Drug safety monitoring: an international perspective

The issue of drug safety must always be considered from the patient's perspective. Efforts in drug safety monitoring must seek to improve care and give prescribers and their patients with the best possible information to make a risk-benefit judgement. The concept of a 'signal' of an adverse reaction to a drug needs to be clearly understood, and the nature of the process to determine which signals become established 'adverse reactions' is important. Good clinical and pharmaco-epidemiological studies and insight are needed for the investigation of a signal. International cooperation utilising the WHO Programme for International Drug Monitoring and other organisations helps with the discovery, evaluation and dissemination of information on drug issues, but in the end it is the alert clinician who is both likely to spot new unexpected drug problems and have the individual patient knowledge to use drugs to their maximum benefit and minimal harm.