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FMD – coming soon to a practice near you

The Falsified Medicines Directive came into force on 9th February 2019 and this means that GP practices (and other dispensing points) will have to;

  • Authenticate each pack by scanning the 2D unique identifier barcode on the pack. That data is then instantly checked against data on a national database which manufacturers have uploaded.
  • Check that the anti-tamper device on the pack is intact.


Only then can the pack be supplied to the patient.

Choose an IT supplier

In order to achieve this you will have to engage with a registered software supplier to allow you to connect to SecurMed (the UK national database).

At a high level there are two principal options for software solutions;

  • Stand-alone
  • Integrated within PMR

Stand-alone is where the software and hardware are not connected to your PMR system or an integrated system where your PMR system captures the data whilst the product is dispensed.

Each option has its benefits and disadvantages – an integrated system may be simpler but a stand-alone system may be quicker to implement and avoid tie-in to a particular PMR system.

Many practices will already be trialling software, if you have not yet engaged with or chosen a software supplier it is important that you act quickly to avoid getting left behind.

Take a look at our FMD ready Dispensary Management System - ProScript Connect

Find out more about ProScript Connect

Register with SecurMed

The SecurMed system is live and practices are encouraged to register. Practices holding WDA (H) licences will also need to register their wholesale function separately.

You can register with SecureMed quickly and easily from their website.

Visit SecurMed website

Once you have your system and have registered with SecurMed – what next?

Update/design dispensing processes

It is really important to think through how the directive will affect the day to day dispensing process:

  • When will you scan the product? Will you use an aggregated barcode on the patient bag to do the final decommission or decommission as you hand out – this will really depend on the software solution you have chosen and what is most efficient for your practice.
  • Where will you scan the product? At the start or end of the dispensing bench? Scanning in front of the patient may lead to awkward questions.
  • Don't forget split packs must be decommissioned when they are first opened.

 

Write/update SOPs and train staff

Once you have designed your new process – ensure you update your current dispensary standard operating procedures (SOPs).

  • When writing your SOPs it is important to remember that it is vital to describe what to do when things don't go to plan, any products which show an adverse scan need to be dealt with in practice (unfortunately you can't just return them to the supplier).
  • What will you do if the product is marked as stolen, or the barcode won't read properly? In most cases a quick call to the manufacturer will be all that is needed – however this should be documented and records kept for regulatory inspections.
  • In the event that a falsification is suspected it is a requirement to report to the UK competent authority (in this case the MHRA).  The MHRA is developing a new website to report FMD incidents but this will not be ready in time for 9th February, in the interim time they have asked that the Yellow Card Scheme is used to report possible instances of falsification of medicines.

 

Of course all of this means a lot of change for you and your staff to deal with; to this end it is important to ensure that staff are trained and that this training is documented for inspection.

Useful websites

SecurMed - https://www.securmed.org.uk/

GOV.UK - https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features

FMD Source - https://fmdsource.co.uk/

The elephant in the room - Brexit is also looming large and at the time of writing the guidance is that we should be FMD compliant or continue to progress towards implementation of FMD.

FMD checklist

  • Chose an IT supplier
  • Register with SecurMed
  • Update/design dispensary processes
  • Write/update SOPs
  • Train staff

Take a look at our FMD ready Dispensary Management System - ProScript Connect

Find out more about ProScript Connect