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Patient Safety: A Priority for the European Commission
Mr Lee McGillHealth and Consumers Directorate-General
European Commission
Royal College of Physicians Roundtable MeetingLondon, 21 July 2008
The need for action on patient safety
Despite the aim across Europe to provide safe, high quality healthcare,
there is an increasing awareness that patients receiving care can incur injuries and adverse events as a consequence of receiving healthcare;
only a few EU Member States have collected information on the prevalence of adverse events, so data on safety levels and the associated economic costs of unsafe care is either partial or does not exist at all in many Member States;
studies and research that have been carried out up until now suggesting sizeable health costs and economic costs arising from adverse events.
Experience and common sense suggest that targeted programmes, policies and initiatives can improve patient safety levels.
Extent of the problemThe UK Department of Health, in its 2000 report, An organisation with a memory, estimated that adverse events occur in around 10% of hospital admissions or about 850 000 adverse events a year.
It is estimated that between 6.7 and 15 million hospital admissions and over 37 million consultations in the primary care setting result in an adverse event for the patient as a result of receiving that healthcare in EU27.
Table 2: Prevalence and burden of adverse event mortality
Adverse care events Adverse drug events
Total deaths
Deaths per 100,000
Years lost /100,000
Total deaths
Deaths per 100,000
Years lost /100,000
EU-27
Austria 99 1.0 16 4 0.0 1
Czech Republic 5 0.0 0 3 0.0 0
Denmark 6 0.1 1 - - -
France 492 0.5 2 848 0.9 3
Germany 635 0.5 5 72 0.1 1
Greece 128 0.9 11 2 0.0 0
Hungary 30 0.2 4 4 0.0 1
Ireland 17 0.4 8 3 0.1 2
Italy4 347 0.4 4 11 0.0 0
Luxembourg 1 0.2 1 2 0.4 3
Netherlands 17 0.1 0 3 0.0 0
Poland 232 0.5 5 22 0.1 1
Portugal 23 0.2 1 13 0.1 1
Slovakia 4 0.1 0 1 0.0 0
Spain 255 0.5 5 264 0.4 2
Sweden 120 0.6 1 9 0.1 0
UK 413 0.5 3 36 0.0 1 No data available for: Belgium, Bulgaria, Cyprus, Estonia, Finland, Latvia, Lithuania, Malta, Romania,
Slovenia
International
USA 2460 0.7 6 317 0.1 2
Australia 176 0.7 2 47 0.2 2
New Zealand 8 0.2 4 5 0.1 3
Canada 197 0.5 4 22 0.1 0
Japan 424 0.2 3 76 0.0 1 Source: OECD Health Data 2007
Legal basisArticle 152 (public health)
“Community action, which shall complement national policies, shall be directed towards [..] preventing human illness and diseases, and obviating sources of danger to human health. [..]
The Community shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. [..]
Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.”
EU added value? - Commission involvement in patient safety to date
Patient Safety Working Group of the High Level Group on Health Services and Medical Care.
Recommendation on Patient safety by patient Safety Working Group (October 2007).
Community co-funded patient safety projects.
Current EC Policies and legislation.
Original basis of the Commission’s planned patient safety initiative
Commission Legislative and Work Programme 2008
Strategic initiatives
Health package
a) Communication and Council Recommendation on Patient Safety and Quality of Health Services
b) Council Recommendation on health care associated infections
Merging
Communication and Council Recommendation on Patient Safety and Quality of Health Services
++Council Recommendation on health care
associated infections
↓↓↓↓Communication and Council Recommendation on patient safety and quality of health services, including the prevention and control of healthcare-associated infections
Timing (2008)Impact Assessment paper submitted to the Impact Assessment Board (IAB) - 13 June
IAB opinion - 14 July
Inter-service consultation – September/October
Adoption of the Communication & Proposal for a Council Recommendation by the Commission - end of November
Commission Communication
A Communication would provide an overarching structure for the Community's many initiatives on patient safety.
It could address the overall cultural, leadership, systemic, communication and process barriers to improved patient safety.
It would map findings and good practice principles on patient safety to be applied in the EU and highlight the need for further action.
