Transcript Slide 1

Le pharmacien d’officine
Pharmacovigilance
Patient Safety
Ph. Dirk BROECKX
Secrétaire général de
l’APB
[email protected]
© APB 2009
Menu

Electronic prescription & patient file

Pharmacovigilance active

Conterfeit and quality of medicines
© APB 2009
Product database
Prescription
module doctor
GMD/DMG
(Patient file)
Scientific database
R/
Product database (APB)
Delivery module
pharmacist
Medication history
Scientific database (DELPHI)
Billing
Statistical data
(IFEB)
© APB 2009
Reference database products
Tool for Chapt IV medication
Prescription
module
Elektronic GMD
(incl. medication)
Scientific database
3
Asssurability
online
feedback
2
Transport of
prescription
Indication on prescription
Reference database products
Tool for Chapt IV medication
Delivery module
pharmacist
Pharmaceutical
patient record
Scientific database
1
Biling
Statistical data
© APB 2009
Prescription et
délivrance
Recip-e
Be.Health
Serveur de prescriptions
8
R/
Prescription par le médecin
Collecte des prescriptions et statut
Interface: API générique
© APB 2009
Feedback et création d’un
dossier pharmaceutique
Dossier pharmaceutique
partagé du patient &
archives de prescriptions
Be.Health
Intermédiaire
médicament
délivré
8
Information du pharmacien concernant la délivrance
Feedback du pharmacien au prescripteur
© APB 2009
Dossier
pharmaceutique
partagé
Be.Health
Recip-e
Intermédiaire
Registre de référence
8
Consultation du dossier
pharmaceutique (out of scope
Recip-e)
Consultation du dossier du patient
© APB 2009
Interface
Menu

Electronic prescription & patient file

Pharmacovigilance active

Conterfeit and quality of medicines
© APB 2009
“Pharmacovigilance active”
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2004: 25% “ seulement “ des soignants communiquent des informations au CBPH
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Nouvelle approche: pharmacovigilance “active” 
Groupe restreint qui mentionne plus spécifiquement certains effets
indésirables de manière systématique.
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Phase de test (2008-2009)
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Objectif 200  300 professionnels des soins de santé volontaires
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Généralistes, spécialistes, médecins, pharmaciens hospitaliers et pharmaciens d’officine
Pourquoi également les pharmaciens ?
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Soins pharmaceutiques = dépistage de problèmes liés aux médicaments
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Dossier pharmaceutique des patients
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Contact très fréquent et direct avec les patients (ou leur représentant)
Un nouveau système convivial de rapport en ligne
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Grand besoin d’un système administratif efficace et simple !
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Opérationnel quand en 2009 ? Entrée des données à l’aide de “fiches types” ?
© APB 2009
Quels effets indésirables?
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“Au départ”:
Mentionner tout effet indésirable grave, inattendu ou suspect.
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Vigilance particulière pour:
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Des groupes vulnérables de la population.
(enfants, femmes enceintes, allaitement, personnes âgés)
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La première administration
d’un médicament innovant ou générique.
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L’administration de vaccins.
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L’utilisation erronée de médicaments (off label).
© APB 2009
Avantages inhérents à la
participation?
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Formations en matière de pharmacovigilance.
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Soutien téléphonique et par mail du CBPH.
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Bulletin d’information électronique mensuel “ VIG-NEWS”
reprenant des informations sur le profil de sécurité des
médicaments.
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(?) Feedback concernant les rapports - réponse individualisée à des
questions portant sur les effets indésirables des médicaments.
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(?) Reconnaissance et “rémunération” de la participation
(points d’accréditation / honoraire spécifique pour les soins
pharmaceutiques ?).
© APB 2009
Menu

