1 Establishing a Pharmacovigilance Centre Sten Olsson the Uppsala Monitoring Centre

2 Decide about a Plan location organisation funding staffing reporting form + routines equipment promotion feed-back use of data

3 Affiliation drug regulatory authority university institution hospital department poison information or drug information centre association of professionals

4 Integrate systems needing similar competence and resources drug information poison information pharmacovigilance

5 Organisation Centralised Regional Centres

6 Where to report? Patient Health Professional Regional Centre Manufacturer Hospital DTC National Centre

7 Gains and losses in report chain Patient Hospital DTC Facts Judgement Speed Reports Speed Reports Facts Judgement Health Professional

8 Where to report? Patient Health Professional Regional Centre Manufacturer Hospital DTC National Centre

9 Countries with decentralised reporting system Argentina Brazil Canada China Cuba France Italy India the Netherlands Poland Portugal Russia Spain Sweden Thailand United Kingdom 16 of 73 member countries

10 Support political economical stable and on a long-term basis

11 Staff pharmaceutical competence medical competence secretarial assistance dedication education –formal training course –visit established centre

12 Centre facilities computer with printer word processor report recording system literature sources telephone, fax, internet access photocopier

13 Routines who should report? what should be reported? voluntary or mandatory reporting? coding system method of causality assessment

14 Mandatory Reporting for Health Professionals Austria Bulgaria Croatia Czech Republic France Greece Hungary Italy Mongolia Morocco Norway Oman Russia Slovak Republic Spain Sweden

15 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

16 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

17 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

18 Highest reporting rates More than 200 reports/ million inhabitants/year –Australia –Denmark –Cuba –Ireland –the Netherlands –New Zealand –Norway –Sweden –United Kingdom –USA

19 Use of data method of signal identification establishment of advisory committee feed-back routines –individual response –adverse reactions newsletter –web site educational activities

20 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

21 Relationships to consider drug regulatory authority public health programmes pharmaceutical companies journalists academic institutions professional associations pharmacovigilance centres in other countries consumer and patient organisations