Policy responses for Italy - HSRM

Italy


Policy responses for Italy

3. Providing health services effectively

The section on PROVIDING HEALTH SERVICES EFFECTIVELY describes approaches for service delivery planning and patient pathways for suspected COVID-19 cases. It also considers efforts by countries to maintain other essential services during periods of excessive demand for health services.

3.1 Planning services

3.2 Managing cases

3.3 Maintaining essential services

COVID-19  vaccination programme
As soon as the leading manufacturers started to communicate the development of candidate vaccines in 2020, the Italian Ministry of Health initiated discussions with other European partners to proceed with joint negotiations to secure the availability of enough doses to immunize citizens.

On 3rd June 2020, Italy joined forces with France, Germany and the Netherlands within the “Inclusive Vaccine Alliance” in negotiations with potential developers and manufacturers of a coronavirus vaccine. The EU Commission and the Member States later signed an agreement under which the negotiations with the manufacturing companies were entrusted exclusively to the Commission, aided by a group of seven negotiators (including one from Italy) representing the Member States, and by a Steering Board that takes the final decisions, made up of representatives from all Member States.  The European Union initially secured around 1.3 billion doses from various companies. Such doses will be distributed to the Member States based on the size of their respective populations (i.e., 13.46% of the doses purchased on behalf of all EU Member States are destined for Italy). 

Given the possible availability of vaccines in the short term, an inter-sectoral working group was set up on 4th November at the Italian Ministry of Health to provide the country with an interim national plan for COVID-19 vaccination, with the aim of defining vaccination strategies, possible organizational models, including staff training, logistics, information system supporting vaccination activities, communication, vaccine vigilance and surveillance, impact models and economic analysis. On 12th November 2020, the Extraordinary Commissioner for the COVID-19 Emergency announced that the first administrations of the Covid-19 vaccine by Pfizer would begin by the end of January 2021 and initially cover 1.7 million Italians. Priority is to be given to hospital workers, the elderly and the most fragile groups of the population.

On 2nd December 2020, the Ministry of Health, the Extraordinary Commissioner for the COVID-19 Emergency, the National Health Institute (ISS), the Italian Medicines’ Agency and the Italian National Agency for Regional Healthcare Services (AGENAS) presented to Parliament the ‘Strategic Plan for vaccination against SARS-CoV-2 / COVID-19’.

The Plan is structured around 8 axes:
1) The vaccine will be managed centrally and provided free of charge as a common good and a right that must be guaranteed to everyone, regardless of income or geographical location.
2) Based on EU agreements, Italy will be provided with a total of 224 million doses of vaccines distributed as follows:
● AstraZeneca: 40.16 million doses
● Johnson & Johnson: 26.57 million doses
● Sanofi 40.38: million doses
● Pfizer / BNT: 65.76 million doses
● CureVac:  29.89 million doses
● Moderna: 21.24 million doses
3) Authorization timings will depend on the scientific community’s safety measures and protocols.
4) Priority will be given to health and social health workers, residents, the elderly and nursing homes’ staff.
5) Logistics, procurement, storage and transport will be of competence of the Extraordinary Commissioner.
6) The governance of the vaccination plan will be continuously coordinated between the Ministry of Health, the Extraordinary Commissioner, the Regions and Autonomous Provinces.
7) The vaccination campaign will be supported by an informative system for integrity, safety and transparency.
8) Pharmacovigilance and immunological surveillance will be set-up throughout the vaccination campaign.

In terms of logistics and administration of vaccines, the administration will occur in phases, structured according to the stratification of the population according to  age groups and risk exposure:
- Phase I (Pfizer/Moderna) :healthcare professionals, people aged above 80, nursing home employees and residents were identified as priority categories and vaccinated in 293 national hospital hubs (or on-site for nursing homes).
- Phase II (Pfizer/Moderna) : vulnerable groups - independent of age, people  aged from 70 to 79 and people from 50 to 69 without specific risks;
- Phase III (Astrazeneca):  school and university personnel, armed forces, penitentiaries;
- Phase IV (the vaccine will depend on available supply): general population over 16. 

Regions have organized already existing large space facilities like community hospitals, public grounds, sport halls, barracks and airport terminals. This phase is coordinated by the Extraordinary Commissioner, the Regions and the Department of Civil Protection, also mobilizing the armed forces and Red Cross volunteers. The Ministry of Defense is converting drive-throughs previously used for swab testing into vaccinations centers.  The national goal is to reach an administration capacity of half a million doses per day, starting from April 2020 and to also use local level resources such as GPs, pediatricians and pharmacies. In Rome, for example, the military base “Cecchignola” is fully operational from 22 February 2021 and available first to vaccinate military personnel and then citizens. It will be able to administer 2,500 doses per day with the support of the Lazio Regional Health Authorities in close collaboration with the Local health Unit Roma 2 and the National Institute for Infectious Diseases “L. Spallanzani”.

Moreover, the Stability Law 2021 enacted at the end of 2020  set aside a budget of EUR 400 million to purchase COVID-19 vaccines and drugs for the treatment of patients with COVID-19, such as monoclonal antibodies (e.g. bamlanivimab and etesevimab). Coverage is provided with the resources of the Next Generation EU Program.

