A couple of weeks ago a friend and colleague shot me an email asking me if I’d heard about the new “pedigree stuff on barcoding”. I consider myself pretty well informed for the most part, but I had no idea what she was talking about. Upon further inquiry she sent me a PDF document titled “Guidance for Industry Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages” (the SNI document). The document is also available in non-PDA format at the FDA website here. I asked other pharmacists about the SNI document while at the Siemens West Coast User Group Meeting on September 16, but no one had a clue what I was talking about; not event the Siemens product manager that was in attendance.
The SNI document discusses the implementation of a package-level standardized numerical identifier (SNI) for prescription medications in an attempt to secure the drug supply chain and cut down on counterfeiting and diversion. SNIs are designed to address the Food and Drug Administration Amendment Act of 2007 (FDAAA), signed into law on September 27, 2007 by President Bush, which amends the Federal Food, Drug, and Cosmetic Act (FDC Act) and the Public Health Service Act. Section 913 of the FDAAA amends the FDC Act (section 505D) and requires the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adultered, misbranded, or expired drugs.” Specifically it calls for the FDA to develop a “standardized numerical identifier” no later than March 2010.
According to the SNI document “the SNI for most prescription drug packages should be a serialized National Drug Code (sNDC). The sNDC is composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) that corresponds to the specific drug product (including the particular package configuration)4combined with a unique serial number, generated by the manufacturer or repackager for each individual package. Serial numbers should be numeric (numbers) or alphanumeric (include letters and/or numbers) and should have no more than 20 characters (letters and/or numbers). An example is shown below with a 10-character NDC.”
The FDA says they chose to use SNIs because they believe it “serves the needs of the drug supply chain as a means of identifying individual prescription drug packages,7 which in turn should facilitate authentication and tracking and tracing of those drugs.” The number does not include expiration or lot number information.
I don’t know about you, but I don’t think the FDA succeeded in doing anything except making things much more complex for foreseeable future. The use of SNIs brings up more questions in my mind than solutions. If and when SNIs goe into production I see trouble for healthcare systems that are already live with BPOC, especially those with older barcode scanners. I don’t know what testing has been done on SNIs as I couldn’t find information on any testing conducted on labels containing the additional numbers as part of the manufacturer’s barcode for medication packaging.
I understand the FDAs desire to keep things simple and cost effective, but I think other technologies might have been a better way to go. RFID comes immediately to mind. While digging around for information on the use of SNIs I came across an article in Pharmacy and Therapeutics (PT 2009 January; 34(1):14) that gives a little perspective on why RFID technology might not have been chosen. Based on information in the article, cost appears to be the largest barrier to use. Hopefully that will change as the cost of RFID technology continues to decrease, but for now it looks like we’re stuck with SNIs. Until someone can explain to me how SNIs are a good solution, I’m going to consider them a bad idea.