Evaluating drug use patterns among paediatric outpatients in Burundi.

Background: Rational prescribing is key to optimising therapeutic outcomes and avoiding risks associated with irrational use of medicines. Using WHO drug use indicators, this study evaluated drug use patterns among paediatric outpatient encounters at Primary Healthcare Centers (PHCs) in Bujumbura Mairie, Republic of Burundi. Methods: Descriptive cross-sectional research assessed paediatric medicine use in 20 PHCs. From 8 February to 7 April 2023, 800 randomly selected paediatric encounters' 2022-year data were retrospectively collected. Data for specific facility indicators were prospectively collected. SPSS 23 was used to analyse data. Results: 800 outpatient child encounters were analysed, 48.4% female and 51.6% male. The mean number of medicines per encounter was 2.4(±0.99). The injection rate was 9.9%. Overall, 78.8% of generics and 85.2% of essential medicines were prescribed. Results show drug prescribing differences between private and government PHCs (p < 0.001). All PHCs studied had no standard treatment guidelines (STGs), while 50% had an essential medicine list (EML) and 85% of key medicines were available. Conclusion: Poor prescribing practices were found indicating the need for interventions to promote good drug use practices. A large study at a national scale is required to provide a more comprehensive understanding of the overall drug use practices.

Assessment of prices, availability and affordability of essential medicines in Juba County, South Sudan.

BACKGROUND: Access to safe, effective, affordable, and high-quality medications has been included in the Sustainable Development Goals (SDGs) of the United Nations as a crucial step towards attaining universal health coverage. Access to medicines is a fundamental human right. If medicines are accessible and affordable, they save lives by reducing mortality and morbidity associated with acute and chronic diseases. WHO recommends that all countries voluntarily reach the minimum target of 80% availability of medicines by 2025. The primary purpose of this research is to assess access to essential medicines in Juba County, South Sudan. METHODS: This study was undertaken using the standard World Health Organization/Health Action International Organization (WHO/HAI) approach for surveying the prices, availability, and affordability of medicines. A survey was conducted in six payams of Juba County, South Sudan, and 55 health facilities were assessed. RESULTS: Prices for generic medicines were better in faith-based health facilities with a median price ratio of 1.95. Private pharmacies and private clinics had MPRs of 4.64 and 4.32, respectively. Local prices were high compared to International referent prices. Availability of medicines was highest in the faith-based health facilities (65.5%) and slightly lower in private pharmacies (55.4%), private clinics (57.7%) and public (50.4%) sectors. Most of the surveyed medicines were unaffordable. The medicines needed to treat non-communicable diseases cost up to 33.7-day wages for one full course of treatment. CONCLUSIONS: In South Sudan, medicines are poorly available in all sectors. Medicines are affordable in the public sector but Most medicines are unaffordable in private pharmacies, private clinics and faith-based health facilities. Poor medicines availability in the public sector contributes to the overall unaffordability of medicines in all the other sectors.

Assessment of medicines cold chain storage conformity with the requirements of the World Health Organization in health facilities of the Eastern Province of Rwanda.

BACKGROUND: Despite the prominent evidence of cold chain monitoring in the health system to reduce wastage and maintain product potency, there are still inefficiencies in the storage and transportation of cold chain products. This study assessed medicine cold chain storage conformity in health facilities in the Eastern Province of Rwanda. METHODS: A cross-sectional and prospective with quantitative and qualitative approaches study was approved, and 44 health facilities (public, faith-based and private) were selected using both convenience, stratified, and purposive sampling techniques. Temperature data loggers were mounted in refrigerators to measure the Mean Kinetic Temperature (MKT). RESULTS: The overall performance of cold chain storage conformity of refrigerators assessed was 54 (73.0%). The conformity found in refrigerators of pharmacy stock in public health facilities was 22 (56.0%), in vaccination program was 25 (100.0%), and in private retail pharmacies was 7 (70.0%). The MKT measured fit the required cold chain storage at this rate. Most refrigerators used in pharmacy stock (27.0%) were aged between 8 and 10 years, while those used in vaccination programs were less than 4 years. Regular calibration of refrigerator and temperature monitoring device (TMD) was 39.0% and 24.0%, respectively. Most respondents, 44 (80.0%), knew the proper cold chain storage. However, few identified the impact of storing cold chain products with vaccines at 16 (29.1%). The transportation of cold chain products from two central medical stores assessed showed inefficiencies as only one of them uses temperature data loggers during transportations of the products mentioned above. CONCLUSIONS: The medicines cold chain storage conformity investigated in seven districts of the Eastern Province in Rwanda was better than reported previously in other LMICs. However, cold chain storage for pharmacy stock often did not meet the requirements. The observed drawback represented a serious risk to public health. Calibrating cold chain equipment, regular maintenance, and commissioning new cold chain equipment should be done to improve cold chain storage.

