Monaco Luca, Melis Mauro, Biagi Chiara, Donati Monia, Sapigni Ester, Vaccheri Alberto, Motola Domenico
a Unit of Pharmacology, Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy.
b Emilia-Romagna Region , Pharmacovigilance Regional Centre , Bologna , Italy.
Expert Opin Drug Saf. 2017 Mar;16(3):271-275. doi: 10.1080/14740338.2017.1284200. Epub 2017 Jan 30.
In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre.
Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe. We are appointed to supervise digoxin, nicardipine, delapril, manidipine and hydrochlorothiazide/ramipril. ADRs are coded through MedDRA Preferred Terms and collected in the electronic Reaction Monitoring Report (eRMR). Statistical analysis is based on the Proportional Reporting Ratio (PRR) as a measure of disproportionality.
Up to April 2016 we have analyzed 45 eRMR for each drug. Two signals for nicardipine were submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency (EMA): acute pulmonary oedema (off-label use as tocolytic) and thrombocytopenia.
Our experience shows the scientific and regulatory value of signal detection activity on EV data in order to continuously evaluate the benefit/risk profile of recent and older drugs.
2012年7月，一项关于药物警戒的新欧洲法规（指令2010/84/EU和第1235/2010号法规）开始生效。该法规通过每月对欧洲药物警戒数据库（EudraVigilance，EV）中的潜在安全信号进行分析，推动了信号检测活动。我们的目的是描述在EV数据上进行信号检测的程序，并展示我们药物警戒中心获得的结果。
数据从EV数据库中提取，该数据库收集欧洲药品的疑似药品不良反应（ADR）。我们被指定监督地高辛、尼卡地平、地拉普利、马尼地平以及氢氯噻嗪/雷米普利。ADR通过MedDRA优选术语进行编码，并收集在电子反应监测报告（eRMR）中。统计分析基于比例报告率（PRR）作为不成比例的衡量标准。
截至2016年4月，我们已对每种药物分析了45份eRMR。向欧洲药品管理局（EMA）的药物警戒风险评估委员会提交了两个关于尼卡地平的信号：急性肺水肿（作为tocolytic的超适应症使用）和血小板减少症。
我们的经验表明，对EV数据进行信号检测活动具有科学和监管价值，以便持续评估新药和老药的获益/风险状况。
