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Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria.
PLoS One. 2015; 10(5):e0125577.Plos

Abstract

BACKGROUND

Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates.

METHODS

ACAs were purchased using three sampling approaches--convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified.

RESULTS

Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified.

CONCLUSION

Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.

Authors+Show Affiliations

Department of Clinical Research, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.Department of Clinical Research, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.Department of Global Health and Development, London School of Hygiene & Tropical Medicine, Tavistock Place, London, United Kingdom.Department of Clinical Research, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.Department of Pharmacology and Therapeutics, University of Nigeria, Enugu, Nigeria.Department of Global Health and Development, London School of Hygiene & Tropical Medicine, Tavistock Place, London, United Kingdom.Department of Clinical Research, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.Department of Clinical Research, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom; Department of Global Health and Development, London School of Hygiene & Tropical Medicine, Tavistock Place, London, United Kingdom.Division of Parasitic Diseases and Malaria, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Division of Parasitic Diseases and Malaria, US Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral, and Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Santa Fe, Argentina.Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.Department of Disease Control, London School of Hygiene & Tropical Medicine, Keppel Street, London, United Kingdom.School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia, United States of America.Department of Pharmacology and Therapeutics, University of Nigeria, Enugu, Nigeria.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26018221

Citation

Kaur, Harparkash, et al. "Quality of Artemisinin-based Combination Formulations for Malaria Treatment: Prevalence and Risk Factors for Poor Quality Medicines in Public Facilities and Private Sector Drug Outlets in Enugu, Nigeria." PloS One, vol. 10, no. 5, 2015, pp. e0125577.
Kaur H, Allan EL, Mamadu I, et al. Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria. PLoS One. 2015;10(5):e0125577.
Kaur, H., Allan, E. L., Mamadu, I., Hall, Z., Ibe, O., El Sherbiny, M., van Wyk, A., Yeung, S., Swamidoss, I., Green, M. D., Dwivedi, P., Culzoni, M. J., Clarke, S., Schellenberg, D., Fernández, F. M., & Onwujekwe, O. (2015). Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria. PloS One, 10(5), e0125577. https://doi.org/10.1371/journal.pone.0125577
Kaur H, et al. Quality of Artemisinin-based Combination Formulations for Malaria Treatment: Prevalence and Risk Factors for Poor Quality Medicines in Public Facilities and Private Sector Drug Outlets in Enugu, Nigeria. PLoS One. 2015;10(5):e0125577. PubMed PMID: 26018221.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria. AU - Kaur,Harparkash, AU - Allan,Elizabeth Louise, AU - Mamadu,Ibrahim, AU - Hall,Zoe, AU - Ibe,Ogochukwu, AU - El Sherbiny,Mohamed, AU - van Wyk,Albert, AU - Yeung,Shunmay, AU - Swamidoss,Isabel, AU - Green,Michael D, AU - Dwivedi,Prabha, AU - Culzoni,Maria Julia, AU - Clarke,Siân, AU - Schellenberg,David, AU - Fernández,Facundo M, AU - Onwujekwe,Obinna, Y1 - 2015/05/27/ PY - 2014/11/28/received PY - 2015/03/24/accepted PY - 2015/5/29/entrez PY - 2015/5/29/pubmed PY - 2016/5/12/medline SP - e0125577 EP - e0125577 JF - PloS one JO - PLoS One VL - 10 IS - 5 N2 - BACKGROUND: Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. METHODS: ACAs were purchased using three sampling approaches--convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. RESULTS: Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. CONCLUSION: Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/26018221/Quality_of_artemisinin_based_combination_formulations_for_malaria_treatment:_prevalence_and_risk_factors_for_poor_quality_medicines_in_public_facilities_and_private_sector_drug_outlets_in_Enugu_Nigeria_ L2 - https://dx.plos.org/10.1371/journal.pone.0125577 DB - PRIME DP - Unbound Medicine ER -