16. Malin Fladvad - Uppsala Monitoring Centre

Wednesday, 20 November, 2013
Latin America Biotherapeutic Conference Day 2

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. Malin Fladvad, Uppsala Monitoring Centre
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

3. Malin Fladvad, Uppsala Monitoring Centre
Individual Case Safety Report
(ICSR)
VigiBase
TM

4. Malin Fladvad, Uppsala Monitoring Centre
VigiBase
TM
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

5. Malin Fladvad, Uppsala Monitoring Centre
The UMC signal detection process
Clinical assessment:
Review Panel
(or UMC)
Pharma Company
’Follow-up’
or ’Not signal’ Triage
Literature check
Potential signals
VigiBase
TM

National Centre

6. Malin Fladvad, Uppsala Monitoring Centre
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.

7. Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionaries

8. Malin Fladvad, Uppsala Monitoring Centre
VigiBase
TM

VigiLyze
National Centre

VigiFlow
TM
Users of WHO Drug Dictionaries
Doctors &
Patients

9. Malin Fladvad, Uppsala Monitoring Centre

10. Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionaries
•A source of international drug (trade) names


260 000 product namnes
2 million entries

11. Malin Fladvad, Uppsala Monitoring Centre
ICSR
mapping

12. Malin Fladvad, Uppsala Monitoring Centre
The WHO Drug Dictionaries holds
standardised medicinal information
•Trade name
•Active ingredient(s)
•Ma Holder
•Form
•Strength
•Country of sales
•ATC

13. Malin Fladvad, Uppsala Monitoring Centre
WHO
DD DRL
WHO
DDE
WHO
DDE+
HD
DDC
CRT
Japan
SDGs
The WHO Drug Dictionaries

14. Malin Fladvad, Uppsala Monitoring Centre
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

15. Malin Fladvad, Uppsala Monitoring Centre
Coding using the WHO Drug
Dictionaries
Reditux
Mabthera
Kikuzubam
Rituximab
Rituxan
Tidecron

16. Malin Fladvad, Uppsala Monitoring Centre
Reditux
Mabthera
Kikuzubam
Rituximab
Rituxan
The added value of WHO Drug
Dictionaries
Tidecron

17. Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionary structure
using current WHO Policy (INN)
Reference
product
Biosimilar
Active
substance,
Biosimilar
Reference
product

18. Malin Fladvad, Uppsala Monitoring Centre
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
product
Biosimilar
Active
substance,
Biosimilar
Reference
product

19. Malin Fladvad, Uppsala Monitoring Centre
ICSR Reports on biotherapeutics
in Vigibase
TM
Drug group Number of ICSR
Biotherapeutics 1 531 822
All 8 480 965

20. Malin Fladvad, Uppsala Monitoring Centre
ICSR per year reported on
biotherapeutics with biosimilars in
Vigibase
TM

0
10000
20000
30000
40000
50000
60000
Rituximab
Etanercept
Somatropin
Filgrastim
Infliximab

21. Malin Fladvad, Uppsala Monitoring Centre
ICSR per regional area reported on
biotherapeutics with biosimilars in
Vigibase
TM

0
50000
100000
150000
200000
250000
AfricaLatin
America
North
America
AsiaEuropeOceania
Rituximab
Etanercept
Somatropin
Filgrastim
Infliximab

22. Malin Fladvad, Uppsala Monitoring Centre
Product classification
Innovation 1 Later innovation Loss of exclusivity Further innovation
Timeline
Reference
product
Non-
Referenced
product
Biosimilar Patent
protected
product

23. Malin Fladvad, Uppsala Monitoring Centre
ICSR reported on biotherapeutics
with biosimilars in Vigibase
TM
0%
20%
40%
60%
80%
100%
RituximabEtanerceptSomatropinFilgrastimInfliximab
Biosimilar
Non-Ref product
Ref product
Active substance

24. Malin Fladvad, Uppsala Monitoring Centre
ICSR reported on biotherapeutics
with biosimilars in Vigibase
TM

0
10000
20000
30000
40000
50000
60000
Drug substance
Trade name
Rituximab
Etanercept
Somatropin
Filgrastim
Infliximab

25. Malin Fladvad, Uppsala Monitoring Centre
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

26. Malin Fladvad, Uppsala Monitoring Centre
Thank you for your attention!
[email protected]