introduction to fmd
play

Introduction to FMD Implementing the EU Falsified Medicines - PowerPoint PPT Presentation

Oct 23, 2023 •204 likes •604 views

Introduction to FMD Implementing the EU Falsified Medicines Directive in the UK Alastair Buxton Director of NHS Services PSNC 6th September 2018 Falsified medicines a real problem The Pharmaceutical Journal, 5 th June 2014 2 Why we need a

  1. Introduction to FMD Implementing the EU Falsified Medicines Directive in the UK Alastair Buxton Director of NHS Services PSNC 6th September 2018

  2. Falsified medicines – a real problem The Pharmaceutical Journal, 5 th June 2014 2

  3. Why we need a Directive • Falsified products still being found in legitimate medicines supply chain – major risk to patient safety • Failure to address falsification could put trust in our entire industry at risk • Up to half of medicines purchased online believed to be falsified – action taken to improve security of legitimate internet pharmacies • Stronger controls now over raw materials and products manufactured under contract outside EU

  4. FMD overview and timeline

  5. Falsified Medicines – what’s the solution? “Safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.” Directive 2011/62/EU, Para 11 • All packs of almost all prescription medicines will have to have two safety features: • Visual tamper-evident seals or packaging • Unique identifiers (serial numbers) in a 2D barcode • Authenticity is checked in two ways: • Visual inspection of the tamper-evident features • Scanning and checking unique identifiers against databases (“repositories”) at EU and national levels 5

  6. FMD and safety features Anti- Safety Unique tampering features Identifier device “Medicinal products subject to prescription shall bear safety features on their packaging” FMD Delegated Regulation 2016/161, Article 2 6

  7. FMD concept for verification Unique Unique Identifiers Identifiers Manufacturers Parallel traders (brands or generics) European Hub National National system system National system National Pharmacies Wholesalers system Wholesalers Pharmacies Pharmacies Wholesalers Pharmacies Wholesalers Data uploads Data exchange Verification Authentication 7

  8. Falsified Medicines Directive (FMD) timeline Directive First elements of EMVO and 2011/62/EU Directive come in to European Hub EU logo for online adopted force (APIs and established pharmacies starts excipients) 2011 2013 2015 Delegated Set up Regulation NMVOs/ Full requirements End of non-2D 2016/161 pick BSPs of Directive start packs (could be FMD published (scanning) earlier) pilots 2019 2016 2017 2018 2024 FMD Brexit? onboarding 8

  9. 9

  10. FMD Delegated Regulation – key questions answered

  11. FMD – key questions answered Who is involved? You are “ 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 .” Delegated Regulation 2016/161, Article 25(1) 11

  12. FMD – key questions answered What is included? Everything “ This Regulation applies to: medicinal products subject to prescription … unless included in the list set out in Annex 1; medicinal products not subject to prescription included in the list set out in Annex 2” Delegated Regulation 2016/161, Article 2(1) 12

  13. FMD – key questions answered When does it start? Very soon “ This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from Saturday 9 th February 2019 .” Delegated Regulation 2016/161, Article 50 13

  14. FMD – key questions answered Will I have to pay for it? In part “ The costs of the repositories system shall be borne by the manufacturers of medicinal products bearing the safety features.” “ The repositories system shall not include the physical scanning equipment used for reading the unique identifier.” Draft Delegated Regulation, Articles 31(5) and 32(4) PSNC is assessing the costs (implementation and ongoing) to discuss with DHSC 14

  15. FMD – key questions answered Can we opt out? No? “ This Regulation shall be binding in its entirety and directly applicable in all Member States .” Delegated Regulation 2016/161, Article 50 15

  16. FMD Delegated Regulation – what do you have to do?

  17. FMD – requirements for manufacturers • Delegated Regulation requires manufacturers to: • Put safety features (tamper-evident and unique identifier) on almost all prescription medicines • Encode unique identifier in 2D barcode meeting certain standards • Print 2D barcodes and certain details on all relevant packs • Upload unique identifiers into repositories system (consisting of European hub and national repositories) • Set up and pay for the repositories system via non-profit legal entities • Report any suspected incidents of tampering or falsification • Decommission certain products • Notify repositories of any recalled, withdrawn or stolen products 17

