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Take-Home Messages from the COVID-19 Pandemic: Strengths
and Pitfalls of the Italian National Health Service from a
Medico-Legal Point of View
Matteo Bolcato 1, * , Marco Trabucco Aurilio 2, Anna Aprile 1, Giulio Di Mizio 3, Bruno Della Pietra 4and
Alessandro Feola 4
Citation: Bolcato, M.; Aurilio, M.T.;
Aprile, A.; Di Mizio, G.; Della Pietra,
B.; Feola, A. Take-Home Messages
from the COVID-19 Pandemic:
Strengths and Pitfalls of the Italian
National Health Service from a
Medico-Legal Point of View.
Healthcare 2021,9, 17. https://
Received: 24 November 2020
Accepted: 22 December 2020
Published: 25 December 2020
Publisher’s Note: MDPI stays neu-
tral with regard to jurisdictional claims
in published maps and institutional
Copyright: © 2020 by the authors. Li-
censeeMDPI, Basel, Switzerland. This
articleis an open accessarticle distributed
under the terms and conditions of the
Creative CommonsAttribution (CCBY)
1Legal Medicine, Department of Molecular Medicine, University of Padua, 35121 Padova, Italy;
2Department of Medicine and Health Sciences “V. Tiberio”, University of Molise, 86100 Campobasso, Italy;
3Forensic Medicine, Department of Law, “Magna Graecia” University of Catanzaro, 88100 Catanzaro, Italy;
4Department Experimental Medicine, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy;
email@example.com (B.D.P.); firstname.lastname@example.org (A.F.)
*Correspondence: email@example.com; Tel.: +39-081-778-316
The World Health Organization (WHO) declared the outbreak of the Coronavirus disease-
2019 (COVID-19) infection a pandemic on 11 March 2020. As of the end of October 2020, there were
50 million cases of infection and over one million deaths recorded worldwide, over 45,000 of which
occurred in Italy. In Italy, the demand for intensive care over the course of this pandemic crisis has
been exceptionally high, resulting in a severe imbalance between the demand for and availability
of the necessary resources. This paper focuses on elements of preventive medicine and medical
treatments in emergency and non-emergency situations which, based on the international scientiﬁc
literature, may prove to be useful to physicians on a behavioral level and avert professional liability
problems. In order to achieve this objective, we have performed a search on MEDLINE to ﬁnd
published articles related to the risks associated with the pandemic that contain useful suggestions
and strategies for mitigating risks and protecting the safety of the population. The results have been
collocated in line with these speciﬁc study areas.
COVID-19; medical liability; ethics; medico-legal evaluation; patient blood management;
clinical risk management
The World Health Organization (WHO) declared the outbreak of the Coronavirus
disease-2019 (COVID-19) infection a pandemic on 11 March 2020. The infection can cause
severe respiratory insufﬁciency, sometimes requiring hospitalization in an intensive care
unit (ICU) in order to provide invasive ventilatory support [
]. The outcome may be
fatal, despite the use of considerable professional and economic resources, equipment,
and facilities, especially in older patients and with the development of acute respiratory
distress syndrome (ARDS). In one particular cohort of 1591 patients admitted to ICU in
Lombardy between 20 February and 18 March 2020, the mortality rate was 26% [
pandemic has attacked and, in many cases, deeply unsettled various aspects of our view
of and relationship with life, society, and rights, raising critical issues and limitations that
were previously believed to have been totally overcome. Nevertheless, Italy recognizes
and guarantees every individual the protection of fundamental rights, including the right
to health (Article 32 of the Constitution), the right to safety (Article 16), and the right
to personal freedom (Article 13). In addition, the Italian legal system contains various
Healthcare 2021,9, 17. https://dx.doi.org/10.3390/healthcare9010017 https://www.mdpi.com/journal/healthcare
Healthcare 2021,9, 17 2 of 13
provisions detailing how to avail oneself of these rights, including the right to refuse
medical assistance, even if the purpose is to prolong life [3–7].
