Track and trace: APhA seeks to limit burden on pharmacists

At FDA meeting, stakeholders discuss standards for a prescription drug track-and-trace system to help secure the supply chain against counterfeit drugs

Addressing the problem of counterfeiting and diversion of prescription drugs, FDA has long sought a multilayered approach to securing the supply chain, including a prescription drug track-and-trace system. As such systems are rolled out, APhA wants to make sure pharmacists can work with such systems.

While expressing support for FDA actions in this area in June 22 comments, the Association said it is specifically interested in how the implementation of track-and-trace standards and technologies could affect the practice of pharmacy, and therefore patient care. “Pharmacists are the last step in the supply chain before dispensing medications to patients and need to be assured that any system will be interoperable with existing pharmacy operating systems, streamlined into practice workflow, and limit burden on pharmacists’ time to deliver patient care.”

“The ability to track and trace finished drug products in the supply chain plays a significant role in providing transparency and accountability in the drug supply chain,” said FDA’s January 7 Federal Register notice announcing a public workshop.

Attended by approximately 120 participants, the February workshop gathered stakeholder perspectives on how to achieve a track-and-trace system for finished prescription drug products and what system attributes and standards would facilitate identification, authentication, and tracking and tracing of prescription drug packages.

FDA reopened the comment period in a May 23 Federal Register notice, leading to APhA’s June letter.

According to FDA’s summary of the February workshop, the meeting’s discussion topics focused on interoperability, authentication, and data management.

On interoperability, APhA in June encouraged consideration of multiple standards, not solely GS1 standards, before deciding on a final single standard. “In-depth consideration should be given to which standard will result in the most support among the end users,” the comments said. “APhA encourages FDA [to] consider the possibility of using financial incentives to help offset costs associated with implementation and compliance.”

On authentication, APhA encouraged clarity concerning who would be responsible if a product could not be authenticated—the sender, the recipient, or the system—“given the impact this could have on recipient pharmacies, especially those with small staffs.”

On data management, APhA agreed with workshop participants that “FDA determining a clear set of system requirements is more important than FDA determining the design of the information technology infrastructure itself,” the comments said. “Pharmacies may need flexibility in how they implement standards into their operating systems.”

Many in the pharmaceutical industry have been trying to secure the supply chain for years, said a September 2010 Pharmacy Today article in the “What’s in the Bottle?” series, “Fakes in the Pharmacy.” No one tactic for track and trace “has won the argument thus far.” Various systems that have been proposed include radio-frequency identification and bar codes.

APhA is part of the Partnership for Safe Medicines coalition, which works on counterfeit issues; is a member of the Pharmaceutical Security Institute; and is monitoring evolving activities of a supply chain stakeholders group. Last year, APhA’s Academy of Pharmaceutical Research & Science and Academy of Pharmacy Practice & Management formed a Counterfeit Task Force, which completed a white paper that has been submitted for publication in a peer-reviewed journal.