Council Recommendation (CR)
A CR could include recommendations on systemic patient safety issues and specific recommendations on the prevention and control of HAIs.
A CR would represent a strong political commitment to addressing patient safety and HAIs.
A CR allows for monitoring and evaluation of the recommended measures.
EU initiative vs MS actions?
A 'soft law' Council Recommendation, will allow Member States sufficient freedom to organise health care nationally as they do at present, while addressing this major challenge of improving patient safety according to agreed best practice.
Sources of Information for the Recommendation
Public consultation on patient safety (May 2008).
Recommendation from the PSWG.
Recommendation Rec(2006)7 of the Council of Europe to member states on management of patient safety and prevention of adverse events in health care (May 2006).
Expert Group on HAIs.
Purpose of the public consultation
The results will help in the development of the systemic patient safety aspects of Commission's proposals on patient safety issues planned for the end of 2008.
That proposal will address the important issue of patient safety throughout the European Union (EU) and will include a detailed first pillar, addressing healthcare-associated infections (HCAI), on which separate public consultations have already been held.
The consultation - timings
Open from 25 March – 23 May 2008
Final report by the end of the summer
Participants in the public consultationParticipants total 185 (+ off-line responses)
Competent authorities (CAs) total including CAs national level including CAs regional level including CAs local level
3216
(CY;CZ;DE;FR;IE;LV;MT;SE;UK;GR)
115
NGOs 35
Health Professional Associations 25
Hospitals 20Patient organisations 8Consumer organisations 3Industry 8
Academia 6
Other 9
Anonymous responses 39
UK participants
Department of HealthRoyal College of Physicians, LondonRoyal College of NursingGeneral Medical CouncilGeneral Osteopathic CouncilNursing and Midwifery CouncilNorth Lancashire PCTCragavon Area Hospital, NIGreater Glasgow and Clyde NHS Trust, ScotlandHealthcare CommissionNHS Confederation EU OfficeMedical Defence UnionMedical Protection SocietyNational Pharmacy AssociationNovartis Pharmaceuticals, UKNational Concern for Healthcare InfectionsFour anonymous replies from the UK
Personal/family experience (1)
Respondents were asked about personal or family members’ first–hand experience of an adverse event in a healthcare setting in:
a) their home country
Type of Adverse Event
23%
22%
17%
12%
12%
9%5%
Medication-related event
Error in diagnosis
Communication problems
Surgery-related event
Medical device orequipment-related event
HAI
other
pers
onal
fam
ilym
embe
r
yesno
020406080
100120
Experience of an adverse event
yes
no
Q 1 & 2
Status quo good enough?
Views about measures being taken in MS to reduce harm to patients in HC-Settings
34%
38%
28%
adequate / more than adequate not adequate / not at all adequate
neither adequate nor inadequate
Q 7
National political support for patient safety needed?
Importance of a national commitment to improve PS
96%
4%
very important / important not ( particularly ) important / at all
Q 8
A national and/or EU-level patient safety strategy needed?
172
164
4
14
0 50 100 150 200
EU Strategy
national PS-Strategy
very important / important not (particularly) important / at all
Q 9 & 10
Which adverse events are of most concern?
