‘‘Patients at the Centre of Patient Safety ’’ Potilasturvallisuuspäivät Kaisa Immonen-Charalambous 19 March 2013 Potilasturvallisuuspäivät, Helsinki, Finland
Overview 1. Introduction to EPF 2. Part I: Our philosophy: the patients’ role in patient safety subtitle 3. Part II: Overview of the EU legislative framework and opportunities for patients’ involvement 4. Part III: EPF member survey on the Council Recommendation on patient safety 5. Conclusions & key messages
EPF – Who Are We?• Independent, non-governmental umbrella organisation set up in 2003• VISION: High-quality, patient- centred, equitable healthcare for all subtitle patients in the EU• MISSION: To provide a strong and united patients’ voice –> Putting patients at the centre of EU health policy• 57 member organisations – diverse chronic conditions across the EU – cross-cutting issues affecting all patients
EPF funding sourcesEuropean Commission – 80% of operating budget + co-funding of projects(PHP, FP7, CIP, IMI-JU)Unrestricted grants from commercial sector – 19% of operating budget +project portfolioMembership fees – 1.4% – annual fee structure ranging from 100-1000e subtitlebased on organisations annual turnoverEPF commitment to transparency and independence in all aspectsof our work: Code of Ethics and Framework for working withfunding partnersFull details of EPFs funding available at our website:http://www.eu-patient.eu/About-EPF/Economy/Balance-Sheet--Accounts/
EPF involvement in Patient Safety• EC Patient Safety & Quality Working Group – EC Communication (2008) and – Council Recommendation (2009) – Reflection paper on quality• Advocacy: EU legislation – Directive on patients’ rights in cross-border healthcare – Pharmacovigilance – Falsified medicines• EU Projects on patient safety – EUNetPas (2008-2011) – Joint Action PaSQ (2012-2015)• Building partnerships and collaboration with WHO, health professionals, other stakeholders
The changing role of patientsPatients moving from passive recipients of healthcare to active,involved & politicised actorsPatient-centredness is a key operating principle of EU health systemsBut big gap between theory and practice … subtitleEPF: involvement of patients in patient safety needed both atindividual and collective levels
“Patient safety – everyone’s business”1. Individual level:Individual patient’s experience of his/her healthcare “journey”Rich resource of information about gaps and failures in the systemPatients can contribute themselves – by getting actively involved intheir treatment subtitleImportant to support and empower: Information to patients Health literacy Communication with health professionals Professionals attitudes Patient-friendly healthcare environment
“Patient safety – everyone’s business”Important caveats:• Respect patients’ willingness to get involved – or not• Do not over-estimate patients’ capacity to get involved• Patients in vulnerable situation – no shifting of burden of subtitle “responsibility” on them• Patients already observe much – healthcare staff need to listen more, take their views seriouslyAppropriate support and enabling environment is key
“Patient safety – everyone’s business”2. Collective level:Patient organisations – role ininforming & educating patients andhealth professionalsEffective advocacy through access subtitle WHO Patients for Patient Safety programmeto the communityInvolvement in co-designing healthcare services to make themmore patient-centred & meet real-life needs and preferences ofpatients Important to involve patient organisations at policy level International, EU and Member States
EU legislative framework in patient safetyHealth: EU has limited competence – Article 168 TFEU – Responsibility for organisation of health systems and delivery of healthcare is with the Member States – Principles of subsidiarity & proportionality – Union action shall complement national policies subtitle Soft law & collaboration for exchange of best practicesBinding legislation (Reg & Dir) to harmonise MS laws in some areas of exception, e.g. medicines, devices, cross-border healthcare: – Article 168(4)(c) – “measures setting high standards of quality and safety for medicinal products and devices for medical use” – Article 114 – internal market
Council Recommendation (2009)“ 2. Empower and inform citizens and patients by: (a) involving patient organisations and representatives in the development of policies and programmes on patient safety at all appropriate levels; (b) disseminating information to patients on: (i) patient safety standards which are in place; subtitle (ii) risk, safety measures which are in place to reduce or prevent errors and harm, including best practices, and the right to informed consent to treatment, to facilitate patient choice and decision- making; (iii) complaints procedures and available remedies and redress and the terms and conditions applicable; (c) considering the possibilities of development of core competencies in patient safety namely, the core knowledge, attitudes and skills required to ” achieve safer care, for patients.
