Origins and definition of pharmacovigilance

In the beginning, there was thalidomide. It can be argued that the history of pharmacovigilance goes back further but, for practical purposes, the story of modern pharmacovigilance begins there. 

FIgura 1.1 Child affected by thalidomide-induced phocomelia. 

The overriding lesson learnt from thalidomide was that we cannot just wait until a drug safety problem, quite literally in this case, hits us between the eyes. So thalidomide led directly to the initial development of the systems we now have, although it is only quite recently (i.e. since the early 1990s) that the term pharmacovigi-lance has become widely accepted. 

Pharmacovigilance has been defined by the WHO as The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. There are other definitions but this very broad one seems to be the most appropriate since there is a clear implication that the process is one of risk management. This is a concept which is applicable to many 

The ramifications of the thalidomide tragedy were many-fold but the key lesson for the development of pharmacovigilance was that active systems for detecting hazards are needed. Within a few years this had been taken forward with the introduction of voluntary (or spontaneous ) schemes for reporting of suspected adverse drug reactions (ADRs). These have stood the test of time as an alerting mechanism or early warning system and wiU be covered in more detail in Chapter 3. 

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