    A series of experiments were conducted to study the turbidity reduction in solar ponds utilizing seawater as salt source. The experiment on the turbidity reduction efficiency with chemicals indicates that alum (KAl(SO{sub 4}){sub 2}.12H{sub 2}O) has a better turbidity control property because of its strongly flocculating and also well depressing the growing of algae and bacteria in the seawater. In comparison with bittern and seawater, our experiment shows that the residual brine after desalination can keep limpidity for a long time even without any chemical in it. Experiments were also conducted on the diffusion of turbidity and salinity, which show that the turbidity did not diffuse upwards in the solution. In the experiment on subsidence of soil in the bittern and saline with the same salinity, it was found that soil subsided quite quickly in the pure saline water, but very slowly in the bittern. In this paper we also proposed an economical method to protect the solar pond from the damage of rain. Finally, thermal performance of a solar pond was simulated in the conditions of different turbidities using a thermal diffusion model. (author)

  5. A study on cavity collapse for utilizing green implosion energy

    NASA Astrophysics Data System (ADS)

    Lee, Hyunhee; Gojani, Ardian; Han, Tae-Hee; Yoh, Jack

    2009-06-01

    The mechanical energy generated by laser-induced implosion and the dynamics between non-condensable gas and liquid are studied experimentally and numerically. We have designed a micro implosion piston (MIP) to utilize the energy of implosion for inducing a piston motion. The MIP has the shape of a cone and is filled with liquid at room temperature and a high pressure (˜ 6 bars). Focusing of a high power laser pulse inside the MIP leads to creation of several bubbles that expand and collapse with successive rebounds. The bubble-liquid interaction develops a micro- jet that destroys the symmetry of the bubble. This bubble implosion motion, induced by the pressure gradient across the cavity wall produces high pressures wave within a few nanoseconds. These pressure waves are affected by different conditions such as the distance between the bubble and piston head, the dimension of the MIP, and the pressure at which the MIP is driven. The radius of the bubble is measured by double exposure photography, while pressure histories are measured by hydrophones. We investigate the relationship between the radius of the bubble, the overpressure of the secondary shock wave and the motion of the micro piston, and compare it to numerical simulations. The aim is to reach a state inside the MIP that would cause a sustainable and efficient motion of piston through cavity collapse induced high pressure pulses.

  6. Pattern of drug utilization for treatment of uncomplicated malaria in urban Ghana following national treatment policy change to artemisinin-combination therapy.

    PubMed

    Dodoo, Alexander N O; Fogg, Carole; Asiimwe, Alex; Nartey, Edmund T; Kodua, Augustina; Tenkorang, Ofori; Ofori-Adjei, David

    2009-01-05

    Change of first-line treatment of uncomplicated malaria to artemisinin-combination therapy (ACT) is widespread in Africa. To expand knowledge of safety profiles of ACT, pharmacovigilance activities are included in the implementation process of therapy changes. Ghana implemented first-line therapy of artesunate-amodiaquine in 2005. Drug utilization data is an important component of determining drug safety, and this paper describes how anti-malarials were prescribed within a prospective pharmacovigilance study in Ghana following anti-malarial treatment policy change. Patients with diagnosis of uncomplicated malaria were recruited from pharmacies of health facilities throughout Accra in a cohort-event monitoring study. The main drug utilization outcomes were the relation of patient age, gender, type of facility attended, mode of diagnosis and concomitant treatments to the anti-malarial regimen prescribed. Logistic regression was used to predict prescription of nationally recommended first-line therapy and concomitant prescription of antibiotics. The cohort comprised 2,831 patients. Curative regimens containing an artemisinin derivative were given to 90.8% (n = 2,574) of patients, although 33% (n = 936) of patients received an artemisinin-based monotherapy. Predictors of first-line therapy were laboratory-confirmed diagnosis, age >5 years, and attending a government facility. Analgesics and antibiotics were the most commonly prescribed concomitant medications, with a median of two co-prescriptions per patient (range 1-9). Patients above 12 years were significantly less likely to have antibiotics co-prescribed than patients under five years; those prescribed non-artemisinin monotherapies were more likely to receive antibiotics. A dihydroartemisinin-amodiaquine combination was the most used therapy for children under five years of age (29.0%, n = 177). This study shows that though first-line therapy recommendations may change, clinical practice may still be affected by

  7. Study of drug diffusion rate by laser beam deflection technique.

    PubMed

    Swapna, Mohanachandran Nair S; Anitha, Madhu J; Sankararaman, Sankaranarayana Iyer

    2017-06-01

    Drug administration is an unavoidable part of treatment. When a drug is administered orally or intravenously, it gets absorbed into the blood stream. The rate and efficiency of absorption depend on the route of administration. When a drug is administered through the oral route, it penetrates the epithelial cells of the intestinal mucosa. The diffusion of the drug into the blood stream depends on various parameters, such as concentration, temperature, and the nature of the mucous membrane. The passive diffusion of drugs is found to obey Fick’s law. Water soluble drugs penetrate the cell membrane through aqueous channel or pores. Hence, the study of diffusion of drugs into the water and finally into the blood stream is important. An attempt has been made to study the diffusion of the drug in water as 60% to 80% of human body is water. For the study of drug diffusion in water, a commonly used cough syrup of specific gravity 1.263 is used. It is found that the diffusion rate increases with the concentration of the drug.

  8. Study of drug diffusion rate by laser beam deflection technique

    NASA Astrophysics Data System (ADS)

    Swapna, Mohanachandran Nair. S.; Anitha, Madhu J.; Sankararaman, Sankaranarayana Iyer

    2017-06-01

    Drug administration is an unavoidable part of treatment. When a drug is administered orally or intravenously, it gets absorbed into the blood stream. The rate and efficiency of absorption depend on the route of administration. When a drug is administered through the oral route, it penetrates the epithelial cells of the intestinal mucosa. The diffusion of the drug into the blood stream depends on various parameters, such as concentration, temperature, and the nature of the mucous membrane. The passive diffusion of drugs is found to obey Fick's law. Water soluble drugs penetrate the cell membrane through aqueous channel or pores. Hence, the study of diffusion of drugs into the water and finally into the blood stream is important. An attempt has been made to study the diffusion of the drug in water as 60% to 80% of human body is water. For the study of drug diffusion in water, a commonly used cough syrup of specific gravity 1.263 is used. It is found that the diffusion rate increases with the concentration of the drug.

