Mind the gaps - the epidemiology of poor-quality anti-malarials in the malarious world - analysis of the WorldWide Antimalarial Resistance Network database

Malaria Journal

Research

Michael Green¹  Facundo M Fernández²  Philippe J Guerin³  Patricia Tabernero⁴  Paul N Newton⁵ 

[1] Division of Parasitic Diseases and Malaria, US Centre for Disease Control and Prevention, Atlanta, GA, USA;School of Chemistry & Biochemistry, Georgia Institute of Technology, Atlanta, GA, USA;Worldwide Antimalarial Resistance Network (WWARN), Churchill Hospital, University of Oxford, Oxford, UK;Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, UK;Worldwide Antimalarial Resistance Network (WWARN), Churchill Hospital, University of Oxford, Oxford, UK;Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, UK;Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR;Worldwide Antimalarial Resistance Network (WWARN), Churchill Hospital, University of Oxford, Oxford, UK;Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, UK;Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR;London School of Hygiene and Tropical Medicine, London, England, UK;

关键词: Malaria;    Active Pharmaceutical Ingredient;    Artesunate;    Artemisinin Combination Therapy;    Chemical Analysis Technique;   

DOI  :  10.1186/1475-2875-13-139

 received in 2013-12-16, accepted in 2014-03-10,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundPoor quality medicines threaten the lives of millions of patients and are alarmingly common in many parts of the world. Nevertheless, the global extent of the problem remains unknown. Accurate estimates of the epidemiology of poor quality medicines are sparse and are influenced by sampling methodology and diverse chemical analysis techniques. In order to understand the existing data, the Antimalarial Quality Scientific Group at WWARN built a comprehensive, open-access, global database and linked Antimalarial Quality Surveyor, an online visualization tool. Analysis of the database is described here, the limitations of the studies and data reported, and their public health implications discussed.MethodsThe database collates customized summaries of 251 published anti-malarial quality reports in English, French and Spanish by time and location since 1946. It also includes information on assays to determine quality, sampling and medicine regulation.ResultsNo publicly available reports for 60.6% (63) of the 104 malaria-endemic countries were found. Out of 9,348 anti-malarials sampled, 30.1% (2,813) failed chemical/packaging quality tests with 39.3% classified as falsified, 2.3% as substandard and 58.3% as poor quality without evidence available to categorize them as either substandard or falsified. Only 32.3% of the reports explicitly described their definitions of medicine quality and just 9.1% (855) of the samples collected in 4.6% (six) surveys were conducted using random sampling techniques. Packaging analysis was only described in 21.5% of publications and up to twenty wrong active ingredients were found in falsified anti-malarials.ConclusionsThere are severe neglected problems with anti-malarial quality but there are important caveats to accurately estimate the prevalence and distribution of poor quality anti-malarials. The lack of reports in many malaria-endemic areas, inadequate sampling techniques and inadequate chemical analytical methods and instrumental procedures emphasizes the need to interpret medicine quality results with caution. The available evidence demonstrates the need for more investment to improve both sampling and analytical methodology and to achieve consensus in defining different types of poor quality medicines.

【 授权许可】

CC BY   
© Tabernero et al.; licensee BioMed Central Ltd. 2014