  18. FMD – requirements for wholesalers • Delegated Regulation requires wholesalers to: • Verify authenticity of any returns and products not bought directly from manufacturers or their contracted distributors • Decommission identifiers of products being exported, withdrawn, destroyed or taken as samples • Decommission products being supplied to public by other routes (i.e. not via pharmacy, dispensing doctors or hospitals) • Not distribute or supply decommissioned products (other than those they are required to decommission for others) • Notify authorities of any suspected incidents of tampering or falsification [Note: also applies to pharmacies who hold wholesale licences] 18

  19. FMD – requirements for pharmacies • Delegated Regulation requires pharmacies to: • Verify the authenticity of products (checking tamper-evident and unique identifiers) and then decommission identifiers “at the time of supplying it to the public” • Only be able to revert decommissioned products (undispense) within 10 days of the original dispensing • Decommission products that cannot be returned to wholesalers or manufacturers or which are taken as samples • Not to supply decommissioned products (other than those they decommission themselves as part of dispensing) • If technical problems prevent authentication, to record unique identifiers and then verify and decommission when possible • Notify authorities of any suspected incidents of tampering or falsification 19

  20. The journey of a patient pack

  22. Potential benefits from FMD (beyond identification of falsified medicines)

  23. FMD – potential benefits Patient safety benefits • Accuracy and date checking made easier • Impact on indemnity costs? Pharmacy stock benefits • Accurate pack-level data for all products Patient information benefits • Able to generate patient-specific information 23

  24. FMD implementation – key players

  25. European Stakeholder Model and EMVO Research -led Generics Parallel Wholesalers Pharmacies manufacturers manufacturers distributors NMVO NMVO NMVO NMVO NMVO 25

  26. SecurMed UK – the UK’s NMVO Research -led Generics Parallel Wholesalers Pharmacies manufacturers manufacturers distributors ABPI HDA BGMA BAEPD NPA/CCA National Medicines Verification System Manufacturers Wholesalers Pharmacies Hospitals GP surgeries 26

  27. UK FMD Working Group for Community Pharmacy Pharmacy contractor associations Pharmacy negotiating bodies NPA AIM CCA PSNC CPNI CPS CPW • Representing contractors’ interests to DH/MHRA • Process mapping and options development • Establishing FMD Source as trusted FMD resource • Bringing suppliers and IT providers together 27

  28. FMD Implementation Advisory Board Health Ministers FMD Implementation Ministerial Advisory Board Wholesale Pharmacy Private Ambulances NHS Digital hospitals NHS Trusts Prisons Manufacturers Distributors Other Devolved GPs healthcare SecurMed UK Administrations • Established by DHSC/MHRA to advise Health Ministers • Brings together all those involved with implementing FMD • Many working groups established • Leading to Impact Assessment and formal consultation 28

  29. Implementing FMD – what happens next?

  30. FMD timeline for the UK Delegated Directive UK bodies EMVO and Regulation 2011/62/EU participating in ESM European Hub 2016/161 adopted discussions established published 2016 2011 2014 UK BSP FMD pilots decision start in UK Full requirements IT system SecurMed UK of Directive start upgrades DH/MHRA established (scanning) consultation 2016 2017 2018 2019 All parties FMD stock starts EU referendum Brexit? connected to appear to NMVS 30

  31. What about Brexit? • The UK’s decision to leave the European Union adds an extra layer of confusion and complexity • In theory, the Delegated Regulation will be incorporated in to UK legislation under EU (Withdrawal) Bill • UK progress on implementation has been heavily delayed • Lack of clarity about what happens afterwards and whether UK would “inside” FMD and connected to EMVS • Clear patient safety risks if UK is outside FMD • Expect a UK solution will be developed if we can’t access the European system 31

Recommend

INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION

INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION

TRAINING COURSE ON SOCIAL PROTECTION & FORMALIZATION TRINIDAD AND TOBAGO MARCH 15, 2017 INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION INTRODUCTION Design of the NIS Assistance from the

547 views • 23 slides
INTRODUCTION Introduction 2/42 INTRODUCTION Alternations I am giving bread to the

INTRODUCTION Introduction 2/42 INTRODUCTION Alternations I am giving bread to the

Patterns of variation in the expression of case and agreement Andrs Brny Leiden University Centre for Linguistics 9 November 2019, BaSIS Workshop a.barany@hum.leidenuniv.nl INTRODUCTION Introduction 2/42 INTRODUCTION

1.37k views • 42 slides
Introduction Introduction Introduction Introduction Outline Motivation Failures

Introduction Introduction Introduction Introduction Outline Motivation Failures

Introduction Introduction Introduction Introduction Outline Motivation Failures Definition and concepts Process and product properties Principles SE Approaches Motivation Software and the economy The economies of

