Putting Safety into Consumers’ Hands
By Anastasia Thrift
Catalent Pharma Solutions (Catalent) has asked FDA to consider adopting a minimum 11-digit serialization code for all prescription drug packages. It also requests requiring human-readable alphanumeric codes so that consumers will be able to verify the authenticity of their medication.
When FDA recently asked the public to respond to its Guidance for Industry on Standards for Securing the Drug Supply Chain: Standardized Numerical Identification for Prescription Drug Packages, it received several replies. These letters shared how several entities encourage a more thorough serialization code. Catalent was one company that expressed its desire for lengthier SNIs, as well as more universally standard ones.
In its letter, Catalent begins by acknowledging the need for safety in the pharmaceutical supply chain. The company backs up its request for longer serialization codes by pointing out that there are at least 60 products in the domestic market dispensed annually in excess of 10 million units, and at least one in excess of 100 million units. Another letter had expressed that with a limited eight-digit serialization code, products will run out of numbers by the 99,999,999th package. This covers only products in the United States. Catalent believes the adoption of the longer standard, preferably that promulgated by GS1, could serve as the foundation of a harmonized international system and—given global product volumes dispensed plus those in production, in distribution, and in retail channels at any given point in time—a longer standard would be necessary for dozens of products today.
“Although the sNDC may be compatible with GTIN, we believe that incorporating the GS1 standard now would provide a system that is more robust and, equally importantly to standards harmonization, globally recognized,” the letter states.
“Using the GS1 standard would . . . align us with other countries around the world and would go further into creating a worldwide standard,” says John Kay, director of operations, printed components, Catalent Pharma Solutions. “As for securing the standard, we need to continue to work closely with FDA to ensure that we develop the best solution possible.”
While other companies, as well as the California State Board of Pharmacy, requested numbers longer than FDA’s initial eight-digit code, Catalent was among the few to also request that human-readable code be included. The company believes that while in the future consumers will be able to authenticate their medication more frequently via cell phone scans, they should now have a verifiable alpha-numeric code.
“It is important that we consider the human element in designing the standard,” Kay says. “The string of codes should be broken into groups of four and include alphanumeric. The easier we make the codes to read, the less chance for error there will be, which will help consumers become more comfortable with the transition.”
Catalent acknowledges that its customers could be hindered by the responsibility of devoting large amounts of a label or carton space to such extended codes. They feel, however, that this will be acceptable especially in light of what such verification ensures.
“Counterfeit drugs pose a serious health risk to both developed and developing markets, and we believe individual patients should also have the ability to verify firsthand that the medication they are taking is not counterfeit,” Kay says. ■