Evidence map›Paper›PMID 38740019›Full record

ArticleThe American journal of tropical medicine and hygiene2024

Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria.

Julia Gabel, Micha Lächele, Katharina Sander, Gesa Gnegel, Nkiru Sunny-Abarikwu, Rita Ezinwanne Ohazulike, Juliet Ngene, Jane Frances Chioke, Christine Häfele-Abah, Lutz Heide

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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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.

Julia GabelPharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.
Micha LächelePharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.
Katharina SanderPharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.
Gesa GnegelPharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.
Nkiru Sunny-AbarikwuFaith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria.
Rita Ezinwanne OhazulikeFaith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria.
Juliet NgeneFaith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria.
Jane Frances ChiokeFaith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria.
Christine Häfele-AbahGerman Institute for Medical Mission (Difaem), Tübingen, Germany.
Lutz HeidePharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigated the quality of 13 essential medicines in the states of Enugu and Anambra, Nigeria. A total of 260 samples were purchased from licensed pharmaceutical manufacturers and wholesalers and from vendors in pharmaceutical markets with unclear licensing status. Samples were analyzed for identity, content, and dissolution according to the United States Pharmacopeia (USP) 42 monographs. Forty-five samples of this study could be examined for authenticity with the Mobile Authentication Service scheme of the Nigerian National Agency for Food and Drug Administration and Control. Out of all samples, 25.4% did not comply with the USP 42 specifications. Strikingly, 21 out of 22 dexamethasone tablet samples (95%) were out of specification (OOS). Nine out of 19 glibenclamide samples (47%) failed dissolution testing, and 7 out of 17 cotrimoxazole samples (41%) failed assay testing. Medicines against noncommunicable diseases showed a slightly higher percentage of OOS samples than anti-infectives (21.2% versus 17.6%). The rates of OOS samples were similar in medicines stated to be produced in Nigeria, India, and China but were very different between individual manufacturers from each of these countries of origin. Therefore, prequalification of products, manufacturers, and suppliers are very important for quality assurance in medicine procurement. Unexpectedly, the total proportions of OOS samples were similar from licensed vendors (25.2%) and from markets (25.5%). Four samples (1.5%), all collected in markets, were clearly falsified and did not contain the declared active pharmaceutical ingredients. The proportion of falsified medicines was found to be lower than frequently reported in the media for Nigeria.

Indexed as

Drugs, EssentialQuality ControlHumansNigeriaDrugs, Essential

Identifiers

PMID38740019
PMCPMC11229646

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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.