With fewer than five months to go to the introduction of the Falsified Medicines Directive (FMD) (from Saturday 9 February, 2019) dispensing GPs and their teams are right to demand answers for their businesses. Already, questions have been asked about the implications of the incoming EU legislation on the viability of low-margin products – as manufacturers are asked to soak up the costs of new barcoded packaging.
With mooted IT costs of almost £4,000 per dispensary payable every five years to remain compliant with the law dispensers are rightly concerned about the lack of clarity on the funding model and the spectre that compliance with EU scanning law could become part of the regulatory inspection.
Where are we now?
Dispensers will soon have to make significant changes to their practice in order to comply with the FMD: they will have to update IT systems and associated hardware, as well as connect to the verification system (“registration/on-boarding”), revise workflows and standard operating procedures, train staff, and ensure patients are up to speed with the changes.
Pharmacists have been warned that before they sign up to the FMD they must ensure that any IT contracts are ‘Brexit-proof’. The DDA would urge dispensing practices to do the same. DDA chief executive officer Matthew Isom says: “The DDA is taking an active role representing members during the implementation of the FMD but I would urge all members to come to our 2018 annual conference to understand all the implications, including the funding situation, before they commit to any systems update.”
Want to hear more?
Wednesday 17 October
14.00 – 14.45 – Falsified Medicines Directive (FMD) – Department of Health and Social Care
Thursday 18 October
12.05 – 12.55 – Sponsored talk – Takeda UK: Jon Neal, managing director; Amy Whyte, regulatory affairs and quality manager – An industry perspective on FMD and Brexit.
So, come along and keep your dispensing ‘ahead of the curve’. Registration is free. To book your place, visit the DDA 2018 conference page.