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.

Teaching Ethics and Professionalism: A National Survey of Ophthalmology Residency Program Directors.

Background While ethics and professionalism are important components of graduate medical education, there is limited data about how ethics and professionalism curricula are taught or assessed in ophthalmology residency programs. Objective This study aimed to determine how U.S. ophthalmology residency programs teach and assess ethics and professionalism and explore trainee preparedness in these areas. Methods Directors from accredited U.S. ophthalmology residency programs completed an online survey about components of programs' ethics and professionalism teaching curricula, strategies for assessing competence, and trainee preparedness in these areas. Results Directors from 55 of 116 programs (46%) responded. The most common ethics and professionalism topics taught were informed consent (38/49, 78%) and risk management and litigation (38/49, 78%), respectively; most programs assessed trainee competence via 360-degree global evaluation (36/48, 75%). While most (46/48, 95%) respondents reported that their trainees were well or very well prepared at the time of graduation, 15 of 48 (31%) had prohibited a trainee from graduating or required remediation prior to graduation due to unethical or unprofessional conduct. Nearly every program (37/48, 98%) thought that it was very important to dedicate curricular time to teaching ethics and professionalism. Overall, 16 of 48 respondents (33%) felt that the time spent teaching these topics was too little. Conclusion Ophthalmology residency program directors recognized the importance of an ethics and professionalism curriculum. However, there was marked variation in teaching and assessment methods. Additional work is necessary to identify optimal strategies for teaching and assessing competence in these areas. In addition, a substantial number of trainees were prohibited from graduating or required remediation due to ethics and professionalism issues, suggesting an impact of unethical and unprofessional behavior on resident attrition.

When Specialty Care Is Unavailable to Rural Families.

We present the case of a 2-year-old boy with epidermolysis bullosa and supraglottic stenosis whose parents refuse an elective tracheostomy because of the significant care the tracheostomy would require. The patient's family lives in a rural area with few health care resources and his parents are already handling hours of daily skin care for his epidermolysis bullosa. In an attempt to convince the parents to pursue the intervention, the medical team recommends that the family move to an area with additional resources to assist in the child's care. The parents refuse to move, citing the many benefits their home environment provides for their son. The medical team calls an ethics consultation, questioning whether this decision constitutes medical neglect. This case raises important questions about medical decision-making in pediatrics. First, is a parent's refusal of a recommended medical intervention because it would require moving their family to a new environment a reasonable decision? Second, how broadly can parents define their child's best interest? Should only physical interests be included when making medical decisions? Is there a limit to what can be considered a relevant interest? Third, can parents only consider the interests of the individual child, or can they consider the interests of other members of the family? Finally, what is the threshold for overruling a parental decision? Is it whenever the parent's definition of a patient's best interest is different from the medical team's, or do other criteria have to be met?

Systematic Review of Typologies Used to Characterize Clinical Ethics Consultations.

INTRODUCTION: Classifying the ethical issues in clinical ethics consultations is important to clinical practice and scholarship. We conducted a systematic review to characterize the typologies used to analyze clinical ethics consultations. METHODS: We identified empirical studies of clinical ethics consultation that report types of ethical issues using PubMed. We screened these articles based on their titles and abstracts, and then by a review of their full text. We extracted study characteristics and typologies and coded the typologies. RESULTS: We reviewed 438 articles; 30 of the articles fulfilled our inclusion criteria. We identified 27 unique typologies. Each typology contained five to 47 categories (mean was 18). The most common categories were DNAR (do-not-attempt-resuscitation) orders (19 of the 27 typologies, or 70 percent), capacity (18 of the typologies, or 67 percent), withholding (18 of the typologies, or 67 percent), withdrawing (17 of the typologies, or 63 percent), and surrogate or proxy (16 of the typologies, or 59 percent). Only seven (26 percent) of the typologies contained all five of the most common categories. The typologies we used to characterize clinical ethics consultation exhibit significant heterogeneity and several conceptual limitations. A common typology is needed whose development may require multi-institutional collaboration and could be facilitated by professional organizations.