Department of Global Health, School of Public Health, Box 357236 University of Washington, Seattle, WA 98195, USA.
Malar J. 2010 May 30;9:148. doi: 10.1186/1475-2875-9-148.
Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests.
The Global Fund-Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund-Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan.
Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities.
There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active direction to strengthen active surveillance and passive adverse event reporting systems to augment the issuance of guidance documents.
药物警戒计划可以监测并有助于确保对全球公共卫生计划的成功至关重要的药物的安全使用。作为全球疟疾行动计划（旨在消除和根除疟疾）的一部分，各国疟疾控制规划广泛部署青蒿素复方疗法（ACT），这使 ACT 成为药物警戒活动的理想候选药物。2008 年，遏制疟疾伙伴关系发布了将药物警戒纳入全球基金和其他相关提案的指导方针。鉴于这一建议以及 ACT 在全球范围内的快速扩大，对全球基金第 8 轮提案和总统疟疾倡议（PMI）2009 年疟疾行动计划进行了分析，以评估药物警戒是否以及如何被纳入各国的国家疟疾计划和捐助者预算请求。
通过方案网站查阅了 26 个国家的全球基金疟疾第 8 轮提案和获得全球基金疟疾第 8 轮或 PMI 资助的 15 个国家的 2009 财年 PMI 疟疾行动计划。分析包括对每份提案和计划进行字数统计和关键词上下文分析。
26 个国家中有 12 个（46%）的全球基金提案提到其国家有现有的药物警戒系统。15 个 PMI 行动计划中有 4 个（27%）提到其国家有现有的药物警戒系统。26 个全球基金提案中只有 7 个（27%）包括为新的或现有的药物警戒活动申请资金。15 个行动计划中有 7 个（47%）包括为药物警戒活动申请资金。
对药物警戒活动的资金申请相对较少，表明受援国对药物警戒系统的重视程度不够。调查结果强调需要更积极的指导，以加强主动监测和被动不良事件报告系统，以补充指导文件的发布。
