72 Amendments of Piernicola PEDICINI related to 2014/2207(INI)
Amendment 1 #
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
- having regard to Decision 1082/2013/EU on serious cross border threats to health;
Amendment 2 #
Motion for a resolution
Citation 4 b (new)
Citation 4 b (new)
- having regard to the Special Eurobarometer 411 " Patient safety and quality of care";
Amendment 3 #
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
- having regard to the Progress report on the Action plan against the rising threats from Antimicrobial Resistance SANTE/10251/2015;
Amendment 23 #
Motion for a resolution
Recital G
Recital G
G. whereas continuous training of doctors and other healthcare professionals is crucial to avoid adverse events, including adverse drug events (ADEs), which are estimated to cost the EU healthcare systems some EUR 2.7 billion per year in care expenses and account for 1.1 % of all hospitalisations in the EU;
Amendment 30 #
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas patients, families and patient organisations play a key role in advocating for safer care, and their role should be promoted through patient empowerment and participation in the healthcare process and policy at all levels;
Amendment 37 #
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas resistant bacteria can be found on medical devices even when the latter have been sterilised in accordance with the manufacturer’s instructions;
Amendment 52 #
Motion for a resolution
Recital M a (new)
Recital M a (new)
Ma. whereas it is acknowledged that the current veterinary medicines legislation does not provide sufficient tools to ensure that risks to human health arising from the use of antimicrobials in animals are adequately managed;
Amendment 53 #
Motion for a resolution
Recital M b (new)
Recital M b (new)
Mb. whereas the vast majority of medicated feed for farmed animals contains antimicrobials;
Amendment 66 #
Motion for a resolution
Recital O a (new)
Recital O a (new)
Oa. whereas the most recent studies show antimicrobial resistance in hospitals has globally increased in the EU in the past years- despite a few exceptions-; whereas, in particular, several Member States (e.g. Italy) now report K.pneumoniae infections that are not only multidrug- resistant, carbapenem-resistant, but now colistin-resistant, hence one step closer to being totally resistant;
Amendment 71 #
Motion for a resolution
Recital P a (new)
Recital P a (new)
Pa. whereas, pharmaceutical companies tend to add new antibiotics within existing classes of antibiotics rather than discover and develop truly new antibacterial agent; as a result, resistance to these new agents will emerge faster than for drugs with a truly new mechanism of action;
Amendment 73 #
Motion for a resolution
Recital P a (new)
Recital P a (new)
Pa. whereas, according to European consumer associations, over 70% of meat products tested in six EU countries were found to be contaminated with antibiotic- resistant bacteria, while in a further eight countries such bacteria were present in 50% of all samples1 a; __________________ 1aAntibiotic use in livestock: Time to act, BEUC Position Paper
Amendment 74 #
Motion for a resolution
Recital P b (new)
Recital P b (new)
Pb. whereas, according to the WHO, antimicrobials are used much more in livestock than they are in human beings in a number of EU countries1 a; __________________ 1a Tackling antibiotic resistance from a food safety perspective in Europe, WHO Europe, 2011.
