Adverse reactions to the ten most reported drugs in Matanzas 2014-2017

Abstract

Background: drugs toxicity is complex and of difficult assessment, due to the quantity of factors intervening in its production, like emergency way, duration, and seriousness of the adverse reactions.  The importance of these reactions is given by the frequency and seriousness a drug or a drug family produces them. Material and methods: descriptive, observational study of a series of cases in pharmacovigilance. The universe was the adverse reactions of the ten drugs most reported by the Provincial Coordinating Unit of Pharmacovigilance in the period 2014-2017. The studied variables were: drugs, pharmacological group, demographic data, health care level, kind of adverse effect, intensity, imputability and frequency.
Results: ten drugs were reported with 2 216 reactions. The pentavalent vaccine was the most reported one, with 17.6 %, followed by amoxicillin and penicillin. There was a predominance of the female sex with 1 279 reports (59.1 %), and adult people with 1 010 reports (46.6 %). The highest number of reports was made by the primary health care, 2 082 (96.1 %). The main reactions were skin rash, fever and urticaria. There was a predominance of mild reactions: 1 972 reports (91.1 %); reactions classified as probable: 1 887 reports (87.1 %): ands frequent ones: 1 284 reports (59.2 %).
Conclusions: the pharmacovigilance system in the province systematically provided information on drugs´ safeness that allowed knowing the benefit-risk relation of the medicines that are in the market, and also which are the most used ones.