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Raimondo Villano
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Raimondo Villano
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Superbugs & Superdrugs
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Raimondo Villano
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Contents index
Sommario 13
Abstract 15
Résumé 17
Abstrakt 19
Abstracto 21
1. A brief history of antibiotics 25
2. Issues and contrast of antibiotic 33
3. Major resistance to antibiotics 49
4. Look back at some super diseases 55
5. Technologies and research directions 65
6. New therapeutic compounds 77
7. Appendix 85
8. Author profile 169
Raimondo Villano
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“Life is short, art is long,
the favorable opportunity,
attempting misleading,
the difficult decision”
Hippocrates
Raimondo Villano
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Parole chiave
antibiotici, resistenza, batteri.
Keywords
antibiotics, resistance, bacteria.
Classification LCC
RM 265 - 267.
Title
Antibiotic resistance.
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Sommario
Si tracciano cenni storici sul concetto di antibiosi, su ricerche, scoperta e
produzione degli antibiotici e sul loro ruolo mondiale non solo terapeutico
ma anche strategico dal secondo dopoguerra. Poi, si esaminano a livello
nazionale ed internazionale: le problematiche inerenti consumo, uso
improprio e abuso di antibiotici nell’uomo, in zootecnia, agricoltura e,
quindi, nel ciclo alimentare e nell’ambiente; le politiche di contrasto al
fenomeno dell’iperprescrizione e nei cittadini il grado di informazione e
consapevolezza dei rischi; le linee guida di buona prassi comportamentale
del malato; i documenti principali di lotta a tale emergenza. Si effettuano,
inoltre, una rassegna analitica e un approfondimento su alcune super
patologie (tubercolosi, gonorrea, meningite, ecc.) e sulle resistenze
batteriche ai principali antibiotici. Si realizzano, infine, una ricognizione
sull’attualità delle tecnologie e degli indirizzi di ricerca applicata e una
rassegna sulle principali recenti nuove terapie. Chiude il lavoro
un’appendice tecnica contenente un apparato essenziale di normative e
direttive ministeriali italiane e comunitarie europee sul tema.
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Abstract
You plot historical notes on the concept of antibiosis, on research,
discovery and production of antibiotics and their global role not only
therapeutic but also strategic since World War II. Then, you look at
national and international issues related consumption, misuse and overuse
of antibiotics in humans, in animal husbandry, agriculture, and thus in the
food chain and the environment; policies to combat the phenomenon of
excessive prescription and citizens in the degree of information and
awareness of the risks; guidelines of good practice behavior of the patient;
the main documents of struggle in this emergency. We make also an
analytical overview and a discussion of some super diseases (tuberculosis,
gonorrhea, meningitis, etc.) And bacterial resistance to major antibiotics.
We realize, finally, a survey on current technologies and addresses of
applied research and a survey on major recent new therapies. Closes work
a technical appendix containing an apparatus essential regulations and
ministerial directives Italian and European Community on the theme.
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Résumé
Vous tracez notes historiques sur le concept de antibiose, sur la recherche,
la découverte et la production d’antibiotiques et de leur rôle dans le monde
non seulement thérapeutique, mais aussi stratégique depuis la Seconde
Guerre mondiale. Ensuite, vous regardez les questions nationales et
internationales liées à la consommation, utilisation abusive et excessive
d’antibiotiques chez l’homme, dans l'élevage, l'agriculture et, donc, dans la
chaîne alimentaire et l’environnement; politiques de lutte contre le
phénomène de la prescription excessive et les citoyens dans le degré
d’information et de sensibilisation des risques; lignes directrices de bonne
conduite de la pratique du patient; les principaux documents de lutte dans
cette situation d’urgence. Nous faisons également un aperçu analytique et
une discussion de certaines super maladies (tuberculose, la gonorrhée, la
méningite, etc.) et de la résistance bactérienne aux antibiotiques majeurs.
Nous nous rendons compte, enfin, une enquête sur les technologies et les
adresses de la recherche appliquée en cours et une enquête sur les
principales nouvelles thérapies récentes. Ferme fonctionne une annexe
technique contenant les règlements essentiels de l’appareil et les directives
ministérielles italiennes et de la Communauté européenne sur le thème.
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Abstrakt
Sie plotten historische Anmerkungen über das Konzept der Antibiose, auf
Forschung, Entdeckung und Herstellung von Antibiotika und ihre Rolle in
der Welt nicht nur therapeutisch, sondern auch strategische dem Zweiten
Weltkrieg. Dann schauen Sie auf nationalen und internationalen Fragen im
Zusammenhang mit Konsum, Missbrauch und übermäßige Einsatz von
Antibiotika bei Menschen, in der Tierhaltung, Landwirtschaft, und damit in
die Nahrungskette und die Umwelt; Politik zur Bekämpfung des
Phänomens die übermäßige Verschreibung und Bürger in den Grad der
Information und Sensibilisierung der Risiken; Leitlinien für die gute Praxis
Verhalten des Patienten; die wichtigsten Dokumente des Kampfes in
diesem Notfall. Wir machen auch einen analytischen Überblick und eine
Diskussion einiger Super Krankheiten (Tuberkulose, Gonorrhö, Meningitis,
etc.) und bakterieller Resistenz gegen wichtige Antibiotika. Wir wissen,
schließlich eine Umfrage zu aktuellen Technologien und Adressen von
angewandter Forschung und eine Umfrage zu den wichtigsten aktuellen
neuen Therapien. Schließt Arbeit eine technische Anlage, die eine
Vorrichtung wesentliche Vorschriften und Ministerialrichtlinien
italienischen und europäischen Gemeinschaft über das Thema.
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Abstracto
Trazar notas históricas sobre el concepto de antibiosis, en la investigación,
el descubrimiento y la producción de antibióticos y su papel global no sólo
terapéutico, sino también estratégico desde la Segunda Guerra Mundial. A
continuación, nos fijamos en los asuntos nacionales e internacionales
relacionados con el consumo, el mal uso y abuso de los antibióticos en los
seres humanos, en la ganadería, la agricultura, y por lo tanto en la cadena
alimentaria y el medio ambiente; políticas de lucha contra el fenómeno de
la prescriptión excesiva y los ciudadanos en el grado de información y
conocimiento de los riesgos; pautas de comportamiento de buenas
prácticas de la paciente; los principales documentos de lucha en esta
emergencia. Hacemos también un resumen analítico y una discusión de
algunas enfermedades súper (tuberculosis, gonorrea, meningitis, etc.) y la
resistencia bacteriana a los principales antibióticos. Nos damos cuenta,
por último, un estudio sobre las tecnologías y las direcciones de la
investigación aplicada en curso y una encuesta sobre las principales
nuevas terapias recientes. Cierra funciona un anexo técnico que contiene
un aparato regulaciones esenciales y directivas ministeriales italianas y de
la Comunidad Europea sobre el tema.
