TraceLink Introduces Digital Recalls Solution

New E2E workflow orchestration service is expected to simplify the processes of health systems and retail pharmacies while also reducing the risk of recalled items reaching patients.

TraceLink, a digital network platform company that works extensively with members of the pharma supply chain, has introduced TraceLink Digital Recalls. According to the company, this branded solution offers health systems and retail pharmacies a new approach to receiving product recall information and enables them to manage those recalls with speed and efficiency.

Managing product recalls has often be known as a manual and time-consuming process for health systems and retail pharmacies. Once receiving paper-based product recall notifications, pharmacy and supply chain staff are faced with the undertaking of sifting through them to identify relevant recalls, followed by the need to retrieve recalled products from inventory in a timely fashion. 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.

TraceLink Digital Recalls is an end-to-end (E2E) recall workflow orchestration solution that offers real-time recall notifications directly sourced from the FDA and delivered in a structured, digital format. This information—alongside workflow tools—allows for coordinated response across all pharmacy locations, and can potentially reduce the risk of recalled products reaching patients.

With this solution, 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 let organizations demonstrate adherence to response plans and grant them more control over the entire product recall management process.

Key features include:

  • Digitalized recall notifications: FDA recall notices are converted into a 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 E2E 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 Drug Supply Chain Security Act (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.

"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," explains Shabbir Dahod, TraceLink’s president and CEO. "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."

As for health systems and retail pharmacies, they are able to protect patients by increasing patient safety through a fully digitalized notification and internal orchestration process across the pharmacy, which helps prevent recalled products from reaching patients. They can also reportedly boost operational efficiency—this includes reducing the time spent coordinating administrative recall tasks by up to 40%, while also decreasing the number of shelf walks necessary to retrieve recalled products by up to 47% with targeted recalls.

Reference

1. TraceLink Unveils Game-Changing Digital Recalls Solution for Health Systems and Retail Pharmacies. News release. November 7, 2023. Accessed November 10, 2023. https://www.prnewswire.com/news-releases/tracelink-unveils-game-changing-digital-recalls-solution-for-health-systems-and-retail-pharmacies-301980615.html#:~:text=Introducing%20Digital%20Recalls%20from%20TraceLink,%2Dfriendly%2C%20and%20digital%20format.