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1.
Pol Merkur Lekarski ; 52(4): 445-452, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39360726

RESUMEN

International armed conflicts often involve the occupation of territories of the state under aggression, where some of the population begins to voluntarily cooperate with the enemy. Currently, under the legislation of certain EU countries, such actions may be deemed collaboration or treason. This article examines the scenarios faced by medical or pharmaceutical workers in occupied territories, using the example of Ukraine, which is currently experiencing armed aggression from the Russian Federation. Despite the declared norms of International Humanitarian Law (IHL), medical and pharmaceutical workers find themselves in quite difficult situations. They have taken an oath and have obligations under the Geneva Conventions and Additional Protocols, and thus are required to continue performing their professional duties during the occupation and are de jure granted medical neutrality. However, they also face limited resources, pressure, and, in some cases, their duties may involve illegal actions that could lead to legal responsibility. The study identifies when medical and pharmaceutical activities are lawful during occupation and when they may constitute unlawful behaviour that results in legal accountability. The authors conclude that the current policies of Russia and its occupation authorities deliberately violate IHL norms. Furthermore, they intentionally create conditions where individuals in occupied territories commit actions that will be recognized as crimes. It is based on dialectical, analytic, synthetic, comprehensive methods, and also uses the case-method and the method of content analysis.


Asunto(s)
Conflictos Armados , Ucrania , Humanos , Conflictos Armados/legislación & jurisprudencia , Federación de Rusia
2.
GMS Hyg Infect Control ; 19: Doc42, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39391860

RESUMEN

The consensus-based guideline "hand antisepsis and hand hygiene" for Germany has the following sections: Prevention of nosocomial infections by hygienic hand antisepsis, prevention of surgical site infections by surgical hand antisepsis, infection prevention in the community by hand antisepsis in epidemic or pandemic situations, hand washing, selection of alcohol-based hand rubs and wash lotions, medical gloves and protective gloves, preconditions for hand hygiene, skin protection and skin care, quality assurance of the implementation of hand hygiene measures and legal aspects. The guideline was developed by the German Society for Hospital Hygiene in cooperation with 22 professional societies, 2 professional organizations, the German Care Council, the Federal Working Group for Self-Help of People with Disabilities and Chronic Illness and their Family Members, the General Accident Insurance Institution Austria and the German-speaking Interest Group of Infection Prevention Experts and Hospital Hygiene Consultants.

3.
J Forensic Leg Med ; 107: 102762, 2024 Sep 23.
Artículo en Inglés | MEDLINE | ID: mdl-39326110

RESUMEN

BACKGROUND: HAIs (Healthcare-Acquired-Infections) have been recently the subject of judgment n. 6386 pronounced on 3rd March 2023 by the Italian Supreme Court. This sentence provided three criteria to determine whether a health facility is responsible for the patient contracting a nosocomial infection, i.e. time criterion, topographical criterion and clinical criterion. Accordingly, the healthcare facility is obliged to prove the fulfillment of a series of preventive hygiene measures specifically detailed by the legislator. Herein, the positive predictive value of these criteria ("juridic criteria") in the identification of professional liability for nosocomial infections was evaluated in comparison with clinical criteria reviewed by Infectious Disease specialists ("Infectious-Disease criteria", i.e. presence of a Multidrug Resistant Organism (MDRO); development of surgical site infection; inadequate antibiotic therapy; inadequate disinfection). METHODS: Two retrospective cohorts were compared from the Portal of Telematic Services of the Ministry of Justice; 51 patients were extrapolated from Italian judgments concerning claims for Gram-negative nosocomial infections in the three-year period 2020-2022. On the other side, from the electronic database of University Hospital of Bari we extracted 349 patients affected by Gram-negative infections in the same timespan. Both "juridic" criteria and "Infectious-Disease" criteria were then applied to the full cohort after stratification for cohort of origin and after stratification for nosocomial or non-nosocomial infections. Predictive value of criteria was evaluated through receiver operating characteristic (ROC) curves and area under the curve (AUC). RESULTS: Overall, the incidence of definite nosocomial infections (according to final judgement or clinical records discharge letter) was 84 % in juridic cohort and 46 % in "real-world" series. Data suggested that the presence of all three juridic criteria [ROC AUC = 0.944 (95%CI = 0.924-0.963)] or the four clinical criteria [ROC AUC = 0.948 (95%CI = 0.928-0.969)] predicted well a case of nosocomial infection with professional liability. Moreover, by summarizing both criteria in a single classification system, the generated ROC curve (was the one with the highest AUC [0.9488 (95%CI = 0.928-0.969)]. Accordingly, further tests were performed, evaluating the predictive value of one juridic criterium plus at one of more Infectious-Disease criteria. Interestingly, the ROCs curves demonstrated that the presence of at least 1 juridic criteria plus at least 2 Infectious Disease criteria reached a predictive value comparable to 2 or 3 juridic criteria. CONCLUSIONS: The results highlight the efficiency of new criteria laid down in the judgment of the Italian Supreme Court to attribute liability for nosocomial infection despite the disputed distance between juridic and scientific decision-making process. In addition, the use of a combined score combining "juridic" and "Infectious-Disease" criteria provides a high-quality tool to be used by technical consultants to make up for lack of clinical documentation by passing judgments concerning litigation about professional liability in case of nosocomial infections. This sheds light on the possibility to face worldwide judicial inquiries with scientific rigor.

