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BACKGROUND: In the COVID-19 pandemic, coordination was certainly late, also due to the scarcity of information disseminated at the very beginning of the pandemic, when countries were inevitably taken by surprise. The lack of information, mainly attributable to the country from which everything seems to have started, has produced a huge delay and numerous uncertainties in the feedback of the WHO and international organizations. OBJECTIVE: The inevitably relevant issue, from a legal point of view, concerns the legitimacy, formal or in any case shared, of the authority in charge of coordinating reactions and policies. The paper analyses the current legislation, soft and hard law, and the undertaken policies concerning emergency responses. METHODS: International and EU legislation analysis. RESULTS: The G20 understood that sustainable, flexible and agile funding systems for health emergencies are essential elements of pandemic prevention, preparedness and response. In EU there are many regulations about coordination and response to emergencies in practice in the EU and the Regulation (EU) 2021/522 (EU4Health programme), broadly extends the Union's competence in the field of health and has the objective of strengthening the Union's capacity for prevention, preparedness and rapid response in the event of serious cross-border threats to health. CONCLUSIONS: It is essential to formalize, within international agreements, the institutionalization of relationships, procedures, and the possible recognition of the reference figure. If in the European Union, at least partially, the protocols are there (even if the COVID-19 emergency has blown them up in principle), certainly in relations with non-EU countries the story is complicated, requiring specific agreements. This is the goal of the path started by the Rome Declaration of 21 May 2021 within the G20 – Global Health Summit. [ABSTRACT FROM AUTHOR]

BACKGROUND: The COVID-19 pandemic represented a global earthquake that made the review of health policies aimed at strengthening common governance necessary. OBJECTIVE: The paper analyses the reasons for which the One Health approach has become fundamental in the control of pandemic phenomena, by arguing the necessity to place it at the basis not only of health policies but also of intersectoral policies. METHODS: The documents of the world organizations published before and after the pandemic were analyzed and studied in order to unpack the close relationship between new lifestyles and the increase of health risks. RESULTS: It emerged that the One Health approach is a paradigm that has been advanced for more than 30 years, but due to the inadequacy of local and world health policies, this approach was never translated into concrete actions to protect health, feeding problems at the cause of the COVID-19 pandemic. CONCLUSIONS: Having ascertained that the adoption of a One Health approach can no longer be postponed, this must be insisted on several interconnected sectors that establish the new concept of healthcare which, in addition to being interdisciplinary, necessarily takes on a global perspective. [ABSTRACT FROM AUTHOR]

In Holland, first tier medical care outside of office hours is provided by regular GP's acting as Locum GP's. On several occasions concerns have been expressed about Locum GP's not visiting the patient when necessary. The number of complaints against Locum GP's submitted to the Medical Boards has been increasing over time and relate in particular to refusals of Locum GP's to visit the patient. In many of these cases the patient died. The paper develops a quantitative estimate of the risk for the patient due to negligence of Locum GP's. The measure of the risk is taken as the number of patients who died unnecessarily due to negligence of Locum GP's as determined by the Medical Boards. The paper estimates that in Holland in the year 2000 about 1500 patients would probably not have died had the Locum GP's working out-of-hours not been negligent by contravening professional standards. In more than half of these cases the Locum GP's did not visit the patient, or did not visit the patient in time, when necessary. This level of patient risk must be regarded as socially unacceptable. One important explanation for these accidents could be that doctors are largely unfamiliar with the professional standards developed by the Medical Boards. Because of the assumptions made and the uncertainty regarding the data used, the actual numbers of these accidents may be higher or lower than estimated here. Although more reliable data will allow the results to be determined more reliably, this is unlikely to change the acceptability of the risk. [ABSTRACT FROM AUTHOR]

Drug safety constitutes the cornerstone of modern therapeutics. Nowadays, the focus tends to be more on the hazards of drugs rather than on their benefits. This article describes from a healthcare professional's viewpoint the history behind two major drug disasters: thalidomide and rofecoxib and the reasons why drug withdrawals continue, taking the classic example of rofecoxib despite our safety concerns and the method to overcome those disasters in the future. The paper highlights the major steps to be followed for pharmacovigilance as an effective component of drug safety. The responsibility of healthcare professionals has ultimately to do with patient care and is to promote a culture of safe and efficacious drug use and thereby preventing future disasters related to modern therapeutics. [ABSTRACT FROM AUTHOR]

