Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION
Chapter 405.
CLIENT (PATIENT) CARE
Subchapter A. PRESCRIBING OF MEDICATION--MENTAL HEALTH SERVICES
25 TAC §§405.1 - 405.18
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Mental Health and Mental Retardation or in the
Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street,
Austin.)
The Texas Department of Mental Health and Mental
Retardation (TDMHMR) proposes the repeal of §§405.1 - 405.18 of
Chapter 405, Subchapter A, governing prescribing of medication--mental health
services. The repealed subchapter provided requirements for prescribing psychoactive
medications for patients receiving services in state mental health programs
in Texas. The repealed Chapter 405, Subchapter A, governing prescribing of
medication--mental health services will be replaced by new Chapter 415, Subchapter
A, governing prescribing of psychoactive medication, which are contemporaneously
proposed in this issue of the
Texas Register
.
The proposed new sections delineate policy and establish uniform operating
standards for prescribing psychoactive medication in both campus-based and
community programs operated or contracted by the Texas Department of Mental
Health and Mental Retardation.
The contemporaneous repeal and adoption of these subchapters would fulfill
the requirements of the Texas Government Code, §2001.039, concerning
the periodic review of agency rules.
Kevin Nolting, Acting Chief Financial Officer, has determined that for
each year of the first five-year period that the proposed repeal is in effect,
enforcing or administering the repeal does not have foreseeable implications
relating to costs or revenues of state or local governments.
Steven P. Shon, TDMHMR Medical Director, has determined that for each year
of the first five years the proposed repeal is in effect, the public benefit
will be the promulgation of requirements that ensure a uniform standard of
care for individuals receiving medications under the ages of TDMHMR and without
reference to service setting. It is anticipated that there would be no additional
economic cost to persons required to comply with the proposed repeal because
the new sections does not impose requirements that differ substantively from
those already required in operations or through contract.
It is anticipated that the proposed repeal will not affect a local economy
because the new sections do not significantly alter the requirements already
followed in operations or articulated in contract.
It is anticipated that the proposed repeal will not have an adverse economic
effect on small businesses or micro-businesses because the new sections do
not place requirements on small or micro-businesses.
Comments concerning the proposed repeal may be submitted in writing to
Linda Logan, Director, Policy Development, Texas Department of Mental Health
and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668; by fax to
(512) 206-4750; or by e-mail to policy.co@mhmr.state.tx.us within 30 days
of publication.
A hearing to accept oral and written testimony from members of the public
concerning this and other related proposals has been scheduled for Thursday,
9:00 a.m., June 17, 2004, in the TDMHMR Central Office Auditorium, Building
2, 909 West 45th Street, Austin, Texas. Persons requiring an interpreter for
the deaf or hearing impaired should contact the department's Central Office
operator at least 72 hours prior to the hearing at TDD (512) 206-5330. Persons
requiring other accommodations for a disability should notify Sharayla Jones
at least 72 hours prior to the hearing at (512) 206-5283 or at the TDY phone
number of Texas Relay, 1-800-735-2988.
The repeal is proposed under Texas Health and Safety Code (THSC), §532.015(a),
which provides the Texas Mental Health and Mental Retardation Board with broad
rulemaking authority; THSC, §571.006, which provides the board with the
authority to adopt rules as necessary for the proper and efficient treatment
of persons with mental illness; THSC, §577.010, which provides the board
with the authority to adopt rules and standards for the proper care and treatment
of patients in community-based crisis stabilization services and crisis residential
services; and THSC, §534.052(a), which provides the board with the authority
to adopt rules and standards necessary to ensure adequate provision of community-based
mental health services through the local mental health authority.
The proposed repeal affects THSC §§534.052, 567.024, 571.006,
574.101 et seq., 576.024, and 577.010.
§405.1.Purpose.
§405.2.Application.
§405.3.Definitions.
§405.4.Foundation.
§405.5.Minimum Standards in All Service Settings for Diagnosis and Documentation of Diagnosis When Initiating Medication.
§405.6.Patient Evaluation and Review in Inpatient and Crisis Stabilization Unit (CSU) Settings.
§405.7.General Guidelines for Prescribing in All Service Settings.
§405.8.General Guidelines for All Service Settings: Records and Monitoring of Prescribing and Administration Procedures.
§405.9.General Guidelines for All Service Settings: Ongoing Evaluation of Patients Taking Prescription Medications (See Also §405.14 of this title (relating to Required Assessments for Patients Receiving Medication in Community-based Services (CBS)).
