Evidence map›Paper›PMID 34801022›Full record

ArticleBMC health services research2021

Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal.

Washington T Samukange, Verena Kluempers, Manvi Porwal, Linda Mudyiwenyama, Khamusi Mutoti, Noel Aineplan, Helga Gardarsdottir, Aukje K Mantel-Teeuwisse, C Micha Nuebling

Open access · goldAbstract read
In one paragraph

Article in BMC health services research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.1field-weighted citation impact, top 6% of its field
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

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. The Current State of in vitro Diagnostics Evaluation in Sub-Saharan African Countries: Insights from the Advanced Workshop.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Strengthening Blood Regulatory Systems to Tackle Africa's Unmet Needs for Blood and Blood Products.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Review
  8. Article
  9. Article
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

9 authors at 4 institutions in 4 countries.

Washington T SamukangeDivision of Pharmacoepidemiology & Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
Verena KluempersPaul Ehrlich Institut, Langen, Germany.
Manvi PorwalPaul Ehrlich Institut, Langen, Germany.
Linda MudyiwenyamaMedicines Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe.
Khamusi MutotiSouth African Health Products Regulatory Authority (SAHPRA), Pretoria, South Africa.
Noel AineplanNational Drug Authority (NDA), Kampala, Uganda.
Helga GardarsdottirDivision of Pharmacoepidemiology & Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
Aukje K Mantel-TeeuwisseDivision of Pharmacoepidemiology & Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands.
C Micha NueblingPaul Ehrlich Institut, Langen, Germany. micha.nuebling@pei.de.
Paul Ehrlich Institut · DEUtrecht University · NLKampala Capital City Authority · UGZimbabwe National Water Authority · ZW

Funding

Bundesministerium für Gesundheit 323 123002
6 · The paper itself

Abstract

backgroundHaemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from the use of blood and blood components with the aim to improve donor and patient safety. We describe the results of the pilot of the integrated GBT+ Blood for the haemovigilance function in 10 sub-Saharan African countries.

methodsWe piloted the integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) to assess the haemovigilance function of national regulatory authorities (NRAs) in Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. Data obtained from documents and face to face interviews were used to determine the status of implementation and performance of the following six indicators; legal provisions regulations and guidelines, organisation and governance, human resources, regulatory processes, transparency and accountability and finally, monitoring progress and assessing impact, by estimating median scores across 20 sub-indicators. In addition, a cluster analysis was performed.

resultsThe countries showed inter-organisation variability in implementation and performance of the haemovigilance function. The overall median score (all sub-indicators) was 44 % (range: 7.5 % - 70 %). The lowest average performance scores were for the arrangement for effective organisation and coordination (35 %) and human resources (35 %) indicators. The highest average scores were observed for the mechanism to promote transparency and mechanism to monitor regulatory performance indicators (50 % and 60 %, respectively). We identified clusters of best-implemented sub-indicators from the procedures for haemovigilance and poorly implemented sub-indicators from the legal provisions, regulations and guidelines for haemovigilance and human resources.

conclusionsImplementation of sub-indicators and performance of haemovigilance systems varied greatly for all countries with a few countries performing reasonably well in the implementation of some sub-indicators under procedures for haemovigilance. Most countries were poorly implementing sub-indicators in the legal provisions, arrangement for effective organisation and human resources indicators. The legislative provisions in most countries were at a nascent stage. There is a need to set up targeted and customised technical support coupled with prioritised interventions to strengthen the capacities of NRAs.

Indexed as

Blood SafetyEthiopiaHumansKenyaRwandaTanzaniaBlood Regulatory SystemsBlood SafetyGlobal Benchmarking ToolHaemovigilance

Identifiers

PMID34801022
PMCPMC8605544
OpenAlexW3215460507

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.