2.1.3 Disclosure of Adverse Events
Maggie Constantine, MD, FRCPC; and Irene Sadek, MD, FRCPC
- To understand the ethical issues related to disclosure of medical information
- To identify the potential benefits and harms of disclosure of medical information
- To examine potential methods of disclosure of medical information
As the resident member of your hospital's ethics committee, you have been asked to advise the Director of Blood Transfusion, who has requested advice on the following situation. Mrs. S., a 45-year-old woman, is currently an in-patient receiving chemotherapy for the treatment of a malignancy. She has consented to transfusion support with blood products as part of her treatment and has thus far received several units of blood products.
The implementation of West Nile Virus (WNV) nucleic acid testing of donated blood units commenced in July 2003 and was undertaken by your local blood manufacturer. The purpose of this testing is to prevent the transmission of WNV infection through the blood supply. Once a donor tests positive for WNV, he or she is notified of the positive test result, and the corresponding products are quarantined and removed from supply or, if already distributed to a hospital, are recalled. As this testing was being implemented, in areas with high levels of activity of WNV, the blood manufacturer quarantined and recalled plasma products from your hospital to prevent the potential transmission of WNV through these untested products.
Upon being notified of this recall of blood products, you initiate the process to locate these units. Unfortunately, only three of the eight blood products could be returned to your blood manufacturer for destruction. The other five units were transfused to Mrs. S. Although Mrs. S. remains immunosuppressed from chemotherapy, she is currently clinically stable and well.
The majority of persons infected with WNV are asymptomatic, with symptoms occurring in approximately 20% of those infected. The most common manifestation is an acute febrile illness with symptoms generally lasting three to 10 days. A much less common manifestation, occurring in less than 1% of the cases, is neurologically invasive disease. This is characterized by encephalitis, muscle weakness, flaccid paralysis and other neurologic abnormalities. The rates of this complication are higher in immunosuppressed patients. Currently, treatment remains largely supportive.
- Is there an ethical obligation to notify Mrs. S. of the potential, although unconfirmed, risk of WNV infection in the blood products she has received?
- What potential benefits and harms may arise out of the disclosure of this information to Mrs. S.?
- Is there an ethical justification for withholding this information from Mrs. S.?
- If this information is to be disclosed to Mrs. S., what should be discussed with her?
- If this information is not to be disclosed to Mrs. S., what alternatives are available?
- What is the legal concept of material risk, and how does it apply to this case?
In conclusion, there is an ethical obligation on the part of the physician to maintain an open relationship with the patient, one that is based on honesty and trust. The respect for patient autonomy is important to ensure that patients are able to make informed decisions about their health care. The ethical obligation to disclose information that may have an unclear and uncertain impact on the patient is not always clear, and disclosure of such information should not be done in a way to unburden the physician. Potential benefits and harms of disclosure should be carefully considered.
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