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      Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries : A Systematic Review and Meta-analysis

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          Abstract

          Key Points Question What are the prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries? Findings In this systematic review of 265 studies comprising 400 647 drug samples and meta-analysis of 96 studies comprising 67 839 drug samples, the prevalence of substandard and falsified medicines in low- and middle-income countries was 13.6% overall (19.1% for antimalarials and 12.4% for antibiotics). Data on the estimated economic impact were limited primarily to market size and ranged widely from $10 billion to $200 billion. Meaning Substandard and falsified medicines are a substantial health and economic problem; a concerted global effort is needed to secure the global supply chain, increase quality control capacity, and improve surveillance to better assess the problem and identify solutions.

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          Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa.

          Gaurvika Nayyar, Joel G. Breman, Paul N. Newton … (2012)
          Poor-quality antimalarial drugs lead to drug resistance and inadequate treatment, which pose an urgent threat to vulnerable populations and jeopardise progress and investments in combating malaria. Emergence of artemisinin resistance or tolerance in Plasmodium falciparum on the Thailand-Cambodia border makes protection of the effectiveness of the drug supply imperative. We reviewed published and unpublished studies reporting chemical analyses and assessments of packaging of antimalarial drugs. Of 1437 samples of drugs in five classes from seven countries in southeast Asia, 497 (35%) failed chemical analysis, 423 (46%) of 919 failed packaging analysis, and 450 (36%) of 1260 were classified as falsified. In 21 surveys of drugs from six classes from 21 countries in sub-Saharan Africa, 796 (35%) of 2297 failed chemical analysis, 28 (36%) of 77 failed packaging analysis, and 79 (20%) of 389 were classified as falsified. Data were insufficient to identify the frequency of substandard (products resulting from poor manufacturing) antimalarial drugs, and packaging analysis data were scarce. Concurrent interventions and a multifaceted approach are needed to define and eliminate criminal production, distribution, and poor manufacturing of antimalarial drugs. Empowering of national medicine regulatory authorities to protect the global drug supply is more important than ever. Copyright © 2012 Elsevier Ltd. All rights reserved.
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            Counterfeit anti-infective drugs.

            Paul N. Newton, F. Gil, David F. Día z Fernández … (2006)
            The production of counterfeit or substandard anti-infective drugs is a widespread and under-recognised problem that contributes to morbidity, mortality, and drug resistance, and leads to spurious reporting of resistance and toxicity and loss of confidence in health-care systems. Counterfeit drugs particularly affect the most disadvantaged people in poor countries. Although advances in forensic chemical analysis and simple field tests will enhance drug quality monitoring, improved access to inexpensive genuine medicines, support of drug regulatory authorities, more open reporting, vigorous law enforcement, and more international cooperation with determined political leadership will be essential to counter this threat.
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              Substandard medicines in resource-poor settings: a problem that can no longer be ignored.

              J.-M. Caudron, N. Ford, M Henkens … (2008)
              The circulation of substandard medicines in the developing world is a serious clinical and public health concern. Problems include under or over concentration of ingredients, contamination, poor quality ingredients, poor stability and inadequate packaging. There are multiple causes. Drugs manufactured for export are not regulated to the same standard as those for domestic use, while regulatory agencies in the less-developed world are poorly equipped to assess and address the problem. A number of recent initiatives have been established to address the problem, most notably the WHO pre-qualification programme. However, much more action is required. Donors should encourage their partners to include more explicit quality requirements in their tender mechanisms, while purchasers should insist that producers and distributors supply drugs that comply with international quality standards. Governments in rich countries should not tolerate the export of substandard pharmaceutical products to poor countries, while developing country governments should improve their ability to detect substandard medicines.
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                Author and article information

                Journal
                Title: JAMA Network Open
                Abbreviated Title: JAMA Network Open
                Publisher: American Medical Association (AMA)
                ISSN (Electronic): 2574-3805
                Publication date Created: August 03 2018
                Publication date (Print): August 10 2018
                Volume: 1
                Issue: 4
                Page: e181662
                Affiliations
                [1 ]Department of Maternal and Child Health, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
                [2 ]Division of Practice Advancement and Clinical Education, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill
                [3 ]Enterprise Analytics and Data Sciences, University of North Carolina Health Care, Chapel Hill
                [4 ]University of Virginia School of Medicine, Charlottesville
                [5 ]Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
                Article
                DOI: 10.1001/jamanetworkopen.2018.1662
                SO-VID: 8b7aa761-3982-4610-beec-fd16ac50d4da
                Copyright © © 2018
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