Department of Clinical Pharmacology, Seth GS Medical College and King Edward Memorial Hospital, Parel, Mumbai, India.
Trans R Soc Trop Med Hyg. 2011 Feb;105(2):61-7. doi: 10.1016/j.trstmh.2010.11.004. Epub 2010 Dec 23.
Pharmacovigilance is concerned with the assessment of benefit and harm. Disease burden, status of healthcare delivery through government centres and practitioners, existing pharmacovigilance programmes, relevant pre-marketing studies and the likely effectiveness and risks of drugs must be considered for planning pharmacovigilance activity. The risk of a drug may be known, unknown, potential or specific to the context of the programme. The potential benefits of a public health programme aimed at reducing or eliminating a specific condition will depend on the health burden due to that condition, which is a function of the seriousness of the condition and its frequency, as well as the likely efficacy of the programme in reaching its goals. The present article has outlined an approach to pharmacovigilance for such a donor-funded programme, using pharmacovigilance in leishmaniasis as an example.
药物警戒关注的是利益和危害的评估。在规划药物警戒活动时，必须考虑疾病负担、通过政府中心和从业者提供的医疗保健服务状况、现有的药物警戒计划、相关的上市前研究以及药物的可能有效性和风险。药物的风险可能是已知的、未知的、潜在的或特定于计划背景的。旨在减少或消除特定疾病的公共卫生计划的潜在益处将取决于该疾病的健康负担，这是疾病严重程度和频率的函数，以及该计划在实现其目标方面的可能效果。本文概述了一种针对这种由捐赠者资助的计划的药物警戒方法，以利什曼病中的药物警戒为例。
