Cazacu Irina, Stroe Roxana, Dondera Roxana, Mogosan Cristina, Haramburu Françoise, Fourrier-Réglat Annie, Loghin Felicia
Faculty of Pharmacy, Department of Pharmacology, Physiology and Pathophysiology, University of Medicine and Pharmacy Iuliu Hatieganu, 400012, Cluj-Napoca, Romania.
Pharmacovigilance and Risk Management Service, National Agency for Medicines and Medical Devices, 011478, Bucharest, Romania.
Fundam Clin Pharmacol. 2018 Jun;32(3):330-336. doi: 10.1111/fcp.12343. Epub 2018 Jan 25.
The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, and 38% male and 1.4% were unknown. Reporters were mainly physicians (74.7%), and 52.1% of ADR reports were transmitted through marketing authorization holders. Of the serious ADRs (32.4%), 34.7% led to hospitalization or prolonged hospitalization. The most frequent ADRs reported were skin and subcutaneous tissue disorders (25.8%) and general disorders and administration site conditions (19.2%). Metamizole, alone or in combination, was the main analgesic suspected in almost 15.5% of the cases and remains one of the most popular analgesics in Romania. Ten cases were assessed as preventable or potentially preventable (14%), of which two cases were serious. Even if the level of reporting is still low, this study conducted on ADRs of analgesics reported to the national pharmacovigilance center represents an essential step toward promoting the rational use of analgesics in Romania.
国家安全研究的结果对于监管层面的决策至关重要，对处方模式也具有教育意义。本研究的目的是分析2011年至2015年期间自发向罗马尼亚国家药品和医疗器械管理局药物警戒与风险管理服务部门报告的镇痛药不良反应（ADR）。在这71份报告中，患者的平均年龄为39.8岁；60.6%的患者为女性，38%为男性，1.4%性别未知。报告者主要是医生（74.7%），52.1%的ADR报告是通过上市许可持有人提交的。在严重ADR中（32.4%），34.7%导致住院或延长住院时间。报告的最常见ADR是皮肤和皮下组织疾病（25.8%）以及全身疾病和给药部位情况（19.2%）。安乃近单独或联合使用，在近15.5%的病例中是主要怀疑的镇痛药，并且仍然是罗马尼亚最常用的镇痛药之一。有10例被评估为可预防或潜在可预防（14%），其中2例为严重病例。即使报告水平仍然较低，但这项针对向国家药物警戒中心报告的镇痛药ADR开展的研究，是罗马尼亚促进合理使用镇痛药的重要一步。
