1. Patient safety and pharmacovigilance: the role of Community pharmacists Flora Giorgio-Gerlach Secretary General PGEU

2. European Health Forum Gastein 6 th October 2005 Contents  PGEU introduction  Patient safety and pharmaceuticals  The role of pharmacists in enhancing safety Pharmacovigilance  Conclusions

3. European Health Forum Gastein 6 th October 2005

4. PGEU Introduction - objectives  Facilitate exchange of information between pharmacy associations on the regulatory framework and pharmacy practice  To promote at European level the role of the pharmacist as a key player in healthcare  PGEU Mission Statement

5. European Health Forum Gastein 6 th October 2005 Patient safety and pharmaceuticals National Patient Safety Alliances HLG – Patient Safety WG EU Presidency LUX Declaration – April 2005 European Health Forum Gastein EU Presidency UK Summit – November 2005

6. European Health Forum Gastein 6 th October 2005 Patient safety and pharmaceuticals EU Presidency LUX Declaration – April 2005 PS in primary settings  Pharmaceuticals  Regulatory Framework  Pharmacovigilance  Correct use of medicines EU Open Forum Workshop 2; 7-8 November 2005

7. European Health Forum Gastein 6 th October 2005 Pharmacovigilance today  5-10% of patients have ADRs (Moore et coll. 1998)  ADRs 4 th cause of death in USA (Lazarou et coll. JAMA, 1994)  30-130 billion dollars/year due to ADRs (Such et coll. Ann. Pharm.2000) Does it work ? Better “use of pharmacists” !

8. European Health Forum Gastein 6 th October 2005 Pharmacist's contribution I  Training “Expert in medicinal products” EU Directive 2005/37/EC Why Pharmacists?  Professional role Dispensing  link with patient  link with authorities/prescribers Trusted  Readers Digest 2005 “Most trusted professional services”

9. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution II  Easy accessible – 1 pharmacy/3400 inhab. (PGEU Database 2004; EU Average) Why Pharmacists ?

10. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution III Why Pharmacists ?  Highly IT literate

11. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution IV  Pharmacists reporting reflects patients concerns  Pharmacists reporting is of high quality (van Grootheest et al. Pharm World sci ; 2004: 26;155-159) But …. Why Pharmacists ?

12. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution V  Regulatory issues  uncertainty … reporting by pharmacists is low  Responsibility/role  conflicts with medical profession  Training  too little focus on “practice”

13. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution … reporting by pharmacists is low ADD CHART

14. European Health Forum Gastein 6 th October 2005 Pharmacists’ contribution VI  Address Regulatory Issues national/EU  Pharmacists in ADRs schemes  Enhance Practice  Raise awareness + IT support tools strengthen communication with patients  using CPD  Promote collaborative care approach  Promote “practice-oriented” training The objective of the profession

15. European Health Forum Gastein 6 th October 2005 Conclusions  Pharmacist role is evolving from “product-focus” to “patient-focus” People should continue to trust medicines Pharmacists can help!  New role a great asset to: Enhance pharmacovigilance Ensure effective medicines management, including enhance concordance

16. European Health Forum Gastein 6 th October 2005 Thank you Flora Giorgio-Gerlach PGEU www.pgeu.org