Large-scale adverse events: Obligation to disclose?
If a provider tells patients they might have been exposed to a blood-borne pathogen when they actually weren't, then the patients worried needlessly when there was no actual health risk. There is also the risk that by not disclosing, a minority of patients will be harmed and have no idea, says Denise M. Dudzinski, PhD, MTS, associate professor and director of graduate studies in the Department of Bioethics & Humanities at the University of Washington School of Medicine. "On the other hand, by disclosing, patients can take behavioral steps to reduce transmission if they might have been exposed to an infectious agent," she says. Dudzinski argues that even if the risks are small or unknown at the time, disclosure is still required based on obligations to tell the truth, protect patients, and provide for their health care.1
"Depending on the seriousness of the potential injury, disclosure might come from an office or phone visit by a treating physician or through a letter from the institution," she says. Dudzinski says disclosure should include the following:
- what occurred;
- what the institution knows and does not know about what occurred;
- information about the level of risk;
- actions taken to prevent the incident from happening again;
- information on how to get follow-up testing and treatment, such as a hotline staffed by trained clinicians to field health-related questions;
- an expression of regret;
- a description of the plan for investigating the issue; and
- a promise to provide follow-up information as it is discovered.
"Disclosure might also require proactive calls to media outlets by the health care institution," she adds. While both the physician and the organization have obligations to disclose both individual and large-scale errors, an institution does not have a discrete therapeutic relationship with an individual patient like the doctor, notes Dudzinski. "An individual doctor is likely to address the disclosure within that therapeutic relationship, often sitting down with the patient and explaining what happened. This may not be possible when hundreds of people are affected."
While the message may be tailored to individual patients by a physician, the message should be consistent and uniform when disclosing to multiple people, and a multidisciplinary group of staff working at the institution should provide input on how to disclose, advises Dudzinski. "An individual clinician might not enlist too many other people before disclosing, but the organization should because the process of addressing the harm is more complex with multiple patients," she says. (See related story on the American Medical Association's recommendations, p. 130.)
Reference
- Dudzinski DM, Hebert PC, Foglia MB, et al. The disclosure dilemma — large-scale adverse events. N Engl J Med 2010;363:978-986.
Source
- Denise M. Dudzinski, PhD, MTS, Associate Professor & Director of Graduate Studies, Department of Bioethics & Humanities, University of Washington School of Medicine. E-mail: [email protected].
AMA gives ethical guidance on disclosure The American Medical Association (AMA) Code of Medical Ethics offers physicians guidance regarding an appropriate response to large-scale adverse events, says H. Rex Greene, MD, chair of the AMA Council on Ethical and Judicial Affairs. The issues are discussed in AMA ethical opinion E-9.032, "Reporting Adverse Drug or Device Events," which states that a physician who "suspects the occurrence of an adverse reaction to a drug or device has an obligation to communicate that information to the broader medical community." "When there is a serious adverse event defined by death, hospitalization, or medical or surgical intervention, it should be reported to the FDA [Food & Drug Administration]," says Greene. When physicians are faced with ambiguity surrounding an adverse event, the AMA ethical opinion states that "certainty, or even reasonable likelihood, of a causal relationship between the drug or medical device and the serious adverse event will rarely exist and is not required before reporting the event to the FDA." In these situations, the burden is on the physician to report the event, he underscores. "Physicians work every day to provide patients with the best care and to ensure their safety, but when mistakes occur, physicians should openly discuss them with their patients," says Greene. AMA ethical opinion E-8.12 "Patient Information" states that in these situations, "the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred." "We understand that many physicians fear that the acknowledgment of error can be used against them in the courtroom," says Greene. "However, studies show a clear benefit when physicians set aside liability concerns and openly discuss mistakes with patients."1 AMA ethical opinion E-8.121, "Ethical Responsibility to Study and Prevent Error and Harm," emphasizes an institution's responsibility to provide effective and confidential review processes for reporting adverse events and errors. "Doing so enhances patient safety by giving physicians an established method of handling these situations," says Greene. Reference
|
If a provider tells patients they might have been exposed to a blood-borne pathogen when they actually weren't, then the patients worried needlessly when there was no actual health risk.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content