TraceLink has joined the Irish Medicines Verification Organization (IMVO) serialization pilot study and will support a number of hospitals, pharmacies and clinics connect to the Irish Medicines Verification System (IMVS).

TraceLink has passed IMVO’s self-certification tests which confirm that its pharmacy system connects correctly to the IMVS. TraceLink will support 16 pharmacies and clinics across Ireland during the pilot, which aims to gather critical data and end user insights into the day-to-day operation of a serialization service for compliance with the EU Falsified Medicines Directive (FMD). As part of the pilot, the 15 pharmacies and one private clinic will use TraceLink’s Android or iOS-based pharmacy applications and a Bluetooth scanner to scan medicine barcodes and verify them against the IMVS.

“The IMVO is a new organization set up to protect patients in Ireland from the dangerous threat of falsified medicines being supplied through legitimate channels. It is beneficial for us to be connected to the TraceLink network in order to have the ability to easily scan the new 2D codes on medicine packaging and ultimately ensure patient safety in our hospital,” said Catherine Kelly, chief pharmacist, UPMC Whitfield, the largest private hospital in the southeast, serving a half million people in the region. UPMC, a leading academic medical center based in Pittsburgh, PA, acquired the hospital in May, where it already operated an advanced radiation therapy center that has treated more than 17,000 patients since opening in 2006.

Purpose-built for flexible integration into any pharmacy workflow, TraceLink’s pharmacy application can be accessed through a smartphone, tablet, or a set of APIs. These APIs can integrate with all capable pharmacy management systems, enabling any pharmacy, clinic or hospital in Ireland to easily comply with verification and decommissioning requirements under the FMD. All equipment is provided by TraceLink for the duration of the pilot. TraceLink is fully connected with SolidSoft, the blueprint provider for the IMVO.

“Serialization pilots at the medicine decommissioning level will help us and our pharmacy partners to understand user adoption and where further training is needed, while also determining best practices for compliance in real-world scenarios. We are extremely pleased to be involved in initiatives like this as we strive for a better connected and safer pharmaceutical supply chain,” said Shabbir Dahod, president and chief executive officer, TraceLink. “The FMD is a significant turning point for the European healthcare industry to create a safer supply chain for the benefits of patients everywhere.”

In order to comply with the EU FMD, which aims to reduce counterfeiting in the pharmaceutical supply chain, pharmacies and clinics in Europe must introduce new processes. Under the regulation, pharmacists and healthcare providers must adopt the end-to-end verification system, which means they must scan and verify the authenticity of drug products against National Medicines Verification Systems (NMVS) before the medicine can be dispensed to patients. Ireland is one of the first countries to have an operational serialization service in place ahead of the FMD deadline in February 2019.

As part of EU FMD, all NMVS systems are required to connect into the EU Hub. Pharmaceutical manufacturers with EU FMD requirements are required to upload serialization data to the EU Hub, which is then distributed to the appropriate NMVS for medicine verification. TraceLink has developed a streamlined program for its more than 190 manufacturing customers with EU FMD requirements to rapidly complete conformance testing and successfully receive European Medicines Verification Organization (EMVO) approval to submit data to the EU Hub. With TraceLink’s conformance test kit, 42 companies have been able to complete their conformance testing, with 21 having already received EMVO approval.