دورية أكاديمية

Quality Assessment of Selected Essential Antimicrobial Drugs from Drug Retail Outlets of Selected Cities in Eastern Ethiopia.

التفاصيل البيبلوغرافية
العنوان: Quality Assessment of Selected Essential Antimicrobial Drugs from Drug Retail Outlets of Selected Cities in Eastern Ethiopia.
المؤلفون: Anjulo H; Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.; Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia., Birhane W; Department of Pharmacy, College of Health Science, Debremarkos University, Debremarkos, Ethiopia., Hymete A; Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia., Ashenef A; Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.; Center for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
المصدر: The American journal of tropical medicine and hygiene [Am J Trop Med Hyg] 2024 Feb 13; Vol. 110 (3), pp. 596-608. Date of Electronic Publication: 2024 Feb 13 (Print Publication: 2024).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: American Society of Tropical Medicine and Hygiene Country of Publication: United States NLM ID: 0370507 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1476-1645 (Electronic) Linking ISSN: 00029637 NLM ISO Abbreviation: Am J Trop Med Hyg Subsets: MEDLINE
أسماء مطبوعة: Publication: Northbrook, IL : American Society of Tropical Medicine and Hygiene
Original Publication: Baltimore.
مواضيع طبية MeSH: Drugs, Essential* , Anti-Infective Agents* , Substandard Drugs* , Counterfeit Drugs*, Humans ; Ethiopia ; Norfloxacin ; Cities ; Amoxicillin ; Ciprofloxacin
مستخلص: The prevalence of substandard and falsified (SF) antimicrobial drugs is increasing around the globe. This poses a great concern for the healthcare system. The consumption of SF antimicrobial drugs has the potential to result in treatment failure, emergence and development of antimicrobial resistance, and ultimately a rise in mortality rate. The objective of this study was to assess the quality of four commonly used antimicrobials marketed in the cities of Dire Dawa and Jijiga and the town of Togo-Wuchale, which have high potential for illegal drug trade activities in Ethiopia because they are located near the border with Somalia. A total of 54 brands/samples of amoxicillin, amoxicillin/clavulanic acid, ciprofloxacin, and norfloxacin formulations were collected covertly from 43 facilities using a convenience sampling strategy from March 16 to March 29, 2022. The samples were first screened using Global Pharma Health Fund (GPHF)-Minilab protocols and then analyzed using U.S. Pharmacopoeial and British Pharmacopoeia official methods. The quality evaluation detected no falsified product; however, it showed that 14.3% of the samples failed the GPHF-Minilab screening test semiquantitatively. Overall, 22.2% of the products analyzed did not meet any of pharmacopoeial specifications assessed: 13%, 12.2%, and 11.1% of the products failed in assay, dissolution, and weight variation, respectively. Additionally, 56.3% of amoxicillin samples, 60% of amoxicillin/clavulanate, 20% of ciprofloxacin, and 54.5% of norfloxacin samples were found to be pharmaceutically nonequivalent with their respective comparator products regarding dissolution profiles. The study showed the presence of substandard antimicrobial medicines in the eastern Ethiopian market.
References: Afr Health Sci. 2013 Jun;13(2):369-75. (PMID: 24235938)
Pharmaceutics. 2017 May 20;9(2):. (PMID: 28531119)
Health Policy Plan. 2019 Dec 1;34(Supplement_3):iii1-iii3. (PMID: 31816069)
Lancet. 2017 Jan 28;389(10067):403-476. (PMID: 27832874)
Global Health. 2021 Sep 23;17(1):114. (PMID: 34556126)
BMJ Glob Health. 2022 Aug;7(8):. (PMID: 35981806)
Infect Drug Resist. 2019 Dec 20;12:3903-3910. (PMID: 31908502)
AAPS J. 2010 Sep;12(3):263-71. (PMID: 20373062)
Drug Des Devel Ther. 2019 Apr 17;13:1241-1249. (PMID: 31118565)
S Afr Med J. 2015 Apr 06;105(5):325. (PMID: 26242647)
AAPS PharmSciTech. 2022 Jul 26;23(6):201. (PMID: 35882662)
Am J Trop Med Hyg. 2020 Aug;103(2):894-908. (PMID: 32394884)
Clin Microbiol Rev. 2015 Apr;28(2):443-64. (PMID: 25788516)
Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):68-74. (PMID: 25897073)
Rev Panam Salud Publica. 2020 Oct 06;44:e125. (PMID: 33033498)
Lancet. 2016 Oct 8;388(10053):1813-1850. (PMID: 27665228)
Eur J Clin Pharmacol. 2015 Sep;71(9):1029-35. (PMID: 26153083)
Pharmaceutics. 2021 Oct 15;13(10):. (PMID: 34683995)
Bull World Health Organ. 2008 Oct;86(10):749-56. (PMID: 18949211)
PLoS One. 2021 May 14;16(5):e0251400. (PMID: 33989309)
Pharmazie. 2009 Aug;64(8):483-90. (PMID: 19746834)
JAMA Netw Open. 2018 Aug 3;1(4):e181662. (PMID: 30646106)
J Antimicrob Chemother. 2007 Aug;60(2):214-36. (PMID: 17550892)
المشرفين على المادة: N0F8P22L1P (Norfloxacin)
0 (Drugs, Essential)
0 (Anti-Infective Agents)
0 (Substandard Drugs)
804826J2HU (Amoxicillin)
5E8K9I0O4U (Ciprofloxacin)
0 (Counterfeit Drugs)
تواريخ الأحداث: Date Created: 20240213 Date Completed: 20240308 Latest Revision: 20240309
رمز التحديث: 20240309
مُعرف محوري في PubMed: PMC10919192
DOI: 10.4269/ajtmh.23-0536
PMID: 38350137
قاعدة البيانات: MEDLINE
الوصف
تدمد:1476-1645
DOI:10.4269/ajtmh.23-0536