PMI Hot Topics - FMDLEONIE CLARKE7TH MARCH 2019

© IMVO 2019

Introduction to FMD & IMVO

FMD recap

Directive 2011/62/EU (Falsified Medicines Directive) set out a series of EU-wide measures to tackle growing threat of falsified medicines: Obligatory safety features on outer packaging of medicines

Common, EU-wide logo to identify legal online pharmacies and medicines retailers – register operated in Ireland by PSI

Tougher rules on controls & inspections of producers of active pharmaceutical ingredients

Additional requirements for wholesalers, included extra record-keeping

New requirements came into effect on 9 Feb 2019

Pack with safety features

Unique identifiers – how does process work?

Verification / decommissioning when dispensing to patient & alert if any mismatched/ missing data

PatientPharmaceutical

Manufacturer

Generates Unique Identifiers

Upload toEU Hub

NationalRepository/

System

Pharmacy/ hospitalWholesaler

ProductFlow

Wholesaler

Verification / decommissioning

as required - & an alert if any problems

Authenticate pack

About IMVO

Role is to set up & manage national repository for Ireland

Set up in April 2017 by five organisations involved in medicines supply chain in Ireland

Key tasks: Set-up & run repository – live since April 2018 Ensure full interconnectivity of repository with EU Hub Register & verify credentials of system end-users in Ireland Levy fees on pharma companies to pay for national system Monitor national system & manage alerts

Where are we now?

From here …

Oct 2015

… to here

NationalSystem

Pharmacies / Hospitals

Wholesalers

Pharmaceutical Manufacturer

ParallelDistributor

NationalSystem

NationalSystem

NationalSystem

NationalSystem

NationalSystem

EUHub

‘Use & learn’ phase

► Safety Features Group lead by Department of Health (DoH) & involving HPRA, PSI, IMVO, HSE & Private Hospitals Association has monitored progress in Ireland & across Europe, for last year

► Decision made by Minister for Health in late Jan to go for ‘use & learn’ phase during to:► allow system time to settle► gain greater understanding of alerts and how to manage

them

‘Use & learn’ phase (ctd)

► Officially announced on Tues 4 Feb► Pharmacies, hospitals & wholesalers must scan packs from 9

Feb, but asked to ignore all alerts & supply packs, unless there are overriding concerns they could be falsified

► Alerts from system to be monitored & analysed by IMVO, HPRA, DoH, and protocols developed for their resolution

► Penalties deferred► Situation to be reviewed after 3 months

State of play since 9 Feb

Remaining end-users are getting connected Known issues with EU Hub & some of other national systems

caused significant pressure on EMVS in first 2 weeks Still some bugs in system to be resolved

Many thousands of alerts being received daily Everything generally calm – expected to see technical

issues & lots of alerts ‘Use & learn’ phase has provided breathing space &

ensures patients still get their medicines

End User statistics as at 4 Mar 2019

CategoryLocations

registered with IMVO

Locations connected to

systemCommunity pharmacy locations 1832 (98% of

1874 on PSI list)1740

Hospital locations 101 91

Wholesaler locations 86 73

Other location (private providers of out-patient services)

5 3

No. of packs uploaded to IMVO repository

67.8 million packs as at 6 Mar 2019

Alert Management

Analysis of alerts 9 Feb-4 Mar

Analysis of alerts 9 Feb-4 Mar (ctd)

IMVO activity

► Process for gathering & analysing alert data refined ► Not investigating individual alerts – focus on trends &

unexpected findings► Working closely with HPRA re monitoring plan for use & learn

phase► HPRA now receiving alert emails► Have asked all MAHs to nominate single point of contact

(SPOC) and back-up SPOC for alert handling in Ireland

IMVO Activity (ctd)

IMVO ‘Use and Learn’ Group set up: Objectives:

Gather data about ‘exceptions’ that do not generate alerts

Gather feedback on day-to-day practicalities

Evaluate system and end user behaviour patterns

Participants from all stakeholder groups have been invited – pharmacies, hospitals, wholesalers and MAHs

Sharing of experiences & learnings with other NMVOs & manufacturers at workshops in Brussels and on ongoing basis

Known causes of alerts – end-user scanners/ systems

Scanners not configured correctly - changing upper case to lower case and/or not able to read to ‘negative’ barcodes

Expiry dates being changed by end-user system software so wrong data is sent to national system NB – this is different issue to already known problem of manufacturer

systems changing expiry dates during data upload to EU Hub

Guidance has been issued to IT software providers on how to eliminate these problems

Known causes of alerts – packaging issues

Problems reading barcodes due to lack of ‘quiet zone’ Need approx. 10% clear black or white space around 2D barcode

so it can be read On some packs, human readable data is partially printed in quiet

zone

HPRA will make pharmaceutical assessors aware of need to watch out for this when assessing packaging artwork

Known causes of alerts – end-user behaviour

Examples from other countries: End-users ‘playing’ in live systems using test data

End-users scanning repeatedly if they don’t get ‘right response’

End-users typing linear barcode numbers into manual entry system & adding extra zeros to make up for shorter barcode number

Will need to educate all end-users on how to avoid these errors

Communications

Go live communications

► IMVO took lead on behalf of manufacturer / wholesaler / pharmacy stakeholders in Ireland

► IMVO & DoH issued press releases on 8th Feb► Positive coverage so far in national media &

trade press

Brexit Impact

Brexit impact

► Contract with Solidsoft has multiple Brexit clauses in it, including obligation to ensure repository is established in EU

► Currently assessing if disconnection of UK system from EU Hub will have any impact on joint packs or unlicensed packs from UK

► Lot of MAH changes due to Brexit► New MAH registrations / agreements required► Many MA transfers not completed by 9th Feb, so we are being

flexible re fees

For more information …

► IMVO website www.imvo.ie

► European Commission Q&A on Safety Features – available on FAQ section of IMVO website

HPRA: http://www.hpra.ie/homepage/medicines/special-topics/falsified-medicines-legislation

PSI: https://www.thepsi.ie/gns/Pharmacy_Practice/FalsifiedMedicinesDirective.aspx

European Medicines Verification Organisation (EMVO): https://www.emvo-medicines.eu/

www.imvo.ie