Joint Action PaSQ (2012-2015)• Following EUNetPas project (2008-2011)• Developing permanent collaboration between EU Member States in the field of quality of care incl. patient safety: – support MS in implementing the Council Recommendation – enhanced cooperation between MS in the field of quality subtitle – sharing of good practices in patient empowerment and involvement• EPF is involved as Associate Partner in all core WPs• Looking at good organisational practices (GOP) and good clinical practices (SCP) involving patients• www.pasq.eu
EU Pharmacovigilance legislation Directive 2010/84 and Regulation 1235/2010Amending Directive 2001/83/EC (nationally authorised products, common provisions) andRegulation (EC) No. 726/2004 (centrally authorised products, European Medicines Agency)• Rules apply from: 2/12 July 2012• Member States audit of their PhV systems: September 2013 subtitle• NEW: 2 patient representatives in EMA PRAC (Pharmacovigilance Risk Assessment Committee)• NEW: direct patient reporting of ADRs in all EU MS – web + other forms• EPF 2012 toolkit on pharmacovigilance: guidance and recommendations
Directive on Cross-Border Healthcare • Directive 2011/24/EU requires Member States to: – Make publicly available their safety and quality standards & guidelines; – cooperate with each other on improving safety and quality standards; – ensure information on health professionals’ right to practise is given to other Member States subtitle • National Contact Points must provide patients all relevant info “to enable them to make an informed choice” • EU legal basis for future actions in: safety & quality, eHealth, HTA, European Reference Networks closer cooperation between Member States, more transparency, more patient involvement. • EPF toolkit: guidance and recommendations
A need and an opportunityNew EU pieces of legislation = a need and an opportunity toincrease patients’ engagement with PS and patients’ collectiveinvolvement at policy level• Need: ensure laws are implemented in a way that is patient- centred and meets patients’ needs subtitle• Opportunity: foster patient involvement and patient-health professional collaboration a cultural shift towards more patient-centred health systems, public trust in the system• More research needed to define best practices in patient involvement in PS• Patient organisation involvement in policy: Value+ model
Meaningful patient involvement“patients take an active role … because of their specific knowledge and relevant experience as patients.”“ Involvement must be planned, appropriately resourced, carried out, and evaluated according to the values of all participants”.
Value + model of patient involvementThe tools: For patients: to become more involved in EU funded projects, including research projects For project promoters: to facilitate patient involvement in practice For policy-makers: highlight areas for action towards patient-centred policies + comprehensive Directory of Patient Organisations in every EU member state, literature review, etc.
EPF survey on Council Recommendation• Autumn 2012-Spring 2013• Exploring perceptions of EPF member organisations• Focus on awareness of EU recommendations, patient subtitle organisations’ involvement at MS level, assessing priorities• Ongoing online survey• Work in progress: interim results!
Survey status (March 2012) Responses received: Responses not received: Bulgaria (2) Austria Czech Republic Belgium Cyprus Denmark Estonia Germany France Italy Greece Lithuania Hungary subtitle Luxembourg Ireland Malta Latvia Portugal Netherlands Finland Poland (2) Romania Slovenia Slovakia Spain (2) Sweden United Kingdom International organisations (2) European based organisations (2)
Awareness of the CRDid you know about the Council Recommendation before thissurvey? subtitle 58,3% (14)Yes 41,7% (10)No answered question 24
Awareness (2)If yes, how did you find out about the Council Recommendation?from the news 6,7% 1from the European Patients’ Forumsubtitle 80,0% 12from an information campaign dedicated to theCouncil Recommendation developed in my 0,0% 0countryinformation from the organization I represent 13,3% 2Other (please specify) 20,0% 3 answered question 15
ImplementationWhich aspects of the Council Recommendation are in place in your country, as far as you know? ResponseAnswer Options Yes No I do not know Count 14 4 5 23national/regional policy/programme on patient safetydesignation of a national authority or body responsible 13 3 7 23for patient safetypatient safety as a priority issue in health policies 13 6 4 23development of safer systems, processes and tools subtitle 13 1 9 23regular update of patient safety standards 8 7 8 23involving health professional organisations in patient 13 4 6 23safetypromotion of safe practices 14 4 5 23empowering and informing citizens and patients 7 8 8 23creation of blame-free reporting and learning systems on 7 8 7 22harmful eventseducation and training of health care workers on patient 10 6 6 22safetyworking with European Commission and other member 7 2 13 22states to measure patient safetyworking with European Commission and other member 6 2 14 22states sharing knowledge and best practicesnational research initiatives on patient safety 5 5 12 22
Patient organisation involvement What was the role of your organization in realising the actions (if any)? Please tick as many options as apply: 60,0% 50,0% 47,8% 47,8% 40,0% subtitle 30,4% 30,0% 26,1% 20,0% 17,4% 10,0% 4,3% 0,0% actions for the Monitoring the None Other (please Being involved in Being part of the the consultation implementation actions in the information Developing interest of procedures specify) patients patients actioneveloping information actions for the patientsthe consultation procedures action Other (please specify) Monitoring the actions in the interest of patients None of the Being involved in Being part implementation
InformationThe 3 main sources of information about patient safetyavailable in your country: 1. Internet Yes 16,7% No subtitle 83,3%2. Your organsation/ other patient 3. Health professionals during face- organisations to-face consultations 37,5% 50,00% 50,0% 62,50%
Information (2) Are patients in your country informed on the following: 25 20 10 Yes 15 8 19 17 subtitle 8 10 No 5 6 5 5 I do not 2 5 6 know 4 5 2 1 0 informed consent? practices that exist in patients if something patients if something that are in place to reduce or prevent the Safety actions actions and/or best patients’ right to medical errors? compensation for the Patient safety standards and/or procedures for your country? goes wrong? goes wrong? complaints availablepatients’ right to informed consent? if somethingSafetywrong?actions and/or best practices that exist medical errors? complaints procedures for patients safety standards and/or that are wrong? to reduce or prevent in availablethe Patient compensation for patients if something goes in place the goes actions your country?
