Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 20052010 period
Pribluda, Victor S; Barojas, Adrian; Añez, Arletta; López, Cecilia G; Figueroa, Ruth; Herrera, Roxana; Nakao, Gladys; Nogueira, Fernando H. A; Pianetti, Gerson A; Povoa, Marinete M; Viana, Giselle M. R; Gomes, Margarete S Mendonça; Escobar, Jose P; Sierra, Olga L Muñoz; Norena, Susana P. Rendon; Veloz, Raúl; Bravo, Marcy Silva; Aldás, Martha R; Semple, Alison Hinds; Collins, Marilyn; Ceron, Nicolas; Krishnalall, Karanchand; Adhin, Malti; Bretas, Gustavo; Hernandez, Nelly; Mendoza, Marjorie; Smine, Abdelkrim; Chibwe, Kennedy; Lukulay, Patrick; Evans III, Lawrence.
Malar. j
; 11(202): 1-11, 2012. tab
Artículo
en Inglés
| BVSDIP, FIOCRUZ | ID: dip-3331
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 skilledlabour; yet, these tests provide reproducible data and information on several critical quality attributes, such asidentity, purity, content, and disintegration. Visual and physical inspection also provides valuable information aboutthe manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detectcounterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistanceto Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism toassess 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 countrys 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 recommendedto store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, suchas disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory...(AU)
Biblioteca responsable:
BR275.1
Ubicación: BR275.1; PCIEC2012
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