Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, M13 9PT, Manchester, UK.
Global Health. 2021 Aug 30;17(1):97. doi: 10.1186/s12992-021-00751-y.
As Arab countries seek to implement the 'Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries', understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait).
Matland's ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between "experimental implementation" and "symbolic implementation". Factors reducing policy ambiguity in Jordan and Oman included: decision-makers' guidance to implementors, stakeholder involvement in the policy's development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy's compliance with internationally recognised standards and the policy's fit with local capabilities (all three countries), decision-makers' cooperation with and support of the national centre as well as stakeholders' agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan).
Using Matland's model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.
随着阿拉伯国家寻求实施“阿拉伯国家良好药物警戒实践指南（GVP）”，了解政策实施机制和影响因素可以为最佳实施实践提供信息。本研究旨在探索在药物警戒系统更为成熟的阿拉伯国家（约旦、阿曼）中药物警戒政策实施的机制和影响因素，以为药物警戒系统尚处于萌芽阶段的国家（科威特）的政策实施提供信息。
Matland 的歧义-冲突模型用于对 56 次面对面访谈进行数据分析，结果表明约旦和阿曼的政策歧义度和冲突度较低，表明存在“行政实施”途径。在科威特，政策歧义度较高，而对政策冲突的看法则各不相同，表明存在“实验实施”和“象征性实施”的混合。降低约旦和阿曼政策歧义度的因素包括：决策者为实施者提供指导、利益相关者参与政策的制定和实施、在整个实施过程中对政策实施者进行培训、明确界定政策目标和手段，以及制定具有适当时间表和监测机制的战略实施计划。相比之下，科威特政策歧义度高是因为这些因素的缺失或缺乏关注。降低政策冲突的因素包括：政策符合国际公认标准和政策符合当地能力（所有三个国家）、决策者与国家中心合作并支持国家中心以及利益相关者对政策目标和手段的一致意见（约旦和阿曼）以及采用逐步实施的方法（约旦）。
使用 Matland 模型，确定了成功实施药物警戒政策的机制和影响因素。这为阿拉伯国家以及其他药物警戒系统尚处于萌芽阶段的国家提供了最佳实施实践的建议，包括增加管理参与和支持、增加利益相关者在政策制定和实施中的参与，以及进行更详细的实施规划。
