Visacri Marília Berlofa, de Souza Cinthia Madeira, Sato Catarina Miyako Shibata, Granja Silvia, de Marialva Mécia, Mazzola Priscila Gava, Moriel Patricia
Department of Clinical Pathology, Faculty of Medical Sciences (FCM), State University of Campinas, Alexander Fleming, 105, Zip Code 13083-881 Campinas, SP, Brazil.
Hospital of Clinics of State University of Campinas (HC/UNICAMP), Vital Brasil, 251, Zip Code 13083-888 Campinas, SP, Brazil.
Saudi Pharm J. 2015 Apr;23(2):130-7. doi: 10.1016/j.jsps.2014.06.008. Epub 2014 Jul 2.
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.
本研究旨在确定巴西一家教学医院药物不良反应（ADR）自发报告的频率和概况以及质量偏差情况，并提出一种统一的分类方法来研究质量偏差。
这是一项描述性回顾性研究，涉及对2010年ADR自发报告和质量偏差的分析。ADR根据反应机制、严重程度和因果关系进行分类。药物根据治疗类别进行分类，症状根据受影响的器官进行分类。质量偏差根据偏差类型和巴西市场上可用药品的类型进行分类。
共检查了68份表格；ADR占报告的39.7%，而质量偏差占60.3%。ADR在男性（51.9%）和成年人（63.0%）中更频繁发生。皮肤（28.0%）是受影响最严重的器官，而抗感染药物（40.7%）是导致ADR最多的治疗类别。最常见的ADR是B型（74.0%）、中度（37.0%）和可能（55.6%）。关于质量偏差，最常见的报告是破损、裂开和泄漏（20.9%），且与仿制药有关（43.9%）。
用于研究质量偏差的分类系统清晰且一致。本研究表明，需要实施与更有效的药物警戒相关的实践和公共政策，以便增加自发报告的数量。