  9. Misuse of "study drugs:" prevalence, consequences, and implications for policy

    PubMed Central

    Sussman, Steve; Pentz, Mary Ann; Spruijt-Metz, Donna; Miller, Toby

    2006-01-01

    Background Non-medical/illegal use of prescription stimulants popularly have been referred to as "study drugs". This paper discusses the current prevalence and consequences of misuse of these drugs and implications of this information for drug policy. Results Study drugs are being misused annually by approximately 4% of older teens and emerging adults. Yet, there are numerous consequences of misuse of prescription stimulants including addiction, negative reactions to high dosages, and medical complications. Policy implications include continuing to limit access to study drugs, finding more safe prescription drug alternatives, interdiction, and public education. Conclusion Much more work is needed on prescription stimulant misuse assessment, identifying the extent of the social and economic costs of misuse, monitoring and reducing access, and developing prevention and cessation education efforts. PMID:16764722

  10. Cholinesterase Inhibitor Utilization: The Impact of Provincial Drug Policy on Discontinuation.

    PubMed

    Fisher, Anat; Carney, Greg; Bassett, Ken; Chappell, Neena L

    2016-01-01

    In October 2007, British Columbia started to cover the cost of cholinesterase inhibitors (ChEIs)-donepezil, galantamine, and rivastigmine-for patients with mild to moderate dementia and prominent Alzheimer's disease. To examine the impact of this policy on persistence with ChEIs. A population-based cohort study was conducted using British Columbia administrative health data. We examined 45,537 new ChEI users aged 40 years and older between 2001 and 2012; 20,360 (45%) started the treatment after the coverage policy was launched. Patients were followed until treatment discontinuation, defined as a ChEI-free gap of 90 days, death, or December 2013. Persistence on ChEIs was estimated using survival analysis and competing risk approach. Hazards of discontinuation were compared using competing risk Cox regression with propensity adjustment. Patients who started ChEI therapy after the introduction of the coverage policy had a significantly longer persistence. Median ChEI persistence until discontinuation or death was 9.37 months (95% confidence interval [CI] 9.0-39.7) and 17.6 months (95% CI 16.9-18.3) in patients who started therapy before and after the new policy, respectively. The propensity-adjusted hazard ratio for discontinuing therapy was 0.91 (95% CI 0.88-0.94). Similar patterns were observed for persistence with the first ChEI (propensity-adjusted hazard ratio of 0.94; 95% CI 0.91-0.98). In rivastigmine users, the hazard ratio was insignificant (0.98; 95% CI 0.92-1.02). The British Columbia ChEI coverage policy was associated with significantly prolonged persistence with donepezil and galantamine, but not rivastigmine. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. Utility of non-human primates in drug development: Comparison of non-human primate and human drug-metabolizing cytochrome P450 enzymes.

    PubMed

    Uno, Yasuhiro; Uehara, Shotaro; Yamazaki, Hiroshi

    2016-12-01

    Cynomolgus monkeys (Macaca fascicularis, an Old World Monkey) have been widely used as a non-human primate model in preclinical studies because of their genetic and physiological similarity to humans. This trend has been followed by common marmoset (Callithrix jacchus, a New World Monkey). However, drug-metabolism properties in these non-human primates have not been fully understood due to limited information on cytochrome P450 (P450) enzymes, major drug-metabolizing enzymes in humans. Multiple forms of cynomolgus monkey P450 enzymes have been identified and characterized in comparison to those of humans, including a cynomolgus monkey specific form, P450 2C76. Similarly, marmoset P450 1A/B, 2A, 2C, 2D, and 4F enzymes were recently identified and characterized to understand drug metabolism properties. In this research update, updates for marmoset, cynomolgus monkey, and human P450 cDNAs are provided. Marmoset and cynomolgus monkey P450 enzymes showed high sequence homology to their human counterparts and generally had similar substrate recognition functionality to human P450 enzymes; however, they also possibly contribute to limited specific differences in drug oxidative metabolism partly due to small differences in amino acid residues. These findings provide a foundation for successful use of non-human primates as preclinical models and will help to further understand molecular mechanisms of human P450 function. In addition to the P450 enzymes, flavin-containing monooxygenases, another monooxygenase family, in these non-human primates have been found to be involved in the oxidation of a variety of compounds associated with pharmacological and/or toxicological effects in humans and are also described. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. An Exploration of the Utility of a Knowledge Utilization Framework to Study the Gap between Reading Disabilities Research and Practice

    ERIC Educational Resources Information Center

    Davidson, Katherine; Nowicki, Elizabeth

    2012-01-01

    This pre-pilot study explored the usefulness of a knowledge utilization framework comprised of Knott and Wildavsky's (1980) seven stages of knowledge use and Stone's (2002) three routes to knowledge use to investigate the gap between reading disabilities research and teachers' self-reported use of that research. Semi-structured interviews of ten…

  13. An Exploration of the Utility of a Knowledge Utilization Framework to Study the Gap between Reading Disabilities Research and Practice

    ERIC Educational Resources Information Center

    Davidson, Katherine; Nowicki, Elizabeth

    2012-01-01

    This pre-pilot study explored the usefulness of a knowledge utilization framework comprised of Knott and Wildavsky's (1980) seven stages of knowledge use and Stone's (2002) three routes to knowledge use to investigate the gap between reading disabilities research and teachers' self-reported use of that research. Semi-structured interviews of ten…

  14. Drug utilization pattern in children and off-label use of medicines in a pediatric intensive care unit.

    PubMed

    Blanco-Reina, E; Medina-Claros, A F; Vega-Jiménez, M A; Ocaña-Riola, R; Márquez-Romero, E I; Ruiz-Extremera, Á

    2016-01-01

    This study aims to assess the prescription profile and license status of drugs used in a neonatal and pediatric intensive care unit (NPICU). A prospective observational study was conducted on a dynamic cohort of children admitted to an NPICU (N=81) in a tertiary hospital (Granada, Spain). All prescriptions were classified as off-label or unlicensed based on the summary of product characteristics (SPC). Of a total of 601 prescriptions, the patients received a mean of 7.4 ± 6 drugs each. The most commonly prescribed drugs corresponded to classes J (anti-infectious, systemic use) N (nervous system) and C (cardiovascular). A little over one-half of the prescriptions were off-label (52%), usually due to dosages differing from the SPC recommendations (79%), followed by different indications (13.5%), age (5%) and administration route (2.5%). In this NPICU, unlicensed usage represented only 5% of all prescriptions. This study contributes data on prescription of this kind in a Spanish NPICU, revealing at least one off-label prescription in 89% of the children and at least one unlicensed use in 22.3%. These are high figures, but are to be expected given the inclusion of newborn infants and the critical care setting. Even though such usage follows clinical protocols, we underscore the dual need to base treatment on the best available evidence, and to upgrade the SPC accordingly. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  15. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study

    PubMed Central

    Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-01-01

    labeling of annotated PDDIs across a broader range of drug product labels. Preannotation of drug mentions may ease the annotation task. However, preannotation of PDDIs, as operationalized in this study, presented the participants with difficulties. Future work should test if these issues can be addressed by the use of better performing NLP and a different approach to presenting the PDDI preannotations to users during the annotation workflow. PMID:27066806

  16. Lymphocyte transformation studies in drug hypersensitivity

    PubMed Central

    Warrington, R.J.; Tse, K.S.

