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Consistency in the safety labeling of bioequivalent medications
Pharmacoepidemiology and drug safety, 2013-03, Vol.22 (3), p.294-301
Duke, Jon
Friedlin, Jeff
Li, Xiaochun
2013
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Duke, Jon
Friedlin, Jeff
Li, Xiaochun
Titel
Consistency in the safety labeling of bioequivalent medications
Ist Teil von
Pharmacoepidemiology and drug safety, 2013-03, Vol.22 (3), p.294-301
Ort / Verlag
Chichester: Blackwell Publishing Ltd
Erscheinungsjahr
2013
Quelle
Wiley-Blackwell Journals
Beschreibungen/Notizen
ABSTRACT Purpose Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real‐world consistency of electronic labeling for bioequivalent drugs from different manufacturers. Methods Using natural language processing, we indexed the adverse drug reactions (ADRs) found in the Adverse Reactions and Post‐Marketing sections of 9105 structured product labels. We calculated the standard deviation in ADR labeling for each bioequivalent drug and the percent deviation of each generic label from its corresponding brand. We also analyzed the performance of individual generic manufacturers. For the 25 drugs with the greatest discrepancy in labeled ADRs, we performed manual review to identify causes of inconsistency. Results 68% of multi‐manufacturer drugs had discrepancies in ADR labeling. For a given drug, the mean deviation in number of labeled ADRs was 4.4, and the median was 0.8 (IQR 0 to 3.2). The mean range in number of labeled ADRs was 12 +/− 0.9, and the median was 2 (IQR 0 to 9). Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post‐marketing reports, and formatting issues. Conclusions Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels. Copyright © 2012 John Wiley & Sons, Ltd.
Sprache
Englisch
Identifikatoren
ISSN: 1053-8569
eISSN: 1099-1557
DOI: 10.1002/pds.3351
Titel-ID: cdi_proquest_miscellaneous_1314714287
Format
–
Schlagworte
Adverse Drug Reaction Reporting Systems - legislation & jurisprudence
,
Adverse Drug Reaction Reporting Systems - standards
,
adverse reactions
,
Biological and medical sciences
,
Clinical trial. Drug monitoring
,
Descriptive labeling
,
Drug and Narcotic Control - legislation & jurisprudence
,
Drug Industry - legislation & jurisprudence
,
Drug Industry - standards
,
drug labeling
,
Drug Labeling - legislation & jurisprudence
,
Drug Labeling - standards
,
drug safety
,
Drugs, Generic - adverse effects
,
Federal regulation
,
General pharmacology
,
generic medications
,
Guideline Adherence
,
Guidelines as Topic
,
Humans
,
Medical sciences
,
Natural Language Processing
,
Patient Safety
,
Pharmacoepidemiology
,
Pharmacology. Drug treatments
,
Prescription drugs
,
Risk Assessment
,
Risk Factors
,
Safety
,
Therapeutic Equivalency
,
United States
,
United States Food and Drug Administration - legislation & jurisprudence
,
United States Food and Drug Administration - standards
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