Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
ROSSI Oreste ( EFD)
|
SOMMER Renate ( PPE),
SCHALDEMOSE Christel ( S&D),
TAYLOR Rebecca ( ALDE),
RIVASI Michèle ( Verts/ALE),
YANNAKOUDAKIS Marina ( ECR)
|
| Committee Opinion | EMPL |
Lead committee dossier:
Legal Basis:
RoP 54
Legal Basis:
RoP 54Subjects
Events
The European Parliament adopted a resolution on the report from the Commission to the Council on the basis of Member States' reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated.
In its resolution, Parliament recommended that issue of patient safety, and in particular the prevention and control of HAIs, should be given a place near the top of the political agenda in the EU , both at national level in the Member States and at regional and local level.
According to estimates, health-care associated infections (HAIs) are contracted by an estimated 5% of patients in hospitals . HAIs, which have a high impact in terms of morbidity, mortality (with 37 000 people dying directly of such infections in the EU) and cost (estimated at over EUR 5.5 billion per annum Union-wide), constitute a major public health problem in the Member States.
Members welcomed the measures put in place by Member States with the principal aim of improving general patient safety and preventing the incidence of HAIs. They also welcomed the fact that some of the actions recommended by the Council have thus far been implemented by only a limited number of Member States , and that there is room for improvement – in both hospital and non-hospital care.
Improving patient safety in Europe, including by preventing and controlling HAIs : Member States are urged to continue their efforts to improve patient safety by taking, if they have not already done so, additional measures, including setting up action plans for combating HAIs. Measures should aim to:
empower citizens in respect of patient safety and the prevention and control of HAIs; promote thorough and continuous training , based on well-defined standards, of healthcare workers in the area of patient and healthcare worker safety; encourage research into patient safety using an evidence-based approach with a focus on implementation and focusing in particular on forms of therapy that offer an alternative to treatment with antibiotics; include measures to prevent the occurrence of and combat the spread of antimicrobial resistance , including the development of new antimicrobials; improve the information provided to patients by healthcare establishments; support research into the prevention and control of HAI s, particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and other emerging difficult-to-treat infections.
The resolution urged the Commission and the relevant EU agencies to introduce, or strengthen if they already exist, arrangements for reporting adverse events – in particular those involving medicines and medical devices – which make it possible to identify those responsible in the event of a breakdown in the chain of care. Member States are urged to re-evaluate their adverse event reporting structures.
Prevention : while acknowledging that the EU may not interfere with the Member States’ competences in the field of health, Parliament has encouraged the Member States and their delegated partners to:
make sufficient human, financial and technological resources available to ensure that care provided in the home or in hospital is of the highest possible quality, calling on them, in particular, to allocate adequate budgets to patient safety and to ensure that care provided in the home or in hospital is of the highest possible quality; also prioritise effective workforce planning as a means of ensuring that staffing levels are adequate to deal with increasing patient throughput and the attendant negative impact on infection control practices.
Member States are called upon to: draw up national guidelines for hand hygiene and general cleaning of hospitals and care homes; (ii) promote targeted action to prevent errors in hospitals; (iii) encourage efforts to study hospital outbreaks; (iv) conduct specific information and training campaigns to raise awareness among patients and healthcare professionals of the issue of antimicrobial resistance.
Communication, education and training : Parliament recommended Member States to:
conduct specific awareness-raising and training measures concerning HAIs which are aimed not only at healthcare professionals but also, for example, formal and informal carers and hospital volunteers who have contact with patients; introduce national guidelines for health professionals on how to train patients in the use of antibiotics.
Patients’ rights : Member States are invited to: (i) ensure that patients trust their health systems and, in particular, to involve patients closely in patient safety; (ii) involve patient organisations in the development of new laws and health programmes; (iii) designate at local level an authority or a contact person responsible for providing patients with information and data concerning patient safety; (iv) encourage practising doctors to inform patients of their rights and the possibilities open to them in terms of lodging complaints and reporting errors and adverse events.
Control, diagnosis and follow-up : Parliament called on:
the Commission, the relevant EU agencies and the Member States are called upon to consider action to ensure the provision of feedback on patient safety , not only from medical staff but also from patients; all Member States to introduce specific national HAI prevalence surveys ; the European Medicines Agency to develop guidelines on the off-label use of medicines; the European Centre for Disease Prevention and Control (ECDC) to draw up, in cooperation with the EMA, a list of pathogens that can cause serious or potentially fatal antibiotic-resistant infections and pose a serious health risk.
European and international cooperation : Parliament called on the Member States and the Commission, in conjunction with the WHO and the OECD, to improve cooperation with a view to developing standardised definitions , terminology and indicators in the area of patient safety, in particular so as to ensure that high-risk patients can be isolated should a pandemic or cross-border threat emerge.
The resolution emphasised the importance of establishing an effective European network of national surveillance systems which would work, on the basis of standardised criteria to be adopted by the Commission and the Member States.
Member States are called upon to collaborate in the creation of platforms which allow the sharing of information concerning adverse events in healthcare.
The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Oreste ROSSI (EPP, IT) as a follow-up to the report from the Commission to the Council on the basis of Member States' reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated.
According to estimates, health-care associated infections (HAIs) are contracted by an estimated 5% of patients in hospitals . HAIs, which have a high impact in terms of morbidity, mortality (with 37 000 people dying directly of such infections in the EU) and cost (estimated at over EUR 5.5 billion per annum Union-wide), constitute a major public health problem in the Member States.
Against this background, the report recommended that issue of patient safety, and in particular the prevention and control of HAIs, be given a place near the top of the political agenda in the EU , both at national level in the Member States and at regional and local level.
Members welcome the measures put in place by Member States with the principal aim of improving general patient safety and preventing the incidence of HAIs. They also welcome the fact that some of the actions recommended by the Council have thus far been implemented by only a limited number of Member States , and that there is room for improvement – in both hospital and non-hospital care.
Improving patient safety in Europe, including by preventing and controlling HAIs : Member States are urged to continue their efforts to improve patient safety by taking, if they have not already done so, additional measures, including setting up action plans for combating HAIs. Measures should aim to:
empower citizens in respect of patient safety and the prevention and control of HAIs;
promote thorough and continuous training , based on well-defined standards, of healthcare workers in the area of patient and healthcare worker safety; encourage research into patient safety using an evidence-based approach with a focus on implementation and focusing in particular on forms of therapy that offer an alternative to treatment with antibiotics; introduce, or strengthen if they already exist, arrangements for reporting adverse events – in particular those involving medicines and medical devices. improve the information provided to patients by healthcare establishments; support research into the prevention and control of HAI s, particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and other emerging difficult-to-treat infections.
Prevention : Member States are called upon to: draw up national guidelines for hand hygiene and general cleaning of hospitals and care homes; (ii) promote targeted action to prevent errors in hospitals; (iii) encourage efforts to study hospital outbreaks; (iv) conduct specific information and training campaigns to raise awareness among patients and healthcare professionals of the issue of antimicrobial resistance.
The state of health of patients (particularly older persons and persons with reduced mobility) returning home after a period of hospitalisation must be assessed thoroughly when they leave hospital.
Communication, education and training : the report recommended Member States to:
conduct specific awareness-raising and training measures concerning HAIs which are aimed not only at healthcare professionals but also, for example, formal and informal carers and hospital volunteers who have contact with patients; introduce national guidelines for health professionals on how to train patients in the use of antibiotics.
Patients’ rights : Member States are invited to: (i) ensure that patients trust their health systems and, in particular, to involve patients closely in patient safety; (ii) involve patient organisations in the development of new laws and health programmes; (iii) designate at local level an authority or a contact person responsible for providing patients with information and data concerning patient safety; (iv) encourage practising doctors to inform patients of their rights and the possibilities open to them in terms of lodging complaints and reporting errors and adverse events.
Control, diagnosis and follow-up : the Commission, the relevant EU agencies and the Member States are called upon to consider action to ensure the provision of feedback on patient safety , not only from medical staff but also from patients. Members called on the European Centre for Disease Prevention and Control (ECDC) to draw up, in cooperation with the EMA, a list of pathogens that can cause serious or potentially fatal antibiotic-resistant infections and pose a serious health risk.
European and international cooperation : Members called on the Member States and the Commission, in conjunction with the WHO and the OECD, to improve cooperation with a view to developing standardised definitions , terminology and indicators in the area of patient safety, in particular so as to ensure that high-risk patients can be isolated should a pandemic or cross-border threat emerge.
The report emphasised the importance of establishing an effective European network of national surveillance systems which would work, on the basis of standardised criteria to be adopted by the Commission and the Member States.
Member States are called upon to collaborate in the creation of platforms which allow the sharing of information concerning adverse events in healthcare.
PURPOSE: to present a report on the implementation of Council Recommendation on patient safety.
BACKGROUND: in June 2009, the Council adopted a Recommendation on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters.
1) The first chapter concerns general patient safety , where Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare. These measures include:
· developing national policies on patient safety ;
· empowering and informing patients;
· establishing reporting and learning systems on adverse events;
· promoting the education and training of healthcare workers;
· developing research on the issue.
The Recommendation invites Member States to share knowledge, experience and best practice and to classify and codify patient safety at EU level by working with each other and with the Commission.
2) The second chapter concerns the prevention and control of healthcare-associated infections (HAIs), where Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This strategy should comprise:
· infection prevention and control measures at national/regional level and at the level of healthcare institutions, and
· providing surveillance systems, the education and training of healthcare workers, information to patients, and research.
The report summarises the main actions taken at Member State and EU level with regard to the Council Recommendation.