    1979-01-01

    In a group of patients with clinically diagnosed drug hypersensitivity the in vitro lymphocyte response to the suspected drug was assessed by the lymphocyte transformation test. The test gave positive results in all 15 patients with penicillin-induced immediate or accelerated allergic reactions and positive immediate skin-test reactivity to the major or the minor antigenic determinant of penicillin, or both, but in only 3 of the 12 patients with delayed-onset maculopapular rashes induced by penicillin, despite positive immediate reactivity to the skin-test reagents. Lymphocyte stimulation greater than five times the control level was demonstrated for five patients with penicillin-induced erythroderma, Stevens-Johnson syndrome or a serum-sickness-like illness, or with methicillin-induced interstitial nephritis, all of whom had negative reactions to the appropriate skin-test reagents. A low level of stimulation was seen in eight other skin-test-negative patients with possible allergic reactions induced by penicillins. However, in all subjects tested the stimulation was significantly greater than the mean for control subjects. For 9 of 11 patients with isoniazid-induced hepatitis or maculopapular rashes, but for only 8 of 31 patients with eruptions induced by a variety of drugs other than penicillins and isoniazid, significant stimulation occurred in the lymphocyte transformation test. It is concluded that the lymphocyte transformation test is useful in the detection of hypersensitivity to the penicillins (although in IgE-mediated reactions skin testing is clearly preferable) and isoniazid but is of limited value in the demonstration of hypersensitivity to other drugs. PMID:445303

  17. Lymphocyte transformation studies in drug hypersensitivity.

    PubMed

    Warrington, R J; Tse, K S

    1979-05-05

    In a group of patients with clinically diagnosed drug hypersensitivity the in vitro lymphocyte response to the suspected drug was assessed by the lymphocyte transformation test. The test gave positive results in all 15 patients with penicillin-induced immediate or accelerated allergic reactions and positive immediate skin-test reactivity to the major or the minor antigenic determinant of penicillin, or both, but in only 3 of the 12 patients with delayed-onset maculopapular rashes induced by penicillin, despite positive immediate reactivity to the skin-test reagents.Lymphocyte stimulation greater than five times the control level was demonstrated for five patients with penicillin-induced erythroderma, Stevens-Johnson syndrome or a serum-sickness-like illness, or with methicillin-induced interstitial nephritis, all of whom had negative reactions to the appropriate skin-test reagents. A low level of stimulation was seen in eight other skin-test-negative patients with possible allergic reactions induced by penicillins. However, in all subjects tested the stimulation was significantly greater than the mean for control subjects.For 9 of 11 patients with isoniazid-induced hepatitis or maculopapular rashes, but for only 8 of 31 patients with eruptions induced by a variety of drugs other than penicillins and isoniazid, significant stimulation occurred in the lymphocyte transformation test.It is concluded that the lymphocyte transformation test is useful in the detection of hypersensitivity to the penicillins (although in IgE-mediated reactions skin testing is clearly preferable) and isoniazid but is of limited value in the demonstration of hypersensitivity to other drugs.

  18. The utility of the zebrafish model in conditioned place preference to assess the rewarding effects of drugs.

    PubMed

    Collier, Adam D; Echevarria, David J

    2013-09-01

    Substance abuse is a significant public health concern both domestically and worldwide. The persistent use of substances regardless of aversive consequences forces the user to give higher priority to the drug than to normal activities and obligations. The harmful and hazardous use of psychoactive substances can lead to a dependence syndrome. In this regard, the genetic and neurobiological underpinnings of reward-seeking behavior need to be fully understood in order to develop effective pharmacotherapies and other methods of treatment. Animal models are often implemented in preclinical screening for testing the efficacy of novel treatments. Several paradigms exist that model various facets of addiction including sensitization, tolerance, withdrawal, drug seeking, extinction, and relapse. Self-administration and, most notably, conditioned place preference (CPP) are relatively simple tests that serve as indicators of the aforementioned aspects of addiction by means of behavioral quantification. CPP is a commonly used technique to evaluate the motivational effects of compounds and experiences that have been associated with a positive or negative reward, which capitalizes on the basic principles of Pavlovian conditioning. During training, the unconditioned stimulus is consistently paired with a neutral set of environmental stimuli, which obtain, during conditioning, secondary motivational properties that elicit approach behavior in the absence of the unconditioned stimulus. For over 50 years, rodents have been the primary test subjects. However, the zebrafish (Danio rerio) is gaining favor as a valuable model organism in the fields of biology, genetics, and behavioral neuroscience. This paper presents a discussion on the merits, advantages, and limitations of the zebrafish model and its utility in relation to CPP.

  19. A pilot randomized clinical trial utilizing the drug burden index to reduce exposure to anticholinergic and sedative medications in older people.

    PubMed

    Gnjidic, Danijela; Le Couteur, David G; Abernethy, Darrell R; Hilmer, Sarah N

    2010-11-01

    The drug burden index (DBI) is an evidence-based tool that utilizes pharmacologic principles to calculate an individual's total exposure to anticholinergic and sedative medications. Higher DBI has been associated with functional impairment in observational studies of older people. To assess the impact of providing information about DBI to general practitioners (GPs) on prescribing for older people. This was a cluster randomized controlled trial with 3 months of follow-up. Participants were volunteers aged ≥70 years, living in self-care retirement villages in Sydney, Australia. The study intervention involved a letter and phone call to GPs, using DBI to prompt them to consider cessation or dose reduction of anticholinergic and sedative medications. The primary study outcome was to assess the impact of information about DBI on prescribing practices of the GPs. A total of 115 participants were enrolled, 57 in the intervention group (from 6 sites) and 58 in the control group (from 6 sites). At baseline, 19 of 57 participants in the intervention group and 31 of 58 participants in the control group had a DBI >0 (p < 0.05). At follow-up, a DBI change was observed in 16 participants. DBI decreased in 12 participants, 6 (32%) in the intervention group, and 6 (19%) in the control group. GPs identified the following barriers to reducing anticholinergic and sedative drugs: uncomfortable altering prescriptions initiated by specialists; unable to influence patients' attitudes; unaware of patients' medications and strong clinical indication. The intervention targeting GPs' prescribing practices was less effective than anticipated in reducing anticholinergic and sedative drug exposure, and barriers were identified. Future studies should explore multidisciplinary interventions, engaging patients, specialists, GPs, and pharmacists.

  20. Plasmonic nanocarrier grid-enhanced Raman sensor for studies of anticancer drug delivery.

    PubMed

    Kurzątkowska, Katarzyna; Santiago, Ty; Hepel, Maria

    2017-05-15

    Targeted drug delivery systems using nanoparticle nanocarriers offer remarkable promise for cancer therapy by discriminating against devastating cytotoxicity of chemotherapeutic drugs to healthy cells. To aid in the development of new drug nanocarriers, we propose a novel plasmonic nanocarrier grid-enhanced Raman sensor which can be applied for studies and testing of drug loading onto the nanocarriers, attachment of targeting ligands, dynamics of drug release, assessment of nanocarrier stability in biological environment, and general capabilities of the nanocarrier. The plasmonic nanogrid sensor offers strong Raman enhancement due to the overlapping plasmonic fields emanating from the nearest-neighbor gold nanoparticle nanocarriers and creating the enhancement "hot spots". The sensor has been tested for immobilization of an anticancer drug gemcitabine (2',2'-difluoro-2'-deoxycytidine, GEM) which is used in treatment of pancreatic tumors. The drawbacks of currently applied treatment include high systemic toxicity, rapid drug decay, and low efficacy (ca. 20%). Therefore, the development of a targeted GEM delivery system is highly desired. We have demonstrated that the proposed nanocarrier SERS sensor can be utilized to investigate attachment of targeting ligands to nanocarriers (attachment of folic acid ligand recognized by folate receptors of cancer cells is described). Further testing of the nanocarrier SERS sensor involved drug release induced by lowering pH and increasing GSH levels, both occurring in cancer cells. The proposed sensor can be utilized for a variety of drugs and targeting ligands, including those which are Raman inactive, since the linkers can act as the Raman markers, as illustrated with mercaptobenzoic acid and para-aminothiophenol.

