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.


    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



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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  1. World Health Organization, 2017. Definitions of Substandard and Falsified (SF) Medical Products. Available at: http://www.who.int/medicines/regulation/ssffc/defintions/en/. Accessed January 22, 2018.
  2. Trapsida JM, Desta AT, Kasilo O, 2012. Preventing and Controlling Substandard and Counterfeit Medical Products in the Who African Region. World Health Organization, Regional Office for Africa. Brazzaville, Republic of Congo: African Health Monitor.
  3. Almuzaini T, Choonara I, Sammons H, 2013. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3: e002923.
    [Google Scholar]
  4. Osei-Safo D, Harrison JJEK, Addae-Mensah I, 2010. Validation and application of quality assurance methods developed for artemisinin-based anti-malarial drugs to assess the quality of a selection of such drugs distributed in Accra, Ghana. Afr J Pharm Sci Pharm 1: 125.
    [Google Scholar]
  5. Derda R et al., 2015. Enabling the development and deployment of next generation point-of-care diagnostics. PLoS Neg Trop Dis 9: e0003676.
    [Google Scholar]
  6. Weaver A, Reiser H, Barstis T, Benvenuti M, Ghosh D, Hunkler M, Joy B, Koenig L, Raddell K, Lieberman M, 2013. Paper analytical devices for fast field screening of beta lactam antibiotics and antituberculosis pharmaceuticals. Anal Chem 85: 64536460.
    [Google Scholar]
  7. Newton PN et al., 2009. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6: e1000052.
    [Google Scholar]
  8. World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations, 2002. WHO Expert Committee on Specifications for Pharmaceutical Preparations: Thirty-Sixth Report. WHO Technical Report Series 902. Geneva, Switzerland: WHO.
  9. USP, 2018. Amoxicillin Capsules. Pharmacopeial Forum 30: 1583.
    [Google Scholar]
  10. Weaver A, Lieberman M, 2015. Paper test cards for presumptive testing of very low quality antimalarial medications. Am J Trop Med Hyg 92 (Suppl): 1723.
    [Google Scholar]
  11. Chikowe I, Lieberman M, 2016. Presented: Evaluation of a New Tool for Assessing Pharmaceutical Quality at College of Medicine (CoM). 20th Annual Research Dissemination Conference. September 2016, Blantyre, Malawi.
  12. Khuluza F, Kigera S, Heidi L, 2017. Low prevalence of substandard and falsified antimalarial and antibiotic medicines in public and faith-based health facilities of southern Malawi. Am J Trop Med Hyg 96: 11241135.
    [Google Scholar]
  13. Kelesidis T, Falagas ME, 2015. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 28: 443464.
    [Google Scholar]
  14. Low C, Pop-Eleches C, Rono W, Plous E, Kirk A, Ndege S, Goldstein M, Thirumurthy H, 2013. The effects of home-based HIV counseling and testing on HIV/AIDS stigma among individuals and community leaders in western Kenya: evidence from a cluster-randomized trial. AIDS Care 25 (Suppl 1): S97S107.
    [Google Scholar]
  15. Nga DTT et al., 2014. Antibiotic sales in rural and urban pharmacies in northern Vietnam: an observational study. BMC Pharmacol Toxicol 15: 6.
    [Google Scholar]
  16. Foster EK, Bandawe CR, 2014. How much do patients in Blantyre, Malawi know about antibiotics and other prescription only medicines? Malawi Med J 26: 1215.
    [Google Scholar]
  17. Akinyandenu O, Akinyandenu A, 2014. Irrational use and non-prescription sale of antibiotics in Nigeria: a need for change. J Sci Innov Res 3: 251257.
    [Google Scholar]
  18. Crisostomo S, 2013. FDA: Report Drugstores Selling Antibiotics without Prescription. Taguig, Philippines: The Philippine Star.
  19. Bin Abdulhak AA et al., 2011. Non prescribed sale of antibiotics in Riyadh, Saudi Arabia: a cross sectional study. BMC Public Health 11: 538.
    [Google Scholar]
  20. Llor C, Cots JM, 2009. The sale of antibiotics without prescription in pharmacies in Catalonia, Spain. Clin Infect Dis 48: 13451349.
    [Google Scholar]
  21. Al-Faham Z, Habboub G, Takriti F, 2011. The sale of antibiotics without prescription in pharmacies in Damascus, Syria. J Infect Dev Ctries 5: 396399.
    [Google Scholar]
  22. Goodman CA, Kachur SP, Abdulla S, Bloland P, Mills A, 2007. Drug shop regulation and malaria treatment in Tanzania—why do shops break the rules, and does it matter? Health Policy Plan 22: 393403.
    [Google Scholar]
  23. Lima SIVC, Diniz RS, Egito EST, Azevedo PRM, Oliveira AG, Araujo IB, 2015. Rationality of antimicrobial prescriptions in community pharmacy users. PLoS One 10: e0141615.
    [Google Scholar]
  24. Musicha P et al., 2017. Trends in antimicrobial resistance in bloodstream infection isolates at a large urban hospital in Malawi (1998–2016): a surveillance study. Lancet Infect Dis 17: 10421052.
    [Google Scholar]
  25. Ministry of Health, 2015. Malawi Standard Treatment Guidelines, 5th edition. Lilongwe, Malawi: Government of Malawi.
  26. Mossad SB, 2013. Upper Respiratory Tract Infections, Disease Management. Lyndhurst, Ohio: Center for Continuing Education, Cleveland Clinic.

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