1. The EU Falsified Medicines Directive: one year to go
Raj Patel and Gareth Jones

2. Background
“There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. These products usually contain sub-standard or falsified ingredients, or no ingredients, or ingredients (including active substances) in the wrong dosage thus posing an important threat to public health.”
Directive 2011/62/EU, Para 2
Involving nearly 2500 cases, EU Customs seized 27.4 million doses of falsified medicines at EU borders in an almost seven-fold increase from 2007
MHRA seized £8.6m and discovered fraudsters are infiltrating the NHS drugs supply chain and diverting medicines to street drug dealers and illegal websites – May 2014
Herceptin, Spiriva Turbohaler

4. Overview Overview of Falsified Medicines Directive
Potential implications for community pharmacy
EU-wide systems architecture
UK database
UK FMD working group and “how to prepare”

6. Data-matrix and tamper evident seal
Product #:
Batch: A1C2E3G4I5
Expiry:
S/N: AZRQF
Visual inspection of anti-tamper device required
Examples of anti-tamper device:
Ends glued shut
Seals or tear-ff strips over pack closures
Shrink-wraps over packs and bottle necks
Foil-packed products

7. Legislation
Article 25(1) - Persons authorised or entitled to supply medicinal products to the public shall verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public at the time of supplying it to the public.
Article 13(1) - Prevents a reversal of the authentication process after more than 10 days
Article 23 – some exemptions for parts of the supply chain

8. Changes in community pharmacy
A significant change in practice
Hardware and software and on-going operational costs
Training
Data ownership concerns
A significant change in practice
Hardware and software and on-going operational costs
Training
Data ownership concerns

9. Changes in community pharmacy
Visual check of the tamper-evident seal
Scanning and decommissioning all POMs
2D scanners in every pharmacy
Software upgrade
Changing the flow of the dispensing process to incorporate an authentication scan
Setting up a process for MDS and part packs
Not supply products that have not been decommissioned

10. Opportunities Reduce risk of patients receiving counterfeit medicines
Electronic accuracy checking
Expiry date check
Recall check
Improve stock control

11. Challenges Lack of OPD MDS OTCs on the Black List
Limit on reversing decommissioning
Temporary system failure
Products failing to authenticate (false positives)

12. Challenges Cost of authentication Data ownership
Training all pharmacy staff to use the system
Compatible with hub and spoke?
Implementation period

13. So how will this work? Scan medicines on point of entry to pharmacy?
Scan at point of assembly?
Use aggregated bar codes on bags?
Open bags and scan in front of patients?

14. Required by Delegated Regulation

15. Pan-European Structure
National (Blueprint) System
National (Blueprint) System
National System
European Hub
Pharmaceutical Manufacturer
Parallel Distributor
National (Blueprint) System
National System
Replace “National System 2” by “National System n”
Pharmacy
Wholesaler

16. European Medicines Verification Organisation
System set up and governed by stakeholders under supervision of authorities

17. UK Medicines Verification Organisation (SecurMed UK)
System set up and governed by stakeholders under supervision of national competent authorities

18. SecurMed UK Stakeholder-led organisation
NPA, CCA, ABPI, BGMA, HDA, BAEPD
DH and MHRA observers
In the process of appointing a UK database operator

19. UK FMD working group
Chaired by the NPA – 7 community pharmacy bodies (PSNC, CPW, CPS, CPNI, CCA, AIM)
On-going engagement with the DH and MHRA
Published the “Way Forward” document

20. Progress
New scanners, updated SOPs, staff training, patient awareness, procedures for dealing with packs that do not authenticate, funding
UK FMD repository, development of FMD-compliant software, sector awareness, clarity on enforcement, confirmation of flexibilities
EU hub
Progress to date – a huge amount still to do.
Many elements are behind

21. 29th March 2019?
Brexit due to take place 7 weeks after FMD is implemented
UK govt position is that we must implement FMD
No information on what happens 7 weeks later
But UK govt desire to stay in UK drug regulatory system
However, EU may not agree to this request and UK may be forced out of FMD at this point
UK govt would then move to introduce a separate local form of FMD

22. How to prepare Brief guide Webinar www.fmdsource.co.uk
Talk to PMR providers
Think about process changes
Look out for further advice from the NPA