title: Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.
abstract: OBJECTIVE
  Given use of uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent uterotonics is indisputable. This study evaluated access to and potency of injectable uterotonics in Ghana.
  
  
  METHODS
  Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board.
  
  
  METHODS
  The study was conducted in three contrasting districts in Ghana.
  
  
  METHODS
  The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine.
  
  
  RESULTS
  69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively.
  
  
  CONCLUSIONS
  The quality of injectable uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.
authors.affiliation: Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Stanton
authors.forename: Alissa
authors.initials: A
authors.lastname: Koski
authors.forename: Patience
authors.initials: P
authors.lastname: Cofie
authors.forename: Ellie
authors.initials: E
authors.lastname: Mirzabagi
authors.forename: Breanne L
authors.initials: BL
authors.lastname: Grady
authors.forename: Steve
authors.initials: S
authors.lastname: Brooke