What is the Falsified Medicines Directive?
The Falsified Medicines Directive (FMD) has introduced new measures aimed at preventing falsified medicines reaching patients. It originated in the EU several years ago and is now part of UK law. The deadline for FMD implementation across the UK and other European countries was 9 February 2019.
FMD requires medicine manufacturers to add an anti-tamper device and unique identifier barcode to each pack of medicine. The unique barcode information is then uploaded to a central database allowing packs to be scanned and verified as authentic.
It applies to all prescribed medicines and can also apply to certain designated OTC medicines.
What does this mean for hospitals?
FMD requires hospitals 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.
Hospitals are required to scan each pack, but they can do so at any time in advance of that medicine being dispensed to the patient. Hospitals will have to identify when and where they will scan the product, (at the point of administration, dispensing or at goods in) this will really depend on the software solution you have chosen and what is most efficient for your hospital. Hospitals are likely to need equipment in satellite dispensaries or off site clinics.
It is important to note that once a pack has been scanned it is deemed to have been “decommissioned”. In the event of an erroneous decommissioning the product can be re-commissioned within 240 hours of the original decommission activity providing a) it is at the same premises where it was decommissioned, b) the product is intact, c) it has not been recalled, d) it has not expired and e) it has not been supplied to a member of the public.
Will all packs have the new safety features from February 2019?
No. Eventually all packs will have the new safety features. In the meantime there will still be existing stock without these features, this situation will remain for a number of years as pre FMD packs are sold through. Those packs without safety features can still be dispensed.
What if a pack does not return a positive verification?
If the pack has been withdrawn or recalled then the normal process applies. If the system identifies it as a potential falsified medicine then it must be quarantined and the MHRA informed, the current indications are that this will be done through the existing ‘Yellow Card’ scheme.
It is essential that adverse scan products are not simply returned to wholesaler – this avoids the risk of falsified medicines being returned to the supply chain.
What technical system solutions are available? What is your advice?
We would advise customers to check www.securmed.org.uk/ for a list of IT providers.
Which solution is best- the stand alone or PMR compatible?
There are many systems available and operational models within Trusts can vary significantly. It is therefore difficult to recommend one solution over another. PHOENIX do however have an integrated FMD-compliant solution available through our PMR provider, EMIS.
How much will it cost - both the IT system upgrade and scanners?
You will need to talk to your system provider. NHS Digital also give advice on their website.
Is there any funding to cover the cost?
At present, there is no specific Government funding available.
Manufacturers are funding the central databases.
What about staff training?
Staff training will be needed and SOPs will have to be rewritten. Hospitals will only be able to do that once they have chosen a FMD-compliant IT system. It is therefore prudent to consider your system options as early as possible.
How much longer will it take to issue a prescription?
That will depend upon the system and processes chosen and each hospitals connectivity to the hub.
Will I need to change all of my SOPs?
Yes. SOPs will need to be rewritten but the extent depends upon the nature of your business as defined by the FMD legislation and your chosen FMD compliant IT solution or stand-alone system.
Who will be checking that I am following the legislation?
The MHRA is the competent authority in relation to FMD, some of its inspections may be carried out by other regulators such as the GPHC and/or CQC.
Do I actually have to comply or will this project be scrapped in the event of a no deal Brexit
The UK is proceeding with implementation of the EU requirements for new safety features to prevent the entry into the legal supply chain of falsified medicinal products in the UK. However, as stated in the MHRA’s consultation, in the event of no deal, it is expected UK stakeholders would no longer be able to comply with the requirement to verify and authenticate. Therefore, the legal obligations related to this would be removed for all actors in the UK supply chain.
If a no deal scenario is avoided and there is an extension/revocation of article 50 or a deal is agreed and a transition period is introduced meaning the UK is still part of the EU then FMD will go ahead as initially planned.
See more guidance via GOV website
How soon can we link to the NMVS?
The SecurMed system is live and connection is now available. End user registration is now open and end users are encouraged to register in time for the 9th February 2019 deadline.
What about specific scenarios including split packs decommission or splitting bulk packs etc, opening stock bottles, preparing blister packs for domiciliary patients, methadone or other substance misuse prescriptions etc.
Decommissioning occurs at the point the seal is broken on the pack. The pack should be marked to indicate this has been done.
What are the contingencies should the NMVS go down - i.e. will we still be able to issue prescriptions?
Yes the IT system should store scans and send the decommissioning info when the system is live again.
What happens on February 9th if our hospital is not FMD compliant?
The UK competent authority, (the MHRA in this case) in a recent consultation on FMD non-compliance sanctions, has indicated that they are aware that many parts of the supply chain may not be fully complaint by the February 9th deadline, they have also indicated they will pursue a pragmatic collaborative approach with the industry to work towards compliance in the first instance before regulatory sanctions are invoked.
It should be noted though that the government intends to change the HMR 2012 and that non-compliance with FMD will become a sanctionable offence.
Our advice is to make sure you are working towards compliance.
How will returns work?
Wholesalers will be required to scan and verify each item returned – for this reason you must ensure that any products you return have not been decommissioned.
Read more about PHOENIX return updates