Abstract

BackgroundEvaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices. However, larger distribution chain supply in developing countries such as Cameroon is often challenged by counterfeit drugs, poor manufacturing, storage and degradation leading to health and patient adverse consequences. Yet, access to supply chain management in strengthening ARVs quality assurance and outcomes remains poorly documented. More than 53,000 patients have been enrolled on free ARVs medications, but little is documented on quality assurance and validity of safety for affected populations along the supply chain management since 2008.MethodsThe cross sectional study was conducted in ARVs distribution units and centers in central, littoral and south west regions of Cameroon. ARVs drugs samples included Nevirapine, Efavirenz, and fixed dose combinations of Zidovudine + Lamivudine, Lamivudine + Stavudine and Zidovudine + Lamivudine + Nevirapine. Drugs packaging and labeling was assessed and galenic assays were performed at National Laboratory of quality Control of Medications and Expertise (LANACOME), Yaoundé, Cameroon.ResultsThe study covered 16 structures located in eight different towns including the central ARVs store, two regional pharmaceutical procurement centers and thirteen HIV approved treatment centers and management units. A total of 35 ARVs products were collected. Only eight ARVs drugs containing Lamivudine and Stavudine presented with white stains on tablets, however these drugs were standard for all other tests performed. The others 28 ARVs products were standards to all assays performed.ConclusionWe concluded that ARVs drugs freely accessible and distributed to PLWHA are of good quality in Cameroon. However, with the increase number of patients under HAART since 2013, adoption of “Test and Treat” approach to reach the 90-90-90 goals and with the implementation of new national antiretroviral regimen guidelines and molecules such as boosted protease inhibitors, continuous quality control and assurance surveillance, monitoring and evaluation is recommended. Assessment of quality of formulations that are more susceptible to degradation such as pediatric formulations for averting the rising multidrug resistance trend is also desired.

Highlights

  • Evaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices

  • While on the other hand, the effective use and compliance to highly active antiretroviral therapy (HAART) and HIV service delivery have shown to significantly reduce morbidity and mortality in people living with HIV/AIDS (PLHA) by preventing relapse and opportunistic infections as well as improvement of quality of life and productivity of patients [17,18,19]

  • In Cameroon, data and information related to ARVs quality is based on a 2005 joint project in seven African countries [20] with the adoption and implementation of free ARVs treatment since 2008, thousands of people living with HIV/AIDS (PLWHA) are under HAARVs in the country

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Summary

Introduction

Evaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices. It is documented that counterfeit drugs, poor manufacturing and unregulated drugs are found or reported in most developing countries including Cameroon [4] This situation is worsened by multifactorial challenges and issues including the lack of competent local regulatory authorities, lack or inexistent drugs quality control laboratories, and poverty related socio-economic factors [6,7,8]. These gaps explain why sub standards medications may be found in legal drug supply chain [9, 10]. In Cameroon, data and information related to ARVs quality is based on a 2005 joint project in seven African countries [20] with the adoption and implementation of free ARVs treatment since 2008, thousands of people living with HIV/AIDS (PLWHA) are under HAARVs in the country

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