Despite efforts on hospital and national levels to raise the quality and efﬁcacy of
healthcare, the demand for intensive care over the course of this pandemic crisis has been
exceptionally high, resulting in a severe imbalance between the demand for and availability
of the necessary resources. This situation has raised unprecedented dilemmas and situa-
], which the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive
Care (SIAARTI) addressed in a document entitled: “Clinical ethics recommendations for
the allocation and suspension of intensive care treatments in exceptional, resource-limited
]. This document provides a concrete analysis of the issue which involves
a complex and detailed procedure. It also proposes a method for the ethical-scientiﬁc
evaluation of ICU admission criteria, described by the various healthcare professionals and
operators involved .
Furthermore, to stem the spread and severity of the pandemic, national and European
authorities issued numerous emergency provisions of a logistical and economic nature to
suspend production activities and movement, including a general lockdown on economic
and social activities that lasted until the beginning of May 2020 [
]. Thereafter began a new
phase of coexistence with the virus in circulation with protection measures in place mostly
consisting of personal hygiene, protection of airways using masks, and social distancing.
As of the end of October 2020, there were 50 million cases of infection and over one
million deaths recorded worldwide, over 45,000 of which occurred in Italy [12,13].
The epidemiological situation in Italy seems to be relatively under control, despite the
slight and continual increase in cases of infection.
New and signiﬁcant challenges have emerged due to the need to coexist with the
virus until a sufﬁcient population immunity threshold has been reached, primarily through
vaccination. This paper focuses on elements of preventive medicine and medical treatments
in emergency and non-emergency situations which, based on the international scientiﬁc
literature, may prove to be useful to physicians on a behavioral level and avert professional
liability problems. Furthermore, as part of this literature review, we have analyzed articles
that contain recommendations of strategies and conduct to mitigate pandemic-related risks
and to protect the population.
2. Materials and Methods
We searched for all articles written in English in the literature available on MEDLINE
in the last year until 31 October 2020 using the following search terms: “medical liability
SARS-CoV-2,” “medical liability COVID-19,” “medical liability pandemic,” “malpractice
SARS-CoV-2,” “malpractice COVID-19,” “medico-legal litigation SARS-CoV-2,” “medico-
legal litigation COVID-19,” “liability claims SARS-CoV-2,” and “liability claims COVID-19.”
The objective of this review is to concentrate on articles and documents that contain useful
information on prevention techniques for containing dissemination and contamination
within the broader program of clinical risk management. We included only articles available
in the literature that contain information concerning pandemic-related situations of risk and
that recommend the implementation of speciﬁc activities designed to mitigate these risks
and facilitate the proper operation of strategic sectors to protect the population. Articles
that contained merely clinical or microbiological indications regarding the nature and
characteristics of the virus were excluded. All sources were evaluated independently by
two of the authors to determine their relevance to the present study and then selected for
inclusion by all the authors.
Using the above search strings, MEDLINE produced 53 results that the authors
considered relevant to the study in that they contain useful information for the prevention
of adverse events despite the persistence of the pandemic. Details of the documents
Healthcare 2021,9, 17 3 of 13
analyzed and excluded are displayed in PRISM format in Figure 1. In order to facilitate
comprehension of the text, we have collocated the results according to the speciﬁc study
areas and reviewed them in a paragraphical narrative.
Healthcare 2021, 9, x 3 of 13
Using the above search strings, MEDLINE produced 53 results that the authors
considered relevant to the study in that they contain useful information for the preven-
tion of adverse events despite the persistence of the pandemic. Details of the documents
analyzed and excluded are displayed in PRISM format in Figure 1. In order to facilitate
comprehension of the text, we have collocated the results according to the specific study
areas and reviewed them in a paragraphical narrative.
Figure 1. Flowchart depicting the choice of studies.
3.1. Healthcare and Safety of Care
In the course of a pandemic, reaching a high level of care safety [14,15] may prove to
be a complex challenge . It is clear that healthcare professionals have concerns re-
garding professional liability disputes that arise due to pandemic-related issues [17–19].