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S U P E R B U G S & S U P E R D R U G S
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7. Appendix
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Council Recommendation on patient safety, including the
prevention and control of healthcare associated infections
2947th EMPLOYME_T, SOCIAL POLICY, HEALTH A_D
CO_SUMER AFFAIRS Council meeting
Luxembourg, 9 June 2009
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
particular the
second subparagraph of Article 152(4) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament1
,
Having regard to the opinion of the European Economic and Social
Committee2
,
Having regard to the opinion of the Committee of the Regions3
,
Whereas:
(1) Article 152 of the Treaty provides that Community action, which shall
complement national policies, shall be directed towards improving public
health, preventing human
illness and diseases, and eliminating sources of danger to human health.
(2) It is estimated that in Member States between 8 % and 12 % of patients
admitted to hospital suffer from adverse events whilst receiving
healthcare4
.
European Commission, published 2008 by the RAND Cooperation.
(3) The European Centre for Disease Prevention and Control (ECDC) has
estimated that, on average, healthcare associated infections occur in one
hospitalised patient in twenty, that is to say 4,1 million patients a year in
the EU, and that 37 000 deaths are caused every year as a result of such
infections.
(4) Poor patient safety represents both a severe public health problem and a
high economic burden on limited health resources. A large proportion of
adverse events, both in the hospital sector and in primary care, are
preventable with systemic factors appearing to account for a majority of
them.
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(5) This Recommendation builds upon, and complements, work on patient
safety carried out by the World Health Organisation (WHO) through its
World Alliance for Patient Safety, the Council of Europe and the
Organisation for Economic Cooperation and Development (OECD).
(6) The Community, through the Seventh Framework Programme for
Research and Development5
, supports research in health systems, in
particular in the quality of healthcare provision under the Health Theme,
including a focus on patient safety. The latter is also given particular
attention under the Information and Communication Technology Theme.
(7) The Commission, in its White Paper "Together for Health: A Strategic
Approach for the EU 2008-2013" of 23 October 2007, identifies patient
safety as an area for action.
(8) Evidence suggests that Member States are at different levels in the
development and implementation of effective and comprehensive patient
safety strategies6
. Therefore, this Recommendation intends to create a
framework to stimulate policy development and future action in and
between Member States to address the key patient safety issues confronting
the EU.
(9) Patients should be informed and empowered by involving them in the
patient safety process. They should be informed of patient safety standards,
best practices and/or safety measures in place and on how they can find
accessible and comprehensible information on complaints and redress
systems.
(10) Member States should set up, maintain or improve comprehensive
reporting and learning systems so that the extent and causes of adverse
events can be captured in order to develop efficient solutions and
interventions. Patient safety should be embedded in the education and
training of healthcare workers, as the providers of care.
(11) Comparable and aggregate data should be collected at Community
level to establish efficient and transparent patient safety programmes,
structures and policies, and best practices should be disseminated among
the Member States. To facilitate mutual learning, a common terminology
for patient safety and common indicators need to be developed through
cooperation between Member States and the European Commission, taking
into account the work of relevant international organisations.
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(12) Information and communication technology tools, such as electronic
health records or e-prescriptions, can contribute to improving patient
safety, for instance by systematically screening for potential medicinal
product interactions or allergies. Information and communication
technology tools should also aim to improve the understanding of users of
the medical products.
(13) A national strategy, complementary to strategies targeted towards the
prudent use of antimicrobial agents7
, should be developed incorporating
prevention and control of
healthcare associated infections into national public health objectives and
aiming to reduce the risk of healthcare associated infections within
healthcare institutions. It is essential that the necessary resources for
implementing the components of the national strategy are allocated as part
of the core funding for healthcare delivery.
(14) The prevention and control of healthcare associated infections should
be a long-term strategic priority for healthcare institutions. All hierarchical
levels and functions should cooperate to achieve result-oriented behaviour
and organisational change, by defining responsibilities at all levels,
organising support facilities and local technical resources and setting up
evaluation procedures.
(15) Sufficient data on healthcare associated infections are not always
available to allow meaningful comparisons between institutions by
surveillance networks, to monitor the epidemiology of healthcare
associated pathogens and to evaluate and guide policies on the prevention
and control of healthcare associated infections. Therefore, surveillance
systems should be established or strengthened at the level of healthcare
institutions and at regional and national levels.
(16) Member States should aim to reduce the number of people affected by
healthcare associated infections. In order to achieve a reduction in
healthcare associated infections, recruitment of health professionals
specialising in infection control should be encouraged. Furthermore,
Member States and their healthcare institutions should consider the use of
link staff to support specialist infection control staff at the clinical level.
(17) Member States should work closely with the health technology
industry to encourage better design for patient safety in order to reduce the
occurrence of adverse events in healthcare.
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(18) To achieve the patient safety objectives mentioned above, including
the prevention and control of healthcare associated infections, Member
States should ensure a fully comprehensive approach while considering the
most appropriate elements having a real impact on the prevalence and
burden of adverse events.
(19) Community action in the field of public health should fully respect the
responsibilities of the Member States for the organisation and delivery of
health services and medical care,
HEREBY RECOMMENDS,
applying the following definitions for the purpose of this Recommendation:
"Adverse event" means an incident which results in harm to a patient;
"Harm" implies impairment of the structure or function of the body and/or
any deleterious effect arising therefrom;
"Healthcare associated infections" means diseases or pathologies related to
the presence of an infectious agent or its products in association with
exposure to healthcare facilities or healthcare procedures or treatments;
"Patient safety" means freedom, for a patient, from unnecessary harm or
potential harm associated with healthcare;
"Process indicator" means an indicator referring to the compliance with
agreed activities such as hand hygiene, surveillance, standard operating
procedures;
"Structure indicator" means an indicator referring to any resource, such as
staff, an infrastructure or a committee;
THAT MEMBER STATES:
I. Recommendations on general patient safety issues
(1) Support the establishment and development of national policies and
programmes on patient safety by:
(a) Designating the competent authority or authorities or any other
competent body or
bodies responsible for patient safety on their territory;
(b) Embedding patient safety as a priority issue in health policies and
programmes at national as well as at regional and local levels;
(c) Supporting the development of safer and user-friendly systems,
processes and tools,
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including the use of information and communication technology;
(d) Regularly reviewing and updating safety standards and/or best practices
applicable to healthcare provided on their territory;
(e) Encouraging health professional organisations to have an active role in
patient safety;
(f) Including a specific approach to promote safe practices to prevent the
most commonly occurring adverse events such as medication-related
events, healthcare associated infections and complications during or after
surgical intervention.
(2) Empower and inform citizens and patients by:
(a) Involving patient organisations and representatives in the development
of policies
and programmes on patient safety at all appropriate levels;
(b) Disseminating information to patients on:
(i) patient safety standards which are in place;
(ii) risk, safety measures which are in place to reduce or prevent errors and
harm, including best practices, and the right to informed consent to
treatment, to facilitate patient choice and decision-making;
(iii) complaints procedures and available remedies and redress and the
terms and conditions applicable;
(c) Considering the possibilities of development of core competencies in
patient safety namely, the core knowledge, attitudes and skills required to
achieve safer care, for patients.
