Evidence map›Paper›PMID 39162987›Full record

ArticleDrug safety2024

Short-Term Training, a Useful Approach for Sustainable Pharmacovigilance Knowledge Development in Tanzania, Kenya, Ethiopia and Rwanda.

Eugène van Puijenbroek, Abbie Barry, Christabel Khaemba, Lazare Ntirenganya, Tigist Dires Gebreyesus, Adam Fimbo, Omary Minzi, Eyasu Makonnen, Margaret Oluka, Anastasia Guantai and 1 more

Abstract read
In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Eugène van PuijenbroekUniversity of Groningen, Groningen Research Institute of Pharmacy, Pharmacotherapy, Epidemiology and Economics, Groningen, The Netherlands. e.p.van.puijenbroek@rug.nl.ORCID http://orcid.org/0000-0002-2236-1398
Abbie BarryDepartment of Global Public Health, Karolinska Institute, Stockholm, Sweden.
Christabel KhaembaPharmacy and Poisons Board, Nairobi, Kenya.ORCID http://orcid.org/0000-0003-0543-9920
Lazare NtirenganyaRwanda Food and Drugs Authority, Kigali, Rwanda.
Tigist Dires GebreyesusEthiopian Food and Drug Authority, Addis Ababa, Ethiopia.ORCID http://orcid.org/0000-0002-8969-9916
Adam FimboTanzania Medicines and Medical Devices Authority, Dar es Salaam, Tanzania.ORCID http://orcid.org/0000-0002-9356-2218
Omary MinziDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.ORCID http://orcid.org/0000-0001-8692-1924
Eyasu MakonnenDepartment of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.ORCID http://orcid.org/0000-0002-9259-5288
Margaret OlukaDepartment of Pharmacology, Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, University of Nairobi, Nairobi, Kenya.ORCID http://orcid.org/0000-0002-4881-8667
Anastasia GuantaiDepartment of Pharmacology, Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, University of Nairobi, Nairobi, Kenya.
Eleni AklilluDepartment of Global Public Health, Karolinska Institute, Stockholm, Sweden.ORCID http://orcid.org/0000-0002-9788-0790

Funding

European and Developing Countries Clinical Trials Partnership (EDCTP) 2 CSA2016S-1618
6 · The paper itself

Abstract

Continuous professional development among stakeholders involved in drug safety monitoring and surveillance is imperative in strengthening pharmacovigilance (PV) systems. The "Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa" (PROFORMA) project aims to enhance the national PV infrastructure, post-marketing surveillance systems and clinical trial regulatory capabilities in Ethiopia, Tanzania, Kenya and Rwanda. To achieve this, training, including short-term training (STT) activities, at various levels is required. This article aims to describe the experiences of the authors during the development and implementation of STT in an attempt to improve the PV training landscape of these countries. To identify gaps, a baseline assessment of PV teaching and practices at the national medicines regulatory authorities (NMRAs) and medical universities was conducted. Five successive training sessions, tailored to each country's specific needs and regulatory environments, were conducted; three focusing on fundamental concepts in PV and two dedicated to training-of-trainers courses. The training targeted staff from PV units of the NMRAs and medical universities. Enabling participation from all four countries in the same training fostered cross-country learning and collaboration. The contribution of STT to university education and the operational methodologies within NMRAs are explored, showcasing the impact on knowledge transfer and skill development in each country. In conclusion, by investing strategically in STT activities and fostering partnerships with academic institutions and NMRAs, we demonstrated a sustainable approach to PV capacity strengthening in resource-limited settings. The success of this model underscores its potential for adoption and replication across the African continent, offering a valuable framework for strengthening drug safety regulation and ultimately protecting public health.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceCapacity BuildingEthiopiaHumansKenyaProduct Surveillance, PostmarketingRwandaTanzania

Identifiers

PMID39162987
PMCPMC11554700

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.