EU Falsified Medicines Directive. Gareth Jones

Transcription

1 EU Falsified Medicines Directive Gareth Jones

2 Why is it important to NPA Members? Will require new processes within community pharmacy from Feb 2019 (barcode scan and tamper check) Requires new IT systems May affect dispensary flow Data security issues Costs for process transformation, new hardware/software and labour

3 EU FMD EU Directive Delegated Acts System Opportunities and challenges Working groups What will be the impact of Brexit?

4 The EU Directive Stronger controls on the export of active pharmaceutical ingredients Stricter rules for inspections Greater transparency of agents involved in the distribution chain Measures in relation to internet pharmacy

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6 The EU Directive Authentication Unique identifier for every pack Unique identifier placed into a repository Unique identifier checked out prior to supply to the patient Tamper evident packaging

7 The Directive vs Delegated Acts What Does the Directive Mandate? Safety features that enable relevant persons to verify authenticity identify individual packs Tamper evidence Rx included, all OTCs excluded Some exceptions based on a risk assessment Govts can use the system for reimbursement and/or pharmacovigilance purposes MAHs will pay for the repositories systems What Will Be Decided by Delegated Acts? Characteristics & technical specifications of the unique identifier Criteria for the risk assessments & process for notification of products included Extent and modalities of verification of the safety features to ensure the verification of authenticity of each dispensed pack Establishment (including accessibility) of the repositories

8 Delegated Act Delegated Act became EU Law on 9 th February 2016 Compliance at member state level will be required on 9 th February 2019

9 The final Delegated Act

10 The final Delegated Act All POMs will display a data matrix and have a tamper evident seal Pharmacies will connect to a stakeholderrun database to decommission unique serial numbers

11 Delegated Acts As a general rule: POMs are in scope OTCs are out of scope White list POMs that are out of scope (rare exceptions for a few specialist products) Black list OTCs that are in scope (eg, omeprazole)

12 Delegated Acts Four key data elements: 14 digit Manufacturer Product Code Randomised Unique Serial Number Expiry Date Batch Number Product #: (01) Batch: (10)A1C2E3G4I5 Expiry: (17) S/N: (21)12345AZRQF

13 The final Delegated Act 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.

14 The final Delegated Act Also prevents a reversal of the authentication process after more than 10 days Healthcare institutions benefit from some derogations Omeprazole 20mg and 40mg will require the safety features, even when supplied without a prescription

15 System Pharmaceutical Manufacturer Product Flow Wholesaler Wholesaler Pharmacist Patient Unique Serialisation with Random Numbers 2D Data Matrix Code on 2 nd Pack Random Verification Verification upon Dispense to Patient Upload Number GTIN Batch Expiry S/N Medicines Verification Repository Authenticate Number

16 Repositories Pharmaceutical Manufacturer European Hub Parallel Distributor National System 1 National System n National Blueprint System 1 National Blueprint System n Pharmacy Wholesaler Pharmacy Wholesaler Wholesaler Pharmacy Wholesaler Pharmacy

17 UK implementation opportunities Electronic accuracy checking Expiry date check Recall check Improve stock control

18 UK implementation challenges Lack of OPD MDS (POMs on the White List) OTCs on the Black List Limit on reversing authentication Temporary system failure

19 UK implementation challenges False positives Multiple dispensing outlets Hospitals Cost of authentication Access to dispensing data Compatible with hub and spoke?

20 EMVO Body established to run the EU Hub PGEU holds the Presidency of this organisation Solidsoft has been engaged to provide the hub

21 UKMVO (SecurMed UK) Stakeholder group involving NPA, CCA, ABPI, BGMA, BAEPD and HDA Marketing authorisation holders must fund the database all stakeholders will share the costs of the governance mechanism NPA and CCA Currently selecting UK provider

22 UK FMD working group Representatives of AIMp, CCA and NPA Engaged with PMR suppliers and DH/MHRA over interpretation of regulations Five workstreams established: Comms/PR, IT, Costings, Operational, Repository

23 DH/MHRA FMD Implementation Group Government-led Committee set up to consider the practicalities of implementing FMD in the UK

24 Impact of Brexit?

25 Questions?

26 Hub and Spoke

27 DH proposal Amend s10(1) of the Medicines Act 1968 Enable inter-company Hub and Spoke arrangements create a level playing field

28 DH proposal Part of the DH narrative on efficiencies referred to repeatedly at Parliamentary meeting by the Minister and Chief Pharmaceutical Officer

29 DH proposal impact assessment 45% of medicines will be dispensed in hub and spoke arrangements within 3 years 10% reduction in pharmacist labour costs in spokes

30 DH proposal impact assessment For every job lost in the spoke, 0.4WTE will be created in the hub

31 DH proposal impact assessment Capital investment costs excluded from the calculations

32 NPA Hub and Spoke T&F Group Manchester University literature review Over 400 members responded to survey Visit to an automated hub Interview 20 experts Legal opinion from a QC Members of group from NPA, PSNC and PV

33 Capacity Benefits Some opportunity to support capacity release to deliver other services No evidence that there are cash savings within pharmacies

34 More efficient? Can t reduce staffing in a typical independent you can redeploy capacity Reducing staff can be counterproductive and potentially less safe Hub service fee Replication of process Accuracy check in spoke FMD check in spoke

35 Ineligible lines Barriers More efficient? Lack of original pack dispensing Low level of repeat dispensing Reduce stock levels? Resilience? Can MDS packs be done within intercompany Hub and Spoke?

36 Safer? Misleading to portray this as a case of humans versus machines Existing error rate is low FMD authentication process may deliver the safety benefit without automated dispensing New opportunities for error

37 Impact on competition & procurement Risk of a duopoly due to barriers to entry DTP / restricted wholesaler schemes Investment Infrastructure Risk to short-liners Reducing amount of business open to shortliners, challenge to reach critical mass Risk to the tax-payer

38 Barriers EU Falsified Medicines Directive Accuracy check requirement DTP/limited wholesaler schemes Lack of competition between hubs

39 Enablers Original pack dispensing Electronic Repeat Dispensing New service commitment, eg, Pharmacy First Public specification for hubs

40 Enablers Fair contractual arrangements GPhC recognition of the additional risks involved within inter-company hub and spoke

41 Summary DH document shows a complete lack of understanding of the issues This politically driven proposal, as currently framed, can not deliver the promised level playing field DH needs to go back to the drawing board