Sources
- Law Decree 19th May 2020, n. 34  - Urgent measures in the field of health, support for work and the economy, as well as social policies connected to the epidemiological emergency caused by COVID-19. [Available at https://www.gazzettaufficiale.it/eli/id/2020/05/19/20G00052/sg]
- Amendments to Law Decree 19th May 2020, n. 34 of 28th June – [Available at http://www.quotidianosanita.it/allegati/allegato8651425.pdf]
- https://www.adnkronos.com/fatti/cronaca/2020/09/09/vaccino-astrazeneca-sospende-test-reazione-anomala_p6S4kDrmy7iFwCdUpSAx2J.html
- https://www.adnkronos.com/fatti/esteri/2020/09/12/vaccino-covid-riparte-test-astrazeneca-oxford_98kvqRSD85ND1kXPfMDzXK.html 
- https://www.google.it/amp/www.strettoweb.com/2020/11/vaccino-coronavirus-astrazeneca-marzo-2021-costo-dosi-dettagli/1082835/amp/
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=89880
- Ministry of Health. (2020). Covid-19, approvate dal Parlamento le linee guida del piano strategico sui vaccini anti-Covid. [Avalialble at: shorturl.at/cPW26]
- https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=91256
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=92606
- https://www.sanita24.ilsole24ore.com/art/europa-e-mondo/2021-02-15/giornata-contro-cancro-infantile-primo-report-impatto-pandemia-102217.php?uuid=ADs0y3JB
- http://www.salute.gov.it/portale/nuovocoronavirus/dettaglioContenutiNuovoCoronavirus.jsp?lingua=italiano&id=5452&area=nuovoCoronavirus&menu=vuoto
- https://www.corriere.it/cronache/21_febbraio_17/coronavirus-piano-draghi-vaccini-produzione-anche-italia-protezione-civile-3c2b859a-7138-11eb-b26f-1b97a5632ac6.shtml
- https://www.difesa.it/Primo_Piano/Pagine/Il-Ministro-Guerini-al-Presidio-vaccinale-anticovid-alla-Cecchignola-Roma.aspx
- https://www.government.nl/latest/news/2020/06/03/france-germany-italy-and-the-netherlands-working-together-to-find-a-vaccine-for-countries-in-europe-and-beyond
- http://www.salute.gov.it/portale/ministro/p4_5_2_4_2.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1360
- https://lab24.ilsole24ore.com/numeri-vaccini-italia-mondo/

- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=89880
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=89880
- Ministry of Health. (2020). Covid-19, approvate dal Parlamento le linee guida del piano strategico sui vaccini anti-Covid. [Avalialble at: shorturl.at/cPW26]


Outpatient services
After the Ministry of Health suspended such activities on 29th February 2020, in Phase 2 regions have started individually defining guidelines to restart outpatient and elective surgical activity. This has been the case in most Southern regions (Puglia, Campania, Calabria, Sicily), whereas in the North only Emilia Romagna and Veneto have resumed the aforementioned services by 8th May. By May 26th, practices, recommendations and instructions to reactivate outpatient and elective surgeries were defined at a regional level in 85% of Regions and by June 9th, the percentage rose to 90%.

On 1st June 2020, the Ministry of Health issued "Guidelines for the reorganization of deferrable elective activity during the  COVID-19 emergency", aimed at gradually reactivating all essential levels of assistance guaranteeing safety in social or health services that had been reduced or suspended.

If required, regions are allowed to progressively reactivate specialized outpatient activities, with particular attention to all activities related to oncologic screening, according to the priority class given to such services defined in the National Plan for the Management of Waiting Lists Government (PNGLA) for the period 2019-2021. Such plan categorizes all outpatient services into 4 categories: U (Urgent) to be performed within 72 hours; B (Brief) to be performed within 10 days; D (Deferrable), to be performed within 30 days in case of visits or 60 days for check-ups and diagnostics; P (Programmed) to be performed within 120 days. Thus, for categories D, P and all outpatient activities possibly deferred due to the emergency from COVID-19, it is required that all general prevention measures are guaranteed, with specific attention towards:

• Preferring virtual management of booking and payments, including access to waiting rooms;
• Preferring virtual service delivery systems (telemedicine, video call, video conference) when possible
• Reorganizing logistics and organizational flows to avoid overcrowding within facilities and to guarantee social distancing, for example by setting up dedicated routes, extending opening hours.
• Detecting body temperature and respiratory symptoms for all those entering the facilities;
• Maintaining hand hygiene (providing gel dispensers instructions for correct hand washing) and monitoring of the correct use of compulsory PPE;
• Activating protection measures for staff and for the most vulnerable patients, for example creating separate paths for cancer, transplant, immunosuppressed, paediatric and geriatric patients;
• Providing effective protocols for the sanitation of rooms, with particular attention to the frequent and adequate ventilation of rooms;
• Conducting surveillance and on-site visits to make sure that safety conditions are being maintained, on behalf of Infection Control Committees or Risk Management Units.
• Training staff adequately and promoting informative systems for users.

The Ministry of Health and Regions have agreed to scale-up GPs and paediatricians’ diagnostic possibilities, following the 2020 Budget Law that allocated EUR 235 million for this purpose. With the needs of non-Covid-19 patients (especially chronic patients and cancer patients) in mind, the Head of the Department of Civil Protection has been requested to purchase additional medical devices for primary care, including telecare, tele-health services, telemonitoring and tele-dermatology devices that will be distributed by Regions through specific agreements, to prepare for future containment measures. Consequently, doctors will have to be specially trained for their usage and will receive a ‘certification’ for acquired skills.  Management costs will be borne by physicians themselves who are not allowed to use the technology for freelance activity.

