Revista Cubana de Medicina General Integral
On-line version ISSN 1561-3038
DEBESA GARCIA, Francisco et al. Principales resultados del sistema cubano de farmacovigilancia en el año 200. Rev Cubana Med Gen Integr [online]. 2003, vol.19, n.4, pp. 0-0. ISSN 1561-3038.
The functioning and main results of the Cuban Drug Surveillance System in the year 2001 at all the health care levels throughout the country are described. In that period, cases were identified by the Voluntary Notification of suspected adverse drug reaction System. The National Coordinating Unit of Drug Surveillance received 16 195 notes on Adverse Drug Reactions that included 33 601 suspected adverse drug reactions, for a notification rate of 1 447 reports per 1 000 000 pop.; 62% of adverse drug reactions were reported in females and 39,8% in males. Regarding the level of assistance, primary health care level is the one that presented more reports with 83,3% of the total amount. Results were encouraging in the year 2001 since the ratio of moderate and serious reactions to slight ones (59,2%/40,6%) is still favorable in relation to the VER.... Fatal outcome occurred in 33 reported reactions for 0,2%. The reports received in our unit allow us to quantify and characterize the Adverse Drug Reactions, additionally, they are very useful to issue warnings and surveil drug safety in our country.
Keywords : PHARMACEUTICAL PREPARATIONS [adverse effects]; PRODUCT SURVEILLANCE, POST MARKETING; DRUG EVALUATION; PHARMACOEPIDEMIOLOGY; ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG TOXICITY.