A four-year assessment of the characteristics of Rwandan FDA drug recalls.

BACKGROUND: A drug recall is an act of removing products from the market and/or returning them to the manufacturer for disposal or correction when they violate safety laws. Action can be initiated by the manufacturing company or by the order of a regulatory body. This study aimed to assess the characteristics of Rwanda FDA drug recall and determine the association between classes of recall and recall characteristics. METHODOLOGY: This was a retrospective descriptive cross-sectional study. Data about recalled drugs were collected from the official website of the Rwanda FDA in the section assigned to "Safety alerts". The search included data reported between February 2019 and February 2023 covering four years. Data cleaning was conducted in Microsoft Excel to address missing data and inconsistencies, followed by importation into STATA/SE software version 17.0 for further cleaning and subsequent analysis. Descriptive statistics were computed for independent variables. Categorical variables were described in terms of counts and relative frequencies. Bivariate analyses used Pearson's chi-square test to illustrate the associations between categorical independent variables and recall classes. RESULTS: The study revealed that a large proportion (33.0%) of the recalled products belonged to Class I. Antibiotics constituted 35.8% of the recalled products, with contamination emerging as a leading cause and responsible for 26.4% of the recalls. India was the leading manufacturing country for the recalled products (29.2%), followed by France (17.9%), China (17.0%), Kenya (13.2%), and Russia (6.6%). An association was found between the class of recall and several recall characteristics, including the year of recall, drug category, safety issues, reporter, and manufacturing country. CONCLUSION: This study provides a comprehensive overview of the characteristics of drug recalls in Rwanda. The insights gained contribute to a nuanced understanding of recall dynamics and provide evidence-based strategies to enhance drug quality, safety, efficacy, regulatory compliance, and patient welfare.

Global prevalence of coronavirus disease 2019 reinfection: a systematic review and meta-analysis.

BACKGROUND: In December 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged with a high transmissibility rate and resulted in numerous negative impacts on global life. Preventive measures such as face masks, social distancing, and vaccination helped control the pandemic. Nonetheless, the emergence of SARS-CoV-2 variants, such as Omega and Delta, as well as coronavirus disease 2019 (COVID-19) reinfection, raise additional concerns. Therefore, this study aimed to determine the overall prevalence of reinfection on global and regional scales. METHODS: A systematic search was conducted across three databases, PubMed, Scopus, and ProQuest Central, including all articles pertaining to COVID-19 reinfection without language restriction. After critical appraisal and qualitative synthesis of the identified relevant articles, a meta-analysis considering random effects was used to pool the studies. RESULTS: We included 52 studies conducted between 2019 and 2022, with a total sample size of 3,623,655 patients. The overall prevalence of COVID-19 reinfection was 4.2% (95% confidence interval [CI]: 3.7-4.8%; n = 52), with high heterogeneity between studies. Africa had the highest prevalence of 4.7% (95% CI: 1.9-7.5%; n = 3), whereas Oceania and America had lower estimates of 0.3% (95% CI: 0.2-0.4%; n = 1) and 1% (95% CI: 0.8-1.3%; n = 7), respectively. The prevalence of reinfection in Europe and Asia was 1.2% (95% CI: 0.8-1.5%; n = 8) and 3.8% (95% CI: 3.4-4.3%; n = 43), respectively. Studies that used a combined type of specimen had the highest prevalence of 7.6% (95% CI: 5.8-9.5%; n = 15) compared with those that used oropharyngeal or nasopharyngeal swabs only that had lower estimates of 6.7% (95% CI: 4.8-8.5%; n = 8), and 3.4% (95% CI: 2.8-4.0%; n = 12) respectively. CONCLUSION: COVID-19 reinfection occurs with varying prevalence worldwide, with the highest occurring in Africa. Therefore, preventive measures, including vaccination, should be emphasized to ensure control of the pandemic.

Pediatric self-medication use in Rwanda - a cross sectional study.

BACKGROUND: Self-medication, a worldwide practice, has both benefits and risks. Many countries have regulated non-prescription medications available for use in self-medication. However, in countries such as Rwanda, where prescriptions are not required to purchase medications, prescription, non-prescription and traditional medications have been used for self-medication. OBJECTIVES: To determine the reported self-medication use in Rwanda and to determine attitudes and reasons associated with parental decisions to self-medicate their children. METHODS: A cross-sectional multi-center questionnaire based quantitative study of 154 parents/caregivers of children under ten years undertaken in private and public health facilities. RESULTS: The use of self-medication was reported to be 77.9%. Among these parents/caregivers, 50.8% used modern self-medication only, 15.8% used traditional self-medication only and 33.3% used both types of self-medication. Paracetamol was the most commonly used drug in modern self-medication; the traditional drugs used were Rwandan local herbs. Parents/caregivers who used modern medicines had slightly more confidence in self-medication than self-medication users of traditional medicines (p=0.005). Parents/caregivers who used modern self-medication reported barriers to consultation as a reason to self-medicate more frequently than those who used traditional drugs. Having more than one child below 10 years of-age was the only socio-demographic factor associated with having used self-medication (AOR=4.74, CI: 1.94-11.58, p=0.001). Being above 30 years (AOR= 5.78, CI: 1.25-26.68, p=0.025) and living in Kigali (AOR=8.2, CI: 1.58-43.12, p=.0.012) were factors associated with preference of modern self- medication compared to traditional self-medication. CONCLUSION: Self-medication is common in Rwanda. Parents/caregivers are involved in this practice regardless of their socio-demographic background.