HDMA warns industry may not be ready for drug traceability

The trade body representing healthcare distributors in the US has warned the industry may not be ready to meet next year's traceability deadline.

In a letter to the FDA, the Healthcare Distribution Management Association (HDMA) said the complexities associated with implementing the Drug Supply Chain Security Act (DSCSA) mean the supply chain "will not be 100 per cent compliant" by January 1.

The letter - addressed to the Ilisa Bernstein and Connie Jung of the FDA's Office of Compliance - reiterates HDMA's support for the DSCSA  - warns specifically that not all the players in the supply chain will be ready to exchange and receive lot-level transaction information as products are delivered to them.

The FDA had been set a deadline of November 27 for delivering guidance on establishing standards for interoperable exchange of transaction information/history/statement in paper or electronic format, giving the pharma industry just a few weeks to meet the requirements.

The draft guidance was eventually made available on November 26 with a tacit recognition by the FDA that it will need to be updated "to reflect standards for interoperable data exchange at the package level."

"This is one of the most widespread and cooperative efforts the pharmaceutical distribution chain has ever engaged in," said the HDMA's letter, signed by the organisation's president and chief executive John Gray and sent the day before the draft was published on the FDA website.

"This is … a learning experience for all involved and at this time, we expect continued development through at least the first quarter of 2015, particularly as distributors expand their focus to also include on-boarding dispenser customers."

Gray notes that "the complexities of implementing a law of this magnitude across the entire chain could impair the timely flow of product on January 1, absent additional guidance or enforcement discretion from the FDA related to handling of product transactions that are non-compliant."

"To forestall potential disruptions to the pharmaceutical supply chain, we urge the agency to ensure that the overarching priority in implementing this law is that patients continue to receive the products they need," he writes.

A lack of communication or responsiveness by some supply chain members, vendor resources, inability to adequately test data exchanges between all trading partners and questions about the reliability of untested data exchange are all outstanding issues, says Gray.

Another pressing issue is the need for a clear process detailing how to handle exceptions - for example when a shipment arrives without the necessary documentation - short of shipping the goods back to the manufacturer.

HDMA member distributors shipped nearly $305bn in goods 2013, equivalent to around 90 per cent of all US pharmaceutical sales that year.

It is encouraging that most of its members will be ready for the deadline, but the concerns expressed in the letter - as well as the fact that one in 10 shipments are handled by non-HDMA members which may be less in touch with the evolving requirements - raise the spectre of shortages unless the FDA takes a pragmatic approach to the implementation.

The DSCSA - also known as Title II of the Drug Quality and Security Act (DQSA) - was adopted last year and lays out a schedule for the introduction of a track-and-trace system for pharmaceutical products.

The primary objective of the DSCSA is to introduce full traceability for medicine packs through the supply chain within 10 years, with a requirement for all drug packages to carry a unique serial number within four years.