Amendment 75 #
Motion for a resolution
Recital P c (new)
Recital P c (new)
Pc. whereas in the EU the sub-therapeutic use of antibiotics, which involves low doses of antibiotics being fed to livestock to promote their growth, has been banned since 2006;
Amendment 76 #
Motion for a resolution
Recital P d (new)
Recital P d (new)
Pd. whereas high levels of Campylobacter resistance to fluoroquinolones have been observed and most human Campylobacter infections come from the handling, preparation and consumption of chicken; whereas such high levels of resistance reduce the effective treatment options for human Campylobacter infections;
Amendment 78 #
Motion for a resolution
Recital Q
Recital Q
Q. whereas it is of paramount importance to encourage pharmaceutical companies to invest in developing new antibiotic compoundsacterial agents that are potentially active against multidrug-resistant bacteria, in particular with activity against prevalent multidrug- resistant Gram-negative bacteria, and against diseases that are particularly prone to antimicrobial resistance, such as K. pneumoniae and, Acinetobacter, E. Coli, HIV, staphylococcus aureus, tuberculosis and malaria, in addition to alternative methods aimed at fighting HAIs without using antibiotics;
Amendment 83 #
Motion for a resolution
Recital Q a (new)
Recital Q a (new)
Qa. whereas ensuring patient safety, prevention and control of HAIs and prevention of the spread of multidrug- resistant bacteria are very difficult, if not impossible, in overcrowded and understaffed healthcare environments;
Amendment 85 #
Motion for a resolution
Recital Q a (new)
Recital Q a (new)
Qbis. whereas para 2 of article 4 of Directive 18/2001/CE sets a deadline for the use of genes conferring antibiotic resistance to transgenic plants;
Amendment 86 #
Motion for a resolution
Recital Q b (new)
Recital Q b (new)
Qb. whereas there is a high turnover of sophisticated medical devices whose utilisation is often delegated to non- medical staff, so called product specialists, illegally performing highly specialised tasks that should be only entrusted to highly competent medical staff; whereas this behaviour poses serious threats to all patients in need of therapeutic treatments;
Amendment 87 #
Motion for a resolution
Recital Q c (new)
Recital Q c (new)
Qc. whereas product specialists should never perform therapeutic treatments but only support medical staff when and if required by the medical staff, for example to perform operations of assembling or disassembling specific instruments;
Amendment 88 #
Motion for a resolution
Recital Q d (new)
Recital Q d (new)
Qd. whereas home-care medical treatments can psychologically help patients and result in better healthcare performances;
Amendment 89 #
Motion for a resolution
Recital Q e (new)
Recital Q e (new)
Qe. whereas the introduction of collective redress could help patients who are harmed by the same illegal practice causing the same adverse event attributable to HAI;
Amendment 91 #
Motion for a resolution
Recital R a (new)
Recital R a (new)
Ra. whereas the internet is the biggest unregulated pharmaceuticals market in the world; whereas 62% of pharmaceuticals bought on-line prove to be false or non-compliant with standards; whereas a very large proportion of operators operating online do so illegally and the annual global turnover from the illegal online sale of prescription medicines is estimated at around USD 200 bn;
Amendment 94 #
Motion for a resolution
Recital R b (new)
Recital R b (new)
Rb. whereas the use of antimicrobials in pets is an additional risk factor for the development and transmission of antimicrobial resistance in human beings and whereas the upward trends in antibiotic resistance encountered at veterinary clinics for pets run parallel to similar trends at hospitals;
Amendment 95 #
Motion for a resolution
Recital R c (new)
Recital R c (new)
Rc. whereas the risk of transmission of antimicrobial resistance from pets to human beings cannot be fully quantified and whereas further research into this is needed;
Amendment 96 #
Motion for a resolution
Recital S
Recital S
S. whereas Article 168 of the Treaty on the Functioning of the European Union stipulates that Union action must complement national policies; and must be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health;
Amendment 103 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the latest measures put in place by Member States to improve general patient safety and reduce the incidence of HAIs, and more particularly the progress made by Member States in developing patient safety strategies and programme, including patient safety in health legislation and in developing reporting and learning systems;
Amendment 116 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on Member States to set specific and ambitious quantitative targets for reducing the use of antibiotics;
Amendment 117 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Welcomes the work of the EU working group on patient safety and quality of careco-financed by the EU and performed by OECD on comparable indicators to assess patient safety, and calls on the Member States to implement such indicators to assess patient safety;