4.
Healthcare (Basel) ; 12(18)2024 Sep 13.
Artículo en Inglés | MEDLINE | ID: mdl-39337169

RESUMEN

Dental identification systems (DISs) encompass various techniques used for forensic identification, serving as alternatives or complements to genetic methods. Technologies such as microchip implants, prosthetic inscriptions, microSD cards, and identification plaques have been proposed to address limitations in comparative methods, offering streamlined processes for forensic experts. This study reviews current and potential DIS implementations, emphasizing cost-effectiveness and community benefits. Literature analysis from PubMed (2008-2024) yielded 17 relevant articles on implantable DISs, enabling direct subject identification via teeth or prostheses. The integration of DIS aims to enhance accuracy and speed in personal profiling and legal identification, promoting technology transfer in dentistry. It will be necessary to develop strict privacy regulations to protect patient data and establish ethical guidelines for their use. The study's aim is to highlight that the universal adoption of DISs could mitigate healthcare disputes and facilitate data exchange in clinical settings, which is particularly beneficial for vulnerable populations.

5.
Front Med (Lausanne) ; 11: 1428504, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39309674

RESUMEN

The integration of robotics and artificial intelligence into medical practice is radically revolutionising patient care. This fusion of advanced technologies with healthcare offers a number of significant benefits, including more precise diagnoses, personalised treatments and improved health data management. However, it is critical to address very carefully the medico-legal challenges associated with this progress. The responsibilities between the different players concerned in medical liability cases are not yet clearly defined, especially when artificial intelligence is involved in the decision-making process. Complexity increases when technology intervenes between a person's action and the result, making it difficult for the patient to prove harm or negligence. In addition, there is the risk of an unfair distribution of blame between physicians and healthcare institutions. The analysis of European legislation highlights the critical issues related to the attribution of legal personality to autonomous robots and the recognition of strict liability for medical doctors and healthcare institutions. Although European legislation has helped to standardise the rules on this issue, some questions remain unresolved. We argue that specific laws are needed to address the issue of medical liability in cases where robotics and artificial intelligence are used in healthcare.

6.
Front Nutr ; 11: 1458442, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39253325

RESUMEN

Background: Telomere has been recognized as a biomarker of accelerating aging, and telomere length (TL) shortening is closely related to diverse chronic illnesses. Human serum metabolites have demonstrated close correlations with TL maintenance or shortening in observational studies. Nevertheless, little is known about the underlying pathological mechanisms, and Mendelian randomization (MR) analysis of serum metabolites may provide a more comprehensive understanding of the potential biological process. Methods: We employed a two-sample MR analysis method to assess the causal links between 486 serum metabolites and TL. We applied the inverse-variance weighted (IVW) approach as our primary analysis, and to assure the stability and robustness of our results, additional analysis methods including the weighted median, MR-Egger, and weighted mode were conducted. MR-Egger intercept test was utilized to detect the pleiotropy. Cochran's Q test was implemented to quantify the extent of heterogeneity. Furthermore, the pathway analysis was conducted to identify potential metabolic pathways. Results: We identified 11 known blood metabolites associated with TL. Among these metabolites, four were lipid (taurocholate, dodecanedioate, 5,8-tetradecadienoate, and 15-methylpalmitate), one amino acid (levulinate (4-oxovaleate)), one carbohydrate (lactate), one nucleotide (pseudouridine), one energy (phosphate), and three xenobiotics (2-hydroxyacetaminophen sulfate, paraxanthine, and ergothioneine). The known protective metabolites included levulinate (4-oxovaleate), dodecanedioate, 5,8-tetradecadienoate, lactate, phosphate, paraxanthine, and ergothioneine. Multiple metabolic pathways have been identified as being implicated in the maintenance of telomere length. Conclusion: Our MR analysis provided suggestive evidence supporting the causal relationships between 11 identified blood metabolites and TL, necessitating further exploration to clarify the mechanisms by which these serum metabolites and metabolic pathways may affect the progression of telomeres.

