Matching safety to access: global actors and pharmacogovernance in Kenya- a case studyReport as inadecuate




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Globalization and Health

, 13:20

Global governance and health

Abstract

BackgroundThe 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.

ResultsGlobal 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.

ConclusionA 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.

KeywordsDrug safety Global actors Governance Kenya Pharmacovigilance Regulation  Download fulltext PDF



Author: Kathy Moscou - Jillian C. Kohler

Source: https://link.springer.com/







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