Namibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia; Department of Pharmacy Practice & Policy, School of Pharmacy, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia.
Department of Pharmacy Practice & Policy, School of Pharmacy, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia.
Res Social Adm Pharm. 2020 Aug;16(8):1111-1116. doi: 10.1016/j.sapharm.2019.11.010. Epub 2019 Nov 18.
Pharmacovigilance systems increase access to safe medicines and healthcare, but their integration in public healthcare remains a challenge in many countries. The main barriers to pharmacovigilance integration are attributed to high patient load and limited capacities.
To explore the challenges associated with the effective integration of pharmacovigilance systems in public healthcare in a developing country such as Namibia.
A nationwide qualitative assessment of integration of pharmacovigilance systems particularly spontaneous adverse drug reaction (ADR) reporting at public health facility level was conducted. Key informant interviews were conducted among pivotal healthcare professionals involved in pharmacovigilance. The main outcomes were themes on challenges and strategies for effective integration of PV services at the facility level. Qualitative data were collected over a one-month period (i.e., March 2019), and thematically analysed.
Eight (8) key informants were recruited; the majority were pharmacists (n = 7) and male (n = 5). The main challenges affecting the effective integration of pharmacovigilance systems reporting at public health facilities were "weak pharmacovigilance policies and structures", "negative attitude of healthcare workers towards pharmacovigilance", and "limited capacity and support for implementation of pharmacovigilance activities". The main strategies for effective integration of PV systems at facilities included local capacity-building through continuing profession education and support, advocacy, stakeholder engagement, facility/region based pharmacovigilance champions, and facility-based policies for universal and inclusive reporting, (i.e. patients and health workers at all levels) as well as development of workable standard operational procedures.
The pharmacovigilance systems at healthcare facilities in Namibia were observed to have sub-optimal policies, structures and support systems, and lack health care worker buy-in. There is a need for a policy framework to ensure effective and sustainable integration of pharmacovigilance activities at public healthcare facilities.
药物警戒系统可增加安全药品和医疗保健的可及性,但在许多国家,其融入公共医疗保健仍然是一个挑战。药物警戒融入的主要障碍归因于患者负担过重和能力有限。
探索在纳米比亚等发展中国家,将药物警戒系统有效融入公共医疗保健所面临的挑战。
对药物警戒系统的整合情况,特别是在公立卫生机构一级自发药物不良反应报告进行了全国范围的定性评估。对参与药物警戒的关键医疗保健专业人员进行了关键信息人员访谈。主要结果是在机构层面有效整合药物警戒服务的挑战和策略主题。在一个月的时间内(即 2019 年 3 月)收集了定性数据,并进行了主题分析。
共招募了 8 名关键信息人员,其中大多数是药剂师(n=7)和男性(n=5)。影响公立卫生机构药物警戒系统报告有效整合的主要挑战是“薄弱的药物警戒政策和结构”、“医疗保健工作者对药物警戒的负面态度”和“实施药物警戒活动的能力和支持有限”。有效整合药物警戒系统的主要策略包括通过持续职业教育和支持、宣传、利益相关者参与、基于设施/地区的药物警戒拥护者以及基于设施的普及和包容报告政策(即各级患者和卫生工作者),以及制定可行的标准操作程序来加强本地能力建设。
纳米比亚医疗机构的药物警戒系统观察到政策、结构和支持系统欠佳,且缺乏医疗保健工作者的支持。需要制定政策框架,以确保药物警戒活动在公共医疗保健设施中的有效和可持续整合。