During this particular pandemic, several countries have contemplated creating a legal
shield that limits the professional liability of healthcare personnel throughout this
emergency situation [20,21]. More specifically, in March 2020, pending the approval of
the Cura Italia Decree, certain amendments were issued stipulating that a healthcare
worker shall be held liable only if the alleged harm caused to the patient is caused di-
rectly by malicious misconduct or gross negligence, where gross negligence represents an
unjustified violation of the basic principles that govern the healthcare profession or of
any emergency protocols established to handle the situation [22–26]. Furthermore, it was
feared that various profiles of liability may ensue in connection with the following sce-
(a) Lack of or reduced ability to care for and treat infected patients due to the insuffi-
ciency of available resources, which has contributed to causing harm or patient
(b) Harm to or death of patients not infected by COVID-19 but affected by ingravescent
diseases (e.g., tumors or cardiopathy) indirectly caused by the pandemic, the reduc-
Figure 1. Flowchart depicting the choice of studies.
3.1. Healthcare and Safety of Care
In the course of a pandemic, reaching a high level of care safety [
] may prove to be
a complex challenge [
]. It is clear that healthcare professionals have concerns regarding
professional liability disputes that arise due to pandemic-related issues [
this particular pandemic, several countries have contemplated creating a legal shield
that limits the professional liability of healthcare personnel throughout this emergency
]. More speciﬁcally, in March 2020, pending the approval of the Cura Italia
Decree, certain amendments were issued stipulating that a healthcare worker shall be
held liable only if the alleged harm caused to the patient is caused directly by malicious
misconduct or gross negligence, where gross negligence represents an unjustiﬁed violation
of the basic principles that govern the healthcare profession or of any emergency protocols
established to handle the situation [
]. Furthermore, it was feared that various proﬁles
of liability may ensue in connection with the following scenarios:
(a) Lack of or reduced ability to care for and treat infected patients due to the insufﬁciency
of available resources, which has contributed to causing harm or patient death.
Harm to or death of patients not infected by COVID-19 but affected by ingravescent
diseases (e.g., tumors or cardiopathy) indirectly caused by the pandemic, the reduction
Healthcare 2021,9, 17 4 of 13
of available healthcare resources, or the cessation of medical activities pertaining to
non-pandemic-related inﬁrmities preventing access to adequate, timely care.
(c) Patient infection within hospitals or residential facilities used as shelters due to failure
to observe prevention recommendations and protocols.
(d) Infection and consequent harm to or death of employees in ill-prepared companies, or
more likely, hospitals and residential care homes that lack adequate safety equipment.
Harm to or death of patients infected with COVID-19 and treated with experimental
or off-label drugs.
Before analyzing each of the hypothetical proﬁles listed above, it is worth remember-
ing that from a general point of view the Italian legal system, even without speciﬁc liability
exemption laws, contains certain important institutions that relate to this situation. Regard-
less of the speciﬁc liability proﬁle envisaged, the fact that there is no scientiﬁc evidence
available regarding the nature, transmissibility, and treatment for the SARS-CoV-2 infection
necessitates careful consideration. At the time this document was drafted and even less
so towards the beginning of the epidemic, there were no guidelines or recommendation
documents based on solid evidence that could provide reasoned and speciﬁc direction to
guide medical decisions. In effect, with no covering laws, this meant extreme difﬁculty in
delineating either proper or censurable conduct with scientiﬁc certainty.
The second aspect of interest concerns the effect a substantial lack of hospital resources
has on the decisions made by individual operators, liability for which in no way attributable
to the operator personally but to institutional decision-makers. This is a particularly
signiﬁcant factor in criminal proceedings where liability is necessarily attributed to a
The proﬁle of liability described in point (a), where an individual operator is unable
to administer life-saving treatment due to insufﬁcient resources [
], represents the
legal scenario of inability to perform a service for reasons not attributable to the healthcare
professional. The professional would therefore be exempted from any compensation
obligation pursuant to Articles 1218 and 1256 of the civil code. These laws are more easily
applied within the context of personal liability as opposed to the liability of facilities,
which are obliged to demonstrate their inability to fulﬁll their duties due to (objectively)
unpredictable and unavoidable causes [
], to a crisis and to an inability to ensure the
standard of care previously delivered [
]. To that end, Article 2236 of the civil code may
be invoked, which sanctions that “If performing the service requires the solution to particularly
difﬁcult technical problems, the service provider is not liable for damages in the absence of malicious
misconduct or gross negligence.” According to some authors, this provision could serve as
an initial shield against possible attacks, especially if brought for speculative purposes.
