Solving: Anti Counterfeit Pharmaceuticals

At PaladinID, we’ve been following a conversation about combating counterfeiting with a more tightly controlled approach to labeling and the introduction of the idea of anti-counterfeit pharmaceuticals.  The pharmaceutical prescription drug supply chain is unique in its handling of regulated and controlled substances as they move through a very complex global distribution system. From factory to shelf to consumer, products may have been through as many as five transfers.  Contract packagers, primary and secondary distributors, retail pharmacies, hospitals are only some of the entities that may have handled the drugs.  Each transfer represents an opportunity in the supply chain where counterfeit products can be introduced, and where authentic drugs can be diluted or diverted to more profitable channels.

The ingestion of mislabelled and counterfeit pharmaceuticals can cause deadly results. 

Growing public awareness comes with the recent revelation that the performing artist, Prince’s death was caused by counterfeit drugs. This list of popular pharmaceuticals that have been successfully counterfeited is an excerpt from the Congressional Record in July, 2013. *

Lipitor

Cholesterol-lowering medication used to help prevent serious heart disease. Over 200,000 bottles recalled due to a large quantity of counterfeit product entering the U.S. market.

Clarithromycin

Antibiotic used to treat pneumonia, bronchitis and other infections — including infections in children.  Counterfeit product, known as Biaxin, was found to contain absolutely no active ingredients.

Neurontin, Accupril and Celebrex

Respectively used to treat seizures and shingles pain, high blood pressure, and debilitating arthritis pain. Counterfeit doses of all three medications found in California were actually vitamins, containing no active ingredient.

Allegra (Fexofenadine) – Allergy medication

Medication ordered through an Internet resource proved to be a fexofenadine-based product that was not approved by the U.S. FDA, and had an expiration date of 1/03 — when actually the product had already expired in 1/02. Although the website appeared to promise products from the UK, the medication actually came from Vanuatu, an island off the coast of New Zealand well known for businesses that traffic illegitimate prescription drugs to the U.S.

Losec (Omeprazole – sold as Prilosec in the U.S.)

Treatment for ulcers and other gastric conditions. Counterfeit Prilosec was manufactured with such sophisticated techniques that only the manufacturer had the technical information required to determine the product was fake.

Procrit (Epoetin alpha)

Anemia medication for patients with cancer, chronic kidney disease and HIV. The counterfeit product contained either bacteria-contaminated water instead of active ingredients, or 20 times less active ingredient than the real drug.

More stringent and comprehensive FDA regulations are being introduced to combat the increased presence of counterfeit product in the market.  Along with the need for anti counterfeit pharmaceuticals, there is a greater emphasis on chain of custody reporting, and label printing requirements are becoming more sophisticated.

RFID labeling is a popular channel for connecting products to a central database using the Internet.  As the pharmaceutical industries are leveraging the Internet of Things (IoT) to manage the new, more stringent requirements, we are following this conversation closely.

• Tracking product temperature: We’ve seen an uptick in thermal data logging recently, the ability to track, record and include the product’s ongoing temperature state as part of the chain of custody. **
• Increased Factory Automation: Automated applicators, conveyors with RFID reading stations and RFID label printers are becoming standard issue.  Almost all new factory equipment can be enabled to connect to the Internet.
• On-site Barcode Label Printing: Up to the moment information can be transmitted to mobile and portable barcode printers on the factory floor to capture data down to the millisecond.

At PaladinID, we help our customers update or adjust their current labelling systems to accommodate new and pending mandates.  If you’ve recently been asked to update or change your labeling practices, please call us to discuss your options for a smooth transition.

* Congressman John D. Dingell’s statement before the House of Representatives
** Freshtime Sensor Platform powered by NXP’s ucode8 NFC chip (link inserted https://www.prnewswire.com/news-releases/infratab-unwraps-freshtime-sensor-platform-at-internet-of-things-300186286.html)