Electronic prescription & patient file

Pharmacovigilance active

Conterfeit and quality of medicines
© APB 2009
Definition « counterfeit drug » (WHO)
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Deliberately and fraudulently mislabeled with respect to
identity and/or source
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Can apply to both branded and generic products
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May include products with :
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The correct or the wrong ingredients
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Without active ingredients or with insufficient active ingredients
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With fake packaging
© APB 2009
Belgium NOT at stake ???
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Sep 2006 : 100.000 tabs. counterfeit VIAGRA seized at Brussels
National Airport
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July 2007: 600.000 tabs. of counterfeit antibiotic seized at Brussels
National Airport (Dubai, Belgian importer, destination unknown)
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2007: two Belgian wholesalers involved in shipping counterfeit
Casodex to UK-wholesalers with legal US-market as final
destination
(source: Rapport Annuel 2007 – Cellule Multidisciplinaire Hormones)
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Sep 2008: 2.134.000 units of counterfeit Tramal and Fansidar
coming from Mumbai (India) seized at Brussels National Airport
© APB 2009
The problem goes beyond
the economic context
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Economic issue
 Trade
 Financial
 Intellectual Property
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Social issue
 Undermines public confidence in :
 Health care systems
 Health care professionals
 Pharmaceutical manufacturers
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Health problem
 Treatment failure
 Serious intoxication / injury
 Death
© APB 2009
Why is counterfeiting medicines
on the rise ?
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Globalization
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Parallel trade (relabelling and repackaging)
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Supply chain complexity
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Not readily detectable
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Low public awareness
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Lack of political awareness
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Poor legal framework
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Inadequate enforcement capacity
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Weak penal sanctions
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Internet sales
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Organised crime moving into medicines
© APB 2009
Counterfeiting T-shirts
or medicines..?
U.S. Federal Criminal Code
Trafficking in Counterfeit Goods or Services, 18 U.S.C. § 2320
1st offence : 10-year prison
 2nd offence : 20-year prison

$2 mio max. fine
$5 mio max. fine
Federal Food Drug and Cosmetic Act
Counterfeit Drugs, 21 U.S.C. § 331 (i)
1st offence
 2nd offence

1-year misdemeanor
3-year prison
& « significant fines »
& « significant fines »
© APB 2009
EFPIA proposal
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EFPIA proposes to verify the authenticity of each product
at the point of dispensing
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To employ a common European product-coding standard
in order to capture the cross-border trade
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Unique coding standard :
2 D Data Matrix ECC-200
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Central piece of IT-infrastructure is PILL (Pharmaceutical
Interchange Logistics Link)
© APB 2009
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
 « Modernised » Royal Decree (21/1/2009) confirms
the full legal responsibility of every pharmacist
for every product he delivers
© APB 2009
Belgium : a unique country
 1885 legal « NO FAULT responsibility »
 1952 Start-up by APB of the Medicines Control
Laboratory (MCL – DGO – SCM) to combat postwar fraud of penicillin-containing pharmaceuticals.
 1974 Official legal recognition and compulsory
contribution by all pharmacists to guanatee the
quality of all medicines delivered in Belgian
pharmacies
© APB 2009
Medicines Control Lab
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Financed by all Belgian pharmacies (0,013€ per pack)
Staff : +/-60 (pharmacists & lab technicians)
Co-management with FAGG/AFMPS
DGO-SCM operates centralised recall procedure
173 batches of 94 products recalled in 2006
© APB 2009
Belgium : a unique country

1885 legal « NO FAULT responsibility »
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1952 APB starts the Medicines Control Laboratory

1974 Official legal recognition and compulsory contribution by all pharmacists
 2004 Healthcare Authorities introduce
Unique Barcode per package:
mass serialisation of reimbursed pharmaceuticals
to combat healthcare insurance fraud
© APB 2009
Belgium : a unique country
 1885 legal « NO FAULT responsibility »
 1952 APB starts the Medicines Control Laboratory
 1974 Official legal recognition and compulsory contribution by all pharmacists
 2004 Unique Barcode per package to combat healthcare insurance fraud
 2006
APB and Aegate start collaboration,
using existing mass serialisation
to combat counterfeiting of medicines
 first launch worldwide of an authentication system
© APB 2009
APB’s rationale for collaboration
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Logical extension of APB’s efforts relating to quality
assurance of pharmaceuticals and to patient safety
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Pro-activity is better than reactivity
(when safety of patients is at stake)
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Opportunity to steer the evolution of the system
(content, functionalities, ease of use etc)
to the benefit of the pharmacist
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Have impact on and control of dispensing data
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Have impact on and control of a powerfull
communication tool at the most important
communication moment
© APB 2009
Authentication at the point of dispensing
to combat counterfeiting
Pharmaceutical products