Inpatient care
During Phase 1, most regions defined their own plan for the re-organization of hospital care. In fact, in almost all Italian regions ICU bed capacity was increased by over 50%, exceeding the amount suggested by the Ministry of Health.

During the first week of Phase 2, however, it was shown that as of 8th May 2020, only two regions out of 20 (Tuscany and Emilia Romagna) started planning and remodelling the hospital network for the new phase. In this period, with the combination of an overall increase in number of beds and a reduction of patients requiring IC, indicators measuring bed capacity saturation showed that the situation is currently sustainable, with a national average of 11.79%.

By 26th May 2020, the organization of hospital care was showing a very heterogeneous behaviour among Italy’s regions, however none of them had issued specific resolutions or acts relating to the reorganization of hospital care for phase 2. Only 9 regions defined Covid-19 hospital networks, albeit with different levels of detail and, by 11th June 2020, the number rose to 10 out of 20.

By July 8th 2020, 13 regions had reorganized their hospital network. Throughout the country, the management of inpatient stay for Covid-19 was mainly organized by setting-up Covid-19 hospitals, as shown in Marche, Umbria, Abruzzo, Sicily, Basilicata and Sardinia; Lombardy, Liguria, Veneto and Tuscany have preferred a network model, whereas Lazio, Emilia-Romagna (only for IC), Puglia and Calabria are oriented towards a Hub and Spoke system.

Regarding delivered services, Phase 1 was characterized by the high volume of hospitalizations for Covid-19 and the saturation of ICUs, as well as by a decrease in the number of hospitalizations for non-Covid causes. Comparing volumes of interventions in 2019 and in 2020, significant reductions of procedures with greater impact on intensive care have emerged. For example, since the end of February, the number of hospitalizations for acute coronary syndrome diminished, with repercussions on the number of percutaneous transluminal coronary angioplasties (PTCAs) performed. At a national level it appears that there have been impacts on timeliness and accessibility to hospitalization even for acute events like Acute Myocardial Infarction with repercussions in terms of mortality and time-to-care. Furthermore, it was also shown that cardiologic Hub&Spoke models have allowed to contain the impact of Covid-19 on clinical outcomes with a crucial role played by the re-definition of patient pathways.

As for gastroenterology divisions, an ALTEMS report shows that, at a national level, only 2.5% did not vary their activity volume during the emergency. Centers carrying out endoscopic practices suspended services in 3.8% of cases, while 66.7% recorded a 60% decrease in volumes. The variation, however, was lower for emergency procedures.

The "Guidelines for the reorganization of deferrable elective activity during the COVID-19 emergency” suggest the same progressive approach as for outpatient services (see paragraph above) for elective hospitalizations belonging to classes B, C and D. For such services, however, the Ministry of Health advises to base the reprogramming also on risk-benefit evaluations in relation to the clinical status of individual patients.

Alongside elective procedures, specific safety measures must be guaranteed:

• Prior to their hospitalization, patients must be systematically screened (i.e. SARS-CoV2 virus swab, X-ray or chest ultrasounds, chest CTs). In case of suspected or confirmed positivity, patients will undergo a re-evaluation of eligibility to hospitalization/surgery. Should such service be postponed, all risk-containing preventive measures are to be activated. Patients treated in a different region from their residency should, in fact, carry out the pre-hospitalization screening in their region of provenance.
• Prior to hospital admission, body temperature must be taken and respiratory symptoms checked. Patients with a temperature above 37.5 ° C or with respiratory symptoms will undergo a re-evaluation of eligibility to hospitalization/surgery.

Furthermore, patients are recommended to minimize all social interactions or even isolate at home in the two weeks prior to hospitalization.

Special Units for Continuity of Care
By June 9th, special units for continuity of care (USCAs), which provide care for patients who do not need hospitalization, reached coverage of 47% of the population, with an increase mainly due to the progressive activation of more USCAs Marche, Sicily, Liguria, Sardinia Campania and Puglia. The highest coverage rates belong to Valle d’Aosta and Emilia Romagna while in Campania (South), Lombardy and Lazio continue to experience the lowest coverage rates in the country.

Intermediate care
Intermediate care responds to the health needs of patients who require nursing assistance and monitoring with low amount of medical attention. In response to this, regions have been adopting several approaches. Almost all regions (85%) have made available some of their existing nursing homes, health and social care facilities exclusively to Covid-19 patients. During the months of the epidemic, though, more and more regions followed the Northern example and converted hotels or community hospitals to deliver intermediate intensity care. At 8th May, these facilities are found in Lombardy, Veneto, Trentino-Alto-Adige, Liguria, Piedmont, Emilia Romagna, Tuscany, Marche, Umbria, Lazio, Abruzzo, and Molise.  
Overall, each region has chosen their own ratio to balance intermediate care services and home care, however Tuscany, Veneto, Lazio, Emilia Romagna Marche and Lombardy seem to be the most dedicated to managing their services at a territorial level, whereas Calabria, Sicily and Friuli Venezia Giulia are at the opposite end.

