Review of National Spontaneous Reporting Schemes
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Adv Drug React Toxicol Rev 2002; 21 (4): 231-241 0964-198X/02/0004-0231/$25.00/0 © Adis International Limited. All rights reserved.
Review of National Spontaneous Reporting Schemes Strengths and Weaknesses M. Louise Hughes, Cate M.C. Whittlesea and David K. Luscombe The Welsh School of Pharmacy, Cathays Park, Cardiff, Wales, UK
Abstract
Objective: To investigate and compare the operation of different national spontaneous reporting schemes for adverse drug reactions. Design: Drug safety agencies in 18 countries were contacted by letter to request information about their spontaneous reporting scheme for adverse drug reactions. This information related to the background of the scheme, operational aspects of the scheme and numbers of reports received. Results: Replies were received from 12 countries. Many differences were found between the schemes operating in different countries. Some schemes had been in operation for over 30 years, while others were more recently established. While most schemes rely on voluntary reports, in two countries (France and Spain), reporting is a legal requirement for healthcare professionals. Reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. There were also differences in the types of reactions for which reports are requested, and the products covered by the schemes. In some countries (e.g. Denmark) reports of all reactions are sought, while other countries focus on only serious reactions or reactions to newly marketed products. In Australia, there is a separate scheme for drug-induced congenital malformations and Canada, South Africa and the US run separate schemes for reactions to vaccines. However, other countries include these reactions in the general spontaneous reporting schemes. The numbers of reports received by the countries also varies considerably – from a few hundred each year in South Africa to over 20 000 in the US. Conclusions: While the schemes all operate on the basic principle of collecting reports of adverse reactions to identify potential hazards, they showed many different approaches to the spontaneous reporting of adverse drug reactions. Features of one scheme may serve to improve reporting rates for another. In addition, all 12 countries participate in the World Health Organization International Drug Monitoring Programme, thus helping to inform the whole international community of drug safety problems.
All drugs undergo extensive testing prior to marketing. However, the small numbers of patients involved mean that it is unlikely that all potential adverse drug reactions will be observed. It is there-
fore important that monitoring takes place once the drug is in use among the general population. As a result of the thalidomide tragedy, in the 1960s a number of countries, including the UK, set up
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spontaneous reporting schemes for the monitoring of adverse drug reactions.[1] Since then, many further countries have established ad
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