Evidence map›Paper›PMID 36167960›Full record

ArticleScientific reports2022

Effectiveness of a structured stimulated spontaneous safety monitoring of medicines reporting program in strengthening pharmacovigilance system in Tanzania.

Kissa W Mwamwitwa, Adam M Fimbo, Elias M Bukundi, Alex F Nkayamba, Deus Buma, Eva P Muro, Betty A Maganda, Danstan H Shewiyo, Morven C Shearer, Andrew D Smith and 1 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 37% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Improving adverse drug event reporting by healthcare professionals.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. 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

11 authors at 4 institutions in 2 countries.

Kissa W MwamwitwaPharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, 65545, Dar es Salaam, Tanzania. ki313ssa@yahoo.com.ORCID 0000-0001-9106-6707
Adam M FimboTanzania Medicines and Medical Devices Authority, 77150, Dar es Salaam, Tanzania.
Elias M BukundiMuhimbili University of Health and Allied Sciences, 65001, Dar es Salaam, Tanzania.
Alex F NkayambaTanzania Medicines and Medical Devices Authority, 77150, Dar es Salaam, Tanzania.
Deus BumaDepartment of Pharmacy, Muhimbili National Hospital, 65000, Dar es Salaam, Tanzania.
Eva P MuroKilimanjaro Christian Medical University College, 2240, Moshi, Kilimanjaro, Tanzania.
Betty A MagandaDepartment of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences, 65013, Dar es Salaam, Tanzania.
Danstan H ShewiyoTanzania Medicines and Medical Devices Authority, 77150, Dar es Salaam, Tanzania.
Morven C ShearerSchool of Medicine, University of St. Andrews, Fife, KY16 9TF, Scotland, UK.
Andrew D SmithSchool of Chemistry, University of St. Andrews, Fife, KY16 9TF, Scotland, UK.
Eliangiringa A KaalePharm R&D Lab and Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, 65545, Dar es Salaam, Tanzania.
Muhimbili University of Health and Allied Sciences · TZUniversity of St Andrews · GBKilimanjaro Christian Medical Centre · TZMuhimbili National Hospital · TZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Under-reporting of adverse drug events (ADEs) is a challenge facing developing countries including Tanzania. Given the high magnitude of under-reporting, it was necessary to develop and assess the effectiveness of a 'structured stimulated spontaneous safety monitoring' (SSSSM) reporting program of ADEs which aimed at strengthening pharmacovigilance system in Tanzania. A quasi-experimental design and data mining technique were used to assess the effect of intervention after the introduction of program in seven tertiary hospitals. ADEs reports were collected from a single group and compared for 18 months before (July 2017 to December, 2018) and after the program (January 2019 to June 2020). Out of 16,557 ADEs reports, 98.6% (16,332) were reported after intervention and 0.1% (23) death related to adverse drug reactions (ADRs) were reported. Reports increased from 20 to 11,637 after intervention in Dar es salaam, 49 to 316 in Kilimanjaro and 17 to 77 in Mbeya. The population-based reporting ratio per 1,000,000 inhabitants increased from 2 reports per million inhabitants in 2018 to 85 reports in 2019. The SSSSM program can increase the reporting rate of ADEs and was useful in detecting signals from all types of medicines. This was first effective developed spontaneous program to monitor medicine safety in Tanzania.

Indexed as

Drug-Related Side Effects and Adverse ReactionsPharmacovigilanceAdverse Drug Reaction Reporting SystemsData MiningHumansTanzania

Identifiers

PMID36167960
PMCPMC9515199
OpenAlexW4297326457

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.