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Strengthening the Pharmacovigilance Programme in Nepal

机译:加强尼泊尔的药物警戒计划

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The aims of pharmacovigilance are early recognition of previously unknown adverse drug reactions (ADRs), recognition of changes in frequency of known ADRs, identification of risk factors and mechanism of ADRs, quantitative analysis of benefit/risk ratio and dissemination of safety information for rational drug prescribing and regulation. The pharmacovigilance programme in Nepal is a recent development. The Department of Drug Administration (DDA) took the initiative to set up a pharmacovigilance program in 2002; however, it was initiated systematically only after two years. DDA acts as the National Pharmacovigilance Centre (NPC). It collects ADR case reports from the Regional Pharmacovigilance Centre (RPC). Currently there are six RPCs operating in the country. The current reporting trends suggest high under-reporting of suspected ADRs. This paper is a review of those studies which are focused on pharmacovigilance and healthcare professionals’ perspectives on ADR reporting in Nepal. It also recommends the possible ways to improve the ADR reporting based on the context of Nepal. DOI: http://dx.doi.org/10.3126je.v3i1.8286 Nepal Journal of Epidemiology 2013;3 (1): 230-235.
机译:药物警戒的目的是及早识别先前未知的药物不良反应(ADR),识别已知ADR频率的变化,识别ADR的危险因素和机理,对效益/风险比进行定量分析以及分发合理药物的安全性信息处方和规定。尼泊尔的药物警戒计划是最近的发展。药物管理局(DDA)于2002年主动制定了药物警戒计划。但是,只有两年后才有系统地启动。 DDA充当国家药物警戒中心(NPC)。它从区域药物警戒中心(RPC)收集ADR病例报告。目前,该国有六个RPC在运营。当前的报告趋势表明可疑ADR的报告不足。本文是对那些侧重于药物警戒和医疗保健专业人员对尼泊尔ADR报告的看法的研究的综述。它还建议根据尼泊尔的情况,改进ADR报告的可能方法。 DOI:http://dx.doi.org/10.3126je.v3i1.8286尼泊尔流行病学杂志2013; 3(1):230-235。

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