Evidence map›Paper›PMID 39353417›Full record

ArticleThe American journal of tropical medicine and hygiene2024

A Comprehensive Assessment of Quality of Antimalarial Medicines in Mainland Tanzania: Insights from Five Years of Postmarket Surveillance.

Eulambius M Mlugu, Jacob Mhagama, Damas Matiko, Siya Agustine, Moses Nandonde, Emmanuel Masunga, Peter P Kunambi, Raphael Zozimus Sangeda, Yonah H Mwalwisi, Adam Fimbo

Abstract read
In one paragraph

Article in The American journal of tropical medicine and hygiene, 2024. 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
–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

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

  1. 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

10 authors.

Eulambius M MluguDepartment of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Jacob MhagamaTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Damas MatikoTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Siya AgustineTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Moses NandondeTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Emmanuel MasungaTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Peter P KunambiDepartment of Clinical Pharmacology, School of Biomedical Sciences, Campus College of Medicine, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.
Raphael Zozimus SangedaDepartment of Pharmaceutical Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Yonah H MwalwisiTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.
Adam FimboTanzania Medicines and Medical Devices Authority, Dodoma, Tanzania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sustainable access to high-quality antimalarial medicines is pivotal to achieving universal and effective malaria control. Poor-quality antimalarial medicines are prevalent in sub-Saharan Africa, impeding malaria control initiatives and claiming the lives of many children. Regular monitoring of the quality of antimalarial medicines is crucial to ensure the quality of service to the community. A cross-sectional study using a postmarket surveillance (PMS) approach was conducted from 2019 to 2023. Samples were collected from the port of entry, local manufacturers, and various distribution outlets in 15 regions of mainland Tanzania. The samples were subjected to tier 1 evaluation, comprising a product information review (PIR) and identification using the Global Pharma Health Fund-Minilab® techniques. Samples that failed the identification tests and 10% of the samples from distribution outlets that passed the tests were subjected to confirmatory testing (tier 2), which included assays, related substances, dissolution, and sterility per the pharmacopeial monographs. During five annual PMSs, 2,032 antimalarial samples were collected and subjected to quality tests. All samples complied with the standard specifications for identity, dissolution, related substances, sterility, physical evaluation, disintegration, and assay. A total of 292 (55.5%) tested samples failed the PIR evaluation, with incomplete package information in leaflets contributing to 64.7% of all deviations. Antimalarial medicines circulating in the mainland Tanzanian market meet expected quality standards. Continuous monitoring of the quality of antimalarial medicines is recommended.

Indexed as

AntimalarialsProduct Surveillance, PostmarketingCross-Sectional StudiesHumansMalariaQuality ControlTanzaniaAntimalarials

Identifiers

PMID39353417
PMCPMC11619501

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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.