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BOSTON, MA (November 7, 2023) - In a groundbreaking effort to enhance patient safety and streamline a largely manual, paper-driven product recall process in healthcare and life sciences, TraceLink is proud to introduce TraceLink Digital Recalls. This innovative solution offers health systems and retail pharmacies a new approach to receiving product recall information and enables them to manage those recalls with unprecedented speed and efficiency.
Managing product recalls has long been a manual and time-consuming process for health systems and retail pharmacies. Often in receipt of scores of paper-based product recall notifications at any given time, pharmacy and supply chain staff face the laborious task of sifting through them to identify relevant recalls, followed by the need to rapidly retrieve recalled products from inventory. This challenge has been further compounded by tight deadlines for patient contact, vulnerability to notification delays, and reporting back to regulatory bodies and supply chain partners.
To address these critical issues and bolster patient safety, health systems, and retail pharmacies need a digital capability that leverages a proven digital network backbone to facilitate rapid and effective product recall notification, identification, and management.
Introducing Digital Recalls from TraceLink
TraceLink Digital Recalls is a collaborative, end-to-end recall workflow orchestration solution that offers real-time recall notifications directly sourced from the U.S. Food and Drug Administration (FDA) and delivered in a structured, user-friendly, and digital format. Access to this information, when combined with powerful collaboration, orchestration, and workflow tools, enables an immediate, coordinated response across all pharmacy locations while significantly reducing the risk of recalled products reaching patients.
With TraceLink Digital Recalls, communication between pharmacy leadership, individual dispensing sites, and supply chain stakeholders is streamlined and synchronized. Real-time monitoring of recall response actions and improved reporting capabilities empower organizations to demonstrate adherence to response plans and grant them greater control over the entire product recall management process.
"We understand the critical importance of swift and precise recall management in the pharmaceutical industry. For the last four years, we’ve engaged directly with the FDA and TraceLink customers across manufacturing, wholesale distribution, and dispensing to ensure we’ve captured the needs of all stakeholders," said Shabbir Dahod, President and CEO at TraceLink. "With Digital Recalls, we are proud to offer a comprehensive solution that empowers organizations to protect patients, improve operational efficiency, and navigate recall challenges with confidence."
TraceLink Digital Recalls delivers a comprehensive set of capabilities designed to enable pharmacy staff to seamlessly manage and expedite recalls, significantly reducing their operational burden.
Key features of Digital Recalls:
- Digitalized Recall Notifications: FDA recall notices are converted into an easy-to-understand digital format with real-time recall notifications, updates, and scope increases.
- Recall Response Orchestration: Digital workflow coordinates the orchestration of responses across dispensing sites and back to approved supply chain stakeholders.
- Real-Time Recall Management Tracking: Monitor recall response status across multiple locations in real time to track progress across an organization and ensure on-time completion.
- Audit Trail: A complete audit trail of the end-to-end recall process supports regulatory compliance requirements by tracking adherence to recall response plans.
- Recalled Product Identification: Identify recalled product upon receipt of EPCIS compliance data by integrating with the TraceLink DSCSA Compliance solution to prevent recalled product from entering inventory.
- Targeted Recalls: Leverage EPCIS data to ensure that pharmacy team alerts are received only for recalled products that have been received.
Key Benefits for Health Systems and Retail Pharmacies:
- Protect Patients: Increase patient safety through a fully digitalized notification and internal orchestration process across the pharmacy, which helps prevent recalled products from reaching patients.
- Boost Operational Efficiency: Reduce time spent coordinating administrative recall tasks by up to 40% and reduce the number of shelf walks necessary to retrieve recalled products by up to 47% with targeted recalls.
- Improve Inventory Visibility: Immediate visibility into recalls enables inventory impact to be assessed faster.
- Improve Recall Response Visibility: Gain better visibility into recall response progress across the organization, as well as the capability to show process adherence during audits.
- Receive Return Credits Faster: Ensure that reimbursement credits are received more quickly by rapidly identifying recalled products and removing them from inventory.
- Reduce Risk: Manage all aspects of the process to reduce risk and ensure that recalls are promptly, efficiently, and thoroughly executed for patient safety.
By leveraging the power of the TraceLink digital network of more than 291,000 authenticated and pre-onboarded entities, we aim to transform the industry's approach to recall management, making the process more transparent, collaborative, and effective.
For more information about TraceLink Digital Recalls, join our upcoming live webinar, Reduce Staff Time Spent on Recall Management by 40%: Introducing TraceLink Digital Recalls, Tuesday, Nov. 14 at 11 a.m. (EST).
About TraceLink
TraceLink Inc. is the leading digital network platform company, enabling end-to-end product orchestration by connecting more than 291,000 healthcare and life sciences entities through its B2N Integrate-Once™ network. Leading businesses trust TraceLink to deliver complete global connectivity, intelligence, and traceability of pharmaceuticals, ensuring that every patient gets the medicines they need when needed, safely and securely. For more information, visit www.tracelink.com.