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Preparing for the Latest DSCSA Deadline: Are You Ready?

09/20/18

In 2013, the Drug Quality and Security Act (DQSA) was signed into law. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), was designed to help ensure the safety and integrity of our nation’s drug supply and to avoid counterfeit medicines from entering the market. With this legislation came a 10-year timeline to have a completely electronic, interoperable system in place which tracks a drug from the manufacturer all the way through the supply chain to the patient.

“As with most legislative acts put into place to improve our health care system, there are milestones along the way that must be met," said Katrina Harper, PharmD, MBA, BCPS, DPLA, senior clinical manager, pharmacy services, for Vizient. “Some of the requirements have already gone into effect, yet many in the industry are unaware or unprepared for what is already in play and what is yet to come.”

In 2015, the first milestone required pharmacies to have a system in place to quarantine, investigate and notify the Food and Drug Administration (FDA) of any product that is received and suspected of being counterfeit or tampered with.

A second milestone, also in 2015, required pharmacies to have a process for receiving, validating and storing 3T information – transaction history, transaction statement, and transaction information – data which is uniquely linked to every drug and stays with it as it moves through system. Pharmacies must hold this data for six years after receiving it from the supplier.

According to Harper, adoption of this step has been slow because 3T information currently comes in both paper and electronic formats, adding additional time to the verification process. “Until the system is completely electronic, the deadline for which is November 2019, compliance in this area has been sketchy.”

But the milestone which Harper believes will have the largest impact is just over 60 days away. Beginning on Nov. 27, drugs shipped by suppliers and manufacturers must contain a 2D barcode. This “serialization” of the drug, which is different from the current labeling with NDC information, assigns it a lot number, expiration date and a unique product identifier to allow for additional lot-level traceability. While this may sound straightforward – grocery stores have been using similar barcode technology for a long time – it has the potential to create significant challenges for hospital pharmacies not adequately prepared to read and receive those barcodes.

How can you turn this potential process disruptor into a streamlined success? Harper offers the following recommendations.  

  1. Review current processes for compliance. The best first step is to ensure your organization is compliant with the requirements that have already been mandated. Start by conducting an audit of your current system to confirm that there are established policies and procedures to address suspicious or illegitimate products.

Perform regular audits to validate all 3T information. Is it available for every product? Is it correct?   

  1. Prepare for new 2D barcodes. Because this development will affect numerous departments across an organization outside of pharmacy, Harper recommends creating a multidisciplinary team with representation from IT, supply chain and nursing, among others.

For stakeholders to be in a position to receive goods with the new barcodes, compatible scanners with the ability to parse out the necessary information will be essential in several departments. This will require new technology within the hospital’s information system to process and store the data, so having those departments involved at the beginning is crucial.

While the new barcodes might feel like a logistics nightmare, there is an upside. This now provides information that wasn’t available before, such as expiration date tracking and data for tracking patients to alert them of medication recalls.

Depending on the size of the institution, implementing the technology necessary to read the 2D barcodes could take up to three months, so the time to act is now.

The next milestone for hospital pharmacies to know? November 2020: pharmacies cannot take possession of any product that doesn’t have a 2D barcode.

The DSCSA is an evolving, unfolding regulation to improve drug safety that will undoubtedly require regular changes in how hospital pharmacies conduct their daily operations. “The next 12 months represent a real paradigm shift that many pharmacies are likely ill-prepared for,” said Harper. “But those organizations that take steps now and plan accordingly will reap the benefits and be that much closer to achieving full DSCSA compliance.”

To learn more about DSCSA and how your organization can meet the necessary mandates for compliance, register for our upcoming webinar on Wednesday, Sept. 26, “The Impact of the Drug Supply Chain Security Act.”

For more information about how to maximize your pharmacy performance, contact us today.

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