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Marketed Drugs (marketed + drug)
Selected AbstractsDeveloping an optimal approach to global drug safetyJOURNAL OF INTERNAL MEDICINE, Issue 4 2001R. Balkrishnan Abstract.,Balkrishnan R, Furberg CD (Wake Forest University School of Medicine, Winston-Salem, NC, USA). Developing an optimal approach to global drug safety (Review). J Intern Med 2001: 250; 271,279. An increasing number of media reports on a number of marketed drugs withdrawn because of harmful effects, a scientific report on epidemic proportions of serious adverse drug reactions in hospitalized patients, and a disturbing report on medical mistakes that includes medication errors have recently all brought drug safety into intense focus and placed it under greater scrutiny. Concerted efforts are now being made to understand the causes of drug safety problems and to find ways to reduce their frequency. An international symposium, ,Developing an Optimal Approach to Drug Safety' was held at Wake Forest University in the Fall of 2000 to identify the issues and solutions to extant problems in this area. This report summarizes the resulting discussions of global postmarketing surveillance initiatives and describes efforts to reduce medication errors, and improve global communication about drug safety. [source] Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980,1999,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2002James Cross MS Abstract Purpose Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time. Methods We compiled a list of NMEs approved by FDA from 1 January 1980 to 31 December 1999 using FDA's website, Freedom of Information Act request, and PhRMA (Pharmaceutical Research and Manufacturers of America) database. Original labeled dosages and indicated patient populations were tracked in labels in the Physician's Desk Reference®. Time and covariate-adjusted risks for dosage changes by 5-year epoch and therapeutic groups were estimated by survival analysis. Results Of 499 NMEs, 354 (71%) were evaluable. Dosage changes in indicated populations occurred in 73 NMEs (21%). A total of 58 (79%) were safety-motivated, net dosage decreases. Percentage of NMEs with changes by therapeutic group ranged from 27.3% for neuropharmacologic drugs to 13.6% for miscellaneous drugs. Median time to change following approval fell from 6.5 years (1980,1984) to 2.0 years (1995,1999). Contrary to our premise, 1995,1999 NMEs were 3.15 times more likely to change in comparison to 1980,1984 NMEs (p,=,0.008, Cox analysis). Conclusions Dosages of one in five NMEs changed, four in five changes were safety reductions. Increasing frequency of changes, independent of therapeutic group, may reflect intensified postmarketing surveillance and underscores the need to improve pre-marketing optimization of dosage and indicated population. Copyright © 2002 John Wiley & Sons, Ltd. [source] Prospective cohort study of adverse events monitored by hospital pharmacistsPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2001Angela Emerson BPharm, MRPharmS Abstract Purpose To examine the feasibility of pharmacist-led intensive hospital monitoring of adverse events (AEs) associated with newly marketed drugs. Subjects/setting 303 patients admitted to Southampton Hospitals who were prescribed selected newly marketed drugs during their inpatient stay in 1998. Methods Prospective observational study. Patients were identified from computerized pharmacy records, clinical pharmacist ward rounds, dispensary records or via nursing staff. The pharmacist reviewed medical notes and recorded AEs, suspected adverse drug reactions (ADRs) and reasons for stopping drugs. Outcomes Incidence of AEs, ADRs; proportionate agreement between the physician's and pharmacist's event recording. Results 303 patients were monitored. Of the patients taking newly marketed drugs 92% were identifiable using pharmacy computer systems and pharmacist ward visits. There were 21 (7%) suspected ADRs detected during this pilot study. The types of adverse events detected were broadly similar to those identified by general practice-based prescription event monitoring. However, biochemical changes featured more frequently than in general practice. Differences between adverse events recorded by pharmacist and physician were systematic and attributed to differences in event coding. Conclusion Pharmacist-led monitoring in a typical NHS hospital setting was effective at detecting ADRs in newly marketed drugs. However, this effort might have been substantially less time-consuming and more effective were electronic patient records (EPRs) available. Pharmacy computer systems are not designed to be patient focused and are therefore unable to identify patients taking newly marketed drugs. It is argued that future EPR and computerised patient-specific prescribing systems should be designed to capture this data in the same way as some US systems are currently able to do. Copyright © 2001 John Wiley & Sons, Ltd. [source] False Discovery Rate Estimation for Frequentist Pharmacovigilance Signal Detection MethodsBIOMETRICS, Issue 1 2010I. Ahmed Summary Pharmacovigilance systems aim at early detection of adverse effects of marketed drugs. They maintain large spontaneous reporting databases for which several automatic signaling methods have been developed. One limit of those methods is that the decision rules for the signal generation are based on arbitrary thresholds. In this article, we propose a new signal-generation procedure. The decision criterion is formulated in terms of a critical region for the P-values resulting from the reporting odds ratio method as well as from the Fisher's exact test. For the latter, we also study the use of mid-P-values. The critical region is defined by the false discovery rate, which can be estimated by adapting the P-values mixture model based procedures to one-sided tests. The methodology is mainly illustrated with the location-based estimator procedure. It is studied through a large simulation study and applied to the French pharmacovigilance database. [source] | ||||||||||