ISMP Urges Increased Action at the Practice Level to Halt the Growing Danger of Counterfeit Drugs

Problem: Counterfeit drugs, or fake drugs, made to resemble genuine pharmaceutical manufacturers’ medications (Figure 1), have been a longstanding threat to the health and safety of patients. Alarmingly, this problem has grown far more ubiquitous in recent years. Most have attributed this rise to the skyrocketing profits made by criminal groups, the growth of unregulated online marketplaces posing as legitimate pharmacies, and the increasing use of social media to advertise counterfeit medications. For example, during the coronavirus disease 2019 (COVID-19) pandemic, more patients became accustomed to purchasing medications online. However, not all online pharmacies are created equal. According to the National Association of Boards of Pharmacy (NABP), about 95% of so-called online pharmacies operate illegally.¹ Lack of awareness and education about this issue results in serious risks to patients’ lives.

Figure 1. Examples of the medications (right side of each pair): CYTOTEC (miSOPROStol) (top), SUTENT (SUNItinib) (middle), and DIFLUCAN (fluconazole) (bottom), along with counterfeit versions (left side of each pair). 

In 2023, the Drug Enforcement Administration (DEA) seized more than 79.5 million fentaNYL-laced counterfeit tablets.² DEA testing shows as many as 7 out of 10 counterfeit medications contained a potentially lethal dose of fentaNYL. While anyone can unknowingly purchase counterfeit medications, young adults and individuals in marginalized groups are most at risk. According to the Centers for Disease Control and Prevention (CDC), fentaNYL-related adolescent overdose deaths tripled from 2019 to 2021. About a quarter of these deaths are linked to counterfeit medications.³

More Than an Illicit Drug Problem

Counterfeit medications are often associated with illicit drug use, which may cause some people to believe “it can’t happen to me.” However, counterfeit drugs represent a serious threat to all, from young people seeking help with attention-deficit/hyperactivity disorder (ADHD) to elderly patients looking for the lowest price for their prescriptions. Examples of counterfeit drugs include chronic medications for diabetes and heart disease, cancer drugs, and antivirals for infectious diseases such as human immunodeficiency virus (HIV). Counterfeit drugs are frequently adulterated with potentially lethal ingredients including lead, mercury, toxins, or harmful chemicals. More troubling, as mentioned above, an increasing number of fake drugs are laced with fentaNYL, fueling the epidemic of overdose deaths plaguing the United States. FentaNYL is now the leading cause of death for Americans aged 18 to 45.⁴

Even when not contaminated with dangerous or deadly material, counterfeit drugs often lack the required active ingredients to be effective. Their use can lead to treatment failures, complications, and other morbidities. They also impose significant economic burdens on patients and healthcare organizations due to the costs associated with ineffective treatments and management of prolonged illnesses.

A Global Crisis

The World Health Organization (WHO) identified counterfeit medications as “one of the urgent health challenges for the next decade.”⁵ Fake drugs have become a big business globally–estimated to be worth as much as $431 billion a year.⁶ According to WHO, counterfeit drugs account for roughly 10% of the medical products circulating in low- and middle-income countries, with an estimated one million people dying annually from taking fake or substandard medications.⁷ 

Counterfeit medications have entered the supply chain worldwide, including the European Union, Canada, and the United States. As the internet has become a global marketplace, it can be difficult for federal and state authorities to track and prosecute rogue sites, which sophisticated criminal networks often operate. Many illegal online pharmacies pass themselves off as Canadian pharmacies providing prescription medications at lower prices. Criminal groups may include the word “Canada” in their URL or show individuals dressed as medical professionals and a maple leaf symbol on their landing page, making it difficult to discern between a legitimate and fake site. Some online pharmacies source their drugs from other countries known to produce counterfeit medications.

Adverse Events

Whether they were aware of the scheme or not, some healthcare practitioners have been caught in the dark world of counterfeiters. For example, in 2021, two California oncologists pled guilty to purchasing more than $1 million of unapproved and counterfeit cancer drugs from a company owned by a Winnipeg internet pharmacy. The US Food and Drug Administration (FDA) found the discounted oncology drugs contained no active ingredients. Canadian authorities prosecuted and sentenced the owner of the Winnipeg internet pharmacy.⁸

We also shared concerns about the impact of counterfeit medication in our March 7, 2024, newsletter article, Accidental overdoses and adverse effects from compounded GLP-1 agonists. A hospital reported that, in less than a week, three patients required admission to the intensive care unit due to severe hypoglycemia from compounded semaglutide. The patients had received multiple pens without a prescription from people identified as “nurses” in a hotel room or a gathering akin to a “Botox party,” and the drugs were thought to be counterfeit.

Safe Practice Recommendations: Healthcare organizations have a crucial role in raising awareness of this threat to patients and should consider the following strategies:

Educate practitioners. Educate staff about the potential for patients to present to different healthcare settings (e.g., emergency department, physician's office) with adverse reactions after knowingly or unknowingly taking counterfeit medications. Monitor patients for unexpected outcomes (e.g., increased side effects, medication not working as it previously had) and consider if counterfeit medications could be the culprit. When reviewing a patient’s medication history, include a scripted open-ended question asking where they obtain their medications.

