What Can Consumer Adverse Drug Reaction Reporting Add to Existing Health Professional-Based Systems?: Focus on the Developing World

Authors: Fernandopulle R.B.M.; Weerasuriya K.

Source: Drug Safety, Volume 26, Number 4, 2003 , pp. 219-225(7)

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Abstract:

The current system of pharmacovigilance encourages reporting of adverse drug reactions (ADRs) mainly from healthcare professionals. Underreporting is a major problem, more so in the developing world than in the developed world. Less than 3% of reports added to the WHO database in the year 2000 originated from developing countries, although around 80% of the global population lives in the developing world. Also a considerable time lag still exists in recognition of serious ADRs. Hence, there is a need for a different approach to pharmacovigilance.

We present an overview of possible reasons for underreporting by healthcare professionals with particular emphasis on the developing world, and the potential benefits of encouraging consumer reporting. Only a few countries accept consumer reports. We suggest an independent consumer reporting system for hypothesis generation to complement the present health professional-based system. We also highlight the low priority given by multinational pharmaceutical companies to the developing countries regarding new safety information.

The important questions are whether the resources available would be sufficiently robust to sustain such a system in the developing world, and whether it will be sufficiently robust and sensitive for the early detection of signals.@SUMMARY TEXT =

Keywords: Adverse reaction monitoring

Document Type: Research article

Affiliations: 1: Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka

Publication date: 2003-01-01