Evaluating the Quality of Anti-Hypertensive Drugs in Lagos State, Nigeria

Abstract

<p>ABSTRACT</p><p>Background</p><p>As the burden of non-communicable diseases grows, access safe to medical therapy is increasing in importance. The aim of this study was to develop a methodology for establishing the prevalence of the quality of anti-hypertensive drugs and to examine whether this prevalence varies by socio-economic variables.</p><p>Methods</p><p>Through a cross-sectional survey study design, 6 local government areas(LGA) in Lagos State,Nigeria were sampled. A list of all registered pharmacies in the state, derived from the Pharmacists Council of Nigeria, was used in the sampling process. A mystery shopper randomly purchased 102 samples (14 brands) of the antihypertensive nifedipine from 17 pharmacies in each of the six LGA in Lagos State. Definitive drug quality was assessed through High-Performance Lipid Chromatography (HPLC). The quality assessment comprised two main domains; the level of active pharmaceutical ingredients (API) was used to identify falsely labelled drugs whereas the amounts of impurities revealed substandard drug samples. Good quality drugs met specifications for both the API and impurities.</p><p>Results</p><p>Seventy-eight (76%) drug samples did not meet both quality standards. Of the 30 falsely labelled drugs,17(56.67%) emanated from LGA categorized as low social economic status or hard-to-reach, 18( 60%) were manufactured in Asia and had a price average of 375.67 Nigerian Naira(NGN).Seventy six(74.51%) drug samples were substandard with 40(52.63%) drug samples emanating from high social economic status LGA,37(48.68%) were manufactured in Asia and had a price average of 383.33 NGN.</p><p>Of the 102 samples collected, 24 (23.53%) complied with both tolerance limits; 72 (70.59%) met the active pharmaceutical ingredient standards; and 26 (25.49%) met the drug purity standards. Most of the good quality drug samples, 14(58.33%),were from low social economic status LGA,15 (62.5%) were manufactured in Asia and had a price average of 375.67 NGN.</p><p>Conclusion</p><p>We found a high prevalence of falsely labeled and substandard drug samples with only 24(23.53%) having good quality. To treat non-communicable diseases, we need efforts to monitor and assure drug quality for populations.</p>