Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period
- Equal contributors
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
Malaria Journal 2012, 11:202 doi:10.1186/1475-2875-11-202Published: 15 June 2012
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.
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 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.
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.