Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.

The US Food and Drug Administration (FDA) approval of the biologics license application for the Pfizer-BioNTech coronavirus disease 2019 vaccine (Comirnaty) on August 23, 2021, opened the door to the off-label vaccination of children younger than the age range currently covered by either the biologics license application (16 years old and older) or the emergency use authorization (12 to 15 years old). Although prescribing medications at doses, for conditions, or in populations other than those approved by the FDA is generally legal and is common in pediatrics, the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics have recommended against off-label prescription of the coronavirus disease 2019 vaccine. Several commentaries consider a case in which parents ask their child's pediatrician to prescribe the vaccine for their 11-year-old with special health care needs before approval or authorization in her age group. The first commentary considers the potential benefits and risks to the patient, as well as to the family, the provider, and society, emphasizing the unknown risks in younger patients and the need for adequate informed consent. The second commentary describes an algorithm and principles for evaluating off-label prescribing and argues that the current benefits of prescribing Comirnaty off label to children <12 do not outweigh the risks. The third commentary addresses ethical and legal issues, ultimately calling on federal agencies to remove legal barriers to making the vaccine available to children in age groups that currently lack authorization.

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

Importance: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. Objective: To identify and characterize high-risk devices with pediatric age indications derived from PMA statements. Design, Setting, and Participants: In this cross-sectional study of PMA statements, those statements containing the words indicated or intended for medical devices listed in the FDA PMA database as of February 2020 were retrieved. Age indications were manually annotated in these approval statements via PubAnnotation. Based on the PMA identification from the PMA statements, device metadata including product codes, regulation numbers, advisory panels, and approval dates were queried. Main Outcomes and Measures: The main outcome was discernment of the distribution of devices indicated for the pediatric population (neonate, infant, child, and adolescent). Secondary measures included outlining the clinical specialties, device types, and lag time between the initial approval date and the first date of an approval statement with a pediatric indication for generic device categories. Results: A total of 297 documents for 149 unique devices were analyzed. Based on the manual age annotations, 102 devices with a pediatric indication, 10 with a neonate age indication, 32 with an infant age indication, 60 with a child age indication, and 94 with an adolescent age indication were identified. For indications for patients from age 17 to 18 years, the number of devices available nearly doubled from 42 devices to 81 devices. Although more than half of the surveyed devices had a pediatric age indication, many were available only for a limited range of the pediatric population (age 18-21 years). For indications for patients from age 0 to 17 years, the mean (SD) number of clinical specialties at each age was 7.27 (1.4), and 12 clinical specialties were represented from ages 18 to 21 years. Conclusions and Relevance: In this cross-sectional study on device PMA statements, a gap was identified in both quantity and diversity of high-risk devices indicated for the pediatric population. Because the current scarcity of pediatric devices may limit therapeutic possibilities for children, this study represents a step toward quantifying this scarcity and identifying clinical specialties with the greatest need for pediatric device innovation and may help inform future device development efforts.

Vigilando las palabras de la historia clínica / Watching the words of the medical history

Las reclamaciones judiciales en Pediatría son menos frecuentes que en otras especialidades médicas. Además, en la mayoría de los casos es posible demostrar que la actuación se ajustó a lex artis ad hoc. Sin embargo, es posible que una serie de errores durante la realización de la historia clínica compliquen el proceso judicial, aunque la praxis fuera correcta en todo momento. Por ello, es importante difundir entre los pediatras la importancia de la correcta redacción de la historia clínica, una herramienta que debemos saber utilizar no solo en beneficio de nuestros pacientes, sino también para evitar acciones judiciales que pueden perjudicar seriamente nuestra vida personal y nuestra carrera profesional. Basándome en mi propia experiencia como perito judicial desde 2009, en las siguientes líneas daré algunos consejos para vigilar lo que escribimos en la historia clínica, expondré en qué consiste un dictamen pericial y definiré cuáles son los principales tipos de reclamaciones a las que un médico puede estar expuesto (AU)

Analysis of lawsuits related to diagnostic errors from point-of-care ultrasound in internal medicine, paediatrics, family medicine and critical care in the USA.

