La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
« Creation of a better medication
safety culture in Europe:
building up safe medication practices »
http://www.coe.int/t/e/social_cohesion/soc-sp/Medication%20safety%20culture%20report%20E.pdf
Dr Patrik Muff
Pharmacien hospitalier FPH
Pharmacien-chef clinicien
Hôpital Fribourgeois - site de Riaz
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
The Big Bang
US Institute of Medicine of the
US National Academy of Sciences,
Committee of Quality on Health Care
in America
44’ - 98’000 death / year
caused by medical errors
of which
7’000 death / year caused
by medication errors !
Kohn LT et all. To err is human - building a safer health system. Report of the Institute of Medicine. 1999; Nat. Academy Press
1
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
International patient safety initiatives
•
•
2002, May : World Health Assembly x WHO
2004, October: WHO x World Alliance for Patient Safety
x London Declaration (17 January 2006)
•
2005, April : EU, European Commission (DG Health and Consumer Protection) : 1st conference on patient safety
« Patient safety - making it happen - the European perspective »
x Luxembourg Declaration on Patient Safety (5 April 2005)
•
2005, February - 2007: European Commission + Council of Europe:
project SIMPATIE « Safety IMprovement for PATIents in Europe »
x tool box of terms, indicators and instruments for improvement of safety
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
Council of Europe:
Some facts and figures
•
•
•
•
•
•
Founded on 5 May 1949 by the treaty of London
Head quarter in Strasbourg (F)
Aim: achieve a greater unity between its members and develop
common and democratic principles
Since 11 May 2007: 47 member states
(1 applicant countries: Belarus;
5 observer countries : the Holy See, the United States, Canada, Japan, Mexico)
Main components:
• Committee of 47 foreign ministers (decision making body)
• Parliamentary Assembly (318 members (x2) )
• Congress of Local and Regional Authorities
• Secretariat (1800 collaborators)
Swiss representatives
• Permanent: Mr Jean-Claude Joseph (extraord. ambassador)
• Minister of foreign affairs: Ms Micheline Calmy-Rey
www.coe.int/T/E/Com/About_Coe/Member_states/default.asp; 4.9.2007
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
Council of Europe’s
two patient safety initiatives
Directorate General of Social Cohésion (DG III)
Activities
Health Policy
StCo: European Health Committee (CDSP)
ad hoc Committee of Experts on Management of
Safety and Quality in Health Care (SP-SQS)
Partial Agreements
Social and Public Health Field *
StCo: Public Health Committee (Partial Agreement) (CD-P-SP)
Committee of Experts on Pharmaceutical Questions (P-SP-PH)
ad hoc Expert Group on Safe Medication Practices
* Sept. 2007: 18 member states: Austria, Belgium, Bulgaria, Cyprus, Finland, France, Germany,
Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland,
United Kingdom. 7 observer states: Estonia, Hungary, Iceland, Latvia, Lithuania, Poland; Canada
www.coe.int/T/E/Social_cohesion ; 4.9.2007
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
SP-SQS: Prevention of adverse events
in health care, a system approach
1. Committee of Experts on Management of Safety and Quality
in Health Care (SP-SQS)
•
Committee: Experts of the governments of (all) member states;
representatives of the European Commission, of the observers states and of
inter- and non-governamental organisations
•
Timing: from spring 2003 to adoption of the final report by the
Committee of Ministers on 24 May 2006 at the 965th meeting of
the Ministers’ Deputies
x Political Statement: Recommendation Rec(2006)7 of the
Committee of Ministers to member states on
« Management of patient safety and prevention of adverse
events in health care, a system approach »
https://wcd.coe.int/ViewDoc.jsp?id=1005439&BackColorInternet20=9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC75 ; 10.9.2007
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
SP-SQS: Prevention of adverse events
in health care, a system approach
The committee of experts of Experts on Management of Safety and Quality in
Health Care (SP-SQS) is required to:
• Make an ANALYTICAL INVENTORY of the range of existing MEASURES FOR
systematically analysing and IMPROVING THE SAFETY AND RISK MANAGEMENT
in health care institutions.