7.
Herz ; 49(5): 355-360, 2024 Oct.
Artículo en Alemán | MEDLINE | ID: mdl-39251441

RESUMEN

Digital assistants have become an indispensable tool in modern cardiology. The associated technological progress offers a significant potential to increase the efficiency of medical processes, enable more precise diagnoses in a shorter time, and thus improve patient care. However, the integration of digital assistants into clinical cardiology also raises new challenges and questions, particularly regarding the handling of legal issues. This review article aims to raise awareness of individual legal issues resulting from the use of digital technologies in cardiology. The focus is on how to deal with various legal challenges that cardiologists face, including issues related to treatment freedom, professional confidentiality and data protection. The integration of digital assistants in cardiology leads to a noticeable improvement in efficiency and quality of patient care, but at the same time, it involves a variety of legal challenges that need to be carefully addressed.


Asunto(s)
Cardiología , Cardiología/legislación & jurisprudencia , Confidencialidad/legislación & jurisprudencia , Alemania , Telemedicina/legislación & jurisprudencia , Humanos , Seguridad Computacional/legislación & jurisprudencia
9.
Afr J Reprod Health ; 28(8): 133-139, 2024 Aug 31.
Artículo en Inglés | MEDLINE | ID: mdl-39225579

RESUMEN

Diapers, being one of the most used items for infant care, it is imperative that they are always free of contamination from microorganisms. The objective of this study is to determine the rate of bacterial contamination and the antibiotics profile of isolated bacteria from unused diapers sold in markets in Enugu Metropolis, southeast Nigeria. The study also investigated the effectiveness of the Nigerian Consumer protection laws towards maintaining the standard of care for infants and toddlers. Fifty pieces of different brands of diapers were sampled for bacterial contamination using standard bacteriological procedures. The results show that out of 50 samples analyzed, bacterial growths were identified in 9 (18%), of which five different bacterial species were isolated. The most prevalent being Escherichia coli and Staphylococcus aureus 3 (33.3%). Other bacteria isolated were Lactobacillus spp, Klebsiella spp, and Streptococcus spp 1 (11.1%). There was no statistically significant difference in the distribution of the bacterial contamination of diapers across the different brands(p>0.05). We conclude that baby diapers sold in markets in Enugu metropolis are prone to contamination with bacteria.We recommend that appropriate measures should be taken during the manufacturing process to reduce or prevent the incidence of bacterial contamination of diapers.


Les couches étant l'un des articles les plus utilisés pour les soins des nourrissons, il est impératif qu'elles soient toujours exemptes de contamination par des micro-organismes. L'objectif de cette étude est de déterminer le taux de contamination bactérienne et le profil antibiotique des bactéries isolées provenant de couches inutilisées vendues sur les marchés de la métropole d'Enugu, dans le sud-est du Nigeria. L'étude a également examiné l'efficacité des lois nigérianes sur la protection des consommateurs pour maintenir le niveau de soins pour les nourrissons et les jeunes enfants. Cinquante morceaux de couches de différentes marques ont été échantillonnés pour détecter toute contamination bactérienne en utilisant des procédures bactériologiques standard. Les résultats montrent que sur 50 échantillons analysés, des croissances bactériennes ont été identifiées dans 9 (18 %), parmi lesquels cinq espèces bactériennes différentes ont été isolées. Les plus répandus sont Escherichia coli et Staphylococcus aureus 3 (33,3 %). Les autres bactéries isolées étaient Lactobacillus spp, Klebsiella spp et Streptococcus spp 1 (11,1 %). Il n'y avait pas de différence statistiquement significative dans la répartition de la contamination bactérienne des couches entre les différentes marques (p>0,05). Nous concluons que les couches pour bébés vendues sur les marchés de la métropole d'Enugu sont sujettes à la contamination bactérienne. Nous recommandons que des mesures appropriées soient prises pendant le processus de fabrication pour réduire ou prévenir l'incidence de la contamination bactérienne des couches.


