Opening plenary
Dr Frank Ulrich Montgomery (CPME) chaired the opening plenary which was opened with a general introduction to the SIMPATIE Project by Boi Jongejan (CBO), explaining the background and the reasons for building a strategy for patient safety in Europe.
Beth Lilja Pedersen followed with an outline of the international perspectives on patient safety, by introducing recent activities performed by international organizations, especially in Europe. She highlighted the activities by the World Health Organisation and presented a model to determine the level of maturity with respect to a safety culture. With her presentation she updated everyone on the developments so far and prepared the ground for the presentation of the preliminary results of the different working packages of the SIMPATIE project.
David Somekh (ESQH) presented preliminary results of the mapping exercise performed in 24 European countries, illustrating the patient safety regulations and activities performed on national level. He announced that this work was still in process, and the analysis of the data and preparation of a sustainable database were further being developed. He also stated that he is looking forward to receiving more data from a few missing countries.
Peter Walsh (AvMA) gave a patients’ perspective to patient safety, highlighting the importance of fairness and justice when dealing with adverse events, as well as the necessity to include the patients in planning, solution work and monitoring of patient safety on the institutional and the national level.
Discussion
A brief discussion followed on the availability of European and national data on patient safety and adverse events. Beth Lilja Pedersen stated that there would be data available for three EU countries, which showed similar results using comparable methodologies. The number of adverse events (including complications and medical errors) would be in the area of 10%. According to HAS a questionnaire and database could be available towards the end of the year, including country and group data. Marianne Takki underlined that the European Commission did not have any concrete data yet, but that the SIMPATIE project should provide directions through the mapping exercise. Regarding the question on the EU activities in helping patients suffering adverse events, she reminded the audience that health-
care and patient safety are a national responsibility, but that the EC would be dedicated to find common elements to support the Member States, e.g. through the work within the High Level Group on Patient Safety.
SIMPATIE toolbox
Piotr Mierzewski (CoE) introduced the ‘Recommendation of the Council of Europe on Management of Patient Safety and Prevention of Adverse Events in Healthcare’, developed by the patient safety working group, explaining process and background. He also highlighted the four Ps (principles, policy, politics, practice): in which principles are laid down by the Council of Europe; policies are developed by the WHO; politics are laid down by the European Union; and Member States are putting it all into practice.
Paul Bartels (ESQH) introduced the set of indicators/outcome measures and vocabulary developed for the SIMPATIE project and explained the methods of selection, characterization and evaluation of patient safety indicators used in the process. He reported that the vocabulary would already be available, as well as the selection/characterization framework for patient safety indicators, which would be tested with 4 known indicators. The full set of indicators will be selected for evaluation after the conference.
Charles Bruneau (HAS) explained the work performed on audit and external evaluation with regards to patient safety, by using the three times of auditing: making the objectives of auditing clear, introducing known methods and associated human resources, as well as by deciding on follow-up actions. He concluded by presenting the feasibility of different levels of harmonisation of external evaluation on European level.
Cule Cucic (CBO) presented a not inclusive set of instruments and internal audit mechanisms identified to improve patient safety in healthcare organizations. He advised instruments for measurement, analysis and intervention, but stressed that the instruments identified were not based on any preference or hierarchy, but that their use and combination should be adapted to the local needs.
Discussion
A brief discussion followed in which the need for evidence based data on adverse events, and the effectiveness of patient safety interventions was addressed. The development of a, preferably web-based, toolkit for member states, healthcare organizations and healthcare professionals was promoted. Further research would be needed with regard to the analysis of patient safety instruments.
The representative of the Dutch Health Care Inspectorate indicated the need to further discuss the differences between certification and accreditation and the respective regulatory frameworks. He suggested using and discussing all alternatives presented.