  1. Prescribing psychotropic drugs in general practice: three year study.

    PubMed Central

    Jones, L; Simpson, D; Brown, A C; Bainton, D; McDonald, H

    1984-01-01

    A three year longitudinal study of psychotropic drug prescribing in one inner city general practice showed that there was a greater use of such drugs among women and elderly men and women. Repeat prescriptions without consultation accounted for 44% of prescriptions written. We think that any attempt to reduce the volume of prescriptions for psychotropic drugs should take into account the prescribing habits and attitudes of doctors as well as the problems and needs of patients. PMID:6435768

  2. Membrane–drug interactions studied using model membrane systems

    PubMed Central

    Knobloch, Jacqueline; Suhendro, Daniel K.; Zieleniecki, Julius L.; Shapter, Joseph G.; Köper, Ingo

    2015-01-01

    The direct interaction of drugs with the cell membrane is often neglected when drug effects are studied. Systematic investigations are hindered by the complexity of the natural membrane and model membrane systems can offer a useful alternative. Here some examples are reviewed of how model membrane architectures including vesicles, Langmuir monolayers and solid supported membranes can be used to investigate the effects of drug molecules on the membrane structure, and how these interactions can translate into effects on embedded membrane proteins. PMID:26586998

  3. Utility of in vitro systems and preclinical data for the prediction of human intestinal first-pass metabolism during drug discovery and preclinical development.

    PubMed

    Karlsson, Fredrik H; Bouchene, Salim; Hilgendorf, Constanze; Dolgos, Hugues; Peters, Sheila Annie

    2013-12-01

    A growing awareness of the risks associated with extensive intestinal metabolism has triggered an interest in developing robust methods for its quantitative assessment. This study explored the utility of intestinal S9 fractions, human liver microsomes, and recombinant cytochromes P450 to quantify CYP3A-mediated intestinal extraction in humans for a selection of marketed drugs that are predominantly metabolized by CYP3A4. A simple competing rates model is used to estimate the fraction of drug escaping gut wall metabolism (fg) from in vitro intrinsic clearance in humans. The fg values extrapolated from the three in vitro systems used in this study, together with literature-derived fg from human intestinal microsomes, were validated against fg extracted from human in vivo pharmacokinetic (PK) profiles using a generic whole-body physiologically-based pharmacokinetic (PBPK) model. The utility of the rat as a model for human CYP3A-mediated intestinal metabolism was also evaluated. Human fg from PBPK compares well with that from the grapefruit juice method, justifying its use for the evaluation of human in vitro systems. Predictive performance of all human in vitro systems was comparable [root mean square error (RMSE) = 0.22-0.27; n = 10]. Rat fg derived from in vivo PK profiles using PBPK has the lowest RMSE (0.19; n = 11) for the prediction of human fg for the selected compounds, most of which have a fraction absorbed close to 1. On the basis of these evaluations, the combined use of fg from human in vitro systems and rats is recommended for the estimation of CYP3A4-mediated intestinal metabolism in lead optimization and preclinical development phases.

  4. Sampling of illicit drugs for quantitative analysis. Part I: heterogeneity study of illicit drugs in Europe.

    PubMed

    Dujourdy, L; Csesztregi, T; Bovens, M; Franc, A; Nagy, J

    2013-09-10

    Sampling of illicit drugs for qualitative and quantitative analysis would normally be considered as routine and comparable tasks in forensic drugs laboratories and previously similar statistical sampling approaches have been applied. However, we believe that two different sampling approaches, based on two different theoretical and statistical backgrounds are more appropriate. Furthermore the application of the qualitative sampling approach can be impractical for quantitative sampling as it could generate many analytical samples from a single seizure. In some countries the purity of the illicit drug in a seizure may affect the criminal sentence and therefore, reliable results for quantitative analysis are crucial. It was decided to investigate a new approach, which although incorporating some statistics also took account of our background knowledge about the composition of the drugs we were analysing. The ultimate goal was to produce recommendations for a practical sampling plan for quantitative analysis. It was found that the two key factors which had a significant effect on obtaining a representative analytical sample from a bulk seizure were the heterogeneity of the drug powder and the particle sizes of its components. This article concentrates on drug heterogeneity. Particle size effects will be addressed in part II of this study. A sampling plan was devised for a range of drug seizure types and asked ENFSI member laboratories to use it when analysing real drug seizures to provide heterogeneity data for the most common illicit drugs (heroin, cocaine, amphetamine, MDMA and cannabis (herbal and resin)). It was found that for routine quantitative drugs analysis, the sampling problems caused by heterogeneity can be solved by using an incremental sampling protocol. Furthermore, the number of increments that need to be taken for a particular drug is dependent on the relative standard deviation (RSD) required by an individual laboratory and the analytical method that

  5. Results of a retrospective database analysis of drug utilization and costs for treatment of chronic hepatitis B virus infection in the northern Netherlands between 2000 and 2006.

    PubMed

    Tu, Hong Anh T; Bos, Jens H J; Woerdenbag, Herman J; Visser, Sipke T; Wilschut, Jan C; van Assen, Sander; de Jong-van den Berg, Lolkje T W; Postma, Maarten J

    2010-01-01

    The main aims of this work were to describe patterns of medication use in the treatment of chronic hepatitis B virus (HBV) infection in patients in the northern part of the Netherlands and to compare these practices with established guidelines. In addition, the duration of use and the costs of these treatments were investigated. We selected subjects from the University of Groningen's IADB.nl database; by 2006, the database provided information about drug utilization from 55 community pharmacies in the northern Netherlands and included a population of 528,911 individuals, of which 49% were male. Eligible subjects had received >or=1 prescription for drugs used to treat chronic HBV infection (ie, lamivudine, pegylated interferon-alpha2a, pegylated interferon-alpha2b, adefovir, tenofovir, and entecavir) between the years 2000 and 2006. The annual prevalence and cumulative incidence of HBV treatment per 1000 people covered in the database were calculated and stratified by sex. Kaplan-Meier survival analysis was used to analyze the duration of use. Drug costs in the treatment were calculated for all patients or per patient, and by drugs used per subperiod (2000-2003 and 2004-2006). Treatments for hepatitis C virus and HIV were excluded from the analyses. From the database, we identified 59 patients (46 male, 13 female), aged 25 to 60 years, who received >or=1 prescription for a medication to treat chronic HBV infection between 2000 and 2006. The overall prevalence of people using chronic treatments for HBV was between 0.03 and 0.06 per 1000 during the years of the study. The cumulative incidence of treatment was approximately 0.01 per 1000 per year (ranging from a high of 0.021 in 2000 to a low of 0.009 in 2006). When stratified by sex, there were more male than female subjects who received medications for HBV. Lamivudine was the most commonly prescribed drug, followed by adefovir and pegylated interferon-alpha2b. In 2000 and 2001, lamivudine was the only medication

