Background Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Purpose The aim of this study is quantify and assess the suspected adverse drug reactions (ADRs) that occurred and related technical defects (TDs) with four types of drugs available in Brazil.
Materials and methods This descriptive, prospective and exploratory study was conducted January to December 2010 in a Public Tertiary Hospital (359 beds). Data involving adverse drug reactions and technical defects were collected in the Pharmacovigilance section of the hospital (ADR and TD notification form, internationally known as the ‘yellow card’). The information was acquired through multidisciplinary spontaneous (voluntary) reporting. The reactions were classified according to the mechanism of action, severity and causality (using the Naranjo algorithm). The drugs were classified according to their therapeutic class and the symptoms according to the organ involved. The technical defects were classified according to the type of quality deviation and the type of medicines available in the Brazilian market (branded, generic, ‘similar’ (Brazilian Class Drugs) and compounded drugs).
Results A total of 70 forms were examined. Adverse drug reactions accounted for 38.6% of yellow card reports, technical defects for 58.6% and two reports contained both (2.8%). The skin was the organ most affected (28.0%) and the therapeutic class mostly associated with ADRs was general anti-infectives for systemic use (40.7%). The largest category of patients to suffer from ADRs were the over 60s (29.7%), there was no important difference between the sexes (51.5% male). The most common adverse reactions were type B (74.0%), moderates (37.0%) and probables (55.6%). Generic drugs showed more technical defects (36.4%) the more common of which were breaks/cracks/leaks (20.9%) and lack of product inside drug packaging/ volume less than that reported in the label (20.9%).
Conclusions Every drug has a risk and besides detecting adverse events, it is essential to prevent them, mainly through monitoring by clinical/hospital pharmacists, and also for the drug control authority to ensure the quality.
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