Uterotonic drug quality

An assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana

Cynthia Stanton, Alissa Koski, Patience Cofie, Ellie Mirzabagi, Breanne L. Grady, Steve Brooke

Research output: Contribution to journalArticle

Abstract

Objectives: 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. Design: 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. Setting: The study was conducted in three contrasting districts in Ghana. Outcome measure: 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.

Original languageEnglish (US)
Article numbere000431
JournalBMJ Open
Volume2
Issue number3
DOIs
StatePublished - 2012

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Ghana
Ergonovine
Oxytocin
Injections
Pharmaceutical Preparations
Pharmacopoeias
Postmarketing Product Surveillance
Counterfeit Drugs
Postpartum Hemorrhage
Antimalarials
Financial Management
Obstetrics
Communicable Diseases
Research Design
Outcome Assessment (Health Care)
Anti-Bacterial Agents
Food

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Uterotonic drug quality : An assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana. / Stanton, Cynthia; Koski, Alissa; Cofie, Patience; Mirzabagi, Ellie; Grady, Breanne L.; Brooke, Steve.

In: BMJ Open, Vol. 2, No. 3, e000431, 2012.

Research output: Contribution to journalArticle

Stanton, Cynthia ; Koski, Alissa ; Cofie, Patience ; Mirzabagi, Ellie ; Grady, Breanne L. ; Brooke, Steve. / Uterotonic drug quality : An assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana. In: BMJ Open. 2012 ; Vol. 2, No. 3.
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abstract = "Objectives: 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. Design: 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. Setting: The study was conducted in three contrasting districts in Ghana. Outcome measure: 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.",
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