Opinion & Special Articles: Shared Decision-Making During the COVID-19 Pandemic: Three Bullets in 3 Hemispheres.

Patients with traumatic brain injury may be dependent on the decision-making of their families. Restrictive visitation policies implemented during the coronavirus disease 2019 (COVID-19) pandemic disproportionately affect these patients and their families. This narrative aims to illustrate this phenomenon and catalyze discussions regarding the need for careful evaluation of restrictive family visitation policies and exceptions that may be required for patients with brain injuries.

Availability of Internationally Controlled Essential Medicines in the COVID-19 Pandemic.

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access.

Knowledge of the law about withholding or withdrawing life-sustaining treatment by intensivists and other specialists.

OBJECTIVE: Decisions about withholding or withdrawing life-sustaining treatment (WWLST) from adults who lack capacity are an integral part of intensive care (IC) practice. We compare the knowledge, attitudes and practice of intensivists in relation to the law about WWLST with six other specialties most often involved in end-of-life care. DESIGN, SETTING AND PARTICIPANTS: We used a cross-sectional postal survey of medical specialists in the three most populous Australian states, and analysed responses from 867 medical specialists from the seven specialties most likely to be involved in WWLST decisions in the acute-care setting (emergency, geriatric, palliative, renal and respiratory medicine, medical oncology and IC). MAIN OUTCOME MEASURES: Attitudes to, and knowledge and practice of, the law relating to end-of-life care. RESULTS: Of 2702 surveys sent to eligible practitioners, 867 completed questionnaires were returned. There was an overall response rate of 32% and an IC response rate also of 32% (125/388). Intensivists performed better than average in legal knowledge but important knowledge gaps remain. Intensivists had a more negative attitude to the role of law in this area than other specialty groups but reported being seen as a leading source of information about legal issues by other medical specialists and nurses. Intensivists also reported being the specialists most frequently making decisions about end-of-life treatment. CONCLUSIONS: Improved legal knowledge and open engagement with the law can help manage the risk of harm to patients and protect intensivists from liability. IC guidelines and continuing professional development are important strategies to address these issues.

[Pharmacogenetics in anesthesia and intensive care medicine : Clinical and legal challenges exemplified by malignant hyperthermia]. / Pharmakogenetik in Anästhesie und Intensivmedizin : Klinische und juristische Herausforderung am Beispiel der Malignen Hyperthermie.

Pharmacotherapy is a key component of anesthesiology and intensive care medicine. The individual genetic profile influences not only the effect of pharmaceuticals but can also completely alter the mode of action. New technologies for genetic screening (e.g. next generation sequencing) and increasing knowledge of molecular pathways foster the disclosure of pharmacogenetic syndromes, which are classified as rare diseases. Taking into account the high genetic variability in humans and over 8000 known rare diseases, up to 20 % of the population may be affected. In summary, rare diseases are not rare. Most pharmacogenetic syndromes lead to a weakening or loss of pharmacological action. In contrast, malignant hyperthermia (MH), which is the most relevant pharmacogenetic syndrome for anesthesia, is characterized by a pharmacologically induced overactivation of calcium metabolism in skeletal muscle. Volatile anesthetic agents and succinylcholine trigger life-threatening hypermetabolic crises. Emergency treatment is based on inhibition of the calcium release channel of the sarcoplasmic reticulum by dantrolene. After an adverse pharmacological event patients must be informed and a clarification consultation must be carried out during which the hereditory character of MH is explained. The patient should be referred to a specialist MH center where a predisposition can be diagnosed by the functional in vitro contracture test from a muscle biopsy. Additional molecular genetic investigations can yield mutations in the genes for calcium-regulating proteins in skeletal muscle, e.g. ryanodine receptor 1 (RyR1) and calcium voltage-gated channel subunit alpha 1S (CACNA1S). Currently, an association to MH has only been shown for 35 mutations out of more than 400 known and probably hundreds of unknown genetic variations. Furthermore, MH predisposition is not excluded by negative mutation screening. For anesthesiological patient safety it is crucial to identify individuals at risk and warn genetic relatives; however, the legal requirements of the Patients Rights Act and the Human Genetic Examination Act must be strictly adhered to. Specific features of insurance and employment law must be respected under consideration of the Human Genetic Examination Act.

