With the Nov. 27, 2024, deadline for the Drug Supply Chain Security Act (DSCSA) less than three months away, many pharmacies and the organizations that represent them are sounding the alarm about lack of readiness from upstream trading partners, particularly at the manufacturer level.
When it was initially passed in 2013 with the goal of creating a single, consistent federal traceability framework for prescription medications, the DSCSA laid out a 10-year time line for establishing an interoperable electronic system to exchange transaction information, history and statements throughout the pharmaceutical supply chain, from manufacturers through distributors to the dispensers. In late August 2023, the FDA announced a one-year “stabilization period,” postponing enforcement to Nov. 27, 2024.
But as pharmacies test the systems they and their vendors have put in place to enable compliance, they are sometimes discovering significant gaps in the data they are receiving from trading partners, particularly at the manufacturer level.
“Most of our members have had a plan in place for a while, and have been working with solution providers handling DSCSA compliance, but we are hearing from many of them that the manufacturers are only [providing] 20% to 30% of the data they need to actually track things through the system,” said Jillanne Schulte Wall, ASHP’s senior director of health and regulatory policy. “That seems to be in large part due to the fact that there have been cascading enforcement discretion periods, and there has not been an absolute compliance push. I don’t think manufacturers are trying to be noncompliant; rather, the practical realities of DSCSA have been more complex than people initially expected.”
These concerns have been reflected in surveys conducted by the FDA and the Partnership for DSCSA Governance (PDG), an independent, sector-neutral governance body. In a June 2024 FDA/PDG joint public “check-in” meeting, it was reported that although dispensers have seen improvements in onboarding processes (establishing connections) and increases in data received from trading partners, there are still significant issues with master data and data inconsistency. Nearly one-third of pharmacies surveyed reported that they are routinely receiving serialized data, such as transaction information, from 20% or less of their suppliers; only 10% said they were getting such data routinely from 95% to 100% of suppliers.
“Ask 10 dispensers what verification means, and you will get 10 different answers. There are so many new applications that are unfolding,” said Neal Long, the CEO of DSCSA compliance solution vendor ConsortiEx. “It’s more than just EPCIS [Electronic Product Code Information Services] files. It’s tracking, tracing, sellable returns, decommissioning and new ways of verification. There are just so many new elements that November 27 will come and go, and there will still be a lot of work to be done to protect patients and the supply chain.”
In June, the FDA announced that it would grant small dispensers a two-year extension for complying with DSCSA’s enhanced tracking requirements, but that only applies to those with fewer than 25 employees. The agency also said it would consider requests for waiver, exceptions and exemption (WEE) from other trading partners that are not fully ready for implementation by this November.
“If you don’t think you will be ready or won’t have complete data from your trading partners upstream, we advise that you consider going through the process of filing for a WEE,” said Josh Bolin, the associate executive director for government affairs and innovation for the National Association of Boards of Pharmacy (NABP). “And if you are doing that, it is very important to document specifically why you are seeking the WEE and why it is important for public health to get that request granted.”
Although the FDA announcement recommended that such requests were to be submitted by Aug. 1, Mr. Bolin noted that this is not a statutory date. “Trading partners can still submit a request, and they should keep records of what they submitted and when.”
The National Association of Chain Drug Stores (NACDS) has also weighed in on DSCSA preparedness. In a July 29 letter to the FDA, the group renewed its request for a phased, stepwise approach to implementation of the DSCSA requirements. NACDS’s concerns echoed the findings of the FDA/PDG survey. “Anecdotally, we are hearing that manufacturer-level trading partners are providing accurate, consistent, and complete EPCIS data for only about 25% to 50% of prescription drug products that pharmacies receive,” wrote Steven Anderson, NACDS president and CEO.
