El Sistema Cubano de Farmacovigilancia: seis a？os de experiencia en la detección de efectos adversos

the center for the development of pharmacological epidemiology has several working lines such as research, teaching, drug information, therapeutic consultation, program for the rational utilization of drugs (purmed) and drug surveillance with the national coordinating unit. the objective of this paper was to present the main working results achieved in 6 years after the creation of this drug surveillance system. a retrospective descriptive study was performed to characterize the reports of suspected adverse reactions from the national coordinating unit of drug surveillance. in the period, 89 540 notifications of adverse drug reactions were received for an average of 17 908 notifications per year, and a report rate of more than 1000 notifications per 1 million inhabitants. these results reflected a regular behaviour in some of these indicators like the predominance of adverse effects in females, affected skin and digestive system as the most reported reactions and the prevalence of antimicrobials, non-steroidal antinflammatory drugs and antihypertensive drugs as the pharmacological groups with more reactions. similarly, the number of less frequent adverse drug reactions has increased and serious adverse effects have been followed-up. drug surveillance continue to be a very dynamic scientific and clinical discipline worldwide, being indispensable to face the possible problems of an armory of drugs that does not cease to grow in potency and variety. therefore, it is necessary that, as soon as adverse effects or toxicity signs occur - mainly if they have not been yet classified - they must be notified and analyzed, and then the importance of the episode should be adequately reported to corresponding health professionals