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De officina-apotheker Farmacovigilantie
Patient Safety
Apr. Dirk BROECKX
Secretaris-Generaal [email protected]
© APB 2009
Menu
Electronic prescription & patient file
Actieve Geneesmiddelenbewaking
Conterfeit and quality of medicines
© APB 2009
Delivery module pharmacist
Billing
Medication history
Statistical data(IFEB)
Product database (APB)
Scientific database (DELPHI)
Scientific database
Prescriptionmodule doctor
GMD/DMG(Patient file)
Product database
R/
© APB 2009
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23
Reference database products
Scientific database
Prescription module
Transport of prescription
Delivery modulepharmacist
Biling
Pharmaceutical patient record
Statistical data
Tool for Chapt IV medication
Reference database products
Scientific database
Tool for Chapt IV medication
Asssurabilityonline
feedback
Indication on prescription
Elektronic GMD(incl. medication)
© APB 2009
Voorschriftenserver
R/
Voorschrijven door arts
Be.Health
Voorschrijven en afleveren
Ophalen voorschrift en status
8
Interface: generische API
Recip-e
© APB 2009
afgeleverde medicatie
Afleveringsinfo van apothekerFeedback van de apotheker naar de voorschrijver
Gedeeld farmac.Patiëntendossier
& archief voorschriften
Be.Health
8
Intermediair
Feedback en opbouwen farmaceutisch dossier
© APB 2009
Recip-e
Verwijsregister
Gedeeld farmaceutisch dossier
Be.Health
8
Intermediair
Raadpl. Pat.dossierInterface
Raadplegen farmaceutisch dossier (out of scope Recip-e)
© APB 2009
Menu
Electronic prescription & patient file
Actieve Geneesmiddelenbewaking
Conterfeit and quality of medicines
© APB 2009
“Actieve geneesmiddelenbewaking” 2004: “Slechts” 25% van de meldingen aan BCGH
vanwege zorgverstrekkers
Nieuwe benadering “actieve” geneesmiddelenbewaking Beperkte groep die meer specifiek bepaalde bijwerkingen systematisch meldt.
Testfase (2008-2009) Doelstelling 200 300-tal vrijwillige gezondheidszorgbeoefenaars Huisartsen, specialisten, artsen en apothekers ziekenhuizen en officina
Waarom ook apothekers ? farmaceutische zorg = opsporen van geneesmiddelengebonden problemen Farmaceutisch patiëntendossier Zeer frequent en direct contact met de patiënten (of vertegenwoordiger)
Een nieuw en gebruiksvriendelijk online meldingssysteem Grote nood aan een administratief efficiënt en eenvoudig systeem ! Wanneer operationeel in 2009 ? Input aan de hand van “typefiches” ?
© APB 2009
Welke bijwerkingen?
“Baseline”: Elke ernstige, onverwachte of verdachte bijwerking te melden.
Extra waakzaamheid naar:
Kwetsbare bevolkingsgroepen (kinderen, zwangere vrouwen, bij borstvoeding, ouderen)
De eerste toediening van een innovatief of generisch geneesmiddel.
De toediening van vaccins.
Het verkeerd gebruik van een geneesmiddel (off label).
© APB 2009
Voordelen bij deelname ?
Opleidingen op het gebied van geneesmiddelenbewaking.
Telefonisch en per mail ondersteuning van het BCGH
Maandelijkse elektronische nieuwsbrief “ VIG-NEWS” met info over het veiligheidsprofiel van geneesmiddelen.
(?) Feedback op meldingen geïndividualiseerd antwoord op vragen betreffende bijwerkingen van geneesmiddelen.
(?) Erkenning en “vergoeding” voor deelname (accrediteringspunten / specifiek honorarium farmaceutische zorg ?)
© APB 2009
Menu
Electronic prescription & patient file
Actieve Geneesmiddelenbewaking
Conterfeit and quality of medicines
© APB 2009
Definition « counterfeit drug » (WHO)
Deliberately and fraudulently mislabeled with respect to identity and/or source
Can apply to both branded and generic products
May include products with :
The correct or the wrong ingredients
Without active ingredients or with insufficient active ingredients
With fake packaging
© APB 2009
Belgium NOT at stake ???