(3) Support the establishment or strengthen blame-free reporting and
learning systems on adverse events that:
(a) Provide information on the extent, types and causes of errors, adverse
events and near misses;
(b) Encourage healthcare workers to actively report through the
establishment of a reporting environment which is open, fair and non
punitive. This reporting should be differentiated from Member States'
disciplinary systems and procedures for healthcare workers, and, where
necessary, the legal issues surrounding the healthcare workers' liability
should be clarified;
(c) Provide, as appropriate, opportunities for patients, their relatives and
other informal caregivers to report their experiences;
(d) Complement other safety reporting systems, such as those on
pharmacovigilance and medical devices, whilst avoiding multiple reporting
where possible.
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(4) Promote, at the appropriate level, education and training of healthcare
workers on patient safety by:
(a) Encouraging multi-disciplinary patient safety education and training of
all health professionals, other healthcare workers and relevant management
and administrative staff in healthcare settings;
(b) Embedding patient safety in undergraduate and postgraduate education,
on-the-job training and the continuing professional development of health
professionals;
(c) Considering the development of core competencies in patient safety
namely, the core knowledge, attitudes and skills required to achieve safer
care, for dissemination to all healthcare workers and relevant management
and administrative staff;
(d) Providing and disseminating information to all healthcare workers on
patient safety standards, risk and safety measures in place to reduce or
prevent errors and harm, including best practices, and promoting their
involvement;
(e) Collaborating with organisations involved in professional education in
healthcare to ensure that patient safety receives proper attention in the
higher education curricula and in the ongoing education and training of
health professionals, including the development of the skills needed to
manage and deliver the behavioural changes necessary to improve patient
safety through system change.
(5) Classify and measure patient safety at Community level, by working
with each other and with the Commission:
(a) To develop common definitions and terminology, taking into account
international standardisation activities such as the International
Classification for Patient Safety being developed by WHO and the Council
of Europe's work in this area;
(b) To develop a set of reliable and comparable indicators, to identify
safety problems, to evaluate the effectiveness of interventions aimed at
improving safety and to facilitate mutual learning between Member States.
Account should be taken of the work done at national level and of
international activities such as the OECD healthcare quality indicators
project and the Community Health Indicators project;
(c) To gather and share comparable data and information on patient safety
outcomes in terms of type and number to facilitate mutual learning and
inform priority setting, with a view to helping Member States to share
relevant indicators with the public in the future.
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(6) Share knowledge, experience and best practice by working with each
other and with the Commission and relevant European and international
bodies on:
(a) The establishment of efficient and transparent patient safety
programmes, structures and policies, including reporting and learning
systems, with a view to addressing adverse events in healthcare;
(b) The effectiveness of patient safety interventions and solutions at the
healthcare setting level and the evaluation of the transferability of these;
(c) Major patient safety alerts in a timely manner.
(7) Develop and promote research on patient safety.
II. Additional recommendations on prevention and control of
healthcare associated infections
(8) Adopt and implement a strategy at the appropriate level for the
prevention and control of healthcare associated infections, pursuing the
following objectives:
(a) Implement prevention and control measures at national or regional level
to support the containment of healthcare associated infections and in
particular:
(i) to implement standard and risk-based infection prevention and control
measures in all healthcare settings as appropriate;
(ii) to promote consistency in, and communication of, infection prevention
and control measures between healthcare providers treating or caring for a
particular patient;
(iii) to make guidelines and recommendations available at national level;
(iv) to encourage the adherence to prevention and control measures by
using structure and process indicators, as well as the results of accreditation
or certification processes in place;
(b) Enhance infection prevention and control at the level of the healthcare
institutions in particular by encouraging healthcare institutions to have in
place:
(i) an infection prevention and control programme addressing aspects such
as organisational and structural arrangements, diagnostic and therapeutic
procedures (for example antimicrobial stewardship), resource requirements,
surveillance objectives, training and information to patients;
(ii) appropriate organisational governance arrangements for the elaboration
and the monitoring of the infection prevention and control programme;
(iii) appropriate organisational arrangements and qualified personnel with
the task of implementing the infection prevention and control programme;
Superbugs & Superdrugs
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(c) Establish or strengthen active surveillance systems by:
(i) at national or regional level:
– organising prevalence surveys at regular intervals, as appropriate;
– taking into account the importance of surveillance of targeted infection
types to establish national reference data, accompanied by process and
structure indicators to evaluate the strategy;
– organising the timely detection and reporting of alert healthcare
associated organisms or clusters of healthcare associated infections to the
relevant body as per requirements at Member State level;
– reporting of clusters and infection types of relevance for the Community
or international level in accordance with the Community legislation8
or
international regulations in place;
(ii) at the level of healthcare institutions:
– encouraging high quality microbiological documentation and patient
records;
– performing the surveillance of the incidence of targeted infection types,
accompanied by process and structure indicators to evaluate the
implementation of infection control measures;
– considering the use of surveillance of particular infection types and/or
particular strains of healthcare associated pathogens for the timely
detection of alert healthcare associated organisms or clusters of healthcare
associated infections;
(iii) using, where appropriate, surveillance methods and indicators as
recommended by ECDC and case definitions as agreed upon at Community
level in accordance with the provisions of Decision No 2119/98/EC;
(d) Foster education and training of healthcare workers by:
(i) at national or regional level, defining and implementing specialised
infection control training and/or education programmes for infection
control staff and strengthening education on the prevention and control of
healthcare associated infections for other healthcare workers;
(ii) at the level of healthcare institutions:
– providing regular training for all healthcare personnel, including
managers, on basic principles of hygiene and infection prevention and
control;
– providing regular advanced training for personnel having particular tasks
related to the prevention and control of healthcare associated infections;
(e) Improve the information to the patients by healthcare institutions:
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(i) making available objective and understandable information about the
risk of healthcare associated infections, the measures implemented by the
healthcare institution to prevent them and on how patients can help to
prevent those infections;
(ii) providing specific information, for example on prevention and control
measures, to patients colonised or infected with healthcare associated
pathogens;
(f) Support research in fields such as epidemiology, the applications of
nanotechnologies and nanomaterials, new preventive and therapeutic
technologies and interventions and on the cost-effectiveness of infection
prevention and control.
(9) Consider, for the coordinated implementation of the strategy referred to
in (8) as well as for the purposes of information exchange and coordination
with the Commission, the ECDC, the European Medicines Agency and the
other Member States, the establishment, if possible by …*, of an inter-
sectoral mechanism or equivalent systems corresponding to the
infrastructure in each Member State, collaborating with, or integrated into,
the existing inter-sectoral mechanism as set up in accordance with Council
Recommendation No 2002/77/EC of 15 November 2001 on the prudent use
of antimicrobial agents in human medicine9
.
III. Final recommendations
(10) Disseminate the content of this Recommendation to healthcare
organisations, professional bodies and educational institutions and
encourage them to follow the approaches suggested therein so that its key
elements can be put into everyday practice.
(11) Report to the Commission on the progress of the implementation of
this Recommendation by …* and subsequently on request by the
Commission with a view to contributing to the follow-up of this
Recommendation at Community level.
HEREBY INVITES THE COMMISSION TO:
Produce, by …*, an implementation report to the Council assessing impact
of this Recommendation, on the basis of the information provided by
Member States, to consider the extent to which the proposed measures are
working effectively, and to consider the need for further action.
