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Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries

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  • Stephanie Kovacs
  • Stephen E Hawes
  • Stephen N Maley
  • Emily Mosites
  • Ling Wong
  • Andy Stergachis

Abstract

Falsified and substandard drugs are a global health problem, particularly in low- and middle-income countries (LMIC) that have weak pharmacovigilance and drug regulatory systems. Poor quality medicines have important health consequences, including the potential for treatment failure, development of antimicrobial resistance, and serious adverse drug reactions, increasing healthcare costs and undermining the public's confidence in healthcare systems. This article presents a review of the methods employed for the analysis of pharmaceutical formulations. Technologies for detecting substandard and falsified drugs were identified primarily through literature reviews. Key-informant interviews with experts augmented our methods when warranted. In order to aid comparisons, technologies were assigned a suitability score for use in LMIC ranging from 0–8. Scores measured the need for electricity, need for sample preparation, need for reagents, portability, level of training required, and speed of analysis. Technologies with higher scores were deemed the most feasible in LMICs. We categorized technologies that cost $10,000 USD or less as low cost, $10,000–100,000 USD as medium cost and those greater than $100,000 USD as high cost technologies (all prices are 2013 USD). This search strategy yielded information on 42 unique technologies. Five technologies were deemed both low cost and had feasibility scores between 6–8, and an additional four technologies had medium cost and high feasibility. Twelve technologies were deemed portable and therefore could be used in the field. Many technologies can aid in the detection of substandard and falsified drugs that vary from the simplest of checklists for packaging to the most complex mass spectrometry analyses. Although there is no single technology that can serve all the requirements of detecting falsified and substandard drugs, there is an opportunity to bifurcate the technologies into specific niches to address specific sections within the workflow process of detecting products.

Suggested Citation

  • Stephanie Kovacs & Stephen E Hawes & Stephen N Maley & Emily Mosites & Ling Wong & Andy Stergachis, 2014. "Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries," PLOS ONE, Public Library of Science, vol. 9(3), pages 1-11, March.
    • Handle: RePEc:plo:pone00:0090601
    DOI: 10.1371/journal.pone.0090601
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    References listed on IDEAS

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    1. Harparkash Kaur & Catherine Goodman & Eloise Thompson & Katy-Anne Thompson & Irene Masanja & S Patrick Kachur & Salim Abdulla, 2008. "A Nationwide Survey of the Quality of Antimalarials in Retail Outlets in Tanzania," PLOS ONE, Public Library of Science, vol. 3(10), pages 1-7, October.
    2. Alessandro Liberati & Douglas G Altman & Jennifer Tetzlaff & Cynthia Mulrow & Peter C Gøtzsche & John P A Ioannidis & Mike Clarke & P J Devereaux & Jos Kleijnen & David Moher, 2009. "The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-28, July.
    3. Paul N Newton & Abdinasir A Amin & Chris Bird & Phillip Passmore & Graham Dukes & Göran Tomson & Bright Simons & Roger Bate & Philippe J Guerin & Nicholas J White, 2011. "The Primacy of Public Health Considerations in Defining Poor Quality Medicines," PLOS Medicine, Public Library of Science, vol. 8(12), pages 1-5, December.
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    1. Graham Lawson & John Ogwu & Sangeeta Tanna, 2018. "Quantitative screening of the pharmaceutical ingredient for the rapid identification of substandard and falsified medicines using reflectance infrared spectroscopy," PLOS ONE, Public Library of Science, vol. 13(8), pages 1-17, August.
    2. Céline Caillet & Serena Vickers & Stephen Zambrzycki & Nantasit Luangasanatip & Vayouly Vidhamaly & Kem Boutsamay & Phonepasith Boupha & Yoel Lubell & Facundo M Fernández & Paul N Newton, 2021. "Multiphase evaluation of portable medicines quality screening devices," PLOS Neglected Tropical Diseases, Public Library of Science, vol. 15(9), pages 1-6, September.

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