CONTENT : in accordance with the above-mentioned Recommendation, the Commission presents, on the basis of Member States' reports, a summary of the main actions taken as regards the implementation of the Recommendation by June 2011 (July 2012 for the general patient safety part). The report highlights those areas of the Recommendation needing further attention. It is accompanied by a Commission Staff Working Document providing a more detailed technical analysis of the replies received by EU Member States and Norway.
Actions taken at Member State level : most Member States have taken a certain number of the measures recommended:
· on general patient safety , most Member States have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety;
· on encouraging training on patient safety , most countries have taken measures in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals;
· regarding systems on adverse events (systems providing information about the causes of adverse events and recording their numbers by type), the existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility of reporting events. However, there is still room for improvement in this crucial area;
· on empowering patients , efforts focus on hospital healthcare through the involvement of patient organisations on patient safety, with only a few examples of actions addressing primary care;
· on research, the report notes the establishment of national research programme on patient safety in 10 Member States. Existing research covers patient safety culture, reducing the risk of medication errors, improving patients’ competence in medication safety, healthcare-associated infections, and prevention of falls in the elderly population;
· on the prevention and control of HAIs, 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77%) as part of a national/regional strategy and/or action plan. Thirteen Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. Most of the strategies for the prevention and control of HAI are linked to strategies for the prudent use of antimicrobial agents in human medicine and/or patient safety strategies.
Actions taken at EU level: Directive on cross-border healthcare: the Recommendation complements other EU initiatives. Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights seeks to clarify the rights of patients when accessing care in another EU Member State. It also seeks to ensure that such care is safe and of good quality. It therefore includes several provisions relating to the safety and quality of healthcare. The implementation of the actions envisaged by the Recommendation will be considered as a reference for assessing safety standards under the Directive.
Apart from the Directive, the report discusses the funding of several actions, particularly in terms of the EU Health Programme or the 7th Framework Research Programme (for a total amount of EUR 16 million.)
With regard to HAIs, the Commission has adopted an ‘Action plan against the rising threats from antimicrobial resistance' which contains 12 actions to be implemented with EU Member States.
Focus of future work : the report notes that there are still various areas of the Recommendation with considerable room for improvement. Based on the findings of the report, the priority areas on which future work should focus include:
General patient safety
-At Member State level:
· actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress ;
· collect information on adverse events through further developing reporting and learning systems, ensure a non-punitive context for reporting on adverse events and evaluate reporting progress;
· extend patient safety strategies and programmes from hospital care to non-hospital care as well;
-At EU level:
· collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation ;
· make progress on common terminology on patient safety;
· pursue exchange of best practice;
· develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies.
Prevention and control of healthcare associated infections
-At Member State level:
· ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals;
· improve the training of specialised infection control staff and better align qualifications between Member States;
· reinforce tailored basic infection prevention and control structures and practices in nursing homes;
· repeat national point prevalence surveys of HAI;
· ensure that surveillance of infections in intensive care units and surgical site infections is in place;
· implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms;
· improve the information on HAI for patients;
· develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan.
-At EU level:
· continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities;
· develop research in the area of the prevention and control of HCA.
The Recommendation invites the Commission to consider the extent to which the proposed measures are working effectively. The Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care.
Documents
- Commission response to text adopted in plenary: SP(2014)62
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament: T7-0435/2013
- Committee report tabled for plenary: A7-0320/2013
- Amendments tabled in committee: PE514.775
- Committee draft report: PE510.691
- Non-legislative basic document published: COM(2012)0658
- Non-legislative basic document published: EUR-Lex
- Committee draft report: PE510.691
- Amendments tabled in committee: PE514.775
- Commission response to text adopted in plenary: SP(2014)62
| Amendments | Dossier |
| 239 |
2013/2022(INI)
2013/07/18
ENVI
239 amendments...
Amendment 1 #
Motion for a resolution Citation 6 Amendment 10 #
Motion for a resolution Citation 6 g (new) – having regard to the Staff working paper of the services of the Commission on antimicrobial resistance of 18 November 2009 (SANCO/6876/2009r6),
Amendment 100 #
Motion for a resolution Recital K n (new) Kn. whereas, on the other hand, some of the specific measures the Council recommended for preventing and combating HAIs in the Member States have been implemented in only a limited number of Member States, and whereas progress is still possible, particularly in respect of provision of information to patients by healthcare establishments and support for research into the prevention and control of HAIs;
Amendment 101 #
Motion for a resolution Paragraph 1 1. Welcomes the measures put in place by Member States with the principal aim of improving general patient safety and reducing the incidence of HAIs
Amendment 102 #
Motion for a resolution Paragraph 1 1. Welcomes the measures put in place by Member States with the principal aim of improving general patient safety and pre
Amendment 103 #
Motion for a resolution Paragraph 1 1. Welcomes the measures put in place by Member States with the principal aim of improving general patient safety and reducing the incidence of HAIs, but urges that these efforts must be increased;
Amendment 104 #
Motion for a resolution Paragraph 2 2. Welcomes the steps taken by the Commission to improve general patient safety by promoting mutual learning between Member States and putting forward common definitions and terminology for patient safety; and in particular: – the Commission fostering the exchange of information on initiatives concerned with patient safety and quality of care in the context of the Working Group on Patient Safety and Quality of Care; – the Commission’s cofinancing of the OECD-led project on healthcare quality indicators, which has made it possible to collect comparable indicators of patient safety in 11 countries; – the European Union’s cofinancing, under the seventh framework programme for research, of six research projects on general patient safety; – the adoption of Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare, which seeks not only to clarify the rights of patients when accessing care in another EU Member State, but also to ensure that such care is safe and of good quality;
Amendment 105 #
Motion for a resolution Paragraph 2 2. Welcomes the steps taken by the Commission to improve general patient safety by promoting mutual learning between Member States and
Amendment 106 #
Motion for a resolution Paragraph 2 2. Welcomes the steps taken by the Commission to improve general patient safety by promoting
Amendment 107 #
Motion for a resolution Paragraph 3 3.
Amendment 108 #
Motion for a resolution Paragraph 3 3. Criticises the fact that
Amendment 109 #
Motion for a resolution Paragraph 4 – introductory part 4.
Amendment 11 #
Motion for a resolution Citation 1 a (new) - having regard to the Council recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine[1] (2002/77/EC) and to the European Parliament resolution of 23 October 2001 on the proposal for that recommendation (COM(2001)0333), [1] OJ L 34, 5.2.2002, p.13
Amendment 110 #
Motion for a resolution Paragraph 4 – indent 1 a (new) - have integrated patient safety into the education and training of health professionals;
Amendment 111 #
Motion for a resolution Paragraph 4 – indent 2 a (new) - have action plans in place for combating HAIs
Amendment 112 #
Motion for a resolution Paragraph 5 5. Welcomes the
Amendment 113 #
Motion for a resolution Paragraph 5 a (new) 5a. Welcomes the Commission’s action in the area of preventing and combating HAIs, which is closely linked to its action in the area of resistance to antimicrobial agents, in particular the financing provided by the Commission for research projects on HAIs and antimicrobial resistance, especially those projects having a European dimension, such as IPSE (Improving Patient Safety in Europe), IMPLEMENT (Implementing Strategic Bundles for Infection Prevention and Management) and PROHIBIT (Prevention of Hospital Infections by Intervention and Training), which seeks to analyse existing practical guidelines on prevention of HAIs in European hospitals and test a strategy for preventing bloodstream infections linked to central venous catheters (infections which are particularly worrying in that they are associated with significant morbidity and a high level of directly related mortality);
Amendment 114 #
Motion for a resolution Paragraph 6 6. Calls for the collection of comparable indicators on patient safety by Member States to be continued and for all the
Amendment 115 #
Motion for a resolution Paragraph 8 a (new) 8a. Welcomes the coordination and monitoring work of the European Centre for Disease Prevention and Control (ECDC), in particular: – its activities in coordinating the European network for surveillance of HAIs, particularly surgical site infections, HAIs acquired in intensive care units and antimicrobial use in long-term care facilities (HALT-2), as well as its support for the European project to support capacity building for surveillance of Clostridium difficile infections (ECDIS- Net); – the coordination of a European study on HAI prevalence and antimicrobial use in acute care hospitals; – the ECDC’s development of guidance for the prevention and control of Clostridium difficile infections; – the publication of recommendations to prevent the spread of carbapenemase- producing Enterobacteriaceae; - the ECDC’s support for the development of guidelines and indicators (on structure and method) for preventing HAIs.
