«Creation of a better medication safety culture in Europe: building up safe medication practices»

Transcription

1 «Creation of a better medication safety culture in Europe: building up» Dr Patrik Muff Pharmacien hospitalier FPH Pharmacien-chef clinicien Hôpital Fribourgeois - 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 death / year caused by medical errors of which 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

2 International patient safety initiatives 2002, May : World Health Assembly WHO 2004, October: WHO World Alliance for Patient Safety London Declaration (17 January 2006) 2005, April : EU, European Commission (DG Health and Consumer Protection) : 1 st conference on patient safety «Patient safety - making it happen - the European perspective» Luxembourg Declaration on Patient Safety (5 April 2005) 2005, February : European Commission + Council of Europe: project SIMPATIE «Safety IMprovement for PATIents in Europe» tool box of terms, indicators and instruments for improvement of safety 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

3 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 ; 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 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» ;

4 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. ; SP-SQS: Prevention of adverse events in health care, a system approach System approach POLITICS LEGISLATION ORGANIZATION / MANAGEMENT GROUP INDIVIDUAL WORK PLACE PRODUCT INTRINSIC EFFECT PHYSICAL DEVICE 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 4

5 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 ; 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 ;

6 2. Expert Group on Safe Medication Practices (origine) : Committee of Experts on Pharmaceutical Questions (P-SP-PH): Survey about medication errors in Europe 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, ), and establishment of a multidisciplinary expert group to carry out the programme 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: Technical Report «Creation of a better medication safety culture in Europe: building up»

7 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 (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.) 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

8 Top Level Actions (1/5) Top Level Actions (2/5) 8

9 Top Level Actions (3/5) Top Level Actions (4/5) 9

10 Top Level Actions (5/5) 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! 10