Do drug-related safety warnings have the expected impact on drug therapy? A systematic review.
contraindications
drug interactions
drug-related side effects and adverse reactions
pharmacoepidemiology
pharmacovigilance
risk assessment
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
13
08
2019
revised:
22
11
2019
accepted:
28
01
2020
pubmed:
12
2
2020
medline:
19
3
2021
entrez:
12
2
2020
Statut:
ppublish
Résumé
The need for drug-related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case-control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the "psychotropic drugs" group (23%) than in the "others" group (53%). Drug-related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
229-251Informations de copyright
© 2020 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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