Over the years, PMP News has been tracking the need for product coding at item levels. In “Cutting Edge Coders” from the October 1995 issue, for instance, then features editor Jennifer Reid Holman wrote that “the latest computer-operated printers—including new models of thermal-transfer coders, ink jets, and laser coders—offer more variability. That means you can automatically print real-time or an individual number on each package.”
And in “Booming Bar Code Systems” from the November 1995 issue of PMP News, it was observed that “Market-specific requirements and the introduction of advanced 2D symbologies has further expanded the capabilities of bar coding. With the technological advances, the limitations of bar code systems are disappearing. New radio-frequency and semiconductor chips allow bar code applications to employ denser information content and read-write capabilities.” The article went on to discuss several systems for bar code printing and for bar code inspection, some of which could be used on packaging lines. Such technology would continue to advance over the next two decades, striving to meet industry’s requirements for accuracy, repeatability, reliability, and line speed.
In May 2002’s “Marking Medical Packages with Serial Codes,” editor Daphne Allen explored the potential of serial codes. “One method of printing directly onto medical packages as they are being formed, filled, and sealed offers the ultimate in product identification and protection—serial coding,” Allen wrote. “In addition to carrying a lot code and an expiration date, each product is marked with a unique number that is part of a series. The numbering system can be downloaded from a database, which can be easily accessed with today’s programmable printers. Serial coding facilitates responses to two unfortunate realities often facing the medical device manufacturer: recalls and unauthorized product distribution, also know as diversion.”
And when PMP News marked its 10th anniversary in the November 2003 issue, one packaging professional predicted the following developments over the subsequent decade:
• Visible bar codes on all products.
• Invisible bar codes on components and semifinished goods to facilitate supply-chain tracking.
• RFID on all pallets.
• Quality inpsections of single units versus lots.
• Increased level of in-line printing: not just variable-information printing, but also package inserts and label copy printing.
• Increased supply-chain security against economic and sociopolitical terrorists.
Now, 10 years later, many of these predictions or approaches have yet to be fully realized. Industry pioneers have invested in the development of item-level serialization, developing packaging lines that utilize state-of-the-art printing, inspection, and verification. But wide-scale changes in product serialization have yet to transform pharmaceutical distribution. Industry has largely been awaiting regulatory action and supply-chain support before making sweeping changes to product identification. FDA did release its guidance on Standardized Numerical Identification (SNI) for prescription drugs in 2010, but industry has still been concerned about the lack of federal regulation. California’s electronic pedigree law appeared to be in-line in with FDA’s SNI guidance, and vice versa, but industry still feared the emergence of other states’ requirements that could complicate regulatory compliance.
The passage of H.R. 3204, the Drug Quality and Security Act (DQSA), appears to put such fears to rest, and gives industry more time for compliance. So, within the next 10 years, will SNI enable stakeholders to pinpoint the exact location, custody, and status of a single pharmaceutical package? Will such information have already transformed the supply chain, leading to more-efficient distribution and minimal or nearly nonexistent counterfeiting and diversion? And will it have yielded robust patient outcomes data through electronic health records capture, leading to more-effective, more-cost-efficient health care?