Unlock Unprecedented Product Recall Efficiency with DSCSA Compliance Data

At a time when many health systems and pharmacies are experiencing staff shortages and high turnover rates, product recalls pose a significant challenge. Pharmacy teams must respond to recalls as they are issued, but pharmacists and pharmacy technicians often need to juggle this responsibility alongside other important duties like patient care. This gets even more difficult given the growing number of recalls, with many pharmacies managing 10 or more recalls at any moment.

The latest release of TraceLink’s U.S. DSCSA Compliance solution, combined with the Product Recalls solution, aims to improve the recall management process by enabling the Targeted Recalls capability. This article explores why the recall process has been so time consuming and labor intensive in the past and how Targeted Recalls addresses a major obstacle in this process by tapping into serialized product data made available through DSCSA compliance.

Serialization: The secret to a more efficient recall process

While the recall process is rife with time-consuming manual processes that hinder recall coordination and slow product retrieval, there are two major challenges at the forefront:

• Sifting through recall noise: Pharmacies often subscribe to several recall alert services and also receive recall notices directly from the U.S. Food and Drug Administration (FDA), manufacturers, and wholesalers. While this redundancy ensures pharmacies receive all relevant recall notifications, it also gives pharmacy teams a lot of notices to read through. This delays product recall initiation and causes alert fatigue.
• Locating recalled product across multiple sites: Determining whether recalled product has been received, which locations received it, and how much was received is difficult. Health systems and pharmacies will often initiate recalled product searches only to discover that the impacted product was never received at that location. This wastes pharmacy team resources that could be spent delivering patient care.

With the latest release of the U.S. DSCSA Compliance solution, combined with the Digital Recalls solution, TraceLink now provides answers to both of these challenges. TraceLink first digitalizes real-time recall notifications directly sourced from the FDA to create a structured data object that includes the relevant NDC, lot number, and recall instructions. This reduces the amount of time spent sifting through redundant recall notices and also enables pharmacies to use the recall data programmatically with other enterprise solutions like inventory management systems.

Once the recall notice has been digitalized, it can then be compared with serialized receiving information captured through TraceLink’s U.S. DSCSA Compliance solution to provide precise information on the quantity and location of received recalled product. With this extra layer of precision, pharmacies can determine how many products were received at each location and execute product searches only at the sites where recalled product was received.

Combined with the recall workflow orchestration capabilities of the TraceLink Digital Recalls solution, pharmacies can reclaim a significant amount of their staff’s time while ensuring regulatory and process compliance. One 70+ site health system estimates it will save over 21,000 hours of its pharmacy team’s time per year with TraceLink Digital Recalls.

The future of recall management has arrived

The Targeted Recall capability enabled in the latest release of the U.S. Compliance solution further augments TraceLink’s collaborative end-to-end recall orchestration solution. TraceLink Digital Recalls delivers a comprehensive set of capabilities designed to enable pharmacy staff to seamlessly manage and expedite recalls, significantly reducing the operational burden recall management imposes on pharmacy teams.

• Boost efficiency with digitalized recall notifications: Digitalize recall notices to get real-time, programmatic access to recall data, which can be leveraged with other critical pharmacy systems. Eliminate the need to sift through redundant recall notices with a single source of truth and optimize end-to-end recall processes by ingesting recall information directly into inventory management systems and other enterprise solutions.  
• Eliminate aimless product sweeps with Targeted Recalls: Leverage EPCIS data captured by TraceLink to get the exact location and quantity of recalled product received into inventory. This spares pharmacy teams from conducting sweeps at locations that don’t have recalled product and ensures locations with impacted inventory know exactly how much product they’re looking for, enabling pharmacies to save up to 47% of the time typically spent on product retrieval.
• Stop recalled product from entering into inventory: By digitalizing recall notices and leveraging this data in receiving processes, health systems and pharmacies can prevent recalled product from being received from wholesalers and manufacturers. This eliminates the need to perform subsequent sweeps after recalled product is initially retrieved and ensures recalled product doesn’t re-enter inventory, where it could reach patients.
• Receive replacement product and return credits faster: Targeted Recalls enables pharmacies and health systems to quickly identify how much recalled product they received so they can assess impact to inventory before it results in product shortages. Exact location and quantity information of received recalled product also accelerates reimbursement, as recalled product can be retrieved much faster.
• Improve recall visibility and coordination with Supply Chain Work Management: Streamline recall workflows and improve recall monitoring across multiple dispensing sites with a shared central platform dedicated to recall management. Recall coordinators at pharmacies and health systems can monitor recall activity as it’s being reported across all locations so they can better assess recall progress, ensuring on-time completion and reducing the risk of delays or mistakes.
• Ensure process adherence and compliance with recorded audit trails: By digitalizing recalls and managing the end-to-end process on one purpose-built platform, health systems and pharmacies can record every step of the process in detail. This enables the creation of complete audit trails, which is vital for demonstrating adherence to recall responses plans and proving regulatory compliance during audits.

For more information about TraceLink Digital Recalls, you can watch our recent webinar, How to Optimize Pharmacy Resources and Accelerate Reimbursements by Digitalizing Drug Recall Processes. If you have more questions on digitalizing the recall process, you can also email us at digitalrecalls [at] tracelink.com.