Sep 2006 : 100.000 tabs. counterfeit VIAGRA seized at Brussels National Airport
July 2007: 600.000 tabs. of counterfeit antibiotic seized at Brussels National Airport (Dubai, Belgian importer, destination unknown)
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)
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
Economic issue Trade Financial Intellectual Property
Social issue Undermines public confidence in : Health care systems Health care professionals Pharmaceutical manufacturers
Health problem Treatment failure Serious intoxication / injury Death
© APB 2009
Why is counterfeiting medicines on the rise ?
Globalization
Parallel trade (relabelling and repackaging)
Supply chain complexity
Not readily detectable
Low public awareness
Lack of political awareness
Poor legal framework
Inadequate enforcement capacity
Weak penal sanctions
Internet sales
Organised crime moving into medicines
© APB 2009
U.S. Federal Criminal Code
Trafficking in Counterfeit Goods or Services, 18 U.S.C. § 2320
1st offence : 10-year prison $2 mio max. fine 2nd offence : 20-year prison $5 mio max. fine
Federal Food Drug and Cosmetic Act
Counterfeit Drugs, 21 U.S.C. § 331 (i)
1st offence 1-year misdemeanor & « significant fines » 2nd offence 3-year prison & « significant fines »
Counterfeiting T-shirts or medicines..?
© APB 2009
EFPIA proposal
EFPIA proposes to verify the authenticity of each product at the point of dispensing
To employ a common European product-coding standard in order to capture the cross-border trade
Unique coding standard : 2 D Data Matrix ECC-200
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 post-war 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
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
1885 legal « NO FAULT responsibility »
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
Belgium : a unique country
© 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
Logical extension of APB’s efforts relating to quality assurance of pharmaceuticals and to patient safety
Pro-activity is better than reactivity (when safety of patients is at stake)
Opportunity to steer the evolution of the system (content, functionalities, ease of use etc) to the benefit of the pharmacist
Have impact on and control of dispensing data
Have impact on and control of a powerfull communication tool at the most important communication moment
© APB 2009
DataData
•Unique BarcodesUnique Barcodes•Batch number Batch number •Expiry datesExpiry dates RecallsRecalls
Medicines Control LaboratoryMedicines Control Laboratory
Authentication at the point of dispensingto combat counterfeiting
Pharmaceutical productsPharmaceutical products
Real timeReal timeProduct Product validationvalidation
Validated andValidated anddispenseddispensed Not validatedNot validatedand withdrawnand withdrawn
© APB 2009
Closed-loop network to the point of dispensing
pharmaceuticalspharmaceuticals
authenticatauthenticateded
recalledrecalled
warningwarningssnoticesnotices
Real Real timetime
productproductvalidatiovalidatio
nnMass Mass serialiseserialise
d d codescodes
© APB 2009
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 Moxifloxacin-containing 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 monohydraatBehandeling 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 Products that can be authenticated
78.2 million UBC in database
35 Recalled products currently in database
308 Product messages added
1283 Pharmacies scanning
776.635 Items scanned
0 Notifications suspicious
493 Notifications expired
3784 Notifications soon to expire
6207 Notifications has been recalled
0.3041 sec Response time
© APB 2009
Practical implications
Allthough imperfect and incomplete, an anti-counterfeiting system is up and running
All the necessary building blocs are in place
Uploading of expiry dates at reception of goods through simple scanning
Real time on-line alerts on recalls are designed and controled by Medicines Control Laboratory (strengthen, speed-up and control)
Ensure proper use of powerfull communication moment (pharmacist has patient in front)
Switch-off function ensured
Strict protection of pharmacists’ proprietary rights of data generated within pharmacies
© APB 2009
(Potential) Issues
Buy-in and co-operation from 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 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
Actieve Geneesmiddelenbewaking 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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