Furthermore, the provision set forth in Article 9 of Law No. 24/2017 on recourse states: “In
order to quantify damages, with the exception of the provisions set forth in Law No. 20, 14 January
1994, Art. 1 (1b) and Art. 52 (2) of the consolidated act referred to in Royal Decree No. 1214, 12
July 1934, particularly difﬁcult situations, including those of an organizational nature, that affect
public health or social care facilities in which healthcare professionals operate must be taken into
. . .
).” Although said provision refers to recourse claims, it is clear that it also
implies that certain organizational difﬁculties may enable the quantum of compensation to
be regulated. The epidemic that has developed in Italy can without doubt be classiﬁed as a
medical, scientiﬁc, and organizational situation of exceptional difﬁculty.
In light of these provisions, although an ad hoc law to limit professional medical
liability may not seem necessary, high-level legal assessment and medico-legal abilities [
compliant with the methodological and scientiﬁc precision required [37,38], are essential.
3.2. Future of the Healthcare System
However, there is still the issue of liability for the decisions of those who have caused
the national situation of general unpreparedness and the constant reduction of social and
public healthcare services by failing to implement policies that foresee both developing and
unanticipated exigencies and situations. Such shortsightedness, the reasons and associated
Healthcare 2021,9, 17 5 of 13
liability for which shall be analyzed, has not only led to a failure to safeguard human
dignity, given in many cases it is impossible to allocate adequate treatment resources to
some patients, but also, no less dramatically, to healthcare professionals being obliged to
implement decisions they would never have wanted to implement.
Though this situation has deﬁned the initial stages of the pandemic, it cannot be
allowed to become the norm in future crisis stages. For that reason, regional and national
initiatives must be activated to increase available therapeutic resources in preparation for a
further rise in demand. Such an increase may require action on three levels: (1) intensive
care, (2) internal medicine, and (3) community care.
As regards the ﬁrst level, national institutions have made signiﬁcant contributions in
the past few months. Prior to the pandemic (2017), there were 5090 intensive care spaces
available in Italy (8.42 per 100,000 inhabitants) [
], whereas the Ministry of Health is
currently aiming to reach 8500 spaces by October. This increase may serve to prevent
situations where a number of patients have no access to intensive care and the potential
medical, social, and legal repercussions. These statistics are calculated on a national basis,
but, as was noted in the ﬁrst wave in March and April 2020, the pandemic did not affect all
areas of the country with equal intensity [
]. Although the Italian National Health Service
is organized on a regional basis, active and effective cooperation between all regions is
essential in order to put available resources to the most effective use on a national level.
Treatment during the pandemic has required not only intensive care unit admission
but also considerable assistance from entire medical and surgical departments, which have
been transformed into reception areas for infected patients. This inﬂux of patients has had
two basic effects: (1) interruption of surgical care and treatment of other diseases that do
not require urgent intervention, and (2) ﬁlling departments with infected patients
This has affected certain geographical areas more than others and involved assisting and
treating many patients. However, in the event the pandemic were to place a further
substantial burden on the health service, employing the same measures as were adopted a
few months ago is not an option in that it is not feasible, due to public health and ethical-
legal liability concerns as regards sick patients, especially the chronically ill, to impose
another substantial suspension on ordinary activities [45–47].
With respect to point (b), in order to prevent this legal scenario, home medical care
services for patients infected with COVID-19 who do not need hospital or intensive care
will have to be enhanced. This approach has been incentivized through the extensive hiring
of healthcare personnel for community care, especially nurses, who can provide support
to sick people and their families in isolation at their homes or in designated facilities to
prevent the spread of infection and enable full physical recovery. It will also prevent
hospital congestion and facilitate the normal practice of non-pandemic-related medical
and surgical services [
]. This level of organization requires action on two fronts: (1)
application of strict protocols to ensure patient safety, and (2) implementation of systemic
strategies for handling acute shortages.
As regards point (1), accurate assessments of patient conditions are essential so as to
decide whether to hospitalize or whether home care would be sufﬁcient. This assessment
should be carried out by trained medical personnel and subjected to periodic reviews by
means of remote monitoring systems so that if the situation were to deteriorate, the patient
could be hospitalized in time and, if necessary, admitted to intensive care [
shared operating protocols are needed both to assist practitioners and to integrate models
of conduct to prevent professional and organizational liability implications.
