Digital Medicines. FMD in England - Challenges and opportunities in pharmacy

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1 Digital Medicines FMD in England - Challenges and opportunities in pharmacy Andrew Davies for Keith Farrar, Senior Responsible Owner Digital Medicines 22 nd November 2017

2 Falsified medicines and the Falsified Medicines Directive Falsified medicines are; Fake medicines that pass themselves off as real, authorised medicines Might contain ingredients, including active ingredients, which are not of a pharmaceutical grade or incorrect strength or indeed may contain no active ingredient. Seen by the EU as a major threat to public health with seizures by regulators increasing annually across the globe. The Falsified Medicines Directive [FMD] (Directive 2011/62/EU) specifies a range of safety measures to ensure that Prescription Only Medicines in the EU are safe and that the trade in medicines is properly controlled. Its aim was to significantly reduce the risk of counterfeit medicines reaching patients. FMD applies to ALL prescription only medicines &; Organisations supplying medicines these medicines, (Manufacturers & Pharmacy Wholesalers). Healthcare Institutions supplying medicines to patients (Community Pharmacies, Hospital Pharmacies and Dispensing Doctors). Exclusions (ref. Article 23) include dentists, opticians, paramedics, prisons, hospices and nursing homes. FMD requires Prescription Only Medicines (POMs) to be verified / decommissioned.

3 The Delegated Regulation (EU) 2016/161 Published on 9 February 2016 implementation, EU wide from 9 th February 2019 "laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use": Anti-tamper device (ATD) Unique identifier (UI) 3

4 Roles and responsibilities Department of Health & MHRA The National Competent Authority (NCA) SecurMed Not-for-profit legal entity for the UK National Medicines Certification Organisation Set up to establish and manage the verification system Funding by the pharmaceutical industry Supervised by the NCA Arvato Bertelsmann Awarded the contract to build and operate the UK National Medicine Verification System (NMVS) Arvato Systems, HQ in Germany, >3000 employees, 425M revenue Implementing the NMVS in 13 countries 4

5 How does it work? 5

6 Potential opportunities

7 Potential opportunities Better and more efficient medicines data secondary uses Track & Trace items For automated stock Control, recalls etc Improve management of products in relation to expiry date FMD barcode Homecare recharging Support electronic Controlled Drug registers Scanners enable further innovation e.g. patient enablement Closed loop checking 7

8 Challenges Scale and timescales More than 20,000 sites impacted with Directive implementation date of 9 February 2019 (Training, hardware, software changes) Linking the product identifier to the product descriptor The product identifier (GTIN) needs to be reliably associated with the drug name (ideally dm+d) within systems from a reliable, central source

9 Challenges Scale and timescales More than 20,000 sites impacted with Directive implementation date of 9 February 2019 (Training, hardware, software changes) Linking the product identifier to the product descriptor The product identifier (GTIN) needs to be reliably associated with the drug name (ideally dm+d) within systems from a reliable, central source Scanning a barcode & decommissioning takes a finite amount of time and frequent repetition means this time could increment to a significant extent Ensuring the benefits of the scan are available will save more time that the scan requires Management of bulk supply poses challenges Some of these would be addressed by the use of automation & software solutions (when available). A mechanism to facilitate mass barcode decommissioning.

10 Current status Intention to proceed with FMD implementation in spite of Brexit. SecurMed are leading a series of system supplier engagement sessions. Series of FAQs to be issued next week for secondary care. NHS Digital are working alongside DH, MHRA and SecurMed to scope out the end to end implementation of FMD and gain greater understanding of business change implications.

11 Benefits of Data, data, data! E-Prescribing & Medicines Administration Monthly medicines spend data Medicines (& Pharmacy) CIP s Reference costs Clinical outcomes from Medicines = Medicines Optimisation Costing Transformation Programme Research Genomics/personalised medicine =GS1?