§405.10.Prescribing Guidelines for All Service Settings: Side Effects and Adverse Effects, Medication Toxicity, Errors in Medication Administration.
§405.11.Special Considerations in All Service Settings: Patients with Dyskinesias, including Tardive Dyskinesia.
§405.12.Additional Considerations in All Service Settings: Special Populations.
§405.13.Minimum Requirements for Auditing the Prescription of Psychotropic Medication for Inpatients in State Hospitals and Related Procedures.
§405.14.Required Assessments for Patients Receiving Medication in Community-based Services (CBS).
§405.15.Dosage of Psychotropic Medications for Patients Receiving Community-based Services.
§405.16.Administration of Medications to Patients Receiving Community-based Services (CBS).
§405.17.Distribution.
§405.18.Review.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on May 28, 2004.
TRD-200403631
Rodolfo Arredondo
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: July 11, 2004
For further information, please call: (512) 206-4516
25 TAC §§405.25 - 405.38
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Mental Health and Mental Retardation or in the
Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street,
Austin.)
The Texas Department of Mental Health and Mental
Retardation (TDMHMR) proposes the repeal of §§405.25 - 405.38 of
Chapter 405, Subchapter B, governing prescribing of psychotropic medication--mental
retardation facilities. The repeal of the sections and adoption of new sections
would provide updated requirements for prescribing psychoactive medications
for patients receiving services in state mental health programs in Texas.
The repealed Chapter 405, Subchapter B, governing prescribing of psychotropic
medication--mental retardation facilities would be replaced by new Chapter
415, Subchapter A, governing prescribing of psychoactive medications, which
are contemporaneously proposed in this issue of the
Texas Register
.
The proposed new sections delineate policy and establish uniform operating
standards for prescribing psychoactive medication in both campus-based and
community programs operated or contracted by the Texas Department of Mental
Health and Mental Retardation.
The contemporaneous repeal and adoption of these subchapters would fulfill
the requirements of the Texas Government Code, §2001.039, concerning
the periodic review of agency rules.
Kevin Nolting, Acting Chief Financial Officer, has determined that for
each year of the first five-year period that the proposed repeal is in effect,
enforcing or administering the repeal does not have foreseeable implications
relating to costs or revenues of state or local governments.
Steven P. Shon, TDMHMR Medical Director, has determined that for each year
of the first five years the proposed repeal is in effect, the public benefit
will be the promulgation of requirements that ensure a uniform standard of
care for individuals receiving medications under the ages of TDMHMR and without
reference to service setting. It is anticipated that there would be no additional
economic cost to persons required to comply with the proposed repeal because
the new sections do not impose requirements that differ substantively from
those already required in operations or through contract.
It is anticipated that the proposed repeal will not affect a local economy
because the new sections do not significantly alter the requirements already
followed in operations or articulated in contract.
It is anticipated that the proposed repeal will not have an adverse economic
effect on small businesses or micro-businesses because the new sections do
not place requirements on small or micro-businesses.
Comments concerning the proposed repeal may be submitted in writing to
Linda Logan, Director, Policy Development, Texas Department of Mental Health
and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668; by fax to
(512) 206-4750; or by e-mail to policy.co@mhmr.state.tx.us within 30 days
of publication.
A hearing to accept oral and written testimony from members of the public
concerning this and other related proposals has been scheduled for Thursday,
June 17, 2004, 9:00 a.m., in the TDMHMR Central Office Auditorium, Building
2, 909 West 45th Street, Austin, Texas. Persons requiring an interpreter for
the deaf or hearing impaired should contact the department's Central Office
operator at least 72 hours prior to the hearing at TDD (512) 206-5330. Persons
requiring other accommodations for a disability should notify Sharayla Jones
at least 72 hours prior to the hearing at (512) 206-5283 or at the TDY phone
number of Texas Relay, 1-800-735-2988.
The repeal is proposed under Texas Health and Safety Code (THSC), §532.015(a),
which provides the Texas Mental Health and Mental Retardation Board with broad
rulemaking authority; THSC, §571.006, which provides the board with the
authority to adopt rules as necessary for the proper and efficient treatment
of persons with mental illness; THSC, §577.010, which provides the board
with the authority to adopt rules and standards for the proper care and treatment
of patients in community-based crisis stabilization services and crisis residential
services; and THSC, §534.052(a), which provides the board with the authority
to adopt rules and standards necessary to ensure adequate provision of community-based
mental health services through the local mental health authority.
