Ministry of Health, Ouagadougou, Burkina Faso.
Drug Saf. 2013 May;36(5):349-58. doi: 10.1007/s40264-013-0043-9.
Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need.
The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements.
We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results.
The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market. In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development.
Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health.
布基纳法索与其他撒哈拉以南非洲国家一样，最近大规模推出了用于预防和治疗公共卫生重点疾病（包括疟疾、艾滋病毒/艾滋病和脑膜炎）的新药。这种新情况使得有必要实施药物警戒，以监测和确定这些药物的安全性和有效性。2008 年，布基纳法索卫生部门在西非启动了正式的药物警戒系统，以满足这一需求。
本研究旨在通过全面系统的方法评估布基纳法索的早期药物警戒系统，以期确定需要改进的领域。
我们在布基纳法索进行了一项描述性的横断面研究。来自国家药品管理局（NDA）、公共卫生方案（PHPs）和医院的 16 名关键信息提供者接受了采访。研究参与者是根据在 NDA、三家教学医院、两家地区医院和六家 PHPs 中的便利抽样选择的。使用最近由美国非营利组织“管理科学促进健康”设计和验证的指标药物警戒评估工具（IPAT）收集数据。评估还涉及评估机构中与药物警戒相关的相关文件的收集和审查。使用评分系统对评估结果进行量化。
布基纳法索的 NDA 作为负责药物警戒的法定机构，取得了 70%的绩效得分。药物警戒活动的基本结构已经到位；然而，缺乏专门的药物警戒法、缺乏国家药物警戒准则和标准作业程序以及国家药物警戒利益攸关方的协调不足，被确定为主要弱点。迄今为止收集的安全性数据尚未导致发现当地与药物相关的风险；然而，正在监测和采取相关的外部安全性警报。2010 年，31 项营销授权被修改以纳入新的安全性信息；另外 7 项被暂停，相应的药物从国家市场撤出。在 PHPs 中，药物警戒活动尚未正式化，而在医院中，药物警戒结构仍在发展中。
应尽快采取相关干预措施，加强药物警戒活动的法律框架和结构，并改善全国利益攸关方的协调。在国家药物警戒系统能够收集自己的数据、产生信号、评估和管理与当地药物相关的风险并成为公共卫生的真正工具之前，需要进行这种投资。