Evaluation of vaccine storage and distribution practices in rural healthcare facilities in Kenya.

BACKGROUND: Vaccines require cold chain storage conditions, and good distribution practices throughout the supply chain to maintain their quality and potency. However, in the last mile of the vaccines supply chain, these requirements may not be guaranteed resulting in reduced effectiveness which could lead to an upsurge in vaccine preventable morbidity and mortality. The aim of this research was to evaluate vaccine storage and distribution practices in the last mile of vaccine supply chain in Turkana County. METHODS: A descriptive cross-sectional study was conducted from January 2022 to February 2022 across seven sub-counties in Turkana County, Kenya, to assess vaccine storage and distribution practices. The study sample size was 128 county health professionals across 4 hospitals, 9 health centers, and 115 dispensaries. The respondents were selected using simple random sampling within the facilities strata. Data were collected using a structured questionnaire, adapted, and adopted from a standardized WHO questionnaire on effective vaccines management and administered to one healthcare personnel working in the immunization supply chain per facility. Data were analyzed using excel and presented as percentages in table forms. RESULTS: A total of 122 health care workers participated in the study. Most respondents (89%, n = 109) had utilized a vaccine forecasting sheet, but only 81% did have an established maximum-minimum level inventory control system. Many of the respondents had sufficient knowledge of ice pack conditioning although 72% had adequate vaccine carriers and ice packs. Only 67% of respondents had a complete set of twice-daily manual temperature records at the facility. Most refrigerators complied with the WHO specifications but only 80% of them had functional fridge-tags. The number of facilities that had a routine maintenance plan was below average while only 65% had an adequate contingency plan. CONCLUSION: Rural health facilities have suboptimal supply of vaccine carriers and icepacks for effective storage and distribution of vaccines. In addition, some vaccine fridges lack functional fridge-tags for proper temperature monitoring. Routine maintenance and contingency plans remain a challenge to ensure optimal service delivery.

Analysis of pharmaceutical inventory management based on ABC-VEN analysis in Rwanda: a case study of Nyamagabe district.

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.

Investigation of the Quality of the 12 Most-Used Antibiotics Available in Retail Private Pharmacies in Rwanda.

Using poor-quality antibiotics leads to increased risk of the development of microorganism-resistant strains, treatment failure, loss of confidence in health systems, and associated socio-economic impacts. The prevalence of poor-quality antibiotics has been found to be high in some of the Low and Middle-Income Countries (LMICs), but no data were available on the situation in Rwanda. This study was conducted to obtain data and inform health professionals on the quality of the 12 most-used selected antibiotics from private retail pharmacies in Rwanda. The investigation was conducted on 232 batches collected from randomly selected private retail pharmacies in all provinces of Rwanda, and concerned only with visual inspection and assay tests. Visual inspection was performed using a tool adopted by the International Pharmaceutical Federation (FIP) to identify manufacturing defects. An assay test quantified the Active Pharmaceutical Ingredient (API) in each collected batch using high-performance liquid chromatography (HPLC) coupled with an ultraviolet-visible (UV) detector, and the results were reported as the percentage content of the amount of APIs stated on the label. A total of 232 batches were analyzed, manufactured in 10 countries; the main country of manufacture was Kenya, with almost half of the batches (49.6%). The results of the visual inspection did not show the presence of counterfeit/ falsified antibiotics on the Rwandan market in this study but revealed weaknesses in labeling: more than 90% of the analyzed batches of the 12 antibiotics did not present the dosage statement on their label, and the complete list of excipients was missing in more than 20% of the analyzed batches. The assay test using HPLC confirmed the presence of APIs in 100% of the analyzed batches. However, moderate deviations from acceptable ranges of the API content defined by M. M. Nasr & C. M. Stanley in 2006 for erythromycin and the United States Pharmacopoeia 2018 for the other 11 molecules were found. The failure rate to meet the quality requirements in terms of the percentage content of active pharmaceutical ingredients declared on the labels was estimated at 8.2% in total, with 3.9% and 4.3% containing more and less than the amount of APIs stated on the labels respectively. The most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.

Quality of oxytocin and misoprostol in health facilities of Rwanda.

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.

Stability of misoprostol tablets collected in Malawi and Rwanda: Importance of intact primary packaging.

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.

Stability of Oxytocin Preparations in Malawi and Rwanda: Stabilizing Effect of Chlorobutanol.

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."

Prices, availability and affordability of medicines in Rwanda.

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 faith-based 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 faith-based sectors. Further improvements of the availability of medicines in the public and the faith-based health facilities represent the most important key to increase accessibility and affordability of medicines in Rwanda.