Amendment 116 #
Motion for a resolution Paragraph 9 9. Urges the Member States to continue their efforts to improve patient safety by taking, if they have not already done so,
Amendment 117 #
Motion for a resolution Paragraph 9 9. Urges the Member States to continue their efforts to improve patient safety by taking, if they have not already done so, new measures, including setting up action plans for combating HAIs, in order to fall fully into line with the Council's recommendations;
Amendment 118 #
Motion for a resolution Paragraph 10 – introductory part 10. Urges the Commission and the Member States, in particular,
Amendment 119 #
Motion for a resolution Paragraph 10 – indent 2 – education and training measures for healthcare workers in the area of patient safety, to include the introduction of compulsory patient safety training modules (covering various areas including medical devices and good use of medicines) in one or more types of study or training for healthcare professionals and carers;
Amendment 12 #
Motion for a resolution Citation 3 a (new) - having regard to the second report from the Commission to the Council of 9 April 2010 on the basis of Member States' reports on the implementation of the Council recommendation (2002/777/EC) on the prudent use of antimicrobial agents in human medicine[1], and to the Commission staff working document accompanying that report[2], [1]http://ec.europa.eu/health/antimicrobia l_resistance/docs/amr_report2_en.pdf [2]http://ec.europa.eu/health/antimicrobia l_resistance/docs/cswd_technicalannex_e n.pdf
Amendment 120 #
Motion for a resolution Paragraph 10 – indent 2 – education and training measures for healthcare workers in the area of patient and healthcare worker safety;
Amendment 121 #
Motion for a resolution Paragraph 10 – indent 2 Amendment 122 #
Motion for a resolution Paragraph 10 – indent 2 – education and training measures for healthcare workers, patients and their carers in the area of patient safety;
Amendment 123 #
Motion for a resolution Paragraph 10 – indent 4 measures to encourage research into patient safety using an evidence-based approach with a focus on implementation;
Amendment 124 #
Motion for a resolution Paragraph 10 – indent 4 – measures to encourage research into patient safety, focusing in particular on forms of therapy that offer an alternative to treatment with antibiotics and a response to resistance to antibiotics, including bacteriophage therapy;
Amendment 125 #
Motion for a resolution Paragraph 10 – indent 4 a (new) - measures to ensure better coherence and continuity in patients’ progress through the system, focusing on transitions between sectors and the transmission of information, for example from the hospital to the primary care sector;
Amendment 126 #
Motion for a resolution Paragraph 10 – indent 4 a (new) - support multidisciplinary wound care as part of patient safety programmes at the Member State level;
Amendment 127 #
Motion for a resolution Paragraph 10 – indent 4 a (new) - measures to prevent the occurrence as well as combat the spread of antimicrobial resistance including the development of new antimicrobials;
Amendment 128 #
Motion for a resolution Paragraph 11 11.
Amendment 129 #
Motion for a resolution Paragraph 11 a (new) 11a. Urges the Member States to introduce, or strengthen if they already exist, arrangements for reporting adverse events which make it possible to identify those responsible in the event of a breakdown in the chain of care and learn lessons from such breakdowns;
Amendment 13 #
Motion for a resolution Citation 6 b (new) – having regard to the Commission Communication of 15 November 2011 on an action plan against antimicrobial resistance (COM(2011)0748),
Amendment 130 #
Motion for a resolution Paragraph 11 11. Urges the
Amendment 131 #
Motion for a resolution Paragraph 11 11. Urges the Member States to introduce, or strengthen if they already exist, arrangements for reporting adverse events which make it possible to identify those responsible in the event of a breakdown in
Amendment 132 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls on the European Medicines Agency (EMA) to draw up a list of off- label medicines which are used in spite of there being an approved alternative; calls on the Member States to ensure that medical professionals and patients are informed when a medicine is used off- label;
Amendment 133 #
Motion for a resolution Paragraph 11 a (new) 11a. Urges the Member States to re- evaluate their adverse event reporting structures, to assess whether such reporting is taking place in a 'no-blame' culture, and that healthcare professionals can come forward with information candidly, without negative consequences for themselves personally;
Amendment 134 #
Motion for a resolution Paragraph 11 b (new) 11b. Urges the Commission and the Member States to make the public more aware of initiatives in the area of patient safety and empower patients in this area;
Amendment 135 #
Motion for a resolution Paragraph 12 Amendment 136 #
Motion for a resolution Paragraph 12 12. Urges the Commission to consider the
Amendment 137 #
Motion for a resolution Paragraph 12 a (new) 12a. Calls on the Member States to adopt measures which raise the quality – and not just the quantity – of reporting on adverse events, so that reporting contains information which can really improve safety, and which makes it easy to call up data from the system for a comprehensive and systematic evaluation;
Amendment 138 #
Motion for a resolution Paragraph 12 b (new) 12b. Calls on the Member States to do far more to incorporate patients’ information into electronic systems on patient safety and adverse events, and to systematically evaluate this information precisely in order to prevent errors;
Amendment 139 #
Motion for a resolution Paragraph 12 c (new) 12c. Urges the Member States to introduce information systems whereby patients and their families themselves are trained to report errors in treatment and adverse events to the authorities;
Amendment 14 #
Motion for a resolution Citation 4 a (new) - having regard to the Commission communication of 15 November 2011 on an action plan against the rising threats from antimicrobial resistance (COM(2011)0748),
Amendment 140 #
Motion for a resolution Paragraph 13 13.
Amendment 141 #
Motion for a resolution Paragraph 13 13. Urges the Commission to consider once again the calls for the introduction of a
Amendment 142 #
Motion for a resolution Paragraph 14 14. Urges the Member States, the Commission and the relevant EU agencies to use all relevant technological and statistical
Amendment 143 #
Motion for a resolution Paragraph 15 15.
Amendment 144 #
Motion for a resolution Paragraph 15 a (new) 15a. Calls on the Member States to apply, wherever possible, hospital patient safety strategies and programmes in non- hospital care environments (in long- and medium-stay facilities, but also in the home);
Amendment 145 #
Motion for a resolution Subheading 5 b) Measures designed to guard against and reduce the number of HAIs
Amendment 146 #
Motion for a resolution Paragraph 16 – introductory part 16. Urges the Member States to continue their efforts to implement, if they have not already done so, additional measures to guard against and reduce the number of HAIs, with a view to falling fully into line with the Council’s recommendations, and in particular
Amendment 147 #
Motion for a resolution Paragraph 16 – introductory part 16. Urges the Member States to
Amendment 148 #
Motion for a resolution Paragraph 16 – indent 1 prevent HAIs, both inside and outside hospitals by the systematic implementation of the One Health approach, whereby both human and veterinary medical professionals undertake to prevent resistant infections and reduce the use of antibiotics;
Amendment 149 #
Motion for a resolution Paragraph 16 – indent 2 – improve the information provided to patients by
Amendment 15 #
Motion for a resolution Citation 6 b (new) - having regard to the Commission communication of 15 November 2011 on an action plan against the rising threats from antimicrobial resistance (COM(2011)0748),
Amendment 150 #
Motion for a resolution Paragraph 16 – indent 3 – support research into the prevention and control of HAIs, particularly those caused by Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile and other emerging difficult-to-treat infections;
Amendment 151 #
Motion for a resolution Paragraph 16 – indent 3 – support research into the prevention and control of HAIs, focusing in particular on forms of therapy that offer an alternative to treatment with antibiotics and a response to antibiotic resistance, including bacteriophage therapy;
Amendment 152 #
Motion for a resolution Paragraph 17 Amendment 153 #
Motion for a resolution Paragraph 17 – subparagraph 1 (new) Calls on the Commission to support further work on the prevention and control of HAIs through the forthcoming EU Health Programme.
Amendment 154 #
Motion for a resolution Paragraph 18 Amendment 155 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to make sufficient human, financial and technological resources available to ensure that care provided in the home or in hospital is of the highest possible quality
Amendment 156 #
Motion for a resolution Paragraph 18 18. Calls on the Member States and their delegated partners to make sufficient human, financial and technological resources available to ensure that care provided in the home or in hospital is of the highest possible quality, and urges them, in particular,
Amendment 157 #
Motion for a resolution Paragraph 18 18. Calls on the Member States to
Amendment 158 #
Motion for a resolution Paragraph 18 18.
Amendment 159 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Member States to introduce mandatory screening of patients for antibiotic-resistant microbes ahead of scheduled hospital stays and outpatient surgery, in order to prevent the spread of these microbes and ensure legal certainty;
Amendment 16 #
Motion for a resolution Citation 6 c (new) - having regard to the Council conclusions of 22 June 2012 on 'The impact of antimicrobial resistance in the human health sector and in the veterinary sector – a "One Health" perspective',
Amendment 160 #
Motion for a resolution Paragraph 18 a (new) 18a. Encourages Member States to develop their national practices on the appropriate use of antibiotics in order to limit the spread of antimicrobial resistance and ensure that antibiotic treatment remains effective;
Amendment 161 #
Motion for a resolution Paragraph 19 19. Calls on the Member States and the Commission to foster, including by means of awareness-raising campaigns, good practices in all areas, in particular all those linked to hygiene (hand hygiene, sterilisation
Amendment 162 #
Motion for a resolution Paragraph 19 19. Calls on the Member States and the Commission to foster
Amendment 163 #
Motion for a resolution Paragraph 19 19. Calls on the Member States and the Commission to
Amendment 164 #
Motion for a resolution Paragraph 19 a (new) 19a. Calls on the Member States to promote targeted action to prevent errors in hospitals, including the implementation of the WHO Surgical Safety Checklist;
Amendment 165 #
Motion for a resolution Paragraph 19 a (new) 19a. Urges Member States to provide the Commission with information on vaccination programmes for healthcare professionals including the levels of coverage achieved within healthcare institutions;
Amendment 166 #
Motion for a resolution Paragraph 19 b (new) 19b. Calls on the Member States to draw up national guidelines for hand hygiene and general cleaning of hospitals and care homes;
Amendment 167 #
Motion for a resolution Paragraph 20 a (new) 20a. Calls on the Member States to encourage efforts to study hospital outbreaks and a way of the spread of healthcare associated infections;
Amendment 168 #
Motion for a resolution Paragraph 20 b (new) 20b. Calls for more and better- coordinated research to avoid the spread of healthcare associated infections;
Amendment 169 #
Motion for a resolution Paragraph 21 21. Calls on the Member States to use the most advanced technological means available to guarantee optimum patient safety, and, in particular, to introduce
Amendment 17 #
Motion for a resolution Citation 6 h (new) – having regard to the Joint Technical Report by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) of 17 September 2009 on ‘The bacterial challenge: time to react – A call to narrow the gap between multidrug- resistant bacteria in the EU and the development of new antibacterial agents’,
Amendment 170 #
Motion for a resolution Paragraph 21 21. Calls on the Member States to use the most
Amendment 171 #
Motion for a resolution Paragraph 21 21.