Done at,
For the Council
The President
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______________
1 Opinion of 23 April 2009 (not yet published in the OJ).
2 Opinion of 25 March 2009 (note yet published in the OJ).
3 Opinion of 22 April 2009 (not yet published in the OJ).
4 Technical report "Improving Patient Safety in the EU" prepared for the
5 Decision No 1982/2006/EC of the European Parliament and of the Council of 18
December 2006 concerning the Seventh Framework Programme of the European
Community for research, technological development and demonstration activities
(2007-2013) (OJ L 412, 30.12.2006, p. 1).
6 Safety improvement for Patients in Europe (SIMPATIE) project funded under the
Community's Public Health Programme 2003-2008, www.simpatie.org.
7 For example Council conclusions on Antimicrobial Resistance adopted on 10 June 2008.
8 For example Decision No 2119/98/EC of the European Parliament and of the Council
of 24 September 1998 setting up a network for the epidemiological surveillance and
control of communicable diseases in the Community and the International Health
Regulations (OJ L 268, 3.10.1998, p. 1) and Regulation (EC) No 726/2004 of European
Parliament and of Council of 31 March 2004 laying down Community procedures for
the authorisation and supervision of medicinal products for human and veterinary use
and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
* OJ: please insert date two years after the adoption of this Recommendation.
9 OJ L 34, 5.2.2002, p. 13.
* OJ: please insert date three years after the adoption of this Recommendation.
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8. Author profile
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Raimondo Villano
171
Born in 1960. He lives in Rome and Torre Annunziata. Role:
General Manager Villano International Business Team (from
2012); Chiron CEO Publisher, Honorary Member (2013) and
Associate Professor in History of Health Pharmaceutical
Administration Department of Ruggero II University (Miami,
2014), Trader (since 1976), Trader operating financial
independent of bags and forex (since 1983), Knight SMO Malta
(since 2002), President of Chiron Humanitarian Foundation (since 1985).
Academies: History Art Health-Ministry BC, former papal Tiberina, Melitensi
Studies, Medical Tradition Smithsonian Institution-USA, International Society
History Pharmacy, Acc. History Italian Pharmacy, Soc. Napoletana National
History in. h. Noble College Chemical Pharmaceutical. Over 100 conferences
and chairman in dozens of conferences. He collaborates with important
national and international magazines. You Advisory Board Member for the US
Publisher DPC, which publishes in more than 150 nations. Studies: Classical;
degree and abil .: Pharmacy (1985); courses certificates: Medicinal herbs,
Cosmetic Techniques, Corporate Security, HACCP, History, Social Doctrine of
the Church, theology. Degrees h.c.: Human and Social Sciences (2009); History
and Philosophy (2010); Communication Sciences (2013). Master h.c.: Science
Medical Ethics (2010). He was author, organizer and chairman Safety Course for
managers, obtaining the High Patronage of the Head of State and the UN (2000),
Secretary International Committee Biothecnologies Wabt-Unesco 2008-13,
Diplomatic Adviser AEREC dpt ENVA (from 2011), member of World
Academy Biomedical Technology (Unesco 2007-12), 11 years in the Scientific
Committee of the Health Security IBD (company responsible for the security of
the Courts Naples Appeal Court), Board Beaumont Foundation Onlus research
on cancer with the Prefect of Naples (2011-12), member of European Academy
for Economic and Cultural Relations (2004-15). 32 years partner and owner of
the pharmacy. Partner since 1990, Secretary to 29 years 1990-95 and 2000
Rotary Club President Pompeii-Vesuvius; Comm.ni in Rotary District 2100-
Italy: Professional Ethics, Global Action, Computer; among the many
international roles: archeology Pompeii-Carthage; Committee Prize Magna
Grecia. Napoli president, national Coordinator and founder Federation Young
Chemists; Representative National Trade Union Federative. Assistant
Microbiology Fac. F.cia Na (1985-90, Chair Prof. Lembo-Inst. Sup. Health).
International awards: Diploma of Honor for exceptional services individually
in 5 Vie Action by President Rotary International (Evanston 2001: only 100 /
Superbugs & Superdrugs
172
year / 1.5 million members); Merit Anti-Crime Task Force-Rotary Italy, Albania,
former Yugoslavia, San Marino (Zurich 2001); Sapientia Mundi-Ethics (Rm
2008); Union Legion of Gold-Work (Rm 2010); Veritas in Charitate-Religion
(2011); Bonifaciano-Culture and Society (2011); Norman-Publishing Gold
Medal (Rm 2014); Norman-Health Galen of Pergamum (Rm 2014). National
Awards: Aesculapius-Health Patronage Ministers Council (Rm 1987); LXVIII
Piccinini-Search (Rm 2006); LXV Stramezzi-Health (Rm 2007); Capitolino-
humanitarian activities (Rm 2010); Tiberino-Culture (Rm 2012); LXXIV
Serono-History (Rm 2012), AEREC-Culture (Rm 2013); Merit Public Health
(DPR 2013), Tiberino-Science (Rm 2014). Author of over 730 publications
health, professional, scientific, historical, religious; more than 50 books (many
translated into English, French, some German, Spanish) with prestigious
publishers as Zanichelli and sponsorship by the Ministry of Cultural Heritage,
Unesco, Rotary, University, etc., present in Italian libraries (including:
Quirinale, National Academy Science, Ministries) and more than 40 countries
(including: National Health Institute-USA, Nationale de France, Congress UK),
in cultural institutes, Universities, Museums; a book made its debut at the
Frankfurt Fair. Catalogues: 2000 Outstanding Intellectuals IBC-Cambridge from
2010; OPAC SBN with over 160 works; from 2010 Sheet Authority Ministry
BAC. Various books are appreciated by authorities, including several times the
Head of State and the Holy Father.
Some books: Global Information Society, 1996; Rotary for Man, 2001;
Managing security in Pharmacy (pres. Dr. Renzulli, already the UN Security
Consultant, 2004); Art and history Pharmacy (pres. Professor Ledermann, Presid.
Em. International Pharmacy History Society, 2 ed., 2006); History and activities
of the SMOM (4th ed., 2007); Pharmaceutical meridians between secular ethics
and Catholic moral (pres. Professor Tarro, Comm. Naz.le Bioethics, 3 ed., 2008);
Thesaurus Pharmacologicus (pres. Presid. Pharmacists Italian Dr. Mandelli
2009); Time sculpted silent eternity. Reflections on diachronic investigation for
memory homo faber (pres. Eminent historian Fra 'von Lobstein and critic Prof.
Carosella, 2 ed., 6 repr., 2010); Pharmaceutical business United Naples (Pres .:
Presid. It Accemia. History Pharmacy Dr. Ravens, 2010); Logos and Theophany
in the digital time (pres. Mons. Trafny, President Dpt Science-Faith Pontifical
Cons. Culture, 2012); Religious aspects and ecclesial dimension SMOM (2013).
Among the more than 40 multimedia: Outline art and history pharmacy (patr.
AISF, 2002); Influenza A / H1N1 (patr. Unesco, 2009).
