Abstract
BackgroundRecent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, but also illustrated the major geographical gaps in data on anti-malarial drug quality from endemic countries. Data are particularly scarce from Central Africa, although it carries the highest burden of malaria. The aim of this medicine quality field survey was to determine the prevalence of poor-quality anti-malarial drugs in Gabon.MethodsA field survey of the quality of anti-malarial drugs in Gabonese pharmacies was conducted using the Global Pharma Health Fund Minilab® tests, following the Medicine Quality Assessment Reporting Guidelines. Anti-malarial drugs were purchased randomly from selected pharmacies in Gabon. Semi-quantitative thin-layer chromatography (TLC) and disintegration testing were carried out to measure the concentration of active pharmaceutical ingredients (APIs). The samples failing the TLC test were analysed by high-performance liquid chromatography. Following the collection of anti-malarial drugs, a street survey was conducted to understand where people purchase their anti-malarial drugs.ResultsA total of 432 samples were purchased from 41 pharmacies in 11 cities/towns in Gabon. The prevalence of poor-quality anti-malarial drugs was 0.5% (95% CI 0.08–1.84%). Two out of 432 samples failed the MiniLab® semi-quantitative TLC test, of which a suspected artemether-lumefantrine (AL) sample was classified as falsified and one sulfadoxine-pyrimethamine (SP) sample as substandard. High performance liquid chromatography with ultraviolet photo diode array detection analysis confirmed the absence of APIs in the AL sample, and showed that the SP sample did contain the stated APIs but the amount was half the stated dose. Of the people interviewed, 92% (187/203) purchased their anti-malarial drugs at a pharmacy.ConclusionUsing the GPHF Minilab®, the prevalence of poor-quality anti-malarial drugs is far lower than anticipated. The findings emphasize the need for randomized and robust sampling methods in order to collect representative data on anti-malarial drug quality.Trial registration: NTR4341 (Dutch Trial Registry)Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-015-0795-z) contains supplementary material, which is available to authorized users.
Highlights
Recent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, and illustrated the major geographical gaps in data on anti-malarial drug quality from endemic coun‐ tries
Low concentrations of active pharmaceutical ingredient (API) in poor-quality drugs will result in sub-therapeutic concentrations of the drug in vivo, which may contribute to the selection of resistant parasites [9]
The population of Gabon is estimated to be around 1.6 million inhabitants (6.3 inhabitants/km2), 86.2% of whom live in urban areas
Summary
Recent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, and illustrated the major geographical gaps in data on anti-malarial drug quality from endemic coun‐ tries. Data are scarce from Central Africa, it carries the highest burden of malaria The aim of this medicine quality field survey was to determine the prevalence of poor-quality anti-malarial drugs in Gabon. In Gabon, the majority of anti-malarial drugs are purchased directly by the patient or caretaker from the pharmacy (licensed and unlicensed) for self- or home treatment. The national malaria control programme of Gabon does not provide anti-malarials for free. Whether quality assured or falsified, anti-malarial drugs have not been reported from the Gabonese markets as from the neighbouring countries. Poor-quality anti-malarial drugs have serious consequences for public health [5]. The use of poor-quality anti-malarial drugs leads to financial loss for patients and their families, healthcare systems and pharmaceutical companies producing the genuine product [10]. The general public can lose confidence in a pharmaceutical brand, drugs, pharmacies, and healthcare providers [11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