Asunto(s)
Antibacterianos , Escherichia coli , Pruebas de Sensibilidad Microbiana , Staphylococcus aureus , Humanos , Nigeria , Antibacterianos/farmacología , Lactante , Escherichia coli/aislamiento & purificación , Escherichia coli/efectos de los fármacos , Staphylococcus aureus/aislamiento & purificación , Staphylococcus aureus/efectos de los fármacos , Klebsiella/aislamiento & purificación , Klebsiella/efectos de los fármacos , Lactobacillus/aislamiento & purificación , Streptococcus/aislamiento & purificación , Streptococcus/efectos de los fármacos
10.
Front Oncol ; 14: 1393833, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39281383

RESUMEN

Background: Some studies have reported that sunburns and cutaneous melanoma (CM) risk is increasing, but a clear causal link has yet to be established. Methods: This current study conducted a two-sample Mendelian randomization (MR) approach to clarify the association and causality between sunburn history and CM using large-scale genome-wide association study data. Results: The inverse-variance weighted method result showed that sunburn might be associated with the risk of CM increasing (p = 2.21 × 10-23, OR = 1.034, 95% CI= 1.027-1.041), causally. The MR-Egger regression, weighted median method, simple mode method, and weighted mode method results showed similar results. Conclusion: This study offers evidence of sunburn history and increased risk of CM, and it shows that there might be common genetic basics regarding sunburns and CM susceptibility in Caucasian, European, or British ethnic groups.

11.
Anaesthesiologie ; 73(9): 571-575, 2024 Sep.
Artículo en Alemán | MEDLINE | ID: mdl-39122792

RESUMEN

Only a few physicians are willing to comprehensively concern themselves with how a legally watertight treatment documentation should be structured, in addition to their practical activities; however, the importance of the documentation cannot be emphasized enough, not only for a potential case of liability but also for the medical (further) treatment. This article therefore illustrates the legal foundations of the mandatory documentation and the most important questions associated with it for the practice, in particular on the content of the documentation, the timing of the documentation, the preservation of treatment documents and on the conduct in cases of an impending incident.


Asunto(s)
Documentación , Humanos , Documentación/normas , Alemania , Responsabilidad Legal , Mala Praxis/legislación & jurisprudencia , Registros Médicos/legislación & jurisprudencia , Registros Médicos/normas
12.
Clin Ter ; 175(Suppl 2(4)): 213-218, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39101430

RESUMEN

Background: In the healthcare system, in the last 30 years, the prognostically negative value of the so-called Weekend Effect (WE) has been internationally recognized. The WE is regarded as the increased risk a patient might incur when hospitalized during non-working days, of enduring severe complications in comparison to the same hospitalization that occur on working days. The aim of this study was to retrospectively verify whether, once a mistake was made during weekends or on holidays, in comparison to a mistake occurred on workdays, it subsequently implied a higher risk of complications, death included, in a statistical and medico-legal way. Methods: Three different evaluators independently examined a total of 378 medico-legal cases over a more than 20-year period. Eventual medical actions and omissions were labelled as 'mistake' when the AJ claimed that at least one occurred; 'alleged mistake' included the cases where the EW's report disagreed with the AJ's one; finally, 'no mistake' when both the AJ and the EW agreed in their evaluations. During weekends there is a higher risk that a mistake occurs (OR=3.3, 95% CI=1.6;7.4; p-value<0.001) compared to weekdays. When death occurs, delayed diagnosis is the main cause (p=0.02), whereas a damaging action is more frequently claimed in general. Conclusions: We verified as actual the impact of the WE on patients' outcome from a medico-legal point of view. The implications for an improvement of the several settings of the Italian NHS are various, and many are the consequences in the healthcare management.


