Problems and possibilities of spontaneous adverse reaction reporting systems

Abstract

Since 1970 the World Health Organization has maintained an international centre for the monitoring of adverse reactions to drugs, based on standardized methods and instruments and with input from a large group of participating countries. The method of spontaneous reporting by health professionals of suspected adverse effects, on which the WHO venture is based, is intended to accelerate the detection of side effects and to provide a constantly updated picture of their profile. Despite setbacks, it has moved steadily closer to the attainment of this ideal. Operation of such a system involves problems relating to confidentiality, the setting of priorities, availability of background information and funding; if input from the medical profession is to be greater and of better quality, both undergraduate and post-graduate training will have to attune the doctor better to this task. A complementary responsibility clearly devolves on the pharmaceutical industry. At the national level there must be an efficient monitoring centre, capable of interfacing physicians on the one hand and with WHO on the other.