Journal of the American Pharmacists Association
Science and Practice
Commentary
Counterfeit drugs: A major issue for vulnerable citizens throughout the world and in the United States
Section snippets
The extent of risk in developing countries
Counterfeit drugs fall into 1 of 2 categories, falsified or substandard drug products.1 Falsified drug products fraudulently misrepresent their identity, composition, or source. This could be due to theft and resale of Food and Drug Administration (FDA)–approved drugs, repackaging unapproved drugs to resemble FDA-approved versions of brand name medications, or creating drugs containing no active ingredients or much lower dosages than indicated on the label. Substandard drug products are
The extent of the problem
The main access point for the average American, Canadian, or Western European citizen to counterfeit drugs is not through the legitimate supply chain but through rogue online pharmacies or purchases while traveling abroad.14 Eighty percent of all rogue Internet pharmacies target English-speaking countries, and there are more than 50,000 online pharmacies.14,15 According to a 2016 Kaiser Family Foundation survey, 8% of households in America (19 million people) obtained medication through
Difficult to implement or unlikely solutions
Internet pharmacies providing counterfeit drugs will not be eliminated because consumers are disappointed in the products delivered.25 In a 48-month assessment, rogue Internet pharmacies were more likely to still be in operation than their higher quality counterparts (60% vs. 26%, P < 0.01).25 This may be because of a higher price point for sales, greater costs for running legitimate businesses, the need for a legal prescription, and limited ability to sell opioids and other drugs with abuse
Alternative solutions
If consumers were more knowledgeable about the potential risks of purchasing or using drugs procured from rogue Internet pharmacies, they might be less willing to make those purchases. Many organizations have a vested interest in combating rogue online pharmacies including pharmacy organizations, manufacturers, wholesalers, pharmacy benefit managers, community pharmacies, and patient advocacy groups. They will all need to be involved in enacting any of the solutions discussed later in the text.
Conclusions
The counterfeit drug market is flourishing at the expense of human health and well-being. This is a global phenomenon that is difficult for any single country to tackle alone. The issues occur in the legitimate supply chain and through rogue Internet pharmacies or international purchases while traveling. We all have a professional responsibility to understand the nature of the issue, and in our sphere of control and influence, educate the public about the dangers and support measures that
C. Michael White, PharmD, FCP, FCCP, Professor and Chair, Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT
References (31)
- et al.
Role of the pharmacist in preventing distribution of counterfeit medications
J Am Pharm Assoc (2003)
(2012) - et al.
The global counterfeit drug trade: patient safety and public health risks
J Pharm Sci
(2011) A study on the public health and socioeconomic impact of substandard and falsified medical products
- et al.
Addressing the barriers to effective monitoring, reporting and containment of spurious/substandard/falsely-labeled/falsified/counterfeit medical products through sustainable multi-stakeholder collaboration and community/consumer-based interventions: A report prepared for the Medicines Transparency Alliance, Philippines
Roles for pharmacy in combatting counterfeit drugs
J Am Pharm Assoc (2003)
(2008)- et al.
The need for comprehensive and multidisciplinary training in substandard and falsified medicines for pharmacists
BMJ Glob Health
(2019) ASCVD (Atherosclerotic cardiovascular disease) 2013 risk calculator from AHA/ACC
- et al.
Interventions to combat or prevent drug counterfeiting: a systematic review
BMJ Open
(2015) Incident trends
- et al.
The health and economic effects of counterfeit drugs
Am Health Drug Benefits
(2014)
Drug Supply Chain Security Act (DSCSA)
A new product anti-counterfeiting blockchain using a truly decentralized dynamic consensus protocol [special issue]
Concurrency Computat Pract Exper
DATAx presents: tackling counterfeit medicine with AI, blockchain and machine learning
E-training course on counterfeit drugs now available
Digital danger: a review of the global public health, patient safety and cybersecurity threats posed by illicit online pharmacies
Br Med Bull
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2022, Forensic Science InternationalCitation Excerpt :In recent years, HIV drug resistance is being observed in developing countries mainly due to poor quality of the antivirals used [39]. Moreover, risk factors such as blood pressure, serum glucose, or serum lipids that are not being adequately controlled by using ineffective counterfeit drugs, could also lead to major health risks [22]. A big challenge in environmental terms is the pollution from pharmaceuticals which in case of counterfeit medicines turns to be even more serious as their actual composition (active ingredients and excipients) may often be unknown.
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Examining factors that shape use and access to diverted prescription opioids during an overdose crisis: A qualitative study in Vancouver, Canada
2021, Journal of Substance Abuse TreatmentCitation Excerpt :Similar to other studies (Cicero & Ellis, 2017; Rigg & Murphy, 2013), participants in this study preferred POs given their known contents and strength; however, participants also discussed the presence of counterfeit pills in the shadow economy. While communities across North America are dealing with an increased presence in counterfeit pills (Centers for Disease Control and Prevention, 2016; Green & Gilbert, 2016; White, 2020), and a recent study suggested that stricter prescribing practices may lead patients to use them (May et al., 2020), findings from this study illustrate mixed perspectives regarding counterfeit pills. Some participants were able to discern “fakes” from real pills based on visual cues.
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C. Michael White, PharmD, FCP, FCCP, Professor and Chair, Pharmacy Practice, University of Connecticut School of Pharmacy, Storrs, CT
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Disclosure: The author declares no relevant conflicts of interest or financial relationships.