Ceará State Pharmacovigilance System: a year of experience

This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE) as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. SIFACE is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM), based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs) were processed, the majority among women (55.7%) and children (34.4%). Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

Pharmacovigilance; Pharmacoepidemiology; Drug Utilization; Drugs

Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz Rua Leopoldo Bulhões, 1480 , 21041-210 Rio de Janeiro RJ Brazil, Tel.:+55 21 2598-2511, Fax: +55 21 2598-2737 / +55 21 2598-2514 - Rio de Janeiro - RJ - Brazil
E-mail: cadernos@ensp.fiocruz.br