FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes.
Decision Making, Organizational
Drug Labeling
/ legislation & jurisprudence
Drug Prescriptions
/ statistics & numerical data
Drug Utilization
/ statistics & numerical data
Humans
Information Dissemination
/ methods
Risk Evaluation and Mitigation
/ legislation & jurisprudence
Treatment Outcome
United States
United States Food and Drug Administration
/ legislation & jurisprudence
drug safety
labeling change
postmarketing
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
04
09
2019
revised:
25
03
2020
accepted:
02
06
2020
pubmed:
14
8
2020
medline:
3
7
2021
entrez:
14
8
2020
Statut:
ppublish
Résumé
Prior literature reviews have identified gaps in understanding of how postmarketing safety labeling changes and related FDA communications impact key clinical and behavioral outcomes. We conducted a review of newly published studies on this topic to determine what new evidence exists and to identify which gaps may still remain. We believe that this information can support FDA as it develops and implements future risk communication approaches. We searched PubMed and Embase for studies published between January 1, 2010, and August 7, 2017 that examined the impact of labeling changes or associated FDA safety-related communications. For each study, we extracted information on research design and findings for key clinical outcomes and behaviors. We also conducted a ROBINS-I review to identify potential for bias in the research design of each study. We found that the estimated impacts of FDA labeling changes on several key outcomes-including adverse events-varied. Labeling changes also yielded unintended consequences on drug prescribing in some cases, despite low provider adherence. Finally, some studies we reviewed exhibited potential for bias due to confounding, among other factors. The new studies we reviewed contain many of the same limitations identified in previously published reviews. While there are several challenges to conducting this research there is substantial room for improvement in the quality of the evidence base. More information, particularly with respect to the types of populations and medications affected by labeling changes, is needed to support the development of more effective and targeted safety communications.
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1022-1029Subventions
Organisme : FDA HHS
ID : 7U19FD004971-04
Pays : United States
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
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