Importation trends in antibiotics for veterinary use in Rwanda: A retrospective study between 2019 and 2021.

Estimating antibiotic consumption in animals is fundamental to guiding decision-making and research on controlling the emergence and spread of antibiotic-resistant bacteria in humans, animals, and the environment. This study aimed to establish importation trends of antibiotics for veterinary use in Rwanda between 2019 and 2021. Data was collected from the Rwanda Food and Drugs Authority's database. Quantities of imported antibiotic active ingredients were computed using the information extracted from the issued import licenses. These quantities were subsequently adjusted per animal biomass. In total, 35,291.4 kg of antibiotics were imported into Rwanda between 2019 and 2021, with an annual mean of 11,763.8 ± 1,486.9 kg. The adjustment of imported quantities of antibiotics per animal biomass revealed that 29.1 mg/kg, 24.3 mg/kg, and 30.3 mg/kg were imported in 2019, 2020, and 2021 respectively. A slight but not statistically significant decline in antibiotic importation was noted in 2020 (p-value = 0.547). Most of the imported antibiotics were indicated to be used in food-producing animals (35,253.8 kg or 99.9% of the imported antibiotics). Tetracyclines (17,768.6 kg or 50.3%), followed by sulfonamides (7,865.0 kg or 22.3%) and aminoglycosides (4,071.1 kg or 11.5%), were the most imported antibiotics over the studied period. It was noted that 78.9% of the imported antibiotics were categorized as highly important antimicrobials for human medicine. This study established a generalized overview of the importation of antibiotics for veterinary use in Rwanda. These results can serve as guidance for the control of antibiotic misuse. They can be used to make a correlation between antibiotic importation, antibiotic consumption, and the occurrence of antibiotic resistance in the country.

The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda.

BACKGROUND: Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study. OBJECTIVE: This study aimed to assess the capacity of the Rwanda FDA, a young NMRA, to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines. METHODS: This study used a descriptive cross-sectional design with both quantitative and qualitative approaches. The quantitative approach used a self-administered questionnaire to collect data from employees of Rwanda FDA who are involved in medicine regulatory practices based on their positions while the qualitative research approach covered a desk review of key regulatory documents. The data collection tool was developed from the World Health Organization (WHO) Global Benchmarking Tool (GBT) for "Evaluation of National Regulatory System of Medical Products Revision VI". RESULTS: Of the 251 WHO sub-indicators assessed, 179 sub-indicators (71%) were fully implemented, 17 sub-indicators (7%) were partially implemented, 9 sub-indicators (4%) were ongoing and 46 sub-indicators (18%) were not implemented by the time of the study. The results of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2. The study reported the challenges hindering the implementation of key regulatory functions that need to be addressed. Challenges reported include but are not limited to understaffing, lack of automation system, poor implementation of the quality management system, lack of screening technologies for SF medicines, low capacity of the quality control laboratory to test all sampled medicines and lack of regulatory inspection tools/equipment. CONCLUSION: Findings indicated that all key regulatory functions were operating and supported by the legal framework. However, the implementation of key regulatory functions faced challenges that need to be addressed for better organizational effectiveness and compliance with the requirements of a higher maturity level.

Detection of Poor Quality Artemisinin-based Combination Therapy (ACT) Medicines Marketed in Benin Using Simple and Advanced Analytical Techniques.

BACKGROUND: Poor quality antimalarial medicines still represent a threat to the public health, especially in Sub-Saharan Africa which bears a disproportionate share of the global burden of malaria. It is essential and urgent to strengthen mechanisms against counterfeit medicines. One of the approaches is regular market surveillance through quality controls. METHODS: 12 samples of artemether/lumefantrine were collected from formal and informal drug sellers in Cotonou (Benin) as well as additional other similar samples from Rwanda (13 samples) and from D.R. Congo (9 samples). Thin Layer Chromatography (TLC) as classical and simple identification test was applied in Benin while an analytical chemistry laboratory in Belgium (ULg, Pharmacy Department) was asked for further analyses with HPLC and Raman spectroscopy using a developed and validated HPLC method for rapid analysis of artemether/lumefantrine. RESULTS: The results obtained in Belgium confirmed the lack of the two active ingredients in the suspected sample of ACT medicine from Benin whereas some samples from Rwanda and D.R. Congo were found to present risk of substandard drugs either for under-dosing or over-dosing. CONCLUSIONS: Counterfeit/falsified of artemisinin-based combination therapy (ACT) medicines are really scourge that needs to be fought through strong collaboration between public health authorities and appropriate quality control laboratories.

Application of design space optimization strategy to the development of LC methods for simultaneous analysis of 18 antiretroviral medicines and 4 major excipients used in various pharmaceutical formulations.

As one of the world's most significant public health challenges in low- and middle-income countries, HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from counterfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviral medicines (ARV) and 4 major excipients. Design of experiments and design space methodology were initially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations and focusing on rapidity and affordability thus using short column and low cost organic solvent (methanol) in gradient mode with 10mM buffer solutions of ammonium hydrogen carbonate. Two other specific methods dedicated to ARV in liquid and in solid dosage formulations were also predicted and optimized. We checked the ability of one method for the analysis of a fixed-dose combination composed by emtricitabine/tenofovir/efavirenz in tablet formulations. Satisfying validation results were obtained by applying the total error approach taking into account the accuracy profile as decision tool. Then, the validated method was applied to test two samples coded A and B, and claimed to contain the tested ARV. Assay results were satisfying only for sample B.