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.
But what is an otolaryngologist’s responsibility to disclose what are termed “near misses” and “no-harm events?” One could certainly pose the argument that, because these events didn’t result in actual harm to the patient, it shouldn’t be necessary to disclose. After all, where there is “no harm,” there is “no fault.” Events such as these, whether acts of omission or commission, occur fairly commonly and, depending on the proximity of the event to a true harm, may not rise to a patient’s awareness. Why should otolaryngologists disclose something that wasn’t really a “happening”? The answer lies in three domains: our professional duties to the patient, our ethical obligations to the patient, and our fiduciary responsibilities to society.
Near Misses and No-Harm Events
We all understand the concepts of near misses and no-harm errors/events. A near miss is an event that didn’t reach the patient because of timely intervention or luck. A no-harm event reached the patient in some manner but caused no real harm. This isn’t to say that the same event might not cause harm if repeated in the future with the same or another patient. The nuanced difference between the two types of events isn’t necessarily significant with respect to the need to disclose, as either may have the potential for repetition and a different outcome if not properly addressed. Although we wish to never have a near miss or no-harm event, if one does occur, we are obliged to act to prevent any further occurrences, and disclosure is the first step in prevention.
Near misses and no-harm events occur quite regularly in life: We or someone else may catch us when we trip, preventing a fall; another car swerves into our lane on the highway and we brake suddenly because no one is close behind us; we’re about to say something unseemly about a co-worker when we notice they’re entering the room. We read about near misses by aircraft and watch videos of trains nearly hitting cars on the tracks.
These events occur not only in life, but also in patient care, and we must always be on the lookout for them. We cannot become lackadaisical about their potential for occurring—think “Murphy’s Law of Medicine”: If something can go wrong it will, and if it doesn’t, we don’t know about it yet. The aviation industry has been a leader in identifying, preventing, and dealing with near misses. Identification, disclosure, and discussion that lead to changes in protocols, with a subsequent feedback loop, are fundamental to root–cause analysis and risk reduction. The same process applies well to healthcare, where patients’ health is at stake.
Our Responsibility
Our professional duties to patients with respect to near misses and no-harm events are fundamentally values-based. The unique patient–physician relationship at its best is based on honesty, trust, forthrightness, compassion, and understanding. Underpinning these values is the need for meaningful communication between the patient and physician that leads to an appropriate shared medical decision-making process. Patients deserve to know all facets of information regarding their health status, which, in turn, informs their choice of placing their trust in their physician. Any health issue, decision, or risk purposefully withheld from patients could potentially undermine trust or shift the balance of the shared decision-making process toward paternalism. It’s far better to disclose near misses and no-harm events directly to patients as soon as possible, as it’s likely patients may learn of such events from other sources, eroding trust.
Ethical obligations also compel us to disclose based on the four principles of medical ethics. Autonomy requires that patients be informed of all aspects of their health, including real or potential risks, to make self-determined decisions. Failure to disclose near misses and no-harm events may deprive the patient of information that could be important and may jeopardize future informed consents.
The dyad of beneficence and nonmaleficence begs for balance in the sense that disclosure provides for the patient’s welfare and recognizes the need to prevent future occurrences that could lead to harm. Social justice requires that all patients are treated fairly and equally. Legal requirements aren’t codified for disclosure of near misses and no-harm events, but they may soon follow, given the advent of new disclosure and apology standards for adverse outcomes.
Physicians have an additional fiduciary obligation to society in that distrust of physicians’ failure to act can become an indictment of the medical profession in general. Near miss and no-harm events shouldn’t be ignored. Quality improvement in medical care implies accepting responsibility for an event that occurs outside the boundaries of good care, cultivating an awareness of the potential effects an event might have had on a patient, and gaining an understanding of why that event should be analyzed for future safety management. Disclosure to the patient, and perhaps the family, including what, how, why, and the steps to be taken to prevent similar occurrences, will have a positive effect on the confidence a patient places in a physician.
Regarding the case scenario, computer and electronic health record crashes aren’t rare, and the circumstances require disclosure to the patient. Bringing Mrs. Smith back to an examination room or your office, preferably with an office staff member in attendance, for the purpose of disclosing the circumstances of concern and apologizing for putting her at risk is fundamental to recognizing her autonomy and your obligation to disclose. If she has not previously been advised to do so by her primary care physician, you could recommend that she purchase a medical ID bracelet indicating the prolonged QT interval syndrome. The responsible otolaryngologist would also discuss instituting new processes for preventing another potential medication error in the same and similar circumstances.
This was a no-harm event that could have resulted in harm save for the fortuitous and timely recovery of the patient’s medical information. Patient safety and ethical obligations should always be priorities, and disclosure should be patient centered and sincere.
Dr. Holt is professor emeritus and clinical professor in the department of otolaryngology–head and neck surgery at the University of Texas Health Science Center in San Antonio.