Campus Centro-Oeste Dona Lindu (CCO), Federal University of São João Del-Rei (UFSJ), Divinópolis, Brazil.
J Eval Clin Pract. 2020 Jun;26(3):957-961. doi: 10.1111/jep.13233. Epub 2019 Jul 10.
RATIONALE, AIMS, AND OBJECTIVES: As a pharmacovigilance measure, the Brazilian Health Regulatory Agency (ANVISA) monitors the postmarketing events of medication and issues alerts on actions to be taken and information updates. The present study has the objective of analysing the profile of all the alerts on medication issued by ANVISA between 2006 and 2018.
A descriptive documentary analysis was carried out through the ANVISA website and double checked with two researchers in order to avoid discrepancies in data collection and interpretation of information.
A total of 79 alerts available in the period were analysed, the mean being 6.07 alerts/year and standard deviation of 3.81. The medications most cited in the alerts were antivirals (9.7%), followed by antidiabetics (7.3%) and contraceptives (7.3%). The main problems identified were adverse reactions (50%) and other problems related to safety (15%). The main actions directed by ANVISA were generation of a new contraindication (37.3%) and alteration in the package insert (22.3%).
Alerts are an important means of communicating new information to health professionals and to society. However, they need better standardization in order to facilitate understanding, dissemination in order to broaden access to information, and studies to corroborate the current literature and improve current pharmacovigilance.
背景、目的和目标：作为药物警戒措施，巴西卫生监管机构（ANVISA）监测药物上市后的事件，并发布有关应采取的行动和信息更新的警报。本研究旨在分析 2006 年至 2018 年期间 ANVISA 发布的所有药物警报的情况。
通过 ANVISA 网站进行描述性文献分析，并由两名研究人员进行双重检查，以避免数据收集和信息解释方面的差异。
共分析了该期间的 79 份可用警报，平均每年有 6.07 份警报，标准差为 3.81。警报中引用最多的药物是抗病毒药物（9.7%），其次是抗糖尿病药物（7.3%）和避孕药（7.3%）。确定的主要问题是不良反应（50%）和其他与安全相关的问题（15%）。ANVISA 主要采取的行动是生成新的禁忌症（37.3%）和修改包装说明书（22.3%）。
警报是向卫生专业人员和社会传达新信息的重要手段。然而，它们需要更好的标准化，以便于理解、传播，以扩大信息获取途径，并进行研究来证实当前的文献并改进当前的药物警戒。