PURPOSE: The purpose of this study is to identify the extent of diagnostic error lawsuits related to point-of-care ultrasound (POCUS) in internal medicine, paediatrics, family medicine and critical care, of which little is known. METHODS: We conducted a retrospective review of the Westlaw legal database for indexed state and federal lawsuits involving the diagnostic use of POCUS in internal medicine, paediatrics, family medicine and critical care. Retrieved cases were reviewed independently by three physicians to identify cases relevant to our study objective. A lawyer secondarily reviewed any cases with discrepancies between the three reviewers. RESULTS: Our search criteria returned 131 total cases. Ultrasound was mentioned in relation to the lawsuit claim in 70 of the cases returned. In these cases, the majority were formal ultrasounds performed and reviewed by the radiology department, echocardiography studies performed by cardiologists or obstetrical ultrasounds. There were no cases of internal medicine, paediatrics, family medicine or critical care physicians being subjected to adverse legal action for their diagnostic use of POCUS. CONCLUSION: Our results suggest that concerns regarding the potential for lawsuits related to POCUS in the fields of internal medicine, paediatrics, family medicine and critical care are not substantiated by indexed state and federal filed lawsuits.

"The Hopkins Mongol Case": The Dawn of the Bioethics Movement.

One of the earliest controversies in the modern history of bioethics was known at the time as "the Hopkins Mongol case," involving an infant with Trisomy 21 and duodenal atresia whose parents declined to consent to surgery. Fluids and feeding were withheld, and the infant died of dehydration after 15 days. The child's short life had a profound impact on the author's career and that of several others and ultimately led to changes in the care of children and adults with disabilities and the way difficult end-of-life decisions are made in US hospitals today. It also contributed to the growth of the modern bioethics movement and scholarship focused on pediatric bioethics issues.

First pediatric organ donation after circulatory determination of death in Singapore: Facing challenges in the absence of a local practice guideline.

Pediatric organ donation represents only a low proportion of overall organ donation in many parts of world, unable to match the needs for pediatric organ transplantation. Pediatric organ donation after circulatory determination of death (DCD) is increasingly explored in pediatric transplantation, as it increases the availability of organ grafts. A 6-year-old Caucasian boy with a history of arteriovenous malformation presented with a catastrophic intracranial bleed, resulting in severe brainstem dysfunction despite maximal medical and surgical measures. He did not fulfill the criteria for brain death, which must be met for pediatric organ donation in Singapore. Due to parental request, his organs were donated after withdrawal of life support and determination of death by circulatory criteria. Pediatric organ DCD poses many challenges in the pediatric population, especially in the absence of a local practice guideline. We present the first case of a pediatric organ DCD that has occurred in Singapore. Further work is needed, particularly in establishing a national policy for pediatric organ DCD and increasing overall awareness and acceptance toward pediatric organ donations.

National child death review statutory and operational guidance: Key concepts for practising paediatricians.

In October 2018, National Health Service England published new operational guidance for reviewing child deaths, which covers all children who die less than 18 years of age regardless of the cause of death. The Guidance is for all healthcare professionals caring for children as well as senior leaders who commission, provide or regulate children's services. It does not aim to be prescriptive but instead sets out a framework of expectations that intends to be flexible and proportionate. Its essential building blocks will be familiar to practising paediatricians: notification, investigation, review and reporting. It should be regarded as a key pillar in the hospital's governance program.

Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.

The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017 to authorize the US Food and Drug Administration (FDA) to require pediatric studies for new cancer drugs that have a molecular target relevant to the growth or progression of a pediatric cancer. To assess the possible scope of this new policy, we examined all 78 adult cancer drugs approved by the FDA from 2007 to 2017. Only 17 (21.8%) drugs received any pediatric labeling information. Based on the FDA's Pediatric Molecular Target List, we found that the RACE Act could have increased the proportion of cancer drugs potentially subject to pediatric study requirements from 0% to 78.2%. However, the actual effect of the legislation will depend on how often regulators require pediatric trials and on timely completion of such trials.

Pediatric drug development in China: Reforms and challenges.

