Implications of EU FMD for Dispensers
The EU Falsified Medicines Directive (FMD) requires that by February 9, 2019, pharmaceutical companies must serialise prescription medicines using a 2D barcode that contains the following information: product code, serial number, national reimbursement number (where required), batch number, and expiration date. This information must also be delivered in human readable text on the medicine’s package.
Entities responsible for dispensing medication, namely hospitals and retail pharmacies, must be able to scan the 2D bardcode at the point of dispensation (wherever that occurs in the facility) to verify that the pharmaceutical product is authentic and decommission it before distributing it to patients. In addition to affecting dispensers, the EU FMD legislation impacts many other pharma supply chain stakeholders, including market authorization holders, wholesalers, and parallel importers.
This 60-minute webinar will focus primarily on the impact of EU FMD on dispensers, including doctors, hospitals, and pharmacies in throughout Europe. Our experts will address the following questions:
- Where could the serialized medicines be scanned/dispensed?
- What hardware and software is needed, and how does it work? (And who pays for it?)
- What is the responsibility of the dispensing site regarding returned, recalled or withdrawn medicine?
- What do I need to know about parallel imported/distributed medicines?
- What is my role in interfacing with the European Medicines Verification System (EMVS) and the National Medicines Verification Systems (NMVS)?
- How is EU FMD different than the U.S Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA), and how do I avoid making the mistakes my North American counterparts made during DSCSA implementation.
- What is the potential for additional benefits beyond compliance, such as patient engagement?
- What medication is on the black list and what is on the white list or products that aren’t aggregated (i.e., which meds need to be scanned and which ones don’t? Will the dispenser need more resources?
We will also provide an update on the Oxford Hospital decommissioning pilot, which is extremely important for the European healthcare industry because it will help define how hospital management teams can use this requirement to improve patient safety.
With only a few months before the EU FMD’s “big bang,” dispensers must make decisions now to be ready for this directive. If you have been tasked with quickly get up to speed on how the EU FMD impacts dispensers, join us for this hour-long webinar, which features a 15-minute question and answer session.
Barry Holleman, Account Director, Healthcare, OPTEL Group
Barry has 20 years of experience in healthcare technologies and healthcare logistics centered around hospital pharmacies. He is passionate about optimizing medication logistics, deploying medication automation and engineering of the pharmacy workflow in order to accomplish the safest way for medication delivery. Barry holds a master’s degree from the University of Nijmegen, Netherlands and is associated with the Logistics Institute of the University of Hull, UK.
Dhermita Desai, Senior Project Manager, UK and EU, Verify Brand Software®, part of OPTEL
Dhermita Desai’s operational skills have been honed through 16 years of work in the Life Sciences industry. Before coming to OPTEL, Dhermita worked as a serialisation programme manager for Concordia International, where she coordinated the Concordia International programme for implementation of serialisation across all defined markets and SKUs. Her responsibilities at Concordia included authoring validation documents and onboarding more than 100 trading partner CPOs and CMOs.
She has also held quality and program management roles at Amdipharm Mercury Company, Mercury Pharma, Lexon UK and Reckitt Benckiser Healthcare International. She views constantly evolving regulatory compliance mandates as tremendous opportunities to leverage her organizational and management skills to ensure that her clients’ serialization projects meet regulatory market and business requirements. Dhermita has a degree from De Montfort University in Pharmaceutical Chemistry.