Raimondo Villano
173
“There are remedies worse than the disease”
Publilius Syrus, Sentences
Superbugs & Superdrugs
174

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R. villano - Superbugs & superdrugs (p.te 7: appendix one)

  • 3. Superbugs & Superdrugs 6 Copy no. __________________ The author _________________________ © Copyright Raimondo Villano. © Searches, processing, cover by Raimondo Villano. Tutti i diritti sono riservati. Nessuna parte del libro può essere riprodotta in pubblicazioni e studi senza citare la fonte. Nessuna parte del libro può essere diffusa con un mezzo qualsiasi, fotocopie, microfilm o altro, senza il permesso scritto dell’editore. All right reserved. No part of this book shall be reproduced in publications and studies without root’s citation. No part of this book shall be stored in a retrieval system, or transmitted by ani means, electronic, mechanical, photocopying, recording or otherwise, without written permission from the publisher. Editorial production: Prof. Dr. Maria Rosaria Giordano. Editing: farmavillano@libero.it. Advisor executive: Francesco Villano. Editions Chiron Foundation - Praxys dpt. © 2015 Chiron Foundation. Website: www.raimondovillano.com (no-profit); Secretary: chironfound@gmail.com. Sales: chironeditore@gmail.com; Catalog: www.raimondovillano.com (business). Print AQ - Rome. 1st edition: May 2015 1st reprint: June 2015. 2nd edition: July 2015. Total number of pages: 176. Finished writing: June 3, 2015. Limited numbered series. This volume without cutting the proof of purchase is to be considered free and without serial number and signature of the author is to be considered counterfeit. ISBN 978-88-97303-28-2. CDD 610 VIL sup 2015 en. LCC RM 265 - 267.
  • 4. Raimondo Villano 7 Contents index Sommario 13 Abstract 15 Résumé 17 Abstrakt 19 Abstracto 21 1. A brief history of antibiotics 25 2. Issues and contrast of antibiotic 33 3. Major resistance to antibiotics 49 4. Look back at some super diseases 55 5. Technologies and research directions 65 6. New therapeutic compounds 77 7. Appendix 85 8. Author profile 169
  • 5. Raimondo Villano 9 “Life is short, art is long, the favorable opportunity, attempting misleading, the difficult decision” Hippocrates
  • 6. Raimondo Villano 11 Parole chiave antibiotici, resistenza, batteri. Keywords antibiotics, resistance, bacteria. Classification LCC RM 265 - 267. Title Antibiotic resistance.
  • 7. Raimondo Villano 13 Sommario Si tracciano cenni storici sul concetto di antibiosi, su ricerche, scoperta e produzione degli antibiotici e sul loro ruolo mondiale non solo terapeutico ma anche strategico dal secondo dopoguerra. Poi, si esaminano a livello nazionale ed internazionale: le problematiche inerenti consumo, uso improprio e abuso di antibiotici nell’uomo, in zootecnia, agricoltura e, quindi, nel ciclo alimentare e nell’ambiente; le politiche di contrasto al fenomeno dell’iperprescrizione e nei cittadini il grado di informazione e consapevolezza dei rischi; le linee guida di buona prassi comportamentale del malato; i documenti principali di lotta a tale emergenza. Si effettuano, inoltre, una rassegna analitica e un approfondimento su alcune super patologie (tubercolosi, gonorrea, meningite, ecc.) e sulle resistenze batteriche ai principali antibiotici. Si realizzano, infine, una ricognizione sull’attualità delle tecnologie e degli indirizzi di ricerca applicata e una rassegna sulle principali recenti nuove terapie. Chiude il lavoro un’appendice tecnica contenente un apparato essenziale di normative e direttive ministeriali italiane e comunitarie europee sul tema.
  • 8. Raimondo Villano 15 Abstract You plot historical notes on the concept of antibiosis, on research, discovery and production of antibiotics and their global role not only therapeutic but also strategic since World War II. Then, you look at national and international issues related consumption, misuse and overuse of antibiotics in humans, in animal husbandry, agriculture, and thus in the food chain and the environment; policies to combat the phenomenon of excessive prescription and citizens in the degree of information and awareness of the risks; guidelines of good practice behavior of the patient; the main documents of struggle in this emergency. We make also an analytical overview and a discussion of some super diseases (tuberculosis, gonorrhea, meningitis, etc.) And bacterial resistance to major antibiotics. We realize, finally, a survey on current technologies and addresses of applied research and a survey on major recent new therapies. Closes work a technical appendix containing an apparatus essential regulations and ministerial directives Italian and European Community on the theme.
  • 9. Raimondo Villano 17 Résumé Vous tracez notes historiques sur le concept de antibiose, sur la recherche, la découverte et la production d’antibiotiques et de leur rôle dans le monde non seulement thérapeutique, mais aussi stratégique depuis la Seconde Guerre mondiale. Ensuite, vous regardez les questions nationales et internationales liées à la consommation, utilisation abusive et excessive d’antibiotiques chez l’homme, dans l'élevage, l'agriculture et, donc, dans la chaîne alimentaire et l’environnement; politiques de lutte contre le phénomène de la prescription excessive et les citoyens dans le degré d’information et de sensibilisation des risques; lignes directrices de bonne conduite de la pratique du patient; les principaux documents de lutte dans cette situation d’urgence. Nous faisons également un aperçu analytique et une discussion de certaines super maladies (tuberculose, la gonorrhée, la méningite, etc.) et de la résistance bactérienne aux antibiotiques majeurs. Nous nous rendons compte, enfin, une enquête sur les technologies et les adresses de la recherche appliquée en cours et une enquête sur les principales nouvelles thérapies récentes. Ferme fonctionne une annexe technique contenant les règlements essentiels de l’appareil et les directives ministérielles italiennes et de la Communauté européenne sur le thème.
  • 10. Raimondo Villano 19 Abstrakt Sie plotten historische Anmerkungen über das Konzept der Antibiose, auf Forschung, Entdeckung und Herstellung von Antibiotika und ihre Rolle in der Welt nicht nur therapeutisch, sondern auch strategische dem Zweiten Weltkrieg. Dann schauen Sie auf nationalen und internationalen Fragen im Zusammenhang mit Konsum, Missbrauch und übermäßige Einsatz von Antibiotika bei Menschen, in der Tierhaltung, Landwirtschaft, und damit in die Nahrungskette und die Umwelt; Politik zur Bekämpfung des Phänomens die übermäßige Verschreibung und Bürger in den Grad der Information und Sensibilisierung der Risiken; Leitlinien für die gute Praxis Verhalten des Patienten; die wichtigsten Dokumente des Kampfes in diesem Notfall. Wir machen auch einen analytischen Überblick und eine Diskussion einiger Super Krankheiten (Tuberkulose, Gonorrhö, Meningitis, etc.) und bakterieller Resistenz gegen wichtige Antibiotika. Wir wissen, schließlich eine Umfrage zu aktuellen Technologien und Adressen von angewandter Forschung und eine Umfrage zu den wichtigsten aktuellen neuen Therapien. Schließt Arbeit eine technische Anlage, die eine Vorrichtung wesentliche Vorschriften und Ministerialrichtlinien italienischen und europäischen Gemeinschaft über das Thema.
