1921
Volume 99, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

    f Amoxicillin Quality and Selling Practices in Urban Pharmacies and Drug Stores of Blantyre, Malawi

  • Ibrahim Chikowe1, Sarah L. Bliese2, Samuel Lucas2, Marya Lieberman2
  • View Affiliations Hide Affiliations
    *Address correspondence to Marya Lieberman, 271 Stepan Hall of Chemistry, Department of Chemistry and Biochemistry, University of Notre Dame, Notre Dame, IN 46556. E-mail: mlieberm@nd.edu

    fn1Financial support: I. C. reports grants from CTSI Global Pilot grant during the conduct of the study. S. L. reports grants from USAID during the conduct of the study. M. L. reports grants from Indiana CTSI Global Pilot Grant and has a patent US 9354181 licensed to Veripad LLC.

    fn2Ethical considerations: The study was conducted with permission from the Pharmacy, Medicines and Poisons Board (PMPB) of Malawi and approval by the College of Medicine Research and Ethics Committee (COMREC, Ref P.06/16/1975) and by the University of Notre Dame Institutional Review Board (15-05-2542).

    fn3Declarations: One author, M. L., holds a patent (US 009354181B2) on the paper analytical devices (PADs) used to perform field screening of the amoxicillin samples in this study. Licensing negotiations for this patent with a U.S. company are underway. The U.S. patent will not prevent others from manufacturing or selling PADs outside the United States, and M. L. has no international patents or patent applications on the PAD technology.

    fn4Conflicts of interest: ML and IC received joint funding from Indiana Clinical and Translational Science Institute (CTSI) to carry out this study. The other authors declare that they do not have any competing interests or conflicts of interest.

    fn5Authors’ addresses: Ibrahim Chikowe, Faculty of Biomedical Sciences and Health Professions, University of Malawi, College of Medicine, Blantyre, Malawi, E-mail: ichikowe@medcol.mw. Sarah L. Bliese and Marya Lieberman, Department of Chemistry and Biochemistry, University of Notre Dame, Notre Dame, IN, E-mails: sbliese@nd.edu and mlieberm@nd.edu. Samuel Lucas, Unity Healthcare, Washington, DC, E-mail: slucas@alumni.nd.edu.

    Notes

    Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the United States National Institutes of Health.

  • Publisher: The American Society of Tropical Medicine and Hygiene
  • Source: The American Journal of Tropical Medicine and Hygiene, Volume 99, Issue 1, 5 Jul 2018, p. 233 - 238
  • DOI: https://doi.org/10.4269/ajtmh.18-0003

Abstract

Abstract.

This study evaluated a newly developed paper analytical device (PAD) for screening amoxicillin samples in Blantyre urban townships. Covert shoppers attempted to buy amoxicillin from a geographically stratified selection of private pharmacies ( = 22 out of 26) and drug stores ( = 23 out of 103) in the township area. According to the PAD results, all 42 samples obtained by the shoppers contained amoxicillin and none contained suspicious filler materials. Next, the products were assayed using high-performance liquid chromatography. Consistent with the PAD results, all samples contained the correct amount of amoxicillin with no unexpected ingredients. However, one sample was purchased as amoxicillin and contained that ingredient, but was packaged in capsules that are normally used to package ampicillin. Almost every sample failed a simple packaging analysis. Nine in 10 samples were missing their original packaging and/or inserts (52.4% repackaged capsules and 35.7% repackaged blister packs). Only 33.3% of the packages had expiry dates, 16.7% had batch numbers, and 47.6% had the manufacturer’s name. Dispensing practices were likewise unsatisfactory. Ninety-five percentage of the sellers sold the amoxicillin without a prescription, even though this medicine is regulated as prescription-only in Malawi. Although the chemical analysis showed that amoxicillin quality was good, our market survey revealed poor adherence to prescription-only medicine dispensing of antibiotics, which threatens antimicrobial stewardship efforts. Furthermore, the wide prevalence of repackaging deprives medicines of important information needed during patient’s use, regulatory investigations, and pharmacovigilance reporting.

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  • Received : 02 Jan 2018
  • Accepted : 13 Mar 2018
  • Published online : 23 Apr 2018

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