Injectable Uterotonics In Ghana Improperly Stored – FDA

The Food and Drugs Authority (FDA) study shows that almost all uterotonic injectables in the country are not stored according to manufacturers and official compendia, recommended storage conditions of 2°–8°C.

The study indicates that recommended storage conditions for more than 50 per cent of both Oxytocin and Ergometrine injections were not consistent with recommendations in the official compendia.

The FDA report made available to the Ghana News Agency through Ms Betty Blay Ackah, Maternal Health Channel Publicity Officer, said it identified lack of awareness of the appropriate storage conditions for uterotonic products as the main problem.

The study entitled: “Post-market quality surveillance project maternal healthcare products -oxytocin and ergometrine on the Ghanaian market,” is a joint project of FDA, Laboratory Services Department and Promoting the Quality of Medicines Programme.

A total of 303 samples -185 Oxytocin injection, 103 Ergometrine injection, and 15 Ergometrine tablets were sampled from public and private hospitals, clinics, medical stores, pharmaceutical outlets, and the informal sector across the 10 regions.

It said 20 samples of both Oxytocin and Ergometrine had no labelling information to indicate their batch number or manufacturing and expiry dates, making it difficult to establish their authenticity and valid shelf-life.

“Only 8.11 per cent of Oxytocin samples and 57.63 per cent of Ergometrine samples had a marketing authorisation.

“These came from three companies, two supplying Oxytocin and one supplying Ergometrine injection,” the study stated.

It noted that none of the samples of Ergometrine tablets were from companies that have marketing authorisations.

“The origin of 10 per cent of the Oxytocin samples and 4.24 per cent of the Ergometrine samples could not be established,” the study said.

This study focuses only on the sampling and testing of the maternal healthcare products Oxytocin and Ergometrine.

The objective of the study was to determine for all Oxytocin injection and Ergometrine tablets and injections products distributed and sold on the Ghanaian Market: “If they conform to the specifications and standards listed by the manufacturer upon which their marketing authorisations were granted.

“And if there were unregistered and/or counterfeits products within this therapeutic group circulating in Ghana’s market.”

Uterotonic drugs are used for the prevention and treatment of postpartum haemorrhage.

Comments