Falsified Medicines Directive (FMD) Dispensing Doctors Association Wednesday 18-Oct-17 Jerome Bertin
Objectives What is FMD all about and when does it need to happen? Who are SecurMed and what is our role in FMD? What is the scope of FMD and who is obliged to comply? What do you need do to prepare for FMD?
Falsified Medicines - What is the problem? 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 substandard 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 2011- 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 MHRA seized 6.2m medicine doses/ medical devices worth 15.8m as part of Operation Pangea June 2015 Herceptin, Spiriva Turbohaler and Kaletra WHO estimated in 2014 that 1% of sales in developed countries could be counterfeit. With approx. 2 billion items dispensed per year in the UK, this would equate to 20 million medicine packs if correct. But where is the evidence?
Safety features added to medicine packs Introduced to enable wholesale distributors (all WDA holders) and those who supply to patients: to verify the authenticity of the medicinal product, to identify individual packs, to verify whether the outer packaging has been tampered with (Anti-Tamper Device check) Marketing Authorisation Holders (MAHs) obliged to add Safety Features on all Prescription Only Medicines (POMs), except excluded POM medicines and included General Supply List (GSL) medicines Anti-tamper Device Unique identifier Data-Matrix Code Randomised serial number Product #: 09876543210982 Batch: A1C2E3G4I5 Expiry: 140531 S/N: 12345AZRQF1
Some labelled packs are already out there FMD requires Prescription Only Medicines (POMs) to be verified/decommissioned Key labelling feature s shown Product Code (GTIN) Batch Number Expiry Date Unique serial number 2D encoded matrix (for scanner) No anti-tamper proofing on these packs Picture taken at Minal Pharmacy, Twickenham, 15-Sep-17
Point of Dispense Verification Required by Delegated Regulation Commissioning Verification Decommissioning
SecurMed UK - NMVO Service A not for profit legal entity to establish and manage the verification system. A joint venture funded by pharmaceutical industry via industry associations Scope governed by Delegated Regulation of Falsified Medicines Directive UK Blueprint Service Provider is Arvato s GmbH Supervised by National Competent Authority (DH/MHRA)
Wholesaler Interface Manufacturer Interface Interface NMVO Scope of Responsibility Manufacturer European Medicines Verification (EMVS) Paralell Parallel Distributor Interface Wholesaler/ Distributor Interface UK MVS UK Medicines Verification (SecurMed MVS) Interface Interface Build and test SecurMed MVS Enable IT providers to create connections On-board wholesale and dispensing users Develop UK NMVO Service Reporting exceptions & compliance to NCAs. Maintain data integrity and security for all users Pharmacy Hospital Other Article 23 Locations Community Pharmacy Hospital Pharmacy Other Dispensing 8
UK FMD Implementation Overview NMVO IT Solution Providers Community Pharmacy UK Medicines Verification (UK MVS) Wholesaler /Distributor to Connections End User to IT Provider Hospital Pharmacy GP Practice /Health Centre End User Registration/ Legitimacy Check SecurMed/Arvato provide IT Provider Solution Developers Kit and User Onboarding IT Solution Providers develop end user solutions encompassing IT system changes, interface to UK MVS, scanners, upgraded IT infrastructure and working practices changes End Users Community Pharmacy Users Wholesaler Users/ Article 23 Hospital Pharmacy Users GP Practice /Health Centre Users Registration Body e.g GPhC, CQC, GMC, PSNI End users verify/ decommission/ dispense medicines in supply chain through to dispense to patients 9
Costs are incurred by all stakeholders Verification system (Hub & national systems) Installation for pack coding Installations for pack verification Pharmaceutical Manufacturer European Hub Parallel Distributor Pharmacy Wholesaler Manufacturers and Marketing Authorisation Holders Manufacturers and Marketing Authorisation Holders Dispensing & Verification Entities e.g. Pharmacies, Hospitals and Wholesalers Each stakeholder pays for costs of own installations. Manufacturers pay for cost of the verification system. SecurMed is funded only for UK system set-up, no-one else.
FMD and Brexit FMD legislation passed into UK law in 2013 (part of Human Medicines Act). Delegated Regulation approved by UK government in 2015. DH MHRA position April 2017 - Until exit negotiations are concluded the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. During this period, the government will continue to negotiate, implement and apply EU legislation, including the Safety Features policy under the Falsified Medicines Directive. The outcome of the exit negotiations will help determine what arrangements will apply once the UK has left the EU, however the government remains committed to providing a regulatory environment which protects health and improves lives. SecurMed UK has been instructed to continue as full member of Europe-wide FMD implementation. SecurMed has sought guidance from Dept of Health/MHRA since the General Election and the direction remains the same. Arvato s appointed on 18-Jul-2017 as UK Blueprint Service Provider.
FMD is a Regulatory requirement Objective: Protection of patients from falsified medicines in the legal distribution chain Delivery: Pan-European system to verify the authenticity of medicinal products 2011 2013 2015 2016 2019 July 2011 Jan 2013 Publication of FMD except FMD Safety Features implemented Oct 2015 Delegated Regulation approved by UK Ministers 9 February 2016 Publication of Delegated Regulation 36 Mon. 2018 (2015+3) Complete Implementation Non-compliance puts supply and sales at risk FMD Go-Live - 09 February 2019
FMD Implementation Scope In FMD Implementation Scope England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man All persons authorized to dispense medicines to the public All pharmacies and healthcare institutions supplying medicines to the public All wholesalers holding Wholesaler Dealer Authorisations Article 3 healthcare institution means a hospital, in- or out-patient clinic or a health centre. Dept of Health have confirmed all GP practices and surgeries are considered healthcare institutions (July 2016). Article 23 persons authorized to supply medicines to the public who do not operate within a healthcare institution or a pharmacy (managed by wholesaler) Dentists, vets, opticians, paramedics, universities/ higher education, prisons, hospices, nursing/ care homes (subject to confirmation by DH/MHRA) Out of FMD implementation scope British Overseas Territories e.g. Gibraltar and Crown Dependencies e.g Bermuda, Falkland Islands, St Helena (subject to MHRA confirmation) All other healthcare organisations e.g Phone/Advice Lines
Size of UK User Community Channel Islands Isle of Man England, Scotland, Wales, Northern Ireland, Channel Islands, Isle of Man 15,000 Community Pharmacies 260 Acute NHS Hospital Trusts 190 Private Hospitals 1,200 Dispensing Doctors 9,800 GP Practices & Surgeries 2,160 Wholesaler/ Dealer Authorisations 200,000+ End Users to be trained 17,000+ Article 23 locations 18,000 Other Locations (Care Homes, etc) 750-1000 Market Authorisation Holders (MHRA & EMA) Ministry of Defence 60+ IT Solution Providers
What happens next? FMD is a regulatory change Dept of Health/MHRA to issue a Public Consultation later this year. Legislation for the Delegated Regulation issued in 2018. Department of Health to initiate GP/Health Centre change programme NHS Digital are aware for NHS England and are setting up a team to support GPs/Health Centres. NHS Services in devolved countries not yet engaged. NHS Digital to advise on when GP IT providers will be engaged. Changes will be needed to IT systems IT system change to enable medicines verification. Scanners to scan medicine packs. Changes to ways of working. Raise awareness this is coming so impact can be assessed and change planned.
Where to get more information? SecurMed UK: www.securmed.org.uk Community Pharmacy FMD: www.fmdsource.co.uk To register for the monthly MHRA FMD Safety Features newsletter please email: fmd.safetyfeatures@mhra.gov.uk with your name, organisation and your title.
Questions?