Digital solutions
From 1st March to 8th of May 2020, Italy witnessed the launch of a total of 108 initiatives to enhance the delivery of services through digital technology, rising to 149 by May 26th and to 174 by June 11th. Of these, 50 are Covid-specific, whereas the others are dedicated to diabetology, cardiology, general medicine, oncology, neurology and psychology and the latest aim to respond to health needs that are not Covid-19 related. At 11th June 2020, such services resort to phone calls (20%) or video calls (29%), with the possibility of exchanging documents by e-mail or through instant messaging platforms. Some of these are Apps that have been specifically designed for teleconsultations and monitoring (13%) and some web platforms allow access collaboration between multiple operators (38%). The services mostly provided by using digital solutions are medical examinations (47%) and monitoring of some vital parameters (33%), followed by counselling (8%). Also included are assistance to nursing homes, and contacts with family members. The aforementioned web platforms are mostly used for Covid-19 and cardiology patients. Diabetic patients, on the other hand, are usually assisted through telephone contact and web video-calls. Telephone contacts are frequently used by GPs while oncologic doctors and dermatologists have reported to resort to web platforms.

In June 2020, the Ministry provided the “Guidelines for the progressive reactivation of elective activities considered deferrable during the COVID-19 emergency” in which it recommends the switch to remote assistance methods (teleconsultations, telemedicine) whenever possible, precisely referring to check-ups and updates of treatment plans). It also advises to favour remote methods for booking and payments such as phone calls or online transactions. 

By 26th May 2020, four Italian regions (out of 20) - Emilia Romagna, Lombardy, Tuscany and Veneto – plus the Autonomous Province of Trento had already formally enabled provision of health services through telemedicine by issuing regional resolutions. Initiatives to formalise the delivery of services via telemedicine within the National Health Service are, in fact, a competence of regions as defined by the National Guidelines defined by the Ministry of Health in 2014.

A report by ALTEMS shows that, by 3rd September, the number of regions that released resolutions to define the implementation of telemedicine within their health systems rose to 10 plus two autonomous provinces. Whereas some have defined general organizational plans, others have defined instructions for specific health problems such as diabetes or autism in Abruzzo (April); targeted specific categories of the population, such as Lazio with paediatric patients (June/July). Lombardy (May/August) and Piedmont (July) have established which precise services are deliverable at a distance. Seven have defined specific tariffs (Tuscany and the Province of Trento in April; Veneto in May; Lazio and the Province of Bolzan in June and Sardinia in August).

Governmental guidelines  and support regarding the use of Telemedicine

On 14th April, the ISS released a set of guidelines in the report “Temporary indications for telemedicine assistance during the COVID-19 health emergency” valid at national level.
Since the beginning of the emergency, the National Center for Telemedicine and New Assistive Technologies of the National Health Institute, has been collaborating with local bodies around Italy to support the realization of practical solutions for home assistance via telemedicine, that are rapidly applicable for those in isolation in order to proactively monitor their health conditions, in relation both to the prevention and treatment of COVID-19 and grant the continuity of care that may be necessary to accompany also other health issues.

The ISS’s recommendations point out that, as at the time being there is little experience in the field, it is not advisable to resort to telemedicine services with:

● Unknown patients who manifest altered state of consciousness, dyspnea at rest and low values of systolic pressure;
● Patients with acute pathologies or exacerbations of chronic pathologies, even if in isolation;
● Frail or chronic patients for whom home stay would not constitute a safe choice in the presence of COVID-19 symptoms.

However, the final evaluation of suitability for each patient is still up to the attending physician. Additionally, in a parliamentary hearing of 10th June 2020, the Minister of Health stressed the need to invest in AI, digitization also to connect research institutions and territorial healthcare facilities to other centers located in other parts of the country and the world.

It was also mentioned that a study carried out by the Digital Innovation Observatory in Health showed that most citizens use at least one online service and high approval and adherence of citizens to the digitalized medical prescription that was introduced during the Covid emergency.

The March call for proposals on behalf of the Ministry for Technological Innovation and Digitization:
On March 31st 2020, the Ministry for Technological Innovation and Digitization set up a Working Group divided into the following subgroups:

1. General coordination of activities;
2. Infrastructure and data collection;
3. Economic impact;
4. Web data and socio-economic impact;
5. Medical tele-assistance
6. Technologies for emergency management;
7. Big data & AI for policies;
8. Legal profiles of data management related to the emergency.

In particular, Subgroups 5 and 6 dealt with evaluating the proposals and technological solutions presented to the "Fast Call for technologies to combat the spread of Covid-19" launched from 24th to 26th March and promoted together with the Ministry of Economic Development, the Ministry of University and Research and the Ministry of Health. The aim was to identify the best apps and technical remote assistance solutions for patients at home, both for diseases related to COVID-19, and for others, including chronic ones. The proposals had to be available already usable and available on the market.  The selection gave priority to solutions focused on active surveillance of patients in home isolation for Covid-19, to aid the delivery of home assistance services.

The call for proposals led to a total of 504 technological solutions from which five were extracted and selected for their technical characteristics, methodology of identification and authentication of patients and citizens and for the time necessary for their implementation. The 5 solutions found, detailed in the section “How are digital tools being used for isolation and quarantine?” are: LazioDrCovid, Co4Covid-19, Smart Axistance Covid-19 Control, Ticuro Reply and eLifeCare Covid-19.


