History of WHO Programme - Global Monitoring

SIGNAL GENERATION

WHO Programme - Global Monitoring

HISTORY

The Programme was established in 1968 as a pilot project with the participation of 10 countries that had organised national pharmacovigilance systems at that time. The intent was to develop international collab-oration to make it easier to detect rare adverse drug reactions (ADRs) not revealed during clinical trials. The international drug monitoring centre was moved from the World Health Organisation (WHO) head-quarters in Geneva, Switzerland, to a WHO Collab-orating Centre for International Drug Monitoring in Uppsala, Sweden, in 1978. This was the result of an agreement between WHO and the government of Sweden by which Sweden assumed the operational responsibility for the Programme. WHO headquarters, Geneva, retained the responsibility for policy matters. The WHO Collaborating Centre is often referred to as the Uppsala Monitoring Centre (UMC).

It is easiest to record the history of pharmacovigilance as a series of milestones that led to the introduction of new concepts or the re-thinking of old concepts within the discipline. A chronological list of these milestones is listed in Table 12.1. It is interesting to note that up to and including the benoxaprofen (‘Opren’) incident in 1989, changes in drug safety procedures were imple-mented as a result of drug disasters that had a high media profile. The responses to these disasters constituted a major re-thinking of drug safety issues. Since the benoxaprofen incident, there have been many drug withdrawals related to safety issues, but these have been managed much more effectively and expeditiously. It may seem that we now have safety systems in place that enable effective action to be taken globally before disturbing numbers of patients are affected. However, it is ironic that the pill scare in the United Kingdom may have caused more distress because of a rapid regulatory response to a safety issue. Since the benoxaprofen inci-dent, the main changes made in pharmacovigilance have been proactive improvements involving fine-tuning of regulatory systems and the adoption of better epidemi-ological techniques often associated with improve-ments in information technology (IT). Recently, the withdrawal of the COX2 receptor inhibitor rofecoxib (Vioxx) has led to more criticism of both the regulatory authorities as well as industry. Chief amongst these is the slow action taken over the suspicion of an increase in cardiovascular events. Because this problem is thought to be due to the COX inhibition, it is very complex because of the variable amounts of COX selectivity of older NSAIDS as well as many other new drugs with the attribute of COX2 receptor selectivity. Moreover, there is concern that the COX2 drugs may not produce the wanted reduction in gastrointestinal bleeding thought to result from selectivity (Edwards, 2005a).