  6. A pilot study of loss aversion for drug and non-drug commodities in cocaine users.

    PubMed

    Strickland, Justin C; Beckmann, Joshua S; Rush, Craig R; Stoops, William W

    2017-09-12

    Numerous studies in behavioral economics have demonstrated that individuals are more sensitive to the prospect of a loss than a gain (i.e., loss aversion). Although loss aversion has been well described in "healthy" populations, little research exists in individuals with substance use disorders. This gap is notable considering the prominent role that choice and decision-making play in drug use. The purpose of this pilot study was to evaluate loss aversion in active cocaine users. Current cocaine users (N=38; 42% female) participated in this within-subjects laboratory pilot study. Subjects completed a battery of tasks designed to assess loss aversion for drug and non-drug commodities under varying risk conditions. Standardized loss aversion coefficients (λ) were compared to theoretically and empirically relevant normative values (i.e., λ=2). Compared to normative loss aversion coefficient values, a precise and consistent decrease in loss aversion was observed in cocaine users (sample λ≈1). These values were observed across drug and non-drug commodities as well as under certain and risky conditions. These data represent the first systematic study of loss aversion in cocaine-using populations and provide evidence for equal sensitivity to losses and gains or loss equivalence. Futures studies should evaluate the specificity of these effects to a history of cocaine use as well as the impact of manipulations of loss aversion on drug use to determine how this phenomenon may contribute to intervention development efforts. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Pueblo of Laguna Utility Authority Renewable Energy Feasibility Study

    SciTech Connect

    Carolyn Stewart, Red Mountain Tribal Energy

    2008-03-31

    The project, “Renewable Energy Feasibility Study” was designed to expand upon previous work done by the Tribe in evaluating utility formation, generation development opportunities, examining options for creating self-sufficiency in energy matters, and integrating energy management with the Tribe’s economic development goals. The evaluation of project locations and economic analysis, led to a focus primarily on solar projects.

  8. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.

  9. A Study of Pharmacy Students' Attitudes Toward Drug Abuse

    ERIC Educational Resources Information Center

    Miederhoff, Patrick; And Others

    1978-01-01

    Pharmacy students' attitudes toward drug abuse was compared with those of students with different majors. Scores were compared with professional practitioners in other studies using the Measurement of Attitudes Toward Drugs scale. Changes in attitudes as students proceed through their pharmacy curricula were also investigated. (SW)

  10. Case Studies: Profiles of Women Recovering from Drug Addiction.

    ERIC Educational Resources Information Center

    Miller, Suzanne M.

    1995-01-01

    Profiles two women over an eight-month study who abused alcohol and other drugs while pregnant and describes their recovery from the addiction. Examines, from an ecological framework, the women's experiences with drug addiction, treatment, and recovery, and recounts their situation through each. (JPS)

  11. Case Studies: Profiles of Women Recovering from Drug Addiction.

    ERIC Educational Resources Information Center

    Miller, Suzanne M.

    1995-01-01

    Profiles two women over an eight-month study who abused alcohol and other drugs while pregnant and describes their recovery from the addiction. Examines, from an ecological framework, the women's experiences with drug addiction, treatment, and recovery, and recounts their situation through each. (JPS)

  12. Analytical and Characterization Studies of Organic Chemicals, Drugs, and Drug Formulation

    DTIC Science & Technology

    2010-11-01

    release the drug product, and to conduct stability studies under cGMP shelf-life and accelerated conditions. Afton Scientific Corporation is to... Afton also served in this capacity in 2004 for the first batch of artesunic acid IV drug product, SRI batch # 14462-16. A second emphasis of our...support during the report period is as follows: Dalton Pharma Services Afton Scientific Corporation Steris Isomedix Services USAMRMC

  13. Discovery of a novel B-cell lymphoma 6 (BCL6)-corepressor interaction inhibitor by utilizing structure-based drug design.

    PubMed

    Yasui, Takeshi; Yamamoto, Takeshi; Sakai, Nozomu; Asano, Kouhei; Takai, Takafumi; Yoshitomi, Yayoi; Davis, Melinda; Takagi, Terufumi; Sakamoto, Kotaro; Sogabe, Satoshi; Kamada, Yusuke; Lane, Weston; Snell, Gyorgy; Iwata, Masashi; Goto, Masayuki; Inooka, Hiroshi; Sakamoto, Jun-Ichi; Nakada, Yoshihisa; Imaeda, Yasuhiro

    2017-09-01

    B-cell lymphoma 6 (BCL6) is a transcriptional repressor that can form complexes with corepressors via protein-protein interactions (PPIs). The complexes of BCL6 and corepressors play an important role in the formation of germinal centers (GCs), and differentiation and proliferation of lymphocytes. Therefore, BCL6-corepressor interaction inhibitors would be drug candidates for managing autoimmune diseases and cancer. Starting from high-throughput screening hits 1a and 2a, we identified a novel BCL6-corepressor interaction inhibitor 8c (cell-free enzyme-linked immunosorbent assay [ELISA] IC50=0.10µM, cell-based mammalian two-hybrid [M2H] assay IC50=0.72µM) by utilizing structure-based drug design (SBDD) based on an X-ray crystal structure of 1a bound to BCL6. Compound 8c also showed a good pharmacokinetic profile, which was acceptable for both in vitro and in vivo studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Propeller aircraft interior noise model utilization study and validation

    NASA Technical Reports Server (NTRS)

    Pope, L. D.

    1984-01-01

    Utilization and validation of a computer program designed for aircraft interior noise prediction is considered. The program, entitled PAIN (an acronym for Propeller Aircraft Interior Noise), permits (in theory) predictions of sound levels inside propeller driven aircraft arising from sidewall transmission. The objective of the work reported was to determine the practicality of making predictions for various airplanes and the extent of the program's capabilities. The ultimate purpose was to discern the quality of predictions for tonal levels inside an aircraft occurring at the propeller blade passage frequency and its harmonics. The effort involved three tasks: (1) program validation through comparisons of predictions with scale-model test results; (2) development of utilization schemes for large (full scale) fuselages; and (3) validation through comparisons of predictions with measurements taken in flight tests on a turboprop aircraft. Findings should enable future users of the program to efficiently undertake and correctly interpret predictions.

  15. Interaction of Antipsychotic Drugs with Sucrase, Kinetics and Structural Study.

    PubMed

    Jafari, Narges; Dehganpour, Helia; Ghavanini, Nava; Mollasalehi, Hamidreza; Minai-Tehrani, Dariush

    2017-01-01

    In patients with the Congenital Sucrase-Isomaltase Deficiency (CSID), who lack intestinal sucrase-isomaltase enzyme, a suspension of yeast sucrase is applied as a drug to compensate the enzyme deficiency. While antipsychotic drugs are used for the treatment of schizophrenia, administering multiple drugs at the same time may counteract each other. In this study, the interaction between trifluoperazine and haloperidol as antipsychotic drugs on oral drug yeast sucrase was investigated. In this regard, the kinetic parameters of enzyme were determined in the presence or absence of the drugs. The kinetic parameters of the drugs such as Ki and IC50 were also calculated. Lineweaver - Burk plot was used to reveal the type of inhibition. The results showed that both drugs could reduce sucrase activity and decrease the Vmax of the enzyme by non-competitive inhibition. The IC50 and Ki values of the drugs were determined to be 0.7 and 0.068 mM and 0.45 and 0.063 mM for haloperidol and trifluoperazine, respectively. The results suggested that trifluoperazine binds to the enzyme with higher affinity than haloperidol. Fluorescence measurement was used for conformational investigations of the drugs and sucrase interaction. It was shown that the drugs bind to free enzyme and enzyme-substrate complex which are accompanied with hyperchromicity. This suggests that tryptophan residues of the enzyme transferred to hydrophobic medium after binding of the drugs to the enzyme. The finding of this research revealed that both trifluoperazine and haloperidol could inhibit sucrase in non-competitive manner. The kinetic parameters and conformational changes due to binding of trifluoperazine to the enzyme were different from that of haloperidol. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  16. Immortal time bias in drug safety cohort studies: spontaneous abortion following nonsteroidal antiinflammatory drug exposure.

