You could practically hear a sigh of relief from the pharmacy community when the FDA announced a delay in enforcing new DSCSA regulations. Yet even with this reprieve, the challenge of managing even more data remains. And let’s be honest: in our industry, November 27 will be here before you can say “potential non-compliance penalties.”
That’s why strategic pharmacies will use this delay for proactive preparation. There are steps you can take now to manage these changes. You’ll be ready for these new requirements which will save you time and money and provide some peace of mind.
Pharmacies have had to factor Drug Supply Chain Security Act compliance into their operations since 2013. DSCSA mandates tracking prescription drug products throughout the entire supply chain: from the drug manufacturer producing pharmaceuticals to the pharmacy dispensing medications to their patients. It’s a crucial step to ensure patient safety. It’s also a legal requirement for pharmacies (with substantial penalties for failure to comply).
The most recent update to DSCSA requires systems and processes for product verification at the package level. Pharmacies must now work with their trading partners to verify package-level data and record it while checking that those packages aren’t suspicious. The key data in these transactions must be stored in a historical, interoperable standard new to the industry known as Electronic Product Code Information Services (EPCIS).
Alongside these new requirements, pharmacies still have to quarantine and report suspect products within 24 hours and respond to audits within 48 hours. Finally, pharmacies must retain their EPCIS data in an acceptable electronic format for six years.
Pharmacy professionals should review the most recent DSCSA language and updates to understand the exact requirements for package-level data. You should also review the exact requirements for how you’ll need to respond to recalls and investigations into specific products.
If that sounds like a lot, you’re not alone. That’s why the FDA decided not to enforce these regulations until November 27, 2024. That’s how substantial this change is: a federal agency determined that more time is needed for systems to stabilize and develop the adequate capacity for accurate, secure, timely electronic data tracking and exchange.
That’s also why pharmacies should use this extra time wisely. These new DSCSA requirements are more than just new compliance boxes to check off; they may demand transformative initiatives for your pharmacy, staff and systems.
You’ll need multiple robust tools to capture, verify, store and supply such large amounts of data from your entire portfolio of sources and vendors. These systems must consistently confirm that sources and vendors supply accurate product tracking data on time. If you’re managing multiple pharmacy locations, that’s even more data, so you’ll want a unified process.
Put simply, there’s a ton of data, and it’s on you to accurately capture and store everything. Now’s the time to find a solution that will enable you to meet these requirements.
Confirming the legality of these products should not disturb the timely dispensing of products to your patients. Even if you’re DSCSA-compliant, these more stringent tracking and verification requirements may slow down the supply chain. Are you prepared for potential drug shortages? Your entire procurement strategy should be ready to face these challenges.
Since vendors produce the necessary product data, and it’s up to your pharmacy to verify their information, you’ll need to develop a strategic approach to this aspect of your vendor relationships. Establishing additional connections with vendors takes time.
Use this time to build stronger, more collaborative partnerships. Failure to do so may result in strained relationships, jeopardizing the timely flow of products. There’s no time like the present to have these conversations. Yet once you and your vendors are on the same page, how will you verify the products and information you receive from them?
Pharmacies should be ready to respond to all of these DSCSA impacts. Otherwise, patients may feel them (and, by extension, so will your business). With all these changes, you don’t want to overhaul your existing systems, juggle multiple solutions, or waste hours in tedious training.
Compliance is just one part of your pharmacy operations. Don’t silo it. Given the complexity of this product data—alongside every other aspect of your pharmacy—manage it as an integrated element of your pharmacy. Once you’ve established that you’re working with authorized trading partners, DSCSA compliance continues the moment you submit a purchase order. An integrated, streamlined purchasing and inventory solution also allows you to save more and work smarter as you
The right tool will consolidate DSCSA-relevant data and transactions, purchasing and inventory into a single source of truth. You gain a comprehensive view of package-level data as well as all purchase orders and pricing transparency into your entire vendor portfolio. You also have a single repository for the electronic storage of DSCSA-compliant transactions and receiving data for the required retention schedule.
Best-in-class solutions go beyond tracking and storage. With automation, you can receive instant alerts if DSCSA data doesn’t match up. You’ll immediately catch potential issues, and you can quickly initiate a quarantine and reconciliation process. While DSCSA does not apply to product transfers across locations with common ownership, knowing where a specific serialized package is within your organization can still help with inventory and audits. Look for tools to help ensure package-level verification compliance at each step of your own chain of custody for traceable products.
Leveraging a single solution for compliance, purchasing and inventory streamlines how you track and manage purchasing, receiving, available stock and transfers. With a holistic process that allows a granular view of transactions and products, you maintain compliance with DSCSA requirements more efficiently and consistently. This also enhances patient safety and promotes operational efficiency.
Again, if you want to enhance these capabilities further, investigate a potential solution’s reporting power. Accurate data is only helpful if you can quickly and easily pull up the information you need whenever you need it. You should be able to respond to precisely what a DSCSA audit demands and analyze data for your business to thrive.
DSCSA is just one form of compliance. Compliance with your primary vendor’s purchasing contract, secondary vendor agreements, and GPOs are just more requirements for your pharmacy to track. And compliance is reciprocal: vendors have to comply with pricing, rebates, shipping and other agreed-upon terms.
Don’t segment your compliance processes; you’ll risk missing something and lose time, money and sanity comparing multiple systems. Instead, look for a solution that combines DSCSA package-level verification, primary vendor compliance and vendor accountability. This provides enhanced visibility of metrics, enabling pharmacies to track compliance with DSCSA regulations and monitor vendor performance.
If your solution provides intelligent automation, you can program compliance parameters to flag potential issues, reducing the risk of non-compliance and fines as well as missed purchasing opportunities.
A unified inventory management solution empowers you to optimize inventory management and ensure shelf life compliance while overcoming DSCSA challenges. The package-level data is now at your fingertips, assisting you and your team in ensuring compliance with DSCSA and reducing the risk of suspect, counterfeit, or expired medications on your shelves (or patients’ homes).
These inventory solutions enable you to maintain ideal stock levels and minimize waste by tracking inventory from receiving until it’s dispensed. You can also prevent out-of-stocks and overstocks by having accurate, updated information integrated with purchasing data at your fingertips.
Smarter inventory also means smarter purchasing based on actual inventory levels, demand and shelf life. Ideally, these features should also work through a mobile app that quickly scans product barcodes and receives inventory information anywhere in the pharmacy. That way, you’re not jogging between your desk and the receiving area.
Even the best-prepared pharmacies must manage drug shortages and other issues mentioned above. Automated purchasing capabilities are critical in helping pharmacies overcome these challenges by enabling smarter purchasing. For example, finding therapeutic equivalents helps pharmacies find substitutes, maintain patient care and reduce the risk of non-compliance.
Integrating your entire vendor portfolio into a single interface provides a transparent
pricing system so you can view prices upfront. You avoid unexpected charges while discovering the best purchasing option (without spending hours comparing catalogs). If the solution includes a mobile app, you can conveniently upload purchase orders without being tied to the terminal.
Even if DSCSA enforcement is delayed, don’t procrastinate, and don’t just prepare for DSCSA. This is an opportunity to consider several facets of your pharmacy including standard operating procedures, policies and workflows whether they apply to DSCSA compliance or not. Now is the time to tighten up your pharmacy’s operations. Find the right solution to ease the stress of this transition, improve how you serve patients and grow your business in a competitive market.