Transcript Causality assessment

Establishing a
Pharmacovigilance Centre
Sten Olsson
the Uppsala Monitoring Centre
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Decide about a Plan
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location
organisation
funding
staffing
reporting form +
routines
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equipment
promotion
feed-back
use of data
Affiliation
• drug regulatory authority
• university institution
• hospital department
• poison information or drug
information centre
• association of professionals
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Integrate systems needing similar
competence and resources
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drug information
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poison information
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pharmacovigilance
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Organisation
• Centralised
• Regional Centres
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Where to report?
Hospital
DTC
Patient
Regional
Centre
Health
Professional
National
Centre
Manufacturer
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Gains and losses in report chain
Patient
Speed
Reports
Speed
Reports
Health
Professional
Hospital
DTC
Facts
Judgement
Facts
Judgement
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Where to report?
Hospital
DTC
Patient
Regional
Centre
Health
Professional
National
Centre
Manufacturer
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Countries with decentralised
reporting system
16 of 73 member countries
 Argentina
 Brazil
 Canada
 China
 Cuba
 France
 Italy
 India
 the Netherlands
 Poland
 Portugal
 Russia
 Spain
 Sweden
 Thailand
9  United Kingdom
Support
• political
• economical
stable and on a long-term
basis
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Staff
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pharmaceutical competence
medical competence
secretarial assistance
• dedication
• education
– formal training course
– visit established centre
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Centre facilities
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computer with printer
• word processor
• report recording system
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literature sources
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telephone, fax , e-mail
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internet access
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photocopier
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Routines
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who should report?
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what should be reported?
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voluntary or mandatory
reporting?
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coding system
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method of causality assessment
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Mandatory Reporting for
Health Professionals
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Austria
Bulgaria
Croatia
Czech Republic
France
Greece
Hungary
Italy
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Mongolia
Morocco
Norway
Oman
Russia
Slovak Republic
Spain
Sweden
Methods to stimulate
reporting by professionals
• Facilitate access to reporting forms
• Facilitate reporting
• Acknowledge receipt of report
• Feedback
• Publication in medical journals
• Participation in scientific conferences
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Methods to stimulate
reporting by professionals
• Include ADR monitoring in curricula
• Set up regional centres
• Engage drug/therapeutics committees
• Approach professional associations
• Support development of clinical
pharmacology/pharmacy
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Methods to stimulate
reporting by patients
• Approach patient associations
• Publication in lay press
• Include in patient drug information
advice to report to doctor
• Telephone medicines information
service
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Highest reporting rates
• More than 200 reports/ million
inhabitants/year
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Australia
Denmark
Cuba
Ireland
the Netherlands
New Zealand
Norway
Sweden
United Kingdom
USA
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Use of data
• method of signal
identification
• establishment of advisory
committee
• feed-back routines
– individual response
– adverse reactions newsletter
– web site
• educational activities
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Use of data (2)
• National Centre
– follow-up
cases
– preliminary
case
assessment
– recording
– carry out
actions
• Advisory Committee
– final case
assessment
– promote reporting
– analyse problems
– propose actions
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Relationships to consider
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drug regulatory authority
public health programmes
pharmaceutical companies
journalists
academic institutions
professional associations
pharmacovigilance centres in other
countries
• consumer and patient
organisations
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