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Matching safety to access: global actors and pharmacogovernance in Kenya- a case study

BACKGROUND: 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 d...

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Autores principales: Moscou, Kathy, Kohler, Jillian C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363016/
https://www.ncbi.nlm.nih.gov/pubmed/28335786
http://dx.doi.org/10.1186/s12992-017-0232-x
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author Moscou, Kathy
Kohler, Jillian C.
author_facet Moscou, Kathy
Kohler, Jillian C.
author_sort Moscou, Kathy
collection PubMed
description BACKGROUND: 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. RESULTS: 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. CONCLUSION: 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.
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spelling pubmed-53630162017-03-24 Matching safety to access: global actors and pharmacogovernance in Kenya- a case study Moscou, Kathy Kohler, Jillian C. Global Health Research BACKGROUND: 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. RESULTS: 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. CONCLUSION: 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. BioMed Central 2017-03-23 /pmc/articles/PMC5363016/ /pubmed/28335786 http://dx.doi.org/10.1186/s12992-017-0232-x Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Moscou, Kathy
Kohler, Jillian C.
Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title_full Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title_fullStr Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title_full_unstemmed Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title_short Matching safety to access: global actors and pharmacogovernance in Kenya- a case study
title_sort matching safety to access: global actors and pharmacogovernance in kenya- a case study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363016/
https://www.ncbi.nlm.nih.gov/pubmed/28335786
http://dx.doi.org/10.1186/s12992-017-0232-x
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