Assessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab®: a field study

Malaria Journal

Research

Emmanuel Bache¹  Judith Mougoula¹  Selidji T Agnandji²  Harparkash Kaur³  Michèle van Vugt⁴  Jimmy Boersma⁴  Rieke Vingerling⁵  Daniëlle Kroon⁵  Benjamin J Visser⁶  Martin P Grobusch⁶  Janneke Meerveld-Gerrits⁷ 

[1] Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon;Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon;Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany;Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK;Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, PO Box 22700, Meibergdreef 9, 1100 DE, Amsterdam, The Netherlands;Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, PO Box 22700, Meibergdreef 9, 1100 DE, Amsterdam, The Netherlands;Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon;Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, PO Box 22700, Meibergdreef 9, 1100 DE, Amsterdam, The Netherlands;Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon;Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany;Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, PO Box 22700, Meibergdreef 9, 1100 DE, Amsterdam, The Netherlands;Department of Pharmaceutical Technology and Biopharmacy, Utrecht University, Utrecht, The Netherlands;

关键词: Artemisinin combination therapy (ACT);    Central Africa;    Counterfeit;    Falsified;    Field survey;    Gabon;    Malaria;    Medicine quality;    MEDQUARG;    Sub-standard;   

DOI  :  10.1186/s12936-015-0795-z

 received in 2015-04-19, accepted in 2015-07-03,  发布年份 2015

来源: Springer

【 摘 要 】

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)

【 授权许可】

CC BY   
© Visser et al. 2015