Asunto(s)
Errores Médicos , Calidad de la Atención de Salud , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Posterior/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Italia , Mala Praxis/estadística & datos numéricos , Mala Praxis/legislación & jurisprudencia , Errores Médicos/estadística & datos numéricos , Errores Médicos/legislación & jurisprudencia , Estudios Retrospectivos , Factores de Tiempo
13.
Artículo en Inglés | MEDLINE | ID: mdl-39171891

RESUMEN

The urgency of protecting ecosystems and their recovery from contamination has been highlighted in several recent European strategies because Europe's biodiversity and landscapes are declining rapidly due to different human pressures. Despite the existence of EU and national laws addressing environmental contamination, practical procedures are often missing. For example, competent authorities must deal promptly and effectively with environmental accidents, noncompliance, and criminal offenses but relevant tools that facilitate these processes are often lacking. For example, thorough planning is crucial for effective investigation and assessment to improve environmental damage assessments in line with the European Environmental Liability Directive (ELD, 2004/35/EC). With regard to soils, a specific European legislation for their protection, the European Soil Monitoring Law, is currently being developed. However, it is crucial that this law bridges the gaps between existing chemical regulations and that it aligns with current European strategies for environmental protection and sustainability. Continuous feedback of soil monitoring results to regulatory frameworks will be essential. This feedback loop ensures that chemical regulations are relevant and effective in protecting soil health. In this context, development and sharing of effective and practical procedures for recovering ecosystems from contamination are crucial. This was the case at the RemTech Europe meeting, which was held online and onsite in Ferrara, Italy, in September 2022. The discussion covered all aspects of environmental contaminants. It ranged from the basic understanding of these contaminants to the various types that pose a threat to organisms, studies of their environmental fate, detection methods, and sustainable practices for contaminant management. The special series dedicated to RemTech Europe 2022 is particularly relevant to these purposes and resulted in six articles that were selected from oral presentations. The articles emphasize the need for integrated approaches to risk management and remediation to address the problems of soil, sediment, and groundwater contamination. Integr Environ Assess Manag 2024;00:1-5. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

14.
Clin Ter ; 175(Suppl 2(4)): 153-157, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39101415

RESUMEN

Background: The issue of restraint has long been considered a difficult political and social situation, affecting both healthcare wor-kers and facilities. The practice of restraint is still widespread in many public and private care settings, but there is a lack of systemic studies capable of monitoring the phenomenon. The framing of the question essentially concerns the right to personal freedom, guaranteed by the Italian Constitution. Materials and Methods: An anonymous questionnaire was developed containing questions on knowledge of the regulations on restraints, how, ways, and when they are implemented, and general information such as age, gender, educational qualification, qualification, O.Us. to which they belong. The collected data were statistically processed (Chi-square test) with the Epi Info 7.1.5 program (CDC-Atlanta- USA). A total of 1002 questionnaires were completed. The stratification of the sample by structure shows that 73.9% were public facilities. The indicative figure is represented by the 23.8% of respondents who say that "the restraint is not noted in the medical record". Conclusions: Restraint could be a real risk for the healthcare worker, encroaching on the issue of health liability. It is therefore important to raise awareness among healthcare professionals and top management of the need to structure, at company level, procedures that comply with the "Recommendations on physical restraint" to overcome the use of restraint through the improvement of care pathways in compliance with organizational and risk management standards.


Asunto(s)
Restricción Física , Restricción Física/ética , Restricción Física/legislación & jurisprudencia , Restricción Física/estadística & datos numéricos , Humanos , Italia , Masculino , Femenino , Adulto , Persona de Mediana Edad , Encuestas y Cuestionarios , Hospitales , Responsabilidad Legal
15.
Clin Ter ; 175(Suppl 2(4)): 158-161, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39101416

RESUMEN

Background: In the hospital environment, any liability for organizational inadequacy and/or inefficiency, or again for defects in the facilities, or inadequacy of health equipment may be found in the work of the apex professional figures: Medical Director, the General Manager, and/or others. The responsibility for the internal organization of the department falls on the figure of the Director of the Complex Structure where the deficiencies have not been promptly and adequately reported to the top figures. Case Report: A woman 61-year-old, was admitted on a voluntary basis to the Department of Psychiatry. On the third day, in the early morning hours, the patient was found on the ground floor, lying on the floor near the entrance door of the ward with a lacerated contusion wound to the head. The woman underwent total body CT examination with findings of fractured polytrauma as well as subarachnoid hemorrhage and complete fracture of the spleen, which was surgically removed. Three days later, despite the care given, death occurred. The injuries ascertained were consistent with voluntary precipitation from the second-floor stairwell window. The investigations conducted by the police and the checks carried out by the head of the Internal Prevention and Protection Service and the company's Risk Manager, highlighted multiple critical issues. Conclusion: The case allows for numerous considerations relating to liability profiles in the determinism of the patient's death, the hospital's company failure to implement measures to prevent the patient's suicide in the hospital was influential.