In China, child and adolescent pediatricians often face challenges in treating children with the appropriate medications. Within the last 8 years, the Chinese government has already initiated a series of policies to promote development of age-appropriate medicines for children. In this study,we introduced the current status of pediatric drugs, obstacles for pediatric drugs development and regulatory reforms in China. The lack of label information in drugs for children, inadequacy of age-appropriate dosage forms and strengths, and shortage of pediatric drugs are some of the problems commonly faced. There exists neither mandatory requirements nor enough financial drivers for development of pediatric medicines. Though some progress in terms of pediatric drugs development as well as distribution have been made by Chinese government over past years, further efforts are necessary to improve availability of pediatric medications.

Electronic Communication of the Health Record and Information With Pediatric Patients and Their Guardians.

Communication of health data has evolved rapidly with the widespread adoption of electronic health records (EHRs) and communication technology. What used to be sent to patients via paper mail, fax, or e-mail may now be accessed by patients via their EHRs, and patients may also communicate securely with their medical team via certified technology. Although EHR technologies have great potential, their most effective applications and uses for communication between pediatric and adolescent patients, guardians, and medical teams has not been realized. There are wide variations in available technologies, guiding policies, and practices; some physicians and patients are successful in using certified tools but others are forced to limit their patients' access to e-health data and associated communication altogether. In general, pediatric and adolescent patients are less likely than adult patients to have electronic access and the ability to exchange health data. There are several reasons for these limitations, including inconsistent standards and recommendations regarding the recommended age for independent access, lack of routine EHR support for the ability to filter or proxy such access, and conflicting laws about patients' and physicians' rights to access EHRs and ability to communicate electronically. Effective, safe electronic exchange of health data requires active collaboration between physicians, patients, policy makers, and health information technology vendors. This policy statement addresses current best practices for these stakeholders and delineates the continued gaps and how to address them.

Shortage of paediatric radiologists acting as an expert witness: position statement from the British Society of Paediatric Radiology (BSPR) National Working Group on Imaging in Suspected Physical Abuse (SPA).

One of the most challenging areas of radiological imaging in children is the diagnosis of physical abuse. There is a dearth of paediatric radiologists willing to act as expert witnesses, particularly in the family courts. There are a number of reasons why radiologists may not be interested or willing to put themselves forward to work as expert witnesses in this field. A group of imaging experts recently formed the "British Society of Paediatric Radiology (BSPR) Working Group on Imaging in Suspected Physical Abuse (SPA)". The group comprises radiologists and neuroradiologists with current or previous experience of providing expert witness reports to the court in cases of SPA. The group met in January 2019 to explore pragmatic solutions to the chronic inefficiencies in both medical and legal practices and the challenges that arise from working in a legal arena with different structures, goals, and assessment criteria. Key issues concerned organisational inefficiencies, variable support from National Health Service Trusts and the Royal College of Radiologists to conduct this work, and the risk/benefit of involvement. This work is important for the patient, parents, and society in general, and highly rewarding for clinical practitioners who are involved, but there are several issues with current practices that discourage active participation. With several members of the group either retired or close to retirement, the shortage of experts is becoming a pressing issue within the UK, which requires an engaged multidisciplinary group to come up with creative solutions. Here, the group provide a consensus opinion highlighting the current barriers and potential facilitators to increasing the number of radiologists willing to provide opinions to the court.

Understanding Liability Risks and Protections for Pediatric Providers During Disasters.

Although most health care providers will go through their careers without experiencing a major disaster in their local communities, if one does occur, it can be life and career altering. The American Academy of Pediatrics has been in the forefront of providing education and advocacy on the critical importance of disaster preparedness. From experiences over the past decade, new evidence and analysis have broadened our understanding that the concept of preparedness is also applicable to addressing the unique professional liability risks that can occur when caring for patients and families during a disaster. Concepts explored in this technical report will help to inform pediatric health care providers, advocates, and policy makers about the complexities of how providers are currently protected, with a focus on areas of unappreciated liability. The timeliness of this technical report is emphasized by the fact that during the time of its development (ie, late summer and early fall of 2017), the United States went through an extraordinary period of multiple, successive, and overlapping disasters within a concentrated period of time of both natural and man-made causes. In a companion policy statement (www.pediatrics.org/cgi/doi/10.1542/peds.2018-3892), recommendations are offered on how individuals, institutions, and governments can work together to strengthen the system of liability protections during disasters so that appropriate and timely care can be delivered with minimal fear of legal reprisal or confusion.