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Falsified Medicines (FMD)

FMD Checklist

FMD

The Falsified Medicines Directive (FMD) has now come into force and this means that hospitals (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 hospitals 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.

Register with SecurMed

Hospitals holding WDA (H) licences are reminded that they will also need to register their wholesale function separately.

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

Visit SecurMed website - www.securmed.org.uk/

Design your decommissioning process

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

  • When will you scan the product? At the point of administration, dispensing or at goods in? As a healthcare institution you are able to decide (community pharmacies must decommission at the time of supply – hospitals are derogated from this requirement). This will really depend on the software solution you have chosen and what is most efficient for your hospital.
  • Where will this be done? This is dependent on when you scan the product and space and staff availability - do you need equipment in satellite dispensaries or off site clinics?
  • Who will do this? Don't forget split packs must be decommissioned when they are first opened.

Write/update your SOPs and train staff

Once you have designed your new process – you should ensure you update your current goods in/dispensary/ward 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 the hospital - 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

FMD checklist

  • Choose an IT supplier
  • Register with SecurMed
  • Design decommissioning process
  • Write/update SOPs
  • Train staff

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.