The World Health Organization (WHO) defines a counterfeit medication as a medication that is deliberately and fraudulently mislabelled with respect to identity and/or source. According to WHO, counterfeiting can apply to both branded and generic products and can include products with the correct ingredients, without active ingredients or with fake packaging.
Counterfeit drugs rose in prominence as a global health concern during the 1985 WHO Conference of Experts on Rational Drug Use, one of the first times it was recognized on a global scale as a pervasive and dangerous trend4.
In the subsequent three decades, it has become increasingly difficult to track the pervasiveness of drug counterfeiting due to erroneous tracking by regulatory agencies, a lack of communication amongst health care and pharmaceutical providers and general confusion about how to categorize a medication as counterfeit.
On Nov. 27, 2013 President Obama signed the Drug Quality and Security Act into law, effectively setting the framework of what would become a nationwide initiative toward wide-scale pharmaceutical serialization. The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain. This system would establish nationwide drug serial numbers that allow for efficient tracing to respond to recalls and notices of theft and counterfeiting1.
Serialization in the pharmaceutical supply chain is a massive logistical undertaking the FDA requires to be completed by 2017. While that may seem to be awhile down the road, logistics companies had to meet the first regulatory benchmark by January 1, 20152.
This white paper will discuss why serialization is a necessity for the integrity and visibility of pharmaceutical supply chains as well as three traits that are essential to successful serialization implementation.