The audience also discussed differences between the SIMPATIE vocabulary and the WHO taxonomy of events, which although similar in scope tackle different aspects in patient safety. Ed Kelley (OECD) briefly presented his experiences, based on his work for the OECD (pdf-file). Paul Bartels indicated that the 4 indicators presented were only examples used in the process, and echoed the difficulties in directly measuring indicators as they would not be stable over time and would often not be comparable in different settings. He also stressed that the indicators would be sensitive for biases by external evaluation or management interventions. For future use he suggested using a sophisticated database linked to a probability function to minimize bias and achieve comparable results.
Workshop 1: PS on national and EU level
Chair: Piotr Mierzewski (CoE)
The presented draft framework strategy document from the national and European perspective was topic of debate.
The following presentations were given:
- Barbara Kutryba (TPI): Patient Safety developments in Poland,
- Marianne Takki (EC, DG SANCO): Past, present and future activities of DG Health and Consumer Protection in the field of Patient Safety
- Peter Mansell (NPSA Patient Experience): The role of patients in ensuring patient safety
The results of the mapping exercise (WP2), the Council of Europe Recommendations (WP3) and the report on external auditing to develop recommendations for action on national and European level (WP5) served as input for the debate.The participants discussed and reached consensus on the results of the previous working packages from a national and European perspective. David Somekh (ESQH) reported on behalf of the designated rapporteur Charles Bruneau (HAS) suggesting the following actions:
Proposed actions for EU Institutions:
Priorities:
Harmonisation at national level (Patient Safety Platform)
Support Member States to adapt programs to local systems
Make knowledge and experiences available (solutions database)
Encourage Ministries of Health to report annually
Instruments for EU level:
Establish a Patient Safety Network (HLG initiative of an EU platform involving all MS was applauded)
Include: all health care providers (not just hospitals), longterm and acute
Ensure patient voice at EU level
Recognize the relevance of medical competence for PS
Establish an inventory of indicators
Introduce data sets on PS and objectives to build PS profiles
Promote European twinning programmes and peer review
Proposed actions on national level:
Establish a culture of change, by avoiding that professionals feel threatened by change
Identify that no-fault compensation is a mixed blessing
Ensure that indicators are owned by professional organisations to ensure state-of-the-art education
Recognise the role and impact of the media
Recognise the relevance of human resources in PS
Recognise that the introduction of national PS platformsv
Convince the Member States of the value of investment in PS
Questions for further study:
How can EU recommendations work?
Coordination mechanism? Use of drivers for change
How to understand what open and fair system means in practice?
How to identify the real costs of adverse events and financial benefits of PS interventions by following the ‘cost and reality principle’?
Workshop 2: PS on provider level
Chair: Paul Bartels (ESQH)
The workshop discussed and supported the presented draft framework strategy document from the perspective of healthcare organizations.
The following presentations were given:
- Kaj Essinger (HOPE): Patient Safety - from the provider point of view,
- Jesper Poulsen (CPME Expert): Patient Safety in a European perspective – seen from the healthcare professionals point of view, and
- Arnold Vulto (EAHP): The Hospital Pharmacist your stakeholder when it comes to medication
Input for the debate were the mapping exercise (WP2), the Council of Europe recommendations (WP3) and the definitions and indicators (WP4), as well as the instruments which can be used by health care providers to ensure patient safety (WP6 internal instruments). The participants agreed to the need of an increased exchange of best practices based on a basic vocabulary, common indicators and interventions, while taking the involvement of patients, as well as cultural, organisational and educational matters into account.
Harmonisation at national level (Patient Safety Platform)
Organizational nature of differences in healthcare systems
Implications of an increasing density of treatment
The risk of purely focusing on cost-effectiveness might lead to a lack of competency
Dissemination of information within and between healthcare organizations and healthcare professionals
Qualitative aspects in healthcare organizations, accepting that medicines are high risk tools even after market approval
Quantitative aspects with regard to human resources, more specifically the critical mass of healthcare professionals needed in direct contact to patients
The added value of the EU support regarding reporting systems and the lessons being currently learned
The importance of the involvement of all healthcare professionals, more specifically hospital pharmacists as 60% of adverse events involve medicines
In addition to the issues raised in the
draft strategy framework (pdf-file), the following actions were proposed on provider level.
