Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005-2010 period.
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.
Promoting the Quality of Medicines Program, United States Pharmacopeia, Rockville, MD 20852, USA. vsp@usp.org
Victor S
VS
Pribluda
Adrian
A
Barojas
Arletta
A
Añez
Cecilia G
CG
López
Ruth
R
Figueroa
Roxana
R
Herrera
Gladys
G
Nakao
Fernando Ha
FH
Nogueira
Gerson A
GA
Pianetti
Marinete M
MM
Povoa
Giselle Mr
GM
Viana
Margarete S Mendonça
MS
Gomes
Jose P
JP
Escobar
Olga L Muñoz
OL
Sierra
Susana P Rendon
SP
Norena
Raúl
R
Veloz
Marcy Silva
MS
Bravo
Martha R
MR
Aldás
Alison
A
Hindssemple
Marilyn
M
Collins
Nicolas
N
Ceron
Karanchand
K
Krishnalall
Malti
M
Adhin
Gustavo
G
Bretas
Nelly
N
Hernandez
Marjorie
M
Mendoza
Abdelkrim
A
Smine
Kennedy
K
Chibwe
Patrick
P
Lukulay
Lawrence
L
Evans
D000962:Antimalarials / Q000737:chemistry / Q000494:pharmacology* / Q000592:standards*; D002623:Chemistry Techniques, Analytical; D006801:Humans; D008288:Malaria / Q000188:drug therapy; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards*; D011786:Quality Control; D013020:South America
D000962:Antimalarials; D004364:Pharmaceutical Preparations