Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy).

Introduction: Among adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immunization reported from 2020 to 2021 in Puglia, a region in the South-East of Italy with around 4 million inhabitants. Its main objective is to describe the allergic safety profile of currently employed vaccines. Materials and methods: This is a retrospective observational study. The study period spanned from January 2020 to December 2021, and the whole Apulian population was included in the study. Information regarding AEFIs reported in Puglia during the study period was gathered from the Italian Drug Authority's pharmacovigilance database (National Pharmacovigilance Network, RNF). The overall number of vaccine doses administered was extrapolated by the Apulian online immunization database (GIAVA). Reporting rates were calculated as AEFIs reported during a certain time span/number of vaccine doses administered during the same period. Results: 10,834,913 vaccine doses were administered during the study period and 95 reports of allergic AEFIs were submitted to the RNF (reporting rate 0.88/100,000 doses). 27.4% of the reported events (26/95) were classified as serious (reporting rate 0.24/100,000 doses). 68 out of 95 (71.6%) adverse events were at least partially resolved by the time of reporting and none of them resulted in the subject's death. Conclusions: Allergic reactions following vaccination were rare events, thus confirming the favourable risks/benefits ratio for currently marketed vaccines.

Digital Health Care, Telemedicine, and Medicolegal Issues in Orthopedics: A Review.

The use of technologies in medicine has great potential to reduce the costs of health care services by making appropriate decisions that provide timely patient care. The evolution of telemedicine poses a series of clinical and medicolegal considerations. However, only a few articles have dealt with telemedicine and orthopedics. This review assesses the ethical and medicolegal issues related to tele-orthopedics. A systematic review was performed including papers published between 2017 and 2021 focusing on the main medicolegal and clinical-governance aspects of tele-orthopedics. Most of the articles were published during the COVID-19 pandemic, confirming the impetus that the pandemic has also given to the spread of telemedicine in the orthopedic field. The areas of interest dealt with in the scientific evidence, almost exclusively produced in the USA, Europe, the UK, and Canada, are quality, patient satisfaction, and safety. The impact of telemedicine in orthopedics has not yet been fully evaluated and studied in terms of the potential medicolegal concerns. Most of the authors performed qualitative studies with poor consistency. Authorizations and accreditations, protection of patient confidentiality, and professional responsibility are issues that will certainly soon emerge.

THE PHON EFFECT IN THE ABANDONED MUMMIFIED

Social isolation, confinement in the domestic context up to abandonment, phenomena as serious as they are frequent in modern society, has been emphasized by the advent of the Sars-Covid19 pandemic. The authors report the case of a 39-year-old woman found lifeless and in a partial state of mummification ("hair dryer effect"), lying on her back on the bed and covered, in part, by a quilt. At the foot of the bed a hairdryer was found connected to the electrical outlet. The environmental conditions favored the initiation of special transformative putrefactive processes, such as that of mummification. Investigating a mummified body found, to determine the cause and manner of death, can be difficult for the forensic pathologist. For the definition of the time of death we generally use the degree of evolution ofpostmortal transformative phenomena which, as we move away from the moment of death, offer less and less possibilities to delimit this period within narrow time limits, especially when these phenomena are strongly affected by the environmental factors in the context of which the corpse has stayed, as occurred in the present case. A careful analysis of the places where the death occurred and the circumstantial data possibly available to the coroner can provide useful data for the proper assessment of the case. The reporting of this event must be considered an important isolated case study for the analysis of the mummification process, as well as a warning light on an increasingly widespread social problem.

COVID-19 Vaccination in Italian Children: The Limits of Parental Rights.

SARS-CoV-2 vaccination campaigns initially targeted the adult population. After the authorization of the main agencies, including the EMA (European Medicines Agency), the European Vaccination Plan now involves young people between the ages of 12-17 and 5-11. In assessing the child's "best interests", the refusal of vaccination by parents or guardians, in addition to the increased circulation of the virus, is responsible for the risk of social distancing. This reduction in social contacts, particularly during very sensitive ages such as adolescence, has been linked to the increased incidence of psychiatric illness, a significant reason for extending vaccination against SARS-CoV-2 in these younger children. One may consider that government should issue a law that allows the child to decide on the vaccination plan, even without the consent of the parents or guardians, without the need for a judge's ruling. The availability of the child should be the point of reference, according to the National Bioethics Committee, for consent to vaccination. The authors investigate the subject in depth in order to counteract vaccination hesitation, and promote the dissemination of correct scientific information, using every different possible communication tool, as well as social networks and schools.

Improving Healthcare Workers' Adherence to Surgical Safety Checklist: The Impact of a Short Training.

BACKGROUND: Although surgery is essential in healthcare, a significant number of patients suffer unfair harm while undergoing surgery. Many of these originate from failures in non-technical aspects, especially communication among operators. A surgical safety checklist is a simple tool that helps to reduce surgical adverse events, but even if it is fast to fill out, its compilation is often neglected by the healthcare workers because of unprepared cultural background. The present study aims to value the efficacy of a free intervention, such as a short training about risk management and safety checklist, to improve checklist adherence. METHODS: In March 2019, the medical and nursing staff of the General Surgical Unit attended a two-lesson theoretical training concerning surgical safety and risk management tools such as the surgical safety checklist. The authors compared the completeness of the surgical checklists after and before the training, considering the same period (2 months) for both groups. RESULT: The surgical safety checklists were present in 198 cases (70.97%) before the intervention and 231 cases (96.25%) after that. After the training, the compilation adherence increased for every different type of healthcare worker of the unit (surgeons, nurses, anesthetists, and scrab nurses). Furthermore, a longer hospitalization was associated with a higher surgical checklist adherence by the operators. CONCLUSIONS: The results showed that a free and simple intervention, such as a two-lesson training, significantly stimulated the correct use of the surgical safety checklist. Moreover, the checklist adherence increased even for the operators who did not attend the training, maybe because of the positive influence of the colleagues' positive behaviors. As the results were promising with only two theoretical lessons, much more can be done to build a new safety culture in healthcare.

