Track-and-Trace Law Puts Supply Chain Under Scrutiny

In an effort to prevent the transfer of stolen or counterfeit drugs, a new law will require pharmacies to supply more data about pharmaceutical shipments moving through the supply chain.

A track-and-trace law that will go into effect on July 1, 2015, will hold all pharmacies, including specialty pharmacies, responsible for more data about their pharmacy shipments, as well as their process of managing illegitimate or suspect products. The law will require specific supply chain entities to exchange transaction details, history, and product tracing information as prescription drugs pass through the supply chain to the specialty pharmacy. The law unifies individual, state-level track-and-trace laws enacted to prevent counterfeit, diverted, or stolen drugs from entering the supply chain. In response, many states have changed their regulations to conform with the federal law.

“The idea is to find and take counterfeit products out of the supply chain, as well as take criminals out of the supply chain,” Bob Celeste, industry development director at GS1 US, a nonprofit standards organization for supply chain processes, said in an interview with Pharmacy Times. “They really want to know who owned that product throughout its lifespan. It’s really focused around change of ownership.”

While many specialty pharmacies buy directly from manufacturers, particularly in the case of limited-distribution products, the new law creates a documentation process to ensure product integrity. By 2017, pharmacies will see new 2-dimensional (2D) bar codes on prescription products, although they will not need to alter operations around the bar codes at that point, Celeste said. The bar codes contain a National Drug Code identifier, serial number, lot number, and expiration date for each product; by 2023, pharmacies will be expected to track and furnish that information if inspected.

Pharmacies will also need to keep 6 years of tracking information history, Celeste added. “There’s going to be a very long period where pharmacists see a mix of things happening,” he said. “There will be new data, serialized data, and a mix of products. It could be a little confusing for pharmacists to understand what is legitimate unless they take action to understand the provisions in this law.”

Despite the mix of products and new requirements, the system offers several features helpful to pharmacists, Celeste said. Including lot numbers and expirations dates will allow pharmacists to quickly find recalled lot numbers in their inventory and whether any products from those lot numbers have been dispensed to patients. The systems can also synchronize pharmacy inventory so drugs with earlier expiration dates are used before those that expire later, Celeste said.

Of course, the requirements will necessitate changes within pharmacies, since existing linear bar code readers will not be able to read the 2D or DataMatrix bar codes used in the new labels. In addition, pharmacy systems must be able to read and interpret the data, Celeste said, adding that all pharmacies, including specialty and independent pharmacies, may encounter a larger burden when implementing the new systems. As is the case with most specialty pharmacies, a reliance on outside software service providers may help these pharmacies adapt to the new regulations. In addition, pharmacies will need to have processes for quarantining illegitimate or suspect products. Expect that URAC and other accrediting bodies will specifically be looking for these changes in a specialty pharmacy’s policies and procedures.

Once the guidance goes into full effect, pharmacies will also be subject to compliance inspections, which will gauge their level of adherence to the regulations. The extent of any punitive actions associated with noncompliance remains to be seen, however, and will likely involve a shared responsibility between the FDA and the state Board of Pharmacy, Celeste said. GS1 US provides training on the guidance, as well as the ways in which the standards are applied in each area of pharmacy operations. You can read up on the guidance on GS1 US’s information page at www.gs1us.org/dscsa.

“GS1 US has work groups working on the standards,” Celeste said. “We’re very open to and would very much like to have discussions with pharmacies and pharmacists who can provide that insight into their needs in this whole process.” SPT