Mental Health
The Italian Society of Psychiatry has estimated that an extra 300,000 patients are suffering from post-traumatic stress linked to losing their beloved ones, financial damage and uncertainty about the future. Thus, as these individuals are likely to develop psychological issues, they will need access to mental health services. A study conducted by the Universitat Oberta de Catalunya confirmed the relevance of such concern as 42% of Italians are at risk of developing mental health issues because of the pandemic. Up to 59% of the population has experienced feelings of stress, anxiety or depression during the lockdown.

Pediatric Patients
The Pediatric Units of Fondazione Policlinico Universitario A. Gemelli – IRCCS, a tertiary care centre in Rome, has designed a remote assistance program dedicated to families who have children with complex pathologies and disabilities who have not been able to access health services and have been kept at a distance from healthcare facilities during the emergency. The project is developed on several levels of care and is called "Contactless: no place is far". Assistance will be provided with intervention methods such as structured video conferences, training of caregivers through special tutorials and psychological support for both children and their families.

Vaccination Services
Public health measures that have required people to stay at home, except for reasons of health, work or urgent needs, have led some people to decide to postpone scheduled vaccinations for themselves or their children. In addition, the need to reorganize health services to increase the availability of dedicated personnel to deal with the emergency had an impact on the regular performance of vaccination activities.

The Ministry Of Health published the results of a survey the showed that almost all of the Local Health Authorities (94/97 = 96.9%) had a decrease in vaccinations during the COVID-19 emergency, compared to the corresponding period of the previous year. Furthermore, at national level more than 33% of the health personnel (doctors, nurses, health assistants, administrative staff), have been reallocated to COVID19 related activities (especially contact tracing). About 5.5% of the staff working in the vaccination centres contracted the SARS-CoV-2 infection.

Different organizational methods have been adopted for maintain vaccinations during the COVID-19 emergency, consisting, more frequently, in carrying out vaccination by reservation only, assigning priority to some vaccines / subjects (primary cycles (<1 year) and vaccinations of pregnant women, people at risk, and vaccinations in case of emergencies, such as trauma, bites, etc.) and extending the vaccination time to avoid overcrowding. Concerning age groups, the most affected by the reduction in vaccinations were children aged over 1 year, adolescents and adults; HPV, Herpes Zoster, DTPa and Meningococcal B, IPV and MPR are the most affected vaccinations.

Following this analysis, the Ministry Of Health provided a series of general recommendations to restore services, strengthen communication, recover the immune gaps and expand routine vaccination services to reach the unvaccinated. The Ministry encourages the activation of a local task force led by the department of prevention aimed to cooperate with all the figures that could help to fill the gap, in particular General Practitioners and Paediatricians, Occupational Physicians and schools and to identify all possible solutions to expand vaccination services and supply. 
In this context, most of the Local Health Authorities s have organized (or are going to organize) mass vaccination campaigns using large buildings (such as sports halls) or innovative ways, such as Drive-Through Vaccination Clinics.


Sources
- Law Decree 19th May 2020, n. 34  - Urgent measures in the field of health, support for work and the economy, as well as social policies connected to the epidemiological emergency caused by COVID-19. [Available at https://www.gazzettaufficiale.it/eli/id/2020/05/19/20G00052/sg]
- Amendments to Law Decree 19th May 2020, n. 34 of 28th June – [Available at http://www.quotidianosanita.it/allegati/allegato8651425.pdf]
- https://www.adnkronos.com/fatti/cronaca/2020/09/09/vaccino-astrazeneca-sospende-test-reazione-anomala_p6S4kDrmy7iFwCdUpSAx2J.html
- https://www.adnkronos.com/fatti/esteri/2020/09/12/vaccino-covid-riparte-test-astrazeneca-oxford_98kvqRSD85ND1kXPfMDzXK.html 
- https://www.google.it/amp/www.strettoweb.com/2020/11/vaccino-coronavirus-astrazeneca-marzo-2021-costo-dosi-dettagli/1082835/amp/
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=89880
- Ministry of Health. (2020). Covid-19, approvate dal Parlamento le linee guida del piano strategico sui vaccini anti-Covid. [Avalialble at: shorturl.at/cPW26]
- https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=91256
- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=92606
- https://www.sanita24.ilsole24ore.com/art/europa-e-mondo/2021-02-15/giornata-contro-cancro-infantile-primo-report-impatto-pandemia-102217.php?uuid=ADs0y3JB
- http://www.salute.gov.it/portale/nuovocoronavirus/dettaglioContenutiNuovoCoronavirus.jsp?lingua=italiano&id=5452&area=nuovoCoronavirus&menu=vuoto
- https://www.corriere.it/cronache/21_febbraio_17/coronavirus-piano-draghi-vaccini-produzione-anche-italia-protezione-civile-3c2b859a-7138-11eb-b26f-1b97a5632ac6.shtml
- https://www.difesa.it/Primo_Piano/Pagine/Il-Ministro-Guerini-al-Presidio-vaccinale-anticovid-alla-Cecchignola-Roma.aspx
- https://www.government.nl/latest/news/2020/06/03/france-germany-italy-and-the-netherlands-working-together-to-find-a-vaccine-for-countries-in-europe-and-beyond
- http://www.salute.gov.it/portale/ministro/p4_5_2_4_2.jsp?lingua=italiano&menu=uffCentrali&label=uffCentrali&id=1360
- https://lab24.ilsole24ore.com/numeri-vaccini-italia-mondo/


In the last week of October, Regions have mostly resorted to home isolation of new cases (95%).  Specifically, 156.5 people per 100,000 inhabitants have been isolated at home, 8.1 have been hospitalized in ordinary wards and 0.8 have been hospitalized in ICUs (ALTEMS, 29th October).

