1. Falsified Medicines Directive (FMD)
Leyla Hannbeck MRPharmS, MBA, MSc, MA
NPA Chief Pharmacist and Director of Pharmacy

2. Falsified medicines: the facts
Falsified medicines may:
Be fraudulently mislabelled
Contain low quality ingredients
Contain the wrong dose
Contain wrong ingredients
Have fake packaging
Falsified medicines do not pass efficacy, evaluation, quality and safety required for EU authorisation and MHRA authorisation
Falsified medicines may:
contain ingredients of low quality or in the wrong doses;
be deliberately and fraudulently mislabelled with respect to their identity or source;
have fake packaging, the wrong ingredients, or low levels of the active ingredients.
Falsified medicines do not pass through the stringent evaluations of efficacy, quality and safety that are used in the European Union authorisation process and for this reason falsified medicines can be a serious threat to health
Action has already been taken to tackle falsified medicines entering the UK supply chain and prevent such items being sold – in 2015 any organisation selling medicines online in the UK was and are required to register with the MHRA on the MHRAs list of UK registered online retailers

3. Aims to prevent falsified medicines entering the supply chain
FMD: background
Aims to prevent falsified medicines entering the supply chain
Approved by European Parliament
Two mandatory safety features
Allows medicines to be verified and authenticated
To be implemented from 9 February 2019
The impact of Brexit is currently unknown
In 2013 in order to combat the ever increasing risk that falsified medicines reach patients, the “Falsified Medicines Directive” –  Directive 2011/62/EC which aims to prevent the entry into the legal supply chain of falsified medicinal products, came into force
In 2015, the Commission Delegated Regulation (EU) 2016/161 supplemented Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.
The requirements of FMD are to be met by all marketing authorisation holders by 9 February 2019
The impact of Brexit on the implementation of FMD is currently unknown

4. FMD: background FMD requires :
Mandatory safety features on medicine packaging; an anti-tamper device (ATD) and unique identifier (UI) in the form of a 2D barcode
All online pharmacies register and display an EU wide logo
Restrictions on the import of active ingredients
Heightened record keeping requirements for wholesalers
FMD harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.
Measures include:
Obligatory safety features  – a unique identifier and an anti-tampering device - on the outer packaging of medicines
A common, EU-wide logo to identify legal online pharmacies
Tougher rules on import of active pharmaceutical ingredients
Strengthened record-keeping requirements for wholesale distributors

5. FMD medicine safety features
As discussed, from February 2019 all new packs of prescription medicines placed on the European market will be required to have two safety features:
A unique identifier (UI) in the form of a 2D data matrix (barcode) – where pack size allows, this info will also be printed adjacent to the 2D code as human-readable text
And
An anti-tamper device (ATD)
The UI will include:
Product code (name, common name, form, strength, pack size and pack type)
Serial number
National reimbursement number (national identifying code if required by member state but not likely to be relevant in the UK)
Batch number
Expiry date
There is the possibility that the UI code can be used to assist pharmacy activities such as accuracy checking, stock re-ordering and stock rotation

6. Verifying and authenticating medicines
Manufacturers enter each medicines UI code to the National Medicines Verification System (SecurMed UK)
Pharmacies will be required to authenticate medicines “at the time of supplying it to the public”
This includes checking the ATD is still intact
And scanning the UI on the medicines outer packaging – referred to as ‘decommissioning’
As part of FMD, manufacturers will upload a valid UI onto the National Medicine Verification System (NMVS) for each prescription medicine that enters the EU supply chain
In the UK, a National Medicines Verification Organisation was formally established under the name SecurMed UK in July 2016.
Pharmacies are then required to check the anti-tamper device to ensure it is not broken and then scan the unique identifier barcode into the national system/database – wholesalers will also input information into the same national system/database as they bear there own responsibilities under FMD
The National Medicine Verification System (NMVS) will act as the hub and will link all national systems across Europe together, allowing across border parallel trading of medicines to continue as normal
Scanning and authentication will come into effect from 9 February 2019