  • 11. Raimondo Villano 21 Abstracto Trazar notas históricas sobre el concepto de antibiosis, en la investigación, el descubrimiento y la producción de antibióticos y su papel global no sólo terapéutico, sino también estratégico desde la Segunda Guerra Mundial. A continuación, nos fijamos en los asuntos nacionales e internacionales relacionados con el consumo, el mal uso y abuso de los antibióticos en los seres humanos, en la ganadería, la agricultura, y por lo tanto en la cadena alimentaria y el medio ambiente; políticas de lucha contra el fenómeno de la prescriptión excesiva y los ciudadanos en el grado de información y conocimiento de los riesgos; pautas de comportamiento de buenas prácticas de la paciente; los principales documentos de lucha en esta emergencia. Hacemos también un resumen analítico y una discusión de algunas enfermedades súper (tuberculosis, gonorrea, meningitis, etc.) y la resistencia bacteriana a los principales antibióticos. Nos damos cuenta, por último, un estudio sobre las tecnologías y las direcciones de la investigación aplicada en curso y una encuesta sobre las principales nuevas terapias recientes. Cierra funciona un anexo técnico que contiene un aparato regulaciones esenciales y directivas ministeriales italianas y de la Comunidad Europea sobre el tema.
  • 12. Raimondo Villano 23 S U P E R B U G S & S U P E R D R U G S
  • 15. Raimondo Villano 87 Council Recommendation on patient safety, including the prevention and control of healthcare associated infections 2947th EMPLOYME_T, SOCIAL POLICY, HEALTH A_D CO_SUMER AFFAIRS Council meeting Luxembourg, 9 June 2009 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular the second subparagraph of Article 152(4) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament1 , Having regard to the opinion of the European Economic and Social Committee2 , Having regard to the opinion of the Committee of the Regions3 , Whereas: (1) Article 152 of the Treaty provides that Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and eliminating sources of danger to human health. (2) It is estimated that in Member States between 8 % and 12 % of patients admitted to hospital suffer from adverse events whilst receiving healthcare4 . European Commission, published 2008 by the RAND Cooperation. (3) The European Centre for Disease Prevention and Control (ECDC) has estimated that, on average, healthcare associated infections occur in one hospitalised patient in twenty, that is to say 4,1 million patients a year in the EU, and that 37 000 deaths are caused every year as a result of such infections. (4) Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. A large proportion of adverse events, both in the hospital sector and in primary care, are preventable with systemic factors appearing to account for a majority of them.
  • 16. Superbugs & Superdrugs 88 (5) This Recommendation builds upon, and complements, work on patient safety carried out by the World Health Organisation (WHO) through its World Alliance for Patient Safety, the Council of Europe and the Organisation for Economic Cooperation and Development (OECD). (6) The Community, through the Seventh Framework Programme for Research and Development5 , supports research in health systems, in particular in the quality of healthcare provision under the Health Theme, including a focus on patient safety. The latter is also given particular attention under the Information and Communication Technology Theme. (7) The Commission, in its White Paper "Together for Health: A Strategic Approach for the EU 2008-2013" of 23 October 2007, identifies patient safety as an area for action. (8) Evidence suggests that Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies6 . Therefore, this Recommendation intends to create a framework to stimulate policy development and future action in and between Member States to address the key patient safety issues confronting the EU. (9) Patients should be informed and empowered by involving them in the patient safety process. They should be informed of patient safety standards, best practices and/or safety measures in place and on how they can find accessible and comprehensible information on complaints and redress systems. (10) Member States should set up, maintain or improve comprehensive reporting and learning systems so that the extent and causes of adverse events can be captured in order to develop efficient solutions and interventions. Patient safety should be embedded in the education and training of healthcare workers, as the providers of care. (11) Comparable and aggregate data should be collected at Community level to establish efficient and transparent patient safety programmes, structures and policies, and best practices should be disseminated among the Member States. To facilitate mutual learning, a common terminology for patient safety and common indicators need to be developed through cooperation between Member States and the European Commission, taking into account the work of relevant international organisations.
  • 17. Raimondo Villano 89 (12) Information and communication technology tools, such as electronic health records or e-prescriptions, can contribute to improving patient safety, for instance by systematically screening for potential medicinal product interactions or allergies. Information and communication technology tools should also aim to improve the understanding of users of the medical products. (13) A national strategy, complementary to strategies targeted towards the prudent use of antimicrobial agents7 , should be developed incorporating prevention and control of healthcare associated infections into national public health objectives and aiming to reduce the risk of healthcare associated infections within healthcare institutions. It is essential that the necessary resources for implementing the components of the national strategy are allocated as part of the core funding for healthcare delivery. (14) The prevention and control of healthcare associated infections should be a long-term strategic priority for healthcare institutions. All hierarchical levels and functions should cooperate to achieve result-oriented behaviour and organisational change, by defining responsibilities at all levels, organising support facilities and local technical resources and setting up evaluation procedures. (15) Sufficient data on healthcare associated infections are not always available to allow meaningful comparisons between institutions by surveillance networks, to monitor the epidemiology of healthcare associated pathogens and to evaluate and guide policies on the prevention and control of healthcare associated infections. Therefore, surveillance systems should be established or strengthened at the level of healthcare institutions and at regional and national levels. (16) Member States should aim to reduce the number of people affected by healthcare associated infections. In order to achieve a reduction in healthcare associated infections, recruitment of health professionals specialising in infection control should be encouraged. Furthermore, Member States and their healthcare institutions should consider the use of link staff to support specialist infection control staff at the clinical level. (17) Member States should work closely with the health technology industry to encourage better design for patient safety in order to reduce the occurrence of adverse events in healthcare.
  • 18. Superbugs & Superdrugs 90 (18) To achieve the patient safety objectives mentioned above, including the prevention and control of healthcare associated infections, Member States should ensure a fully comprehensive approach while considering the most appropriate elements having a real impact on the prevalence and burden of adverse events. (19) Community action in the field of public health should fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care, HEREBY RECOMMENDS, applying the following definitions for the purpose of this Recommendation: "Adverse event" means an incident which results in harm to a patient; "Harm" implies impairment of the structure or function of the body and/or any deleterious effect arising therefrom; "Healthcare associated infections" means diseases or pathologies related to the presence of an infectious agent or its products in association with exposure to healthcare facilities or healthcare procedures or treatments; "Patient safety" means freedom, for a patient, from unnecessary harm or potential harm associated with healthcare; "Process indicator" means an indicator referring to the compliance with agreed activities such as hand hygiene, surveillance, standard operating procedures; "Structure indicator" means an indicator referring to any resource, such as staff, an infrastructure or a committee; THAT MEMBER STATES: I. Recommendations on general patient safety issues (1) Support the establishment and development of national policies and programmes on patient safety by: (a) Designating the competent authority or authorities or any other competent body or bodies responsible for patient safety on their territory; (b) Embedding patient safety as a priority issue in health policies and programmes at national as well as at regional and local levels; (c) Supporting the development of safer and user-friendly systems, processes and tools,
  • 19. Raimondo Villano 91 including the use of information and communication technology; (d) Regularly reviewing and updating safety standards and/or best practices applicable to healthcare provided on their territory; (e) Encouraging health professional organisations to have an active role in patient safety; (f) Including a specific approach to promote safe practices to prevent the most commonly occurring adverse events such as medication-related events, healthcare associated infections and complications during or after surgical intervention. (2) Empower and inform citizens and patients by: (a) Involving patient organisations and representatives in the development of policies and programmes on patient safety at all appropriate levels; (b) Disseminating information to patients on: (i) patient safety standards which are in place; (ii) risk, safety measures which are in place to reduce or prevent errors and harm, including best practices, and the right to informed consent to treatment, to facilitate patient choice and decision-making; (iii) complaints procedures and available remedies and redress and the terms and conditions applicable; (c) Considering the possibilities of development of core competencies in patient safety namely, the core knowledge, attitudes and skills required to achieve safer care, for patients. (3) Support the establishment or strengthen blame-free reporting and learning systems on adverse events that: (a) Provide information on the extent, types and causes of errors, adverse events and near misses; (b) Encourage healthcare workers to actively report through the establishment of a reporting environment which is open, fair and non punitive. This reporting should be differentiated from Member States' disciplinary systems and procedures for healthcare workers, and, where necessary, the legal issues surrounding the healthcare workers' liability should be clarified; (c) Provide, as appropriate, opportunities for patients, their relatives and other informal caregivers to report their experiences; (d) Complement other safety reporting systems, such as those on pharmacovigilance and medical devices, whilst avoiding multiple reporting where possible.
