Policy responses for Italy - HSRM


Policy responses for Italy

1.3 Isolation and quarantine

On 18th June 2020, an extraordinary administrative act amended Law Decree n° 33 of 16 May, by introducing the so-called “soft quarantine” for football players. The Ministry of Youth Policies and Sports has allowed an exception to isolation and quarantine rules for professional football players. “Soft quarantine” was proposed by the Italian Football Federation (FIGC) with the endorsement of the Scientific Technical Committee and, in the event of a positive player, imposes isolation of the case with a mandatory rapid test for all the other members of the team, to allow those who test negative to take part in the game and a return to isolation at the end of the match.

With the second wave of the pandemic, the government has recognized that it is not possible to sustain the isolation measures that have been imposed on the general population up to now (see Section 1.3 Isolation and quarantine in the main entry); prolonged isolation of large parts of the population is found to be practically impossible and unethical (Alwan et al, 2020). Circular no. 32850 of 12 October 2020 of the Ministry of Health has provided new updates regarding indications for isolation and quarantine.

• Firstly, positive asymptomatic individuals are authorized to return to everyday life after at least 10 days of isolation from the confirmaton of their positivity, at the end of which they must test negative through a molecular swab (10 days + test).

• Secondly, positive symptomatic cases can return to everyday life after at least 10 days of isolation from the onset of symptoms (except for anosmia and ageusia /dysgeusia which have been known to be persistent over time), including at least three days without symptoms, and the execution of a molecular test with negative outcome (10 days, of which at least 3 days without symptoms + test).

• Lastly, so-called ‘long-term positive’ cases, meaning people who, although no longer symptomatic (except for anosmia and ageusia /dysgeusia) keep testing positive for at least one week, will be released from isolation after 21 days from the onset of symptoms. Health authorities, in agreement with clinicians, microbiologists or virologists, may readapt such terms for immunosuppressed patients, in which case the period of contagiousness may be longer.

Furthermore, asymptomatic close contacts of positive cases should:
• quarantine for 14 days from their last exposure to the case;
• quarantine for 10 days from last exposure and undergo an antigen or molecular test on the tenth day.

- https://www.repubblica.it/sport/calcio/serie-a/2020/06/18/news/quarantena_soft_approvata_ministero-259598325/ 
- http://1.flcgil.stgy.it/files/pdf/20201013/circolare-ministero-della-salute-32850-del-12-ottobre-2020-covid-19-indicazioni-per-la-durata-ed-il-termine-dell-isolamento-e-della-quarantena.pdf 

Isolation is imposed upon those who have tested positive to COVID-19 but do not require hospitalization and to those who have had contact with somebody who has tested positive, to inhibit the transmission of SARS-CoV-2 and avoid overloading the hospital system.

Domiciliary confinement is mandatory for all COVID-19 cases and lasts till the subject is declared recovered and no longer contagious after testing negative in two sequential SARS-CoV-2 RT-PCR tests, conducted at a distance of 24 hours. It must last a total of 14 days for those who have had close contact with a positive case, even if they are asymptomatic.
Isolation may, however, take place in a dedicated facility outside the home if necessary.
Those who have had close contact and exhibit light symptoms must be tested. If they test positive, they must remain in quarantine until tested negative and symptoms disappear; those with a negative result must stay in quarantine for 14 days from their last contact with the case. However, if the symptoms clearly suggest a Covid-19 diagnosis, it is recommended to repeat the test at different time and from a different respiratory tract. Since the end of May, the Minister of Health suggests to test the close contacts at the end of the quarantine even if they remained asymptomatic for all the duration of their isolation.

Public Health Operators (PHOs) are assigned to each quarantined case and are in charge of providing face masks, monitoring patients’ health conditions through regular phone calls, and collaborating with local General Practitioners (GPs) in case management.  The PHO is requested to inform patients about measures to avoid infecting cohabitees and ensure they measure body temperature twice a day. The GP activates emergency services and evaluates the relevance of symptoms even, if necessary, through in-home visits. The subject must stay in a dedicated room of the house with adequate ventilation and possibly a dedicated bathroom. S/he must sleep alone and limit movement to other areas of the house where there are other people. If there is only one bathroom, it must be cleaned with products containing chlorine or alcohol. An interpersonal distance of at least one metre must be maintained and no physical contact can take place, except for breastfeeding mothers. Kitchen utensils may be washed with normal soap and waste must be disposed of in an impermeable bag. All surfaces used by the isolated subject must be cleaned with detergents and disinfected (chlorine or alcohol) and the person involved must wear a disposable coat and gloves. Laundry must be washed separately from the rest of the family’s. In case of difficulty breathing, the subject must call 112 or 118 and, if possible, inform their GP.

Isolation and quarantine have been supported by means of numerous digital tools such as mobile apps or Web platforms. So far, none of these has been imposed upon the population as usage and adherence are completely voluntary. Due to the multiplicity of available services, we report and describe the 5 digital solutions selected at Central Government level after the “Fast Call for technologies to combat the spread of Covid-19” (please refer to section 5.1 Governance for further details about the call for proposals).