Priority Ranking of AE
26%
25%18%
15%
7% 5% 4%
HAI
Medication-related event
Communication problems
Error in Diagnosis
Medical device or equipment-related event
Surgery-related event
Other
Q 11
Essential components of a national level patient safety strategy/policy
27%
20%11%10%
8%
7%5% 5% 4% 3%
Political leadership and financial supportA reporting and learning system
Health professional involvement in policy developmentPS-education for health professionals
Standards and / or external assessment for PSA dedicated PS research agenda and budgetPatient involvement in policy development
PS indicatorsA compensation system for those harmed by Healthcare
Other
Q 12
The importance of a dedicated financial resource for patient safety
16410
15225
1678
0 50 100 150 200
healthcareorganisation level
EU-level
national level
very important / important not (particularly) important / at all
Q 13 - 15
Patient & public involvement in patient safety improvements
125 146161
151162
4926
142313
0 50 100 150 200
very important /important
not (particularly)important / at all
patients (and/or their families) support in the aftermath of a PS-Incidentpublic information about actual PS-Incidents and AEinvolvment of patients groupspatients empowerment and participation on PS-Programmespatients seen as experts on PS
Q 16 - 20
The importance of a positive patient safety culture at the local healthcare management level
168168
148
67
22
0 20 40 60 80 100 120 140 160 180
very important /important
not (particularly)important / at all
responsibility of a senior person for PS
effective and comprehensive communications systems on PS
serious treatment of PS by management of healthcare organisations
Q 22 -24
The role of health professionals in patient safety
172172
167156116
65 8
2058
0 50 100 150 200
very important /important
not (particularly)important / at all
regulation systems for HP including disciplinary proceduresprofessional codes and standarts of practice for HPsupport for HP in the aftermath of a PS-Incidentcontinuing professional development of HPfurther education of HP in PS
Q 25 -29
A role for reporting & learning systems
Q 31 -34
169162162
1525
1310
29
0 50 100 150 200
very important /important
not (particularly)important / at all
Importance of evaluation and sharing of data at EU levelImplementation of a national or regional organisation to spread out best practice Importance of a a national reporting and learning systemImportance of evaluation and sharing of data at national level
Other information & the sharing of that information (1)
Q 35 & 36
15124
15915
0 50 100 150 200
EU-level
national level
Importance of a common PS classification / terminology
very important / important not (particularly) important / at all
Other information & the sharing of that information (2)
Q 37 & 38
14136
150
21
0 20 40 60 80 100 120 140 160
EU-level
national level
Importance of a common set of PS Indicators
very important / important not (particularly) important / at all
A need for patient safety standards?
Q 39 & 40
142
31
159
11
0 50 100 150 200
EU-level
national level
Importance of an Implementation of a system of minimum PS-Standards for HC-Organisations
very important / important not (particularly) important / at all
A need for external assessment?
Q 41 & 42
12349
14324
0 20 40 60 80 100 120 140 160
EU-level
national level
Importance of an Implemantation of external PS-Assessment for HC-Organisations
very important / important not (particularly) important / at all
Patient safety research & development
Q 45 - 48
167157
155151
7916
24
0 50 100 150 200
very important /important
not (particularly)important / at all
Importance of different options according to PS-Research
Implementation of a database of PS-Research at EU-level
Increased cooperation of MS on priority-setting & commissioning of PS-Research ( Coordination by EU )Allocation of resources for PS-Research at national level
Use of IT-Tools to enforce PS-efforts
Complaints and redress
Stakeholder's Opinions on Complaints & Redress Systems
153
13
131
28
122
31
110
49
87
72
85
58
0 20 40 60 80 100 120 140 160 180
very important / important
not (particularly) important / atall
redress system at national level based on the ability of Patients to prove an error made by one or more HC-Professionals
implementation of an EU-wide system of redress
implementation of a national-wide system for the calculation of compensation payments
implementation of a national compensation system not only for physical harm but also for other factors e.g. loss of income
national arbitration system for settling complaints without involvement of the court
Patient access to information on the available redress if harmend within a national HC-Setting or another EU HC-Setting
Q 52 - 57
Member State actionsPS problem is tackled by adequate steps at national
level
58%27%
15%
( strongly) agree ( strongly) disagree neither / nor
Q 58
A role for the EU?
Role for the EU to support MS in their efforts to address PS concerns
90%
3% 7%
( strongly) agree ( strongly) disagree neither / nor
Q 59
Conclusions (1)
Respondents overwhelmingly ranked as important or very important the need for (continued) action on:
Budgetary commitment to patient safety;Patient and public involvement;Local healthcare management engagement;Education and training of health professionals;A common taxonomy and set of indicators;Reporting and learning systems;Standards and external assessment;More Research;More information on Redress for patients.
Conclusions (2)
Patient Safety is a priority for citizens and stakeholder groups.
Much that can be done at Member State level.
A definite role for the European Union.
What concrete proposals at the EU level are appropriate?
A big role for UK stakeholders
Conclusions
Thank you for your valuable input!
lee.mcgill@ec.europa.eu
http://ec.europa.eu/dgs/health_consumer/index_en.htm