Amendment 172 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and Member States to
Amendment 173 #
Motion for a resolution Paragraph 21 21. Calls on the Member States to use the most advanced technological means available to guarantee optimum patient safety, and, in particular, to introduce across the board electronic health passports containing all relevant information about the patient, including his or her antecedents; points out that the confidentiality of the personal data provided in connection with the issue of such passports must be guaranteed;
Amendment 174 #
Motion for a resolution Paragraph 22 – introductory part 22.
Amendment 175 #
Motion for a resolution Paragraph 22 a (new) 22a. Urges the Member States to encourage information input by health professionals on how patients can avoid being harmed as a result of contact with the health system;
Amendment 176 #
Motion for a resolution Paragraph 22 b (new) 22b. Calls on the Member States to take measures to increase patients’ families’ involvement in preventing errors in medication and self-treatment;
Amendment 177 #
Motion for a resolution Paragraph 22 – indent 1 – the state of health of patients (particularly
Amendment 178 #
Motion for a resolution Paragraph 22 – indent -1a (new) – the state of health of patients (particularly elderly persons and persons with reduced mobility) returning home after a period of hospitalisation must be assessed thoroughly when they leave hospital, with a view, in particular, to evaluating and countering the risk of falls;
Amendment 179 #
Motion for a resolution Paragraph 22 – indent 2 – patients and their carers must be properly informed, in particular about hand hygiene
Amendment 18 #
Motion for a resolution Citation 4 b (new) - having regard to the Joint Technical Report by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) of 17 September 2009 on 'The bacterial challenge: time to react – A call to narrow the gap between multidrug- resistant bacteria in the EU and the development of new antibacterial agents',
Amendment 180 #
Motion for a resolution Paragraph 22 – indent 3 – the use of
Amendment 181 #
Motion for a resolution Paragraph 22 – indent 3 –
Amendment 182 #
Motion for a resolution Paragraph 22 – indent 2 a (new) – the taking of basic precautions should be encouraged, in particular as regards the storage and use of medicines, and patients should, in particular, be made aware of the risks involved in using medicines that have no marketing authorisation;
Amendment 183 #
Motion for a resolution Paragraph 22 – indent 2 b (new) – the use of throwaway medical equipment must be encouraged as far as possible;
Amendment 184 #
Motion for a resolution Paragraph 23 23.
Amendment 185 #
Motion for a resolution Paragraph 23 23. Calls on the Member States to carry out specific awareness-raising and training measures concerning HAIs which are aimed not only at healthcare professionals (doctors, nurses, paramedics, etc.)
Amendment 186 #
Motion for a resolution Paragraph 23 a (new) 23a. Calls on the Member States to introduce national guidelines for health professionals on how to train patients in the use of antibiotics;
Amendment 187 #
Motion for a resolution Paragraph 23 a (new) 23a. Calls on the Member States to draw on and accord proper importance to expertise built up as a result of patients’ own experience when compiling best practices;
Amendment 188 #
Motion for a resolution Paragraph 24 Amendment 189 #
Motion for a resolution Paragraph 24 24. Calls on the Member States to designate at local level an authority or a contact person responsible for providing patients with information and data concerning patient safety in order to strengthen the public confidence in safety of health systems through increased provision of adequate and understandable information;
Amendment 19 #
Motion for a resolution Citation 6 o (new) – having regard to Special Eurobarometer 338 on Antimicrobial Resistance, published in April 2010,
Amendment 190 #
Motion for a resolution Paragraph 24 – subparagraph 1 (new) Calls on the Member States to do what they can to ensure that patients trust their health systems and, in particular, to involve patients closely in patient safety;
Amendment 191 #
Motion for a resolution Paragraph 24 a (new) 24a. Calls on the Member States to involve patient organisations in the development of new laws and health programmes;
Amendment 192 #
Motion for a resolution Paragraph 25 25.
Amendment 193 #
Motion for a resolution Paragraph 25 25. Calls on the Commission, the relevant EU agencies and the Member States to provide patients or their legal representatives with information about risks, safety levels and the measures taken to prevent adverse events in healthcare, in order to ensure that patients or their legal representatives can give informed consent to the treatment they are being offered and, more generally, to enable patients to learn more about the issue of patient safety, and urges them to inform patients about complaints procedures and the legal remedies available to them should adverse events in healthcare occur;
Amendment 194 #
Motion for a resolution Paragraph 25 25. Calls on the Member States to provide patients with information about risks, safety levels and the measures taken to prevent adverse events in healthcare, in order to ensure that patients can give
Amendment 195 #
Motion for a resolution Paragraph 25 – subparagraph 1 (new) Calls on the Member States to conduct specific information and training campaigns to raise awareness among patients and healthcare professionals of the issue of antimicrobial resistance;
Amendment 196 #
Motion for a resolution Paragraph 25 a (new) 25a. Calls on the Member States to encourage practising doctors to inform patients of their rights and opportunities to lodge complaints and report errors and adverse events;
Amendment 197 #
Motion for a resolution Paragraph 25 a (new) 25a. Calls on the Member States to guarantee patients and their legal representatives the right to refuse any form of treatment they consider inappropriate, in particular in the light of their age or state of health; points out that this right is intended in particular to protect babies against vaccines containing aluminium and children and pregnant women against treatments containing or releasing endocrine disruptors;
Amendment 198 #
Motion for a resolution Paragraph 26 a (new) 26a. Urges the Member States to allow class actions to be brought by patients, their representatives or legal successors in cases where at least two patients are affected by similar healthcare-related adverse events;
Amendment 199 #
Motion for a resolution Paragraph 27 Amendment 2 #
Motion for a resolution Citation 6 a (new) - having regard to the Directive on Patients Rights in Cross Border Healthcare (2011/24/EU),
Amendment 20 #
Motion for a resolution Citation 6 j (new) – having regard to the 2008 and 2012 annual epidemiological reports by the European Centre for Disease Prevention and Control (ECDC),
Amendment 200 #
Motion for a resolution Paragraph 27 Amendment 201 #
Motion for a resolution Paragraph 27 Amendment 202 #
Motion for a resolution Paragraph 27 Amendment 203 #
Motion for a resolution Paragraph 27 27.
Amendment 204 #
Motion for a resolution Paragraph 27 – subparagraph 1 (new) Calls, in particular, on the Member States to set up a mediation service to improve dialogue between healthcare system users and healthcare professionals and to analyse and respond to all requests for information and all complaints concerning healthcare system quality and healthcare safety;
Amendment 205 #
Motion for a resolution Paragraph 27 a (new) 27a. Urges the Commission to continue to maintain contacts with patients’ associations, in particular the European Patients’ Forum;
Amendment 207 #
Motion for a resolution Paragraph 28 Amendment 208 #
Motion for a resolution Paragraph 28 Amendment 209 #
Motion for a resolution Paragraph 28 28. Calls on the Member States to encourage the submission of reports and the provision of feedback concerning patient safety not only from medical staff, but also from patients and their relatives. Their reporting should be transparent at all levels;
Amendment 21 #
Motion for a resolution Citation 6 k (new) – having regard to the European Centre for Disease Prevention and Control (ECDC) technical document entitled ‘Core competencies for infection control and hospital hygiene professionals in the European Union’ published on 26 March 2013,
Amendment 210 #
Motion for a resolution Paragraph 28 28. Calls on the Commission, the relevant EU agencies and the Member States to encourage the submission of reports and the provision of feedback concerning patient safety not only from medical staff, but also from patients and their relatives;
Amendment 211 #
Motion for a resolution Paragraph 28 – subparagraph 1 (new) Urges the Member States to introduce checklists, with a view to making surgical operations safer;
Amendment 212 #
Motion for a resolution Paragraph 29 29.
Amendment 213 #
Motion for a resolution Paragraph 29 29. Urges the Member States to adopt standardised criteria to identify places where contamination with HAIs occurs (including facilities outside hospitals) and to continue their efforts to collect comparable, up-to-date information on general patient safety and HAIs; calls on the Member States to publish this data on an annual basis;
Amendment 214 #
Motion for a resolution Paragraph 29 29. Urges the Commission and the Member States to adopt standardised criteria to identify and monitor places where contamination with HAIs occurs
Amendment 215 #
Motion for a resolution Paragraph 30 30. Calls in particular on those Member States which conduct specific national HAI prevalence surveys using a harmonised methodology developed by the ECDC to do so on a regular basis, and urges those Member States which do not do so to introduce such surveys; urges the Commission to look more closely at the Global Microbial Identifier system1, which is supported by a large number of researchers throughout the world, and which can monitor and detect alert healthcare associated organisms and boost capacity to respond to the spread (including the cross-border spread) of infections; __________________ 1 http://www.globalmicrobialidentifier.org/
Amendment 216 #
Motion for a resolution Paragraph 30 30. Calls
Amendment 217 #
Motion for a resolution Paragraph 30 a (new) 30a. Recommends that a list of HAIs which should be screened for in all hospitals and healthcare establishments in the EU be drawn up in cooperation with the EMA and the ECDC;
Amendment 218 #
Motion for a resolution Paragraph 31 Amendment 219 #
Motion for a resolution Paragraph 31 31. Recommends that regional or local working parties be set up to consider specific issues relating to patient safety; by way of an example, working parties could focus on accident prevention among
Amendment 22 #
Motion for a resolution Citation 6 l (new) – having regard to the communication of 15 December 2008 from the Commission to the European Parliament and the Council on patient safety, including the prevention and control of healthcare- associated infections (COM(2008) 837 final),
Amendment 220 #
Motion for a resolution Paragraph 31 a (new) 31a. Calls on the Member States to encourage hospitals and care homes to focus on basic care tasks such as observation of patients and assessment of pressure sores, which are a major but often hidden problem for hospitalised patients and inmates;
Amendment 221 #
Motion for a resolution Paragraph 32 32. Calls on the Member States and the Commission
Amendment 222 #
Motion for a resolution Paragraph 32 32. Calls on the Member States and the Commission to step up cooperation, including with the WHO and the OECD, with a view to standardising measures, definitions, terminology and indicators in the area of patient safety, in particular so as to ensure that high-risk patients may be isolated should a pandemic or cross- border threat emerge;
Amendment 223 #
Motion for a resolution Paragraph 33 33. Calls
Amendment 224 #
Motion for a resolution Paragraph 33 a (new) 33a. Calls on the Member States to share, where they exist, good practice benchmarks in the area of HAI prevention and control and the transmission of multi-resistant bacteria (e.g. measures to prevent the spread of legionella bacteria in hospital hot-water systems);
Amendment 225 #
Motion for a resolution Paragraph 34 34. Encourages the ECDC in its efforts to support and standardise the monitoring of HAIs, and, in particular, calls on it to
Amendment 226 #
Motion for a resolution Paragraph 34 34.