1. LazioDrCovid
The Lazio Region has launched the LazioDrCovid app to create a simple, quick and safe access to health care services for people who are probable or confirmed positives. It is addressed to all citizens of the region who:
• Manifest Covid-19 related symptoms
• Wish to get in touch with their family doctor remotely
• Have come into close contact with positive people
• Are included in the surveillance program of their Local Health Unit

Users fill-in questionnaires provided by the app regarding symptoms, body temperature and, for those who have tested positive, specific parameters that can be measured through user-friendly devices delivered to patients when diagnosed. The app collects such data and delivers it to healthcare professionals that monitor the health status of isolated patients, also activating home care services if necessary.For positive cases, the app activates an entire system of remote management by directly contacting GPs, local health authorities and specialists, along the entire cycle of care.

2. Co4Covid-19
Co4Covid-19, created by the Florentine company Dedalus, is an app that allows screening of the population, manage cases, carry out real-time surveillance of Covid-19 patients in quarantine or isolation and manage chronic patients, by maintaining direct communication between citizens and doctors. The tool has several features such as:

• Alert and reminder generators
• Tutorials
• A personal diary
• Chats and chatbots
• Virtual rooms to allow multi-professional collaborations
• Telemonitoring systems supported by specific kits for the registration of parameters
• A WebApp to provide pre-triage and clinical self-assessment questionnaires during quarantine or isolation.
• Remote consultation services, including psychological support

All information is stored in a clinical repository and made available to an Operational Centre.
Citizens register by filling in a questionnaire with details about their health and some personal information. After registration, information is sent via text messages and through the dedicated Web App. When necessary, the Co4Covid-19 activates the request for a diagnostic swab.

3. Axistance Covid-19 Control
Developed by ENEL X Italia, this app can be used by public health facilities and GPs to monitor the health status of patients and their families. Remote monitoring - conducted by users or by a health worker remotely – can occur for a series of vital parameters for the management of Covid-19 and also for chronic diseases.
The app allows for measurements (e.g. body temperature, saturation) to be uploaded either manually or automatically, from biomedical devices connected Via Bluetooth or Near Field Communication (NFC) technology. It also generates reminders, enables video consultations, and provides questionnaires and latest news. Users can interact with an integrated chatbot and the "Symptoms Checker", based on AI, supports diagnoses.

4. Ticuro Reply
Ticuro Reply, by Reply S.p.A., collects vital parameters via medical devices or manual insertion and is based on the Internet of Things and Big Data. It enables remote, personalized, continuous and real-time assistance and monitoring, allowing professionals to maintain interactive communication with their patients and their family units. It is a platform able to integrate over 50 devices (Computers, smartphones, smartwatches and medical devices) for each user. The gathered data is inserted into clinical diaries and alerts are automatically generated when the system detects abnormal values, established according to thresholds set by physicians. Patients can contact their doctors via audio and video calls or even chats, sharing documents and accessing their clinical diary when needed. In fact, a virtual pharmacological diary, daily activity plans, video tutorials and interactive questionnaires support the entire process.

5. eLifeCare Covid-19
The eLife-care Telemedicine Platform for Covid-19, by Exprivia Spa, is a smartphone app available for both iOS and Android, specifically configured for remotely assisting patients with Covid-19 in home isolation or quarantine. It acquires and monitors vital parameters such as body temperature, saturation and heartbeat, sending out alerts in case of critical values.
In fact, it enables communication between an Operational Centre, healthcare professionals and patients via the following features:

• Audio or Video calls and live chat between patients, the Operational Centre and attending physicians;
• Consultations regarding treatment plans between professionals;
• Alerts in case of failed compliance to treatment plans;
• Measurement and acquisition of vital signs relative to Covid-19;
• Tutorials to support individuals in using the app and its integrated devices;
• Guided self-assessment questionnaires;
• Real-time data sharing with patients’ GP and the Local Hygiene and Public Health Unit (SISP) via smartphones and safe two-way text-audio communications;
• Insertion and graphic display of vital parameter trends acquired via self-recorded measurements;
• Calendar with sound and visual alerts for medical instructions.

Measures directed at special confined populations

On 3rd April, the first case of a prison inmate dying of Covid-19 was recorded. Italian jails currently house 58 000 prisoners, exceeding the total capacity of 47 000 places. Due to this overcrowding, which cannot guarantee social distancing, the government has, up to April 7th, placed 3 000 prisoners under home detention.

The Parliamentary Intergroup for Rare Diseases has called to action several associations caring for people with rare diseases and requested the enhancement and broadening of home therapy services across the whole country (previously only available in some regions) with the dual aim of saving this special category of patients from having to enter hospital facilities and lightening the burden on the national healthcare system. For example, some pharmaceutical companies such as Takeda and Sobi are providing free home deliveries of pharmaceuticals and treatments for people suffering from haemophilia, lysosomal storage disease, immuno-deficiency or hereditary angioedema.

On 11th March, the Italian Medicine Agency (AIFA) communicated a transitional provision extending the validity of Therapeutical Plans expiring in March or April for 90 days, starting from the expiry date, to minimize the inflow of elderly, chronic or higher risk patients to healthcare facilities to request the renewal of such plans.

