[Pharmacovigilance IV. The institutional experience]

The main purpose of this fourth paper of the pharmacovigilance series proposes to communicate the institutional experience during the year 2003 represented by 890 adverse drug reaction reports (ADRs) and to compare these with the international experience. The therapeutic drug classes more frequently included in these reports were antibiotic and antiparasitic drugs (38.2%) followed by oncologic (17.7%), analgesic (16.6%), and cardiologic drugs (7.1%), among others; the drug most frequently implicated in the reports was sulfamethoxazole-trimethoprim (12%). In addition, we processed data ascertain the 10 drugs most frequently implicated in each therapeutic class, including vaccines and toxoid-group ADRs; using the body system-organ classification, the 20 clinical manifestations most frequently reported are presented herein, skin the most frequently affected organ (874 reports). In relation to severity of suspected adverse drug reactions reported, 68.7% were mild, 26.4% moderate, 3.9% severe, and 0.8%, lethal. This article also includes causality assessment results, quality of information contained in the reports, and patient consequences. After reviewing the results of both the International Drug Monitoring Programme and the Institutional Program during the year 2003, it is possible to conclude that comparisons are similar.