  • 20. Superbugs & Superdrugs 92 (4) Promote, at the appropriate level, education and training of healthcare workers on patient safety by: (a) Encouraging multi-disciplinary patient safety education and training of all health professionals, other healthcare workers and relevant management and administrative staff in healthcare settings; (b) Embedding patient safety in undergraduate and postgraduate education, on-the-job training and the continuing professional development of health professionals; (c) Considering the development of core competencies in patient safety namely, the core knowledge, attitudes and skills required to achieve safer care, for dissemination to all healthcare workers and relevant management and administrative staff; (d) Providing and disseminating information to all healthcare workers on patient safety standards, risk and safety measures in place to reduce or prevent errors and harm, including best practices, and promoting their involvement; (e) Collaborating with organisations involved in professional education in healthcare to ensure that patient safety receives proper attention in the higher education curricula and in the ongoing education and training of health professionals, including the development of the skills needed to manage and deliver the behavioural changes necessary to improve patient safety through system change. (5) Classify and measure patient safety at Community level, by working with each other and with the Commission: (a) To develop common definitions and terminology, taking into account international standardisation activities such as the International Classification for Patient Safety being developed by WHO and the Council of Europe's work in this area; (b) To develop a set of reliable and comparable indicators, to identify safety problems, to evaluate the effectiveness of interventions aimed at improving safety and to facilitate mutual learning between Member States. Account should be taken of the work done at national level and of international activities such as the OECD healthcare quality indicators project and the Community Health Indicators project; (c) To gather and share comparable data and information on patient safety outcomes in terms of type and number to facilitate mutual learning and inform priority setting, with a view to helping Member States to share relevant indicators with the public in the future.
  • 21. Raimondo Villano 93 (6) Share knowledge, experience and best practice by working with each other and with the Commission and relevant European and international bodies on: (a) The establishment of efficient and transparent patient safety programmes, structures and policies, including reporting and learning systems, with a view to addressing adverse events in healthcare; (b) The effectiveness of patient safety interventions and solutions at the healthcare setting level and the evaluation of the transferability of these; (c) Major patient safety alerts in a timely manner. (7) Develop and promote research on patient safety. II. Additional recommendations on prevention and control of healthcare associated infections (8) Adopt and implement a strategy at the appropriate level for the prevention and control of healthcare associated infections, pursuing the following objectives: (a) Implement prevention and control measures at national or regional level to support the containment of healthcare associated infections and in particular: (i) to implement standard and risk-based infection prevention and control measures in all healthcare settings as appropriate; (ii) to promote consistency in, and communication of, infection prevention and control measures between healthcare providers treating or caring for a particular patient; (iii) to make guidelines and recommendations available at national level; (iv) to encourage the adherence to prevention and control measures by using structure and process indicators, as well as the results of accreditation or certification processes in place; (b) Enhance infection prevention and control at the level of the healthcare institutions in particular by encouraging healthcare institutions to have in place: (i) an infection prevention and control programme addressing aspects such as organisational and structural arrangements, diagnostic and therapeutic procedures (for example antimicrobial stewardship), resource requirements, surveillance objectives, training and information to patients; (ii) appropriate organisational governance arrangements for the elaboration and the monitoring of the infection prevention and control programme; (iii) appropriate organisational arrangements and qualified personnel with the task of implementing the infection prevention and control programme;
  • 22. Superbugs & Superdrugs 94 (c) Establish or strengthen active surveillance systems by: (i) at national or regional level: – organising prevalence surveys at regular intervals, as appropriate; – taking into account the importance of surveillance of targeted infection types to establish national reference data, accompanied by process and structure indicators to evaluate the strategy; – organising the timely detection and reporting of alert healthcare associated organisms or clusters of healthcare associated infections to the relevant body as per requirements at Member State level; – reporting of clusters and infection types of relevance for the Community or international level in accordance with the Community legislation8 or international regulations in place; (ii) at the level of healthcare institutions: – encouraging high quality microbiological documentation and patient records; – performing the surveillance of the incidence of targeted infection types, accompanied by process and structure indicators to evaluate the implementation of infection control measures; – considering the use of surveillance of particular infection types and/or particular strains of healthcare associated pathogens for the timely detection of alert healthcare associated organisms or clusters of healthcare associated infections; (iii) using, where appropriate, surveillance methods and indicators as recommended by ECDC and case definitions as agreed upon at Community level in accordance with the provisions of Decision No 2119/98/EC; (d) Foster education and training of healthcare workers by: (i) at national or regional level, defining and implementing specialised infection control training and/or education programmes for infection control staff and strengthening education on the prevention and control of healthcare associated infections for other healthcare workers; (ii) at the level of healthcare institutions: – providing regular training for all healthcare personnel, including managers, on basic principles of hygiene and infection prevention and control; – providing regular advanced training for personnel having particular tasks related to the prevention and control of healthcare associated infections; (e) Improve the information to the patients by healthcare institutions:
  • 23. Raimondo Villano 95 (i) making available objective and understandable information about the risk of healthcare associated infections, the measures implemented by the healthcare institution to prevent them and on how patients can help to prevent those infections; (ii) providing specific information, for example on prevention and control measures, to patients colonised or infected with healthcare associated pathogens; (f) Support research in fields such as epidemiology, the applications of nanotechnologies and nanomaterials, new preventive and therapeutic technologies and interventions and on the cost-effectiveness of infection prevention and control. (9) Consider, for the coordinated implementation of the strategy referred to in (8) as well as for the purposes of information exchange and coordination with the Commission, the ECDC, the European Medicines Agency and the other Member States, the establishment, if possible by …*, of an inter- sectoral mechanism or equivalent systems corresponding to the infrastructure in each Member State, collaborating with, or integrated into, the existing inter-sectoral mechanism as set up in accordance with Council Recommendation No 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine9 . III. Final recommendations (10) Disseminate the content of this Recommendation to healthcare organisations, professional bodies and educational institutions and encourage them to follow the approaches suggested therein so that its key elements can be put into everyday practice. (11) Report to the Commission on the progress of the implementation of this Recommendation by …* and subsequently on request by the Commission with a view to contributing to the follow-up of this Recommendation at Community level. HEREBY INVITES THE COMMISSION TO: Produce, by …*, an implementation report to the Council assessing impact of this Recommendation, on the basis of the information provided by Member States, to consider the extent to which the proposed measures are working effectively, and to consider the need for further action. Done at, For the Council The President
  • 24. Superbugs & Superdrugs 96 ______________ 1 Opinion of 23 April 2009 (not yet published in the OJ). 2 Opinion of 25 March 2009 (note yet published in the OJ). 3 Opinion of 22 April 2009 (not yet published in the OJ). 4 Technical report "Improving Patient Safety in the EU" prepared for the 5 Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1). 6 Safety improvement for Patients in Europe (SIMPATIE) project funded under the Community's Public Health Programme 2003-2008, www.simpatie.org. 7 For example Council conclusions on Antimicrobial Resistance adopted on 10 June 2008. 8 For example Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community and the International Health Regulations (OJ L 268, 3.10.1998, p. 1) and Regulation (EC) No 726/2004 of European Parliament and of Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). * OJ: please insert date two years after the adoption of this Recommendation. 9 OJ L 34, 5.2.2002, p. 13. * OJ: please insert date three years after the adoption of this Recommendation.
