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De officina-apotheker Farmacovigilantie Patient Safety Apr. Dirk BROECKX Secretaris-Generaal APB © APB 2009.

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Presentatie over: "De officina-apotheker Farmacovigilantie Patient Safety Apr. Dirk BROECKX Secretaris-Generaal APB © APB 2009."— Transcript van de presentatie:

1 De officina-apotheker Farmacovigilantie Patient Safety Apr. Dirk BROECKX Secretaris-Generaal APB © APB 2009

2 Menu  Electronic prescription & patient file  Actieve Geneesmiddelenbewaking  Conterfeit and quality of medicines © APB 2009

3 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

4 1 2 3 Reference database products Scientific database Prescription module Transport of prescription Delivery module pharmacist Biling Pharmaceutical patient record Statistical data Tool for Chapt IV medication Reference database products Scientific database Tool for Chapt IV medication Asssurability online feedback Indication on prescription Elektronic GMD (incl. medication) © APB 2009

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

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

7 Recip-e Verwijsregister Gedeeld farmaceutisch dossier Be.Health 8 Intermediair Raadpl. Pat.dossier Interface Raadplegen farmaceutisch dossier (out of scope Recip-e) © APB 2009

8 Menu  Electronic prescription & patient file  Actieve Geneesmiddelenbewaking  Conterfeit and quality of medicines © APB 2009

9 “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 ( )  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

10 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

11 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

12 Menu  Electronic prescription & patient file  Actieve Geneesmiddelenbewaking  Conterfeit and quality of medicines © APB 2009

13 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

14 Belgium NOT at stake ???  Sep 2006 : tabs. counterfeit VIAGRA seized at Brussels National Airport  July 2007: 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: units of counterfeit Tramal and Fansidar coming from Mumbai (India) seized at Brussels National Airport © APB 2009

15 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

16 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

17 U.S. Federal Criminal Code Trafficking in Counterfeit Goods or Services, 18 U.S.C. § 2320  1 st 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)  1 st offence1-year misdemeanor & « significant fines »  2nd offence3-year prison & « significant fines » Counterfeiting T-shirts or medicines..? © APB 2009

18 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

19 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

20 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

21 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

22  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

23 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

24 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

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

26 Closed-loop network to the point of dispensing pharmaceuticals authenticated recalled warnings notices Real time product validation Mass serialised codes © APB 2009

27 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

28 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 – Hyperlink to BFAMH website opening in new screen Message live for 2-3 weeks (depending on turnover) © APB 2009

29 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

30 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

31 October 2008 report 695 Products that can be authenticated 78.2 millionUBC in database 35 Recalled products currently in database 308 Product messages added 1283 Pharmacies scanning Items scanned 0Notifications suspicious 493 Notifications expired 3784 Notifications soon to expire 6207 Notifications has been recalled sec Response time © APB 2009

32 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

33 (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

34 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

35 The healthcare professionals magazine 6x/year - FR/NL readers —————————— Hot topics seminars driven by reknown opinion leaders


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