Aileen Bryson MRPharmS Practice and Policy Lead RPS in Scotland - - PowerPoint PPT Presentation

Aileen Bryson MRPharmS Practice and Policy Lead RPS in Scotland

Objectives for this session

• EU rationale for FMD
• The Counterfeit Challenge
• The Delegated Act
• Overview of the proposals
• Brexit
• The timeline
• Questions

World Health Organisation Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products

Recent EU Counterfeits in Legitimate Supply Chain

Falsified Medicines Directive

FMD Overview: Directive

FMD concept for verification

Manufacturers (brands or generics)

European Hub

Parallel traders

National system National system National system National system

Pharmacies Wholesalers Pharmacies Wholesalers Pharmacies Wholesalers Pharmacies Wholesalers

Data uploads Data exchange Verification Authentication Unique Identifiers Unique Identifiers

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Falsified Medicines Directive

Unique identifiers:

A tamper-proof seal and a 2-D barcode containing an identifier that is unique to individual packs. a.Name of manufacturer. b.Drug name.

• c. Common name.

d.Form e.Strength

• f. Pack size and type.

g.Expiry date. h.Batch number

FMDUK: Routes to patients via secondary care

FMD Overview: UK Hub

Work of RPS to date

• Responded to initial concept paper and consultations
• Engaged with EU Commission to amend delegated Act
• Authentication as soon as possible after any IT failure
• 10 day for reverting status
• Split packs allowed
• Recognition of complexity of NHS
• No personal data to be stored in hubs
• Worked with NHS in Brussels
• Developed RPS policy to advocate for additional safety features.
• Participated in UK NMVO stakeholders to guide on professional issues

RPS Falsified medicines Policy 2013

• Enhance Patient safety
• No delay - integrated
• Back up systems
• Protect patient confidentiality

Delegated Act February 2016

• Secondary legislation - detail of the directive
• Healthcare institutions must comply
• Wholesalers will authenticate for some persons and institutions
• Verification “at the time the medicinal product is supplied to the public” (or when it

leaves the EU)

• Possible to revert status under strict criteria
• Same place
• Within 10 days
• Person with same authorisation or entitlement
• Not been supplied to the public
• Expired

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

Authentication

 Checking the Anti Tampering Device – visual  Verification of UI –bar code scanning – can be at any point in the supply chain  Decommissioning – end point – pack is out the system on way to patient

Potential Posit itives of f FMD

• Reduced picking error ?
• Expiry date checks
• Potential for recall systems to be improved
• Patient information embedded

Challenges and is issues

• Cost – who will pay ?
• Training
• Supply across trusts / Wholesale dealing
• Time to scan
• 3rd party ward supply

Falsified Medicines Directive (FMD) timeline

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2011 2013 2015 2016 2019 2024 Directive 2011/62/EU adopted First elements of Directive come in to force (APIs and excipients) EMVO and European Hub established Delegated Regulation 2016/161 published Full requirements

• f Directive start

(scanning) End of non-2D packs (could be earlier) Brexit? 2017 Set up NMVOs/ pick BSPs 2018 FMD pilots FMD

• nboarding

EU logo for online pharmacies starts

Brexit

9th February 2019