Ministry of Health, Medical Department, Nairobi, Kenya.
Yorkshire Centre for Health Informatics, University of Leeds, Leeds, UK.
J Am Med Inform Assoc. 2018 Jun 1;25(6):627-634. doi: 10.1093/jamia/ocx102.
Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation.
Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya.
The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system.
Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives.
While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.
许多发展中国家正在实施电子药物警戒报告系统,以努力提高报告率。本研究旨在确定电子药物警戒报告系统在肯尼亚实施 3 年后成功的障碍因素。
在文献回顾中确定了可能成为使用电子报告系统障碍的因素,然后使用这些因素开发了一份调查问卷,该问卷分发给肯尼亚 6 个县的政府医院的药剂师。
共有 115 名目标药剂师中的 103 名(89.5%)完成了调查,其中包括自由文本评论。确定的主要障碍因素包括:无法获得、不可靠或昂贵的互联网接入;纸质和电子报告工具混合系统带来的挑战;以及系统可用性问题。国家药物警戒中心的协调挑战以及国家卫生管理结构的变化也对电子报告系统的成功产生了影响。
不同的个人、组织、基础设施和报告系统因素以不同的方式影响电子报告系统的成功,具体取决于背景。针对特定环境的形成性评估有助于确定电子报告系统的性能,以发现问题并确保实现预期目标。
虽然肯尼亚电子药物警戒报告系统的使用存在一些障碍因素,但所有这些因素都被认为是可以改变的。应努力解决已确定的问题,以促进使用并提高药物警戒报告率。