On November 27, 2023, the remaining measures of the Drug Supply Chain Security Act will go into enforcement, including:
The enforcement deadline will cement the need for one-to-one interoperable connections between every pair of trading partners, and the need for matching transaction data to accompany pharmaceutical product every time it changes hands.
It's crucial to understand that under DSCSA, if the data is missing or doesn’t reflect the product as delivered, the trading partners involved must quarantine the product, and report and investigate the issue. At that point, movement stops, and the product can't be received or sold until the data matches.
These situations are already familiar occurrences in shipping and receiving, where delays, split shipments, or other mishaps keep a product shipment from matching the purchase order upon delivery. However, the need for data to match at the time of the exchange means there may be additional layers of difficulty to some current resolution methods.
Pharma trading partners have less than a year left to complete this transition. Some have been studying the issue and preparing for months or years; others are getting resources in place now. The Healthcare Distribution Alliance noted in its annual survey on DSCSA serialization preparedness that much of the industry is still only in the early phases of compliance.
Distributors polled by HDA called particular attention to dispensers, highlighting the possibility that, at the essential patient-facing end of the industry, pharmacies lack the bandwidth to implement the new rules, despite the potential for the change to directly stall their business.
While there was still positive progress, overall, the results indicated that too many companies may have left too much of the critical implementation work for late 2023. This could create a dangerous crunch, for a variety of reasons. Information overload poses a real threat.
First, it's important to know is that EPCIS files are much larger and more detailed than previous transactions records. They consist of events, tracking every point in a product's history since its manufacture. Reading for a problem in an EPCIS file manually, whether in a (very long and ill-advised) printout or on a screen, is extremely time-consuming; "inefficient" doesn't cover it. EPCIS files are extremely good at tracking where an item's been and how it got there, but the tradeoff is size and complexity.
Next, with the final DSCSA enforcement deadline, every trading partner across the prescription drug supply chain will be tracking each shipment at the item level. This will create a hundredfold increase in the number of EPCIS files exchanged over the course of 2023; even with aggregation to cases and pallets, this jump, in a relatively short span of time, will seem like a tidal wave, particularly for companies who don't have solutions in place for DSCSA data.
Finally, the biggest potential danger of information overload is the accompanying leap in exceptions, given the massive boost to both complexity and volume. Simply put, tougher data and more data mean more new problems.
LSPedia's easy-to-use, automated exceptions management technology Investigator is essentially the ground floor for exceptions management, with hundreds of prebuilt and customizable rules, the ability to alert personnel to exceptions, and guide the resolution process.
However, with the wave of new exceptions on the way, we're is pursuing the matter in our Exceptions Pilot, developing standards to ensure that pharmaceutical trading partners have pre-tested resources and SOPs to handle the interactions needed quickly and smoothly.
Our aim is to remove guesswork by outlining distinct error scenarios, so that companies can categorize and understand a problem when it surfaces; to prove which communications and resolution options are optimal for continued smooth supply chain operation; and to illustrate the practices and policies that fix the issue, or, better, keep it from happening in the first place.
DSCSA's changes aren't just paperwork requirements, but process reworks that mandate new, essential elements of doing business. Given the complexity of the task, some pharma trading partners are continuing to ask whether regulators will extend the enforcement deadline.
At present, there's every indication that the deadline will stand. The US has been phasing in DSCSA over the last decade, and the FDA signaled in its draft guidance last July that its updates were at the stage of clarification rather than broader shifts in compliance, indicating that the final rules will indeed go into enforcement on schedule.
Trading partners should be working on forming the connections needed for the interoperability requirement, the technical capability to manage a massive increase in the amount of data transacted for receiving and shipping, and the resources to easily identify problems with that data when they occur.
Those who wait until late 2023 to get DSCSA done run a very real risk of information overload, requiring significant time and budget -- during an already hectic season --to ensure that file processing and data errors don't stop products from getting to patients.
If you need help making your DSCSA plan, or ensuring that the one you have is going to work, get in touch with LSPedia today, or write to us at DSCSA@lspedia.com.
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