Amendment 227 #
Motion for a resolution Paragraph 34 34. Encourages the ECDC in its efforts to support and standardise the monitoring of HAIs, and, in particular, calls on it to continue developing structure and process indicators and to facilitate the exchange of best practice in monitoring HAIs;
Amendment 228 #
Motion for a resolution Paragraph 35 Amendment 229 #
Motion for a resolution Paragraph 35 35. Calls on the Commission, the relevant EU agencies and the Member States to establish and monitor a joint database to be used to compile and make available to the public information concerning adverse events in healthcare, clinical trials of medicines and clinical investigations of medical devices, and to encourage the use of all relevant data collection and alert mechanisms (including those based on confidential declarations);
Amendment 23 #
Motion for a resolution Citation 6 m (new) – having regard to the Commission’s Impact Assessment of December 2008,
Amendment 230 #
Motion for a resolution Paragraph 35 35. Calls on the Member States to
Amendment 231 #
Motion for a resolution Paragraph 35 35. Calls on the Member States to establish a joint database to be used to compile information concerning adverse events in healthcare and to encourage the use of all relevant data collection mechanisms (including those based on confidential declarations). Patients should be dealt with in accordance with ethical principles and their personal data should be protected;
Amendment 232 #
Motion for a resolution Paragraph 35 35. Calls on the Member States to establish a joint database to be used to compile information concerning adverse events in healthcare and to encourage the use of all relevant data collection mechanisms (including those based on confidential declarations) and for this database to be shared with both the Commission and the ECDC;
Amendment 233 #
Motion for a resolution Paragraph 35 a (new) 35a. Calls on the European Medicines Agency to develop guidelines on the off- label use of medicines on the basis of medical need and taking account of patient protection;
Amendment 234 #
Motion for a resolution Paragraph 35 a (new) 35a. Urges the Member States to give a further boost to nosocomial infection surveillance programmes by encouraging hospitals to play a full and active part in the European nosocomial infection surveillance network;
Amendment 235 #
Motion for a resolution Paragraph 35 b (new) 35b. Calls on the European Centre for Disease Prevention and Control (ECDC) to draw up, in cooperation with the European Medicines Agency (EMA), a list of pathogens that can cause serious or potentially fatal antibiotic-resistant infections and pose a serious health risk; calls for that list to be updated on a regular basis with information supplied by the ECDC’s European Surveillance of Antimicrobial Consumption Network (ESAC-Net) and European Antimicrobial Resistance Surveillance Network (EARS- Net);
Amendment 236 #
Motion for a resolution Paragraph 35 a (new) 35a. Calls on the Commission and the Member States to cooperate in introducing incentives for the development of new antibacterial medicines; considers that these incentives should be introduced as part of an appropriate EU legislative framework, with a view to fostering cooperation between the public and private sectors in order to revitalise antimicrobials-related research and development;
Amendment 237 #
Motion for a resolution Paragraph 35 b (new) 35b. Believes that, under the eighth framework programme for research, which is to commence in 2014, the EU should cofinance research into general patient safety, HAIs and resistance to antimicrobial agents;
Amendment 238 #
Motion for a resolution Paragraph 36 36. Urges the Member States and the Commission to
Amendment 239 #
Motion for a resolution Paragraph 37 37. Urges the Member States to step up their cooperation with the ECDC in the area of the prevention and control of HAIs; encourages national authorities in particular to ask the ECDC to carry out regular in situ audits and to publish the reports submitted to them by the ECDC
Amendment 24 #
Motion for a resolution Citation 6 n (new) – having regard to the Special Eurobarometer survey on ‘Patient Safety and Quality of Healthcare’, published in April 2010,
Amendment 25 #
Motion for a resolution Citation 6 p (new) – having regard to the Special Eurobarometer survey on ‘Patient involvement’ published in May 2012,
Amendment 26 #
Motion for a resolution Citation 6 q (new) – having regard to the Council Conclusions on common values and principles in European Health Systems (OJ C 146, 22.06.2006, p.1),
Amendment 27 #
Motion for a resolution Citation 6 r (new) – having regard to the WHO report entitled ‘Core components for infection prevention and control programmes’,
Amendment 28 #
Motion for a resolution Citation 6 s (new) – having regard to the Report of the second meeting of the Informal Network on Infection Prevention and Control in Health Care (June 2008),
Amendment 29 #
Motion for a resolution Citation 6 t (new) - having regard to World Health Assembly Resolution WHA55.18 on ‘Quality of care: patient safety’ of 18 May 2002,
Amendment 3 #
Motion for a resolution Citation 6 a (new) – having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare,
Amendment 30 #
Motion for a resolution Citation 6 u (new) – having regard to the Commission's White Paper entitled ‘Together for Health: A Strategic Approach for the EU 2008-2013’ of 23 October 2007.
Amendment 31 #
Motion for a resolution Citation 6 v (new) - having regard to the second programme of Community action in the field of health (2008-13) which seeks to improve citizens’ health security, and to promote measures aimed at optimising patient safety by means of high-quality, safe health care, including in the area of microbial resistance to antibiotics and nosocomial infections,
Amendment 32 #
Motion for a resolution Recital A A. whereas patient safety
Amendment 33 #
Motion for a resolution Recital A a (new) Aa. whereas high-quality healthcare is the cornerstone of any high-quality health system and whereas access to high-quality healthcare is recognised as a fundamental right by the EU, the European institutions and European citizens;
Amendment 34 #
Motion for a resolution Recital A A. whereas patient safety is key to overall healthcare quality and efforts to increase the safety of patients depends on the use of effective and long-term policies and programmes across Europe;
Amendment 35 #
Motion for a resolution Recital B a (new) Ba. whereas the issue of patient safety is becoming a growing concern in health systems throughout the world, including in Europe;
Amendment 36 #
Motion for a resolution Recital C – footnote 3 3. For the purposes of this report, HAI means any infection which occurs during or following the provision of medical services (for diagnostic, therapeutic or preventive purposes) and which was not present or incubating prior to such provision. The infectious micro-organisms (bacteria, fungi, parasites and other transmissible agents) involved in HAI cases may come either from the patient's own organism (intestines, skin, etc.), in which case they are called endogenous infections, or from the patient's environment, in which case they are known as exogenous or cross infections. The term healthcare associated infection covers all infections associated with healthcare systems in general and with individual treatment pathways. These include nosocomial infections (acquired in healthcare establishments, either as an inpatient or an outpatient) and infections acquired during treatment provided outside healthcare establishments, in collective facilities (such as medium- and long-stay facilities, in particular care homes for
Amendment 37 #
Motion for a resolution Recital C C. whereas
Amendment 38 #
Motion for a resolution Recital C C. whereas the most common healthcare- related adverse events are healthcare associated infections (HAIs), medication- related events, including those resulting from off-label use, and complications arising during or after surgical operations;
Amendment 39 #
Motion for a resolution Recital C C. whereas the most common healthcare- related adverse events are healthcare associated infections (HAIs) , medication- related events, diagnostic errors and complications arising during or after surgical operations;
Amendment 4 #
Motion for a resolution Citation 6 d (new) – having regard to the report of the European Parliament on the proposal for a Council recommendation on patient safety, including the prevention and control of healthcare associated infections (COM(2008)0837 – C6-0032/2009 – 2009/0003(CNS)),
Amendment 40 #
Motion for a resolution Recital D D. whereas it is estimated that between 8% and 12% of patients admitted to hospitals in the EU suffer from adverse events while receiving healthcare, including HAIs, errors during treatment or surgery, problems arising from the failure or inadequate decontamination of medical equipment, errors in diagnosis and failure to act on the results of tests;
Amendment 41 #
Motion for a resolution Recital K b (new) Kb. whereas it is essential to uphold citizens’ confidence in the health systems of the European Union;
Amendment 42 #
Motion for a resolution Recital K a (new) Ka. whereas patients’ experiences and inputs often differ from those of health professionals and can be of great value in establishing measures aimed at improving patient safety;
Amendment 43 #
Motion for a resolution Recital E a (new) E a. whereas reliable information on patient safety and HAIs is subject to limitations, including the ability of healthcare professionals to undertake adverse event reporting candidly and without reservations;
Amendment 44 #
Motion for a resolution Recital A a (new) Aa. whereas any natural or legal person has the right to make public or distribute in good faith, and in safety, information on a fact, an item of data or an action, as soon as a lack of knowledge of this fact, this item of data or this action appears to present a danger to public health;
Amendment 45 #
Motion for a resolution Recital E E. whereas some adverse events are the result of risks inherent in
Amendment 46 #
Motion for a resolution Recital H b (new) Hb. whereas, however, it is estimated that between 30% and 40% of adverse events in both hospital and out-of-hospital (ambulatory) care appear to be caused by systemic factors and are thus avoidable;
Amendment 47 #
Motion for a resolution Recital F F. whereas, furthermore,
Amendment 48 #
Motion for a resolution Recital F F. whereas, furthermore, elderly patients and patients with immunodeficiencies or chronic diseases, in particular degenerative diseases, are especially vulnerable to healthcare-related adverse events, such as: diagnostic errors; lack of follow-up on medical examinations; the prescription, dispensing or administration of an inappropriate (e.g. off-label) medicine, of an incorrect dose or of two medicines which should not be combined; the failure or poor disinfection of medical equipment; or the infection of surgical scars;
Amendment 49 #
Motion for a resolution Recital G a (new) Ga. Whereas that patient safety enjoys a high priority on the political agenda, the Member States have established a mechanism for debate related to patient safety issues and other work in this area in 2005. A working group was established, through which the European Commission intends to promote the work and activities of the Member States. The active members of the working group are the World Health Organization (especially through the World Alliance for Patient Safety), the Council of Europe, OECD and European associations of patients, physicians, nurses, pharmacists, dentists and hospitals;
Amendment 5 #
Motion for a resolution Citation 6 f (new) – having regard to its resolution of 12 May 2011 on antibiotic resistance,
Amendment 50 #
Motion for a resolution Recital I a (new) Ia. whereas the European Centre for Disease Prevention and Control (ECDC), with the involvement of international experts, has the task of developing scientific recommendations on evidence- based measures for the effective prevention of HAIs;
Amendment 51 #
Motion for a resolution Recital G a (new) Ga. whereas, therefore, the European Union’s action in the field of patient safety consists in helping Member States to coordinate their efforts in this area and supporting their actions in fields where its intervention can provide an added value;
Amendment 52 #
Motion for a resolution Recital H a (new) Ha. whereas international studies estimate that between 13% and 16% of hospital costs (one euro in every seven) are incurred as a result of healthcare related incidents;
Amendment 53 #
Motion for a resolution Recital G b (new) Gb. whereas a lack of financial, technical and human resources is particularly associated with an increased risk of healthcare related adverse events;
