Association of the Pharmacists of Belgium Dr. Guido Hoogewijs

© APB 2012

GH – 16th October 2012, BirminghamAnnual Seminar

© APB 2012

Association of the Pharmacists of Belgium

Dr. Guido Hoogewijs

Patient Protection in Belgian Pharmacies Using Online Authentication

© APB 2012


Association Pharmaceutique Belge

National federation of professional

associations of independent community

pharmacies

Representing >90% of independent pharmacies

and >80% of all public pharmacies

Role: support, develop and promote

the community pharmacist ‘s added value

to the benefit of his patient’s health

© APB 2012


Belgian pharmacies have an anti-counterfeiting system in operation

Our rationale for implementing an online authentication system in October 2006 :

1. PATIENT SAFETY IS PARAMOUNT

2. OUR INTEGRITY AS HEALTHCARE PROVIDER IS AT STAKE

3. COUNTERFEITING MEDICINES IS ON THE RISE

4. EUROPE AND BELGIUM ARE NOT IMMUNE

5. MANUFACTURERS’ INITIATIVES LACKING OR UNSUITABLE

6. HEALTHCARE AUTHORITIES ARE LATE AND SLOW

7. TIME FOR ACTION !!!

© APB 2012


Presentation Outline

Belgian community pharmacies have an anti- counterfeiting system in operation

What and how ?

What’s the fit with European Legislation Plans?

What’s the fit with Pharma Industry Plans?

What’s the fit with other Stakeholder Plans?

© APB 2012


Belgium : a unique country

1885

The Pharmaceutical Practice Law introduces

the principle of « NO FAULT responsibility »

The pharmacist has the final responsibility for

every product (s)he delivers

© APB 2012



1885 The Pharmaceutical Practice Law introduces the principle of

« NO FAULT responsibility »

1952

Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM)

To combat post-war fraud of penicillin-containing pharmaceuticals

© APB 2012


Medicines Control Lab

The MCL has become instrumental in guaranteeing the quality of all medicines delivered in Belgian pharmacies

Unique model of auto-control

Financed by all pharmacies through 0.015 € per pack

Staff : +/-60 (pharmacists & lab technicians)

© APB 2012

Independent quality control lab, operated by APB in conjunction with the National Drug Regulatory Agency

Operates centralised recall procedure on behalf of MCL, DRA or the manufacturer

2011: 134 batches (of 45 products) recalled

Medicines Control Lab

© APB 2012


1885 The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility »

1952 Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM) to combat post-war fraud of penicillin-containing pharmaceuticals

2004 Healthcare Authorities introduce Unique

Barcode per package Mass serialisation of reimbursed

pharmaceuticals to combat healthcare insurance fraud


© APB 2012


Unique Barcode permits to identify each single pack

© APB 2012


Unique Barcode

16 digits (7=CNK national code + 8 serial + 1 control)– CNK identifies product, dosage & pack size (determined

by APB/IMS)– serial : determined by manufacturer

Allows National Sickfunds Organisation to check :– pack was really dispensed before reimbursing– pack was dispensed only once

UBC introduced to combat reimbursement fraud UBC = basis for mass serialisation

© APB 2012


1885 The Pharmaceutical Practice Law introduces the principle of « NO FAULT responsibility »

1952 Start-up by APB of the Medicines Control Laboratory (MCL – DGO – SCM) to combat post-war fraud of penicillin-containing pharmaceuticals

2004 Mass serialisation of reimbursed pharmaceuticals to combat healthcare insurance fraud

2006 APB and Aegate start collaboration Use existing mass serialisation to combat

counterfeiting of medicines Prepare first launch worldwide of an authentication

system


© APB 2012


Authentication in the pharmacy :how does it work ?

Pharmaceutical products

Unique BarcodesBatch numbers Expiry dates Validated

& dispensed

Not validated & withdrawn

Product dictionary

Recalls

© APB 2012


pharmaceuticals

authenticated

Real timeproduct

validationMass

serialised

codes

Authenticated

Authentication in the pharmacy :in real time

© APB 2012


Authentication in the pharmacy: rapid alerts

© APB 2012


Authentication in the pharmacy :pharmaceutical care information

© APB 2012


Authentication in the Pharmacy:practical patient use information

© APB 2012


Authentication in the pharmacy:practical patient use information

© APB 2012


Authentication in the pharmacy :practical information

© APB 2012


From authentication to info tool

Originally :– Authentication system– Internet based– At point of dispensing– To combat counterfeiting

