Poll: 1 in 3 Pharmacies Have Earlier DSCSA Serialization Deadline

This week, hospitals and retail pharmacies joined a live TraceLink webcast to review learnings from our report, Dispensers and DSCSA: Using Lot-Level Learnings to Prepare for the Serialized World. You can access a replay of the presentation here.

Live polling during the event revealed a noteworthy reality: Although the next formal DSCSA regulation for dispensers is in 2020, many pharmacy businesses have to comply with this next phase earlier because they conduct the business operations of other supply chain roles—wholesale distributors, repackagers—whose deadlines are sooner.

One-third of poll respondents said they’re subject to regulatory deadlines sooner than 2020.

The majority are pharmacy operations that loan, borrow, or resell product, and must comply with wholesaler serialization requirements by November 2019. Some repackage product—about 1 of 4 businesses that have an earlier deadline—and must meet similar requirements by the repackager deadline of November 2018.

Other poll results of note from the webcast:

Only 58% of respondents said their pharmacy operation is compliant with DSCSA lot-level regulations.

This is surprisingly low considering lot-level requirements have been in effect since July 2015. However, 34% said they weren’t sure if their business was compliant, and this may be for a myriad of reasons. Pharmacy leadership may not be sharing their compliance status with their staff; this response may also reflect a general lack of understanding about lot-level requirements.

9% of respondents said they still weren’t compliant, nearly two years after the regulation was put into place. This is roughly the same percentage that hadn’t yet addressed compliance based on our 2015 data, so progress still needs to be made.

General awareness of the 2020 requirement is improving – but a lack of deeper knowledge prevails.

According to our poll, there is some improved awareness among dispensers about the 2020 DSCSA regulation. Only 7.5% of hospitals and pharmacies said they were unfamiliar with the 2020 serialization requirement – compared to nearly one-third that lacked that basic knowledge in our original report data.

That number roughly triples, however, when it comes to the 2023 electronic traceability requirement – 23% of respondents are not familiar with the regulation.

When it comes to being familiar with the details of the regulations, a large majority of dispensers simply aren't. A whopping 79% said they were not familiar with the details of the 2020 requirement; 64% said the same of the 2023 requirement.

Some dispensers are on the right path toward an electronic-only future.

With manufacturers required to send compliance documentation electronically by November, and a digital-only unit-level traceability system on the horizon for 2023, transitioning now to a digital system is a recommended best practice.

3 out of 4 dispensers in our polling said they’re already receiving electronic documentation the majority of the time, and 8% said they’re now fully, 100% electronic. Only 2% said paper is their only method of documentation.

If a review of the DSCSA timeline illustrates anything for dispensers, it should be this: As you continue preparing for future DSCSA regulations, understand what's involved in the 2020 and 2023 dispenser requirements, but also look at the dates coming up sooner. Set your readiness plans based on the operations your business conducts within the supply chain – that determines your pharmacy operation’s requirements and deadlines.

For more details, check out the on-demand replay of the webinar. The one-hour presentation includes:

• 4 lessons learned from DSCSA lot-level experiences.
• A complete rundown of DSCSA deadlines, from 2015 to 2023.
• How the activity of upstream partners can affect dispensers’ processes.
• Next steps to prepare for future compliance requirements.