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TraceLink Unveils Smart Rx Manager, a Flexible Pharmacy Solution for EU Falsified Medicines Directive (FMD) Compliance

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TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced Smart Rx Manager, a solution that enables pharmacists, hospitals, clinics and dispensing doctors to achieve compliance with the verification and decommissioning requirements of the European Union Falsified Medicines Directive (FMD).

The requirements of EU FMD dictate that healthcare providers must scan, check and verify a medicine’s authenticity against a national repository before a pack is decommissioned and supplied to a patient. Available as a mobile application – or as a solution that can be integrated with existing pharmacy systems, Smart Rx Manager requires no additional scanning hardware, making it a flexible EU FMD solution for hospitals, pharmacies and dispensing doctors, and minimizing disruption in any pharmacy environment. 

With Smart Rx Manager, pharmacists and doctors can use mobile devices running iOS or Android operating systems to scan serial numbers of any prescription medicine and submit the product code (GTIN/NTIN), serial number, lot or batch number and expiry date with a verification or decommission request to their national medicines verification systems (NMVS). Upon submission, Smart Rx Manager will immediately receive a status from the NMVS as required under EU FMD. Larger hospital and pharmacy operations can choose to integrate Smart Rx Manager directly into their existing PMR software, based on the specific workflow requirements.

“More than 130,000 community pharmacists, hospitals and dispensing doctors will be affected by the approaching February 2019 EU FMD deadline. With many concerned about the financial and resource intensive burden of implementing EU FMD processes, Smart Rx Manager has been designed to streamline the process of achieving EU FMD compliance, through a light-weight mobile device or integrating into existing pharmacy operations with minimal investment,” said Shabbir Dahod, president and CEO, TraceLink. “Using Smart Rx Manager will enable pharmacists to meet their immediate EU FMD compliance needs, but also connect to TraceLink's network of more than 270,000+ trade partners and take advantage of new digital solutions for product recalls, patient engagement and personalized medicine.”

Designed to streamline FMD compliance, Smart Rx Manager can be used immediately once purchased and downloaded for €9.99 per month for pharmacists and dispensing doctors and €1.49 per bed, per month for hospitals. The application is not dependent on other pharmacy software or hardware and provides full visibility into pharmacy transactions through a configurable dashboard. Smart Rx Manager can also be integrated with pharmacy management software systems and dispensing robot manufacturers to assist with FMD compliance.

Smart Rx Manager provides the following features for EU pharmacists to easily comply with EU FMD:

  • Simple, Out-of-Box Set Up: The application runs on mobile devices (iOS or Android) and can be easily downloaded through the TraceLink website.

  • Easy-to-Use FMD Compliant Scanner: Any mobile device camera can be used for scanning, eliminating the need for purchasing extra scanning hardware.

  • Optional Higher Volume Scanner Compatible: Smart Rx Manager can also connect wirelessly with optional Bluetooth scanners.

  • Low Cost: With low monthly subscription pricing, Smart Rx Manager offers pharmacists the most cost-effective option to comply with EU FMD, without investing in hardware or annual lock-in subscriptions.

  • Flexible Workflow: As a mobile application, Smart Rx Manager can be used anywhere; eliminating the need to have stationary scanning hardware at fixed dispensing stations within the pharmacy.

  • Safe, Secure Transaction Messaging: Pharmacy users are connected and verified through the TraceLink Network and within the application. Additionally, transactions are encrypted and stored in a secure web service that is GDPR compliant. 

  • Reliable Updates and Support: Smart Rx Manager will automatically update software as regulatory requirements change, which is as simple as updating iOS or Android software. With unlimited transaction scalability offered by the TraceLink network, users can depend on the application to handle all their FMD needs and also have access to TraceLink Support.

  • Integrated Service: Built on secure and proven APIs, Smart Rx Manager can also be integrated directly into existing PMR software, based on the workflow requirements of hospitals and pharmacies.
  • Digital Recall Alerts & Medicine Information – In 2019, new features will become available that will provide early alerts on digital recalls and medicinal information to deliver both pharmacist and patient value.

TraceLink’s Smart Rx Manager is expected to be available in late October 2018 at no charge until the EU FMD requirements take effect in February 2019. User can pre order Smart Rx Manager now at:  https://tracelink.com/solutions/global-compliance/eu-fmd-for-hospitals-and-pharmacies

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