دورية أكاديمية
A four-year assessment of the characteristics of Rwandan FDA drug recalls.
| العنوان: | A four-year assessment of the characteristics of Rwandan FDA drug recalls. |
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| المؤلفون: | Bahizi M; Rwanda Food and Drugs Authority, Kigali, Rwanda. bahimarce@yahoo.fr.; University of Rwanda, Kigali, Rwanda. bahimarce@yahoo.fr.; Kigali Independent University, Kigali, Rwanda. bahimarce@yahoo.fr., Nyirimigabo E; Rwanda Food and Drugs Authority, Kigali, Rwanda.; University of Rwanda, Kigali, Rwanda., Ntirenganya L; Rwanda Food and Drugs Authority, Kigali, Rwanda., Umuhoza MI; Rwanda Food and Drugs Authority, Kigali, Rwanda., Habyalimana V; Rwanda Food and Drugs Authority, Kigali, Rwanda., Bikorimana G; University of Rwanda, Kigali, Rwanda., Ukwishaka J; Biomedical Center/ Maternal Child and Community Health Division, Kigali, Rwanda. |
| المصدر: | BMC public health [BMC Public Health] 2024 Jul 04; Vol. 24 (1), pp. 1784. Date of Electronic Publication: 2024 Jul 04. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968562 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2458 (Electronic) Linking ISSN: 14712458 NLM ISO Abbreviation: BMC Public Health Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : BioMed Central, [2001- |
| مواضيع طبية MeSH: | United States Food and Drug Administration* , Drug Recalls*, Cross-Sectional Studies ; Humans ; Retrospective Studies ; United States ; Rwanda |
| مستخلص: | 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. (© 2024. The Author(s).) |
| References: | PLoS Negl Trop Dis. 2021 Feb 18;15(2):e0009138. (PMID: 33600494) Lancet Infect Dis. 2018 Jan;18(1):18-20. (PMID: 29303731) BMJ Open. 2022 Jul 4;12(7):e053479. (PMID: 35788073) J Med Access. 2022 Dec 25;6:27550834221141767. (PMID: 36601496) J Pharm Policy Pract. 2020 Apr 22;13:7. (PMID: 32337049) J Glob Infect Dis. 2011 Apr;3(2):175-82. (PMID: 21731306) Nat Rev Microbiol. 2014 Jul;12(7):465-78. (PMID: 24861036) Biomed Res Int. 2014;2014:913696. (PMID: 25276830) BMC Health Serv Res. 2023 Sep 12;23(1):980. (PMID: 37700302) Epidemiol Infect. 2021 Jun 03;149:e141. (PMID: 34078502) Afr Health Sci. 2020 Dec;20(4):2032-2043. (PMID: 34394269) Am J Trop Med Hyg. 2015 Apr;92(4):865-70. (PMID: 25646259) Int J Pharm Investig. 2015 Jan-Mar;5(1):13-9. (PMID: 25599028) Antimicrob Resist Infect Control. 2020 Jul 22;9(1):115. (PMID: 32698895) Am J Health Syst Pharm. 2016 Feb 15;73(4):235-40. (PMID: 26843501) |
| فهرسة مساهمة: | Keywords: Class of recall; Drug recall; Quality issues; Rwanda FDA |
| تواريخ الأحداث: | Date Created: 20240704 Date Completed: 20240705 Latest Revision: 20240707 |
| رمز التحديث: | 20240707 |
| مُعرف محوري في PubMed: | PMC11223409 |
| DOI: | 10.1186/s12889-024-19245-8 |
| PMID: | 38965502 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1471-2458 |
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| DOI: | 10.1186/s12889-024-19245-8 |