Actions proposed at provider level:
Further define the collaboration between patients/carers and healthcare providers/healthcare professionals
Develop instruments for clinical governance, esp. regarding the contribution of hospital managers to patient safety (toolbox)
Identify the real costs of adverse events that are not reported (estimated at around 10% of hospital budget), by developing business cases for patient safety. These are to provide the economic evidence for patient safety interventions, and making it practical, by using indicators, instruments and external auditing
Support national initiatives on patient safety and collaborate in the collection of national data. Provide the evidence needed to promote the implementation of concrete interventions
Develop and promote high quality post-graduate training and continuous professional development in patient safety interventions
Discuss the role of public private partnerships, especially with regard to medical devices industry and pharmaceutical industry
The implementation and dissemination of solution banks and rapid alert systems for patient safety
Implement concerted actions on European level incl. all stakeholders
Increase the pace of the process by starting actions on all levels
Open questions
What comes first: culture changes or actions?
How to define the context in which a culture of safety develops?
How to address the whole system instead of individual aspects?
How to involve national decision makers and hospital managers?
How to report adverse events to payers? (currently around 10%)
Should patient safety interventions be introduced in a top down and/or bottom-up approach?
Conclusion;
> General feeling of impatience, desire to do more
Closing plenary
The closing plenary chaired by: Lisette Tiddens-Engwirda (CPME) started with a key-note speech (pdf-file) on
‘EU initiatives on Patient Safety’ by Dr. Andrzej Rys, Director at the Health and Consumer Protection DG of the European Commission, Public Health & Risk Assessment Directorate. In his speech he highlighted the past, current and future activities of the European Commission with regard to patient safety, covering initiatives from DG Health and Consumer Protection, the opportunities within the upcoming 7th Framework Programme by DG Research, as well as the activities performed by DG Information Society. He specified and explained the tasks and the 5 priority areas of the Patient Safety Working Group of the High Level Group on Health Services and Medical Care, set up in April 2005:
1. Education and training of health professionals,
2. Establishing effective reporting and learning mechanisms,
3. Develop knowledge and evidence,
4. Develop indicators of patient safety for different healthcare settings,
5. Support development of national policies and programmes.
In addition to the priority action areas, he also raised two cross cutting issues namely, empowering citizens and patients by providing them with information on patient safety and rights for safe health care services and patients, engaging stakeholders such as patients, health professionals, service providers in improving patient safety in health care settings. He also announced that the Working Group will address a recommendation on patient safety for the High Level Group. The concrete proposal will be to recommend the establishment of a European network on patient safety to support Member States in promoting this area. All identified priority areas as well as new issues will be included. He also reminded that patient safety should be an integral part of undergraduate and postgraduate training of healthcare professionals and that respective proposals would be discussed the High Level Group meeting on 6 December.
Lisette Tiddens-Engwirda highlighted the EU involvement on patient safety. A brief discussion followed on the need and possibilities of funding for patient organizations, especially those dealing with adverse events. MEP Belohorska reminded the participants on the subsidiarity principle and the limitations regarding EU funding for national organizations.
Drawing conclusions
The rapporteurs of the two workshops, David Somekh on behalf of Charles Bruneau (Workshop 1 - Patient safety on the National and European level) and Benno van Beek (Workshop 2 - Patient safety on the Provider level) reported from the two workshops on day one and proposed conclusions.
