Informed Consent for Nursing Home Residents Q&A
1. For which conditions is informed consent required in a nursing
All residents with all conditions have a right to be
informed about their care and participate in care planning. Specific
requirements for written informed consent are found in Wis.
Admin.Code ch. DHS 94 Wis. Stats.
50.08. Chapter DHS 94 applies to residents receiving treatment for mental
illness, a developmental disability, alcohol abuse or dependency or other
drug abuse or dependency under Wis. Stat. Wis Stats.
50.08 is the new requirement for written informed consent for an individual with a
degenerative brain disorder who receives a psychotropic medication with a
black box warning.
2. What is a degenerative brain disorder?
WI Stats 55.01 (1v) "Degenerative brain disorder" means the loss or
dysfunction of an individual's brain cells to the extent that he or she [an
individual] is substantially impaired in his or her ability to provide
adequately for his or her own care or custody. Wis. Stats. 55.01 (1v)
3. Which medications require informed consent?
Psychotropic medications with a black box warning require written informed
4. What is a psychotropic medication?
"Psychotropic medication" means an
antipsychotic, an antidepressant, lithium carbonate, or a tranquilizer. Wis.
Stats. 50.08 (1)(d)
5. What is a black box warning?
A "boxed warning", also known as a "black box warning",
or a "black label warning" is named for the border surrounding the
text of the warning that appears on the package insert, label, and other
literature describing the medication (e.g., magazine advertising). It
is the most serious medication warning required by the FDA. All
antipsychotics and antidepressants along with many other psychotropic
medications have a black box warning.
6. If a resident has been on a medication for many years in our
facility do we need to now get informed consent?
Yes, if the medication is a psychotropic medication and has a boxed warning
the facility must obtain a written consent. If the resident refuses to
consent the medication may need to be discontinued; this may take
some time as the medication may be gradually reduced.
7. What is considered an emergency in which a psychotropic
medication may be administered with oral
Wis Stats. 50.08(4)(a) allows a facility to obtain oral consent prior to
written consent under the following circumstances:
- There is an emergency in which a resident is at significant risk of
physical or emotional harm, or the resident puts others at significant
risk of physical harm,
- Time and distance preclude obtaining written informed consent before
administering the psychotropic medication, and
- A physician has determined that the resident or others will be harmed
if the psychotropic medication is not administered before written
informed consent is obtained.
Oral consent shall be entered in the resident's medical record and is
valid for 10 days. If the nursing home has made a good faith effort to
obtain oral consent of a person acting on behalf of the resident but has
been unable to contact such a person, the nursing home may administer the
psychotropic medication to the resident for up to 24 hours.
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July 16, 2013