Most uterotonics on Ghanaian market not standardised – FDA

Food and Drugs Authority’s  (FDA) Quality of Medicines study shows that an extremely high percentage of uterotonics available on the Ghanaian market do not meet the required quality standard.

This situation could have serious implications for maternal mortality and  as a result a number of regulatory actions have been taken by FDA, including product recalls.

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

The report was made available to the Ghana News Agency through Ms Betty Blay Ackah, Maternal Health Channel Publicity Officer.

It said , post-marketing quality surveillance was carried out to assess the quality of Oxytocin and Ergometrine on the market from August and September 2012.

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

The samples were assessed with respect to: source and registration-marketing authorization status; cold chain status for injectables at the time of sampling from the distribution channel; recommended storage conditions by the manufacturer; and content of active pharmaceutical ingredient (assay) and sterility.

Eighty-six per cent of the Oxytocin samples found on the market were manufactured in China, where as 90.68 per cent of Ergometrine samples were produced in India.

Of those collected and tested, 8.11 per cent of Oxytocin samples and 57.63 per cent of Ergometrine samples had been issued marketing authorisations.

The report identified two companies supplying Oxytocin and one supplying Ergometrine injection.

All the samples of Ergometrine tablets were from companies that did not hold 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.

According to the report almost all of the injectables were not stored according to the recommended storage conditions  of 2o–8oC either of some manufacturers or of the official compendia, the US Pharmacopeia and British Pharmacopeia.

In addition, the storage conditions recommended by the manufacturers of more than 50 per cent of both the Oxytocin and Ergometrine injections were not consistent with recommendations in the official compendia.

The study noticed lack of awareness of the appropriate storage conditions for the uterotonic products.

According to the report 20 samples of both Oxytocin and Ergometrine had no labelling information – batch number, manufacture and expiry dates, making it difficult to establish their authenticity and valid shelf-life.

It said out of the 169 Oxytocin samples assayed, 55.62 per cent failed. Of the 99 Ergometrine injection samples, 73.74 per cent failed, and all of the 11 representing 100 per cent)Ergometrine tablets tested failed assay.

Two samples of Oxytocin injection and three samples of Ergometrine tablets (two of the three Ergometrine tablets had the same batch number) were determined to be counterfeit products.

According to the report, due to resource constraints, a random sample of 80 products (40 Oxytocin and 40 Ergometrine injections) was subjected to sterility testing.

Forty Oxytocin samples randomly selected for sterility testing, 97.5 per cent failed either assay or sterility testing, or both; 94.87 per cent of the 40 Ergometrine injection samples tested for sterility failed either assay or sterility testing, or both.

Source: GNA