Science and Practice
Commentary
Counterfeit drugs: A major issue for vulnerable citizens throughout the world and in the United States

https://doi.org/10.1016/j.japh.2020.04.020 Get rights and content

Abstract

Instruct clinicians on counterfeit drugs and their implications for patient health. Counterfeit drugs imperil patients around the globe, and their penetration into the United States, Canada, and Western Europe is only increasing over time. In addition to inserting counterfeit drugs in the legitimate drug supply, rogue Internet pharmacies and consumer purchases while traveling abroad allow counterfeit drugs to endanger patients. Pharmacists need to understand the nature and severity of the issue and directly counter it through personal actions to secure a legitimate drug supply, such as by using verified distributors and examining the shipment packaging, product packaging, the bottle, and the label for evidence to determine if it is counterfeit or has been tampered with. They can also indirectly counter it through patient education and by working with other key stakeholders in the health care system. Given the risk to patients, pharmacists have an important role to play in limiting patient use of counterfeit drugs.

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

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      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

    Disclosure: The author declares no relevant conflicts of interest or financial relationships.

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