7. Verifying and authenticating medicines
There are two potential messages displayed once the UI has been scanned:
Medicine can be dispensed as long as the ATD is undamaged
If the ATD is broken in order to dispense the medicine, this is exempt
Successfully decommissioned
“Active”
Cannot be supplied
Additional messages include “already dispensed”, “recalled”, “withdrawn”, “stolen” or “locked”
“Inactive”
The nation medicines verification system will send back the current status of the product once the UI barcode has been scanned into the system and verify the product:
“Active” – this means the product can be supplied as normal as long as the anti tamper device has not been damaged – the only exception to this would be where the anti-tamper device has been broken in order to prepare/assemble the medicine
“Inactive” – the product cannot be dispensed if this message shows
The system is likely to provide an additional message to indicate why it is classed as “inactive”
Those messages include:
Already dispensed
Recalled
Withdrawn
Stolen
Locked (this means it is temporarily inactive during investigations)

8. Decommissioned medicines
“Active”
“Inactive – dispensed”
Decommissioned medicine status change from:
If the product is not supplied, the status can be reversed
Once a medicine has been decommissioned, the status of the medicine will change to “inactive dispensed”
This prevents the same UI code being authenticated by another dispensing site
Once the product is decommissioned, this may affect your ability to return medicines to wholesalers and this will depend on their terms and conditions, but in general as long as the stock has not been decommissioned and the anti tamper device is intact the returns process should remain unaltered – wholesalers will verify the status of any product returned and any products with an “active” status will not be accepted
If the product is not supplied to the patient, there is the option for the status to be reversed

9. Reversing the medicine status
Reversing the “decommissioned” status of a medicine can only occur if:
It takes place at the same pharmacy it was decommissioned
It occurs no more than 10 days after decommissioning
The product has not expired
The product has not been recalled, withdrawn, stolen or intended for destruction
The medicine has not been supplied to a patient
If for some reason the product is not then supplied to a patient, there is an opportunity to reverse the status of a decommissioned UI, so the product can be re-dispensed against another prescription.
This can only take place in the following circumstances:
The reversal takes place in the same location as the original decommissioning (ie, within the same pharmacy)
The reversal is done not more than 10 days after the decommissioning (commonly known as the “10-day rule”)
The product has not expired
The product has not been marked by the National Medicines Verification System as recalled, withdrawn, stolen or intended for destruction
The product has not been supplied to the public.

10. Enforcement and monitoring
Update legislation and set penalties
Department of Health
Enforcement for manufacturers and wholesalers
Medicines and Healthcare products Regulatory Agency (MHRA)
Enforcement for community pharmacies
General Pharmaceutical Council (GPhC) and Pharmaceutical Society of Northern Ireland (PSNI)
Different national authorities are responsible for enforcing and monitoring the implementation of FMD:
The Department of Health is responsible for updating legislation and setting out penalties – yet to be decided
The MHRA is responsible for enforcement for manufacturers and wholesalers
The GPHC and PSNI are responsible for enforcement for community pharmacies – how the GPHC and PSNI will monitor and enforce FMD is also yet to be decided

11. Implications for pharmacy contractors
All community pharmacies will be required to:
Connect to the UK National Medicines Verification System
Update software
Obtain scanners
Introduce SOPs
All pharmacy contractors will be required to connect to and access the UK National Medicines Verification System – this will involve updating/obtaining necessary software and hardware, such as scanners to complete the process
Software may be a standalone programme or may have the ability to be linked to PMR systems
Additionally, pharmacies will need to implement staff training and standard operating procedures (SOPs) to cover the full process of authenticating and decommissioning medicines, prior to providing these to the patient
This includes SOPs and processes outlined to deal with unexpected messages on scanning and reversing product status

