Abstract
Post-marketing quality surveillance was carried out to assess the quality of uterotonics (Oxytocin and Ergometrine) on the Ghanaian market between 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 ten regions of Ghana.
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 percent (86%) of the Oxytocin samples found on the market were manufactured in China, whereas 90.68% of Ergometrine samples were manufactured in India. Of those collected and tested, 8.11% of Oxytocin samples and 57.63% of Ergometrine samples had been issued marketing authorizations: Two companies supplying Oxytocin and one company supplying Ergometrine injection. All the samples of Ergometrine tablets were from companies that did not hold marketing authorizations. The origin of 10% of the Oxytocin samples and 4.24% of the Ergometrine samples could not be established.
It was observed that almost all of the injectables were not stored according to the recommended storage conditions (2 o –8 oC) either of some manufacturers or of the official compendia, the U.S. Pharmacopeia and British Pharmacopeia; the only exception was one Regional Medical Store.
In addition, the storage conditions recommended by the manufacturers of more than 50% of both the Oxytocin and Ergometrine injections were not consistent with recommendations in the official compendia. This indicates a lack of awareness of the appropriate storage conditions for these uterotonic products. Twenty (20) samples of both Oxytocin and Ergometrine had no labeling information providing batch number manufacture and expiry dates, making it difficult to establish their authenticity and valid shelf-life.
Out of the 169 Oxytocin samples assayed, 55.62% failed. Of the 99 Ergometrine injection samples, 73.74% failed, and all of the 11 (100%) Ergometrine tablets tested failed assay. Two (2) samples of Oxytocin injection and three (3) samples of Ergometrine tablets (two of the three Ergometrine tablets had the same batch number) were determined to be counterfeit products.
Due to resource constraints, a random sample of 80 products (40 Oxytocin and 40 Ergometrine injections) was subjected to sterility testing. Of the 40 Oxytocin samples randomly selected for sterility testing, 97.5% failed either Assay or Sterility testing, or both; 94.87% of the 40 Ergometrine injection samples tested for sterility failed either Assay or Sterility testing, or both.
The results of this project established that an extremely high percentage of uterotonics available on the Ghanaian market do not meet required standards of quality. This situation could have serious implications for maternal mortality in the country.
A number of regulatory actions have been taken by the Ghana FDA, including product recalls, and those suspected of being involved in criminal acts have been referred to the police.