Asunto(s)
Responsabilidad Legal , Humanos , Femenino , Persona de Mediana Edad , Sicilia , Suicidio Completo , Resultado Fatal
16.
Behav Genet ; 54(5): 375-385, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39078541

RESUMEN

Regular cigarette smoking and cannabis consumption are strongly positively related to each other, yet few studies explore their underlying variation and covariation. We evaluated the genetic and environmental decomposition of variance and covariance of these two traits in twin data from three countries with different social norms and legislation. Data from the Netherlands Twin Register, FinnTwin12/16, and the Minnesota Center for Twin Family Research (total N = 21,617) were analyzed in bivariate threshold models of lifetime regular smoking initiation (RSI) and lifetime cannabis initiation (CI). We ran unstratified models and models stratified by sex and country. Prevalence of RSI was lowest in the Netherlands and prevalence of CI was highest in Minnesota. In the unstratified model, genetic (A) and common environmental factors (C) contributed substantially to the liabilities of RSI (A = 0.47, C = 0.34) and CI (A = 0.28, C = 0.51). The two liabilities were significantly phenotypically (rP = 0.56), genetically (rA = 0.74), and environmentally correlated in the unstratified model (rC = 0.47and rE = 0.48, representing correlations between common and unique environmental factors). The magnitude of phenotypic correlation between liabilities varied by country but not sex (Minnesota rP ~ 0.70, Netherlands rP ~ 0.59, Finland rP ~ 0.45). Comparisons of decomposed correlations could not be reliably tested in the stratified models. The prevalence and association of RSI and CI vary by sex and country. These two behaviors are correlated because there is genetic and environmental overlap between their underlying latent liabilities. There is heterogeneity in the genetic architecture of these traits across country.


Asunto(s)
Fumar Tabaco , Humanos , Masculino , Femenino , Países Bajos/epidemiología , Adulto , Finlandia/epidemiología , Minnesota/epidemiología , Adolescente , Prevalencia , Adulto Joven , Persona de Mediana Edad , Fenotipo , Gemelos Dicigóticos/genética , Fumar Marihuana/genética , Fumar Marihuana/epidemiología , Gemelos Monocigóticos/genética , Sistema de Registros , Fumar/genética , Fumar/epidemiología
17.
Int J Toxicol ; 43(5): 435-455, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39031995

RESUMEN

Nonclinical safety studies are typically conducted to establish a toxicity profile of a new pharmaceutical in clinical development. Such a profile may encompass multiple differing types of animal studies, or not! Some types of animal studies may not be warranted for a specific program or may only require a limited evaluation if scientifically justified. The goal of this course was to provide a practical perspective on regulatory writing of a dossier(s) using the weight of evidence (WOE) approach for carcinogenicity, drug abuse liability and pediatric safety assessments. These assessments are typically done after some clinical data are available and are highly bespoke to the pharmaceutical being developed. This manuscript will discuss key data elements to consider and strategy options with some case studies and examples. Additionally, US FDA experience with dossier(s) including WOE arguments is discussed.


Asunto(s)
Trastornos Relacionados con Sustancias , Humanos , Animales , Estados Unidos , Niño , Pruebas de Carcinogenicidad , Medición de Riesgo , United States Food and Drug Administration , Carcinógenos/toxicidad , Evaluación Preclínica de Medicamentos/métodos
18.
Clin Ter ; 175(4): 203-207, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39010801

