Background Access to affordable and good quality medicines is a key to meeting Sustainable Development Goal No. 3 by the year 2030. Prices, availability and affordability of essential medicines have been studied in many developing countries, but no such information has been published about Rwanda yet. This study aimed at providing data on prices, availability and affordability of medicines in different health facilities of Rwanda. Methods A survey was carried out on availability, prices and affordability of 18 medicines in Kigali City and five districts of Rwanda. 44 health facilities were surveyed, including public and faithbased hospitals, public and faith-based health centers and private pharmacies. The standardized methodology developed by WHO and Health Action International (HAI) was used to collect and analyze the data. Findings Prices for generic medicines in public and faith-based health facilities were remarkably low, with median price ratios (MPRs) of 1.0 in comparison to the international procurement prices published by Management Sciences for Health. In private pharmacies, prices were twice as high (MPR = 1.99 for generics). Availability of medicines fell short of the of 80% target set by WHO, but was better than reported from many other developing countries. Availability of medicines was highest in the private sector (71.3%) and slightly lower in the faith-based (62.8%) and public (59.6%) sectors. The government procurement agency was found to work efficiently, achieving prices 30% below the international procurement price given in the International Medical Product Price Guide. Affordability of medicines was better in the public and faith-based sectors than in the private sector. Conclusion In Rwanda, medicines are affordable but poorly available in both the public and the faithbased sectors. Further improvements of the availability of medicines in the public and the

Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for abortions. The compound is unstable, and substandard misoprostol preparations have been detected in low-and middle-income countries. We now investigated the stability of misoprostol tablets according to the international guidelines for stability testing of pharmaceutical products. Three brands (four batches) of misoprostol tablets were collected in Malawi and Rwanda: the originator product, a WHO-prequalified product, and a generic product without WHO prequalification. A further batch of the originator product was collected in Germany. To investigate the effect of damage to the primary packaging, additional blister strips of one sample were intentionally damaged with a needle and investigated in parallel. Samples were placed in stability chambers for six months at 40˚C/75% relative humidity (RH) and at 25˚C/60% RH. After 0, 1, 2, 3 and 6 months, misoprostol content was determined according to the International Pharmacopeia. At 40˚C/75% RH, all samples showed a decline of misoprostol content, but four of the batches still remained within the pharmacopeial specifications, while one of the two batches of the generic product without WHO-prequalification showed a final content of 86.2% which is out of specifications. Damage to the primary packaging greatly decreased stability, resulting in a final content of only 48.2% of the declared misoprostol amount. At 25˚C/60% RH all samples remained in specifications for six months, even the sample with the damaged blister. Dissolution of misoprostol remained in specifications of the pharmacopoeia for six months for all batches, except for the sample with damaged blisters stored at 40˚C/75% RH. This study confirms that the stability of misoprostol tablets must be ensured by intact, good-quality primary packaging. Careful supplier qualification is required in the procurement process.

Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2–8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2–121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5–48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely substandard brands of misoprostol tablets were found. The Rwandan authorities reacted quickly and efficiently, and recalled these substandard medicines from the market. For oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to medicines which are WHO-prequalified or which have been manufactured in countries with stringent regulatory authorities.

Oxytocin is used for the prevention and treatment of postpartum hemorrhage, the leading cause of maternal mortality in low-and middle-income countries. Because of the high instability of oxytocin, most products are labeled for storage at 2-8°C. Some other products are on the market which are labeled for non-refrigerated storage, but independent evaluations of their stability hardly exist. In the present study, seven brands (nine batches) of oxytocin were purchased from wholesalers and medical stores in Malawi and Rwanda and investigated by accelerated stability testing according to the ICH/WHO guidelines. Two oxytocin brands approved by a stringent regulatory authority (SRA) or by the WHO Prequalification of Medicines program and purchased in Europe were used as comparison. All investigated brands which were either produced in countries with SRAs, or were WHO-prequalified products, were labeled for storage at 2-8°C, and all of them passed stability testing with very good results. Even exposure to 25°C or 30°C for several months hardly affected their oxytocin content. However, two other investigated brands were labeled for non-refrigerated storage, and both of them had been produced in countries without SRAs. These two preparations showed not higher but lower stability than the brands labeled for storage at 2-8°C, and, for both of them, noncompliance with pharmacopoeial specifications was found after accelerated stability testing. At 40°C, and in forced degradation studies at 80°C, chlorobutanol showed a remarkable stabilizing effect on oxytocin, which may deserve further investigation. The results of the present study support the policy "Buy Quality Oxytocin, Keep It Cool."

Background Pharmaceuticals account for a large portion of healthcare spending in healthcare organizations. Their effective inventory management is required to match the cost of stocks with the customer demand and avoid shortage of supplies at any health facility level. This study aimed to analyze pharmaceuticals' inventory management using ABC-VEN analysis. Methods The study was conducted at Rwanda Medical Supply (RMS) Ltd, Nyamagabe Branch for products distributed to health facilities in Nyamagabe District catchment area from the financial years 2017–2018 to 2019–2020. It consisted of a descriptive retrospective study of 457 items. The latter are generic essential medicines distributed to public health facilities during the study period. Products were arranged according to a descending order of importance, and we performed a breakdown of products according to the Pareto Principle. Following an ABC analysis of distribution data for such drugs billed to healthcare facilities, a VEN analysis was performed to identify high-value vital products that require more attention. Results During the ABC analysis, 76 products were classified in group A. These accounted for 19.84% and had a value of 74.91% of the total cost of all products. Group B included 116 products, representing 30.29% with a value of 20% of the total cost, while Group C had 191 products, representing 49.87% with a value of only 5.09% of the total cost. During the VEN analysis, 202 products (44.20%) were classified as vital, 231 (50.54%) as essential, and 24 products (75.26%) as non-vital. The analysis with ABC-VEN resulted in Class I representing 55.80% of all medicines that cost 87.88% of all total cost, Class II representing 40.70% with a total cost of 11.82%, and Class III representing 3.50% with a cost of 0.3%. Conclusions This study results show that inventory management of vital and expensive products, such as antibiotics, antihypertensive pharmaceuticals, consumables, and massive solutions would be carefully monitored to prevent a shortage of such products at health facility levels. The ABC-VEN analysis is one of the practical and affordable method to achieve their optimized supply chain.