(2002; 166 pages)
Sources of information for regulators
Dr Benjamin Kwame Botwe, Ghana
Countries should broaden safety monitoring to include medical devices, traditional medicines, homoeopathic medicines, natural health products, lifestyle drugs, rationality of drug use (medication error, poor dispensing practices), and drug quality defects, such as counterfeit drugs.
A multisectoral approach to safety monitoring should be encouraged. Industry, academia, other regulatory bodies, health care professionals, technical agencies such as drug information centres and poisons control centres, consumer groups and patient groups should be involved locally, while international partners, such as WHO/UMC, CIOMS, ICH and other national regulatory agencies should also be involved.
Countries should develop and institutionalize outcome evaluation, feedback mechanisms, appropriate monitoring mechanisms, and success indicators for safety intervention. WHO, together with its Collaborating Centre for International Drug Monitoring, should develop guidelines and assist countries to develop systems for outcome evaluation.