Pharmacovigilance study of spontaneous adverse drug reaction in a tertiary care centre

Wazid Ali, Smita Manjavkar, Imran Kazmi, Shamim Khan
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Abstract

Background: Adverse drug reactions (ADRs) are a rapidly growing universal problem that has a significant impact on users worldwide. They are the cause of significant disability and mortality and are expected to be associated with an economic burden on the health-care system. Aims: To promote patient safety from pharmaceutical products. Materials and Methods: A prospective, observational evaluation of the ADRs collected during spontaneous pharmacovigilance reporting over a period of 18 months in various hospital departments. During the study period, 214 individual case safety reports (ICSR) were reported. Results: The 214 reports that were identified, a slightly higher percentage of ADRs in females 105 (50.93%) was observed as compared to males 109 (49.07%), 73 (34.1%) serious and 141 (65.9%) non serious ADRs. In serious ADRs, the male patients were 35 (33.3%) and females were 38 (34.9%) including 6 (2.8%) deaths. The largest number of reports was associated with antimicrobials 41% followed by non-steroidal anti-inflammatory drugs − 21.1%, antidiabetic − 10.9%. The most commonly implicated organ system was skin − 46.62% followed by gastrointestinal reactions − 18.05%, blood and metabolic disorder − 11.65%, central nervous system − 6.77%, liver − 6.02% and cardiovascular system (3.38%). The outcomes were recorded as recovering (45.8%), recovered (26.2%), continuing (19.2%) and unknown (6.1%) at the time of processing ICSR through vigiflow database. The causality of more than half of ADRs were recorded as possible (59.8%) followed by probable (24.8%), certain (15%) and unlikely (0.5%). Conclusion: Limited ADR is permissible in normal clinical trials setting; hence, spontaneous adverse reaction reporting systems need to be developed, which may improve rational drug prescribing habits to obtain maximum benefits meanwhile minimizing the risk of health from undesirable effects of drugs.
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某三级保健中心自发性药物不良反应的药物警戒研究
背景:药物不良反应(adr)是一个迅速增长的普遍问题,对全世界的使用者产生了重大影响。它们是造成严重残疾和死亡的原因,预计会给卫生保健系统带来经济负担。目的:促进患者对药品的安全。材料和方法:对18个月来各医院部门自发药物警戒报告中收集的不良反应进行前瞻性观察性评估。在研究期间,报告了214例个案安全报告(ICSR)。结果:214例adr报告中,女性105例(50.93%)高于男性109例(49.07%),严重adr 73例(34.1%),非严重adr 141例(65.9%)。严重不良反应中,男性35例(33.3%),女性38例(34.9%),死亡6例(2.8%)。报告数量最多的是抗菌素(41%),其次是非甾体抗炎药(21.1%)和降糖药(10.9%)。最常涉及的器官系统为皮肤(46.62%),其次是胃肠道反应(18.05%)、血液和代谢紊乱(11.65%)、中枢神经系统(6.77%)、肝脏(6.02%)和心血管系统(3.38%)。在vigiflow数据库处理ICSR时,结果记录为恢复(45.8%)、恢复(26.2%)、持续(19.2%)和未知(6.1%)。超过半数adr的因果关系为可能(59.8%),其次为可能(24.8%)、确定(15%)和不可能(0.5%)。结论:在正常的临床试验环境下,有限的不良反应是允许的;因此,需要建立自发的不良反应报告系统,以改善合理的用药习惯,获得最大的利益,同时最大限度地减少药物不良反应对健康的风险。
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