Living in general is a risky endeavour. Certain risks are taken without much thought because of the apparent overwhelming benefits. This is often the case for many consumers of medicines who assume medicines to be wholly safe and health care providers infallible. Patients rely on healthcare providers for information, risk assessment, and protection from risks due to medical interventions. Some common risks due to medical interventions include medication errors, exposure to radiation, over/under dosing, adverse events/reactions, hospital acquired infections, counterfeit drugs, etc. Unfortunately, risk factors such as counterfeit medicines (though occurring for a long time) are just becoming apparent in the last three decades, first to only a few countries while others still seem unaware or choose to dwell in denial of their existence. There has been an astronomical increase in the detection of counterfeit medicines worldwide. The magnitude of this increase and consequent death toll demands greater attention in the consideration of the safety of medicines. Counterfeit medicines constitute a risk to the pharmaceutical industry, healthcare providers, the healthcare system as a whole and ultimately to the patient. The risks to the patient include, lack of effect, toxicity, adverse drug reactions (ADRs), loss of economic and other resources and ultimately death. Due to dearth of information and research and lack of a globally coordinated approach to anti‐counterfeiting, global estimates of deaths due to counterfeit medicines can only be guessed. Indications from both published data and anecdotal evidence indicate that millions of lives may be saved annually if there are no counterfeit antibiotics, antiretrovirals, anti‐malarial, anti‐tubercular drugs, vaccines and other life saving medicines. This paper identifies these risks and proposes a concerted global action towards reducing the production and circulation of counterfeit pharmaceuticals on the world market. It also suggests a possible role for pharmacovigilance in anti‐counterfeiting. [ABSTRACT FROM AUTHOR]

In the context of the Sars-Cov-2 pandemic, according to the various periods of emergency and the rate of infections, hospitalized subjects also contracted the infection within the ward, sometimes with the development of disease (COVID-19) and sometimes with permanent damage. The authors wondered if Sars-Cov-2 infection should be considered on a par with other infections acquired in the healthcare setting. The non-diversified diffusion between the health and non-health sectors, the ubiquity of the virus and the high contagiousness, together with the factual inability to prevent it by the health structures, despite the adoption of entry control, practices of isolation of positive subjects, and staff surveillance, lead to consider COVID-19 in a different way, in order to otherwise burden health structures in the face of unmanageable risks, clearly also dependent on exogenous and uncontrollable factors. The guarantee of care safety must, in the pandemic, be able to compare with the real capacity for intervention according to the asset of the current health service, requesting State intervention with alternative instruments, such as una tantum compensation, for COVID-19 damage reparation occurred in the health sector. [ABSTRACT FROM AUTHOR]

BACKGROUND: Human error has been studied for large decades with special application to critical infrastructures and processes where the impact of such errors can induce severe or catastrophic consequences. In this sense it is of utmost importance to extend this type of analysis to other fields as medicine. OBJECTIVE: This study proposes a semi-quantitative human error risk assessment methodology, including the analysis of the so-called Performance Shaping Factors (PSFs), in order to contribute to health services improvement. METHODS: A questionnaire including the considered PSFs is answered in order to determine the impact of each PSF and its influence on human error. It allows performing a Human Error Risk Assessment (HERA) for both the patient (HERAp) and the quality of the service (HERAq). RESULTS: The results show the PSFs with the highest impact factor. After applying corrective measures, it is possible to observe the impact on the reduction of the risk for patient and for the quality of the service. CONCLUSIONS: The application of the methodology with the inclusion of the impact of PSFs allows minimizing or mitigating failure modes with greater risk as well as increasing patient safety and promoting a better quality of medical procedures. [ABSTRACT FROM AUTHOR]

