Presidential Viewpoint

BY MICHAEL JACKSON, RPH DANIEL E. BUFFINGTON, PHARMD, MBA, FAPHA

Pharmacists Beware: Increased Prevalence and Accessibility of Counterfeit Medications

The U.S. Drug Enforcement Agency (DEA) and law enforcement have reported an increase in the number of counterfeit medications being sold on the internet by illegal vendors and websites. On September 27, 2021, the DEA issued a public safety alert warning of the increase in the number of counterfeit pills containing fentanyl and methamphetamine across the United States. Previous public notices by the DEA occurred in 2014 and 2015 relating to the surge in synthetic fentanyl and synthetic fentanyl analogs.

In 2021, a single DEA sting operation confiscated nearly 2 million fraudulent medications that contained fentanyl and over 1,500 pounds of raw fentanyl. They estimate that nearly 10 million fraudulent pills were confiscated in 2021. Additionally, DEA lab tests revealed that approximately 40% or more of the pills contained quantities of fentanyl capable of producing severe adverse side effects or death.

Law enforcement data shows that people attempting to abuse or purchase illicit substances are encountering products from clandestine vendors in China and Mexico that have increasingly tested positive for fentanyl and methamphetamine. These vendors have then sold the products to U.S. citizens attempting to illegally purchase products on websites and social media sites such as Facebook and Snapchat. These social media platforms could be considered accountable if they provided services to those vendors while knowing that the services constituted healthcare fraud.

The ease with which consumers were able to illegally shop for and purchase counterfeit pills revealed the magnitude of the problem arising from the ability to circumvent the DEA and other law enforcement. The illegal vendors go to great lengths to make the fake products appear similar (including shape, color, size, and established

markings) to legitimate FDA-approved and commercially available products such as benzodiazepines, opioids, and amphetamines (i.e., alprazolam (Xanax®), hydrocodone (Vicodin®), oxycodone (Oxycontin®, Percocet®), hydrocodone (Vicodin®), and amphetamines (Adderall®)).

It is apparent that the DEA is not doing enough to collaborate with healthcare practitioners and web-based companies to help them understand the public safety risk and methods of distributing fraudulent pharmaceutical substances. The DEA Administrator, Anne Milgram, admitted that the DEA is aware that individuals intent on substance abuse are purchasing illegal substances online every day. Frank Pallone, Jr., the Chairman of the U.S. Energy & Commerce Committee, stated, “These platforms are not passive bystanders - they are knowingly choosing profits over people, and our country is paying the price.” The House of Representatives, E&C Committee proposed a bill to amend Section 230 to remove legal immunity in cases where social media platforms, in cases where they “knowingly” and “recklessly” promote illegal drug distribution. This creates a significant duty for DEA and other law enforcement to work more directly with healthcare providers, including pharmacists, and social media or other web-based platforms, to protect the public.

Many people attempt to circumvent licensed pharmacies (physical or online) by purchasing substances for illicit use from non-licensed vendors. In some cases, legitimate patients may be confused by or unaware of the risks of purchasing medications from nonlicensed online sources. Patients should be educated on the importance of using

Daniel E. Buffington, PharmD, MBA, FAPhA

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610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web address: www.floridapharmacy.org. only credible licensed pharmacies and how to recognize indicators and characteristics of non-licensed vendors. People should be made more aware that medications purchased from anyone other than a credible licensed pharmacy are dangerous, illegal and potentially life-threatening.

In an effort to ensure improved public safety and confidence, the National Association of Boards of Pharmacy (NABP) developed the Verified Pharmacy Program (VPP). VPP is a nationally recognized, multistate, uniform inspection program accepted by state boards of pharmacy across the nation. VPP Certification processes include documentation of pharmacy licensure, site inspections and data monitoring methods. VPP Certification provides patients, consumers, payers and law enforcement with confidence that the medications are being tracked and dispensed from a credible licensed pharmacy and not an illegal entity.

While the future of this proposed legislation is uncertain, the dialogue it stimulated has helped to promote public awareness as to the risks associated with purchasing or acquiring medications illegally from non-licensed pharmacies. Just like patients develop physician-patient relationships, it is equally important to develop an ongoing pharmacistpatient relationship.

Pharmacists are the leading healthcare practitioners trained in clinical pharmacology. Florida law recognizes the importance of the role that pharmacist clinical services provide in optimizing medication therapy management and patient safety. Pharmacists should be increasingly aware of the potential for individuals to acquire pharmaceutical substances from legal and illegal external sources including websites, social media platforms, medical clinics, mail-order vendors, automated dispensing systems and pharmaceutical company-based Patient Assistance Programs (PAP).

It is clear, and especially in the current climate of illicit and counterfeit drug use and sales, that law enforcement agencies should develop open communications and collaborative efforts with healthcare practitioners and healthcare organizations to identify individuals who may be illegally acquiring medications from fraudulent sources. Public service announcements, community outreach, and providing detailed reviews of patients’ medical profiles will improve health outcomes and public safety. n

REFERENCES: DEA Issues Public Safety Alert on Sharp Increase in Fake Prescription Pills Containing Fentanyl and Meth

DEA Warns that International and Domestic Criminal Drug Networks are Flooding the United States with Lethal Counterfeit Pills Sep 27, 2021 https://www.dea.gov/pressreleases/2021/09/27/dea-issues-publicsafety-alert

NABP - DEA Takes Action Against Deadly Counterfeit Pills

Oct 21, 2021 http://www.leg.state.fl.us/Statutes/ index.cfm?App_mode=Display_ Statute&URL=0400-0499/0465/ Sections/0465.003.html

The Justice Against Malicious Algorithms Act Removes Liability Shield When a Platform Knowingly or Recklessly Promotes Harmful Content

Oct 14, 2021 https://energycommerce.house.gov/ newsroom/press-releases/ec-leadersannounce-legislation-to-reformsection-230

Florida Pharmacy Practice Act: Chapter 465.003 (13)

(Accessed on 12/09/21) http://www.leg.state.fl.us/Statutes/ index.cfm?App_mode=Display_ Statute&URL=0400-0499/0465/ Sections/0465.003.html

NABP - Verified Pharmacy Programs

(Accessed on 12/05/21) https://nabp.pharmacy/programs/ accreditations-inspections/verifiedpharmacy-program/