Emergency ECT in an incapacitated, medically compromised patient with Huntington's disease.

Electroconvulsive therapy (ECT) is infrequently considered an "emergency" medical procedure; however, there are certain conditions in which there is considerable urgency to initiate ECT. For example, prompt administration of ECT to treat neuroleptic malignant syndrome and malignant catatonia is necessary to improve a patient's overall prognosis and potentially save the patient's life. In this case, a 57-year-old woman with Huntington's disease was admitted to our medical intensive care unit for failure to thrive due to severe psychotic symptoms. Prior to her admission, the patient had become increasingly psychotic and agitated, resulting in her refusal and/or inability to eat. Efforts to treat her severe psychiatric and behavioral symptoms with various psychopharmacological strategies were largely unsuccessful. As the patient's physical health continued to decline, with loss of approximately 35 pounds over 2 months, her family began making arrangements to transfer her to a hospice facility. The day before she was to be transferred, the psychiatry consultation-liaison service recommended ECT. Unfortunately, this recommendation was complicated because the patient was unable to provide consent. This case report describes the legal and administrative process used to ethically and legally administer ECT without consent from the patient or a court-appointed guardian in order to treat a life-threatening condition. To the best of our knowledge, this report documents the first time ECT has been granted "medical emergency" status in Texas.

[From medical complication to compensation for the prejudice]. / De la complication médicale à l'indemnisation du préjudice.

Claims in anesthesia and intensive care remains high, despite the reduction of morbidity and mortality associated with this activity. The absence of a national register makes it difficult to quantify. The Medical Committee of MACSF-Sou Medical Group, professional liability insurer of more than half of French physicians, provided us support. The amount of compensation paid is growing and the scope of compensated damage is expanded by the Dintilhac mission. The Act of March 4, 2002 has fully confirmed the principle of medical liability for misconduct. Generally, compensation for bodily injury is based on the demonstration of a causal link between a wrongful event and injury. The proof of fault lies with the applicant. Information accountable to patients and nosocomial infection are a particular setting. The Act of March 4, 2002 has also defined the concept of therapeutic risk. With the establishment of the Regional Commissions of Conciliation and Compensation (RCCI) and the National Office for Compensation of Medical Accident (Oniam), it is now possible for a patient to be compensated for an injury resulting from an accident Medical non-offending, while acknowledging the lack of accountability of the practitioner. The expertise conducted by an RCCI is adversarial. For the practitioner called to the cause, it is important to prepare for both substance and form, with the assistance of the medical board's insurance company.

[Ethical aspects in end-of-life care]. / Ethische Aspekte in der Therapie am Lebensende.

Therapy decisions in the care of critically ill and dying patients in intensive care and emergency medicine must reflect probably conflicting issues of medical indications, ethics and law. This is of particular relevance when treatment preferences of patients are not known or are in contrast to those of the carers. Difficulties regarding prognostication or with determining the beginning of an irreversible dying process may also lead to treatment situations that need ethical reflection. It is recommended to tackle medico-ethical issues by discussion of the meaning of relevant terms and medico-ethical principles, analyzing the professional self-image in intensive care and emergency medicine, consideration of options of palliative medicine and by use of an ethics case consultation.

[End of life decisions, the Dutch form through Spanish eyes]. / Toma de decisiones al final de la vida, el modo neerlandés a traves de ojos españoles.

Abroad, but also in The Netherlands, there are many misunderstandings concerning end of life decisions and euthanasia. In general, euthanasia does not play any role in the intensive care units, simply because it does not fulfill the conditions to carry it out. However, there is still confusion, merely due to the assumption that the Dutch situation is different because of their legislation on euthanasia. The use of the unclear terminology such as "passive euthanasia", "voluntary euthanasia" or "involuntary euthanasia" contributes to the confusion of lay people and physicians, and should therefore be avoided. End of life decisions in intensive care patients are in fact a structural part of work of intensivists. Collecting all necessary information including the wishes and will of the patient, medical expertise and acknowledging limitations of medical treatment will help to determine futility of treatment goals. Once it is determined that surviving the intensive care unit with a quality of life acceptable for the patient is beyond reach, the goal of treatment should be improved and the dying process optimized. Stopping a treatment modality at the request of a will-competent patient or because of futility is not euthanasia.