12. Scanning and decommissioning medicines
“At the time of supplying it to the public” is not defined but the FMD process must be completed before the medicine is released to the patient
‘Aggregated barcodes’ may can be used where more than one medicine is dispensed
This code links multiple items together and allows decommissioning of all items in one go by scanning the aggregated code on the bag label
‘10 day’ rule
All pharmacy staff will require training in regards to FMD and competent staff involved in decommissioning medicines to follow protocols in place
PMR software may be updated to include a message requesting the medicines Unique Identifier code during prescription assembly
There is no confirmation as to what, “At the time of supplying it to the public” means – currently the only clarity is that the check of the ATD and the scan of the UI must be completed before the product is handed to the patient
It is unlikely wholesalers will be able decommission products on behalf of pharmacies, nor will the pharmacy be able to decommission a product when stock is received from the wholesaler as decommissioning must happen as close to the time of supply to the patient as possible – wholesalers will decommission products on behalf of some healthcare professionals/public bodies but this does not include pharmacy
There is also the ‘10 day rule’ to bear in mind –
Anything decommissioned more than 10 days ago would not be able to be returned to the wholesaler and reversal of the product status cannot be changed after 10 days of decommissioning
Additionally, it is not clear if the ATD check and UI scan can occur as separate steps
One way of efficiently scanning multiple items is by using an aggregated barcode on the bag label – this is where more than one product is involved
The aggregated code would link information from multiple UIs for a single patient – then when the prescription bag is handed out the aggregated code is scanned, which will trigger the decommissioning of all the medicine packs in a single operation
This avoids the need to empty all the medicines out of the bag at the point of collection/delivery and scan each individually, however it means an additional step where all the products are scanned during dispensing to be included in the aggregated code will need to be included

13. Split packs MDS Split packs and MDS
Check the ATD and scan UI when first opening a pack
Remainder of pack does not require further checks before use
Split packs
Before dispensing into an MDS, ATDs must be checked and UI scanned to decommission the product
MDS
Split packs – before splitting a medicine pack in order to meet dispensing requirements, the ATD must be checked and UI scanned in order to decommission the product
Further use of the split pack does not require any further checks to be undertaken
MDS - Packs will have to be checked and decommissioned before they are opened to be repacked in MDS trays

14. Potential decommissioning points
During assembly
During accuracy check
At point of hand out
At point of hand out with aggregated code
There are four potential points at which could be considered (each carry risks – next slide):
Decommissioning taking place during assembly (e.g. for Monitored Dosage Systems when packs are split)
Decommissioning taking place at the point of an accuracy check
Decommissioning taking place at the point of hand out to the patient / their representative (including delivery drivers)
Decommissioning taking place at the point of hand out to the patient / their representative (including delivery drivers) using an aggregated code on the bag label (this would require ‘link scans’ of each pack during the assembly process)
Ref – communication/own ideas

15. Decommissioning points and patient safety concerns
Additional step/increase workload
Time period between assembly and handing out
Increased pressure/distraction
During assembly or
during accuracy check
There are potential patient safety concerns associated with each of the potential points at which medicines can be decommissioned:
During assembly or accuracy check –
Decommissioning at this stage increases a step in the process and workload to the pharmacy team
With increased pressures it may increase the risk of dispensing errors
The additional step of scanning and checking the ATD may be a distraction and lead to more dispensing errors
All dispensing staff will require training in how to complete the ATD check and UI scan
There may be a time period from the point of decommissioning during assembly or accuracy check of the prescription and the patient collecting/or being delivered – this presents issues – if the patient comes a few days later, did the decommission actually happen “at the time of supply” as stated in FMD legislation and if this time period over 10 days then the product status cannot be reversed which may lead to medicine wastage
Therefore this system may only be suitable for acute prescriptions where the patient is waiting in the pharmacy for their prescription to be dispensed

16. Decommissioning points and patient safety concerns
Prescription bags need to be re-opened
Training required for all support staff
Increased workload/pressure
At point of hand out with/without aggregated code
Decommissioning at the point of handing out (either to patient or delivery driver) with or without an aggregated code:
All staff, including counter assistants, would require training in order to complete the scan at this step (with or without an aggregated code)
Without an aggregated code the prescription bag would need to be re-opened before handing out and all items scanned – this could breach patient confidentiality (depending on where this is carried out in the pharmacy), increase waiting times and pressure on staff, increase the risk of dispensing errors if not all the medicines are placed back into the bag or there are mix ups with medicines
With an aggregated code – all items will need to be scanned into the link code during dispensing, this removes the pressure at the point of handing out but increases the steps during dispensing, leading to risk of errors occurring
However this system (with or without aggregated code removes the concerns around the time gap between decommissioning a product and the patient receiving – therefore it is less likely to lead to wastage)