RESUMEN

Background: Tracheal injury may be a rare complication of the endotracheal intubation procedure. Incidence and determinant factors are not well known, nevertheless a greater incidence have been recognized with a difficult maneuver or the use of nitrogen peroxide. The therapeutic approach can be conservative or surgical, depending on the characteristics of the lesion and of the patient and therefore the outcomes of medico-legal interest can be different. Case description: It is a case of alleged medical liability regarding a 70-year-old woman, that during the intubation procedure was pouncing on the right. Furthermore, nitrous oxide was used as an anaesthetic. A few hours after the operation the patient showed swelling on the right half of the face and on the right lateral region of the neck. The emergency chest CT scan highlighted subcutaneous emphysema and pneumomediastinum. In the operating room, fibrobronchoscopy was performed with a double-lumen bronchial tube which confirmed the hypotheses lesion; then, right posterolateral thoracotomy was perfor-med followed by suturing of the tracheal lesion. Subsequently, the patient was discharged in good clinical conditions but with a scar in the region of the right hemithorax. Conclusions: Iatrogenic tracheal injury is a rare and fearful complication of the orotracheal intubation procedure. Although risk factors that increase the probability of its onset have been recognized, in most cases it is not possible to identify the cause. From a medico-legal point of view, tracheal injury after intubation is unpredictable and inevitable, so in the case reported it was decided to proceed with a conciliatory solution.


Asunto(s)
Intubación Intratraqueal , Tráquea , Humanos , Intubación Intratraqueal/efectos adversos , Anciano , Femenino , Tráquea/lesiones , Rotura/etiología , Gestión de Riesgos , Enfermedad Iatrogénica , Enfisema Subcutáneo/etiología , Responsabilidad Legal
19.
Clin Ter ; 175(Suppl 1(4)): 36-39, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39054978

RESUMEN

Background: At the end of a long definition and legislative process (Law No.3 of 11 January 2018 and DPR No 131 of 2021), started under the thrust of the European directives, with the Decree of the Ministry of Universities and Research of 29 November 2023, in agreement with the Minister of Health, osteopathy in Italy has become a healthcare profession in all respects. Materials and Methods: In order to understand the current legislative and professional position of the Osteopath, research of the original definitions and the history of the profession has been carried out, assessing an overview of the current situations among EU countries. Therefore, an analysis of the current Italian legislation has been carried out in a medical-legal key, with a critical eye aimed above all at assessing the current shortcomings. Conclusions: The inclusion of osteopathy as a healthcare profession in Italy is a significant step towards the regulation and recognition of this practice, implying considerable innovations both in terms of access to the profession, both in the field of the professional health responsibility. Even if with the Decree of 29 November 2023, a significant step forward has been made, further regulatory and control measures are needed to ensure the quality, safety, and effectiveness of osteopathic treatments, as well as the protection of patients and the professionalism of operators.


Asunto(s)
Medicina Osteopática , Italia , Medicina Osteopática/legislación & jurisprudencia , Humanos , Rol Profesional , Médicos Osteopáticos/legislación & jurisprudencia
20.
Clin Ter ; 175(4): 226-233, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39010806

RESUMEN

Background: Mistrust of doctors and the desire for compensation are driving a rise in malpractice litigation worldwide. Aim: To estimate the extent to which Italians view birth complications as malpractice in obstetric care, and how widespread this perception is. Method: WhatsApp® and Facebook® contacts of one of the authors were invited to respond to an online questionnaire. The answers of 265 Italian respondents were used to estimate how common the perception of obstetric staff errors is and how this perception spreads over time: the denigration curve. To test if the denigration curve is reliable, the curve has been plotted along with the trend of the rate of litigation in Italy. Results: Almost a 50% of respondents deemed that birth complications are due to obstetric staff errors. The likelihood of the percep-tion that one has experienced a birth complication was 64.5%. The communication of obstetric staff error seemed low overall among the respondents. The denigration curve shape is almost coincident with the curve of claim rates in Italy, proving that it would be reliable. Conclusion: The respondents provided an estimate of the rate of birth complications that was higher than the real occurrence rate, and attributed these complications to obstetric staff errors. The denigration curve could predict whether and when there might be litigation related to any birth complications (both error related and non-error related).


Asunto(s)
Comunicación , Mala Praxis , Errores Médicos , Obstetricia , Humanos , Italia , Errores Médicos/estadística & datos numéricos , Femenino , Embarazo , Mala Praxis/estadística & datos numéricos , Adulto , Encuestas y Cuestionarios , Masculino , Actitud del Personal de Salud , Complicaciones del Trabajo de Parto/epidemiología , Persona de Mediana Edad
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