دورية أكاديمية
Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks.
| العنوان: | Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle - a focus on benefits and risks. |
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| المؤلفون: | Bloem LT; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Pharmacovigilance department, Dutch Medicines Evaluation Board, Utrecht, The Netherlands., Karomi M; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., Hoekman J; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Pharmacovigilance department, Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands., van der Elst ME; Pharmacovigilance department, Dutch Medicines Evaluation Board, Utrecht, The Netherlands., Leufkens HGM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands., Klungel OH; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.; Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Mantel-Teeuwisse AK; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. |
| المصدر: | Expert opinion on drug safety [Expert Opin Drug Saf] 2021 Nov; Vol. 20 (11), pp. 1433-1442. Date of Electronic Publication: 2021 Jul 15. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101163027 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-764X (Electronic) Linking ISSN: 14740338 NLM ISO Abbreviation: Expert Opin Drug Saf Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2015- : Abingdon, Oxford : Taylor & Francis Original Publication: London : Ashley Publications, c2002- |
| مواضيع طبية MeSH: | Drug Approval/*legislation & jurisprudence , Drug Labeling/*legislation & jurisprudence , Drug and Narcotic Control/*legislation & jurisprudence , Drug-Related Side Effects and Adverse Reactions/*epidemiology, Cohort Studies ; European Union ; Government Agencies ; Humans ; Retrospective Studies ; Time Factors |
| مستخلص: | Background: Prior studies investigated regulatory actions that reflected a negative impact on drug risks. We aimed to evaluate occurrence of regulatory actions that reflected a negative or positive impact on benefits or risks, as well as relations between them. Research design and methods: We followed EMA-approved innovative drugs from approval (2009-2010) until July 2020 or withdrawal to identify regulatory actions. We assessed these for impact on benefits or risks and relations between actions. Additionally, we scrutinized drug lifecycles for time-variant characteristics that may contribute to specific patterns of regulatory actions. Results: We identified 14 letters and 361 label updates for 40 drugs. Of the label updates, 85 (24%) reflected a positive impact, mostly concerning indications, and 276 (76%) a negative impact, mostly adverse drug reactions. Many updates (54%) occurred simultaneously with other updates, also if these reflected a different impact. Furthermore, levels of patient exposure, innovativeness, needs for regulatory learning and unexpected risks may contribute to patterns of regulatory actions. Conclusions: Almost a quarter of regulatory actions reflected a positive impact on benefits and risks. Also, simultaneous learning about benefits and risks suggests an important role for drug development in risk characterization. These findings may impact regulatory analyses and decision-making. |
| فهرسة مساهمة: | Keywords: Drug regulation; European Medicines Agency; adverse effects; benefit-risk; clinical trials; drug lifecycle; pharmacovigilance; regulatory data |
| تواريخ الأحداث: | Date Created: 20210715 Date Completed: 20211103 Latest Revision: 20211103 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1080/14740338.2021.1952981 |
| PMID: | 34263667 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1744-764X |
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| DOI: | 10.1080/14740338.2021.1952981 |