Amendment 54 #
Motion for a resolution Recital E a (new) Ea. whereas the financial and economic crisis and the budget cuts which it necessitated may in some Member States lead, or already have led, to an increased incidence of patients being prescribed cheaper off-label medicines;
Amendment 55 #
Motion for a resolution Recital G c (new) Gc. whereas the economic crisis has slowed the implementation of measures adopted by the Member States in 2009, as a result of changed priorities in public health;
Amendment 56 #
Motion for a resolution Recital C a (new) Ca. whereas HAIs are among the most common – and often the most dangerous – causes of involuntary harm to patients;
Amendment 57 #
Motion for a resolution Recital C a (new) Ca. whereas it is estimated that the annual number of patients with acquiring at least one Healthcare Associated Infection during their stays in European acute care hospitals in 2011-2012, in the European Union as a whole is 3.2 million 1 . __________________ 1 according to Commission reply E- 004648/2013
Amendment 58 #
Motion for a resolution Recital C b (new) Cb. whereas HAIs, which, on average, are acquired by 5% of patients admitted to hospital, some 4.1 million patients each year, in the European Union and have a high impact in terms of morbidity, mortality (with 37 000 people dying directly of such infections in the European Union) and cost (estimated at over EUR 5.5 billion per year in Europe), constitute a major public health problem in the countries of the European Union;
Amendment 59 #
Motion for a resolution Recital H H. whereas HAIs, which, on average, are acquired by 5% of patients admitted to hospital, are a major public health problem in the Member States and place a heavy burden on limited
Amendment 6 #
Motion for a resolution Citation 6 c (new) – having regard to the Commission recommendation of 27 October 2011 on the research Joint Programming Initiative ‘The Microbial Challenge – An Emerging Threat to Human Health’ (C(2011)7660),
Amendment 60 #
Motion for a resolution Recital I I. whereas HAIs can occur as a result of time spent in healthcare establishments or during the provision of any healthcare services, including home-based services (in particular as a result of contamination
Amendment 61 #
Motion for a resolution Recital I I. whereas HAIs can occur as a result of time spent in healthcare establishments or during the provision of any healthcare services, including home-based services (in particular as a result of errors in dosage, errors in packaging the medicine, contamination of medical instruments or equipment);
Amendment 62 #
Motion for a resolution Recital K c (new) Kc. whereas, since the micro-organisms responsible for HAIs are capable of colonising the human body for long periods, patients can spread them not only during their hospital stay but also afterwards, and whereas HAIs can thus affect all care premises, medium- and long-term care establishments and even the patient’s home;
Amendment 63 #
Motion for a resolution Recital I I. whereas HAIs can occur as a result of time spent in
Amendment 64 #
Motion for a resolution Recital I I. whereas HAIs can occur as a result of time spent in healthcare establishments
Amendment 65 #
Motion for a resolution Recital I a (new) Ia. whereas a HAI contracted during a hospital stay may not display symptoms until after the patient has been discharged;
Amendment 66 #
Motion for a resolution Recital J a (new) Ja. whereas the average length of a hospital stay in the Member States of the European Union is falling;
Amendment 67 #
Motion for a resolution Recital J b (new) Jb. whereas the percentage of patients affected by infections following home care is unknown, and whereas home care is often provided to patients with chronic or degenerative diseases who have not been admitted to hospital;
Amendment 68 #
Motion for a resolution Recital J d (new) Jd. whereas patients with chronic or degenerative diseases often receive home care instead of being admitted to hospital;
Amendment 69 #
Motion for a resolution Recital J e (new) Je. whereas the condition of some people with chronic or degenerative diseases often requires permanent and continuous medical assistance, very frequently necessitating, in particular, the use of medical devices (cardiac stimulators, respiratory devices, catheters, urinary catheters, etc.);
Amendment 7 #
Motion for a resolution Citation 6 e (new) – having regard to its resolution of 27 October 2011 on the public health threat of antimicrobial resistance,
Amendment 70 #
Motion for a resolution Recital J f (new) Jf. whereas the use of such medical devices requires strict application of the procedures for use, in accordance with guidelines and established good practice;
Amendment 71 #
Motion for a resolution Recital J g (new) Jg. whereas the use of such medical devices carries a risk of infection;
Amendment 72 #
Motion for a resolution Recital K a (new) Ka. whereas demographic changes are leading to an increase in the proportion of older patients, who are frequently prescribed a large number of different medicines but are often unable to cope with taking them correctly;
Amendment 73 #
Motion for a resolution Recital J c (new) Jc. whereas simple and cost-effective action to prevent HAIs, such as sanitation education (in particular, the promotion of hospital hygiene), already exists or is currently being tested on an experimental basis, with promising results, and whereas potential alternative, cost-effective ways of combating HAIs could usefully be explored;
Amendment 74 #
Motion for a resolution Recital K b (new) Kb. whereas the rules on patient mobility are being implemented in the EU, and hence European patients have a greater need to know about patient safety in the various Member States;
Amendment 75 #
Motion for a resolution Recital K K. whereas, furthermore, people’s increasing mobility within and between
Amendment 76 #
Motion for a resolution Recital K a (new) Ka. whereas the results of the Eurobarometer survey on ‘Patient Safety and Quality of Healthcare’ indicate both that European public opinion is highly aware of this issue and also that there is a marked lack of information on patient safety;
Amendment 77 #
Motion for a resolution Recital K a (new) Ka. whereas only 13 Member States have implemented national surveillance of Clostridium difficile infections1 and in only 3 of the surveillance systems are general practitioners also involved in the data collection - a situation that should be improved. E-004649/2013 __________________ 1 According to reply from the Commission E-004649/2013 these 13 countries are: Austria, Belgium, Bulgaria, Denmark, Germany, Finland, France, Hungary, Ireland, the Netherlands, Spain, Sweden and United Kingdom. http://www.europarl.europa.eu/sides/getAl lAnswers.do?reference=E-2013- 004649&language=EN
Amendment 78 #
Motion for a resolution Recital K d (new) Kd. whereas HAIs are often difficult to treat, as the micro-organisms responsible for them are frequently resistant to antimicrobial agents;
Amendment 79 #
Motion for a resolution Recital H d (new) Hd. whereas antibiotic resistance in Europe is continuing to increase, and for certain bacteria may be 25%, or even more, in several Member States;
Amendment 8 #
Motion for a resolution Citation 6 i (new) – having regard to its report of 15 November 2012 on ‘The Microbial Challenge – Rising threats from Antimicrobial Resistance’ (2012/2041),
Amendment 80 #
Motion for a resolution Recital H c (new) Hc. whereas in the EU, Iceland and Norway alone antimicrobial resistant bacteria cause some 400 000 infections and 25 000 deaths annually, with at least EUR 1.5 billion spent on extra healthcare costs and productivity losses;
Amendment 81 #
Motion for a resolution Recital D a (new) Da. whereas there is a decline in the development of new antimicrobials
Amendment 82 #
Motion for a resolution Recital K e (new) Ke. whereas the development of resistance to antimicrobial agents can be accelerated, in particular, by the inordinate and indiscriminate use of these products in human medicine, which, combined with insufficient hygiene and infection control, can compromise the effective use of an already limited number of existing antimicrobial agents;
Amendment 83 #
Motion for a resolution Recital F a (new) Fa. whereas the issue of antimicrobial resistance is a serious, and in some countries growing, threat to patient safety, that can complicate the recovery from and treatment of infections and that increases the national costs for health;
Amendment 84 #
Motion for a resolution Recital H e (new) He. whereas the latest available data indicate that antibiotic resistance markers for the bacteria involved in HAIs highlight an increasing global trend towards multi-resistance, and, in particular, an increase in the percentage of Enterobacteriaceae resistant to 3rd generation cephalosporins and of methicillin resistant S. aureus;
Amendment 85 #
Motion for a resolution Recital H f (new) Hf. whereas there is a growing gap between increasing resistance to antimicrobial agents and the development of new antimicrobial agents;
Amendment 86 #
Motion for a resolution Recital H g (new) Hg. whereas the development of resistance to antimicrobial agents is a natural and unavoidable consequence of their use, but whereas it can be limited through their prudent and rational use;
Amendment 87 #
Motion for a resolution Recital H h (new) Hh. whereas the development of resistance to antimicrobial agents can be accelerated, in particular, by the inordinate and indiscriminate use of these products in human medicine, which, combined with insufficient hygiene and infection control, can compromise the effective use of an already limited number of existing antimicrobial agents;
Amendment 88 #
Motion for a resolution Recital H i (new) Hi. whereas, in view of the lack of development of new antibiotics/antimicrobial agents, it is vital for current antimicrobial agents to be used effectively for as long as possible;
Amendment 89 #
Motion for a resolution Recital K a (new) Ka. whereas, in view of the lack of development of new antibacterial medicines, the Commission and the Member States should work together to support the development and availability of such products, making use of the European Centre for Disease Prevention and Control (ECDC) and the expertise of the European Medicines Agency (EMA);
Amendment 9 #
Motion for a resolution Citation 6 a (new) - having regard to the report of the Committee on the Environment, Public Health and Food Safety on the Microbial Challenge - Rising threats from Antimicrobial Resistance (2012/2041(INI)),
Amendment 90 #
Motion for a resolution Recital K a (new) Ka. whereas intensive farming policies promote the occurrence of antibiotic resistance, both through the food chain as well as through animal waste entering the water cycle;
Amendment 91 #
Motion for a resolution Recital K f (new) Kf. whereas, according to the results of the Eurobarometer survey on ‘Antimicrobial Resistance’, 53% of people questioned still believed in 2010 that antibiotics were effective against viruses, 20% took antibiotics to tackle influenza and 14% to combat colds, and 5% of people took antibiotics obtained without a medical check-up;
Amendment 92 #
Motion for a resolution Recital K g (new) Kg. whereas consumption of antibiotics is higher among people who are objectively least well informed and whereas better objective knowledge of antibiotics is associated with more responsible behaviour in terms of their use;
Amendment 93 #
Motion for a resolution Recital K h (new) Kh. whereas certain Member States do not have a solid regulatory and legal framework to support and make compulsory the rational use of medicines, and whereas there are strong disparities in Europe in terms of consumption of antibiotics, in the context of both community and hospital care;
Amendment 94 #
Motion for a resolution Recital K i (new) Ki. whereas there is a need to educate and raise awareness among those involved in antimicrobial use, including policy- makers, health professionals and the general public, in order to encourage necessary changes in the behaviour of prescribers, dispensers and citizens;
Amendment 95 #
Motion for a resolution Recital K j (new) Kj. whereas, since the adoption in 2009 of Council Recommendation 2009/C 151/01, substantial effort has been invested in adopting and implementing strategies (national and regional) for the prevention and control of HAIs in the Member States, particularly through the adoption of guidelines on the prevention and control of HAIs and by setting up active HAI surveillance systems (or strengthening those that already exist);
Amendment 96 #