    PubMed

    Daniel, Sharon; Koren, Gideon; Lunenfeld, Eitan; Levy, Amalia

    2015-03-01

    Experimental research of drug safety in pregnancy is generally not feasible because of ethical issues. Therefore, most of the information about drug safety in general and teratogenicity in particular is obtained through observational studies, which require careful methodologic design to obtain unbiased results. Immortal time bias occurs when some cases do not "survive" sufficient time in the study, and as such, they have reduced chances of being defined as "exposed" simply because the durations of their follow-ups were shorter. For example, studies that examine the risk for spontaneous abortions in women exposed to a drug during pregnancy are susceptible to immortal time bias because the chance of drug exposure increases the longer a pregnancy lasts. Therefore, the drug tested may falsely be found protective against the outcome tested. The objective of the current study was to illustrate the extent of immortal time bias using a cohort study of pregnancies assessing the risk for spontaneous abortions following nonsteroidal antiinflammatory drug exposure. We assembled 3 databases containing data on spontaneous abortions, births and drug dispensions to create the present study's cohort. The risk for spontaneous abortion was assessed using 2 statistical analysis methods that were compared for 2 definitions of exposure (dichotomous, exposed vs unexposed, regular Cox regression vs Cox regression with time-varying exposure). Significant differences were found in the risk for spontaneous abortions between the 2 statistical methods, both for groups and for most specific nonsteroidal antiinflammatory drugs (nonselective Cox inhibitors - hazard ratio, 0.70; 95% confidence interval, 0.61-0.94 vs hazard ratio, 1.10; 95% confidence interval, 0.99-1.22 for dichotomous vs time-varying exposure analyses, respectively). Furthermore, a significant correlation was found between the median misclassified immortal time for each drug and the extent of the bias. Immortal time bias can

  17. Feasibility study of a Raman spectroscopic route to drug detection

    NASA Astrophysics Data System (ADS)

    Wróbel, Maciej S.; Siddhanta, Soumik; Jedrzejewska-Szczerska, Małgorzata; Smulko, Janusz; Barman, Ishan

    2017-02-01

    We present an surface-enhanced Raman spectroscopy (SERS) approach for detection of drugs of abuse in whole human blood. We utilize a near infrared laser with 830 nm excitation wavelength in order to reduce the influence of fluorescence on the spectra of blood. However, regular plasmon resonance peak of plasmonic nanoparticles, such as silver or gold fall in a much lower wavelength regime about 400 nm. Therefore, we have shifted the plasmon resonance of nanoparticles to match that of an excitation laser wavelength, by fabrication of the silver-core gold-shell nanoparticles. By combining the laser and plasmon resonance shift towards longer wavelengths we have achieved a great reduction in background fluorescence of blood. Great enhancement of Raman signal coming solely from drugs was achieved without any prominent lines coming from the erythrocytes. We have applied chemometric processing methods, such as Principal Component Analysis (PCA), to detect the elusive differences in the Raman bands which are specific for the investigated drugs. We have achieved good classification for the samples containing particular drugs (e.g., butalbital, α-hydroxyalprazolam). Furthermore, a quantitative analysis was carried out to assess the limit of detection (LOD) using Partial Least Squares (PLS) regression method. In conclusion, our LOD values obtained for each class of drugs was competitive with the gold standard GC/MS method.

  18. Evaluating the utility of administering a reaction time task in an ecological momentary assessment study.

    PubMed

    Waters, Andrew J; Li, Yisheng

    2008-03-01

    Cognitive processes underlying drug use have typically been assessed in laboratory settings. More detailed and ecologically valid data may be possible if assessments were conducted in an ecological momentary assessment (EMA) setting. We evaluated the feasibility and utility of administering a reaction time task on a hand-held computer (personal digital assistant, PDA) in an EMA setting. Twenty-two smokers and 22 non-smokers carried around the PDA for 1 week as they went about their daily lives. They were beeped at random times four times per day (random assessments, RAs). Participants were also instructed to press an "anxiety assessment" (AA) button on the PDA whenever they felt suddenly anxious. At each assessment (RA, AA), participants responded to items assessing subjective, pharmacological, and contextual variables, and subsequently completed a Stroop task (classic-Stroop, emotional-Stroop, or smoking-Stroop task). Participants responded to 81.2% of RAs, completed assessments in an average of 4.44 min, reported no interruptions on the majority of assessments (62.4%), and produced data with adequate reliability. Using generalized estimating equation (GEE) analyses, age was associated with the classic-Stroop effect, state anxiety was associated with the emotional-Stroop effect, and Fagerstrom Test for Nicotine Dependence scores were associated with the smoking-Stroop effect. The study provided evidence for the feasibility and utility of the approach.

  19. Severe Cutaneous Adverse Drug Reactions: A Clinicoepidemiological Study

    PubMed Central

    Sasidharanpillai, Sarita; Riyaz, Najeeba; Khader, Anza; Rajan, Uma; Binitha, Manikoth P; Sureshan, Deepthi N

    2015-01-01

    Background: Drug eruptions range from transient erythema to the life threatening severe cutaneous adverse reactions (SCAR) that encompass Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms complex (DRESS). Aims and Objectives: To study the clinical and epidemiological aspects of cutaneous adverse drug reactions (CADR). Materials and Methods: Ethical clearance was obtained from the institutional ethics committee. All patients admitted in the Dermatology ward of our tertiary care hospital with CADR (those who fit in the category of probable or possible drug reaction as per WHO casuality assessment) from first September 2011 to 31st August 2012 were included in this cross sectional study after obtaining written informed consent. The drug reaction patterns observed in the study population were determined and the common offending drugs were identified. Results: In the study, population of males outnumbered females and the majority were between 46 and 60 years of age. The commonest reaction pattern observed was SJS- TEN spectrum of illness and aromatic anticonvulsants were the common offending drugs. Prompt withdrawal of the culprit drug and administration of systemic steroids with or without I/V Ig reverted the adverse reaction in all except one. Conclusion: Severe drug reactions predominated as the study population was comprised of inpatients of a tertiary referral centre. Though; previous authors had reported a mortality rate of up to 20% in DRESS, all our patients with this reaction pattern, responded well to treatment. The mortality rate among TEN cases was much lower than the previous reports. Early diagnosis, prompt withdrawal of the suspected drug, careful monitoring for development of complications and immediate intervention can improve the prognosis of CADR. PMID:25657416

  20. A Longitudinal Study of Multiple Drug Use and Overdose Among Young People Who Inject Drugs.

    PubMed

    Riley, Elise D; Evans, Jennifer L; Hahn, Judith A; Briceno, Alya; Davidson, Peter J; Lum, Paula J; Page, Kimberly

    2016-05-01

    To determine the association between multiple drug use and nonfatal overdose among young people (younger than 30 years) who inject drugs. We completed a longitudinal study of 173 injection drug users younger than 30 years living in San Francisco, California, between April 2012 and February 2014. The odds of nonfatal overdose increased significantly as heroin and benzodiazepine pill-taking days increased and when alcohol consumption exceeded 10 drinks per day compared with 0 drinks per day. Heroin, benzodiazepine, and alcohol use were independently associated with nonfatal overdose over time among young people who inject drugs. Efforts to address multiple central nervous system depressant use remain an important component of a comprehensive approach to overdose, particularly among young people.