Tuscany
With Resolution 744/20 of 15th June, Tuscany launched a regional program for the reorganization of clinical pathways for residents with a Covid-19 related clinical situation; this program also includes the launch of studies targeted to better understand medium and long-term consequences of the disease. By the end of June, a surveillance program will be active for those who have contracted Covid-19 and are now clinically cured, in order to ensure that they are taken care of by the Regional Health System (SSR). Such surveillance allows identifying post-acute effects or medium and long-term complications that may, however, still require health interventions.

Cases may include either patients discharged from hospitals or individuals who were treated at home or in social or health facilities and organizational procedures have established that all Covid patients who have been hospitalized in Tuscany are contacted and engaged by the hospital itself which will work in close contact with the patients’ GP to share results and decisions-making on necessary interventions. On the other hand, non-hospitalized patients will be tracked and identified through regionally implemented platforms and contacted directly by their GP. Recruited patients will undergo a series of anamnestic investigations (mainly questionnaires and blood tests) and, at this stage, Special Units for Continuity of Care will be engaged. Consequently, they will be addressed to the most appropriate specialists (pulmonologists, neurologists, cardiologists, intensivists, nephrologists, psychiatrists, psychologists, otolaryngologists, ophthalmologists, diabetologists, physiatrists, geriatricians, physiotherapists, professional dietetics staff, etc.).
Furthermore, specialised Covid-19 surgeries will be activated in all healthcare facilities for multispecialistic day services and all costs will be borne by the SSR without out-of-pocket payments. The program also includes regional training for the involved professionals.

The figure of the GP will be crucial in the management of non-hospitalized patients and they will also be responsible for delivering clinical questionnaires, requesting blood tests and referral to specialists.

Sources:
- https://www.quotidianosanita.it/lettere-al-direttore/articolo.php?articolo_id=86319 
- http://www.quotidianosanita.it/lettere-al-direttore/articolo.php?articolo_id=86437
- ALTEMS, Instant REPORT#26: Analisi dei modelli organizzativi di risposta al Covid-19, 29th October 2020 [Available at: https://altems.unicatt.it/altems-executive%20summary%20instant%20report%2026.pdf]

On 1st March the Ministry of Health issued a circular requiring all regions to take action according to following recommendations/rules:
• Increase by 50% the number of intensive care beds
• Increase by 100% the number of beds in pneumology and infectious diseases wards (these beds should be equipped with adequate assisted pulmonary ventilation systems)
• Mainly use private contractors (private hospitals accredited with the NHS) for non COVID-19 patients; however, in Lazio and Lombardy, private contracted hospitals increased their capacity also for COVID-19 patients
• Re-allocate health professionals according to the internal re-organizations and provide a short training program if required

In the regions with higher infection rates hospitals were designated as COVID-19 hospitals (e.g., Sacco Hospital in Milan). In general, Covid-19 hospitals only admit patients and try to discharge or transfer patients who are not infected. Hospitals that continue to see non-Covid-19 patients must design a triage system to differentiate physical spaces for suspected Covid-19 patients.

Primary care physicians are assumed to be the first point of contact for patients with COVID-19 symptoms. If patients are not critical, they are asked to remain at home and to be taken care by their GP or medical continuity services (medical services for the hours in which GPs are not on duty). Patients are invited to stay at home and not to visit their GPs. GPs either visit their patients or manage them by telephone or skype. Some media report that many GPs in Lombardy and in other area where the incidence of Covid-19 is very high cannot cope with the demand and they often lack basic protection devices (masks and gloves). In general, an increase in the use of telephone and other devices as an alternative to physical visits has been reported.

There is a national designated telephone helpline (1500). In addition, each region has its own helpline that gives more specific information. Some municipalities have activated additional helplines (e.g., for supporting daily life for frail people).

REGULATING AND MONITORING ACCESS TO EXPERIMENTAL TREATMENTS
For the duration of the emergency, the Italian Medicines Agency (AIFA) has activated a simplified procedure to ease, regulate and monitor access to potentially useful pharmaceuticals and treatments in the fight against COVID-19 and the website provides a continuously updated list of drugs that are being experimented (https://www.aifa.gov.it/sperimentazioni-cliniche-covid-19).  On 4th April, ISS highlighted that since 17th March, AIFA evaluated 53 proposals for experimental clinical trials of which 8 were also approved by the ethical committee.  Patient recruitment has already begun. 
By 8th May, AIFA’s Scientific and Technical committee has approved seven clinical studies in Lazio, four in Lombardy and in Emilia Romagna, two in Veneto and one in Piedmont, in Tuscany, in Campania and in Umbria, for a total of 21 trials. Of these, six are managed by for profit promoters and the remaining 15 by not-for-profit agencies.

Source
- https://www.aifa.gov.it/informazione-continua-sui-farmaci
- ALTEMS Covid-19 working group - Instant REPORT#6: 8 Maggio 2020  - Analisi dei modelli organizzativi di risposta al Covid-19, available at https://altems.unicatt.it/altems-6REPORT%20ALTEMS.pdf

Patients who have symptoms but are not in a critical situation are asked to stay at home and contact their GPs (or a local number if the GP is unavailable). The GP makes the diagnosis either physically or virtually and, depending on the symptoms, s/he requests a nasopharyngeal swab that is generally taken at the patient’s home. Only patients who suffer from severe respiratory systems are told to go to the hospital. They generally reach the hospital by ambulance.