NACDS noted that putting too heavy an emphasis on the WEE system could put access to medications in jeopardy. “There are concerns that relying solely on the waiver and exemption process could result in ‘runs’ on the products that are not subject to a waiver or exemption, and drive those prices up,” the group stated in its letter. “This would lead to increases in prescription drug prices throughout the supply chain that ultimately would have to be borne by patients. This could also result in drug shortages, due to limited availability of compliant products, and because manufacturer-level trading partners may decide it is better to discontinue products that are not compliant.”
Although it has not yet issued such a public letter, ASHP is engaging in ongoing communications with the FDA about similar issues related to the DSCSA go-live date, Ms. Schulte Wall said. “We are very concerned about the lack of preparedness we are seeing upstream, and whether or not there should be a continuation of the stabilization period,” she said. “We have also asked our members to share their experiences with FDA. They want to hear directly from the field about what this looks like in practice.” (For some preparedness tips, and assigning responsibility for DSCSA compliance, see sidebars.)
Distributors Also Concerned
At the distributor level, the picture is much the same, said Elizabeth Gallenagh, a general counsel and senior vice president of supply chain integrity at the Healthcare Distribution Alliance. “I would say most of our members are connected, but they are not receiving fully serialized data from all of the manufacturers. I know of at least one distributor that is receiving no data, or bad data, from about 20% of their manufacturers. But we don’t necessarily know what volume that means or what products that represents at a more granular level, such as whether those are essential medicines or shortage products. This could get very complicated for the dispensers at the end of the chain as they try to keep up with all of this variability.”
Assuming the stabilization period is not extended and full enforcement of DSCSA requirements begins in November as scheduled, the FDA’s enforcement plan in such a scenario remains unclear.
“We’ve asked for more detail from FDA on this,” Ms. Gallenagh said. “Are they planning to inspect or do drop-in audits? For manufacturers, this might be done in the course of their regular inspections, but how does that work for distributors and pharmacies? We’re not used to FDA coming in, but rather the state because that’s who licenses us. So the challenge is also that we don’t really know how FDA intends to enforce and at what level.”
What to Expect From Inspections
DSCSA compliance will be rolled into the existing state boards of pharmacy inspections, according to NABP’s Mr. Bolin. “I’m not aware of any state that is establishing a separate process for DSCSA compliance,” he said. “Most of them will be including those questions in their routine inspection processes.”
What should a hospital pharmacy do if it’s December 2024, and they receive product for which they don’t have data from an upstream partner, but they have a patient that needs that medication? “We are advising a risk-based approach,” Mr. Bolin said. “If this is a product that you’ve purchased from the same wholesaler for years and you have an established relationship, you can say you are doing what is in the best interests of the patient and still dispense the product. But you need to have policies and procedures that address this.”
Conversely, if a hospital or health system has a product that is in short supply “and you have purchased it from somebody that you don't normally purchase from, that requires a much different level of due diligence on your side, and you need establish processes for that type of situation as well,” Mr. Bolin said.
NABP will release its “Dispenser Guide to Achieving DSCSA Compliance” in September that addresses these and other compliance questions. Pharmacies interested in obtaining the guide should sign up for the NABP mailing list at www.pulse.pharmacy.
“Remember, DSCSA is not being done for paperwork reasons,” Consortiex’s Mr. Long said. “It is to protect against that one moment where adulterated, recalled, expired or counterfeit drugs enter your supply chain.”
HDA Reaches out to the FDA
On Aug. 19, HDA sent a letter (bit.ly/3XdISuH) to the FDA calling for a phased, stepwise approach to implementing the enhanced drug distribution security (EDDS) requirements of DSCSA. In the letter, HDA encouraged the agency to:
- Establish narrow guardrails to allow more time for the supply chain to stabilize data exchange between trading partners.
- Swiftly approve WEEs requested by trading partners to mitigate supply chain disruption.
- Initiate weekly “rapid response” calls with industry stakeholders leading up to, and in the immediate aftermath of, the implementation of EDDS requirements on Nov. 27, 2024.
The sources reported no relevant financial disclosures beyond their stated employment.
This article is from the September 2024 print issue.