ABSTRACT
Records the proceedings of an international conference convened to consider mechanisms for improving international cooperation in the surveillance of drug safety and the reporting of adverse reactions. Attended by close to 200 representatives of regulatory authorities and the pharmaceutical industry as well as clinical pharmacologists, the conference aimed to identify the strengths and weaknesses of existing mechanisms for international cooperation and to propose improvements for the future. The conference, which marked the 25th anniversary of the World Health Organization's programme for international drug monitoring, also responded to a number of new challenges created by the use of biotechnology to develop novel products, and the recently discovered importance of genetically determined differences in drug metabolism. Papers are grouped according to the five main sessions of the conference. The first, focused on the past twenty-five years of drug surveillance, provides a history of key developments in the monitoring and reporting of adverse drug reactions, emphasizing lessons learned from different national and international systems for collecting, interpreting, and communicating data. Papers in the econd part, on methodological approaches, describe and compare various mechanisms for supervising drugs on the market and alerting regulatory authorities and prescribers to adverse reactions. Part three reports on projects under way to harmonize the reporting of adverse drug reactions and develop a single, universal terminology. Various efforts to standardize definitions and classification systems are described in detail. Part four examines responses to several enduring problems, including the need to educate physicians and patients, the special challenge of safety monitoring of vaccines and other biologicals, and the difficult problems encountered in developing countries. These are illustrated through examples of efforts to monitor the safety of drugs used to treat malaria, onchocerciasis, and tuberculosis. Papers from the final session explore the many practical, legal, and ethical issues surrounding access to information and the decision to release data about drug risks to patients and the public
