Ribeiro Adalton, Lima Silvana, Zampieri Maria-Elisa, Peinado Mirtes, Figueras Albert
a Núcleo de Farmacovigilância , Centro de Vigilância Sanitária de São Paulo , São Paulo , Brazil.
b Núcleo Técnico de Planejamento e Informação , Centro de Vigilância Sanitária de São Paulo , São Paulo , Brazil.
Expert Opin Drug Saf. 2017 Dec;16(12):1329-1334. doi: 10.1080/14740338.2017.1369525. Epub 2017 Aug 23.
The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil).
A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm.
There were 820 reports from manufacturers and 179 from health centres. Only 4.4% (44) were fully filled, thus allowing the adequate analysis of the causal relationship between the suspected medication and the adverse event. In 30% of the reports from manufacturers, the information about the critical variables was lacking or incomplete, preventing the adequate evaluation of the report. It was also noted that the reports' poor filling quality was not related with less severity or with old and well-known medicines.
The poor quality of the information included in the reports received by this centre, especially those sent by pharmaceutical manufacturers, hampers the identification of potential safety signals. Measures to improve the quality of the reports must be urgently adopted.
在药物警戒中，疑似药物不良反应报告的完整性和准确性至关重要。本研究的目的是分析发送至巴西圣保罗药物警戒中心的报告中所包含信息的质量。
选取了2013年1月至2014年12月期间收到的999份报告作为样本。根据应用卡尔奇-拉萨尼亚因果关系算法的“充分性”标准对所填写信息的质量进行评估。
有820份报告来自制造商，179份来自健康中心。仅有4.4%（44份）填写完整，从而能够对疑似药物与不良事件之间的因果关系进行充分分析。在制造商提供的报告中，有30%缺乏或未完整填写关键变量信息，妨碍了对报告的充分评估。还注意到报告填写质量差与不良事件严重程度较低以及与使用老旧且知名药物无关。
该中心收到的报告中所包含信息质量较差，尤其是制药商发送的报告，这妨碍了潜在安全信号的识别。必须紧急采取措施提高报告质量。
