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

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.

Article summary

Article focus

• The need for high-quality uterotonic drugs for the prevention and treatment of maternal mortality and morbidity in poor countries is indisputable.

• Best practice for long-term storage for all injectable uterotonics is refrigeration, which is a key logistical constraint for scale up of postpartum haemorrhage reduction strategies and is a general challenge for maternity services without consistent electricity.

• The objectives of the study were to assess the population's access to uterotonic drugs and to assess the chemical potency of ampoules of oxytocin and ergometrine available to the population.

Key messages

• Quality of uterotonics is likely a serious problem in Ghana; 89% of all ampoules tested in this study did not meet the specifications for active ingredient. The low level of active ingredient in these ampoules is not due to old drugs; only 2% of these ampoules had expired.

• There is little enforcement of the restriction against chemical shops selling uterotonics or of the sale of unregistered uterotonics in these districts.

• Inactive uterotonics are not restricted to the private sector; uterotonics outside specification were purchased from private and public sources. It is also clear that public and private sources procure unregistered uterotonics.

Strengths and limitations of this study

• An up-to-date listing of points of sale was compiled specifically for this study; a sample of randomly selected sites was visited, and in two of three districts, the selected points of sale represented all the existing accessible chemical sellers and pharmacies.

• The simulated client approach prevents possible bias in the selection of ampoules to be sent for chemical testing.

• The number of points of sale selected for visit (25 per district) was based on practical considerations and resulted in a relatively small sample of ampoules available for chemical testing.

• The sampling frame may not have been 100% exhaustive, given the informal nature of some drug sellers. However, study results were strikingly similar across three diverse districts, and this is unlikely to result from sampling error.