Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/235831
Type: Artigo de periódico
Title: Adverse Drug Reactions And Quality Deviations Monitored By Spontaneous Reports.
Author: Visacri, Marília Berlofa
de Souza, Cinthia Madeira
Sato, Catarina Miyako Shibata
Granja, Silvia
de Marialva, Mécia
Mazzola, Priscila Gava
Moriel, Patricia
Abstract: The aim of this study was to determine the frequency and profile of spontaneous reports of Adverse Drug Reactions (ADRs) and quality deviations in a Brazilian teaching hospital and propose a consistent classification to study quality deviations. This is a descriptive and retrospective study involving the analysis of spontaneous reports of ADRs and quality deviations in 2010. ADRs were classified according to the reaction mechanism, severity, and causality. The drugs were classified according to their therapeutic classes and symptoms according to the affected organ. The quality deviations were classified according to the type of deviation and type of medicine available in the Brazilian market. A total of 68 forms were examined; ADRs accounted for 39.7% of the notifications, while quality deviations accounted for 60.3%. ADRs occurred more frequently in men (51.9%) and adults (63.0%). The skin (28.0%) was the most affected organ, while anti-infectives (40.7%) were the therapeutic class that caused the most ADRs. The most common ADRs were type B (74.0%), moderates (37.0%), and probables (55.6%). In relation to quality deviations, the most frequent notifications were breaks, splits and leaks (20.9%) and related to generic drugs (43.9%). The classification system to study quality deviations was clear and consistent. This study demonstrated that practices and public policies related to more effective pharmacovigilance need to be implemented so that the number of spontaneous reports increases.
Subject: Adverse Drug Reaction
Pharmacovigilance
Quality Deviation
Spontaneous Report
Citation: Saudi Pharmaceutical Journal : Spj : The Official Publication Of The Saudi Pharmaceutical Society. v. 23, n. 2, p. 130-137, 2015-Apr.
Rights: embargo
Identifier DOI: 10.1016/j.jsps.2014.06.008
Address: http://www.ncbi.nlm.nih.gov/pubmed/25972731
Date Issue: 2015
Appears in Collections:Unicamp - Artigos e Outros Documentos

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