16. Malin Fladvad - Uppsala Monitoring Centre
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Transcript of 16. Malin Fladvad - Uppsala Monitoring Centre
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
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
Malin Fladvad, Uppsala Monitoring Centre
Individual Case Safety Report (ICSR)
VigiBaseTM
Malin Fladvad, Uppsala Monitoring Centre
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
The UMC signal detection process
Clinical assessment: Review Panel
(or UMC)
Pharma Company
’Follow-up’ or ’Not signal’ Triage
Literature check
Potential signals
VigiBaseTM
National Centre
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.
Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionaries
Malin Fladvad, Uppsala Monitoring Centre
VigiBaseTM VigiLyze
National Centre
VigiFlowTM
Users of WHO Drug Dictionaries
Doctors & Patients
Malin Fladvad, Uppsala Monitoring Centre
Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionaries
• A source of international drug (trade) names
260 000 product namnes 2 million entries
Malin Fladvad, Uppsala Monitoring Centre
ICSR mapping
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
Malin Fladvad, Uppsala Monitoring Centre
WHO DD DRL
WHO DDE
WHO DDE+
HD
DDC
CRT Japan
SDGs
The WHO Drug Dictionaries
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
Malin Fladvad, Uppsala Monitoring Centre
Coding using the WHO Drug Dictionaries
Reditux
Mabthera Kikuzubam
Rituximab
Rituxan
Tidecron
Malin Fladvad, Uppsala Monitoring Centre
Reditux
Mabthera Kikuzubam
Rituximab
Rituxan
The added value of WHO Drug Dictionaries
Tidecron
Malin Fladvad, Uppsala Monitoring Centre
WHO Drug Dictionary structure using current WHO Policy (INN)
Reference product
Biosimilar
Active substance,
Biosimilar
Reference product
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
Malin Fladvad, Uppsala Monitoring Centre
ICSR Reports on biotherapeutics in VigibaseTM
Drug group Number of ICSR
Biotherapeutics 1 531 822
All 8 480 965
Malin Fladvad, Uppsala Monitoring Centre
ICSR per year reported on biotherapeutics with biosimilars in
VigibaseTM
0
10000
20000
30000
40000
50000
60000
Rituximab Etanercept Somatropin Filgrastim Infliximab
Malin Fladvad, Uppsala Monitoring Centre
ICSR per regional area reported on biotherapeutics with biosimilars in
VigibaseTM
0
50000
100000
150000
200000
250000
Africa LatinAmerica
NorthAmerica
Asia Europe Oceania
Rituximab Etanercept Somatropin Filgrastim Infliximab
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
Malin Fladvad, Uppsala Monitoring Centre
ICSR reported on biotherapeutics with biosimilars in VigibaseTM
0%
20%
40%
60%
80%
100%
Rituximab Etanercept Somatropin Filgrastim Infliximab
Biosimilar
Non-Ref product
Ref product
Active substance
Malin Fladvad, Uppsala Monitoring Centre
ICSR reported on biotherapeutics with biosimilars in VigibaseTM
0
10000
20000
30000
40000
50000
60000
Drug substance
Trade name
Rituximab Etanercept Somatropin Filgrastim Infliximab
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