16. Malin Fladvad - Uppsala Monitoring Centre
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Wednesday, 20 November, 2013 Latin America Biotherapeutic Conference Day 2
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16. Malin Fladvad - Uppsala Monitoring Centre
- 1. WHO Program for International Drug Monitoring: Global Pharmacovigilance of Biological products Dr Malin Fladvad, Head of Production Uppsala Monitoring Centre WHO Collaborating Centre for International Drug Monitoring Latin America Conference on Biotherapeutic Medicines Experience: Sharing Experiences and Best Practices Nov 19-20, 2013, Lima, Peru
- 2. UMC’s vision and main tasks Improve worldwide patient safety and welfare by reducing the risk of medicines Collect and analyse individual case safety reports (ICSRs) worldwide Communicate potential patient safety issues Actively support and provide training in Pharmacovigilance Develop the science and practice of Pharmacovigilance Malin Fladvad, Uppsala Monitoring Centre
- 3. Individual Case Safety Report (ICSR) VigiBaseTM Malin Fladvad, Uppsala Monitoring Centre
- 4. VigiBaseTM quality aspects A combination of quantative and qualitative measures Quantity of ICSRs Up-to-date ICSRs Quality of ICSRs Each report is valuable! Structured Complete Correct Malin Fladvad, Uppsala Monitoring Centre
- 5. The UMC signal detection process National Centre Pharma Company VigiBaseTM ’Follow-up’ or ’Not signal’ Triage Literature check Potential signals Malin Fladvad, Uppsala Monitoring Centre Clinical assessment: Review Panel (or UMC)
- 6. Improved adverse drug interaction signal detection • Inclusion of clinical information and pharmacological characteristics give clear performance improvement over previous methods Identification of previously unknown risks. Malin Fladvad, Uppsala Monitoring Centre
- 7. WHO Drug Dictionaries Malin Fladvad, Uppsala Monitoring Centre
- 8. Users of WHO Drug Dictionaries Doctors & Patients National Centre VigiLyze Malin Fladvad, Uppsala Monitoring Centre VigiFlowTM VigiBaseTM
- 9. Malin Fladvad, Uppsala Monitoring Centre
- 10. WHO Drug Dictionaries • A source of international drug (trade) names 260 000 product namnes 2 million entries Malin Fladvad, Uppsala Monitoring Centre
- 11. ICSR mapping Malin Fladvad, Uppsala Monitoring Centre
- 12. The WHO Drug Dictionaries holds standardised medicinal information • Trade name • Active ingredient(s) • Ma Holder • Form • Strength • Country of sales • ATC Malin Fladvad, Uppsala Monitoring Centre
- 13. The WHO Drug Dictionaries CRT Japan WHO DD DRL WHO DDE+ HD Malin Fladvad, Uppsala Monitoring Centre WHO DDE DDC SDGs
- 14. Product types in the WHO Drug Dictionaries – Conventional drugs (Arinate, Cetamol) – Biologicals (monoclonal antibodies, biosimilars, blood products, vaccines etc) – Herbal products – Chemotherapy regimens – Radiopharmaceutical diagnostics – Generic products – Substance and substance synonyms Malin Fladvad, Uppsala Monitoring Centre
- 15. Coding using the WHO Drug Dictionaries Mabthera Rituxan Kikuzubam Rituximab Reditux Tidecron Malin Fladvad, Uppsala Monitoring Centre
- 16. The added value of WHO Drug Dictionaries Reditux Rituxan Mabthera Kikuzubam Rituximab Malin Fladvad, Uppsala Monitoring Centre Tidecron
- 17. WHO Drug Dictionary structure using current WHO Policy (INN) Reference product Biosimilar Reference product Biosimilar Active substance, Malin Fladvad, Uppsala Monitoring Centre
- 18. Some Biosimilars have the same nonproprietary name as reference product No discrimination between Reference product and Biosimilar when only drug substance is reported – Signal analysis – Coding concomittant medication in clinical trials. Reference Biosimilar product Reference product Biosimilar Active substance, Malin Fladvad, Uppsala Monitoring Centre
- 19. ICSR Reports on biotherapeutics in VigibaseTM Drug group Number of ICSR Biotherapeutics 1 531 822 All 8 480 965 Malin Fladvad, Uppsala Monitoring Centre
- 20. ICSR per year reported on biotherapeutics with biosimilars in VigibaseTM 60000 50000 40000 30000 20000 10000 0 Malin Fladvad, Uppsala Monitoring Centre Rituximab Etanercept Somatropin Filgrastim Infliximab
- 21. ICSR per regional area reported on biotherapeutics with biosimilars in VigibaseTM 250000 200000 Rituximab Etanercept Somatropin Filgrastim Infliximab 150000 100000 50000 0 Africa Malin Fladvad, Uppsala Monitoring Centre Latin America North America Asia Europe Oceania
- 22. Product classification Timeline Innovation 1 Later innovation Loss of exclusivity Further innovation Reference product NonReferenced product Biosimilar Malin Fladvad, Uppsala Monitoring Centre Patent protected product
- 23. ICSR reported on biotherapeutics with biosimilars in VigibaseTM 100% 80% Biosimilar 60% Non-Ref product Ref product 40% Active substance 20% 0% Rituximab Malin Fladvad, Uppsala Monitoring Centre Etanercept Somatropin Filgrastim Infliximab
- 24. ICSR reported on biotherapeutics with biosimilars in VigibaseTM 60000 50000 40000 30000 20000 10000 0 Malin Fladvad, Uppsala Monitoring Centre Drug substance Trade name Rituximab Etanercept Somatropin Filgrastim Infliximab
- 25. Reasons for underreporting • • • • • • • • • • Lack of information Lack of understanding Lack of time Lack of routines ADR already known Uncertain causality Failure to recognize ADR Patient confidentiality concern Fear of legal liability Forgetfulness Malin Fladvad, Uppsala Monitoring Centre
- 26. Thank you for your attention! malin.fladvad@who-umc.org Malin Fladvad, Uppsala Monitoring Centre