De officina-apotheker Farmacovigilantie Patient Safety Apr. Dirk BROECKX Secretaris-Generaal APB broeckx.dirk@mail.apb.be © 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 Prescription module doctor GMD/DMG (Patient file) Product database R/ © APB 2009

2 3 1 Prescription module Elektronic GMD (incl. medication) Reference database products Prescription module Elektronic GMD (incl. medication) Tool for Chapt IV medication Scientific database feedback 2 3 Asssurability online Transport of prescription Reference database products Indication on prescription Delivery module pharmacist Pharmaceutical patient record Tool for Chapt IV medication Scientific database 1 Biling Statistical data © APB 2009

Recip-e Voorschrijven door arts Ophalen voorschrift en status Voorschrijven en afleveren Recip-e Be.Health Voorschriften server 8 R/ Ophalen voorschrift en status Voorschrijven door arts Interface: generische API © APB 2009

Intermediair Afleveringsinfo van apotheker Feedback en opbouwen farmaceutisch dossier Gedeeld farmac. Patiëntendossier & archief voorschriften Be.Health Intermediair afgeleverde medicatie 8 Afleveringsinfo van apotheker Feedback van de apotheker naar de voorschrijver © APB 2009

Gedeeld farmaceutisch dossier Be.Health Recip-e Intermediair Verwijsregister 8 Raadplegen farmaceutisch dossier (out of scope Recip-e) Raadpl. Pat.dossier Interface © 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

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 $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 » © 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

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 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 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

Authentication at the point of dispensing to combat counterfeiting Pharmaceutical products Real time Product validation Validated and dispensed Not validated and withdrawn Data Unique Barcodes Batch number Expiry dates Recalls Medicines Control Laboratory © APB 2009

Closed-loop network to the point of dispensing pharmaceuticals authenticated recalled warnings notices Real time product validation Mass serialised codes © 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 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 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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