PrioritiesIn your opinion which 3 actions out of 13 from the CouncilRecommendation are the most important?national/regional policy/programme 11 3 1 65.22% subtitleon patient safetypatient safety as a priority issue in 10 2 5 73.91%health policiesempowering and informing citizens 9 6 1 69.57%and patients
Key competences for patients “Information, guidance, empowerment, health literacy”“Knowledge about patients rights and conviction about their enforceability” “Better communication about p. safety to patients via all media forms” subtitle “More information in the hospitals, in primary care”“Information on patient safety and the possibility to report on side effects”“Understandable information and control body/mechanisms” “Education, seminars” “A genuine partnership with patient input made from the start”
Key competences for patientsDoes your country provide training Do patient organisations provideor education for patients in these education for patients in patient skills? safety? subtitle Yes Yes 21,7% 17,4% 20,8% No No 16,7% I do not 62,5% I do not 60,9% know know
Requests from EPF members What in your opinion would help the implementation of the Council Recommendation in your country? 70,0% 65,2% 60,0% 56,5% 56,5% 47,8% 47,8% 50,0% 40,0% subtitle 30,0% 20,0% 10,0% 4,3% 0,0% information/communi Other (please specify) Involving patients and Stronger advocacy by the national/ regional/ promoting the Council patient organisations citizens in promoting designated authority Better promotion at Recommendation Recommendation cation campaign local level by the Involving health professionals in Organising an the Councilng patients and citizensprofessionals in Stronger advocacy by patientnational/ regional/ local level b Involving health in promoting the Council promotion at the organisations (please specify) Organising an information/communication campaign Other promoting the Council Better
EPF survey shows:• 42% of respondents are unaware of the CR…• … but many respondents had some role in developing patient safety information or participating in consultations• Patient involvement poorly implemented subtitle• EPF by far the most common source of information (80%) followed by patient organisation at national level (13%)• Patient organisations = important source of capacity-building for patients• 65% recommend involving patients and citizens more in promoting patient safety in their country
Conclusions & key messages• Empowered patients can drive change – BUT requires • Much better information and empowerment of patients and citizens • Attitudinal changes, new skills from health professionals subtitle• “Health literate” patients needs “patient literate” health professionals• Collective patient involvement in (re)designing healthcare organisation and delivery more patient-centred empowering the individual healthcare user
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Patient/public empowerment“A multi-dimensional processcapacity of people to actcontrol over their own lives and increases the that helps people gain on issues that they themselves define as important. ” (Luttrell et al. (2009), Understanding and operationalising empowerment. Overseas Development Institute working paper.)“A process through which individuals and social groups are ablefor subtitle to express their needs, present their concerns, devise strategies involvement in decision-making, and take political, social, and cultural action to meet those needs. ” (Deepening our Understanding of Quality improvement in Europe; http://www.duque.eu/) Elements: Information – Informed consent – feedback loop – enabling and supportive healthcare environment – health professional’s training
Patient/public involvement“ The extent to which patients and their families or caregivers, whenever appropriate, participate in decisions related to their condition (e.g. through shared decision-making, self-management) and contribute to organisational learning through their specific experience as patients (e.g. patient reporting of adverse events or participation in root cause analysis related to their care). subtitle Collective patient/public involvement is the extent to which patients and citizens, through their representative organisations, contribute to shaping the health care system through involvement in health care ” policy-making, organisation and delivery. (European Patients Forum for PaSQ, adapted from the Value+ project: http://www.eu-patient.eu/Initatives- Policy/Projects/EPF-led-EU-Projects/ValuePlus/ Levels: Consultation Collaboration User-Led