An overview of spontaneous reporting of adverse drug reactions (ARDs) in Zimbabwe

Abstract

The deaths of over 100 people in 1937 in the USA from the ingestion of antifreeze used as a solvent for sulfanilamide and the foetal malformations of thalidomide in Europe in the 1960s resulted in the development of drug regulatory agencies as we know them today.1 These authorities licence medicines for the market using the criteria of safety, efficacy and quality. However, clinical trials are inefficient at determining safety since they involve relatively few, selected patients in controlled prescribing environments. It is necessary to monitor marketed medicines for safety under normal prescribing. This is post marketing surveillance or pharmacovigilance. Various systems are available ranging from compulsory reporting of adverse drug reactions (ADRs) through intensive hospital monitoring to spontaneous voluntary reporting.2 The latter, is more common since it is inexpensive and easy to* * implement whilst being useful in identifying uncommon ADRs.