Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

• Published in: Malaria Journal
• Main Authors: Pribluda Victor S, Barojas Adrian, Añez Arletta, López Cecilia G, Figueroa Ruth, Herrera Roxana, Nakao Gladys, Nogueira Fernando HA, Pianetti Gerson A, Povoa Marinete M, Viana Giselle MR, Gomes Margarete S, Escobar Jose P, Sierra Olga L, Norena Susana P, Veloz Raúl, Bravo Marcy, Aldás Martha R, HindsSemple Alison, Collins Marilyn, Ceron Nicolas, Krishnalall Karanchand, Adhin Malti, Bretas Gustavo, Hernandez Nelly, Mendoza Marjorie, Smine Abdelkrim, Chibwe Kennedy, Lukulay Patrick, Evans Lawrence
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2012
• Subjects: Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/1475-2875-11-202; https://doaj.org/article/1418cc14d7c74ba48b88251f838ff4b4

Abstract Background Ensuring 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. Methods Trained 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. Results Results 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 ...