Abstract

BackgroundTwo major cities in West Africa, Accra, the capital of Ghana, and Lagos, the largest city of Nigeria, have significant problems with substandard pharmaceuticals. Both have actively combated the problem in recent years, particularly by screening products on the market using the Global Pharma Health Fund e.V. Minilab® protocol. Random sampling of medicines from the two cities at least twice over the past 30 months allows a tentative assessment of whether improvements in drug quality have occurred. Since intelligence provided by investigators indicates that some counterfeit producers may be adapting products to pass Minilab tests, the results are compared with those from a Raman spectrometer and discrepancies are discussed.MethodsBetween mid-2007 and early-2010, samples of anti-malarial drugs were bought covertly from pharmacies in Lagos on three different occasions (October 2007, December 2008, February 2010), and from pharmacies in Accra on two different occasions (October 2007, February 2010). All samples were tested using the Minilab® protocol, which includes disintegration and active ingredient assays as well as visual inspection, and most samples were also tested by Raman spectrometry.ResultsIn Lagos, the failure rate in the 2010 sampling fell to 29% of the 2007 finding using the Minilab® protocol, 53% using Raman spectrometry, and 46% using visual inspection. In Accra, the failure rate in the 2010 sampling fell to 54% of the 2007 finding using the Minilab® protocol, 72% using Raman spectrometry, and 90% using visual inspection.ConclusionsThe evidence presented shows that drug quality is probably improving in both cities, especially Lagos, since major reductions of failure rates over time occur with all means of assessment. Many more samples failed when examined by Raman spectrometry than by Minilab® protocol. The discrepancy is most likely caused by the two techniques measuring different aspects of the medication and hence the discrepancy may be the natural variation in these techniques. But other explanations are possible and are discussed.

Highlights

  • Two major cities in West Africa, Accra, the capital of Ghana, and Lagos, the largest city of Nigeria, have significant problems with substandard pharmaceuticals

  • The reduction in failure rates identified by the Minilab in Accra and Lagos appears to be good news: the obvious implication, if the data reflect a wider phenomenon, is that anti-malarial drug quality is improving in these cities

  • Since all chosen drug quality assessment methods show a reduction in failure rates, it is reasonable to conclude that the quality of anti-malarial drugs in the two cities has probably improved between October 2007 and February 2010

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Summary

Introduction

Two major cities in West Africa, Accra, the capital of Ghana, and Lagos, the largest city of Nigeria, have significant problems with substandard pharmaceuticals Both have actively combated the problem in recent years, by screening products on the market using the Global Pharma Health Fund e.V. Minilab® protocol. The dangers of substandard drugs Substandard drugs can be lethal; diseases like malaria kill rapidly, and without effective drugs, death for a small percentage can come quickly In addition to this problem, the Plasmodium parasite which causes malaria, adapts over time, becoming resistant to previously effective drugs. This adaptation is accelerated if the treatments are substrength - either low active ingredient, or low availability of active ingredient due to poor formulation or product degradation. According to NAFDAC's Elizabeth Awagu, this deployment is helping to close down more of those locations still selling fake products

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