Ghanaian study finds substandard, counterfeit pregnancy meds

A study in Ghana of the quality of uterotonic drugs used in pregnancy has found worrying variations in quality, including product with no active ingredient that is suspected of being counterfeit.

The study, published on the British Medical Journal's open access site, looked at the potency of ergometrine and oxytocin products purchased from various sources across three Ghanaian districts.

Oxytocin and ergometrine are injectable uterotonic drugs often used in combination just after childbirth to facilitate delivery of the placenta and prevent postpartum haemorrhage, a leading direct cause of maternal death in less affluent countries.

The researchers, led by Cynthia Stanton of Johns Hopkins Bloomberg School of Public Health in the USA, bought 55 ergometrine samples and 46 oxytocin samples from a total of 69 sellers, and found that 89 per cent did not meet quality standards. 

None of the ergometrine samples were within specifications for the level of active ingredient, despite all being within expiry date, while only 26 per cent of the oxytocin samples met these criteria. The median ergometrine level in the samples was 50 per cent of the stated dose, and 64 per cent in the case of oxytocin.

While lack of adequate refrigeration was a likely cause of the low levels of active in many of the cases, the discovery of one product with zero levels is an indicator of that it may be counterfeit, according to the authors.

"There is little enforcement of the restriction against chemical shops selling uterotonics or of the sale of unregistered uterotonics in these [Ghanaian] districts," they write, adding that it was also clear that public and private healthcare sources procure unregistered medicines.

"While efforts to reduce maternal mortality have focused on training health workers to prevent and treat postpartum haemorrhage, these efforts and resources are undermined if health workers do not have access to high-quality uterotonics," they note.