Amendment 118 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. welcomes the work of the EU working group on patient safety and quality of care that brings together representatives from all 27 EU countries, EFTA countries, international organisations and EU bodies and assists in developing the EU patient safety and quality agenda;
Amendment 119 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that, on the basis of Decision 1082/2013/EU on serious cross- border threats to health, Member States must provide the Commission with updates on the latest situation with regard to their preparedness and response planning at national level, and calls on Member States to submit the information concerned in accordance with the timetable established by that Decision;
Amendment 122 #
Motion for a resolution
Paragraph 6 – point a a (new)
Paragraph 6 – point a a (new)
aa) Cooperate on defining minimum patient safety standards and indicators for safety and quality of healthcare EU wide, in consultation with all relevant stakeholders including patient organisations;
Amendment 129 #
Motion for a resolution
Paragraph 6 – point c
Paragraph 6 – point c
(c) ensure appropriate training of doctors and other healthcare professionals and set up monitoring systems to verify that their competences are up-to-date with hospital hygiene practices and the technology in place: this would reduce the prevalence of medical errors (including HAIs) caused by partial knowledge and failure to update knowledge to keep pace with new technologies;
Amendment 130 #
Motion for a resolution
Paragraph 6 – point c a (new)
Paragraph 6 – point c a (new)
ca) involve patients' organisations and representatives formally in the development of policies and programmes on patient safety at all appropriate levels, and to provide them with appropriate support to carry out patient safety activities;
Amendment 131 #
Motion for a resolution
Paragraph 6 – point c a (new)
Paragraph 6 – point c a (new)
ca. step up hygiene precautions, making greater use of hygiene specialists to monitor all aspects of health and hygiene, of healthcare facilities, patients and between patients and outside ‘guests’;
Amendment 132 #
Motion for a resolution
Paragraph 6 – point c a (new)
Paragraph 6 – point c a (new)
ca) ensure basic training of any healthcare personnel, even those that are not in direct contact with patients, in infection prevention and control before they start working in a hospital or other healthcare facility, and regularly afterwards;
Amendment 133 #
Motion for a resolution
Paragraph 6 – point c b (new)
Paragraph 6 – point c b (new)
cb) increase the workforce of healthcare professionals that are specialised in infection prevention and control / hospital hygiene, and ensure that a sufficient number of positions for such specialised personnel are available in hospitals and other healthcare facilities;
Amendment 134 #
Motion for a resolution
Paragraph 6 – point d a (new)
Paragraph 6 – point d a (new)
(da) lighten the burden on healthcare facilities by promoting care and medical treatment at home;
Amendment 136 #
Motion for a resolution
Paragraph 6 – point e a (new)
Paragraph 6 – point e a (new)
(ea) ensure that health systems and healthcare facilities are managed independently from political choices, and that managers are appointed on the basis of merit and not of political affiliation;
Amendment 137 #
Motion for a resolution
Paragraph 6 – point e a (new)
Paragraph 6 – point e a (new)
ea) emphasize on the importance of prevention of HAIs in healthcare settings by means of containment of spread through patient and contact screening as well as infection control measures, and continue promoting good hygiene practices (like hand-washing);
Amendment 142 #
Motion for a resolution
Paragraph 6 – point e a (new)
Paragraph 6 – point e a (new)
ea) provide adequate facilities to hospitalise patients, including a sufficient number of single rooms that allow the isolation of patients infected or colonised with multidrug-resistant bacteria;
Amendment 144 #
Motion for a resolution
Paragraph 6 – point e b (new)
Paragraph 6 – point e b (new)
(ea) promote information campaigns for patients concerning the risks of adverse events in the healthcare system and concerning possible preventive measures, starting with basic hygiene measures, and launch awareness-raising campaigns and health education courses at schools concerning the rational use not only of antibiotics but of all pharmaceuticals and concerning the risks entailed by the rise of antibiotic resistance; these campaigns should address parents and carers responsible for young children as well as elderly people, and should be followed by an assessment of their outcomes;
Amendment 147 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Highlights the potential benefits of eHealth in reducing adverse events by tracking information flows and improving the understanding of medical processes, as well as through digital prescriptions and alerts on drug interaction; calls on the Commission and the Member States to further explore the possibilities offered by eHealth in the area of patient safety, including the introduction of electronic patient records;