Motion for a resolution Recital K ja (new) Kja. whereas, on the other hand, some of the action recommended by the Council in its Recommendation 2009/C 151/01 on how to improve patient safety in the Member States has thus far been implemented by only a limited number of Member States, and whereas there is room for improvement – in both hospital and non-hospital care – particularly in respect of patient empowerment and the overall training of health professionals and carers, as well as in the implementation of European classifications on patient safety and the development of European guidelines on patient safety standards;
Amendment 97 #
Motion for a resolution Recital K k (new) Kk. whereas, since the adoption in 2009 of Council Recommendation 2009/C 151/01, substantial effort has been invested in improving patient safety in the Member States, particularly by embedding patient safety as a priority in public health policies in all Member States, by designating a competent authority responsible for patient safety (in 19 Member States) and encouraging training on patient safety in healthcare establishments (in 23 Member States);
Amendment 98 #
Motion for a resolution Recital K l (new) Amendment 99 #
Motion for a resolution Recital K m (new) Km. whereas, on the other hand, some of the action recommended by the Council in its Recommendation 2009/C 151/01 on how to improve patient safety in the Member States has thus far been implemented by only a limited number of Member States, and whereas there is room for improvement – in both hospital and non-hospital care – particularly in respect of patient empowerment and the overall training of health professionals and carers, as well as in the implementation of European classifications on patient safety and the development of European guidelines on patient safety standards;
source: PE-514.775
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On the basis of information provided by the Member States, the current Commission report follows up the Council Recommendation of June 2009, on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters: · in the first chapter on general patient safety, Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare; · in the second chapter on the prevention and control of healthcare-associated infections (HAIs), Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This Report summarises the main actions taken at Member State and EU level by June 2011 (July 2012 for the general patient safety part) and highlights those areas of the Recommendation needing further attention. 1) Main actions taken at Member State level: most Member States have taken a variety of actions as envisaged by the Recommendation. On general patient safety, most Member States: · have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety; · have encouraged training on patient safety in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals. The existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility to report. However, there is still room for improvement in this crucial area. The same applies to provisions for patient empowerment. Also, efforts focus on hospital healthcare, with only a few examples of actions addressing primary care. On the prevention and control of HAI: · 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77 %) as part of a national/regional strategy and/or action plan; · 13 Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. 2) Main actions taken at EU level: On general patient safety, the European Commission has: · pursued the following activities to promote mutual learning among Member States and propose common definitions and terminology for patient safety; · fostered the exchange of information on initiatives concerned with patient safety and quality of care; · allocated EUR 3 600 000 for a three-year collaboration on patient safety, in the form of a joint action for the years 2012-2015, the EU has co-financed six research projects on general patient safety, to a total amount of EUR 16 million. On the prevention and control of HAI: · to have an “Action plan against the rising threats from antimicrobial resistance”; The Commission’s ‘Action plan against the rising threats from antimicrobial resistance’; · to fund numerous research projects in the area of HAI and antimicrobial resistance within the Sixth and Seventh Framework Programmes for Research and Technological Development (2002-2006 and 2007-2013). The European Centre for Disease Prevention and Control (ECDC) coordinates the European surveillance of surgical-site infections, HAI in intensive care units and antimicrobial resistance. 3) Improvements to make: The report notes there are still various areas of the Recommendation with considerable room for improvement. The priority areas on which future work should focus include: General patient safety: - At Member State level: · actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress, work on a common understanding and development of core competencies for patients, and encourage patients and their families to report adverse events; · collect information on adverse events through further developing reporting and learning systems; · ensure a non-punitive context for reporting on adverse events and evaluate reporting progress; · extend patient safety strategies and programmes from hospital care to non-hospital care as well. - At EU level: · collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation; · make progress on common terminology on patient safety; · pursue exchange of best practice, e.g. systematic integration of patient safety in the education and training of health professionals at all levels; · develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies. Prevention and control of healthcare associated infections: - At Member State level: · ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals and other healthcare institutions; · improve the training of specialised infection control staff and better align qualifications between Member States; · reinforce tailored basic infection prevention and control structures and practices in nursing homes and other long-term care facilities; · repeat national point prevalence surveys of HAI as a means to monitor the burden of HAI in all types of healthcare institutions, to identify priorities and targets for intervention, to evaluate the impact of interventions and to raise awareness; · ensure that surveillance of infections in intensive care units and surgical site infections is in place; · implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms and prevent their introduction into healthcare settings; · improve the information on HAI for patients and strengthen their involvement in the compliance with infection prevention and control measures; · develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan and its success in improving the prevention and control of HAI. - At EU level: · continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities; · develop research in the area of the prevention and control of HCA, including studies on cost-effectiveness of prevention and control measures. As in many Member States and at EU level the actions have been implemented only recently or in some cases are still under implementation, it might be advisable to carry out such an assessment again in two years’ time, taking the current report as a comparative reference. This is why the Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care. New
PURPOSE: to present a report on the implementation of Council Recommendation on patient safety. BACKGROUND: in June 2009, the Council adopted a Recommendation on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters. 1) The first chapter concerns general patient safety, where Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare. These measures include: · developing national policies on patient safety ; · empowering and informing patients; · establishing reporting and learning systems on adverse events; · promoting the education and training of healthcare workers; · developing research on the issue. The Recommendation invites Member States to share knowledge, experience and best practice and to classify and codify patient safety at EU level by working with each other and with the Commission. 2) The second chapter concerns the prevention and control of healthcare-associated infections (HAIs), where Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This strategy should comprise: · infection prevention and control measures at national/regional level and at the level of healthcare institutions, and · providing surveillance systems, the education and training of healthcare workers, information to patients, and research. The report summarises the main actions taken at Member State and EU level with regard to the Council Recommendation. CONTENT : in accordance with the above-mentioned Recommendation, the Commission presents, on the basis of Member States' reports, a summary of the main actions taken as regards the implementation of the Recommendation by June 2011 (July 2012 for the general patient safety part). The report highlights those areas of the Recommendation needing further attention. It is accompanied by a Commission Staff Working Document providing a more detailed technical analysis of the replies received by EU Member States and Norway. Actions taken at Member State level: most Member States have taken a certain number of the measures recommended: · on general patient safety, most Member States have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety; · on encouraging training on patient safety, most countries have taken measures in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals; · regarding systems on adverse events (systems providing information about the causes of adverse events and recording their numbers by type), the existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility of reporting events. However, there is still room for improvement in this crucial area; · on empowering patients, efforts focus on hospital healthcare through the involvement of patient organisations on patient safety, with only a few examples of actions addressing primary care; · on research, the report notes the establishment of national research programme on patient safety in 10 Member States. Existing research covers patient safety culture, reducing the risk of medication errors, improving patients’ competence in medication safety, healthcare-associated infections, and prevention of falls in the elderly population; · on the prevention and control of HAIs, 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77%) as part of a national/regional strategy and/or action plan. Thirteen Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. Most of the strategies for the prevention and control of HAI are linked to strategies for the prudent use of antimicrobial agents in human medicine and/or patient safety strategies. Actions taken at EU level: Directive on cross-border healthcare: the Recommendation complements other EU initiatives. Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights seeks to clarify the rights of patients when accessing care in another EU Member State. It also seeks to ensure that such care is safe and of good quality. It therefore includes several provisions relating to the safety and quality of healthcare. The implementation of the actions envisaged by the Recommendation will be considered as a reference for assessing safety standards under the Directive. Apart from the Directive, the report discusses the funding of several actions, particularly in terms of the EU Health Programme or the 7th Framework Research Programme (for a total amount of EUR 16 million.) With regard to HAIs, the Commission has adopted an ‘Action plan against the rising threats from antimicrobial resistance' which contains 12 actions to be implemented with EU Member States. Focus of future work: the report notes that there are still various areas of the Recommendation with considerable room for improvement. Based on the findings of the report, the priority areas on which future work should focus include: General patient safety -At Member State level: · actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress; · collect information on adverse events through further developing reporting and learning systems, ensure a non-punitive context for reporting on adverse events and evaluate reporting progress; · extend patient safety strategies and programmes from hospital care to non-hospital care as well; -At EU level: · collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation ; · make progress on common terminology on patient safety; · pursue exchange of best practice; · develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies. Prevention and control of healthcare associated infections -At Member State level: · ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals; · improve the training of specialised infection control staff and better align qualifications between Member States; · reinforce tailored basic infection prevention and control structures and practices in nursing homes; · repeat national point prevalence surveys of HAI; · ensure that surveillance of infections in intensive care units and surgical site infections is in place; · implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms; · improve the information on HAI for patients; · develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan. -At EU level: · continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities; · develop research in the area of the prevention and control of HCA. The Recommendation invites the Commission to consider the extent to which the proposed measures are working effectively. The Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care. |
