Malaria Journal | |
Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period | |
Research | |
Karanchand Krishnalall1  Abdelkrim Smine2  Malti Adhin3  Nelly Hernandez4  Marjorie Mendoza4  Gerson A Pianetti5  Fernando HA Nogueira5  Alison HindsSemple6  Marilyn Collins6  Gladys Nakao7  Ruth Figueroa8  Martha R Aldás9  Olga L Muñoz Sierra1,10  Susana P Rendon Norena1,10  Cecilia G López1,11  Margarete S Mendonça Gomes1,12  Marinete M Povoa1,13  Giselle MR Viana1,13  Jose P Escobar1,14  Nicolas Ceron1,15  Arletta Añez1,16  Gustavo Bretas1,17  Adrian Barojas1,18  Patrick Lukulay1,18  Kennedy Chibwe1,18  Lawrence Evans1,18  Victor S Pribluda1,18  Roxana Herrera1,19  Raúl Veloz2,20  Marcy Silva Bravo2,20  | |
[1] Chief Inspector, Vector Control Unit, Ministry of Health, Georgetown, Guyana;Consultant to the Promoting the Quality of Medicines Program, Casablanca, Morocco;Department of Medical Chemistry, Anton de Kom (ADEK) University of Suriname, Paramaribo, Suriname;Dirección General de Salud Ambiental, Ministerio del Poder Popular para la Salud, Caracas, Venezuela;Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil;Food and Drug Department, Ministry of Health, Georgetown, Guyana;Gerencia De Salud, Riberalta, Beni, Bolivia;Gerencia de Salud- Yacuiba, Tarija, Bolivia;Instituto Nacional de Higiene y Medicina Tropical “Leopoldo Izquieta Pérez”, Guayaquil, Ecuador;Laboratorio Departamental de Salud Pública, Antioquia, Medellín, Colombia;Laboratorio de Control de Calidad de Medicamentos y Toxicología, Instituto Nacional de Laboratorios de Salud, La Paz, Bolivia;Laboratório de Controle da Qualidade de Medicamentos do Laboratório Central de Saúde Pública do Amapá, Amapá, Brazil;Laboratório de Pesquisas Básicas em Malária do Instituto Evandro Chagas, Pará, Brazil;Pan American Health Organization, Bogotá, Colombia;Pan American Health Organization, Georgetown, Guyana;Pan American Health Organization, La Paz, Bolivia;Pan American Health Organization, Quito, Ecuador;Promoting the Quality of Medicines Program, United States Pharmacopeia, 20852, Rockville, MD, USA;Servicio Departamental de Salud, Pando, Bolivia;Servicio Nacional de Control de Enfermedades Transmitidas por Vectores Artrópodos, Quito, Ecuador; | |
关键词: Malaria; Informal Sector; Active Pharmaceutical Ingredient; Confirmatory Testing; Artesunate; | |
DOI : 10.1186/1475-2875-11-202 | |
received in 2012-04-04, accepted in 2012-06-15, 发布年份 2012 | |
来源: Springer | |
【 摘 要 】
BackgroundEnsuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions.MethodsTrained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country’s Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory.ResultsResults were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years.ConclusionsBasic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.
【 授权许可】
CC BY
© Pribluda et al.; licensee BioMed Central Ltd. 2012
【 预 览 】
Files | Size | Format | View |
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RO202311107706377ZK.pdf | 336KB | download |
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