3.3. Patient Blood Management
In relation to point (2), plans and strategies to manage severe crisis situations must
be formulated on an institutional level, even when resources are available, making full
use of all the options that scientiﬁc innovation presents. As a result, in times of greater
difﬁculty, all available technical solutions can be utilized to ensure the continuity of es-
sential medical-surgical activities and to develop not only logistical and economic but
Healthcare 2021,9, 17 6 of 13
also scientiﬁc responses to crises. An example of the type of proactivity needed to ensure
such continuity during emergency situations would be the proper management of blood
resources. Maintaining adequate supplies of safe blood in order to guarantee the execution
of necessary surgical procedures or other medical activities can prove to be particularly
difﬁcult in emergency situations, especially epidemics. In the ﬁrst few months of the
pandemic, many countries [
], including Italy [
], experienced a consistent decrease
in donations and, therefore, in the availability of hematic products. Although to date
there is no evidence to suggest the possibility of virus transmission through blood from
symptomatic individuals, the shortage is due to the greater difﬁculty in travel, the risks
associated with congregating in donation centers, and a higher percentage of the popu-
lation that is potentially infected and unable to donate. This decrease has not produced
devastating consequences on the population and on medical activities, since the decision
to postpone non-urgent surgeries was taken simultaneously and, therefore, the demand for
hematic products decreased considerably [
]. Nevertheless, this new-found balance
cannot be maintained; routine activities cannot be interrupted again at the expense of
public health. A systematic, proactive, and organized approach is needed to meet this type
of demand such as patient blood management (PBM).
PBM is a multidisciplinary, multimodal approach adopted to limit or eliminate the
need for allogenic blood transfusions through evidence-based management of anemia,
blood loss reduction, and optimization of blood salvage strategies [
]. This approach
comprises over 100 methods and activities with the aim of optimizing the use of the
patient’s blood instead of resorting to allogenic blood transfusions [
]. In addition to
reducing transfusion risks [
], PBM is also proving instrumental in applying the law on
patient safety in Italy [
]. It does, however, necessitate consistent and systemic planning
and management if it is to be a dependable resource in times of severe crisis [62–65].
The implementation of PBM presents both a challenge and a particularly proﬁtable
opportunity in Italy and other countries with an older average population. In the years
ahead, these countries will ﬁnd themselves unable to satisfy the transfusion demand, as the
population will not be in a position to donate blood due to old age despite their potential
need to receive it. In that sense, the pandemic may accelerate the instituting of processes to
safeguard public health in addition to presenting a remarkable opportunity for economic
3.4. Residential Care Homes
With regard to point (c), in recent months there has been signiﬁcant media attention,
particularly because of the high number of deaths in residential care homes for the elderly
due to, according to critics, superﬁcial management of admissions and preventative activi-
ties to create a safe environment for the frail that occupy it [
]. It is important to state that
the prevention of respiratory infections in such contexts is particularly complex and poses
a challenge [
] on several fronts: ﬁrstly, the frailty of elderly patients in conjunction
with the scarcity of clinical manifestations which can present late and are thus difﬁcult to
detect in a timely manner. Secondly, nursing homes often lack the specialized personnel
and equipment needed to deal with acute events [
]. In emergency situations, many
residential facilities in Italy have had to treat and assist infected patients who were not
promptly hospitalized. This can easily create exposure to medico-legal litigation. Therefore,
it is imperative that risk management programs be set up in every facility in order to deal
with this pandemic effectively .
While the level of unpreparedness during the initial stages of the pandemic may have
been justiﬁable, the current situation necessitates that there be no further procrastination in
the implementation of strategies to improve care by means of early diagnosis of signs and
symptoms, the use of standard diagnostic criteria, the adoption of adequate preventive
measures, and the institution of monitoring and control systems. Such measures will
simultaneously increase the probability of optimizing results and ensure the safety of
patients and the well-being of workers [
]. Further indications include the institution
Healthcare 2021,9, 17 7 of 13
of internal coordination committees, periodic employee and patient screening programs,
careful selection of personal protective equipment (PPE), promotion of training initiatives
that all members of staff must attend as well as the necessary logistical activities for
organizing isolation and monitoring procedures.
