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© 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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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 !!!
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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?
![Page 8: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/8.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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?
![Page 9: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/9.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Belgium : a unique country
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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)
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© 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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
Belgium : a unique country
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Unique Barcode permits to identify each single pack
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
Belgium : a unique country
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy :how does it work ?
Pharmaceutical products
Unique BarcodesBatch numbers Expiry dates Validated
& dispensed
Not validated & withdrawn
Product dictionary
Recalls
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
pharmaceuticals
authenticated
Real timeproduct
validationMass
serialised
codes
Authenticated
Authentication in the pharmacy :in real time
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy: rapid alerts
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy :pharmaceutical care information
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the Pharmacy:practical patient use information
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy:practical patient use information
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy:practical patient use information
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Authentication in the pharmacy :practical information
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
(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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Aegate enabled pharmacies October 2011
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
(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)
![Page 29: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/29.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
(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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
“The June 2009 case”
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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?
Presentation Outline
![Page 36: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/36.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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.
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Harmonisation of the data carrier
• 1D, 2D or RFID
Spain?
Italy
France
Belgium
Turkey
Greece
Germany
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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?
Presentation Outline
![Page 41: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/41.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
![Page 46: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/46.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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?
Presentation Outline
![Page 47: Association of the Pharmacists of Belgium Dr. Guido Hoogewijs](https://reader038.vdocument.in/reader038/viewer/2022110210/56812b26550346895d8f2860/html5/thumbnails/47.jpg)
© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
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)
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
NOT
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© APB 2012
GH – 16th October 2012, BirminghamAnnual Seminar
Thank you !
Guido Hoogewijs
General Manager
APB
Archimedesstraat 111000 BrusselsBelgium
Telephone: +32 2 285 42 18
Mobile: +32 478 49 08 84
www.apb.be