Follow literature and media reports. Maintain an awareness of publicized incidents and the medications involved to focus on known problem drugs and pharmacological categories.

Educate patients. Prescribers, pharmacists, and nurses are among the most trusted sources of medical information and uniquely positioned to educate patients about the risk of counterfeit drugs. Proactively have professional staff share with patients the warning signs that may indicate a pharmacy could be selling counterfeit drugs. Refer patients to the ISMP consumer website and FDA’s BeSafeRx campaign. Even when comparing counterfeit and real medication side-by-side, it can be difficult to tell the difference without laboratory testing. However, there are important safety tips that patients can consider when purchasing medications: 

Use a verified pharmacy. Educate patients about the National Association of Boards of Pharmacy’s (NABP’s) searchable list of accredited online pharmacies that comply with quality assurance criteria. You can also report suspicious online pharmacies via this website. With any online pharmacy, check to see if there is a licensed pharmacist available who can answer questions about the medication. This is not only helpful when seeking information, but also speaks to the legitimacy of the pharmacy. 

Check for spelling errors. Review packages and labeling for spelling errors. Misspellings anywhere on the packaging (e.g., product name, manufacturer, main ingredients on bottle label) are one of the most noticeable mistakes on counterfeit products. 

Evaluate medication appearance. Inform patients that, although manufacturers might change products or pharmacies might provide different generic products, any concerns about differences in size, color, or shape of the medication when the prescription is refilled should be addressed. For this reason, it is best to obtain a refill before the current prescription is finished. Educate patients to compare the new medication and packaging with the previously filled medication. Patients should note any differences and ensure the drug description on the new pharmacy label matches that of the drug inside the container. If they have any questions, patients should consult their prescriber or pharmacy before taking the medication. 

Assess medication quality. Legitimate medications will have a factory-made appearance. If tablets are cracked, have a bubbled-up coating, are crumbly or moldy, or come in jars containing excess powders or crystals, patients should be suspicious. Medications that come in the original manufacturers’ packaging should be sealed. If the package has been opened, has a broken seal, appears to have been tampered with, comes in different or no packaging, is missing the label, or just does not look right, patients should check with a healthcare practitioner before taking the medication.⁹ 

Report concerns. Law enforcement cannot stop the dangerous flow of counterfeit drugs without the support of public and private stakeholders. Many private sector companies have counterfeit drug operations dedicated to supporting law enforcement efforts. Some manufacturers have a team that investigates possible criminal groups creating and distributing counterfeits and have forensic laboratories with scientists who specialize in analyzing and tracking counterfeit medicines. Practitioners should also be aware of and share resources from government agencies that offer information to combat counterfeit drugs, such as:

• CDC  
• FDA  
• The National Intellectual Property Rights Coordination Center 

We thank Aida Habtezion, MD, MSc, FRCPC, AGAF, Chief Medical Officer and Head of Worldwide Medical & Safety, Lev J. Kubiak, Vice President & Global Security Head, and Lubna Merchant, MS, PharmD, Director in Risk Management Center of Excellence, Pfizer Inc. for their help with preparing this article.

To learn more, FDA Division of Drug Information is offering a FREE webinar, FDA Drug Topics: Fraudulent Drugs: You’re Using What?, on May 21, 2024. To register, click here. 

References

1. Brady J, Baney L. Congress holds registries and registrars accountable for rogue online pharmacies. National Association of Boards of Pharmacy (NABP). January 21, 2022. Accessed February 27, 2024.  
2. United States Drug Enforcement Administration (DEA). Accessed April 8, 2024.  
3. Tanz LJ, Dinwiddie AT, Mattson CL, ODonnell J, Davis NL. Drug overdose deaths among persons aged 10–19 years — United States, July 2019–December 2021. MMWR Morb Mortal Wkly Rep. 2022;71(50);1576–82.
4. CBS News. DEA administrator on record fentanyl overdose deaths and how cartels target Americans. August 19, 2022. Accessed February 27, 2024.
5. Ghebreyesus TA. Urgent health challenges for the next decade. World Health Organization (WHO). January 13, 2020. Accessed February 27, 2024.  
6. US: How counterfeit drug diversion operations worth $431 billion are putting lives at risk. National Association of Drug Diversion Investigations. December 18, 2023. Accessed February 27, 2024.  
7. One in 10 medical products in developing countries is substandard or falsified. World Health Organization (WHO). November 28, 2017. Accessed February 27, 2024.  
8. Pauls K. Two doctors enter guilty pleas in international counterfeit cancer drug case. CBC. February 22, 2021. Accessed February 27, 2024.  
9. Fujimori S. A dangerous deal: combating the rise in online counterfeit medicines. Pfizer. September 2022. Accessed February 27, 2024.  

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^{Institute for Safe Medication Practices (ISMP). ISMP urges increased action at the practice level to halt the growing danger of counterfeit drugs. ISMP Medication Safety Alert! Acute Care. 2024;29(10):1-3.}