Additionally:– Uploading expiry dates– Recall info (rapid alert)– Product- & therapy- related messages benefiting patient

counselling– Value adding tool for pharmacy

Not:– Data collection system ( only serial N° + pharmacy captured)

© APB 2012


(Potential) Issues

Buy-in and co-operation from pharmacy software providers

Is Big Brother watching again ? Absolute need for strict and explicit pharmacy data

protection Unique Barcode – based system (presently) limits

authentication check to reimbursed products only Wait and see approach (manufacturers and

pharmacists)

© APB 2012


Aegate enabled pharmacies October 2011

© APB 2012


(Potential) Issues

Buy-in and co-operation from pharmacy software providers

Is Big Brother watching again ? Absolute need for strict and explicit pharmacy data

protection Unique Barcode – based system (presently) limits

authentication check to reimbursed products only Wait and see approach (manufacturers and

pharmacists)

© APB 2012


Simple but effective tools

Social Identity Card(chip card with patients’ certified identity data)

Prescription with Doctors’ unique bar-coded ID-number

Packs with UniqueBarcode

© APB 2012


(Potential) Issues

Buy-in and co-operation from pharmacy software providers Is Big Brother watching again ?

Absolute need for strict and explicit pharmacy data protection

Unique Barcode – based system (presently) limits authentication check to reimbursed products only

Wait and see approach (manufacturers and pharmacists)

© APB 2012


August 2012 report

Response time : 0.206 sec N° products that can be authenticated : 1228 N° UBC in database : 113.56 mio N° recalled products currently live : 58 N° product messages added : 1124 N° pharmacies scanning : 2627 N° items authenticated : 1246174 Notification expired : 2051 Notification soon to expire : 5123 Notification has been recalled : 2731 Already dispensed elsewhere : 794 (5 suspicious)

© APB 2012


“The June 2009 case”

© APB 2012


Duplicate Scan Events 2011

Product Date first alert raised

Duplicate UBC Scans

Issue identified Impact Status

Antibiotic 23/03/2011 10 Labelling error Quality control procedures improved

Closed

Hormone replacement

14/03/2011 6 Labelling error Quality control procedures improved

Closed

Anti-hypertensive

13/05/2011 286 Entire Batch Labelled with same UBC

Pharmacists can not get reimbursed by national sick fund

Batch Recall (16/05/2011)

Closed

© APB 2012


Summary points

Last check at time of dispensation provides ultimate patient safety

Effective, simple, user-friendly and flexible system Based on existing pharmacy practice and tools No interference with workflow (time !) Acceptable infrastructure needs Authentication + expiry date + recall check + product

messages, but NO data collection Helps protecting patients (but pharmacists, wholesalers and

manufacturers as well) Operational in daily practice in 2500+ pharmacies Reliability and relevance is function of rapid and full roll-out

(manufacturers, software providers, pharmacists)

© APB 2012



What and how ?





© APB 2012


EU Directive on Falsified Medicines • Tamper evidence and unique identification• Authenticity to be verified by persons supplying medicines

to the public• All prescription medicines included, unless case for

exemption• Repackers must replace with equivalent safety features

Safety Features

• National and EU list of approved on-line pharmacies• EU logo to be used by approved pharmacies• Public awareness campaigns

Internet

• Mandatory registration of API producers in non EU countries

• Brokering of medicines a recognised within the legislation and subject to regulation

• New rules for medicines entering the EU solely for export

Regulatory

• Criminal penalties to be enforced for infringements of the directive Penalties

© APB 2012


EU Directive on Falsified Medicines

Mandatory harmonized pan-European safety features– unique pack serialisation number – with tamper evident packaging

Applied to all prescription medicines (subject to possible exclusions based on risk assessment)

The Commission will define the mechanisms of how this system will work in Delegated Acts that are expected to be adopted within the next 18-24 months– the characteristics and technical specifications of the unique serial

number– the establishment, management and accessibility of national or regional

product databases that allow verification of each dispensed pack– interoperability between regional systems.

© APB 2012


Harmonisation of the data carrier

• 1D, 2D or RFID

Spain?

Italy

France

Belgium

Turkey

Greece

Germany

© APB 2012


Harmonisation of the number sequence

The numbering sequence within the serialisation code is important

23/27 member states have national product codes for reimbursement purposes

Necessity for collaboration with GS1 to create a harmonised approach

http://www.gs1uk.org/index.asp

© APB 2012


Need for harmonisation !

