Addressing the European Legislation for falsified medicines

Alison Williams, Vice President , Aegate

ISO/IEC 27001:2005 Certificate No: IS 567140

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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 Aegates authentication system and the additional benefits

for pharmacy practice and patient care; e.g. New pharmacovigilance

directive, patient compliance

Timings for these new Directives in Croatia

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Falsified Medicines; a growing and dangerous problem

The Pharmaceutical Security Institute recorded 196 cases of counterfeits in 2002. By 2009 there had been a ten-fold increase to 2003

The EU Commission estimates the rate of counterfeit medicines in the legal supply chain, are growing at 10-20% per annum.

The profile of medicines that are targeted is changing

From lifestyle to life-saving drugsillegal

to legal supply chain

Charts courtesy of PSI

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The type of products that are targeted are unpredictable

6.24 Needles Toothpaste

Inhaler

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New EU legislation for falsified medicines

Mandatory safety features shall allow wholesale distributors, pharmacists and persons authorised to supply medicinal products to the public to:
Identify individual packs by use of a unique number affixed to each

supplied 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 to patient level within 24 hours of a recall taking place.

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

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Medicines authentication
Pharmacist (or wholesaler) authenticates unique code at the time of dispensing by checking the number against the database Patient

Unique code placed on the pack before distribution and the number filed in the database

Database

Patient ultimately knows the pack is genuine and not recalled

Less than half a second

Each serialisation number is decommissioned when it leaves the point of dispensing. This way copies are detected.

Counting off the unique number contained on the individual pack, the unique number can only be valid once.
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Recovery of counterfeit medicines is essential (only a small proportion are ever recovered)

30,000 of the 70,000 batches of counterfeit medicines remain unaccounted for it is not known if they were consumed (MHRA comment in 2009 relating to counterfeits in 2007)

In 2006 fake lipitor was detected but resulted in only seven packs being recovered out of 1,867 that reached the supply chain.

In 2005, 2,523 packs of fake Lipitor were recalled; only 359 of those packs were recovered.

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Authentication of the unique identity closes the loop

The process of authentication at the point of dispense cancels the unique identity.

As a result, any copies that appear in the market will be detected.

Verification within the wholesale environment permits sample checking or returned goods to be checked

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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 wrong batch

Not recalled Not expired Not short expiry

If there appears to be a problem, we immediately inform the pharmacist before issuing the pack.

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In Europe, Aegate have;

Completed installations with 30 different pharmacy software systems which

represent 40,000 of Europes 160,000 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)

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Aegates Authentication Service

In 2010 in Europe we: Alerted the pharmacist to 55,759 recalled packs which were

identified before dispensing

Alerted the pharmacist to check the batch numbers of a further

155,523 packs that may be recalled

Altered the pharmacist to 3,282 expired packs
Informed the pharmacist of 6,907 packs that were short expiry Investigated with the regulatory authorities and manufacturers two

incidents of suspicious packs

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Governance is an important aspect of the system

We provide secure portals for the regulator and the national pharmacy

association 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

Aegates security management system is operated to ISO 270001

Independently validated that the system is robust. External Audit 2008.

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We also provide a portal for national pharmacy associations

To add information that supports pharmacy practice
Pharmacy practice advice Patient advice Disease monitoring eg flu

Pharmacovigilance
Recalls (instructions) Regulatory changes Past Expiry date or soon to expire

Adherence to treatments

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Pack or tablet changes communicated with visual images

Images can also be used to support counterfeit detection

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Treatment reminders via SMS

Both the pharmacist and the patient benefit

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93% Pharmacists have access to Aegates system, 52% are voluntarily participating
This is currently a voluntary system The Pharmacy Association have secure access to input recalls and other safety information 1.5 million packs authenticated per day Less than half a second response time

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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 must adopt the legislation into their local legislation

May 2013 articles relating to control of imports and exports, and active substances 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 tamper

evidence

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Implementation of the EU Directive; Other

A Member State may use the information contained in the repositories system for the purposes of reimbursement, pharmacovigilance 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 the manufacturing authorisation holders of medicinal products that bear the safety features.

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