Substandard and falsified antimicrobials in selected east African countries: A systematic review.

Autor: Tegegne AA; Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, Ethiopia., Feissa AB; Pharmaceutical Sciences, School of Pharmacy, Institute of Health Sciences, Jimma University, Jimma, Ethiopia., Godena GH; Pharmaceutical Sciences, School of Pharmacy, Institute of Health Sciences, Jimma University, Jimma, Ethiopia., Tefera Y; Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, Ethiopia., Hassen HK; Ethiopian Agricultural Authority, Veterinary Drug Quality Control and Inspection Directorate, Addis Ababa, Ethiopia.; Department of Pharmaceutical Technology, Near East University, Turkey., Ozalp Y; Department of Pharmaceutical Technology, Near East University, Turkey., Suleman S; Pharmaceutical Sciences, School of Pharmacy, Institute of Health Sciences, Jimma University, Jimma, Ethiopia.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2024 Jan 26; Vol. 19 (1), pp. e0295956. Date of Electronic Publication: 2024 Jan 26 (Print Publication: 2024).
DOI: 10.1371/journal.pone.0295956
Abstrakt: Background: Globally, millions of people have been affected by fraudulent pharmaceutical products, particularly those in developing countries. Although the problem of falsified and substandard drugs is acknowledged, the extent of the issue is ever-changing, has a dynamic nature, and should be quantified and captured in a recent snapshot.
Objective: This systematic review seeks to examine the data that can quantify and provide a current snapshot of the prevalence of SF antimicrobials in selected east Africa countries.
Methods: Scientific studies on antimicrobial quality were searched in PubMed, Embase, Scopus, and Google Scholar from 2017 to February 2023. The search strategy focused on scientific articles published in peer-reviewed scientific journals written in English and the studies exclusively done in any of the selected countries of east Africa. The articles were carefully reviewed by two individuals for inclusion independently, first by title followed by abstract and the full-text retrieval. To minimize bias associated with the methodology used for data collection, the quality of the studies was assessed for quality according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). The reporting of this systematic review was done following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA).
Results: Fifteen studies that estimated the prevalence of poor-quality antimicrobial medicines in selected four east African countries were included. The overall percentage of samples of antimicrobials that failed at least one quality test was 22.6% (151/669) with each class's prevalence of 17% in antibiotics (73/432), 24% in antimalarial (41/171), and 56% in anthelmintics (37/66). Quality control parameters of API content were the most commonly examined in the included studies, accounting for 14/15 (93%) studies. Fifty (33.1%) of the failing samples failed assay API- content determination, while 26.5% (n = 40) failed the visual inspection and packaging analysis; 19.2% (29) failed dissolution; 14% (n = 21) flawed hardness or friability; 4%(n = 6) failed uniformity, as well as 3.2% (n = 5) failed disintegration test of the quality control parameter.
Conclusion: It was found that this review was general in these selected east African countries and was a catalyst for combating the menace of poor-quality medications that affect millions of lives.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Tegegne et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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