  1. Access to linked administrative healthcare utilization data for pharmacoepidemiology and pharmacoeconomics research in Canada: anti-viral drugs as an example.

    PubMed

    Rawson, Nigel S B

    2009-11-01

    Administrative healthcare utilization data from Canadian provinces have been used for pharmacoepidemiology and pharmacoeconomics research, but limited transparency exists about opportunities for data access, who can access them, and processes to obtain data. An attempt was made to obtain data from all 10 provinces to evaluate access and its complexity. An initial enquiry about the process and requirements to obtain data on individual, anonymized patients dispensed any of four anti-viral drugs in the ambulatory setting, linked with data from hospital and physician service claims, was sent to each province. Where a response was encouraging, a technical description of the data of interest was submitted. Data were unavailable from the provinces of New Brunswick, Newfoundland and Labrador, and Prince Edward Island, and inaccessible from British Columbia, Manitoba and Ontario due to policies that prohibit collaborative work with pharmaceutical industry researchers. In Nova Scotia, patient-level data were available but only on site. Data were accessible in Alberta, Quebec and Saskatchewan, although variation exists in the currency of the data, time to obtain data, approval requirements and insurance coverage eligibility. As Canada moves towards a life-cycle management approach to drug regulation, more post-marketing studies will be required, potentially using administrative data. Linked patient-level drug and healthcare data are presently accessible to pharmaceutical industry researchers in four provinces, although only logistically realistic in three and limited to seniors and low-income individuals in two. Collaborative endeavours to improve access to provincial data and to create other data resources should be encouraged. (c) 2009 John Wiley & Sons, Ltd.

  2. In vitro drug release study of methacrylate polymer blend system: effect of polymer blend composition, drug loading and solubilizing surfactants on drug release.

    PubMed

    Li, Jun; Barrow, David; Howell, Holly; Kalachandra, Sid

    2010-02-01

    The application of polymers as the drug delivery systems for treating oral infections is a relatively new area of research. The present study was to test the release of the antibacterial drug chlorhexidine diacetate (CHDA), the antifungal drug Nystatin (NYS) and the antiviral drug acyclovir (ACY) from polymer blends of poly(ethyl methacrylate) and poly(n-hexyl methacrylate) of different compositions. The effects of polymer blend composition, drug loading and solubilizing surfactants on the release of the drugs have been studied. Measurements of the in vitro rate of drug release showed a sustained release of drug over extended periods of time. Drug release rates decreased with increasing PEMA content in polymer blends. CHDA release rates increased steadily with increasing drug load. The drug release rates increased with the addition of surfactants. This study demonstrates that the three therapeutic agents show a sustained rate of drug release from polymer blends of PEMA and PHMA over extended periods of time. By varying polymer blend compositions as well as the drug concentration (loading), it is possible to control the drug release rates to a desired value. The drug release rate is enhanced by addition of surfactants that solubilize drugs in the polymer blends.

  3. Drug abuse in Nepal: a rapid assessment study.

    PubMed

    Chatterjee, A; Uprety, L; Chapagain, M; Kafle, K

    1996-01-01

    A rapid assessment of drug abuse in Nepal was conducted at different sites, including eight municipalities in the five development regions of the country. To interview various groups of key informants, such methods as semi-structured interviews, in-depth interviews and focus group discussions were used. A snowball sampling strategy for respondents who were drug abusers and a judgemental sampling strategy for the non-drug-using key informants were applied. About one fifth of the sample was recruited from the treatment centres and the rest from the community. Drug abusers in prison were interviewed, and secondary data from treatment centres and prisons analysed. The study revealed that the sample of drug abusers had a mean age of 23.8 years and was overwhelmingly male. Most respondents lived with their families and were either unemployed or students. About 30 per cent of the sample was married. A large majority of the sample had a family member or a close relative outside the immediate family who smoked or drank alcohol and a friend who smoked, drank or used illicit drugs. Apart from tobacco and alcohol, the major drugs of abuse were cannabis, codeine-containing cough syrup, nitrazepam tablets, buprenor-phine injections and heroin (usually smoked, rarely injected). The commonest sources of drugs were other drug-using friends, cross-border supplies from India or medicine shops. The commonest source of drug money was the family. There has been a clear trend towards the injection of buprenorphine by abusers who smoke heroin or drink codeine cough syrup. The reasons cited for switching to injections were the unavailability and rising cost of non-injectable drugs and the easy availability and relative cheapness of injectables. About a half of the injecting drug users (IDUs) commonly reported sharing injecting equipment inadequately cleaned with water. Over a half of IDUs reported visiting needle-exchange programmes at two of the study sites where such programmes were

  4. Study of Dynamic Characteristics of Aeroelastic Systems Utilizing Randomdec Signatures

    NASA Technical Reports Server (NTRS)

    Chang, C. S.

    1975-01-01

    The feasibility of utilizing the random decrement method in conjunction with a signature analysis procedure to determine the dynamic characteristics of an aeroelastic system for the purpose of on-line prediction of potential on-set of flutter was examined. Digital computer programs were developed to simulate sampled response signals of a two-mode aeroelastic system. Simulated response data were used to test the random decrement method. A special curve-fit approach was developed for analyzing the resulting signatures. A number of numerical 'experiments' were conducted on the combined processes. The method is capable of determining frequency and damping values accurately from randomdec signatures of carefully selected lengths.

  5. Utilization of micellar electrokinetic chromatography-tandem mass spectrometry employed volatile micellar phase in the analysis of cathinone designer drugs.

    PubMed

    Švidrnoch, Martin; Lněníčková, Ludmila; Válka, Ivo; Ondra, Peter; Maier, Vítězslav

    2014-08-22

    A micellar electrokinetic chromatography method with tandem mass spectrometry has been developed for the selective separation, identification and determination of twelve new designer drugs from the group of synthetic cathinones. Ammonium salt of perfluorooctanoic acid at various concentrations as a volatile background electrolyte (BGE) to create micellar phase was studied for separation of selected synthetic cathinones with direct tandem mass spectrometry without significant loss of detection sensitivity. The optimized BGE contained 100 mM perfluorooctanoic acid with 200 mM ammonium hydroxide providing acceptable resolution of studied drugs in the MEKC step. In order to minimize interferences with matrix components and to preconcentrate target analytes, solid phase extraction was introduced as a clean-up step. The method was linear in the concentration range of 10-5000 ng mL(-1) and the limits of detection were in the range of 10-78 ng mL(-1). The method was demonstrated to be specific, sensitive, and reliable for the systematic toxicological analysis of these derivatives in urine samples.

