EN Official Journal of the European Union C 200/63

Opinion of the Committee of the Regions on patient safety

(2009/C 200/12)

THE COMMITTEE OF THE REGIONS RECOMMENDS

— better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services;

— better definition of participation by citizens and associations thereof in the programming and decision-making processes associated with risk management;

— the inclusion of a reference to the processes, indicators and standards for risk management and patient safety within the context of approval, accreditation and certification systems for healthcare providers;

— the definition of specific channels of legal and regulatory protection that promote the reporting by healthcare operators of errors, adverse events and situations where incidents were narrowly averted;

— embedding risk management and patient safety in (higher) education and further training for doctors and other healthcare professionals;

— the inclusion of additional recommendations to increase the efforts, already under way in individual scientific committees, to define regulatory and procedural instruments specifically dedicated to the safe use of pharmaceuticals.

Rapporteur : Mr Piero Marrazzo (IT/PES), President of the Lazio Region

Reference documents

Communication from the Commission to the European Parliament and the Council on patient safety, including the prevention and control of healthcare-associated infections

COM(2008) 836 final

Proposal for a Council Recommendation on patient safety, including the prevention and control of healthcare associated infections

COM(2008) 837 final

I. POLICY RECOMMENDATIONS

THE COMMITTEE OF THE REGIONS

General recommendations

1. emphasises that the Committee has on several previous occasions expressed concern and interest in this issue, calling on the Commission to make specific proposals, stating that ‘structured and coordinated European-level cooperation with a view to exchanging experience, sharing knowledge and simplifying arrangements relating to developments in health technology may bring clear value added to the Member States’ (see opinion CdR 153/2004 fin);

2. notes that other organisations such as the WHO, the OECD and the Council of Europe have already considered and tackled the issue of safety in healthcare;

3. notes that the Commission proposal fits in to this context and places significant emphasis on the effective involvement of Member States in the matter, thus emphasising subsidiarity as a key tool for properly understanding the phenomenon and as the instrument of choice for seeking solutions to it;

4. considers that the Commission, by opting to promote increased cooperation between Member States via a communication from the Commission and a Council Recommendation, is responding to the Committee of the Regions' request;

5. notes that the Commission communication and the proposal for a Council Recommendation on patient safety are quite properly aimed at securing political commitment from all EU countries so that the Member States, individually or collectively, implement the proposed recommendations, with the support of the Commission, and take practical steps to improve patient safety;

6. considers that the defining characteristics of the proposal are closely related: — to the political weight and profile that a specific Community proposal gives to the issue of patient safety; — to the possibility of improving individual Member States' knowledge of the phenomenon by consolidating and sharing databases containing data collected uniformly; — to the possibility of individual member states sharing best practice with each other in order to improve and reinforce patient safety;

7. notes that the initiative does not remove any competencies in the area of health from the Member States in that the Council Recommendation is a legal instrument that leaves the Member States sufficient freedom to organise, as is currently the case, their healthcare systems at national, regional or local level.

General comments about the proposal and the recommendation

8. notes that several reports show that safety in diagnosis and treatment, and the risk of iatrogenic harm, is widely perceived by the European public to be a major issue, not only in relation to safeguarding their own health and that of their loved ones, but more generally as an issue of public safety;

9. stresses that local and regional authorities are, in many countries, directly responsible for providing health services and thus have a particular interest in improving systems for safety and quality in healthcare;

10. considers that the negative consequences of iatrogenic harmimpact directly on the public perception of the quality and safety of the services provided, which in many countries is one of the key factors in the public's assessment of the effectiveness of local and regional authorities;

11. believes that the spread of the phenomenon, associated with an increase in litigation, constitutes not just an ethical, social and public health problem for the authorities directly responsible for providing health services, but also an economic one, in the light of the rising costs of insurance policies and the rising trend in compensation for damages payable to members of the public;

12. therefore believes that, whilst there are already a number of sectoral initiatives (safety of medicines and medical equipment, resistance to antimicrobials, etc.) in many areas of patient safety and of risk reduction in healthcare, an initiative such as that set out in the proposal and the recommendation, aimed at establishing an integrated approach to reducing the many potential causes of iatrogenic harm, is very useful;