Validated and
dispensed
Data
•Unique Barcodes
•Batch number
•Expiry dates
Recalls
Real time
Product
validation
Not validated
and withdrawn
Medicines Control Laboratory
© APB 2009
Closed-loop network
to the point of dispensing
authenticated
pharmaceuticals
Real time
product
validation
Mass serialised
codes
recalled
warnings
notices
Caution: Modification of contents
The new tablets are oval with the
code " xxx 740" on one side and
nothing on the other side.
Before the tablets were round with "
xx 740" on one side and either" xxx"
or a line of caesura on the other side.
Click here for an image
© APB 2009
Pharmacovigilance
August 2008 : EMEA and Belgian Federal Agency for Medicines
and Health Products recommend restricting the use of oral
moxifloxacin-containing medicines
APB programs message in Aegate system for all Moxifloxacincontaining oral forms available on Belgian market (within same
day).
Informatie van APB
Moxifloxacine: nieuwe aanbevelingen van het
Europees Geneesmiddelenbureau (EMEA)
Klik hier voor het artikel – 04 08 2008
Hyperlink to BFAMH website opening in new screen
Message live for 2-3 weeks (depending on turnover)
© APB 2009
Info on new product launches
Every 1st of the month for ± 5 products
- New active principles, new routes of administration, new
therapeutic indication
- Short, basic pharmacotherapeutic information (before complete
information is available in pharmacy software)
Ex. Vaniqa 11,5 %
Nieuwe specialiteit - Informatie van APB
Eflornithine hydrochloride monohydraat
Behandeling van hirsutisme in het aangezicht bij de vrouw.
2 maal daags een dunne laag crème aanbrengen met
minimum 8 uur interval tussen 2 applicatie
Message live from 31/10/2008 to 31/12/2008
© APB 2009
Independent Audit confirms Drug
Authentication protects Patients
in « real world » Setting
System was independently audited by
Katholieke Universiteit Leuven (June - Aug 08) :
 Tested in 116 pharmacies
 656 authentic products
 327 recalled products
 220 expired products
 106 suspicious products
 The actual response for each test code corresponded with the
correct response
 Reliability of [ 99.8%-100%] (95% confidence interval)
 The Aegate system protects patients from harmful products at
point of dispense
© APB 2009
October 2008 report
695
78.2 million
35
308
1283
776.635
0
493
3784
6207
0.3041 sec
Products that can be authenticated
UBC in database
Recalled products currently in database
Product messages added
Pharmacies scanning
Items scanned
Notifications suspicious
Notifications expired
Notifications soon to expire
Notifications has been recalled
Response time
© APB 2009
Practical implications

Allthough imperfect and incomplete, an anti-counterfeiting system is
up and running
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All the necessary building blocs are in place
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Uploading of expiry dates at reception of goods through simple
scanning
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Real time on-line alerts on recalls are designed and controled by
Medicines Control Laboratory (strengthen, speed-up and control)
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Ensure proper use of powerfull communication moment (pharmacist
has patient in front)
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Switch-off function ensured
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Strict protection of pharmacists’ proprietary rights of data generated
within pharmacies
© APB 2009
(Potential) Issues
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Buy-in and co-operation from software providers
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Is Big Brother watching again ?
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Absolute need for strict and explicit
pharmacy data protection
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Unique Barcode – based system (presently)
limits authentication check
to reimbursed products only
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« Wait and see » approach
(manufacturers and pharmacists)
© APB 2009
Added value for patient safety ?
Electronic prescription & patient file
 Medication errors
 Working with the same prescription & patient data / file
 Collaboration & communication between healthcare providers
Pharmacovigilance active
 Post Marketing Surveillance
 Safety profile of medicines
 Sharing data with authorities and pharmaceutical companies
Conterfeit and quality of medicines
 Detecting non-quality of medication; counterfeit & quality
 Communication at the moment of delivery
 Real time, online checks and messaging between HCP & PhCom
© APB 2009
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