1.03k views • 49 slides
Introduction Introduction Introduction Nationwide Cause for Concern 1

Introduction Introduction Introduction Nationwide Cause for Concern 1

Introduction Introduction Introduction Nationwide Cause for Concern 1 https://www.cdc.gov/std/stats17/infographic.htm Introduction Epidemiology in Western Colorado CPHE Surveillance Data Report, May 2018 Chlamydia Epidemiology in Western

977 views • 39 slides
DAQ introduction Purpose of this talk : (1) Introduction for those who have not been in every

DAQ introduction Purpose of this talk : (1) Introduction for those who have not been in every

DAQ introduction Purpose of this talk : (1) Introduction for those who have not been in every meeting (2) Some ideas of diagrams for section 7.1 (Introduction) of TP. Giles Barr 25 Jan 2018, Pembroke College On DUNE, the reality is there is a

474 views • 10 slides
INTRODUCTION cf. Schneider, Chapter 1 INTRODUCTION THEY ARE OUT TO GET YOU INTRODUCTION WHAT

INTRODUCTION cf. Schneider, Chapter 1 INTRODUCTION THEY ARE OUT TO GET YOU INTRODUCTION WHAT

ADVANCED COMPUTER SECURITY INTRODUCTION cf. Schneider, Chapter 1 INTRODUCTION THEY ARE OUT TO GET YOU INTRODUCTION WHAT IS SECURITY? A systems security policies describe What the system is supposed to do Store and provide access

479 views • 16 slides
Overview Introduction to SMIL Introduction to W3C and XML Introduction to SMIL

Overview Introduction to SMIL Introduction to W3C and XML Introduction to SMIL

Overview Introduction to SMIL Introduction to W3C and XML Introduction to SMIL Writing a SMIL file Adding Media Objects Martin Halvey Clipping media files January 2008 Timing and Synchronising Layout World Wide

387 views • 14 slides
14 Introduction Introduction Bad guys can put malware into Example: hosts

14 Introduction Introduction Bad guys can put malware into Example: hosts

Introduction Introduction source Encapsulation ISO/OSI reference model message M application segment H t H t M transport network datagram H n H n H t M presentation: allow applications to frame link H l H n H t M interpret

583 views • 4 slides
Previous Lecture Introduction to SMIL 2 Introduction to W3C and XML Introduction to SMIL

Previous Lecture Introduction to SMIL 2 Introduction to W3C and XML Introduction to SMIL

Previous Lecture Introduction to SMIL 2 Introduction to W3C and XML Introduction to SMIL Writing a SMIL file Adding Media Objects Martin Halvey Clipping media files January 2008 Timing and Synchronising Layout

322 views • 8 slides
Lecture 1 Andreas Habegger Introduction Zynq Introduction Zynq Introduction Zynq PS vs. PL

Lecture 1 Andreas Habegger Introduction Zynq Introduction Zynq Introduction Zynq PS vs. PL

Introduction Zynq Lecture 1 Andreas Habegger Introduction Zynq Introduction Zynq Introduction Zynq PS vs. PL Processing System Processor Peripherals Data Buses AXI Bus Conclusion BTE5380 - Embedded Systems Octobre 2014 Andreas Habegger

1.81k views • 30 slides
2018.06 01 SMILE5 Introduction S E 5 02 Alpha Cloud M I L 03 Company Introduction 04

2018.06 01 SMILE5 Introduction S E 5 02 Alpha Cloud M I L 03 Company Introduction 04

2018.06 01 SMILE5 Introduction S E 5 02 Alpha Cloud M I L 03 Company Introduction 04 Project References S E 5 PART.1 SMILE5 Introduction M I L Introduction STORION-SMILE5 Residential Energy Storage System Inverter 5kW Output Input

1.06k views • 25 slides
Introduction to CICS Course introduction Course introduction What is CICS? What is an

Introduction to CICS Course introduction Course introduction What is CICS? What is an

Introduction to CICS Course introduction Course introduction What is CICS? What is an application server? Why use an application server? Course introduction Services provided by CICS How CICS applications are defined Scaling CICS to meet

1.84k views • 146 slides
Network Visualization Introduction Presented by Shahed Introduction Introduction Basic

Network Visualization Introduction Presented by Shahed Introduction Introduction Basic

Network Visualization Introduction Presented by Shahed Introduction Introduction Basic building blocks Node Links (relationship between nodes) Spatial information Network data

