The Dawn of Pharmacovigilance

Abstract

This paper provides an anecdotal view from a Dutch perspective on some historical aspects of both the awareness and the systematic attention regarding adverse drug reactions in a period before the term ‘pharmacovigilance’ even existed. What we can learn from history is illustrated by the 1971 study by Lely, who discovered that 19 people died from digitalis intoxication, caused by a production error of the digitalis tablets. Observations of the symptoms of digitalis intoxication had been previously described in the 18th century by Whitering in his study on the foxglove. The Professor of Medicines, Van Doeveren provided another early example of awareness of adverse drug effects when he gave the academic lecture called Remedio Morbi in 1789 on diseases caused by treatment. This academic lecture was given attention by Meyler, who wrote his famous book on adverse drug reactions in 1951. His book Side Effects of Drugs is currently in its 14th edition and is still a standard work in this field. An early example of a systemic collection of adverse drug reactions occurred in the beginning of the 19th century when reactions were reported during a smallpox vaccination campaign in the Netherlands. Systematic attention to adverse drug reactions, including the collection of adverse drug reaction reports, was boosted by the so-called thalidomide disaster in the early 1960s. Since then, governments have started to organise national pharmacovigilance centres to prevent such a disaster happening again. The World Health Organization (WHO) has played an important role in developing this reporting of adverse drug reactions with its WHO International Drug Monitoring Program and the WHO Uppsala Monitoring Centre, which maintains the international database of adverse drug reactions. A comprehensive review of the history of pharmacovigilance is still to be written.