Amendment 149 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls the European Commission and Member States to assess the potential of mobile health (mhealth) on care efficiency, hospitalisation's incidence and on the annual per capita healthcare cost reduction;
Amendment 155 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission and Member States to promote the introduction of the European logo provided for by Implementing Regulation 699/2014 in order to identify clearly online pharmacies which offer medicines for sale to the public remotely while safeguarding consumers against the purchase of fake medicines, which are often a health hazard;
Amendment 184 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Welcomes the Commission’s work on antimicrobial resistance and on the prevention and control of HAIs, as well as the coordination and surveillance efforts of the European Centre for Disease Prevention and Control (ECDC); and in particular in the framework of the European Antimicrobial Resistance Surveillance Network (EARS-Net), and the European Surveillance of Antimicrobial Consumption Network (ESAC-Net) and the Healthcare- Associated Infections surveillance Network (HAI-Net);
Amendment 186 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the joint work of coordination and surveillance on antimicrobial resistance of the ECDC, the EMA and the European Food Safety Authority (EFSA);
Amendment 188 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Notes with concern that between 2010 and 2013 the percentages of K. pneumoniae resistant to fluoroquinolones, third-generation cephalosporins and aminoglycosides, as well as combined resistance to all three antibiotic groups and resistance to carbapenems, a last-line group of antibiotics, significantly increased in many Member States and at EU level; further notes that during the same period resistance to third- generation cephalosporins also significantly increased in many Member States and at EU level for E. coli;
Amendment 191 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Notes with concern that in countries with high levels of multi-drug resistance, including resistance to carbapenems, only a few therapeutic options are available, among these are polymyxins; emphasizes that, in these countries, presence of bacteria resistant to polymyxins is an important warning that options for the treatment of infected patients are becoming even more limited;
Amendment 197 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Welcomes and encourages further research for genuinely new antimicrobial drugs, in particular antibiotics with activity against prevalent multidrug-resistant Gram- negative bacteria and against diseases particularly prone to antimicrobial resistance, such as K. pneumoniae and, Acinetobacter, E. Coli, HIV, staphylococcus aureus, tuberculosis and malaria, as well as for alternative methods aimed at fighting HAIs without using antibiotics;
Amendment 213 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Considers it of paramount importance that the Commission should ensure the continuation of the EU Action Plan on Antimicrobial Resistance post-20176, with an emphasis on the prevention and control of healthcare-associated infections;
Amendment 216 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20bis. Calls upon the Commission to ensure that neither new authorization for the placing on the market and cultivation nor the renewal of existing permits will be further granted to any transgenic plants containing genes for antibiotic resistance;
Amendment 222 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Member States to promote the responsible and sensible use in human medicine of all antimicrobial agents and in particular antibiotics that are considered last-line treatment of bacterial infections in hospitals, such as the carbapenems and the polymyxins;
Amendment 228 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Recalls that self-medication with antibiotics shall be strictly prohibited and that there is a necessity of enforcing of a 'prescription only' policy for antibacterials by the National Competent Authorities of the Member States;
Amendment 254 #
Motion for a resolution
Paragraph 22 – point e a(new)
Paragraph 22 – point e a(new)
(ea) develop, in the case of diseases which have a tendency to relapse, an antibiogram in order to get a clear picture of the pathogen in question and reduce the risk of drug resistance;
Amendment 257 #
Motion for a resolution
Paragraph 22 – point e a (new)
Paragraph 22 – point e a (new)
ea) to monitor carefully potential carriage of multidrug-resistant bacteria in patients that are admitted after transfer from a hospital or another healthcare facility from another country, from another region in the same country, from another hospital in the same region;
Amendment 258 #
Motion for a resolution
Paragraph 22 – point e b (new)
Paragraph 22 – point e b (new)
eb) to perform risk assessments of patients' transfers from a country, a region, or a hospital known for its high prevalence of multidrug-resistant bacteria, and isolating positive patients in single rooms or cohort nursing, re- enforcing infection control procedures to prevent cross-transmission to other patients in the receiving hospital healthcare facility;
