When medicines do not work the way they should (as is the case with most substandard and falsified medical products), they can prolong illness and the inconvenience, time off work and often the misery that go with it. Doctors and other health workers waste precious time trying out alternative treatments, when all that is really needed is a quality version of the same treatment. In the worst cases, several of which are described in this report, people die, either from untreated disease or because the product itself kills them.
According to WHO 2017, substandard and falsified medical products can be:
Research conducted by WHO, existing data show that:
According to Almuzaini et al, the prevalence of substandard antimicrobials is high throughout Africa and Asia in lower income countries and lower middle-income countries. The prevalence of substandard/counterfeit medicines was significantly higher in the unlicensed markets. Inadequate amount of active ingredients were the largest problem identified. Substandard and falsified (SF) medicines are a “wicked problem” and a global issue with substantial estimated economic and public health impact (Ozawa S, et al. 2018). They affect countries across the full spectrum of financial levels, from low-income countries (LICs) to high-income countries (HICs) 6. SF medicines exist in many different therapeutic classes, are sold with the explicit intent to deceive the end user of their origin, authenticity and efficacy and can have wide ranging effects including failure of treatment, toxicity and antimicrobial resistance (Renshler JP, et al. 2015). Arguably, the most morally reprehensible crime is the willing sale of falsified lifesaving treatments, such as antimalarial products, in area where the disease is endemic, a practice that continues at great cost to human life (Bassat Q, et al. 2016).
In cases of substandard medication that arise through inadequate production processes, rather than through deliberate falsification of drugs, the lack of quality may be the result of a variety of factors, including the following: inadvertent use of substandard or incorrect APIs or excipients; poor control of drug quantity; manufacturing processes that cause contamination or do not adequately ensure sterility; and inadequate packaging design or quality. In addition, ineffective quality-control measure, either on the part of the manufacturer of the NMRA, allow such faults to remain undetected. Any formulation of medication may be regarded as substandard if it has either too much or too little of the API compared with the formulation specifications. Official national pharmacopoeias, such as the British Pharmacopoeia (BP) and United States Pharmacopeia (USP), publish the quality standards for medicinal substances and preparations manufactured or sold in the country. The information given specifies the acceptable limits for the amount of the API that should be present in a given formulation. However, many examples from a range of drug classes have been published of over/underconcentration of APIs in marketed drugs. In some cases, all sampled antibiotics or antimalarial were found to contain API concentrations outside the officially specified limits (Johnston & Holt, 2013).
In short, substandard and falsified medical products are most likely to be found at the intersection where:
Very broadly speaking, substandard medical product reach products reach patients when the tools and technical capacity to enforce quality standards in manufacturing and the supply chain are limited. Technical limitations also affect falsified products, but their circulation in the market is further promoted by corruption and other shortcomings of regulation and governance, including unethical practice by wholesalers, distributors, retailers and health care workers. However, a high proportion of cases so far reported to WHO occur where these problems overlap with constrained access.
Almuzaini T, Choonara I, et all. Substandard and Counterfeit Medicines: a Systematic Review of the Literature. BMJ Open 2013;3:e002923
Bassat Q, Tanner M, Guerin PJ, et al. Combating poor-quality antimalarial medicines: a call to action. Malar J. 2016;15:302
Hamilton W, Doyle C, et al. Public health interventions to protect against falsified medicines: a systematic review of international, national and policies. Health Policy and Planning, 31, 2016, 1448-1466
Handayani R, Purwadianto A, et al. Collaborative stakeholders approach in combating substandard and falsified medical products in Indonesia: A qualitative study. AIP Conference Proceeding 2092, 040004 (2019).
Johnston & Holt. Substandard drugs: a potential crisis for public health. British Journal of Clinical Pharmacology. 2013
McManus D, Naughton BD. A Systematic Review of Substandard, Falsified, Unlicensed and Unregistered Medicine Sampling Studies: a Focus on Context, Prevalence and Quality. BMJ Global Health. 2020;5:e002393
Ozawa S, Evans DR, Bessias S, et al. Prevalence and Estimate Economic Burden of Substandard and Falsified Medicine in low and middle-income countries: a systematic review and meta analysis. JAMA Netw Open 2018;1:e181662
PSI-Inc (Pharmaceutical Security Institute). Counterfeit Situation. http://www.psi-inc.org/incidentTrends.cfm (accessed 06 October 2021)
Renschler JP, Walters KM, Newton PN, et al. Estimated Under-five deaths associated with poor quality antimalarials in sub-Saharan Africa. Am J Trop Med Hyg 2015;92:119-26
The Institute of Medicine (IOM). Countering the Problem of Falsified and Substandard Drug Report. 2013. http://www.iom.edu/Reports/2013/Countering-the-Problem-of-Falsified-and-Substandard-Drugs. (accessed 06 October 2021)
WHO. A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Product. http://www.who.int/medicines/regulation/ssfc/publication/layout-SEsrudy-WEB.pdf (in McManus D, Naughton BD. A Systematic Review of Substandard, Falsified, Unlicensed and Unregistered Medicine Sampling Studies: a Focus on Context, Prevalence and Quality. BMJ Global Health. 2020;5:e002393)
WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. Geneva: World Health Organization; 2017. License: CC BY-NIC-SA 3.0 IGO.
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