[Pharmacovigilance IV. The institutional experience]. / Farmacovigilancia IV. La experiencia institucional.

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.

[Pharmacosurveillance III: international experience]. / Farmacovigilancia III. La experiencia internacional.

This article, the third of the series called pharmacovigilance, deals with international experience with adverse drug reactions. It highlights the countries with the greatest cumulative number of reports and how their position changes with the use of the country-adjusted number of reports by million of inhabitants/year. It includes, in decreasing order, the number of reports of twenty therapeutic drug classes. Included in each one are the most plausible explanations for their frequency and, finally, the cumulative number of reports for clinical manifestations of adverse drug reactions.