Amendment 259 #
Motion for a resolution
Paragraph 22 – point e c (new)
Paragraph 22 – point e c (new)
(ec) improve safety standards, especially for medical devices that are resistant to sterilisation (e.g. endoscopes), and monitor carefully to ensure that medical devices originally designed and CE- marked for single use, if regenerated, meet all safety standards in order to protect consumer health;
Amendment 262 #
Motion for a resolution
Paragraph 22 – point f
Paragraph 22 – point f
(f) launch awareness campaigns and health education courses in schools on the rational use not only of antibiotics but of all medicines and the risks entailed by increasing antibiotic resistance; these campaigns should address parents and carers responsible for young children as well as elderly people, and should always be followed by an assessment of their outcomes;
Amendment 267 #
Motion for a resolution
Paragraph 22 – point f a (new)
Paragraph 22 – point f a (new)
fa) calls on Member States to invite the ECDC to carry out one week mission in their country to give scientific and technical assistance and training on antimicrobial resistance as foreseen in article 9 of the ECDC Regulation (EC) no 851/2004; urges those Member States who have not done it yet, and especially those in which antimicrobial resistance is already high or alarmingly increasing, to invite ECDC to carry out such missions;
Amendment 270 #
Motion for a resolution
Paragraph 22 – point f b (new)
Paragraph 22 – point f b (new)
fb) Make the records of hospitals and other healthcare facilities with regard to healthcare associated infections publicly available, so that patients can make informed choices;
Amendment 291 #
Motion for a resolution
Paragraph 23 – point b a (new)
Paragraph 23 – point b a (new)
(ba) Confirm the prohibition of the use of antibiotics as growth promoters in livestock;
Amendment 292 #
Motion for a resolution
Paragraph 23 – point b b (new)
Paragraph 23 – point b b (new)
(bb) Limit the use of antibiotics for therapeutic purposes, by progressively eliminating their use for prophylactic purposes, where antibiotics are administered to animals for disease prevention, and minimise cases of metaphylaxis, i.e. the mass medication of animals to cure sick specimens on farms whilst preventing infections in healthy animals;
Amendment 293 #
Motion for a resolution
Paragraph 23 – point b c (new)
Paragraph 23 – point b c (new)
(bc) Limit the use of the oral administration of animal medicines and study the feasibility of individually tailored treatment for animals;
Amendment 294 #
Motion for a resolution
Paragraph 23 – point b d (new)
Paragraph 23 – point b d (new)
(bd) Limit the use of critically important antibiotics such as cephalosporins, fluoroquinolones and macrolides in animals, especially for group therapeutic treatment and for cases of metaphylaxis, providing for a total ban of the use of carbapenems;
Amendment 295 #
Motion for a resolution
Paragraph 23 – point b e (new)
Paragraph 23 – point b e (new)
(be) Consider regulation to limit the use of antibiotics in medicated feed;
Amendment 296 #
Motion for a resolution
Paragraph 23 – point b f (new)
Paragraph 23 – point b f (new)
(bf) Conduct, also with the help of consumer associations and under the control of veterinary professionals, tests on food products, especially on slaughtered meat, to assess the presence of antibiotic-resistant bacteria;
Amendment 297 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls on the European Medicines Agency to draw up a list of antibiotics used in animals for which a significant risk to public health has been identified;
Amendment 298 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
Amendment 316 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the co-legislator, when negotiating the proposal for a regulation on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (2014/0255 (COD)) to ensure that it provides provisions aiming to substantially limit the use of medicated feed containing antimicrobials for food- producing animals and in particular to strictly prohibit the preventive use of antimicrobials included in medicated feed;
Amendment 317 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission and on the ECDC to carry out research on potential direct or indirect damage that can be caused by the use of antimicrobials in pets and to develop mitigation measures to reduce the risk of antimicrobial resistance that is potentially transmissible from pets to people;
Amendment 322 #
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls the Commission, Member States and the pharmaceutical industry to optimising EU partnerships between academia and the pharmaceutical industry, as exemplified by the Innovative Medicines Initiative (IMI);
Amendment 328 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Welcomes the Joint Programme Initiative on Antimicrobial Resistance, which allows Member States to agree on research needs so as to avoid duplication and calls for an increase in funding for the development of new medicines as an alternative to antibiotics, to combat antimicrobial resistance;