To our knowledge there are no official clinical protocols for patients with COVID-19. Nor are there specific therapies for the virus. Experts make suggestions and clinicians adopt their own strategy. The main strategies aim to alleviate symptoms (e.g., paracetamol to lower fever).
There are three ongoing studies on three different pharmaceutical regimens: a) Emapalumab + Anakinra; b) Sarilumab; c) Tociluzumab. They are phase 2/3 studies. More in info at:
http://www.salute.gov.it/portale/nuovocoronavirus/dettaglioNotizieNuovoCoronavirus.jsp?lingua=italiano&menu=notizie&p=dalministero&id=4344

Decree Law n° 14 released on 9th March 2020 requested the activation of one Special Unit for Continuity of Care every 50,000 inhabitants, for the management of home care to patients that do not require hospitalization (70,000 cases on the 12th April). Such newly dedicated structures are responsible for phone or video consultations and domiciliary visits and must be active seven days per week from 8.00 am to 8.00 p.m. Staff was recruited among volunteer medical doctors, nurses and administrative staff and serve as actual frontline gatekeepers of the health system, with a  remuneration of EUR 40 every hour.

Further, there are reports of “up and go” tests and 1-flight of stairs climbing tests being performed, followed by pulse oximeter reading to monitor oxygen saturation. Oxygen therapy is also offered, and a network of tanks replacements is organized through the producers, leveraging existing COPD services. The Lombardy region purchased 100 thousand pulse oximeters to do monitoring of oxygen saturation and do three follow-up calls a day to all of those who have been told to stay home rather than going to hospital.

There is no official reporting of rationing care for COVID-19 patients. However, it cannot be excluded that in certain situations, some patients would not have received the best standard of care due to the limits of hospital capacity.

The decentralization of the Italian healthcare system has led to different behaviours among regions with regard to the choice of care settings. Some examples are listed:

Lombardy
Lombardy has primarily managed cases by resorting to inpatient care (49% of positive cases are hospitalized – as of 8th April). Special Units for Continuity of Care (USCA) and dedicated nursing teams (ADI COVID) were instituted at the beginning of April to aid home care; moreover, intermediate care structures (cfr. residenze di sorveglianza) have been set up for those who are clinically stable but have not yet tested negative.

Emilia Romagna
Emilia Romagna has opted for a shared inpatient and outpatient management. Overall, 36% of positive cases have been hospitalized (as of 8th April), ranking among the lowest regions in Italy for the proportion of hospitalized patients. Several Local Health Units have already activated Special Units for Continuity of Care for homecare and, aside from intermediate structures, Emilia-Romagna is also activating Covid-19 dedicated practices.
Veneto
Veneto, with a very low hospitalization rate of 21% (as of 8th April), has been resorting mainly to outpatient care. Hospitalization has been almost entirely restricted to those requiring IC. It is currently working to institute Special Units for Continuity of Care for home-care and has set up 110 beds in intermediate care structures, known as community hospitals.

Lazio
Lazio has mainly responded with inpatient services by activating 5 Covid-19 centres and has hospitalized 44% of positive cases (as of 8th April). ICU capacity is not as saturated as the North of the country due to the lower number of infected cases. Monitoring of patients at home takes place through an app called LAZIODOCTOR, a tool that all citizens can use to find information and have online telemedicine consultations.   A total of 292 beds have been set up from the hospitality sector, for patients requiring low intensity care.
Order n° Z00034, issued by the President of the Lazio Region on 18th April 2020, has released further measures for the prevention, containment and management of the outbreak in local health and social and health care facilities. All healthcare professionals employed in these facilities must carry out their work exclusively within one single structure. Hospitals, local health and social and health care facilities must provide their staff adequate PPE and guarantee specific training to their employees on how to correctly utilize such equipment, resorting to distance learning platforms if necessary. Inadequately protected or untrained healthcare workers must limit movement and social interactions within the facility and must return to their home, avoiding all forms of contact along the way and with cohabitees. Should this not be possible, facilities must set up dedicated spaces for staff to stay overnight. Local health and social and health care facilities are required to check and record body temperature of employees twice a day, before entering the workplace and before returning home. For those with a temperature above 37.5 ° C, oxygen saturation must be measured.
Local Health Units are responsible for the continuous monitoring of all structures present in their territory by carrying out inspections and filling in checklists to assess the appropriateness of their conditions. They must also keep track of demand for PPE and, in case of an outbreak within one of the structures, they must alert the Regional Crisis Unit and to the Regional Service for Epidemiology, Surveillance and Control of Infectious Diseases (Servizio Regionale per l'Epidemiologia, Sorveglianza e controllo delle Malattie Infettive, SeReSMI) in order to activate the Regional Audit Groups  and the Special Regional Unit for Continuity of Care.

Piedmont
Initially, Piedmont resorted mainly to hospital care. However, by the end of March, it increasingly involved territorial care also due to the increase in the number of infected. As of 8th April, 43% of positive cases have been hospitalized. Starting from 27th March, they have instituted Special Units for Continuity of Care.

