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Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveilla...

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Autores principales: Stegmann, Jens-Ulrich, Jusot, Viviane, Menang, Olga, Gardiner, Gregory, Vesce, Sabino, Volpe, Stephanie, Ndalama, Anderson, Adou, Felix, Ofori-Anyinam, Opokua, Oladehin, Olakunle, Mendoza, Yolanda Guerra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9383683/
https://www.ncbi.nlm.nih.gov/pubmed/35978276
http://dx.doi.org/10.1186/s12889-022-13867-6
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author Stegmann, Jens-Ulrich
Jusot, Viviane
Menang, Olga
Gardiner, Gregory
Vesce, Sabino
Volpe, Stephanie
Ndalama, Anderson
Adou, Felix
Ofori-Anyinam, Opokua
Oladehin, Olakunle
Mendoza, Yolanda Guerra
author_facet Stegmann, Jens-Ulrich
Jusot, Viviane
Menang, Olga
Gardiner, Gregory
Vesce, Sabino
Volpe, Stephanie
Ndalama, Anderson
Adou, Felix
Ofori-Anyinam, Opokua
Oladehin, Olakunle
Mendoza, Yolanda Guerra
author_sort Stegmann, Jens-Ulrich
collection PubMed
description Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d’Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country’s needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000–2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d’Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1–2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture.
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spelling pubmed-93836832022-08-17 Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa Stegmann, Jens-Ulrich Jusot, Viviane Menang, Olga Gardiner, Gregory Vesce, Sabino Volpe, Stephanie Ndalama, Anderson Adou, Felix Ofori-Anyinam, Opokua Oladehin, Olakunle Mendoza, Yolanda Guerra BMC Public Health Research in Practice Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d’Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country’s needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000–2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d’Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1–2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture. BioMed Central 2022-08-17 /pmc/articles/PMC9383683/ /pubmed/35978276 http://dx.doi.org/10.1186/s12889-022-13867-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research in Practice
Stegmann, Jens-Ulrich
Jusot, Viviane
Menang, Olga
Gardiner, Gregory
Vesce, Sabino
Volpe, Stephanie
Ndalama, Anderson
Adou, Felix
Ofori-Anyinam, Opokua
Oladehin, Olakunle
Mendoza, Yolanda Guerra
Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title_full Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title_fullStr Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title_full_unstemmed Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title_short Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa
title_sort challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-saharan africa
topic Research in Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9383683/
https://www.ncbi.nlm.nih.gov/pubmed/35978276
http://dx.doi.org/10.1186/s12889-022-13867-6
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