This essay, using case studies from an interdisciplinary approach to medicine, clinical risk management and the law, explores the interrelationship between unreasonable clinical risk and medical negligence (prevention) under the law of negligence. For this purpose, the essay analyzes the judgment criteria of predictability and preventability of clinical risk, discusses suitable evidence for the determination of reasonable/unreasonable clinical risk, sums up the conditions for the transformation from reasonable clinical risk to unreasonable clinical risk, and presents unreasonable clinical risk in medical processes. The paper is aimed at both healthcare providers and legal professionals. It aims to raise the study of the relationships between clinical risk management and the law to a higher level. [ABSTRACT FROM AUTHOR]

Focuses on the emergence of an alternative school of holistic medicine which claims to approach the patient as an individual an not merely a carrier of organs and symptoms. Tendency for the specialist to pursue one-track medicine; Concerns regarding the physical health of people with mental illness; Means to improve physical health care services for people with mental illness.

Editorial. Discusses the challenges facing mass medical care. State of the the medical care system; Developments in public health services; Information on megacare.

The aim of this article is to present available strategies to develop healthcare safety systems by merging Hospital Discharge Records and medical malpractice claim data in available regional administrative archives of the Lombardy region (Italy). Firstly, we illustrate the regional database collecting claims and demands of reimbursement declared by patients hospitalized in regional healthcare structures, then we discuss strategies to model the association between quality indicators, obtained by Hospital Discharge Records, and the incidence of clinical errors causing the patient's death or lesions. As first result, the merged database evidences a limited temporal range covered by both informative systems (2004–2006), essentially imputable to a scarce data quality in Hospital Discharge Cards records before 2004 and to a high incidence of open claims in the claims database after 2004. Further, clinical errors show an extreme sparseness among involved Health structures. The analysis, focused on the triennium 2004–2006, was performed in a cross-sectional perspective using Binomial Negative regression models. Results evidenced that re-admissions rate for the same Major Diagnostic Category and discharges against medical advice rate significantly affect the incidence of errors causing the patient's death, whereas unscheduled surgical readmission rate in operating room significantly affects the incidence of surgical error rate. [ABSTRACT FROM AUTHOR]

Adverse drug reaction reporting is an important means of establishing new knowledge and generating early signals of possible drug complications. Several reporting systems exist for adverse events however these reporting systems are associated with relatively low levels of reporting. The quality of the reporting is also important which ultimately depends upon the information furnished by the clinician in the available form. In order to improve the quality of information provided in the form, healthcare professional should know the importance of any information that he/she is providing. In this study hundred filled ADR reporting forms were selected and analyzed with respect to the quality of information provided. It was observed that the columns which were required to be filled completely, but were not filled correctly were diagnosis, description of the event, outcome attributed to adverse event, relevant test/lab data, concomitant medications. These are important details that must be reported, for evaluation of cause–effect relationship. Thus health care professionals should be aware of the importance of the information they are providing in the form and they should get proper instructions for filling the form, so as to improve the quality of information provided in the form. More CMEs and workshops should be conducted to improve awareness. In this article an attempt is made to provide information on how to fill the form completely. [ABSTRACT FROM AUTHOR]

The increase in medical negligence litigation and costs during the past two decades has prompted health care providers, governments and the World Health Organization (WHO) to seek new approaches for the prevention of medical error and the protection of patient safety. The study and practice of clinical risk management has gradually been taken up by medicine, risk management, and even law in the world. Their participation has developed rapidly in recent years. This essay surveys contemporary research in clinical risk management, medical negligence prevention and relevant legal issues, examines their interrelationship, identifies the main categories of research topics and methodologies and explores the appropriate direction for further research. [ABSTRACT FROM AUTHOR]

The impact of medical litigation and its controversial and damaging consequences are reviewed, along with a number of the proposals for tort and other reforms. As an important effect of the threat of litigation, the practice of defensive medicine is discussed. Proposals are made for improvements in the quality of doctor–patient relationships as a significant contribution to improved clinical care and reduction in the risk of doctors being sued. [ABSTRACT FROM AUTHOR]

Reports on the state of medical care in the Netherlands in 2004. Application of medicines and medical appliances in care institutions and at home; Efforts to raise awareness regarding the safe use of medicines and medical devices; Prescription of harmful drugs to the elderly.

