Events such as the thalidomide tragedy highlight the extreme importance of effective drug monitoring systems for all medicines. The principal aims of pharmacovigilance programmes are:

• to improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions;

• to improve public health and safety in relation to the use of medicines;

• to contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use;

• to promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public.

Over the last decade, it has been increasingly recognized that the scope of pharmacovigilance needs to be extended beyond the strict confines of detecting new signals of safety concerns. Globalization, consumerism, the resulting explosion in free trade and communication across borders, and increasing use of the Internet have all contributed to a change in the way people access medicinal products and information about them. These changing patterns in drug use require a shift in the approach to pharmacovigilance, more specifically, towards one that is more closely linked, and thus better able to respond, to the prevailing patterns of drug use within society.