Representatives from across the pharmaceutical industry shared updates and concerns on upcoming FDA’s new Enhanced Drug Distribution Security requirement in 2023 during Tuesday’s virtual Meeting on Enhanced Drug Distribution Security at the Package Level.
The overarching concern echoed by virtually all of the speakers centered around the point that in the pharmaceutical industry, most companies have not yet begun implementation of the FDA’s new standards.
Speakers suggested a need for further explanation of the requirement to help DSCSA implementation. Ryan Katt of Pharmaceutical Research and Manufactures of America (PhRMA) asked for clarity about Enhanced Security Draft Guidance, specifically about the requirement for the sender to correct clerical errors in the Product Tracing Information in 3 business days.
Michele Davidson of Walgreens spoke of the tremendous size and scope of their pharmacy and shared that the pharmaceutical industry has been on the front line due to the Covid-19 pandemic. Additionally, labor concerns as well as supply chain traceability require smooth real time coordination.
“The pharmacy is a real time environment,” stated Davidson. Real time environment runs on real time data. Three days of waiting for good data will derail the pharmacy work flow altogether.
Speakers additionally reported on efforts and challenges of trading partner engagement. Maryanne Nelson of Cardinal Health noted, less than 10 percent of their trading partners were currently sending serialized EPCIS data. She also called for trading partners to implement 2023 standards a year ahead of time.
Brad Pine of the Smith Drug Company relayed that only 38 of their 320 trading partners have. responded that they were in the process of implementation ahead of 2023. As Pine noted, with a four-to-six-week process to onboard manufacturers “It’s really a matter of time and effort, and with 103 weeks to do this, the math just doesn’t add up,” he said. Pine also raised concerns about staffing, estimating that Smith Drug Company would have to increase warehouse headcount by about 15 percent – a challenge in the midst of a widespread labor shortage.
Echoing similar comments, Llisa Bernstein of the American Pharmacists Association warned that most community pharmacies have not begun implementation, and cited increased workload due to the Covid-19 pandemic as the reason. Additionally, Bernstein noted that currently there are no final guidelines on implementation of the FDA’s new standards.
LSPedia CEO Riya Cao, shared recent polls that captured those areas where trading partners see challenges and where action can develop. The poll results were telling and gave an indication of where “lack of good data from the sender” is root cause of inefficient trading partner onboarding.
As pharma companies begin to add serialization transactions such as EPCIS and VRS into their daily operations, integration errors with trading partners are inevitable. These initial errors can be as high as 36% % for EPCIS errors and 44% for VRS errors.
To resolve errors and ensure successful EPCIS data exchange, LSPediA offers a cloud solution called Investigator. With automation, technology, and process workflows, Investigator provides data quality, quality control, and data remediation capabilities that meet FDA’s Enhanced Drug Distribution Security requirement.
Dr. Leigh Verbois, the Director of the FDA’s Office of Drug Security, Integrity, and Response closed out the meeting by assuring attendees that although the undertaking was large, through perseverance and teamwork the industry will prevail and be better for it. The net benefit being increased consumer protections. LSPediA is prepared and ready with solutions to tackle the necessary need to meet the FDA’s 2023 DSCSA requirement.