Anti-malarial drug quality in Lagos and Accra - a comparison of various quality assessments

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.

A pilot study on quality of artesunate and amodiaquine tablets used in the fishing community of Tema, Ghana

“…However, further analysis of the tablets found some with less active ingredient (substandard). It is important to note that anecdotal evidence from some markets supports the outcome of this work [16]. It has been determined that counterfeiters include small amounts of the active ingredient in order to pass basic qualitative test, which identifies the presence of API only and not the amount.…”

“…In Ghana, the extent of substandard or counterfeit anti-malarial drugs has been evaluated in the major cities of Accra and Kumasi, with a reported low failure rates in all types of anti-malarials in 2010 to 54% of 2007 findings [16-18]. However, the extent of counterfeit or substandard drugs in fishing village settings in Ghana has not been assessed because information and drug regulatory enforcement is unavailable.…”

Does price reveal poor-quality drugs? Evidence from 17 countries

“…Some of these pharmacological data have been previously published in the literature (Bate et al, 2008(Bate et al, , 2009a(Bate et al, ,b, 2010aBate and Hess, 2010). We do not have access to a compendial laboratory to assess all possible problems with medicines, hence some medicines could pass all of the above tests but still fail certain tests for solubility, permeability, product degradation, trace element contamination and pathogenic contamination.…”

Medicine registration and medicine quality: a preliminary analysis of key cities in emerging markets

“…The brand effects could reflect certain poor-quality manufacturers or the location of manufacture (as many of the medicines procured were not domestically produced). Furthermore, medicines collected in 2007 in Africa performed worse than those collected in 2010, 7 and improved performance could reflect more medicines being registered; this temporal effect will be analyzed in future research. As the earlier collection consisted of only antimalarials, this could be another reason for poorer performance of this medicine type.…”

“…Some of these data have been previously published in the literature. [6][7][8] Registration status was determined after quality testing to eliminate possible bias. Not all medicines were procured from countries where it was possible to ascertain whether they were registered by the local competent authority.…”