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One of the cornerstones for enhancing the patient safety culture is the incident reporting system (IRS). It is a process for detecting, reporting, collecting, and summarizing adverse events (AEs) and near-misses in healthcare, and so it represents a vital tool for clinical risk management. We analyzed the 5-year experience of a third-level hospital's IRSs, showing its trends and highlighting its main strengths and weaknesses. Patients' falls and physical or verbal aggression toward the providers or between patients are the most reported events. Underreporting is the main limitation of the system, especially among nurses. Visible actions, forceful analysis of the reports, operators' education, no-blame culture promotion, and organizational adjustments may improve operators' adherence to IRS. Providers do not willingly inform patients' relatives about fatal incidents. Despite that, the IRS is far from its potential, and the number of data collected has increased. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Many drugs used for neonates are unlicensed or off-label. An increased risk of medication errors and unexpected adverse drug reactions is associated with their use. This risk is even higher in preterm newborns, because of their physiological immaturity and the exposure to many different medicines. The objective of this study was to evaluate the use of unlicensed or off-label drugs in eight tertiary-level neonatal intensive care units ( NICU) from two different southern Italian regions. Methods All drugs prescribed to newborns admitted to each NICU, during 1 month of observation, were recorded and classified as licensed, unlicensed or off-label, according, respectively, first, to their license status and, then, their indications, dose, treatment route, and duration of treatment specified in each specific marketing authorization. Results A total of 126 newborns were treated with at least one drug during the observation period. A total of 483 prescriptions referred to 87 different drugs, classified as licensed, unlicensed or off-label. Each newborn was exposed to three (median) different drugs; 88.6% were licensed and 11.4% unlicensed (range, according to different NICU, 1.9-26.7%). Among licensed drugs, 37.4% were used as off-label (range, 27.3-53.4%). Conclusions The use of unlicensed or off-label drugs use is common practice in NICU, with wide variation in local policies and newborn characteristics. Well-designed and -conducted pharmaceutical studies in newborns are needed to increase the number of licensed drugs, thereby reducing any risk for patients due to over- or under-treatment, and also legal issues for clinicians. [ABSTRACT FROM AUTHOR]

Sepsis is a leading cause of morbidity and mortality worldwide. It is defined as the presence of a Systemic Inflammatory Response Syndrome, and it represents a significant burden for the healthcare system. This is particularly true when it is diagnosed in the setting of nosocomial infections, which are usually a matter of concern with regard to medical liability being correlated with increasing economic costs and people's loss of trust in healthcare. Hence, the Italian governance promotes the clinical risk management with the aim of improving the quality and safety of healthcare services. In this context, the role of medico-legal experts working in a hospital setting is fundamental for performing autopsy to diagnose sepsis and link it with possible nosocomial infections. On the other hand, medico-legal experts are party to the clinical risk management assessment, and deal with malpractice cases and therefore contribute to formulating clinical guidelines and procedures for improving patient safety and healthcare providers' work practices. Due to this scenario, the authors here discuss the role of medico-legal experts in Italy, focusing on sepsis and nosocomial infections. [ABSTRACT FROM AUTHOR]

Abstract: To evaluate the characteristics of the reported workplace violence in a psychiatric intensive care unit (PICU) by analyzing an electronic hospital incident reporting system (IRS). One hundred thirty reports were retrieved from January 2017 to June 2020, referring to assaults committed by patients (71% males) with an average age of 29.8 years (SD, 14.9). The most frequent psychiatric diagnosis was a neurodevelopmental disorder (33%). Physical aggression (84%) was more frequent than the other types of aggression. Nurses and unlicensed assistive personnel were the most frequent victims (65%). Aggressions were more frequent on Friday (18%) and between 4 p.m. and 8 p.m. (35%). A total of 64.9% of the incidents happened in the first 5 days of hospitalization. A significant association between physical aggression and diagnosis of neurodevelopmental disorder emerged. IRS could be helpful to identify high-risk patient groups and develop clinical strategies to reduce adverse events in clinical practice. [ABSTRACT FROM AUTHOR]