• Make a SYSTEMATIC REVIEW of the advantages and disadvantages of mandatory and
voluntary REPORTING SYSTEMS, in the light of the legal implications and their
effectiveness, including linkages to patients’ complaints systems.
• Examine the IMPACT OF DISCLOSURE AND REPORTING of adverse events and
errors on the PATIENT – HEALTH CARE PROVIDER RELATIONSHIP.
• Propose EDUCATIONAL (graduate and postgraduate) MEASURES to improve the
understanding of medical decision making, risk assessment and adequate behaviour in
the case of adverse events and errors;
• Propose a model framework for a system of disclosure, assessment and prevention of
errors and events in order to CONTINUOUSLY IMPROVING SAFETY AND QUALITY
of the health care system and the health care delivery to the individual patient;
• Propose the IMPLEMENTATION MEASURES at all levels of health care system.
https://wcd.coe.int/ViewDoc.jsp?id=1005439&BackColorInternet20=9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC75 ; 10.9.2007
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
SP-SQS: Prevention of adverse events
in health care, a system approach
System approach
POLITICS
LEGISLATION
ORGANIZATION / MANAGEMENT
INTRINSIC EFFECT
PHYSICAL DEVICE
GROUP
INDIVIDUAL
WORK PLACE
PRODUCT
PHYSICAL ERGONOMICS
INDIVIDUAL
BEHAVIOUR
TEAM AND GROUP
BEHAVIOUR
ORGANIZATIONAL AND
MANAGEMENT BEHAVIOUR
LEGAL AND
REGULATORY RULES
SOCIETAL AND
CULTURAL PRESSURES
Gaines RB, Moray N. Development of performance measures for computer-based man-machine interfaces. DCIEM-PER-FIN 1985, Downsview, Ontario.
Cited by: Moray N. Error reduction as a systems problem. In: Bogner MS (ed). Human error in Medicine. Hillsdale, NJ: Lawrence Erlbaum Associates
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
SP-SQS: Prevention of adverse events
in health care, a system approach
Table of contents
A. Prerequisites
B. Cultures of safety / Environment
C. Assessment of patient safety - the rôle of indicators
D. Data sources - reporting systems
E. Medication safety - a specific strategy to promote patient safety
F. Human factors
G. Patients’ enpowerment and citizens’ participation
H. Patient safety education
I. Research agenda
J. Legal framework
K. Implementation of the patient safety policy
https://wcd.coe.int/ViewDoc.jsp?id=1005439&BackColorInternet20=9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC75 ; 10.9.2007
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
SP-SQS: Prevention of adverse events
in health care, a system approach
E. Medication safety - a specific strategy to promote patient safety
Principal « political » messages :
1. consequences of medication errors (ME) = public health issue
2. medication safety = ADR + ME, but ADR ≠ ME
3. definition of ME: following NCC MERP
4. key dimensions for ME prevention: organisation, structure, safety
culture, indicators, staff education in RM
5. recognised national focal points for SMP (+ pharmacovigilance)
6. importance of committment of European Health Authorities
7. necessity of an assessment of ME in Europe
8. improvement of medication use systems by safer : naming, labelling
and packaging; selection and procurement; storage; prescribing;
preparation; dispensing; administration; monitoring; drug
information; patient education; communication + principal measures
https://wcd.coe.int/ViewDoc.jsp?id=1005439&BackColorInternet20=9999CC&BackColorIntranet=FFBB55&BackColorLogged=FFAC75 ; 10.9.2007
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
2. Expert Group on Safe Medication Practices (origine)
• 2001-2002: Committee of Experts on Pharmaceutical
Questions (P-SP-PH):
Survey about medication errors in Europe
• 21-22 November 2002, Den Haag, The Netherlands:
P-SP-PH + WHO/Regional office for Europe:
first scientific expert meeting to share experience, to create
a network, and to establish a work programme for Europe.
