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

Julia Gabel Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany;

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Micha Lächele Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany;

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Katharina Sander Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany;

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Gesa Gnegel Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany;

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Nkiru Sunny-Abarikwu Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria;

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Rita Ezinwanne Ohazulike Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria;

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Juliet Ngene Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria;

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Jane Frances Chioke Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria;

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Christine Häfele-Abah German Institute for Medical Mission (Difaem), Tübingen, Germany

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Lutz Heide Pharmaceutical Institute, Eberhard Karls University Tübingen, Tübingen, Germany;

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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.

Author Notes

Financial support: This study was funded by the University of Tübingen. The contribution of J. Gabel was funded by the Dr. Hilmer Foundation, Deutsches Stiftungszentrum, Essen, Germany, and the Frankfurt Foundation Quality of Medicines, Frankfurt, Germany. The contribution of G. Gnegel was funded by Cusanuswerk e.V., Bonn, Germany.

Disclosure: The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Authors’ addresses: Julia Gabel, Micha Lächele, Katharina Sander, Gesa Gnegel, Lutz Heide, Pharmaceutical Institute, Eberhard Karls University, Tuebingen, Germany, E-mails: julia.gabel@uni-tuebingen.de, micha-benjamin.laechele@uni-tuebingen.de, katharina.sander@student.uni-tuebingen.de, gesa.gnegel@uni-tuebingen.de, and heide@uni-tuebingen.de. Nkiru Sunny-Abarikwu, Rita Ezinwanne Ohazulike, Juliet Ngene, Jane Frances Chioke, Faith-Based Central Medical Foundation (FBCMF), Enugu, Nigeria, E-mails: pharmenkay@gmail.com, sr.ezinwanne@gmail.com, nnejul@yahoo.com, and srjanefrances@yahoo.com. Christine Häfele-Abah, German Institute for Medical Mission (Difaem), Tübingen, Germany, E-mail: haefele@difaem.de.

Address correspondence to Lutz Heide, Pharmaceutical Institute, Eberhard Karls University Tübingen, Auf der Morgenstelle 8, 72076 Tübingen, Germany. E-mail: heide@uni-tuebingen.de
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