Consumer Adverse Drug Reaction Reporting: A New Step in Pharmacovigilance?

Authors: van Grootheest K.¹; de Graaf L.¹; Berg L.T.W.d.J-v.d.²

Source: Drug Safety, Volume 26, Number 4, 2003 , pp. 211-217(7)

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Abstract:

The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports.

We present an overview of experiences with consumer reporting in various countries of the world. The potential contribution of patient reports of adverse drug reactions is discussed, both in terms of their qualitative and quantitative contribution. The crucial question is one of whether patient reports will increase the number and quality of the reports submitted and/or lead to a more timely detection of signals of possible adverse reactions, thus contributing to an enhancement of the existing methods of drug safety monitoring. To date, the data available are insufficient to establish such added value.

Keywords: Adverse reaction monitoring

Document Type: Research article

Affiliations: 1: 1 Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands 2: 2 Department of Social Pharmacy and Pharmacoepidemiology, Groningen University Institute for Drug Exploration, Groningen, The Netherlands

Publication date: 2003-01-01