Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study.

Abstract

Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment. The primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports. All ADR reports sent by GPs to the Midi-Pyrénées Regional Pharmacovigilance Center (Toulouse, France) from 1January 2010 to 31December 2013 were reviewed. Healthcare professionals and patients can forward an ADR using either an online form through the Pharmacology Information Bulletin website ( http://www.bip31.fr ) or 'traditional' ADR reports (i.e. email, letter or fax). According to information provided in ADR reports (i.e. patient identification, ADR, date of occurrence, clinical description, drugs, etc.), reports were classified into three groups: 'well-documented', 'slightly documented' or 'poorly documented'. A multivariate logistic regression was performed to investigate potential factors associated with a 'well-documented' ADR report. During the study period, 613 ADR reports were analysed. Among these reports, only 12.7% were classified as 'well-documented', 68.5% as 'slightly documented' and 18.8% as 'poorly documented'. An association between a 'well-documented' ADR report and its 'seriousness' was found (odds ratio=1.70 [95% CI 1.04-2.76], p=0.01). No association between report completeness ('well-documented' report) and GP practice location or mode of ADR reporting was found. The study shows that only one out of eight ADR reports from GPs was 'well-documented'. Therefore, it appears to be important to promote further information being available regarding the data required in ADR reports to optimise the evaluation of drug causality.