Sources:
- Cicchetti et al. Analisi dei modelli organizzativi di risposta al Covid-19 Focus su Lombardia, Veneto, Emilia-Romagna, Piemonte e Lazio Instant REPORT#2: 8 Aprile 2020, COVID19 – available at https://altems.unicatt.it/altems-ALTEMS-COVID19_IstantReport2-report.pdf
- https://www.quotidianosanita.it/studi-e-analisi/articolo.php?articolo_id=83945
- Lazio Region Order Z00034, 18th April 2020, available at http://www.regione.lazio.it/rl/coronavirus/wp-content/uploads/sites/72/Z00034-del-18_04_2020-Strutture-correzione.pdf

Rather than specifying which services must be maintained during the outbreak, national and regional policies identify those activities that can be suspended or simply transferred to other entities or organizational units. National policy eased requirements for pharmaceutical prescriptions so that it is not required to physically hand in prescriptions to receive medical therapies (see also Section 1.3).

Decisions about the re-organization of services are taken at regional and local level. In some hospitals, especially in the areas with the highest number of cases, beds have been re-purposed in order to increase the capacity of units dealing with COVID-19. This included the closure of some wards and the suspension of non-urgent elective cases. For example, the regional policy of Piedmont requires the suspension of all surgical activities except for urgent cases, for life-threatening conditions or for oncological diseases.

Civil protection personnel, municipality employees and volunteers, and a number of NGOs work to support vulnerable people at home and in long-term care facilities. Despite major efforts, however, fatality rates for the most vulnerable segments of society appear particularly high.
We are not aware of any explicit national policy to expand access to mental health services as a result of the outbreak. However, it is reported that mental care services are under increased pressure to manage the worsening conditions of some patients and to take care of new cases probably attributable to the outbreak. These services are also requested to support health professionals who are under increasing psychological stress.

Protecting pregnant women, newborns and the elderly:

On 31st March, the Ministry of Health released recommendations regarding childbirth, women in labour and new mothers. Childbirth clinical pathways are to remain in function, with the obligation to adopt all safety measures, however all check-ups that are deferable must be postponed. All women showing symptoms, or likeliness, of acute respiratory syndrome or infection, must be tested for Covid-19 and, while awaiting for the result, must stay in dedicated pre-triage rooms within the Obstetric Emergency Room, for precautionary isolation. Those who then result positive must be transferred to specific hubs, known as “Birth Points” of the Maternal and Neonatal Network identified by each region. Transport will be responsibility of the sender.

Particular attention is given to nursing homes for the elderly in which mortality rates have reached 9.7% nationwide, with significant variations across regions (from 5% in Emilia Romagna to 19.2% in Lombardy, for example). Compared to other countries, Italian nursing homes are in fact more similar to long term care facilities with demanding healthcare needs as they are limited to the frailest: 75% of residents over 80 and mostly severely functionally impaired.
On 14th April, the ISS released a survey conducted in State-owned elderly homes managed by regional authorities. In Italy there are more than 4,500 elderly homes, mostly located in the northern regions of which 1,083 - with about 80,000 residents - participated to this survey. The report highlighted that in such centres, since February 2020 a total of 6,773 residents have died and 40.2% were either Covid-19 positive patients or presented flu-like symptoms compatible with Covid-19, but were never tested. In some regions, such as Lombardy and Emilia Romagna, the percentage of deceased patients (Covid-19 positive or with compatible symptoms) reached respectively 53.4% and 57.7% of the total.
In light of this, on 18th April, the ISS released a guide for the prevention and control of Covid-19 infection within nursing homes, specifying organizational and structural requirements aimed at avoiding catching the virus, managing positive cases and guaranteeing an effective flow of information with Local Health Units and families. Among these, for example, family members and people with symptoms are not allowed to visit for the entire duration of the emergency; new residents can be authorized to move in after being tested for Covid-19 and must be placed in a dedicated area, isolated from other residents. Furthermore, nursing homes are recommended to avoid sending their residents to hospitals for diagnostic tests and medical visits. Group activities and the use of shared spaces are to be suspended; all staff, suppliers and maintenance workers must be properly equipped with PPE. As soon as a resident shows signs of a likely infection s/he must be isolated and tested immediately. If positive, they must be kept in isolation when structurally possible and, otherwise, transferred to an appropriately equipped facility. Special Units for Continuity of Care (for further information please see paragraph 3.2) are responsible for guaranteeing continuous communication with infectious disease specialists and protocols to be followed will be those emitted by the Directorates of each facility. Nursing homes with suspected or ascertained Covid-19 cases (even those awaiting transfer), must provide medical and nursing support 24 hours per day.
Sources
- Sources: Ministry of Health, 31st March 2020. Circular N° 0011257 http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=73787&parte=1%20&serie=null
- Arlotti M, Ranci C. Un’emergenza nell’emergenza. Cosa è accaduto alle case di riposo del nostro paese?. Covid-19 Review n° 29 – 13th March 2020, Banchieri, Vannucci
- ISS, Indicazioni ad interim per la prevenzione e il controllo dell’infezione da SARS-COV-2
- in strutture residenziali sociosanitarie, Rapporto ISS COVID-19  n. 4/2020 Rev, 17th April 2020 [available at http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=73875&parte=1%20&serie=null]
- https://www.epicentro.iss.it/coronavirus/pdf/sars-cov-2-survey-rsa-rapporto-3.pdf