13. believes that the proposals and principles set out in the proposal and the recommendation fulfil the requests made in the past by the Committee of the Regions in the area of health, i.e. encouraging the exchange of good practices in the area of patient safety whilst respecting the subsidiarity principle and helping to reduce disparities in the availability and quality of healthcare services;

14. considers that the amendments and additions to the recommendation set out below could make a useful contribution to its implementation by emphasising or improving certain aspects that are of particular interest to the Committee of the Regions, and specifically recommends: — better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services; — better definition of participation by citizens and associations thereof in the programming and decision-making processes associated with risk management; — the inclusion of a reference to the processes, indicators and standards for risk management and patient safety within the context of approval, accreditation and certification systems for healthcare providers; — the definition of specific channels of legal and regulatory protection that promote the reporting by healthcare operators of errors, adverse events and situations where incidents were narrowly averted; — embedding risk management and patient safety in (higher) education and further training for doctors and other healthcare professionals; — the inclusion of additional recommendations to increase the efforts, already under way in individual scientific committees, to define regulatory and procedural instruments specifically dedicated to the safe use of pharmaceuticals; — the inclusion of Annex 2, which relates to supporting actions, with the addition of further specific actions arising from the transposition of the recommendations and amendments suggested here.

II. RECOMMENDATIONS FOR AMENDMENTS

Amendment 1

Recital 15

Text proposed by the Commission Committee of the Regions amendment (15) Insufficient data on healthcare associated infections are available to allow meaningful comparisons between institutions by surveillance networks, to monitor the epidemiology of healthcare associated pathogens and to evaluate and guide policies on the prevention and control of healthcare associated infections. Therefore, surveillance systems should be established or strengthened at the level of healthcare institutions and at regional and national level. (15) Insufficient data on healthcare associated infections are available to allow meaningful comparisons between institutions by surveillance networks, to monitor the epidemiology of healthcare associated pathogens and to evaluate and guide policies on the prevention and control of healthcare associated infections. Therefore, reporting and evaluation systems should be established or strengthened at the level of healthcare institutions and at regional and national level.

Reason

The phrase ‘by surveillance networks’ adds nothing; rather it is a source of confusion.

Amendment 2

Part I, Title II, Article 1

Text proposed by the Commission Committee of the Regions amendment (1) Member States should support the establishment and development of national policies and programmes by: (a) Designating the competent authority or authorities responsible for patient safety on their territory; (b) Embedding patient safety as a priority issue in health policies and programmes at national as well as at regional and local levels; (c) Supporting the development of safer systems, processes and tools, including the use of information and communication technology. (1) Member States should support the establishment and development of national policies and programmes by: (a) Designating the competent authority or authorities responsible for patient safety on their territory, including those at regional or local level; (b) Embedding patient safety as a priority issue in health policies and programmes at national as well as at regional and local levels; (c) Supporting the development of safer systems, processes and tools, including the use of information and communication technology, inter alia by setting specific standards for information technology and communication protocols; (d) Including patient safety and related process, indicators and standards in the criteria set at national level for the approval, accreditation and certification of healthcare providers.

Reason

(a) to ensure better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services.

(c) to harmonise the technical arrangements for collecting and sharing data.

(d) to include in the approval, accreditation and certification process factors related not only to structural standards or technical equipment, but also to aspects of the process aimed at requiring the use of best practice, would be a practical measure to ensure patient safety.

Amendment 3

Part I, Title II, Article 2

Text proposed by the Commission Committee of the Regions amendment (2) Member States should 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 levels; (b) Disseminating information to patients on risk, levels of safety and measures in place to reduce or prevent errors, and ensure informed consent to treatment, to facilitate patient choice and decision-making; (2) Member States should 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 levels, inter alia by providing specifically for participation by citizens and associations thereof in the consultative bodies that are to be set up, including those mentioned in point (1) (a); (b) Disseminating information to patients on risk, levels of safety and measures in place to reduce or prevent errors, and ensure informed consent to treatment, to facilitate patient choice and decision-making, establishing at national, local or regional level the minimum content and the format of information to be provided to patients to ensure that the rights and protections provided for herein can be exercised.