  6. A mechanistic model for drug release from PLGA-based drug eluting stent: A computational study.

    PubMed

    Naghipoor, Jahed; Rabczuk, Timon

    2017-09-08

    Atherosclerosis in the coronary artery is one of the leading causes of death in the world. The stenting as a minimally invasive technique was considered as an effective tool to reduce the severity of atherosclerotic stenosis. In-stent restenosis is the main drawback of the stenting in the coronary artery. Understanding the mechanism of drug release from drug-eluting stents and drug uptake in the arterial wall and obtaining more information about their functionality using mathematical modeling and numerical simulation, could be considered as a predictive tool to investigate in-stent restenosis growth which is experimentally expensive to study. In this work, the local delivery of a therapeutic agent from a PLGA-based bioabsorbable stent implanted in a coronary artery to predict the drug release as well as spatio-temporal drug distribution in a coronary artery with a vulnerable plaque is mathematically modeled and numerically simulated. The effect of copolymer ratio on drug release has been also investigated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Drug taking beliefs of Australian adolescents: a pilot study.

    PubMed

    Skrzypiec, Grace; Owens, Laurence

    2013-01-01

    In this study adolescents offered their insights and perspectives of factors associated with adolescent illicit drug taking intentions. The factors explored were identified using a cross-disciplinary approach involving the Theory of Planned Behavior (TPB) and criminological theories, and these formed the framework for data analysis. Interviews with 24 students aged 15-17 found that adolescents' beliefs to drug taking attitudes, subjective norms, perceived behavioral control, moral norms, negative affect, and reputation enhancement involved a number a sub-themes that provided an in-depth understanding of the association of these components to intended drug use. The incorporation of these elements in drug education programs could be an effective approach in prevention interventions for adolescent drug use.

  8. A 2013 workshop: vaccine and drug ontology studies (VDOS 2013).

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2014-03-20

    The 2013 "Vaccine and Drug Ontology Studies" (VDOS 2013) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have contributed to dramatic improvements in public health worldwide. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, as well as developing new models such as Vaccine Ontology. The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The six full-length papers included in this thematic issue focuses on three main areas: (i) ontology development and representation, (ii) ontology mapping, maintaining and auditing, and (iii) ontology applications.

  9. Emergency Department Frequent Utilization for Non-Emergent Presentments: Results from a Regional Urban Trauma Center Study

    PubMed Central

    2016-01-01

    Objectives First, to test a model of the drivers of frequent emergency department utilization conceptualized as falling within predisposing, enabling, and need dimensions. Second, to extend the model to include social networks and service quality as predictors of frequent utilization. Third, to illustrate the variation in thresholds that define frequent utilization in terms of the number of emergency department encounters by the predictors within the model. Data Source Primary data collection over an eight week period within a level-1 trauma urban hospital’s emergency department. Study Design Representative randomized sample of 1,443 adult patients triaged ESI levels 4–5. Physicians and research staff interviewed patients as they received services. Relationships with the outcome variable, utilization, were tested using logistic regression to establish odds-ratios. Principal Findings 70.6 percent of patients have two or more, 48.3 percent have three or more, 25.3 percent have four or more, and 14.9 percent have five or more emergency department visits within 12 months. Factors associated with frequent utilization include gender, race, poor mental health, mental health drugs, prescription drug abuse, social networks, employment, perceptions of service quality, seriousness of condition, persistence of condition, and previous hospital admittance. Conclusions Interventions targeting associated factors will change global emergency department encounters, although the mutability varies. Policy interventions to address predisposing factors such as substance abuse or access to mental health treatment as well as interventions that speak to enabling factors such as promoting the resiliency of social networks may result in decreased frequency of emergency department utilization. PMID:26784515

  10. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    PubMed

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  11. Biochemical Studies on the Mechanism of Drug Action.

    DTIC Science & Technology

    The primary objectives of this research project were to study the mechanism of action of three common drugs, theophylline, acetylsalicylic acid and diphenylthiohydantoin (DPTH), in normal and thiamin deficient rats.

  12. Bibliometric Analysis of Medication Errors and Adverse Drug Events Studies.

    PubMed

    Huang, Hung-Chi; Wang, Cheng-Hua; Chen, Pi-Ching; Lee, Yen-Der

    2015-07-31

    Medication errors and adverse drug events are a key concern of the health-care industry. The objectives of this study were to map the intellectual structure of the studies of medication errors and adverse drug events and to investigate the developing path of this literature and interrelationships among the main topics. The Web of Science database was searched for documentation of medication errors and adverse drug events from 1961 to 2013. The most cited articles and references were profiled and analyzed using HistCite software to draw a historiograph and Ucinet software to draw a sociogram. The database search revealed 3343 medication errors and 3342 adverse drug event documents. The most cited articles on medication errors focused on 3 key themes from 1961 to 2013, namely, medication errors in adult inpatients, computerized physician order entry in medication error studies, and medication errors in pediatric inpatients. The developing path for the most cited articles about adverse drug events from 1987 to 2013 was as follows: detection, analysis, effect, and prevention from adult inpatient to pediatric inpatient settings and from hospitalized care to ambulatory care. In addition, social network analysis based on the most cited references revealed a close relationship between medication errors and adverse drug events. The mapping results provide a valuable tool for researchers to access the literature in this field and can be used to help identify the direction of medication errors and adverse drug events research.

  13. Evaluation of gliadins nanoparticles as drug delivery systems: a study of three different drugs.

    PubMed

    Duclairoir, C; Orecchioni, A-M; Depraetere, P; Osterstock, F; Nakache, E

    2003-03-06

    In this paper, biopolymer nanoparticles are studied, which unlike many synthetic carriers used for controlled release, are biocompatible and biodegradable systems. Gliadins nanoparticles are obtained by a desolvatation method, also known as drawning-out precipitation. These particles have been shown to be interesting as drug release systems for all-trans-retinoic acid. The aim of this paper was to study the influence of the polarity of different drugs on nanoparticle characteristics such as size and drug loading efficiency. Three drugs of three different polarities were studied: the hydrophobic Vitamin E (VE), the slightly polar mixture of linalool and of linalyl acetate (LLA) and the cationic amphiphilic benzalkonium chloride (BZC). This comparative work shows that the amount of the entrapped VE and LLA is higher than that of the cationic BZC, confirming a strong interaction between gliadins and apolar compounds, due to the apolarity of the proteins. This interaction results in a low diffusion coefficient and a partition coefficient in favour of gliadins, resulting in a low permeability coefficient. The drug release kinetics of two substances, LLA and BZC, are observed, in showing a burst effect, then a diffusion process, which can be modelled assuming that the particles are homogeneous spheres.

  14. Can Utilizing a Computerized Provider Order Entry (CPOE) System Prevent Hospital Medical Errors and Adverse Drug<