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

Initial COVID-19  vaccination programme arrangements

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 was to be given to healthcare 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 (AIFA) 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 has been planned in phases, structured according to the stratification of the population on the base of 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 above 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 2021 and to also use local level resources such as GPs, pediatricians and pharmacies. In Rome, for example, the military base “Cecchignola” has been 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.

Following the advice of the National Health Council, on 3rd March 2021, the Ministry of Health  issued a circular stating that non-immunodeficient individuals who have been already infected by  COVID-19 can be given one single dose of the COVID-19 vaccine, provided that the vaccination is conducted between 3 and 6 months from positivity. Furthermore, in accordance with WHO indications, the circular states that conducting serological tests (or other types of tests) to assess the presence of antibodies should not interfere with the decision to be vaccinated.

Measures concerning vaccines that have accessed the Italian Market

On 12 March, 2021, the Italian Medicines Agency, AIFA, authorized the use of the vaccine developed by the Janssen (Johnson & Johnson group), for people aged 18 and over.

On 7th April 2021, following European Medicines Agency announcements and the AIFA committee’s evaluations on the Vaxzevria (formerly AstraZeneca) vaccine’s possible link to rare cases of unusual blood clots, the Ministry of Health issued a circular recommending this vaccine for people over 60 (since evidence shows very rare cases of thrombosis in younger people). Individuals who have already received the first dose of the Vaxzevria vaccine can complete their vaccination course with the same vaccine.

Measures concerning healthcare professionals’ role in the vaccination campaign

On 29th March 2021, the Government, the Regions, Federfarma and Assofarm signed a Memorandum of Understanding (MoU) for the administration of vaccines in pharmacies that will follow the priority criteria indicated by the Government. To administer vaccinations, pharmacists must have followed specific training programs organized by the National Health Institute. Structural requirements for premises to ensure patient safety include, for example, adequate ventilation and the ability to physically separate vaccination activities from other pharmacy activities.

Legislation on 1st April 2021 set out a national regulatory framework for the vaccination process, including rules applying to the medical indemnification of health professionals who administer vaccinations. Furthermore, vaccination is compulsory and free for all health professionals who carry out their activities in both public and private health and social health facilities, pharmacies, para-pharmacies and medical offices. Being vaccinated becomes, therefore, an essential requirement for practice, unless the professional has specific certified clinical conditions. All Professional Associations are required to send a list of their members to the Regions, so that local authorities can verify their vaccination status. Suspension of pay and of the authorization to practice will occur for non-vaccinated healthcare professionals, until the obligation is fulfilled. Employers can, however, re-assign employees to other (non-medical) tasks.

Measures concerning the logistics of administering vaccinations in Vaccination Centres

With the aim of providing a useful organizational model to support regions and municipalities in setting-up and running Vaccination Centers uniformly throughout the country, on 24th March 2021, the Department of Civil Protection released a set of non-binding guidelines, detailing organizational requirements for the ‘Extraordinary Local Vaccination Points’. First of all, existing large common areas (gyms or supermarket parking lots, for example) are to be identified and integrated with the health facilities already involved in the vaccination campaign.

With the aim of administering up to 750 vaccinations every 12 hours, vaccination centers must be open 12 hours, every day and should normally be located in areas that are easily accessible by local public transport services – and  with access for people with disabilities. It will be necessary to have well-defined paths for acceptance, administration and post-immunization observation with adequate personnel, ensuring timings of 10 minutes from entry to vaccination and 15 minutes for post-vaccination observation. There are 3 types of Vaccination Points, according to structural and functional requisites: two of the stationery types differ in size and capacity but both must be open 2 hours a day, 7 days a week. Mobile Vaccination Points must operate 8 hours a day, 7 days a week. They can be structures such as mobile units or tents, which are close to public spaces and have access to toilets

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/
- https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2021&codLeg=79033&parte=1%20&serie=null
- https://www.epicentro.iss.it/vaccini/covid-19-vaccino-janssen
- https://www.governo.it/it/articolo/comunicato-stampa-del-consiglio-dei-ministri-n-10/16525
- https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=94204
- https://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=94110
- https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2021&codLeg=79629&parte=1%20&serie=null Ministry of health circular

On 1st March 2020 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