1. The data carrier

2. The numbering sequence within the serialisation code

3. The database or databases that authenticate the serialisation codes

© APB 2012


EFPIA Database Model

EU Central Hub

Greenfield countries system

Re-packer

PharmacyPharmacy

Wholesaler

Manufacturer

Pharmacy: mandatory verification transaction

Wholesaler: voluntary verification transaction

Manufacturer; data upload + voluntary verification transaction

Periodic cross-region update

Re-packer: mandatory verification transaction + data upload

Wholesaler

Wholesaler

Pharmacy

National System1/ Regional

National System n/Regional

© APB 2012


EFPIA Database Model = ESM

EU Central Hub

Greenfield countries system

Re-packer

PharmacyPharmacy

Wholesaler

Manufacturer

Pharmacy: mandatory verification transaction

Wholesaler: voluntary verification transaction

Manufacturer; data upload + voluntary verification transaction

Periodic cross-region update

Re-packer: mandatory verification transaction + data upload

Wholesaler

Wholesaler

Pharmacy

National System1/ Regional

National System n/Regional

© APB 2012


EAEPC + EFPIA + GIRP + PGEU

Are collaborating on the development of- a cost effective- scalable system - run by a stakeholders statutory organization

on a non-profit basis- such that it justifies the costs of establishing

such a system Þ 10 core principles agreementÞ MoU

© APB 2012


Possible implications for the Belgian System

Operational Belgian system is compliant with EU-legislation What we have to (consider to) change:

– Migrate from 1D to 2D– Migrate from UBC to GS1 DataMatrix (harmonisation &

multipurpose)– Safety feature on all Rx medicines

What we want to preserve:– Transactional data are the property of the pharmacy – Ensure optimal use of extremely valuable communication

tool (auxiliary advantages for patient safety)– Authentication in the pharmacy just prior to dispensation

that provides optimal patient safety

© APB 2012


eTACT : EDQM traceability project

Manufacturer

DistributionPharmacies

Internet / Mail order pharmacies

Patients

Generate unique identity

Verification of unique identity

Tracing and Verification of unique identity

“EDQM as an intergovernmental organisation guaranteeing sustainable confidentiality of data”

EDQM data repository

Phase 1: Concept

developmentDec 09-March 2010

Phase 2: System development

Live demo Apr 2010 – 2012

Phase 3: Service

development From 2012

© APB 2012


EDQM statements

“a “Track and Trace” system for medicines project”

– Cost estimation: €10 billion investment + €500 million operational costs

– Estimates for end to end authentication range from €200m to €500m– Multiple day delivery would be impossible if every pack has to be

verified in the supply chain and distribution costs would become unacceptable

“a Single European Database”

– Leads to a single point of failure– EAEPC + EFPIA + PGEU + GIRP : 10 principles agreement for

stakeholder led national or regional systems

© APB 2012


EDQM statements

* "Patients should be included in the process, otherwise it will not be effective in protecting them against potentially counterfeit products purchased in the illegal supply chain"

– Patients should be discouraged to purchase medicines in the illegal supply chain

– Patients should be encouraged to use the legal and professional supply chain, where on top of genuine products they can expect the pharmacist to counsel them

* “EDQM has demonstrated its ability to act as a guardian of commercially-sensitive information . EDQM's work on certification over the last 15 years proves that we can hold highly-sensitive data in a secure way”

– Transaction data are the property of the pharmacies that generate them

© APB 2012


Recommendations

Authentication in the pharmacy just prior to dispensation ultimately provides patient safety

Full track & trace (e-pedigree) is of no value to patient & pharmacist Authentication system should be open to all medicines, all

pharmacies and all wholesalers. Not to patients! Over-sophistication is a burden to

– utilisation by the end-user – costs (drugbill !)

Dispensing data are the property of the pharmacy Ensure optimal use of extremely valuable communication

tool/moment Keep Belgian system in operation (compliant with upcoming EU-

legislation and EAEPC + EFPIA + GIRP + PGEU initiative) Migrate from UBC to GS1 DataMatrix (harmonisation & multipurpose)

© APB 2012


Thank you !

[email protected]

Guido Hoogewijs

General Manager

APB

Archimedesstraat 111000 BrusselsBelgium

Telephone: +32 2 285 42 18

Mobile: +32 478 49 08 84

[email protected]

www.apb.be

mailto:[email protected]

Association of the Pharmacists of Belgium Dr. Guido Hoogewijs

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