Reason

(a) participation by citizens and associations thereof, not only in consultative bodies but also in executive ones, becomes binding.

(b) it is helpful to guide and harmonise the arrangements for communicating with the patient at the time of seeking informed consent, by analogy to the provisions already in place concerning information on the use of pharmaceuticals.

Amendment 4

Part I, Title II, Article 4

Text proposed by the Commission Committee of the Regions amendment (4) Member States should promote education and training of healthcare workers on patient safety by: (a) Encouraging multi-disciplinary patient safety education and training of all health professionals, other healthcare workers and relevant management and administrative staff in healthcare settings; (b) Collaborating with organisations involved in professional education in healthcare to ensure that patient safety receives proper attention in the higher education curricula and in the ongoing education and training of health professionals. (4) Member States should promote education and training of healthcare workers on patient safety by: (a) Encouraging multi-disciplinary patient safety education and training of all health professionals, other healthcare workers and relevant management and administrative staff in healthcare settings; (b) Collaborating with organisations involved in professional education in healthcare to ensure that patient safety receives proper attention in the higher education curricula and in the ongoing education and training of health professionals. (c) Introducing specific teaching on patient safety and healthcare risk management in the (higher education) curricula for doctors and other healthcare professionals and in further training.

Reason

(c) the problem of disseminating knowledge and skills relating to risk management techniques needs to be tackled holistically and specifically in higher education curricula as a key element in disseminating knowledge and skills relating to issues of patient safety.

Amendment 5

Part I, Title III, Article 1 (c)

Text proposed by the Commission Committee of the Regions amendment (1) Member States should develop national strategies for the prevention and control of healthcare associated infections by: (c) Establishing or strengthening active surveillance systems at Member State level or at the level of healthcare institutions. (1) Member States should develop national strategies for the prevention and control of healthcare associated infections by: (c) Establishing or strengthening active surveillance registration, monitoring and evaluation systems at Member State level or at the level of healthcare institutions.

Reason

It is important for Member States to register and monitor some healthcare associated infections so that the results can be used to make improvements. The choice of the term ‘surveillance’ does not convey this idea to the same extent. If real improvement is to be achieved, evaluation should also be included.

Amendment 6

Part I, Title III, Article 2

Text proposed by the Commission Committee of the Regions amendment (2) Member States should consider the establishment, if possible within one year after the adoption of this Recommendation, of an inter-sectoral mechanism for the coordinated implementation of the national strategy as well as for the purposes of information exchange and coordination with the Commission, the ECDC and the other Member States. (2) Member States should consider the establishment, if possible within one year after the adoption of this Recommendation, of an inter-sectoral mechanism for the coordinated implementation of the national strategy as well as for the purposes of information exchange and coordination with the Commission, the ECDC and the other Member States, inter alia through the direct involvement of regional and local bodies with specific competences in the healthcare sector.

Reason

(2) ensuring better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services.

Amendment 7

Part I, Title IV, Article 3

Text proposed by the Commission Committee of the Regions amendment (3) Member States should report to the Commission on the implementation of this Recommendation within two years of its adoption and subsequently on request by the Commission with a view to contributing to the follow-up of this Recommendation at Community level. (3) Member States should report to the Commission on the implementation of this Recommendation within two years two of its adoption and subsequently on request by the Commission with a view to contributing to the follow-up of this Recommendation at Community level. Where possible, this should be done using existing data.

Reason

(3) The EU's efforts to address the issue should, given its importance, be backed up by more rapid action.

Amendment 8

Annex 2, Part 2, Article 1 (c)

Text proposed by the Commission Committee of the Regions amendment (c) Establishing or strengthening active surveillance systems by: (c) Establishing or strengthening active surveillance registration, monitoring and evaluation systems by:

Reason

It is important for Member States to register and monitor some healthcare associated infections so that the results can be used to make improvements. The choice of the term ‘surveillance’ does not convey this idea to the same extent. If real improvement is to be achieved, evaluation should also be included.