Matching safety to access: global actors and pharmacogovernance in Kenya- a case study.
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.
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada. kathy.moscou@utoronto.ca.|WHO Collaborating Centre for Governance, Accountability and Transparency for the Pharmaceutical Sector, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada. kathy.moscou@utoronto.ca.|School of Health Policy and Management, Faculty of Health, York University, 4700 Keele St., Toronto, ON, M3J 1P3, Canada. kathy.moscou@utoronto.ca.
Kathy
K
Moscou
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada.|Munk School of Global Affairs1 Devonshire Place (At Trinity College), Toronto, ON, M5S 3K7, Canada.|Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, M5T 3M7, Canada.|WHO Collaborating Centre for Governance, Accountability and Transparency for the Pharmaceutical Sector, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada.
Jillian C
JC
Kohler
D003299:Cooperative Behavior; D014943:Global Health / Q000639:trends; D006291:Health Policy / Q000639:trends; D006293:Health Promotion / Q000379:methods; D006297:Health Services Accessibility / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D007630:Kenya; D061214:Patient Safety / Q000592:standards*; D010593:Pharmaceutical Services / Q000592:standards* / Q000600:supply & distribution*; D036301:Qualitative Research
Drug safety; Global actors; Governance; Kenya; Pharmacovigilance; Regulation