From a medico-legal standpoint, each facility needs to prepare internal protocol
documents with clear behavioral indications for all operators, including a precise plan of
action to guarantee safe crisis management. The objective of such documents, registered
and shared with all facility personnel, is to ensure that all those concerned act responsibly
and to provide an effective, documented defense in the event of litigation [74–77].
3.5. Safety of Employees
Scenario (d) highlights the need to ensure the safety of employees, especially health-
care employees, as they are deemed at greater risk of infection. On 24 March 2020, an agree-
ment between the Italian government and representatives for companies and employees
was proposed and subsequently adopted on 24 April 2020 [
]. The main recommendations
of the agreement have been summarized in Table 1.
Main recommendations listed in the agreement between the Italian government and representatives for companies
and employees signed on the 24 March 2020.
Using the most appropriate and effective methods, the company shall
inform all employees, and any who enter the premises, of the provisions
to contain the spread of the virus and of the rules to be followed. This
information should include: the obligation to stay at home in the event of
a fever above 37.5
C, maintain safe distances, observe handwashing and
hygiene rules, and to inform one’s employer of any ﬂu-like symptoms
that appear during the work period in a timely and responsible manner.
Methods for accessing the workplace and checks
that shall be performed Measurement of body temperature, triage.
Hygiene in the workplace
The company shall ensure the daily cleaning and periodic sanitization of
workstations, common rooms/areas, and entertainment facilities. The
company shall provide appropriate handwashing detergents and
recommend frequent handwashing with soap and water. In the event a
certain work-related activity necessitates proximity between workers of
less than one meter and no other organizational solutions are available,
the use of masks and other protective equipment is mandatory.
Handling a symptomatic person in the workplace
In the event someone present in the workplace develops a fever and
symptoms of respiratory infection such as a cough, said person must
report to the personnel ofﬁce immediately and be isolated. The company
shall immediately inform the competent healthcare authorities and call
the COVID-19 emergency numbers.
Role of the occupational health physician
The doctor shall assist the company in prevention activities and
screening, if required, of employees as well as reporting potentially
The Italian government supports the implementation of these recommendations
as they promote the safety and protection of workers, forming the basis for the safety
activities that companies must adopt, including for the purposes of preventing litigation.
Healthcare personnel must be included among the category of workers who, being in
constant contact with infected patients, are at greater risk of infection. This factor was
particularly highlighted during the initial weeks of the epidemic due to the severe shortage
of PPE. This brings to mind the high number [
] of physicians who died of COVID-
19 infection and the National Institute for Insurance against Accidents at Work (INAIL)
declaration in favor of compensating those affected .
Finally, as far as liability in the event of harm or death caused by the use of experi-
mental or off-label drugs is concerned, Italian law permits and delimits their usage (Law
Healthcare 2021,9, 17 8 of 13
No. 94/98). Despite the fact that the use of off-label drugs may expose a patient to potential
risks, in the speciﬁc context of the pandemic—considering the scarce knowledge of the
virus’ mechanism of action and target organs—physicians must show greater prudence in
resorting to such drugs. Evaluations of proper conduct shall take into account the speciﬁcs
of the case, the severity of the patient’s clinical manifestations, the nature of the drug,
known contraindications, veriﬁed side effects, and the dosage administered.
3.6. Administration of Justice and Scientiﬁc Research
Since the beginning of the year, Italy has experienced a lockdown that is even more
dangerous from a social viewpoint—that of the justice system. Particularly, the justice
system has been paralyzed and come to a standstill with the exception of cases of extreme
urgency and gravity. This has caused a series of problems with regard to maintaining the
country’s social and economic system. The motive for the lockdown is the fear of potential
infection in courtrooms and of court employees. However, as things stand, the justice
system must be reactivated as soon as possible in order to prevent further delays in the
country’s economic activities. To do so safely, courts can take advantage of all the available
technological and organizational resources at their disposal, e.g., videoconferencing sys-
tems, certiﬁed electronic signatures, and remote access to judicial archives [
]. In so doing,
the justice system will see that the majority of the activities in its remit can be performed
using IT systems.
