Pharmacy groups request more time to comply with track/trace requirements

The American Society of Health-System Pharmacists (ASHP), the American Pharmacists Association, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations have asked the FDA to allow more time for pharmacists to comply with the track and trace requirements for “dispensers.”

On June 16, ASHP sent a letter to FDA Acting Commissioner Stephen Ostroff, MD, asking the agency to extend the deadline for enforcement of the “dispenser” requirements to January 1, 2016.

On June 22, NCPA CEO B. Douglas Hoey sent a letter to Ilisa Bernstein, MD, FDA’s Deputy Director of the Office of Compliance, on behalf of NCPA, APhA, and NASPA, requesting additional time for “dispensers” to meet the requirements of Title II of the Drug Quality and Security Act (DQSA), which has a deadline of July 1, 2015. At that time pharmacists must receive and store information, transaction history, and transaction statements for drug products at the lot level from wholesale distributors.

ASHP’s concern

According to Kasey Thompson, PharmD, vice president of ASHP’s Office of Policy, Planning and Communications, “The uncertainty of the level of compliance among trading partners within the supply chain is cause for concern as hospitals and health systems may not have sufficient time to test or operationalize new data collection and storage systems to track certain prescription drug transaction data. Based upon input provided by hospital and health-system pharmacists, we believe that significant challenges remain for hospitals and health systems to fully comply with the new requirements by the July 1 deadline.”

ASHP noted that hospitals and health systems need more time to implement and test their data and storage processes. The association said that the July 1 deadline would be problematic for large health systems, which work with more than one drug supplier.

Another concern of ASHP is the need for clarification about exemptions for medications transferred to first responders. For example, ASHP wants to know if naloxone can be supplied to first responders, such as ambulance workers and law enforcement, without the need to meet the track and trace requirements.

ASHP also wants clarification about the role of dispensers and the common control exemption. Will hospitals that dispense medications to rural health facilities, hospices, and clinics under contracts or through partnerships need a wholesaler license to comply with Title II of the DQSA or is the transaction data sufficient?

ASHP expressed concern about verification of the transaction data when using a wholesaler or third-party data storage system, specific procedures to lessen the risk of illegitimate drugs entering the supply chain, and guidance on identifying illegitimate products.

Concerns of NCPA, APhA, NASPA

More outreach and education are required to help pharmacists comply with the transactional requirements of the Drug Supply Chain Security Act, according to Hoey in his correspondence to FDA.

“About half of the NCPA survey respondents have been in contact with their wholesale distributors to discuss how the transaction information would be provided, and an almost equal number reported being unaware of services that wholesalers are offering to maintain and store the information,” Hoey wrote. “Less than 15 percent have entered into contractual arrangements with their wholesalers.”

Concerns have arisen with secondary wholesale distributors, Hoey noted in his letter to FDA. More than 80% of NCPA members use secondary wholesalers in the case of drug shortages, and less than 20% who were surveyed knew of services that secondary wholesalers offer for storing transaction production information.

“We remain concerned that the DSCSA requires secondary distributors to provide dispensers lot number information in the required documentation, but does not mandate that the information be included in a single document,” Hoey noted.

NCPA and the other pharmacy groups said that it is important for secondary wholesalers to provide the transaction information in a single document electronically or in paper format.