Ref: Gabel J, Lächele M, Sander K, Gnegel G, et al. Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria. Am J Trop Med Hyg. 2024 May 14:tpmd230837. doi: 10.4269/ajtmh.23-0837.
Dear Friends,
This research paper on quality of medicines in Nigeria is an interesting reading for regulators, purchasers, researchers planning to conduct similar surveys, and others in pharmaceutical systems. Here below, a short summary of methods and main findings:
The University of Tübingen (Germany) and the Faith-Based Central Medical Foundation in Enugu (Nigeria) cooperated in a medicine quality study in two states of Nigeria. 260 samples of essential medicines were purchased from licensed pharmaceutical manufacturers/wholesalers and from unlicensed pharmaceutical markets. Of all samples, 25.4% did not comply with the pharmacopeial specifications for assay and/or for dissolution. Unexpectedly, the proportion of out-of-specification (OOS) samples was similar in licensed vendors (25.2%) and in informal markets (25.5%). The NAFDAC (which has regulatory maturity level 3 since 2022) was informed and organized batch recalls. Strikingly, 21 out of 22 dexamethasone tablet samples were OOS. The high demand of this product during COVID could represent a factor triggering the high prevalence of SF products.
While most of the collected samples carried a NAFDAC registration number, only 39% of these numbers could be verified in NAFDAC’s online Registered Drug Product Database. Even among the 96 samples which could be verified, 19% were OOS.
NAFDAC has instituted an interesting medicine package serialization project called the Mobile Authentication Service (MAS) scheme. However, out of the 131 anti-infective medicine samples which should carry a MAS PIN code, only 29% did indeed carry it. None of SMS text messages received from the MAS scheme conformed to the NAFDAC’s MAS guideline, and they were incorrect in four cases.
Four of the 260 samples (1.5%), all collected in markets, were falsified; they did not contain the declared active pharmaceutical ingredients.
Have a nice reading,
Raffaella
2024 AJTMH Quality EMs from Different Sources in Nigeria.pdf (3.68 MB)