| Popis: |
Background Numerous previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for product quality. Between September 2020 and November 2021, Concept Foundation, in collaboration with the International Planned Parenthood Federation, conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries. Methods Collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected low- and middle-income countries. For each sample, data on the product and collection site were collected. Single drug packs as well as co-packaged presentations containing both drugs (combipacks) were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. For misoprostol, identification, assay, related substances, and content uniformity were tested in accordance with the World Health Organization’s International Pharmacopoeia monograph. For mifepristone, identification, assay, related substances, and dissolution were tested using validated in-house methods and specifications supported by the test results of the innovator product. Results Samples tested were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. A total of 64 pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only products and 7 mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of all misoprostol tablets analysed and 23.7% of all mifepristone tablets. One misoprostol-only product was found to be falsified. Conclusions This study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in low- and middle-income countries. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. This study also provides evidence of mifepristone quality issues. |