The use of mobile computed tomography in intensive care: regulatory compliance and radiation protection.

The use of mobile head computed tomography (CT) equipment in intensive care is of benefit to unstable patients with brain injury. However, ionising radiation in a ward environment presents difficulties due to the necessity to restrict the exposure to staff and members of the public according to regulation 8(1-2) of the Ionising Radiation Regulations 1999. The methodology for enabling the use of a mobile head CT unit in an open ward area is discussed and a practical solution given. This required the reduction in scatter doses through the installation of extra internal and external shielding, and a further reduction in annual scatter dose by restricting the use of the equipment based on a simulation of the annual ward workload.

Informed consent in the critically ill: a two-step approach incorporating delirium screening.

OBJECTIVES: Sedation-agitation and delirium are common in critically ill patients and may be important barriers to informed consent. We describe a two-step process for informed consent and evaluate the natural history of patients' competency by repeated application of this process during their hospitalization. DESIGN: Observational study. SETTING: Nine intensive care units (ICUs) in three teaching hospitals in Baltimore, MD. PATIENTS: One hundred fifty patients with acute lung injury. INTERVENTIONS: Two-step process involving objective evaluation with Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (step 1), followed by traditional assessment for competency (step 2) in those patients passing step 1. MEASUREMENTS AND MAIN RESULTS: RASS and CAM-ICU assessments (during ICU stay, at consent and hospital discharge); cumulative proportion of patients providing consent at extubation and at ICU and hospital discharge. Of 150 patients, 86 (57%) survived and 77 (90% of survivors) provided consent. Patients were delirious/deeply sedated in 89% of daily assessments during mechanical ventilation. By extubation, 31 (44%) patients passed step 1 and 8 (11%) passed step 2 and were consented. By ICU and hospital discharge, these numbers were 50 (58%) and 18 (21%), and 81 (94%) and 67 (78%), respectively. The median (interquartile range) time to patient consent after acute lung injury diagnosis was 15 (9-28) days. CONCLUSIONS: More than three fourths of critically ill patients are unable to provide informed consent throughout their ICU stay, even after extubation. Sedation-agitation and delirium are common barriers to consent. A two-step consent process, using validated instruments for sedation-agitation and delirium, provides a means of rapidly screening critically ill patients before a more detailed traditional assessment of competency is conducted.

Legal issues in the practice of critical care medicine: a practical approach.

The intensive care unit is characterized by severely ill patients who frequently succumb to their disease, despite complex modern therapies and the best efforts of dedicated care teams. Although critical care is not historically characterized as a high-risk medical specialty with respect to litigation, the urgency, complexity, and invasive nature of intensive care unit care clearly increases legal risk exposure. Physicians do not practice in a vacuum. Instead, the practice of medicine is increasingly affected by government regulation, societal pressures, and pubic expectations. Law governs the interactions among the government, institutions, and individuals. Therefore, at a time when the practice of medicine itself is becoming increasingly more complex, physicians and other healthcare providers also face increasing administrative and legal challenges. Therefore, it is imperative that physicians develop an understanding of basic substantive and procedural law; first, so that their practices can be more focused and rewarding and less a fear of the unknown; second, that we can work proactively to minimize our legal risk; third, so that we can better communicate with risk managers, attorneys, and insurers; and finally, so that we can better understand and participate in future legal, legislative, regulatory, and public policy development. Accordingly, this general overview briefly addresses the substantive law of medical malpractice, informed consent, the law relating to research in critical care, Emergency Medical Treatment and Active Labor Act, the False Claims Act, peer review, state board disciplinary issues, and the Health Insurance Portability and Accountability Act; in addition, relevant procedural considerations will be briefly summarized.