Track and trace: Is your pharmacy in compliance with the new law?
APhA’s checklist for pharmacy-related requirements is downloadable and printable
Is your pharmacy ready for the new track-and-trace law? Under the Drug Supply Chain Security Act (DSCSA), January 1 and July 1 are the key dates in 2015 for new requirements for pharmacies.
Per the new law, as of January 1, 2015, pharmacies shall only accept drug products from authorized trading partners. Also, pharmacies are required to have processes in place to identify, quarantine, and investigate suspect products and determine whether products are illegitimate.
By July 1, 2015, pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS)—sometimes referred to as “the three Ts”—for each drug product received for 6 years from the date of the transaction.
APhA and other national pharmacy groups have requested FDA delay enforcement of the July 1 deadline for pharmacists. At press time, it was unknown whether FDA would delay enforcement.
Next deadline: July 1
Beginning July 1, pharmacies may not accept product from trading partners unless it is accompanied by the three Ts, and they must maintain these records for 6 years. Pharmacies could contract with their wholesale distributors to maintain the records electronically for them as long as the pharmacy can access and retrieve the data.
FDA has clarified in draft guidance that “e-mail or Web-based platforms (such as Web portals)” are acceptable means to meeting the requirement of providing the TI, TH, and TS—as long as the information can be accessed by pharmacies and other required entities.
If pharmacies are contracting with wholesale distributors and/or cloud-based traceability vendors to maintain the three Ts, it is necessary for pharmacies to have written agreements on record that reflect these new requirements, according to Michael H. Ghobrial, PharmD, JD, former APhA Associate Director of Health Policy.
APhA member Travis Hale, PharmD, works for two different pharmacies in the small community of Remington, VA. At Remington Drug Co., he is a staff pharmacist in the process of buying the pharmacy along with a partner. He is also the Pharmacist in Charge at Family Care Remington Pharmacy, a long-term care pharmacy.
“I had heard about track and trace and the basic idea of what was to be accomplished over the last year or two, but not really any hard information as to how it was going to impact my stores or any specifics on day-to-day operations,” Hale told Pharmacy Today.
On June 1, APhA and other national pharmacy associations attended an FDA Drug Supply Chain and Security Act listening session. APhA articulated a number of concerns related to the impending July 1 deadline and the ability of wholesaler distributors to meet the requirement to provide access to the three Ts to pharmacies. APhA also discussed the concern that access to the three Ts may come at a cost in the future or may limit pharmacists’ ability to switch wholesaler distributors.
Hale spoke at the FDA meeting as an APhA member. He described his experiences interfacing with the more than 10 primary and secondary wholesale distributors from which both pharmacies order medications fairly consistently. One of the wholesalers, he noted to Today, has always offered satisfactory customer service; but Hale has “not been able to get a lot of details on how things will work” with regard to providing the information so pharmacies can meet the July 1 requirements.
The biggest real-world challenge Hale faces with track and trace, he told Today, “is going to be the management of all of this data as a single-store owner/manager when it is being held by potentially 10-plus wholesalers in different portals or clouds where we have 10-plus usernames and passwords.” He continued, “It has the potential to be a very time-consuming administrative task to add to the long list of administrative tasks that independent store owners are being asked to do as everything goes electronic.”
While Hale has no problem with going electronic, and actually welcomes it if efficiency and safety can be improved, he is concerned that “this could result in additional expense for the independent pharmacy owner.”