In the discussion following the workshop presentations, Dr.Rys (European Commission) highlighted the importance of teamwork to ensure patient safety. The need for a multidisciplinary approach and the inclusion of patient safety education in national curricula of healthcare professionals were further aspects addressed by the audience. Mrs Tiddens Engwirda (CPME) explained the role of continuous professional development (CPD) as one step in the education of healthcare professionals, and thus a relevant action point in patient safety. A respective conference on CPD (pdf-file) will be organized by the CPME under the auspices of the Finnish Presidency of the EU and the European Commission (14 December 2006). The possible involvement of the media as a stakeholder in patient safety advocacy was briefly discussed without reaching a consensus.
A roll-call on the most important issues followed highlighting following aspects:
Most important issues:
Collaborate with patients and patient organizations (Basia Kutryba, Poland; Elisabeth Rousseau, France)
Increase the involvement of the insurance industry in patient safety (Agnes Jacquerye)
Prevent adverse events by limiting access to and use of ‘look-alike’ and ‘sound-alike’ pharmaceuticals and medical devices (Marie-Claire Pickaert, EFPIA)
Utilize professional organizations to educate healthcare professionals (Jason Bryan, UK)
Ensure implementation of patient safety instruments on hospital level, e.g. using the presented toolbox WPs (Peter Waanders, the Netherlands)
Use the effective collaboration on EU level (platform) to introduce similar projects and toolboxes on national level, ensuring that cultural differences on national level are addressed and taken into account (Brit Wendelboe, Denmark)
Find a common definition for no-blame and open-and-fair systems (Alois Alkin, Austria)
Keep the momentum and share knowledge and best-practices across the EU (NPSA)
Apply the SIMPATIE experiences (way of working) to other settings (Ivana Silva, PGEU)
Create good conditions for healthcare professionals and deliver high quality healthcare services (Eugen Nagy, Slovak Republic)
Develop local patient safety systems, taking special conditions and particularities into account and find ways to convince policy makers (Anne Broyart, France)
Member States should get EU support to establish a legal framework for patient safety (Jean Bacou, HAS)
Create a business case for patient safety proving the cost-effectiveness of patient safety interventions (UK Department of Health)
All partners should recognize that besides involving the stakeholders, its needed to take notion of the ‘mistake’holders and that the total costs of medical errors should be identified (Martin de Leeuw, NL)
Establish national patient safety systems coordinated on an European level involving the European Union, the Council of Europe and the stakeholders (Jan Vesseur, NL)
Involve all parties concerned and start acting into one direction, without mutual accusations (Raymond Lies, AEMH)
Ensure that the voice of the patients is heard, that the patient rights are included in the EU constitution. Use the structural funds to support patient safety initiatives on Member State level (MEP Belohorska)
Get the different working streams together and find common solutions by identifying the complexity of the business, showing healthcare professionals on how to ensure patient safety. Demonstrate the value of spending money to reduce the number of adverse event cases by a definition of the financial impact of patient safety interventions (Andrzey Rys, EC)
Ensure that information gets through, especially regarding the wide variety of healthcare systems and problems within the EU (Benno van Beek, CBO)
Be as practical as possible to ensure that the recommendations are implemented (Charles Bruneau, HAS)
Piotr Mierzewski concluded that cost-effectiveness and the search for a business/market approach would not always be the only way forward. He reminded the participants of the need for sustainability as topics which are hot on the agenda later on often get forgotten in the process. To ensure sustainability increased collaboration is needed on all levels, involving the EC, the Council of Europe and all stakeholders. Collaboration is essential as the EC is a powerful institution whose work and recommendations are often followed by all member states, not only of the EU but also of the Council of Europe. He reminded all on the need for an increased health democracy to ensure that the priorities of the citizens are well reflected in future policies. With regard to the upcoming dissemination of results, he asked all participants to make the invisible visible and use Brussels as an inspiration and not an excuse.
The chairwoman Mrs Tiddens Engwirda reminded the participants to provide written input to the draft strategy framework until 1 October 2006 using the SIMPATIE website (www.simpatie.org) and closed the meeting on behalf of the CPME and the SIMPATIE partner organisations.
