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. 2012 May 3;2(3):e000431.
doi: 10.1136/bmjopen-2011-000431. Print 2012.

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana

Cynthia Stanton  1 , Alissa Koski, Patience Cofie, Ellie Mirzabagi, Breanne L Grady, Steve Brooke
Affiliations

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana

Cynthia Stanton et al. BMJ Open. .

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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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that (1) CS, AK and EM have contract support from PATH for the submitted work and that PC, BLG and SB have grant support from the Bill & Melinda Gates Foundation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work; (2) CS, AK, PC, EM, BG and SB have no relationships with any companies that might have an interest in the submitted work in the previous 3 years; (3) their spouses, partners or children have no financial relationships that may be relevant to the submitted work; and (4) CS, AK, PC, EM, BG and SB have no non-financial interests that may be relevant to the submitted work. This research was supported by the Oxytocin Initiative project at PATH with funding from the Bill & Melinda Gates Foundation. The funders of the study had no role in the design, conduct, analysis, interpretation of study results, writing of this manuscript or the decision to submit the manuscript for publication. The authors had access to and full control of all primary data. The study was undertaken by PATH, the Johns Hopkins Bloomberg School of Public Health and the Regional Institute for Population Studies at the University of Ghana.

Figures

Figure 1
Figure 1
Number of purchased ampoules of oxytocin by in-country registration status of the product and by type of point of sale.
Figure 2
Figure 2
Number of purchased ampoules of ergometrine by in-country registration status of the product and by type of point of sale.
See this image and copyright information in PMC

References

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    1. WHO WHO Statement Regarding the Use of Misoprostol for Postpartum Haemorrhage Prevention and Treatment. Geneva: Department of Reproductive Health and Research, 2009
    1. WHO WHO List of Priority Medicines for Mothers and Children. Department of Maternal, Newborn, Child and Adolescent Health, 2011
    1. Stability of Injectable Oxytocics in Tropical Climates; Results of Field Surveys and Simulation Studies on Ergometrine, Methylergometrine and Oxytocin. Geneva: Action Program on Essential Drugs, World Health Organisation, 1993
    1. de Groot AN, Hekster YA, Vree TB, et al. Ergometrine and methylergometrine tablets are not stable under simulated tropical conditions. J Clin Pharm Ther 1995;20:109–13 - PubMed

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