falsified medicines

842019 Falsified Medicines

httpslidepdfcomreaderfullfalsified-medicines 118

copyAegate Ltd 2011 All rights reservedISOIEC 270012005

Certificate No IS 567140

Addressing the European Legislation for

falsified medicines

Alison Williams Vice President Aegate

Confidential



copyAegate Ltd 2011 All rights reserved

Discussion topics

Introductions and context of our discussion today

Requirements of the new European Directive for falsified medicines and its

impact on dispensing practice

Introduction to Aegatersquos authentication system and the additional benefits

for pharmacy practice and patient care eg New pharmacovigilance

directive patient compliance

Timings for these new Directives in Croatia

27-May-112 Confidential




Falsified Medicines a growing and dangerous problem

The Pharmaceutical Security Instituterecorded 196 cases of counterfeits in 2002By 2009 there had been a ten-fold increase to2003

The EU Commission estimates the rate of counterfeit medicines in the legal supplychain are growing at 10-20 per annum

The profile of medicines that are targeted ischanging

From lifestyle to life-saving drugshellipillegalto legal supply chain

Charts courtesy of PSI





The type of products that are targeted are unpredictable

Toothpaste

euro624

Needles

Inhaler





New EU legislation for falsified medicines

Mandatory safety features shall allow wholesale distributors pharmacists andpersons authorised to supply medicinal products to the public to

Identify individual packs by use of a unique number affixed to eachsupplied pack of medicine

Verify authenticity Verify whether the outer packaging has been tampered with

Member states must have a system in place to enable recalls to occur topatient level within 24 hours of a recall taking place

To ensure no weaknesses occur between member states Safety features formedicinal products should be harmonised in the EU





Medicines authentication

6

Patient

Pharmacist (or wholesaler)authenticates unique code atthe time of dispensing by

checking the numberagainst the database

Unique code placed onthe pack before

distribution and thenumber filed in the

databasePatient

ultimately knows thepack is

genuine andnot recalled

Each serialisation number is decommissioned when it leavesthe point of dispensing This way copies are detected

Less than half a second

Database

ldquoCounting offrdquo the unique number contained on the individualpack the unique number can only be valid once


httpslidepdfcomreaderfullfalsified-medicines 718copyAegate Ltd 2011 All rights reserved

Recovery of counterfeit medicines is essential (only asmall proportion are ever recovered)

30000 of the 70000 batches of counterfeit medicines remain unaccountedfor ndash it is not known if they were consumed (MHRA comment in 2009 relatingto counterfeits in 2007)

In 2006 fake lipitor was detected but resulted in only seven packs beingrecovered out of 1867 that reached the supply chain

In 2005 2523 packs of fake Lipitor were recalled only 359 of those packs

were recovered




Authentication of the unique identity closes the loop

The process of authentication at the pointof dispense cancels the unique identity

As a result any copies that appear in themarket will be detected

Verification within the wholesaleenvironment permits sample checking

or returned goods to be checked




An authentication system makes the following checks

Every time a pack is dispensed we check the product is-

Not a copy

ie a serialisation number that we have already read

Not suspicious

ie a pack with no number or the wrong number placed on the wrongbatch

Not recalled

Not expired

Not short expiry

If there appears to be a problem we immediately inform the pharmacistbefore issuing the pack




In Europe Aegate have

Completed installations with 30 different pharmacy software systems which

represent 40000 of Europersquos 160000 pharmacies

Installed systems into pharmacies in four countries operating in 5 different

languages

Currently we are scanning more than 28 million packs per month

Tested a verification system in a first wholesaler (in Belgium)




Aegatersquos Authentication Service

In 2010 in Europe we-

Alerted the pharmacist to 55759 recalled packs which were

identified before dispensing

Alerted the pharmacist to check the batch numbers of a further

155523 packs that may be recalled

Altered the pharmacist to 3282 expired packs

Informed the pharmacist of 6907 packs that were short expiry

Investigated with the regulatory authorities and manufacturers two

incidents of suspicious packs




Governance is an important aspect of the system

We provide secure portals for the regulator and the national pharmacyassociation to add recall notices and regulatory notices to the system

Pharmacists maintain ownership of data generated by the system Aegate

has a written agreement with every pharmacy as well as the national

pharmacy association and pharmacy software providers

Aegatersquos security management system is operated to ISO 270001

Independently validated that the system is robust External Audit 2008




We also provide a portal for national pharmacyassociations

To add information that supports pharmacy practice

Pharmacovigilance

Recalls (instructions)

Regulatory changes

Past Expiry date or soon to expire

Pharmacy practice advice

Patient advice

Disease monitoring eg flu

Adherence to treatments




Pack or tablet changes communicated with visual images

Images canalso be used tosupportcounterfeit

detection




Treatment reminders via SMS

27-May-1115

Both the pharmacist and the patient benefit

Confidential



93 Pharmacists have access to Aegatersquos system 52 arevoluntarily participating

This is currently avoluntary system

The PharmacyAssociation havesecure access toinput recalls and

other safetyinformation

15 million packsauthenticated perday

Less than half asecond responsetime




Implementation of the EU Directive Timings

From the date of official publication (May 27th 2011 approval in EU Council )

November 2012 (18 months plus 1 day after publication) member states mustadopt the legislation into their local legislation

May 2013 articles relating to control of imports and exports and activesubstances must be implemented

Following the delegated acts member states must implement

Within 12 months controls relating to internet pharmacy and an EU logo

Within 36 months unique identification authentication and tamperevidence




Implementation of the EU Directive Other

A Member State may use the information contained in therepositories system for the purposes of reimbursementpharmacovigilance or pharmaco-epidemiology

The time to implementation for the pharmacovigilance directive is 18

months from the date of official publication (June 2011)

The costs for the repositories system shall be borne by themanufacturing authorisation holders of medicinal products that bearthe safety features





Discussion topics

Introductions and context of our discussion today

Requirements of the new European Directive for falsified medicines and its

impact on dispensing practice

Introduction to Aegatersquos authentication system and the additional benefits

for pharmacy practice and patient care eg New pharmacovigilance

directive patient compliance

Timings for these new Directives in Croatia
















Toothpaste

euro624

Needles

Inhaler
















6

Patient





databasePatient





Database








were recovered














Not a copy


Not suspicious


Not recalled

Not expired

Not short expiry









languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential










































Toothpaste

euro624

Needles

Inhaler
















6

Patient





databasePatient





Database








were recovered














Not a copy


Not suspicious


Not recalled

Not expired

Not short expiry









languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential










































6

Patient





databasePatient





Database








were recovered














Not a copy


Not suspicious


Not recalled

Not expired

Not short expiry









languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential


































were recovered














Not a copy


Not suspicious


Not recalled

Not expired

Not short expiry









languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential








































Not a copy


Not suspicious


Not recalled

Not expired

Not short expiry









languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential


































languages































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential























































Pharmacovigilance


Regulatory changes



Patient advice








detection





27-May-1115


Confidential
































detection





27-May-1115


Confidential































27-May-1115


Confidential




























falsified medicines

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