What Is a Physician’s Obligation to Disclose ‘Near-Miss’ and ‘No-Harm’ Events to Patients?

Clinical Scenario

You arrive at your office for a full day of patient visits before leaving the next day with your family for a week’s vacation out of town. As soon as you walk through the back entrance, your office manager rushes to inform you that the computer system is down and the electronic medical records on today’s patients aren’t currently available. Patients are already gathering in the waiting room, and cancelling all appointments for the day doesn’t seem to be a viable option. After some deliberation, you decide to continue with the appointments using temporary paper documents, hoping that the computer system can be restored by the service technician as quickly as possible.

The second patient you see, Sally Smith, is a 55-year-old female with a chief complaint of “sinus infection, laryngitis, and cough.” She has seen you previously for seasonal inhalant allergies, which have been controlled well with medical therapy. She’s fully vaccinated, and a self-administered COVID-19 test that morning is reported as negative. Her history and physical examination, including a flexible fiberoptic endoscopy, confirm the presence of an early, uncomplicated rhinosinusitis with mild laryngitis and bronchitis, likely associated with an aggravation of her allergies. Discharge in the right nasal cavity is cultured, and a presumed diagnosis of bacterial infection is made.

After discussing the treatment options with her, you and Mrs. Smith share the decision to initiate appropriate medical therapy, including prescribing azithromycin (using a paper prescription), as she has indicated an allergy to penicillinbased antibiotics.

As you escort her to the front desk to secure a follow-up appointment, you’re notified that the computer system is functional, and the electronic health record is now available. You begin to input your clinic note on Mrs. Smith when you see a new report from her primary care physician that indicates a recent diagnosis of “acquired prolonged QT interval syndrome” identified on an electrocardiogram. As you recognize the safety concern for prescribing azithromycin in this cardiac condition, you quickly intercept the patient as she’s about to leave the office.

Do you disclose this “near-miss” risk incident to the patient, or merely switch the antibiotic prescription to one that doesn’t have the associated cardiac risk? Read below for the discussion.

Discussion

In a previous Everyday Ethics discussion on the disclosure of adverse outcomes (“Physician, Heal Thyself,” ENTtoday, February 2015), the professional and ethical responsibilities to disclose were emphasized. The responsibility for disclosure, and the manner in which it should be performed, are now widely considered a standard of care and are codified in many states’ “apology” laws. There’s an ethical responsibility for a compassionate apology, based on the professional duties of veracity, compassion, and understanding. Grounded in the ethical principles of nonmaleficence and beneficence, a sincere apology also includes a discussion of why the adverse effect occurred, how it will be prevented in the future, what impact the event could have on the patient, and a reassurance that the otolaryngologist will support the patient as the adverse effects are addressed and, hopefully, mitigated. Disclosure of adverse events needs to be fully patient centered and heartfelt.