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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.
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)
Psychotropic medications with a black box warning require written informed consent.
"Psychotropic medication" means an antipsychotic, an antidepressant, lithium carbonate, or a tranquilizer. Wis. Stats. 50.08 (1)(d)
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.
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.
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.