  • 27. Raimondo Villano 171 Born in 1960. He lives in Rome and Torre Annunziata. Role: General Manager Villano International Business Team (from 2012); Chiron CEO Publisher, Honorary Member (2013) and Associate Professor in History of Health Pharmaceutical Administration Department of Ruggero II University (Miami, 2014), Trader (since 1976), Trader operating financial independent of bags and forex (since 1983), Knight SMO Malta (since 2002), President of Chiron Humanitarian Foundation (since 1985). Academies: History Art Health-Ministry BC, former papal Tiberina, Melitensi Studies, Medical Tradition Smithsonian Institution-USA, International Society History Pharmacy, Acc. History Italian Pharmacy, Soc. Napoletana National History in. h. Noble College Chemical Pharmaceutical. Over 100 conferences and chairman in dozens of conferences. He collaborates with important national and international magazines. You Advisory Board Member for the US Publisher DPC, which publishes in more than 150 nations. Studies: Classical; degree and abil .: Pharmacy (1985); courses certificates: Medicinal herbs, Cosmetic Techniques, Corporate Security, HACCP, History, Social Doctrine of the Church, theology. Degrees h.c.: Human and Social Sciences (2009); History and Philosophy (2010); Communication Sciences (2013). Master h.c.: Science Medical Ethics (2010). He was author, organizer and chairman Safety Course for managers, obtaining the High Patronage of the Head of State and the UN (2000), Secretary International Committee Biothecnologies Wabt-Unesco 2008-13, Diplomatic Adviser AEREC dpt ENVA (from 2011), member of World Academy Biomedical Technology (Unesco 2007-12), 11 years in the Scientific Committee of the Health Security IBD (company responsible for the security of the Courts Naples Appeal Court), Board Beaumont Foundation Onlus research on cancer with the Prefect of Naples (2011-12), member of European Academy for Economic and Cultural Relations (2004-15). 32 years partner and owner of the pharmacy. Partner since 1990, Secretary to 29 years 1990-95 and 2000 Rotary Club President Pompeii-Vesuvius; Comm.ni in Rotary District 2100- Italy: Professional Ethics, Global Action, Computer; among the many international roles: archeology Pompeii-Carthage; Committee Prize Magna Grecia. Napoli president, national Coordinator and founder Federation Young Chemists; Representative National Trade Union Federative. Assistant Microbiology Fac. F.cia Na (1985-90, Chair Prof. Lembo-Inst. Sup. Health). International awards: Diploma of Honor for exceptional services individually in 5 Vie Action by President Rotary International (Evanston 2001: only 100 /
  • 28. Superbugs & Superdrugs 172 year / 1.5 million members); Merit Anti-Crime Task Force-Rotary Italy, Albania, former Yugoslavia, San Marino (Zurich 2001); Sapientia Mundi-Ethics (Rm 2008); Union Legion of Gold-Work (Rm 2010); Veritas in Charitate-Religion (2011); Bonifaciano-Culture and Society (2011); Norman-Publishing Gold Medal (Rm 2014); Norman-Health Galen of Pergamum (Rm 2014). National Awards: Aesculapius-Health Patronage Ministers Council (Rm 1987); LXVIII Piccinini-Search (Rm 2006); LXV Stramezzi-Health (Rm 2007); Capitolino- humanitarian activities (Rm 2010); Tiberino-Culture (Rm 2012); LXXIV Serono-History (Rm 2012), AEREC-Culture (Rm 2013); Merit Public Health (DPR 2013), Tiberino-Science (Rm 2014). Author of over 730 publications health, professional, scientific, historical, religious; more than 50 books (many translated into English, French, some German, Spanish) with prestigious publishers as Zanichelli and sponsorship by the Ministry of Cultural Heritage, Unesco, Rotary, University, etc., present in Italian libraries (including: Quirinale, National Academy Science, Ministries) and more than 40 countries (including: National Health Institute-USA, Nationale de France, Congress UK), in cultural institutes, Universities, Museums; a book made its debut at the Frankfurt Fair. Catalogues: 2000 Outstanding Intellectuals IBC-Cambridge from 2010; OPAC SBN with over 160 works; from 2010 Sheet Authority Ministry BAC. Various books are appreciated by authorities, including several times the Head of State and the Holy Father. Some books: Global Information Society, 1996; Rotary for Man, 2001; Managing security in Pharmacy (pres. Dr. Renzulli, already the UN Security Consultant, 2004); Art and history Pharmacy (pres. Professor Ledermann, Presid. Em. International Pharmacy History Society, 2 ed., 2006); History and activities of the SMOM (4th ed., 2007); Pharmaceutical meridians between secular ethics and Catholic moral (pres. Professor Tarro, Comm. Naz.le Bioethics, 3 ed., 2008); Thesaurus Pharmacologicus (pres. Presid. Pharmacists Italian Dr. Mandelli 2009); Time sculpted silent eternity. Reflections on diachronic investigation for memory homo faber (pres. Eminent historian Fra 'von Lobstein and critic Prof. Carosella, 2 ed., 6 repr., 2010); Pharmaceutical business United Naples (Pres .: Presid. It Accemia. History Pharmacy Dr. Ravens, 2010); Logos and Theophany in the digital time (pres. Mons. Trafny, President Dpt Science-Faith Pontifical Cons. Culture, 2012); Religious aspects and ecclesial dimension SMOM (2013). Among the more than 40 multimedia: Outline art and history pharmacy (patr. AISF, 2002); Influenza A / H1N1 (patr. Unesco, 2009).
  • 29. Raimondo Villano 173 “There are remedies worse than the disease” Publilius Syrus, Sentences