Evaluation report for Phd thesis "a survey on the quality of oxytocin and misoprostol as well as accessibility of medicines in Rwanda".

Abstract

Abstract Background The third Sustainable Development Goal (SDG3.1) of the United Nations (UN) urge all countries to reduce the maternal mortality ratio at less than 70 maternal deaths per 100,000 live births by 2030. Oxytocin and misoprostol are used as the first and second choices, respectively, in the prevention and management of post-partum hemorrhage, which is the leading cause of maternal deaths. The SDG3.1 will not be achieved if full access to quality assured oxytocin and misoprostol is not assured. The main objective of this PhD thesis entitled “A survey on the quality of oxytocin AND misoprostol as well as prices, availability and affordability of medicines in Rwanda” was to measure the accessibility to 18 medicines including oxytocin and misoprostol, and investigate on the quality and stability of oxytocin and misoprostol used in health facilities of Rwanda. Methods Data on prices for 18 medicines were collected and analyzed using a standardized method developed by the Department of Medicine Policy and Standards of the WHO (WHO-DMPS) in partnership with the Health Action International (HAI), as updated in 2016. Data on storage conditions and samples of oxytocin and misoprostol were collected from 40 selected (simple random) health facilities and six wholesalers and government stores of Rwanda. Stability testing and quantitative analysis were performed according to the 2016 United States Pharmacopoeia (USP) for oxytocin injectables and the 2017 International Pharmacopoeia for misoprostol tablets. Results In Rwanda, the 18 surveyed medicines were affordable but poorly available in both the public and the faith- based sectors. Prices for generic medicines in the public and faith-based health facilities were low, but these prices were very high in the private pharmacies. The government procurement agency was found with low prices, compared to the international prices, with the MPR less than one for 16 out of 18 surveyed medicines. Affordability of medicines was better in the public and faith-based sectors than in the private sector. Oxytocin, the first choice in the prevention and management of post-partum hemorrhage, was poorly available in the private sector and its availability was less than the target of 80 % in the public and faith-based sectors. vii Storage of oxytocin and misoprostol was found to follow the manufacturers’ recommendations. However, quality problems were identified on the 9/57 samples of oxytocin and 10/25 samples of misoprostol collected from the Rwandan health facilities for the survey on quality. One brand of oxytocin showed contents in oxytocin exceeding the acceptable limit and an undeclared preservative. Two brands of misoprostol contained less than 50 % of the declared content in misoprostol and they released less then 50% of the declared content in misoprostol during the dissolution test. These brands were neither WHO-prequalified nor manufactured in countries with Stringent Regulatory Authority (SRA). Chlorbutanol showed a high stabilizing effect on oxytocin preparations. All four samples/brands of oxytocin passed the accelerated stability testing according to the International Coucil on Harmonization (ICH) in partnership with the WHO. Damage to the primary packaging resulted in a decrease of 52.5 % of the content in misoprostol (from 100.7% to 48.2 %) after a 6 months storage at 40°C +/- 2°C and 75% +/- 5% RH, but no significant effect was found after a 6 months storage at 25°C +/- 2°C and 60% +/- 5% RH. Conclusion In Rwanda, important steps to ensure accessibility to medicines have been made, but more efforts are needed to ensure full access to quality assured oxytocin and misoprostol to expect the achievement of the SDG3.1 and reach the target of maternal mortality ratio by 2030.