Abraham Natnael Araya, Tesfagaber Meron, Tesfamariam Sirak
University of Oxford, Nuffield Department of Medicine, Center of Tropical Medicine and Global Health, Oxford, UK.
Product Evaluation and Registration Unit, National Medicines and Food Administration, Asmara, Eritrea.
Risk Manag Healthc Policy. 2023 Apr 21;16:747-757. doi: 10.2147/RMHP.S398811. eCollection 2023.
Understanding the integration of pharmacovigilance activities in the healthcare system and identifying existing hindering factors systematically through the eyes of stakeholders has paramount importance to realize a successful integration. Thus, this study aimed to assess the perspectives of the stakeholders of the Eritrean Pharmacovigilance Center (EPC) on the integration of pharmacovigilance activities into the Eritrean healthcare system.
An exploratory qualitative assessment of the integration of pharmacovigilance activities into the healthcare system was conducted. Key informant interviews were conducted among the major stakeholders of the EPC via face-to-face and telephone interviews. Data were collected between October 2020 and February 2021, and analyzed through thematic framework analysis.
A total of 11 interviews were completed. The integration of the EPC in the healthcare system was rated as good and encouraging except in the National Blood Bank, and Health Promotion. The relationship between the EPC and Public health programs was described as mutual with an eminent impact. Several facilitating factors for integration were identified namely: the unique work culture of the EPC; provision of basic and advanced training; motivating and recognizing healthcare professionals in vigilance activities; and the financial and technical support provided to the EPC from national and international stakeholders. On the other hand, the absence of concrete communication systems, inconsistencies in training and communication, the absence of data-sharing mechanisms and policies, and the absence of designated pharmacovigilance focal persons were identified as barriers to successful integration.
Integration of the EPC in the healthcare system was found to be commendable except in some areas of the healthcare system. Therefore, the EPC should work towards identifying further areas of integration, mitigate the identified limitations and at the same time sustain the integration already initiated.
了解药物警戒活动在医疗保健系统中的整合情况，并通过利益相关者的视角系统地识别现有的阻碍因素，对于实现成功整合至关重要。因此，本研究旨在评估厄立特里亚药物警戒中心（EPC）的利益相关者对将药物警戒活动整合到厄立特里亚医疗保健系统中的看法。
对药物警戒活动在医疗保健系统中的整合进行了探索性定性评估。通过面对面和电话访谈，对EPC的主要利益相关者进行了关键信息访谈。数据收集于2020年10月至2021年2月之间，并通过主题框架分析进行了分析。
共完成了11次访谈。除了国家血库和健康促进领域外，EPC在医疗保健系统中的整合被评为良好且令人鼓舞。EPC与公共卫生项目之间的关系被描述为相互的，且具有显著影响。确定了几个促进整合的因素，即：EPC独特的工作文化；提供基础和高级培训；在警戒活动中激励和认可医疗保健专业人员；以及国家和国际利益相关者向EPC提供的财政和技术支持。另一方面，缺乏具体的沟通系统、培训和沟通不一致、缺乏数据共享机制和政策以及缺乏指定的药物警戒联络人被确定为成功整合的障碍。
除了医疗保健系统的某些领域外，EPC在医疗保健系统中的整合被认为是值得称赞的。因此，EPC应努力确定进一步的整合领域，减轻已确定的限制，同时维持已经启动的整合。
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