17. FAQs

18. How close are we to implementing FMD?
The UK FMD Working Group for Community Pharmacy work ongoing to ensure the implementation within the time frame
Brexit – questions over how Brexit will affect the implementation of FMD
NEED MORE INFO FROM POLICY FOR THIS SLIDE
The Department of Health has established an FMD Implementation Advisory Board bringing together a wide range of stakeholders from right across the whole of the medicines supply chain and the many health professionals who supply medicines to the public.
FMD Source has been developed by the UK FMD Working Group for Community Pharmacy which brings together all the main bodies representing community pharmacy to influence and inform the implementation of FMD in the UK.
It is designed to help UK pharmacies prepare for whatever new authentication systems are developed and introduced.
Although the result of the referendum in 2016 has started the UK on a path towards leaving the European Union, it is unlikely that this will have taken place before FMD scanning and authentication comes in to effect from 9th February 2019.
The full implementation of FMD may depend on the UK’s future relationship with the EU

19. Do GSL and P medicines need to be decommissioned before supplying?
Non-prescription medicines are not included under FMD
Therefore do not require decommissioning
The only exception is OTC omeprazole
Unlicensed specials and appliances/devices do not require decommissioning
Almost all prescription medicines with a Marketing Authorisation are in scope of FMD
There are only a few specialist products, radionuclide kits and medicinal gases being out-of-scope.
All non-prescription medicines are out-of-scope, with the exception of two omeprazole products (which were subject to falsification in the past).
Unlicensed products, including specials and clinical trial supplies, are out-of-scope, but any licensed products being incorporated in to them (such as ingredients for specials) would have to be authenticated and decommissioned before they could be used.
Medical devices are out-of-scope, but the European Commission is expected to publish an updated Medical Devices Regulation in early 2017 that would come in to force in 2020.

20. How do I deal with medicines that do not have a UI code?
There may be medicines in the supply chain which do not have a 2D barcode by February 2019
These can still be dispensed
They are not required to be
decommissioned
It is likely that there will still be packs without 2D barcodes in the supply chain when the requirements for authentication under the Falsified Medicines Directive come in to effect in February 2019.
These packs will still be able to be dispensed and supplied but they will not be required to be decommissioned.
Some packs are already appearing with 2D barcodes (as well as linear barcodes) as manufacturers and packagers change over in advance of the FMD requirements – further discussions will be required as to how these packs will be handled by national medicines verification systems.

21. Can we still dispense PI medicines?
Yes
PIs will be re-packaged and re-labelled for the intended country
This includes a new UI and barcode and ATD (if required)
Brexit may impact the position of
parallel traded products
Parallel traded products will have to re-packaged and re-labelled for the intended country of use.
This will include applying a new unique identifier and 2D barcode (linked at batch level to the original UI) and replacing the ATD if it has been broken.
They will then be treated in the same way as a pack originally manufactured for the UK market.
Note that the position of parallel traded products after the UK leaves the EU has yet to be clarified.

22. I have a Wholesale Dealers License – do I have additional FMD requirements?
Pharmacies with a WDL will be required to meet both the requirements for pharmacies and wholesalers
This will require a number of additional steps
It is advisable to become familiar with the Deregulated Regulation (2016/161)
Not only will pharmacies with a WDL have to abide by the regulations for pharmacies but you will need to abide by the regulations for wholesalers as well.
This will involve numerous different steps and we recommend that you read the Delegated Regulation [2016/161] as soon as possible to ensure that you will be familiar with the rules to adhere to.

23. Who will pay for the additional equipment and training required?
Pharmacies will be responsible for any costs associated with obtaining or updating software and hardware
Total costs unknown
The costs of establishing each database is to be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees.
Pharmacies and wholesalers will be responsible for making their connections to the database, as well as for software upgrades.
The pharmacy negotiating bodies are represented on the UK FMD Working Group and are working hard to ensure there is a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and their suppliers.
The total costs to individual pharmacies is currently unknown but could be up to £1,500 per pharmacy to cover new software/software updates, scanners, additional screens, training

24. Questions