DSCSA & dispensers: In the relay race of compliance, how to support the anchor

Leading up to the end of August, I was looking forward to attending the HDA Traceability Seminar in Washington, DC. It's always an excellent opportunity to rekindle old connections and chat with clients and peers. What I didn't expect was the news that broke just four days before the conference began. On Friday 25th August, we learned that the FDA does not intend to take action to enforce the enhanced drug distribution security requirements under section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act until 27^th November 2024.

And just a few days later, while we were at the conference, we learned of additional guidance that revises and extends the compliance policies regarding wholesale distributor verification of saleable returned drug products and dispenser verification when investigating suspect or illegitimate products.

Our team was surprised, to say the least. While there have already been enforcement delays, the FDA had been adamant that there would be no more and that, come November 2023, enforcement would take effect. However, it seemed that the writing was on the wall when Congress wrote a letter to the FDA.

Is it the right move?

For me, it comes with mixed emotions. On one hand, I'm glad that the FDA is listening to all the stakeholders who are saying that more time is needed. At a meeting last December, concerns were expressed that not only are trading partners sitting at different levels of readiness, but also in terms of understanding what is being asked of them and what kind of resources will be necessary to catch up.

Just this past July, I attended a webinar where a distributor noted that only 35% of manufacturers send complete data to distributors. As a result, the HDA suggested a two-year delay with a phased approach to implementation.

With this approach, the supply chain would incrementally meet DSCSA's final requirements, progressively enhancing serialised data capacity, ensuring stable, interoperable data exchange, and sustaining the uninterrupted flow of essential medicines to patients, all while preserving existing safeguards.

Currently, the FDA is giving no indication that they will adopt this phased approach. Yet, as the HDA conference hosted discussions on the "stabilisation period" implications, it became even more evident that this one-year blanket delay will not adequately address the readiness issues. And even if all trading partners achieve accurate and complete serialised data exchange by 27th November 2024, transitional difficulties will persist. Namely, how to keep the lot level tracing systems in production and "activate" serialised inbound and outbound scanning running in parallel… But not causing product to quarantine. The only way the stabilisation period will be successful is if the industry provides real-time feedback around the frequency and types of errors, so we can assess readiness and put in fixes. For many companies, this may mean developing new code and "bypass" functionality not originally envisioned to log exceptions or account for transitional inventory, but allowing products to ship and not get pushed to quarantine.

So, where do we go from here?

I am not alone in the industry in saying that this stabilisation period cannot and should not be used as a justification for any trading partners to delay their implementation efforts. This time should be used to execute, troubleshoot, and mature systems, while supporting product availability to patients.

However, I would like to focus on a piece of the supply chain that has been the least engaged in all the DSCSA discussions thus far: the dispensers. They might be the furthest away from the manufacturer in the product flow, but the next 14 months will require everyone to work together and support each other in becoming compliant. The purpose behind the DSCSA is patient safety, and the industry needs to ensure that the work is being done to bring the dispensers up to compliance as soon as possible.

For manufacturers, that includes looking down the chain to the dispensers, the last chain in the relay of delivering products to patients.

The anchor in the relay

Because of the supply chain's interdependent nature, the dispensers cannot work on their DSCSA solutions if they are not receiving data from the wholesale distributors, who, of course, need data from the manufacturers first.

I am grateful that the August conference emphasised dispenser education significantly. Much of this advocacy is coming from various Boards of Pharmacies and the National Association of Boards of Pharmacy, which has been compiling dispenser resources for years. But, notably, this call for dispenser education is coming just as loudly from wholesale distributors.

As dispensers vary greatly in size, the readiness, knowledge, and availability of resources also differ. For many of these dispensers, the education must start at a fundamental "DSCSA 101" level. Foundationally, this must happen before they can receive education in various technologies and tools. It will be an evolution, and as more data starts moving and tracing starts happening, there can be talk about technologies to support interoperability.

The FDA is also attempting to solicit dispenser feedback, particularly from the smaller ones who need the most technological and operational support. From 10th August to 11th September this year, they issued a call for input from small dispensers on their technological readiness.

So, how can other members of the supply chain help dispensers become active in their roles as the final DSCSA data stops?

1. Education and training: Provide comprehensive training and education programmes for pharmacy dispensers. This should cover the requirements of DSCSA, as well as practical implementation strategies.
2. Integration with pharmacy software systems: Collaborate with pharmacy software vendors to integrate DSCSA compliance functionalities into their systems. This can streamline the receiving processes or retrieval of data for pharmacy dispensers.
3. Collaboration with industry associations: Work closely with industry associations, such as the National Association of Boards of Pharmacy (NABP), to develop best practices and guidelines for DSCSA compliance.
4. Support for small pharmacies: Recognise that smaller pharmacies may have limited resources for compliance efforts. Provide tailored support and resources to help them meet DSCSA requirements.
5. Regular communication and updates: Maintain open lines of communication with pharmacy dispensers to keep them informed about any changes in DSCSA requirements or best practices.
6. Audit and compliance assistance: Offer resources or services to help pharmacy dispensers prepare for and pass DSCSA audits.

So, what should dispensers do during this time of stabilisation?

• Evaluate, plan, and execute changes to your inbound receipt process.
  • How will you intake and store serialisation data?
  • Are there opportunities to leverage existing processes and technology?
• Ensure staff are trained to identify suspect products and escalate issues while the product is quarantined.
• Develop work instructions to provide transaction data on the product(s) if you have the mechanisms to produce data and work with trading partners to investigate.

But no matter what guidance the FDA might put forwards in the future - a phased approach, leniency for ill-equipped dispensers, or nothing at all - I stand firm that we need to continue to move forwards, frontload the next 14 months to finalise connection work, and mature systems down the line to ensure no interruption of product to the most important parties in the equation – the patients at the end of the line.