Patient Safety: A Priority for the European Commission Mr Lee McGill Health and Consumers Directorate-General European Commission Royal College of Physicians.

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


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



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



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



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


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


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


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


Patient safety research & development

Q 45 - 48

167157

155151

7916

24

0 50 100 150 200



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!

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