Results: establishment and adoption of a consensus document
(vision statement, 13.11.2003), and establishment of a
multidisciplinary expert group to carry out the programme.
http://www.coe.int/t/e/social_cohesion/soc-sp/Medication%20safety%20culture%20report%20E.pdf; 10.9.2007
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
2. Expert Group on Safe Medication Practices
•
Members
Pharmacists Prof. Marja AIRAKSINEN, University of Helsinki, FIN (Chair)
Dr. Maria-Jose OTERO, Hospital Pharmacist, Vice President ISMP, E (Co-Chair)
Dr. Etienne SCHMITT, Co-ordinator of REEM Network, F (editor)
Prof. David COUSINS, Head of Unit SMP, National Patient Safety Agency, UK
Mrs Ida GUSTAFSEN, EuroPHARM Forum Manager, WHO, DK
Dr. Michael HARTMANN, University Hospital, DE
Dr. Patrik MUFF, Clinical Pharmacist, CH
Stein LYFTINGSMO, Hospital Pharmacist, NO
Ass Prof Jiri VLCEK, Charles University, Faculty of Pharmacy, EA Clin Pharmacol, CZ
Physicians
Dr. Carl Erich THORS, Secretary General European Union of GPs, SE
Nurses
(none)
•
Timing:
11.2003 - 11.2006
x Technical Report « Creation of a better medication safety
culture in Europe: building up safe medication practices »
http://www.coe.int/t/e/social_cohesion/soc-sp/Medication%20safety%20culture%20report%20E.pdf; 10.9.2007
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
• First international report on medication safety with special
focus on Europe
• Structure (274 pages) :
- Executive summary (5 p.)
- Top Level Actions (3 p.)
- 6 chapters (including initial 1-2 pages of key points) :
- Introduction (17 p.)
- Ch. I:
Learning from medication errors (23 p.)
- Ch. II: Assessing safe medication practices (15 p.)
- Ch. III: Improving safety of naming, labelling,
and packaging (31 p.)
- Ch. IV: Improving the safety of the medication use system (28 p.)
- Ch. V: Safer medicine information practices (35 p.)
- 9 appendices (89 p.)
- Lists and bibliography (18 p.)
http://www.coe.int/t/e/social_cohesion/soc-sp/Medication%20safety%20culture%20report%20E.pdf; 10.9.2007
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
- Appendices :
1 : CoE Rec(2006)7 on management of patient safety and
prevention of adverse events in health care
2 : CoE Committee of Experts on Pharmaceutical Questions’
Expert Group on Safe Medication Practices - Vision statement
3 : Glossary of terms related to patient and medication safety
4 : European evidence on medication errors (ADE, M adm E)
5 : Existing Medication Error Reporting Systems (outside Europe,
national MERS in Europe)
6 : Safety assessment template on label information and packaging
7 : Information on dispensing labels
8 : Machine readable codes (GTIN, barcodes, RFID)
9 : Key list of standard and best practices for preventing medicines
errors and improving medication safety
http://www.coe.int/t/e/social_cohesion/soc-sp/Medication%20safety%20culture%20report%20E.pdf; 10.9.2007
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
Top Level Actions (1/5)
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
Top Level Actions (2/5)
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La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
Top Level Actions (3/5)
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
Top Level Actions (4/5)
9
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
P-SP-PH/SAFE: Building up
safe medication practices
Top Level Actions (5/5)
La sécurité des patients en Suisse : Congrès 13-14 septembre 2007
Council of Europe report « Creation of a better medication safety
Culture in Europe: Building up safe medication practices »
Dr Patrik Muff, Pharmacien-chef clinicien, HFR - site de Riaz
Conclusions
1. CoE initiatives = first committments of European
governments for patient and medication safety
2. CoE « medication safety culture report »:
numerous evidence based measures and tools
but no cookbook-solutions !
Medication risk prevention stategies have to be
adapted to national, regional and local environment !
http://www.coe.int/t/e/social_cohesion/socsp/Medication%20safety%20culture%20report%20E.pdf
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