Impact of a New Consumer Form on the Quantity and Quality of Adverse Event Reports Submitted to the United States Food and Drug Administration.
Adverse Drug Reaction Reporting Systems
/ statistics & numerical data
Community Participation
/ methods
Databases, Factual
/ statistics & numerical data
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Humans
Interrupted Time Series Analysis
United States
United States Food and Drug Administration
FDA Adverse Event Reporting System
adverse drug reaction reporting systems
community participation
drug-related side effects and adverse reactions
postmarketing product surveillance
Journal
Pharmacotherapy
ISSN: 1875-9114
Titre abrégé: Pharmacotherapy
Pays: United States
ID NLM: 8111305
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
pubmed:
4
9
2019
medline:
25
7
2020
entrez:
4
9
2019
Statut:
ppublish
Résumé
Consumers and healthcare professionals can voluntarily report adverse experiences associated with drug products to the United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Consumers and healthcare professionals used the same general voluntary reporting form (GVR) until mid-2013, when a consumer voluntary reporting form (ConVR), written in plain language, was implemented. The objective of this study was to examine the effect of the ConVR on the quality and quantity of consumer reports submitted directly to FAERS. Descriptive; quasi-experimental. FAERS database. We identified all consumer and healthcare professional reports received directly by the FDA from January 1, 2011, through December 31, 2015. Report quality was defined by the completeness of 15 individual data fields and a structured tool measuring clinical documentation. An interrupted time series design was used to evaluate the impact on the quantity of consumer reports. Consumer reports submitted on the ConVR generally included more patient, product, and event data in the structured data fields than those submitted on the GVR. Fields with the greatest absolute percentage difference after the ConVR was introduced included race/ethnicity (+77.2%), product start and stop dates (+43% and +40.3%, respectively), dechallenge and rechallenge information (+19.1% and +29.4%, respectively), and medical history (+27%). Our structured assessment also classified more reports received on the ConVR as well documented relative to the GVR consumer reports (64.9% vs 37.8%, p<0.01). The time series model demonstrated an immediate increase of 499 consumer reports in the month following the ConVR's implementation (p<0.01). Our findings suggest that the ConVR has contributed positively to both the quality and quantity of consumer reports in FAERS.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1042-1052Informations de copyright
© 2019 Pharmacotherapy Publications, Inc.
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