Quality of Artemisinin-based Combination Therapy for malaria found in Ghanaian markets and public health implications of their use
Autor: | Albert W. W. Van Wyk, Stephaney Gyaase, Harparkash Kaur, Mathilda Tivura, Dana M. Hostetler, Kwaku Poku Asante, Isaac Asante, Seth Owusu-Agyei, Facundo M. Fernández, Emmanuel Mahama, Naiela Malik |
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Rok vydání: | 2016 |
Předmět: |
Artemether/lumefantrine
Combination therapy Falsified medicines 030231 tropical medicine Health Care Sector Pharmacy Ghana Antimalarials 03 medical and health sciences 0302 clinical medicine Substandard medicines Anti-Infective Agents Artemisinin-based combinations Environmental health parasitic diseases Humans Medicine Pharmacology (medical) 030212 general & internal medicine Mortality Artemisinin Pharmacology Active ingredient Traditional medicine business.industry Artesunate/amodiaquine medicine.disease Counterfeit medicines Artemisinins Malaria Counterfeit Cross-Sectional Studies Drug Therapy Combination Public Health Morbidity business Research Article medicine.drug |
Zdroj: | BMC Pharmacology & Toxicology |
ISSN: | 2050-6511 |
Popis: | BACKGROUND: Ghana changed their antimalarial drug policy from monotherapies to Artemisinin-based Combination Therapies in 2004 in order to provide more efficacious medicines for treatment of malaria. The policy change can be eroded if poor quality Artemisinin-based Combination Therapies are allowed to remain on the Ghanaian market unchecked by regulatory bodies and law enforcement agencies. The presence and prevalence of substandard and counterfeit Artemisinin-based Combination Therapies need to be determined on open markets in Ghana; a review of the current policy; identifying any gaps and making recommendations on actions to be taken in addressing gaps identified are essential as the data provided and recommendations made will help in ensuring effective control of malaria in Ghana. METHODS: A field survey of antimalarial drugs was conducted in the central part of Ghana. The amount of active pharmaceutical ingredient in each Artemisinin-based Combination Therapy sample identified in the survey was measured using high performance liquid chromatographic analyses. Active pharmaceutical ingredient within the range of 85-115 % was considered as standard and active pharmaceutical ingredient results out of the range were considered as substandard. All samples were screened to confirm stated active pharmaceutical ingredient presence using mass spectrometry. RESULTS: A total of 256 Artemisinin-based Combination Therapies were purchased from known medicine outlets, including market stalls, hospitals/clinics, pharmacies, drug stores. Artemether lumefantrine (52.5 %) and artesunate amodiaquine (43.2 %) were the predominant Artemisinin-based Combination Therapies purchased. Of the 256 Artemisinin-based Combination Therapies purchased, 254 were tested, excluding two samples of Artesunate-SP. About 35 % of Artemisinin-based Combination Therapies were found to be substandard. Nine percent of Artemisinin-based Combination Therapies purchased were past their expiry date; no counterfeit (falsified) medicine samples were detected by either high performance liquid chromatographic or mass spectrometry. CONCLUSION: A high proportion of Artemisinin-based Combination Therapies sold in central Ghana were found to be substandard. Manufacturing of medicines that do not adhere to good manufacturing practices may have contributed to the poor quality of the Artemisinin-based Combination Therapies procured. A strict law enforcement and quality monitoring systems is recommended to ensure effective malaria case management as part of malaria control. |
Databáze: | OpenAIRE |
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