Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
DEBESA GARCIA, Francisco et al. Main results of the Cuban system of pharmacological surveillance system in 2004. Rev Cubana Farm [online]. 2005, vol.39, n.3, pp. 0-0. ISSN 1561-2988.
The main results achieved by the Cuban Pharmacological Surveillance System in the year 2004 were described. During these 12 months, the cases were identified by the voluntary notification system of suspected adverse reactions to drugs. The National Coordinating Unit of Pharmacological Surveillance (NCUPs) received 7 063 notifications that included 13 500 adverse drug reactions (ADR) at a rate of 1,9 ADR per notification. Of this amount, 3 185 were “important” for 35.1% (according to criteria of NCUPv and the Working Standards and Procedures of the Cuban Pharmacological Surveillance System to determine important ADR. The yearly notification rate was 628 per one million inhabitants. 64.6% of ADRs corresponded to the female sex and 35,4% to the male sex. Regarding the medical assistance level, the primary care notified 85% of ADRs, the highest figure. The ratio of slight to moderate and severe reactions was 48,3/51,4%, with very good balance for slight reactions in relation to severity. Twenty three reactions with fatal outcomes were reported, for 0.3% of the total. In spite of the reduction in the number of received notifications compared to the previous year, the notification rate is one of the highest among the member countries of the international ADR monitoring system. On the other hand, the quality of these notifications made it possible to quantify and characterize the adverse drug reactions, in addition that they were very useful for generating alerts and monitoring the safety of drugs circulating in our country.
Palabras llave : Adverse drug reactions.