A free 24/7 service, provided by the Red Cross, for the delivery of pharmaceuticals, is available nationally. After receiving a phone call for help, volunteers in uniform collect prescriptions from GPs and specialists and, using the person’s fiscal code, purchase the medicines at the closest pharmacy and deliver it in a sealed container to the person who then refunds the volunteer. Similarly, elderly and frail people living alone can ask for their groceries to be delivered for free. Novartis is providing free pharmaceutical delivery service for cancer patients treated with the company’s medicines at home.

Vulnerable population/migrants

A special order was issued on April 12th by the Civil protection to give healthcare assistance to migrants rescued in the Mediterranean sea. This followed the arrival on the Italian shores of a small group of migrants of which a few were found to be Covid-19 positive. Special locations (ground centers or specially equipped ships) will be identified to ensure quarantine measures and other safety protocols can be carried out and potential cases can be monitored.
To detect and prevent the spread of COVID-19, Sicily has set up a new medical unit in the province of Siracuse, to provide basic healthcare services during the pandemic to several hundred seasonal migrant workers who accessed the island for the harvest season.

On 30th July, the National Institute for the promotion of the health of migrant populations and for the fight against the diseases of Poverty (INMP) released a set of guidelines titled “Operational indications for the management of facilities for people who are marginalized or in frail social and health conditions  during the COVID-19 epidemic”, developed in collaboration with the National Association of Italian Municipalities (Associazione Nazionale Comuni Italiani , ANCI) the National Health Institute (ISS), the Ministry of the Interior, the Presidency of the Council of Ministers, the Department of Anti-Drug Policies and the Department of Civil Protection. The report defines clear and easily applicable procedures, in line with the most recent regulations, for infection prevention and contagion containment. Moreover, it provides risk assessments the several different contexts in which these population groups find themselves, considering different types of facilities, mobility and the various health or demographic profile of residents. The recommendations apply to both phases of the reception system implemented in Italy:  the first phase immediately follows disembarkation or border-crossing, in which interventions consist mostly of providing health assistance; the second phase begins once those in need are received in their reception centres, where long-term integration pathways are managed by local authorities.

Regional approaches to quarantine

Considering the different timing of the COVID19 epidemic across the Italian Regions, regional presidents/governors issued special decrees imposing quarantine on people coming from Regions or Provinces considered at higher risk. For example, following the National DPCM of 8th March 2020, which established the so-called “red-zone” in several Regions and Provinces, some Governors (e.g. in the regions of Marche, Lazio, Apulia and Calabria) ordered 14 days of voluntary isolation for people coming from the red zone. Furthermore, a regional decree of the Marche region requested 14 days of isolation for people moving from Pesaro and Urbino, which have the highest number of cases, to the other four provinces within Marche. Isolation can, however, still be interrupted by those exceptions identified by national legislation (health needs, working requirements and urgencies). 

- Gruppo di lavoro ISS Prevenzione e controllo delle Infezioni. Indicazioni ad interim per l’effettuazione dell’isolamento e della assistenza sanitaria domiciliare nell’attuale contesto COVID-19. Versione del 7 marzo 2020. Roma: Istituto Superiore di Sanità; 2020 (Rapporto ISS COVID-19, n.1/ 2020)
- https://www.osservatoriomalattierare.it/news/terapie-domiciliari/15821-covid-19-takeda-conferma-home-therapy-per-i-malati-rari-in-tutta-italia
- The Italian Medicine Agency (AIFA), 11th March 2020. “Temporary measures regarding the extension of AIFA therapeutic plans in the matter of the containment and  management of the COVID-19 epidemiological emergency” https://www.aifa.gov.it/documents/20142/1124329/comunicato_proroga_PT_AIFA_11-03-2020.pdf/4362b271-212c-7c9f-657f-979f6c34ad9a
- https://www.novartis.it/news/novartis-un%27italia-prova-di-futuro-piano-speciale-covid-19 
- http://www.protezionecivile.gov.it/amministrazione-trasparente/provvedimenti/-/content-view/view/1250434
- http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=74178&parte=1%20&serie=null
- http://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5008
- INMP 2020, Indicazioni operative ad interim per la gestione di strutture con persone ad elevata fragilità e marginalità socio-sanitaria nel quadro dell’epidemia di COVID-19 [available at: http://www.salute.gov.it/imgs/C_17_pubblicazioni_2942_allegato.pdf ]
- http://www.regione.lazio.it/rl/coronavirus/scarica-app/ 
- DPCM 7th September 2020, [Available at: http://www.governo.it/sites/new.governo.it/files/Dpcm_20200907_txt.pdf]
- https://www.enelx.com/it/it/smart-city/soluzioni/soluzioni-smart/dashboard-covid-19
- https://www.exprivia.it/it/show-info-event-full.php?id_event=6117 
- https://www.reply.com/ticuro-reply/it/ 
- https://www.01health.it/tecnologie/app/healthy-reply-ticuro-la-telemedicina-anche-mobile/ 
- https://lifestyleslow.com/2020/03/31/covid-19-in-arrivo-co4-la-app-che-interagisce-con-il-paziente/