Evidence map›Paper›PMID 33671293›Full record

ArticleInternational journal of environmental research and public health2021

Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa-Ethiopia, Kenya, Rwanda, and Tanzania.

Abbie Barry, Sten Olsson, Christabel Khaemba, Joseph Kabatende, Tigist Dires, Adam Fimbo, Omary Minzi, Emile Bienvenu, Eyasu Makonnen, Appolinary Kamuhabwa and 8 more

Abstract read
In one paragraph

Article in International journal of environmental research and public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Drug Safety Monitoring in Health Programs of Cameroon.Journal of pharmacovigilance · 2022
    Article
  13. An observational assessment of the safety of mass drug administration for trachoma in Ethiopian children.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2022
    Observational
  14. Article
  15. 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

18 authors.

Abbie BarryDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden.ORCID 0000-0002-3859-3660
Sten OlssonDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden.ORCID 0000-0002-6078-0649
Christabel KhaembaPharmacy and Poisons Board, Kenya Lenana Road, P.O. Box 27663-00506 Nairobi, Kenya.ORCID 0000-0003-0543-9920
Joseph KabatendeRwanda Food and Drugs Authority, Nyarutarama Plaza, KG 9 Avenue Kigali, Rwanda.ORCID 0000-0002-3718-3213
Tigist DiresEthiopian Food and Drug Authority, Africa Avenue, Kirkos Sub City, P.O. Box 5681 Addis Ababa, Ethiopia.
Adam FimboTanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania.
Omary MinziDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013 Dar es Salaam, Tanzania.
Emile BienvenuCollege of Medicine and Health Sciences, University of Rwanda, KK 737 Kigali, Rwanda.
Eyasu MakonnenDepartment of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, P.O. Box 9086 Addis Ababa, Ethiopia.ORCID 0000-0002-9259-5288
Appolinary KamuhabwaDepartment of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013 Dar es Salaam, Tanzania.
Margaret OlukaDepartment of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya.
Anastasia GuantaiDepartment of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya.
Eugène van PuijenbroekPharmacovigilance Centre Lareb, 5237 MH 's-Hertogenbosch, The Netherlands.
Ulf BergmanDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden.
Alex NkayambaTanzania Medicines and Medical Devices Authority, Off Mandela Road, Mabibo, P.O. Box 77150 Dar Es Salaam, Tanzania.
Michael MugishaCollege of Medicine and Health Sciences, University of Rwanda, KK 737 Kigali, Rwanda.
Parthasarathi GurumurthyPharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, P.O. Box 505155 Gaborone, Botswana.ORCID 0000-0002-5997-1157
Eleni AklilluDivision of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institute, Karolinska University Hospital Huddinge, 141 86 Stockholm, Sweden.ORCID 0000-0002-9788-0790

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Indexed as

Neglected DiseasesPharmacovigilanceEthiopiaHumansKenyaRwandaTanzaniaEast Africamedicine safetyNeglected Tropical Diseases Programpharmacovigilancepublic health program

Identifiers

PMID33671293
PMCPMC7922898

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.