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

Victor S Pribluda1*, Adrian Barojas1, Arletta Añez2, Cecilia G López3, Ruth Figueroa4, Roxana Herrera5, Gladys Nakao6, Fernando HA Nogueira7, Gerson A Pianetti7, Marinete M Povoa8, Giselle MR Viana8, Margarete S Mendonça Gomes9, Jose P Escobar10, Olga L Muñoz Sierra11, Susana P Rendon Norena11, Raúl Veloz12, Marcy Silva Bravo12, Martha R Aldás13, Alison HindsSemple14, Marilyn Collins14, Nicolas Ceron15, Karanchand Krishnalall16, Malti Adhin17, Gustavo Bretas18, Nelly Hernandez19, Marjorie Mendoza19, Abdelkrim Smine20, Kennedy Chibwe1, Patrick Lukulay1 and Lawrence Evans1

  • * Corresponding author: Victor S Pribluda vsp@usp.org

  • † Equal contributors

Author Affiliations

1 Promoting the Quality of Medicines Program, United States Pharmacopeia, Rockville, MD, 20852, USA

2 Pan American Health Organization, La Paz, Bolivia

3 Laboratorio de Control de Calidad de Medicamentos y Toxicología, Instituto Nacional de Laboratorios de Salud, La Paz, Bolivia

4 Gerencia de Salud- Yacuiba, Tarija, Bolivia

5 Servicio Departamental de Salud, Pando, Bolivia

6 Gerencia De Salud, Riberalta, Beni, Bolivia

7 Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

8 Laboratório de Pesquisas Básicas em Malária do Instituto Evandro Chagas, Pará, Brazil

9 Laboratório de Controle da Qualidade de Medicamentos do Laboratório Central de Saúde Pública do Amapá, Amapá, Brazil

10 Pan American Health Organization, Bogotá, Colombia

11 Laboratorio Departamental de Salud Pública, Antioquia, Medellín, Colombia

12 Servicio Nacional de Control de Enfermedades Transmitidas por Vectores Artrópodos, Quito, Ecuador

13 Instituto Nacional de Higiene y Medicina Tropical “Leopoldo Izquieta Pérez”, Guayaquil, Ecuador

14 Food and Drug Department, Ministry of Health, Georgetown, Guyana

15 Pan American Health Organization, Georgetown, Guyana

16 Chief Inspector, Vector Control Unit, Ministry of Health, Georgetown, Guyana

17 Department of Medical Chemistry, Anton de Kom (ADEK) University of Suriname, Paramaribo, Suriname

18 Pan American Health Organization, Quito, Ecuador

19 Dirección General de Salud Ambiental, Ministerio del Poder Popular para la Salud, Caracas, Venezuela

20 Consultant to the Promoting the Quality of Medicines Program, Casablanca, Morocco

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Malaria Journal 2012, 11:202  doi:10.1186/1475-2875-11-202

Published: 15 June 2012

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 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.

Conclusions

Basic 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.