584 views • 9 slides
Introduction Introduction (1) Main argument of the paper: universities are not only

Introduction Introduction (1) Main argument of the paper: universities are not only

Le jugement des pairs comme outil de management des universits Peer-review as a management tool Christine Musselin (CSO, Sciences Po et CNRS) Avril 2013, Lirrsistible ascension du capitalisme acadmique Introduction Introduction (1)

590 views • 28 slides
Introduction Introduction to storage and to storage and filesystems filesystems Introduction

Introduction Introduction to storage and to storage and filesystems filesystems Introduction

Moreno Baricevic Gilberto Daz Axel Kohlmeyer Stefano Cozzini ULA ICTP CNR-IOM DEMOCRITOS Merida, VENEZUELA Trieste, ITALY Trieste, ITALY Introduction Introduction to storage and to storage and filesystems filesystems Introduction

1.19k views • 51 slides
JABLOTRON JA-100 introduction November 2011 Introduction Todays goals First introduction of

JABLOTRON JA-100 introduction November 2011 Introduction Todays goals First introduction of

JABLOTRON JA-100 introduction November 2011 Introduction Todays goals First introduction of the brand new JA-100 alarm system Visions Basic architecture System components Setting Help us with final validations You are the FIRST ones

1.69k views • 111 slides
1 Introduction Introduction Communication System Baseband an adjective that describes

1 Introduction Introduction Communication System Baseband an adjective that describes

Introduction Introduction Physical Layer Mobile network Global ISP Provides the means to transmit bits Basic Concepts of from sender to receiver, Data Transmission Defines the mechanical, electrical, and Home network timing

463 views • 7 slides
Welcome! Todays Agenda: Topic Introduction Course Introduction Team Practical

Welcome! Todays Agenda: Topic Introduction Course Introduction Team Practical

INFOGR Computer Graphics Jacco Bikker - April-July 2015 - Lecture 1: Introduction Welcome! Todays Agenda: Topic Introduction Course Introduction Team Practical Details Assignments Field Study State of

869 views • 62 slides
Introduction (00) RNDr. Martin Madaras, PhD. madaras@skeletex.xyz Introduction Introduction

Introduction (00) RNDr. Martin Madaras, PhD. madaras@skeletex.xyz Introduction Introduction

Virtual and Augmented Reality Introduction (00) RNDr. Martin Madaras, PhD. madaras@skeletex.xyz Introduction Introduction Who am I? What do I do here? 2 About me Short research bio: - 2014 - finished PhD at FMFI UK - 2014 2016 -

1.3k views • 39 slides
PRESENTATION The Introduction What is the Introduction ? The introduction prepares the audience

PRESENTATION The Introduction What is the Introduction ? The introduction prepares the audience

PRESENTATION The Introduction What is the Introduction ? The introduction prepares the audience for your presentation. It tells them what your presentation is about, why it is important, and finally, what to listen for in your speech. Get the

505 views • 3 slides
How to make a presentation with L A T EX? Introduction to L A T EX Introduction to Beamer

How to make a presentation with L A T EX? Introduction to L A T EX Introduction to Beamer

Introduction to Beamer Hafida Benhidour How to make a presentation with L A T EX? Introduction to L A T EX Introduction to Beamer Introduction to Beamer Hafida Benhidour Department of computer science King Saud University November

732 views • 49 slides
Shenzhen Cuilu jewelry Co., Ltd was founded in 1996 and its a large private enterprise

Shenzhen Cuilu jewelry Co., Ltd was founded in 1996 and its a large private enterprise

Introduction Introduction - - Brief Brief Introduction Introduction of of Cuilu Cuilu Group Group Introduction Introduction - - Brief Brief Introduction Introduction of of Cuilu Cuilu Group Group Shenzhen Cuilu jewelry Co., Ltd

147 views • 14 slides
Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org

Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org

V olunteer C ommunications N etwork (V-C-N.org) Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org Academy Course - 2012-02.24-2208 262: Introduction to ICS-214 : V-C-N.org : Slide: 1 V olunteer C

735 views • 34 slides
Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org

Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org

V olunteer C ommunications N etwork (V-C-N.org) Introduction to ICS- -214 214 Introduction to ICS Official Unit / Incident Log - A V-C-N.org Academy Course - 2012-02.24-2208 262: Introduction to ICS-214 : V-C-N.org : Slide: 1 V olunteer C

558 views • 18 slides

More recommend