Keeping Patients Safe From Counterfeit Drugs

Be familiar with why counterfeit drugs are problematic:

Counterfeit drugs are made to look like FDA- or Health Canada-approved versions of drugs.³

Counterfeit drugs may have any of the following characteristics:^1,3

• No active pharmaceutical ingredient
  
• Wrong active pharmaceutical ingredient
  
• Right active ingredient, wrong dosage (too strong or too weak)
  
• Unauthorized active pharmaceutical ingredient
  
• Active pharmaceutical ingredient produced by an unregistered firm and fraudulently labeled
  
• Very good copy of genuine drug or package
  
• False documentation (import status, etc)
  
• Contaminated with toxic ingredients
  
• Made in unsanitary conditions
  

Counterfeit drugs can be ineffective for patient treatment, cause toxicity due to inappropriate ingredients or wrong amounts of ingredients, or even lead to fatalaties.⁶

Take steps to keep counterfeit drugs out of your pharmacy:

Be aware of meds commonly counterfeited, such as:^2,8

• Antimicrobials, including hepatitis C and HIV meds
  
• Cancer meds
  
• Cardiovascular meds (e.g., beta-blockers, statins)
  
• Erectile dysfunction meds
  
• Hormonal meds (e.g., infertility meds)
  
• Psychiatric meds (e.g., antidepressants)
  

Counterfeit opioids are on the rise.⁶

Keep in mind that counterfeiting can happen with any med, brand or generic. OTC meds and products such as glucose test strips and pregnancy tests may also be counterfeited.¹ Even some specialty meds have been counterfeited.²

Only purchase meds from trusted sources.

• In the U.S., vet vendors by checking for their license from your state distributor regulatory board, which can be accessed at https://nabp.pharmacy/programs/vawd/vawd-accredited-facilities/.^1,2
  
• Look for red flags, including vendors who:¹
  
• Have a foreign address or phone number, or no street address.
  
• Want cash payments only.
  
• Offer prices that are too good to be true.
  
• Offer meds that are currently affected by shortages.
  

Inspect product labeling and packaging. Look for signs that a med might be counterfeit, such as:^1,3

• Differences from authentic products, such as labels (e.g., print size, embossing, design) or physical characteristics (e.g., smell of a syrup, markings on caps, texture of tabs).
  
• Formulation problems, such as oral liquids or injectables with particles floating in them.
  
• Patient complaints that meds are different in color, smell, taste, etc.
  
• Lack of intact seals on packaging.
  
• Missing package inserts.
  
• Ink that smudges on labels or package inserts.
  
• Worn-looking packaging.
  
• Missing holograms on labels.
  

Signs of counterfeit meds, continued:

• Misspellings on labels.
  
• Faded, illegible, or missing expiration dates.
  
• Strength not clearly shown on labels.
  
• Missing ® after the trade name.
  
• Extra glue on outside edge of labels.
  

Get our CE, Drug Shortages and Counterfeits, and our technician tutorial, The Ins and Outs of Pharmacy Inventory, for more information.

Help your patients avoid counterfeit drugs:

Watch for signs in your patients that they may have problems with med quality. For example, deterioration of health could be a sign.

Investigate whether patients are getting meds from other sources such as online pharmacies, where there is a high risk of obtaining counterfeit drugs.

Give patients our handout, What You Should Know About Buying Meds Online, to help them identify legitimate online pharmacies.

If patients in the U.S. are using online pharmacies to save money, help them find other ways to save on drug costs by using our chart, Guide for Helping Patients Afford Their Medications.

Take action if a counterfeit drug is suspected:

In the U.S.:

• To report suspicious products, go to https://www.fda.gov/medwatch to fill out Form 3500.¹
  
• Quarantine suspicious products, do not dispose of them.⁵
  
• To report suspicious vendors, go to https://www.fda.gov/oci/.¹
  
• See reporting requirements for pharmacies and suppliers in the next section.
  

In Canada:

• To report suspicious products go to https://www.canada.ca/en/health-canada/services/
  drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html, and fill out FRM-0317.
  

Stay on top of efforts and regulations to combat counterfeit drugs in the U.S. and Canada:

In the U.S. the Drug Quality and Security Act (DQSA), with a section called the Drug Supply Chain Security Act (DSCSA), was enacted in 2013. The goal is to improve traceability of Rx drugs, protect consumers from counterfeit or other potentially harmful drugs, and improve detection of these harmful drugs so they can be removed from the supply chain.⁴ This involves “track and trace” capabilities. The DSCSA outlines steps to build an electronic system for this purpose, and requires national licensure for wholesalers.

• Rx drug packaging must have a product identifier composed of the NDC and a serial number, lot number, and expiration date, if the drug is packaged on or after November 27, 2018.⁴
  
• Tracing documents (i.e., transaction information, transaction history, and transaction statement), also called the “3 Ts,” must be obtained for Rx drugs and stored for six years.⁴
  
• Product tracing on the lot level was required by 2015. By 2023, product tracing on the package level is required.⁷
  
• Reporting via Form 3911 (https://www.fda.gov/downloads/AboutFDA/ReportsManuals Forms/Forms/UCM513942.pdf) is required within 24 hours after determining a product is illegitimate in order to notify FDA. Other “trading partners” such as your distributor or wholesaler should also be notified.⁴
  

In Canada, Health Canada participates in Operation Pangea, which focuses on initiatives such as border control to help keep counterfeit drugs out of the country.