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PURPOSE: to present a report on the implementation of Council Recommendation on patient safety. BACKGROUND: in June 2009, the Council adopted a Recommendation on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters. 1) The first chapter concerns general patient safety, where Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare. These measures include: · developing national policies on patient safety ; · empowering and informing patients; · establishing reporting and learning systems on adverse events; · promoting the education and training of healthcare workers; · developing research on the issue. The Recommendation invites Member States to share knowledge, experience and best practice and to classify and codify patient safety at EU level by working with each other and with the Commission. 2) The second chapter concerns the prevention and control of healthcare-associated infections (HAIs), where Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This strategy should comprise: · infection prevention and control measures at national/regional level and at the level of healthcare institutions, and · providing surveillance systems, the education and training of healthcare workers, information to patients, and research. The report summarises the main actions taken at Member State and EU level with regard to the Council Recommendation. CONTENT : in accordance with the above-mentioned Recommendation, the Commission presents, on the basis of Member States' reports, a summary of the main actions taken as regards the implementation of the Recommendation by June 2011 (July 2012 for the general patient safety part). The report highlights those areas of the Recommendation needing further attention. It is accompanied by a Commission Staff Working Document providing a more detailed technical analysis of the replies received by EU Member States and Norway. Actions taken at Member State level: most Member States have taken a certain number of the measures recommended: · on general patient safety, most Member States have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety; · on encouraging training on patient safety, most countries have taken measures in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals; · regarding systems on adverse events (systems providing information about the causes of adverse events and recording their numbers by type), the existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility of reporting events. However, there is still room for improvement in this crucial area; · on empowering patients, efforts focus on hospital healthcare through the involvement of patient organisations on patient safety, with only a few examples of actions addressing primary care; · on research, the report notes the establishment of national research programme on patient safety in 10 Member States. Existing research covers patient safety culture, reducing the risk of medication errors, improving patients’ competence in medication safety, healthcare-associated infections, and prevention of falls in the elderly population; · on the prevention and control of HAIs, 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77%) as part of a national/regional strategy and/or action plan. Thirteen Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. Most of the strategies for the prevention and control of HAI are linked to strategies for the prudent use of antimicrobial agents in human medicine and/or patient safety strategies. Actions taken at EU level: Directive on cross-border healthcare: the Recommendation complements other EU initiatives. Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights seeks to clarify the rights of patients when accessing care in another EU Member State. It also seeks to ensure that such care is safe and of good quality. It therefore includes several provisions relating to the safety and quality of healthcare. The implementation of the actions envisaged by the Recommendation will be considered as a reference for assessing safety standards under the Directive. Apart from the Directive, the report discusses the funding of several actions, particularly in terms of the EU Health Programme or the 7th Framework Research Programme (for a total amount of EUR 16 million.) With regard to HAIs, the Commission has adopted an ‘Action plan against the rising threats from antimicrobial resistance' which contains 12 actions to be implemented with EU Member States. Focus of future work: the report notes that there are still various areas of the Recommendation with considerable room for improvement. Based on the findings of the report, the priority areas on which future work should focus include: General patient safety -At Member State level: · actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress; · collect information on adverse events through further developing reporting and learning systems, ensure a non-punitive context for reporting on adverse events and evaluate reporting progress; · extend patient safety strategies and programmes from hospital care to non-hospital care as well; -At EU level: · collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation ; · make progress on common terminology on patient safety; · pursue exchange of best practice; · develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies. Prevention and control of healthcare associated infections -At Member State level: · ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals; · improve the training of specialised infection control staff and better align qualifications between Member States; · reinforce tailored basic infection prevention and control structures and practices in nursing homes; · repeat national point prevalence surveys of HAI; · ensure that surveillance of infections in intensive care units and surgical site infections is in place; · implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms; · improve the information on HAI for patients; · develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan. -At EU level: · continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities; · develop research in the area of the prevention and control of HCA. The Recommendation invites the Commission to consider the extent to which the proposed measures are working effectively. The Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care. New
On the basis of information provided by the Member States, the current Commission report follows up the Council Recommendation of June 2009, on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters: · in the first chapter on general patient safety, Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare; · in the second chapter on the prevention and control of healthcare-associated infections (HAIs), Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This Report summarises the main actions taken at Member State and EU level by June 2011 (July 2012 for the general patient safety part) and highlights those areas of the Recommendation needing further attention. 1) Main actions taken at Member State level: most Member States have taken a variety of actions as envisaged by the Recommendation. On general patient safety, most Member States: · have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety; · have encouraged training on patient safety in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals. The existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility to report. However, there is still room for improvement in this crucial area. The same applies to provisions for patient empowerment. Also, efforts focus on hospital healthcare, with only a few examples of actions addressing primary care. On the prevention and control of HAI: · 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77 %) as part of a national/regional strategy and/or action plan; · 13 Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. 2) Main actions taken at EU level: On general patient safety, the European Commission has: · pursued the following activities to promote mutual learning among Member States and propose common definitions and terminology for patient safety; · fostered the exchange of information on initiatives concerned with patient safety and quality of care; · allocated EUR 3 600 000 for a three-year collaboration on patient safety, in the form of a joint action for the years 2012-2015, the EU has co-financed six research projects on general patient safety, to a total amount of EUR 16 million. On the prevention and control of HAI: · to have an “Action plan against the rising threats from antimicrobial resistance”; The Commission’s ‘Action plan against the rising threats from antimicrobial resistance’; · to fund numerous research projects in the area of HAI and antimicrobial resistance within the Sixth and Seventh Framework Programmes for Research and Technological Development (2002-2006 and 2007-2013). The European Centre for Disease Prevention and Control (ECDC) coordinates the European surveillance of surgical-site infections, HAI in intensive care units and antimicrobial resistance. 3) Improvements to make: The report notes there are still various areas of the Recommendation with considerable room for improvement. The priority areas on which future work should focus include: General patient safety: - At Member State level: · actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress, work on a common understanding and development of core competencies for patients, and encourage patients and their families to report adverse events; · collect information on adverse events through further developing reporting and learning systems; · ensure a non-punitive context for reporting on adverse events and evaluate reporting progress; · extend patient safety strategies and programmes from hospital care to non-hospital care as well. - At EU level: · collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation; · make progress on common terminology on patient safety; · pursue exchange of best practice, e.g. systematic integration of patient safety in the education and training of health professionals at all levels; · develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies. Prevention and control of healthcare associated infections: - At Member State level: · ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals and other healthcare institutions; · improve the training of specialised infection control staff and better align qualifications between Member States; · reinforce tailored basic infection prevention and control structures and practices in nursing homes and other long-term care facilities; · repeat national point prevalence surveys of HAI as a means to monitor the burden of HAI in all types of healthcare institutions, to identify priorities and targets for intervention, to evaluate the impact of interventions and to raise awareness; · ensure that surveillance of infections in intensive care units and surgical site infections is in place; · implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms and prevent their introduction into healthcare settings; · improve the information on HAI for patients and strengthen their involvement in the compliance with infection prevention and control measures; · develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan and its success in improving the prevention and control of HAI. - At EU level: · continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities; · develop research in the area of the prevention and control of HCA, including studies on cost-effectiveness of prevention and control measures. As in many Member States and at EU level the actions have been implemented only recently or in some cases are still under implementation, it might be advisable to carry out such an assessment again in two years’ time, taking the current report as a comparative reference. This is why the Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care. |
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