Ill. Admin. Code tit. 77, § 380.150 - Informed Consent
a) For the
purposes of this Section and Section
380.160,
the following definitions shall apply:
1)
Authorized representative - a guardian with a court order granting authority to
consent to psychotropic medication or the use of restraints on behalf of a
consumer, or a person authorized to consent to psychotropic medication or the
use of restraints on behalf of a consumer pursuant to the Power of Attorney Act
or the Mental Health Treatment Preference Declaration Act.
2) Capable consumer - a consumer who is able
to understand the nature of the decision to be made, the information relevant
to making the decision and the possible consequences of any decision, and to
make a reasoned judgment based on this information.
3) Informed consent - written consent for
specific medical care, given freely, without coercion or deceit, by a capable
consumer, or by a consumer's authorized representative, after the consumer, or
the consumer's authorized representative, has been fully informed of, and had
an opportunity to consider, the nature of the care, the likely and possible
benefits and risks to the consumer of receiving the care, any other likely and
possible consequences of receiving or not receiving the care, and possible
alternatives to the proposed care. Written informed consent shall be obtained
from a consumer or from a consumer's authorized representative when he or she
is admitted. Before obtaining informed consent from a consumer, or from a
consumer's authorized representative, the facility shall inform the consumer or
the consumer's authorized representative that the potential consequences of an
emergency situation in a SMHRF may include temporary holding, restraint, or the
use of medications as ordered by the physician for safety purposes. For
psychotropic medications, the informed consent shall comply with subsection
(d).
b) The facility
shall document in the consumer's record whether he or she is capable of giving
informed consent for medical care, including for receiving psychotropic drugs.
If the consumer is not capable of giving informed consent, the identity of the
consumer's authorized representative shall be placed in the consumer's
record.
c) No psychotropic
medication may be given to any consumer without the informed consent of the
consumer or, if the consumer is not capable, the informed consent of a person
authorized to consent for the consumer without capacity. Informed consent shall
be secured in compliance with the requirements of this Section.
d) Procedure for Securing Informed Consent
for Psychotropic Medication
1) Prior to
initiating any detailed discussion designed to secure informed consent, a
licensed medical professional shall inform the consumer or the consumer's
authorized representative that the consumer's physician has prescribed a
psychotropic medication for the consumer, and that an informed decision is
required from the consumer or the consumer's authorized representative before
the consumer may be given the medication.
2) The discussion designed to secure informed
consent shall be private, between the consumer or the consumer's authorized
representative, and the resident's physician, a registered pharmacist who is
not a dispensing pharmacist for the facility where the consumer is receiving
services, or a licensed nurse. The consumer shall be given the opportunity to
ask questions throughout the discussion. The consumer shall be given as much
time as he or she needs to grant informed consent, and shall be told that he or
she is not required to make the decision during the meeting.
3) The discussion shall include information
about:
A) The name of the
medication;
B) The consumer's
illness that the medication is intended to treat;
C) The symptoms of the illness that the
medication is intended to treat, and how those symptoms are affecting the
consumer;
D) How the medication is
intended to affect those symptoms;
E) Other possible effects or side effects of
the medication, and any reasons (e.g., age, health status, other medications)
that the consumer is more or less likely to experience side effects;
F) Dosage information, including how much
medication would be administered, how often, and the method of administration
(e.g., orally or by injection; with, before, or after food);
G) Any tests and related procedures that are
required for the safe and effective administration of the medication;
H) Any food or activities the consumer should
avoid while taking the medication;
I) Any possible alternatives to taking the
medication that could accomplish the same purpose; and
J) Any possible consequences to the consumer
of not taking the medication.
4) The consumer or the consumer's authorized
representative shall be told that his or her informed consent may be withdrawn
at any time, and that, even with informed consent, the consumer may refuse to
take the medication. The consumer or the consumer's authorized representative
shall be told whether stopping the medication poses a risk of serious health
consequences for the consumer, and whether stopping the medication and resuming
it will reduce the subsequent effectiveness of the medication.
5) In addition to the oral discussion, the
consumer or his or her authorized representative shall be given the information
in subsection (d)(2) in writing. The information shall be in plain language,
understandable to the reader. If the document is in a language not understood
by the reader, the facility shall provide a translator capable of communicating
with the reader and the health care professional conducting the discussion. The
health care professional shall guide the consumer through the written
information. The document shall include a place for the consumer or his or her
authorized representative to give, or to refuse to give, informed consent, or
to request more time or more information prior to making a decision. Informed
consent is not secured until the consumer or authorized representative has
given oral and written informed consent.
6) If a consumer has an authorized
representative, the consumer may still be present at the discussion required by
this Section. If a consumer has an authorized representative, that consumer
shall still be given appropriate information about the medication. The
information shall include, at a minimum, written information and an oral
explanation of common side effects of the medication to facilitate the consumer
in identifying the medication and in communicating the existence of side
effects to the nursing staff. If the consumer is capable of understanding, the
explanation shall also include:
A) The
information in subsection (d)(3)(H);
B) Whether stopping the medication poses a
risk of serious health consequences for the consumer; and
C) Whether stopping the medication and
resuming it will reduce the subsequent effectiveness of the
medication.
7) The time
period for informed consent for psychotropic medication shall not exceed one
year.
8) Informed consent shall be
given for a maximum daily dosage. Additional informed consent is not required
so long as the medication administered to the consumer remains within the
maximum daily dosage for which consent was given.
9) If a consumer in a triage center has a
current prescription for psychotropic medication, the triage center shall take
all reasonable steps to confirm that the consumer has given informed consent
for the medication.
10) A consumer
shall be asked to consent to the administration of a new psychotropic
medication in a dosage or frequency that exceeds the maximum recommended daily
dosage as found in the Physician's Desk Reference only when the reason for
exceeding the recommended daily dosage is explained to the consumer by a nurse,
physician, or psychiatrist, and the reason for exceeding the recommended daily
dosage is justified by the prescribing physician or psychiatrist in the
clinical record. The dosage and frequency shall be reviewed and rejustified by
the prescriber on a weekly basis and reviewed by a consulting pharmacist. The
justification for exceeding the recommended daily dosage shall be recorded in
the consumer's record and shall be approved, in writing, by the medical
director of the facility.
11) The
facility shall obtain informed consent using forms provided by the Department
pursuant to Section 2-106.1 of the Nursing Home Care Act.
Notes
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