title: Quality of Artemisinin-based Combination Therapy for malaria found in Ghanaian markets and public health implications of their use.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana.
authors: Mathilda
authors: M
authors: Tivura
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana.
authors: Isaac
authors: I
authors: Asante
authors: London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors: Albert
authors: A
authors: van Wyk
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana.
authors: Stephaney
authors: S
authors: Gyaase
authors: London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors: Naiela
authors: N
authors: Malik
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana.
authors: Emmanuel
authors: E
authors: Mahama
authors: Georgia Institute of Technology, School of Chemistry and Biochemistry, Atlanta, GA, USA.
authors: Dana M
authors: DM
authors: Hostetler
authors: Georgia Institute of Technology, School of Chemistry and Biochemistry, Atlanta, GA, USA.
authors: Facundo M
authors: FM
authors: Fernandez
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana.
authors: Kwaku Poku
authors: KP
authors: Asante
authors: London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK.
authors: Harparkash
authors: H
authors: Kaur
authors: Kintampo Health Research Centre, Ghana Health Service/Ministry of Health, P O Box 200, Kintampo, Ghana. seth.owusu-agyei@kintampo-hrc.org.|London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. seth.owusu-agyei@kintampo-hrc.org.
authors: Seth
authors: S
authors: Owusu-Agyei
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000592:standards; D000962:Antimalarials / Q000008:administration & dosage / Q000592:standards*; D037621:Artemisinins / Q000008:administration & dosage / Q000592:standards*; D003430:Cross-Sectional Studies; D004359:Drug Therapy, Combination / Q000592:standards; D005869:Ghana / Q000453:epidemiology; D019981:Health Care Sector / Q000592:standards*; D006801:Humans; D008288:Malaria / Q000188:drug therapy* / Q000453:epidemiology*; D011634:Public Health / Q000379:methods / Q000592:standards*
chemical_list: D000890:Anti-Infective Agents; D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin
keywords: Artemisinin-based combinations; Counterfeit medicines; Falsified medicines; Ghana; Malaria; Morbidity; Mortality; Substandard medicines