Extended FDA Track & Trace deadline a boon for Rx

'Allows us to finalize negotiations with a portal vendor'
By Anthony Vecchione
05:07 AM
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Medications

Health system pharmacy managers and contracting & purchasing executives got a reprieve when the Food & Drug Administration moved the deadline for compliance with the Drug Supply Chain Security Act from July 1, 2015 to November 1, 2015.

[See also: Rx playing bigger role in EHR strategy]

Health system pharmacy managers and contracting & purchasing executives got a reprieve when the Food & Drug Administration moved the deadline for compliance with the Drug Supply Chain Security Act from July 1, 2015 to November 1, 2015.

[See also: Rx playing bigger role in EHR strategy]

The FDA acknowledged that additional time was needed to implement electronic systems designed to capture and maintain product-tracking data.

Signed into law in November of 2013, the DSCSA outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States. http://www.gpo.gov/fdsys/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf#page=13

[See also: Rx anti-counterfeiting technologies to reach $1.2B by 2015]

Drug manufacturers, wholesale drug distributors, repackagers, and dispensers (primarily pharmacies) will work with the FDA to develop the new system over the next 10 years.

Raymond Lake, corporate director of pharmacy operations for Columbia, Maryland-based MedStar Health, said he would have liked to have seen the deadline or implementation extended a little more, but considers the November deadline a success.

"MedStar is a little ahead of the curve right now in that we had a policy and procedure ready for the original July 1 date," said Lake, pointing out that other health systems around the country were struggling to meet the deadline.

"The additional four months allows us to finalize negotiations with a portal vendor and allows for up to a 60-day on-boarding procedure with them for a system as complex as ours. Even if we had the contract by July 1, they were still telling us that it would take 60-days to fully on-board," said Lake.

In order to be compliant with DSCSA dispensers have to maintain tracing files – a document for every purchase transaction. Drug wholesalers like McKesson, Cardinal Health and AmerisourceBergen maintain those documents.

They can also be maintained by a new kind of vendor called portal vendors, sometimes referred to as track and trace compliance vendors. Some industry experts contend that portal vendors such as Tracelink Inc., rfXcel, Axway Inc. and TrackTraceRx, can do the job in a much more robust fashion.

Portal vendors have worked with drug manufacturers for years on what most people know as pedigree documents.

"We are essentially a new customer base for them because of DSCSA – by we I mean pharmacists.  They typically charge you for this service based on your complexity which is your number of purchasing locations and the number of vendors you purchase from," said Lake.

He added that that kind of pricing methodology is fixed which is more budget-friendly. They could also charge based on the number of purchasing transactions – but that kind of methodology can be variable and for a large system, it may not be practical, Lake asserted.

Portal vendors utilize the cloud, often backed-up by Amazon web services, where the vast amount of purchasing transactions from multiple customers is stored. Lake said a portal developer such as TraceLink for example, has pharmacy customers all over the country and they are storing these multitudes of transactions on a daily basis.

"The users when they utilize a portal vendor their interface is a web page and they connect via publicly available Internet connections with encrypted transmission,' Lake said.

But portal vendors are not for everyone. Using them is not a requirement and many smaller pharmacy operations don't use them because of the added expense.

"We're a system of 10 hospitals and eight retail pharmacies with many physician offices and ambulatory centers. In total we have about 135 dispensers that are buying product that we need to store files for," said Lake.

On the inpatient side Lake pointed out that they use one wholesaler and on the non-acute side they use another wholesaler. "Within a system as large as ours we have two wholesalers. Having one portal for all this information will greatly facilitate things."

Pharmacy directors and buyers are impacted by DSCSA because they need to be assured that when they are making a purchasing transaction that this file is available. It's impractical for them to check every file, every day for that purchase.

"The portal vendor gives you that assurance and so does the wholesaler solution that that file is going to be there," said Lake. "They've taken on the responsibly for assuring you that the file will be there for that transaction."

David Chen, senior director, section of pharmacy practice managers, for the American Society of Health System Pharmacists, said the DSCSA extension is valuable because "it gives us more time to work with FDA and gives the FDA more time to determine how they are going to respond to some of the questions that aren't clear and give the industry more time to get its infrastructure in place."

Chen said that ASHP's communications with the FDA along with other members of the dispensing community helped to provide the evidence to show the FDA that the market wasn't fully prepared for implementation.

"There's a lot of questions in the law itself and when we started digging into it with our members, we started recognizing that the FDA would need to provide some clarification - some potentially additional guidance documents or even guidance documents on how to interpret certain exemptions," said Chen.