Equally important, to provide an adequate response to major emergencies, particularly
to epidemics of mostly unknown infectious agents, it is essential to seek the input of
all scientiﬁc disciplines, especially that of legal medicine. In this regard, it is useful to
reiterate the value of autopsies from a legal and, more importantly, scientiﬁc and clinical
point of view in identifying causes of death and in contributing to the reconstruction of
physiopathological pathways that lead to death. This approach may provide determining
scientiﬁc information to ﬁnd possible therapeutic options that would otherwise have been
impossible to obtain [
]. In order to do that, methodology and adherence to strict
protocols in all analyses and activities are required .
Ultimately, Italy must adopt a proactive mentality towards these and other crises if it
is to be prepared and scientiﬁcally equipped to handle future major emergencies.
The COVID-19 pandemic has highlighted several pitfalls in the National Health Ser-
vice in Italy and, more generally, in Western countries that have had to handle and ﬁnd
extemporaneous solutions to this unforeseen event (e.g., temporary recruitment of physi-
cians and nurses, construction of new departments and even new hospitals, adaptation of
existing facilities, and procurement of PPE). As a result, the health services have been faced
with ethical dilemmas such as deciding who to treat considering the shortage of resources
and inability to ensure all patients receive the necessary intensive care treatment [
dilemmas which Western–particularly the Italian–health services did not envisage having
to face again. In that sense, having a clear understanding of the ethical principles that
govern medical actions means distributive justice, nonmaleﬁcence, respect for patient
autonomy and dignity regardless of their degree of vulnerability, and conﬁdentiality of
medical data in order to make the most appropriate decisions for patients [87,88].
Initially, public opinion was in favor of instituting a legal shield to protect physicians,
but the provision encountered numerous obstacles, abroad as well as in Italy, and to date
has not been approved. Clariﬁcation is necessary since it is proper to safeguard healthcare
professionals who have been forced to serve in dramatic conditions (shortage of PPE, lack
of knowledge regarding the etiopathogenesis of the infection, lack of tried-and-tested
treatments) but also to recognize organizational and medical ﬂaws that have de facto
exacerbated the situation.
The current pandemic has led to profound changes in the lives of individuals and
healthcare professionals, brought to light weaknesses in the more developed health services,
Healthcare 2021,9, 17 9 of 13
and called into question many healthcare policy decisions that have been made in recent
decades. There are obvious limits to this study as many articles have been published in
recent months and, therefore, offering a complete and up-to-date review of the literature
presents a challenge. Although not all areas of pandemic-related risks can be mentioned,
this article has analyzed and explored strategies for mitigating risks associated with the
dissemination of the infection in various key sectors in the administration of public services
for immediate application. In addition, it has highlighted programs that may aid the
National Health Service such as PBM, particularly important in Western countries with an
aged population. Some countries have already implemented praiseworthy organizational
strategies: for example, Australia has put in place an extensive PBM program, such that has
facilitated a 60% reduction in the use of red blood cells [
]. These results show that from
a medical point of view, some countries are more prepared than Italy to handle a major
emergency. It must be said, however, that other European countries have encountered
similar problems to Italy .
In addition to all the issues discussed in this article, the future will present other issues
in connection with the development of a vaccine. It seems that at least one vaccine will be
available from January 2021 and nationwide distribution will soon commence. This may
create further problems in that the probability of procuring sufﬁcient doses for the entire
population is remote, meaning difﬁcult decisions will need to be made in terms of who
to prioritize. Moreover, additional vaccines may become available in the coming months,
resulting in a diversiﬁed vaccination campaign due to the particular characteristics of each
product in terms of efﬁcacy and protection time. The health authorities will need to weigh
these elements carefully, providing full decisional transparency. The public should also be
apprised of these decisions by means of an information campaign in order to maximize
voluntary participation in the vaccination drive.
Conceptualization, M.B., M.T.A., A.F.; writing—original draft preparation,
M.B., M.T.A., A.F.; writing—review and editing, A.A., G.D.M., B.D.P.; supervision, A.A., G.D.M.,
B.D.P. All authors have read and agreed to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.
Data Availability Statement:
The datasets used during the current study are available from the
corresponding author upon reasonable request.
Conﬂicts of Interest:
The authors declare that they have no competing interests.The authors declare
no conﬂict of interest.
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