Abstract: The aim of this study was to ascertain if a relationship between weapon choice and psychopathology existed. The perpetrators (103) were evaluated at the Department of Criminology and Forensic Psychiatry of the University of Bari in southern Italy. Psychiatric examination and psycho-diagnostic tests were administered for each of the perpetrators and a database was subsequently formulated. The results showed a significant correlation between some types of mental disorder and weapon choice. A strong correlation was found between delusional disorders and the use of sharp weapons, whereas depressive disorders were more strongly associated with asphyxia. Organic disorders were found to be highly correlated with the use of blunt instruments. In cases where the homicide was the result of an impulsive reaction, the use of sharp weapons was most often observed. [Copyright &y& Elsevier]

• Dog bites are still a major health problem and may cause injuries or even death. • Italian law establishes the responsibility for any dog aggression lies with its owner. • A technical multidisciplinary evaluation of bite marks may help to identify the dogs involved in the attack. Lethal injuries by animal attacks are a matter of concern for the forensic pathologist; the presented case illustrates a two dogs attack on a 61-year-old man. The authors have focused on a multidisciplinary approach involving forensic pathologists and veterinarians. The victim was cycling in the countryside when he was attacked by two dogs that came out of a large house. He was found lying in the street by the homeowners who called for help. The victim was transported to the hospital where he died five days later. According to recovery data and medico-legal autopsy findings the cause of death was septic shock. Forensic pathologists and veterinarians multidisciplinary evaluation revealed lacerations, abrasions, and multiple small punctures constituting bite marks over the entire body. Six skin dowels with bite marks were taken and compared with the dental cast of the dogs. A comparison of the dog dental casts and the bite marks on the victim's body allowed the identification of the animals involved in the attack. [ABSTRACT FROM AUTHOR]

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.

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.

Clinical risk management constitutes a central element in the healthcare systems in relation to the reverberation that it establishes, and as regards the optimization of clinical outcomes for the patient. The starting point for a right clinical risk management is represented by the identification of non-conforming results. The aim of the study is to carry out a systematic analysis of all data received in the first three years of adoption of a reporting system, revealing the strengths and weaknesses. The results emerged showed an increasing trend in the number of total records. Notably, 86.0% of the records came from the medical category. Moreover, 41.0% of the records reported the possible preventive measures that could have averted the event and in 30% of the reports are hints to be put in place to avoid the repetition of the events. The second experimental phase is categorizing the events reported. Implementing the reporting system, it would guarantee a virtuous cycle of learning, training and reallocation of resources. By sensitizing health workers to a correct use of the incident reporting system, it could become a virtuous error learning system. All this would lead to a reduction in litigation and an implementation of the therapeutic doctor-patient alliance.

Folie à deux is a rare clinical syndrome characterized by the transference of delusional ideas from one person to one or more other people in close association with the primary affected patient. Mummification indicates the preservation of the corpse of a person for a variable period of time. A brief review of the literature in this field is presented, and an exceptional case is described, characterized by the association of both these rare phenomena. The case is an example of folie à fammille which developed out of a condition of extreme religiousness and seclusion of an entire family. The shared psychosis led to the horrible death of some of the family members, while the last surviving member of the family lived for more than a year and a half with their mummified remains. The Judge commissioned a forensic psychiatry assessment to verify the survivor's ability to bear witness. The development of the psychiatric syndrome and its consequences are extensively discussed., (© 2013 American Academy of Forensic Sciences.)