Imaging Appropriateness in Pediatric Radiology during COVID-19 Pandemic: A Retrospective Comparison with No COVID-19 Period.

During the COVID-19 pandemic, the number of accesses to the Pediatric Emergency Department (pED) in Italy sharply decreased by 30%. The purpose of this study is to evaluate how this novel setting impacted on management of children with trauma, and the use and appropriateness of imaging studies in such patients at the pED. All imaging studies performed in patients with trauma at the pED of a tertiary children's Hospital during the first wave of the COVID-19 pandemic (between March and May 2020) were reviewed, in comparison with a control time interval (March to May 2019). In the pre-COVID control era, 669 imaging studies documented bone fractures in 145/568 children (25.5%). In the COVID-era, 79/177 (44.6%) pediatric patients showed bone fractures on 193 imaging studies. Comparative analysis shows a 71% decrease in imaging studies, and the proportion of negative imaging studies (with no evidence of bone fractures) dropped in 2020 by 19% compared to the 2019 control era (p < 0.001). The sharp decrease of negative studies suggests that the rate of appropriateness was higher during COVID-era, suggesting some attitude toward defensive medicine in the previous control year, as a result of some degree of imaging inappropriateness. The impact of a pandemic on emergency medicine may offer a unique opportunity to revisit diagnostic and therapeutic protocols in pediatrics.

Role and Tasks of the Occupational Physician during the COVID-19 Pandemic.

Background and Objectives: The first clusters of SARS-CoV-2 infection were identified in an occupational setting, and to date, a significant portion of the cases may result from occupational exposure; thus, COVID-19 should also be considered a new occupational risk that both directly and indirectly impacts the health of workers. Given the significance of occupational-exposure-related infections and deaths, this study aims to assess the roles and tasks of occupational physicians (OPs) in countering the spread of the infection. Indeed, despite the OP's centrality in risk management in the workplace, its activity in the current epidemic context has rarely been mentioned. Materials and Methods: Three different databases (PubMed, Google Scholar, and Embase) were questioned using the main keywords "COVID-19" and "SARS-CoV-2" that were crossed, according to different needs, with the terms "occupational medicine", "occupational physician", "workplace", and "risk assessment" using, when possible, the MeSH database research. Additionally, a systematic research of the regulatory changes of workplaces health surveillance was performed on reference sites of international, European, and Italian authorities. Results: Fundamental tasks and duties of OPs in the current COVID-19 outbreak are highlighted by examining their clinical activity and technical action. A risk assessment and management workflow is proposed, and medico-legal implications in case of infection at work are also discussed in the light of recent regulatory changes that clearly attribute to OPs an important role in safeguarding public health. Conclusion: The proposed approach can provide new instruments to contrast the spread of the infection as part of a comprehensive system response to the current pandemic, for which OPs are called to assume full responsibility.

Post-mortem persistence of SARS-CoV-2: a preliminary study.

Since the beginning of March 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has been the cause of millions of deaths worldwide. The need to better define the pathogenesis of coronavirus disease 19 (Covid-19) as well as to provide the correct statistical records concerning deaths related to this virus, inevitably involves the role of forensic pathology and routine autopsy practice. Currently, some data on macroscopic and microscopic features in autopsies performed in suspected Covid-19 cases are reported in the literature. The persistence of SARS-CoV-2 in cadavers has not yet been elucidated and only a few reports have emphasized the importance of evaluating the Virus RNA in post-mortem tissues. In this preliminary study, we observed that SARS-CoV-2 survives in multiple cadaver tissues many days after death despite some extreme conditions of post-mortem body preservation. The results of this on-going analysis could help improve the safety of working practices for pathologists as well as understanding the possible interaction between microbiological agents and the cadaver tissue's supravital reactions.

Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective.

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.

Ethical Challenges in Health Care Policy during COVID-19 Pandemic in Italy.

Since the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, Italy has proven to be one of the countries with the highest coronavirus-linked death rate. To reduce the impact of SARS-CoV-2 coronavirus, the Italian Government decision-makers issued a series of law decrees that imposed measures limiting social contacts, stopped non-essential production activities, and restructured public health care in order to privilege assistance to patients infected with SARS-CoV-2. Health care services were substantially limited including planned hospitalization and elective surgeries. These substantial measures were criticized due to their impact on individual rights including freedom and autonomy, but were justified by the awareness that hospitals would have been unable to cope with the surge of infected people who needed treatment for COVID-19. The imbalance between the need to guarantee ordinary care and to deal with the pandemic, in a context of limited health resources, raises ethical concerns as well as clinical management issues. The emergency scenario caused by the COVID-19 pandemic, especially in the lockdown phase, led the Government and health care decision-makers to prioritize community safety above the individuals' rights. This new community-centered approach to clinical care has created tension among the practitioners and exposed health workers to malpractice claims. Reducing the morbidity and mortality rates of the COVID-19 pandemic is the priority of every government, but the legitimate question remains whether the policy that supports this measure could be less harmful for the health care system.