Outside the Box: Cracking Down on Drug Counterfeiters

Drug counterfeiting is a growing problem both for pharmaceutical manufacturers and the patients they serve. According to the U.S. Food and Drug Administration it is estimated that 1 percent of all pharmaceutical products in first-world countries are counterfeit, along with up to half of drugs in developing nations. The fakes may be linked to thousands of deaths worldwide and the original manufacturers experience damage to their brand image, sales and revenue.

Getting tough on counterfeiting
The Internet is the preferred distribution channel for counterfeits with about half of all drugs sold online coming from sources not approved by the FDA. To help pharmaceutical companies’ product security, the FDA, the World Health Organization, the World Customs Organization and Interpol have introduced new regulations requiring more secure pharmaceutical packaging. New regulations encourage measures to improve accuracy in product authentication and anti-tampering measures to indicate when a product has been opened.

For example, a new European Union directive will require pharmaceutical companies to include tamper-evident features in packaging for all prescription and some over-the-counter products. The directive will also extend liability for falsified medicinal products to manufacturers, re-packagers, distributors and retailers.

Compliance challenges
Compliance is another growing challenge for pharmaceutical manufacturers, whose products often travel long distances in their journey to consumers. Pharmaceutical packagers and manufacturers must ensure products include security features that allow wholesale distributors and pharmacists to:

• Verify authenticity of drugs through overt, covert or 
forensic devices
• Track and trace individual packs or units
• Determine whether packaging has been tampered with
• Pinpoint fake or substandard products

Accordingly, more pharmaceutical companies are now looking to label developers to help them with anti-tampering and anti-counterfeiting strategies.

Secure labeling options
From 2-D and 3-D holograms to watermarks to tamper-evident void marks, labels can incorporate a wide range of overt and covert brand protection, giving companies a platform for multiple layers of product security. Some entry-level security features include security threads and holograms. Mid-range options include low-resistance papers, destructible films and tamper-evident void labels. More advanced and customizable features include UV fluorescent prints, microprinting, color shift inks and customized holograms, and security papers such as watermarks.

Still other high-end solutions offer the greatest protection. Using unique and personalized security features, such as infrared detection and forensics, label developers can incorporate bespoke components into a label to identify and track products. One popular technology for product tracking and traceability is radio-frequency identification tags (RFIDs) for labels, which allow companies to track a product through its lifecycle. These solutions are worth the investment for manufacturers of drugs with a high-risk of counterfeiting.

Implementing a secure strategy
Before implementing a protection strategy, all pharmaceutical manufacturers should consider:

• What level of security do we want to build in our packaging design?
• Do we want overt, covert or forensic solutions?
• How much do we want to invest in brand security?

Determining these needs will help manufacturers work better with packagers, label developers and printers to identify and implement solutions that ensure compliance while aggressively counteracting drug counterfeiting and tampering.

Thanks go out to Avery Dennison for its assistance in 
preparing this article.