Background: Ethical issues regarding patient care have recently been raised in Italy by the case of Eluana Englaro, a 36-year-old woman who remained in a persistent vegetative state (PVS) for 17 years. There are no specific laws on the books in Italy regarding euthanasia and physician-assisted suicide. In November 2008, a controversial decision by the Italian Supreme Court granted the woman's father his wish to discontinue nutrition and hydration provided to her. Because of this historic decision, the authors carried out a survey of Italian physicians' beliefs regarding end-of-life practices., Methods: A questionnaire was e-mailed to 70,000 physicians working for the Italian Public Health System and University Medical Hospitals., Results: A total of 22,219 doctors responded to the questionnaire (32.3%), of whom 17,252 (77.6%) had some experience in treating PVS patients. Nearly 70% of responding doctors were aware of PVS diagnostic criteria; most of them (61%) considered tube feeding to be a medical therapy, and 66% of respondents believed that withdrawal of assisted nutrition and hydration (ANH) might be appropriate depending on the patient's wishes. Moreover, even though 50% of doctors surveyed were not in favor of euthanasia, a significant percentage (42%) did approve of it, while 8% of this sample was uncertain., Conclusions: Italian doctors probably have the least experience in end-of-life decisions in Europe, therefore this national survey is a great chance to understand their authentic opinions regarding such remarkable issues. There is broad consensus that a clear legislative position regarding euthanasia and ANH is needed.

Objective: Many drugs used for children are not licensed or are used off-label. An increased risk of medication errors and unexpected adverse drug reactions (ADR) associated with off-label and unlicensed drug prescription has been reported. This risk increases in the newborn, who are more likely to be predisposed to an ADR due to their physiological immaturity. The objective of this study was to describe the use of unlicensed or off-label drugs in a Neonatal Intensive Care Unit (NICU)., Methods: All drugs prescribed to newborn admitted to the Neonatology Unit of Bari University Hospital, from July 1st to August 31st in 2004 were recorded., Main Outcome Measures: All the drugs prescribed were analysed with regard to their license status, then the licensed drugs were compared to the indications, dose, route of administration, duration of treatment, contraindications and warnings specified in the summary of product characteristics of the marketing authorization., Results: Data were collected on 176 prescriptions for 61 different drugs given to 34 newborns. Drugs were licensed in 88% and unlicensed in 12% of cases. About the licensed drugs, in 37.5% medicines were used following the terms of the marketing authorization, in 22.7% of cases medicines were used in an off-label manner as they contained no information for paediatric use in the marketing authorization and in 27.8% of cases medicines were licensed for paediatric use, but they were used off-label with regard to age, dose, route of administration and duration of treatment., Conclusions: Despite European and American initiatives aiming to promote greater awareness and research in the paediatric population, these data demonstrate that there is still a high percentage of unlicensed or off-label drugs use in neonatology, underlining the need to stimulate scientific data collection by means of experimental studies or outcome research.

Fatal gunshot injuries are routinely encountered by forensic pathologists practicing in Southern Italy. Bari, the capital city of the Italian region known as Apulia, is a leader with regard to the number of firearm deaths in Italy. This is mainly attributable to local organized crime groups which control a variety of illicit activities. This retrospective study analyzes autopsy data related to fatal firearm wounds, handled by the Institute of Legal Medicine [University of Bari], between 1988 and 2003. A total of 717 cases were selected and classified as follows: firearm homicides (634); suicides (82); and accidental death (1). A significant number of variables have been reviewed such as: month in which the violent event took place; the victims' nationalities; gender and age of victims; site and number of entrance wounds; weapon type used; and manner of death (i.e. homicide; suicide; accidental). Analysis has revealed a homicide versus suicide ratio of almost 8:1. Victims were mostly male with a lower mean age than in other similar studies. Homicides with multiple gunshot wounds were more common than ones with single entrance wounds. For example, in one case, 30 entrance wounds were identified in the murder of a gang boss. Four suicides with two entrance gunshot wounds were identified. Handguns were the most frequently used weapon in all groups (i.e. homicide, suicide, and accidental), with 7.65 mm and 9 mm being the most common calibres. This study revealed a very low incidence of suicide among females. Mental and other types of illness, as well as financial stress were the apparent motives which prompted most of the suicide victims. The homicide cases described were most often related to continual, ongoing fights among local criminal gangs (75%).

The authors describe a singular case of fatal impalement due to penetration of a metal tube at the level of the neck in a victim of a road traffic accident. The man was traveling in the passenger seat ("death seat") of a car that hit the parapet of a bridge head on; death was attributed to hemorrhagic shock, which was brought on virtually instantly at the moment of impact.