Combat Counterfeit Medications

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Key Takeaways

Counterfeit medications often contain low-quality or harmful substances, posing a significant public health threat.
The digital healthcare shift increases counterfeit drug risks, with 95% of online pharmacies operating illegally.
Pharmacists are vital in combating counterfeit drugs through inspection, patient education, and reporting suspicious medications.
The FDA's guidance on supply chain verification highlights the need for secure drug distribution systems.
Collaboration among healthcare professionals and regulatory agencies is crucial to address counterfeit medication risks.

When educating patients, emphasize the importance of buying drugs from only licensed pharmacies.

Counterfeit medications are fake or imitation drugs that are deliberately mislabeled to resemble authentic products. They often use low-quality or ineffective ingredients, lack the necessary active components, or contain harmful substances. These products are designed to deceive patients, can be dangerous, and pose a significant threat to public health.

The entire health care industry is increasingly going digital, including telemedicine and online sources for patients to directly purchase medications. Although tools like these can be convenient, many consumers do not understand the prevalence of illegal online pharmacies and their associated risks.

About the Author

Kathleen Kenny, PharmD, RPh, earned her doctoral degree from the University of Colorado Health Sciences Center. She has more than 30 years of experience as a community pharmacist and works as a clinical medical writer based out of Homosassa, Florida.

Thanks to the rigorous, closed drug distribution system the FDA uses, the US drug supply is considered one of the safest in the world. Therefore, patients are more likely to encounter counterfeit medications when purchasing online. Of the approximately 35,000 online pharmacies, approximately 95% are operating illegally at any given time. By offering medications without a prescription, not having appropriate licenses, and even selling fake medications, these websites are a threat to patient lives.¹

Identifying Dangerous Online Pharmacies

Patients often turn to online pharmacies for affordability, privacy, and convenience. Safe online pharmacies always require a prescription order for legend drugs. They also have physical addresses and phone numbers in the US. Additionally, a licensed pharmacist must be available to answer questions, and the pharmacy will be licensed by a state board of pharmacy.²

Online pharmacies also have red flags to be aware of, including drugs that arrive in packaging that is damaged or broken, is written in a foreign language, lacks an expiration date, or is already expired. Prices that seem too deeply discounted are a warning sign, along with charges for products never ordered. Finally, an online pharmacy that does not provide clear privacy policies is probably not abiding by other regulations.²

Pharmacists’ Role

Pharmacists play a crucial role in combating counterfeit medications by actively inspecting drug packaging and security features, educating patients about the dangers of buying from unreliable sources, reporting suspicious medications to authorities, and only purchasing drugs from verified distributors.

Key aspects of a pharmacist’s role in addressing counterfeit medications include the following^3,4:

Visual inspection: Always examine medications’ packaging, labels, and security features to identify potential inconsistencies that could indicate counterfeiting. Visual inspection of a product and its packaging by someone who knows the properties of the authentic drug or can compare the sample with the authentic product is the standard first step in any drug quality analysis. Differences from the authentic materials in color, size, shape, tablet quality, and packaging indicate a possible falsified or substandard drug.
Patient education: Emphasize the importance of only buying drugs from licensed pharmacies; checking packaging carefully for inconsistencies such as poor printing, misspelled words, or altered appearance; comparing new medications with previous prescriptions to identify differences; and immediately reporting any suspicions to a physician or pharmacist if patients believe they have received a counterfeit medication.
Supply chain verification: In December 2023, the FDA issued a final guidance, “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs,” explaining the agency’s interpretation of the responsibilities of manufacturers, repackagers, wholesale distributors, and dispensers to establish and maintain certain supply chain verification systems. This guidance addresses how verification systems should handle quarantine and investigation of suspect products, disposition of illegitimate products, and related notification requirements.
Report suspected counterfeits: The FDA keeps track of counterfeit medications in the US drug pipeline. The agency relies on patients, providers, and pharmacies to voluntarily share information about counterfeit or suspected counterfeit medicines. To report fake pharmaceuticals, email druginfo@fda.hhs.gov, call 855-543-3784 or 301-796-3400, email the FDA Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce- CDER@fda.hhs.gov, or visit the MedWatch site.
Stay informed: The FDA website lists reports of counterfeit medications. Keeping current on counterfeit drug trends and alerts helps pharmacists effectively identify suspicious products.
Collaborate with other health care professionals: Collaboration between national regulatory agencies, health care providers, and the pharmaceutical industry is crucial to addressing the issue, along with continued public education on the risks of buying medicines from unverified sources.

Pharmacists are crucial in this fight because they are often the last point of contact before a patient receives medication, allowing them to visually inspect products and identify potential counterfeits. Their knowledge of drug characteristics and packaging details helps them recognize inconsistencies that might indicate counterfeiting. Pharmacists are readily accessible to patients, enabling them to provide crucial information and guidance on how to avoid counterfeit medications.