Discusses the management of the aftermath of iatrogenic injury. Description of ioatrogenic injury; Impact of the aftermath of an adverse event on healthcare staff; Information on psychological responses to medical injury.

Aim: To describe the prevalence, characteristics and impact of community-based adverse events severe enough to warrant hospital admission in New Zealand, to compare them to in-hospital adverse events (AEs) and to consider their potential as a tool to monitor the quality of primary care. Methods: Two-stage retrospective review of 6579 medical records, selected by systematic list sample from admissions for 1998 in 13 generalist hospitals providing acute care. After initial screening, medical records were reviewed by trained medical practitioners using a standardised protocol. Results: Approximately 2.5% of all admissions (12,800 hospitalisations in 1998) to public hospitals in New Zealand may be associated with community-based adverse events. Nearly 20% of all AEs occurred in the community most often in a doctor's office, patient home, or rest home. Patients who sustained a community-based AE were usually elderly, and most frequently related to medications. System issues were important for both inpatient and community-based AEs. AEs regardless of location were most frequently related to the musculoskeletal system. Conclusions: Community-based AEs are a significant public health and hospital workload issue in New Zealand and other Western countries. Urgent attention needs to be directed at developing systems to identify their presence and monitor the effect of interventions to prevent their occurrence. Hospital-based information systems can generate useful data about AEs in the community and can provide an important review of primary care prescribing. Compared to in-hospital events, community-based AEs were most often related to medications, and were more frequently preventable. [ABSTRACT FROM AUTHOR]

Whilst Human Reliability Analysis (HRA) has been well‐accepted and integrated into the safety management process in other industries, the application of such error analysis techniques to the problem of complication and reaction to treatment and the associated risks in healthcare is rare. Though the scarcity of HRA techniques in health‐care is likely to be due in some part to the safety culture, much is likely to be due to a lack of awareness of the usefulness of the techniques and their applicability to the problem of human error in the clinical context. This review attempts to look at the popular HRA techniques used in high‐reliability industries, such as petro‐chemical, nuclear and aviation, and consider their feasibility for use in healthcare. Techniques vary in their scope and have been grouped into those that focus on: data collection, task description, task simulation, human error identification and analysis, and human error quantification. Techniques may cover one or more of these aspects, for example, THERP, HEART and SHERPA include both human error identification and analysis, and human error quantification tools. While some areas of healthcare have used certain HRA techniques, there is considerable scope to use others and to apply techniques to other aspects of healthcare not yet explored. [ABSTRACT FROM AUTHOR]

Examines the provision of low cost medicines in transitional countries. Differences within countries in terms of health status and access to health services; Overview of the drug market in Central Europe and Eastern Europe; Reason for the increase in private spending and greater co-payments for reimbursable drugs.

Discusses the situation in developing countries regarding access to essential medicines. Standard of living attributes of low-income countries; Increase in the global consumption of pharmaceutical products; Problems of countries in ensuring affordability of drugs; Overall funding of health care including financing for prevention and treatment of priority infectious diseases with a high public health impact.

Presents a legal analysis of breakdowns in communication in health care. Law regarding practitioners in health care; Failure in communication between medical specialists; Communication between medical specialists, medical students and resident interns.

Presents updates on medical care and the safety in medicine practice as of July 1998. Launch of anti-depressant Remeron in Thailand; Mortality rate for neonatal cardiac surgery; Increase in the popularity of intracytoplasmatic sperm injection.

Comments on several issues related to safety and risk in medical care. Competencies in the midwifery practice; Assessment of fraud in medical research; Possibilities of post-surgical complications of cervical cancer.

The article deals with the need to provide relevant health information to citizens in Europe. A joint declaration on the provision of relevant health information to citizens has been endorsed by Health Action International Europe, the International Society of Drug Bulletins, the Association Internationale de la Mutualité, the Bureau Européen des Unions de Consommateurs and the Medicines in Europe Forum. They have also called for a clear distinction between information and advertising disguised as information.