title: The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania.
abstract: BACKGROUND
  The purpose of this study was to investigate the quality of a select group of medicines sold in accredited drug dispensing outlets (ADDOs) and pharmacies in different regions of Tanzania as part of an in-depth cross-sectional assessment of community access to medicines and community use of medicines.
  
  
  METHODS
  We collected 242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine from selected ADDOs and pharmacies in Mbeya, Morogoro, Singida, and Tanga regions. The analysis included physical examination and testing with validated analytical techniques. Assays for eight of nine products were conducted using high-performance thin-layer chromatography (HPTLC). For ALu tablets, we used a two-tiered approach, where tier 1 was a semi-quantitative Global Pharma Health Fund-Minilab® method and tier 2 was high-performance liquid chromatography (HPLC) as described in The International Pharmacopoeia's monograph for artemether-lumefantrine.
  
  
  CONCLUSIONS
  The physical examination of samples revealed no defects in the solid and oral liquid dosage forms, but unusual discoloration in an injectable solution, ergometrine maleate. For ALu, the results showed that of 38 samples, 31 (81.6%) passed tier 1 testing and 7 (18.4%) gave inconclusive drug content results. The inconclusive ALu samples were submitted for tier 2 testing and all met the quality standards. The pass rate using the HPTLC and TLC/HPLC assays was 93.8%; the failures were the ergometrine maleate samples purchased from both ADDOs and pharmacies. The disintegration testing of the solid dosage forms was conducted in accordance with US Pharmacopeia monographs. Only two samples of paracetamol, 1.2% of the solid dosage forms, failed to comply to standards. The study revealed a high overall rate of 92.6% of samples that met the quality standards. Although the overall failure rate was 7.4%, it is important to note that this was largely limited to one product and likely due to poor distribution and storage rather than poor manufacturing practices.
  
  
  CONCLUSIONS
  Over 90% of the medicines sold in ADDOs and pharmacies met quality standards. Policy makers need to reconsider ergometrine maleate's place on the list of medicines that ADDOs are allowed to dispense, by either substituting a more temperature-stable therapeutically equivalent product or requiring those sites to have refrigerators, which is not a feasible option for rural Tanzania.
authors.affiliation: School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Eliangiringa
authors.identifier: http://orcid.org/0000-0001-6008-3539
authors.initials: E
authors.lastname: Kaale
authors.affiliation: School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Vicky
authors.initials: V
authors.lastname: Manyanga
authors.affiliation: School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Mhina
authors.initials: M
authors.lastname: Chambuso
authors.affiliation: Pharmaceuticals & Health Technologies Group, Management Sciences for Health, Dar es Salaam, Tanzania.
authors.forename: Jafary
authors.initials: J
authors.lastname: Liana
authors.affiliation: Pharmaceuticals & Health Technologies Group, Management Sciences for Health, Arlington, VA, United States of America.
authors.forename: Edmund
authors.initials: E
authors.lastname: Rutta
authors.affiliation: Pharmaceuticals & Health Technologies Group, Management Sciences for Health, Arlington, VA, United States of America.
authors.forename: Martha
authors.initials: M
authors.lastname: Embrey
authors.affiliation: Pharmaceuticals & Health Technologies Group, Management Sciences for Health, Arlington, VA, United States of America.
authors.forename: Thomas
authors.initials: T
authors.lastname: Layloff
authors.affiliation: Pharmaceuticals & Health Technologies Group, Management Sciences for Health, Arlington, VA, United States of America.
authors.forename: Keith
authors.initials: K
authors.lastname: Johnson
mesh_terms: D001681:Biological Assay; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D004304:Dosage Forms; D004874:Ergonovine / Q000191:economics / Q000494:pharmacology / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000191:economics* / Q000592:standards*; D010594:Pharmacies / Q000191:economics* / Q000592:standards*; D012015:Reference Standards; D013636:Tanzania
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations; D004874:Ergonovine