Moscou Kathy, Kohler Jillian C
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada.
WHO Collaborating Centre for Governance, Accountability and Transparency for the Pharmaceutical Sector, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada.
Global Health. 2017 Mar 23;13(1):20. doi: 10.1186/s12992-017-0232-x.
The Kenyan government has sought to address inadequacies in its National Pharmaceutical Policy and the Pharmacy and Poisons Board's (PPB) medicines governance by engaging with global actors (e.g. the World Health Organization). Policy actors have influenced the way pharmacovigilance is defined, how challenges are understood and which norms are requisite to address drug safety issues. In this paper, we investigate the relationship between specific modes of engagement among global (exogenous) and domestic actors at the national and sub-national level to identify the positive or negative effect on pharmacovigilance and pharmacogovernance in Kenya. Pharmacogovernance is defined as the manner in which governing structures; policy instruments; institutional authority (e.g., ability to act, implement and enforce norms, policies and processes) and resources are managed to promote societal interests for patient safety and protection from adverse drug reactions (ADRs). Qualitative research methods that included key informant interviews and document analysis, were employed to investigate the relationship between global actors' patterns of engagement with national actors and pharmacogovernance in Kenya.
Global actors' influence on pharmacogovernance and pharmacovigilance priorities in Kenya (e.g., legislation and adverse drug reaction surveillance) was positively perceived by key informants. We found that global actors' engagement with state actors produced positive and negative outcomes. Engagement with the PPB and Ministry of Health (MOH) that was characterized as dependent (advocacy, empowerment, delegated) or interdependent (collaborative, cooperative, consultative) was mostly associated with positive outcomes e.g., capacity building; strengthening legislation and stakeholder coordination. Fragmentation (independent engagement) hindered risk communication between public, private, and NGO health programs.
A framework for assessing pharmacogovernance would support policy makers' evidence-based decision making regarding investments to strengthen capacity for pharmacovigilance and guide policies regarding the state and exogenous actor relationship pertaining to pharmacogovernance. Ideally, dependency on exogenous actors should be reduced while retaining consultative, collaborative, and cooperative engagement when inter-dependency is appropriate. The use of global actors to address Kenya's pharmacovigilance inadequacies leaves the country vulnerable to 1) ad hoc drug surveillance; 2) pharmacovigilance fragmentation; 3) shifting priorities; and 4) cross purpose interests.
肯尼亚政府试图通过与全球行为体（如世界卫生组织）合作，来解决其国家药品政策以及药品与毒物管理局（PPB）药品治理方面的不足。政策行为体影响了药物警戒的定义方式、对挑战的理解方式以及应对药物安全问题所需的规范。在本文中，我们调查了全球（外部）和国内行为体在国家和次国家层面的特定参与模式之间的关系，以确定其对肯尼亚药物警戒和药品治理的正面或负面影响。药品治理被定义为管理治理结构、政策工具、机构权威（如行动、实施和执行规范、政策及流程的能力）和资源的方式，以促进社会利益，保障患者安全并防止药物不良反应（ADR）。我们采用了包括关键信息人访谈和文件分析在内的定性研究方法，来调查全球行为体与国家行为体的参与模式之间的关系以及肯尼亚的药品治理情况。
关键信息人对全球行为体对肯尼亚药品治理和药物警戒重点（如立法和药品不良反应监测）的影响持积极看法。我们发现全球行为体与国家行为体的合作产生了正面和负面的结果。与PPB和卫生部（MOH）的依赖型（倡导、赋权、委托）或相互依赖型（协作、合作、协商）合作大多带来了正面结果，如能力建设、加强立法和利益相关者协调。分散型（独立参与）阻碍了公共、私营和非政府组织卫生项目之间的风险沟通。
一个评估药品治理的框架将支持政策制定者基于证据做出关于加强药物警戒能力投资的决策，并指导有关国家与外部行为体在药品治理方面关系的政策。理想情况下，应减少对外源行为体的依赖，同时在相互依赖合适时保留协商、协作和合作的参与方式。利用全球行为体来解决肯尼亚药物警戒方面的不足，使该国容易受到以下问题的影响：1）临时药物监测；2）药物警戒分散化；3）优先事项的变化；4）相互矛盾的利益。