The proposed repeal affects THSC §§534.052, 567.024, 571.006,
574.101 et seq., 576.024, and 577.010.
§405.25.Purpose.
§405.26.Application.
§405.27.Definitions.
§405.28.General Principles.
§405.29.Diagnosis and Documentation of Diagnosis When Initiating Psychotropic Medication.
§405.30.Prescribing Parameters.
§405.31.Emergency Use of Psychotropic Medication.
§405.32.Initiation and Ongoing Evaluation of Medication Response and Clinical Condition.
§405.33.Individuals with Medication-Related Dyskinesia, Including Tardive Dyskinesia.
§405.34.Prescribing of Psychotropic Medication for Special Populations.
§405.35.Prescribing of Psychotropic Medication for New Admissions.
§405.36.Use of Medication Commonly Considered Psychotropic for Nonpsychiatric and Nonbehavioral Conditions.
§405.37.Quality Improvement.
§405.38.Distribution.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on May 28, 2004.
TRD-200403630
Rodolfo Arredondo
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: July 11, 2004
For further information, please call: (512) 206-4516
25 TAC §§405.801 - 405.809
(Editor's note: The text of the following sections proposed for
repeal will not be published. The sections may be examined in the offices
of the Texas Department of Mental Health and Mental Retardation or in the
Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street,
Austin.)
The Texas Department of Mental Health and Mental
Retardation (TDMHMR) proposes the repeal of §§405.801 - 405.809
of Chapter 405, Subchapter FF, governing consent to treatment with psychoactive
medication. The repealed sections provided requirements for obtaining consent
to treatment with psychoactive medications from patients receiving services
in inpatient mental health programs in Texas. The repealed subchapter will
be replaced by Chapter 414, Subchapter I, governing the same matters, which
is contemporaneously proposed in this issue of the
Texas Register
.
Kevin Nolting, Acting Chief Financial Officer, has determined that for
each year of the first five-year period that the proposed repeal is in effect,
enforcing or administering the repeal does not have foreseeable implications
relating to costs or revenues of state or local governments.
Steven P. Shon, TDMHMR Medical Director, has determined that for each year
of the first five years the proposed repeal is in effect, the public benefit
will the promulgation of updated requirements for obtaining patient consent
to treatment with psychoactive medications. There is no anticipated economic
cost to small businesses or micro-businesses which are required to comply
with the repeal of this subchapter. It is not anticipated that there will
be any additional economic cost to persons required to comply with the proposed
repeal. It is not anticipated that the repeal will affect a local economy.
Comments concerning the proposed repeal may be submitted in writing to
Linda Logan, Director, Policy Development, Texas Department of Mental Health
and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668; by fax to
(512) 206-4750; or by e-mail to policy.co@mhmr.state.tx.us within 30 days
of publication.
A hearing to accept oral and written testimony from members of the public
concerning this and other related proposals has been scheduled for Thursday,
June 17, 2004, 10:30 a.m. in the TDMHMR Central Office Auditorium, Building
2, 909 West 45th Street, Austin, Texas. Persons requiring an interpreter for
the deaf or hearing impaired should contact the department's Central Office
operator at least 72 hours prior to the hearing at TDD (512) 206-5330. Persons
requiring other accommodations for a disability should notify Sharayla Jones
at least 72 hours prior to the hearing at (512) 206-5283 or at the TDY phone
number of Texas Relay, 1-800-735-2988.
The repeal is proposed under Texas Health and Safety Code (THSC), §532.015(a),
which provides the Texas Mental Health and Mental Retardation Board with broad
rulemaking authority; THSC, §571.006, which provides the board with the
authority to adopt rules as necessary for the proper and efficient treatment
of persons with mental illness; THSC, §577.010, which provides the board
with the authority to adopt rules and standards for the proper care and treatment
of patients in private mental health facilities, community-based crisis stabilization
services, and crisis residential services; and THSC, §534.052(a), which
provides the board with the authority to adopt rules and standards necessary
to ensure adequate provision of community-based mental health services through
the local mental health authority.
The repeal affects THSC, §§241.001 et seq., 534.052, 567.024,
571.006, 574.101 et seq., 576.024, 577.001 et seq., and Texas Probate Code, §770A.
§405.801.Purpose.
§405.802.Application.
§405.803.Definitions.
§405.804.Information Required To Be Given.
§405.805.Documentation of Informed Consent.
§405.806.Patients Admitted under Texas Statutes.
§405.807.Patients Committed under Texas Statutes.
§405.808.Emergencies.
§405.809.Order Authorizing Administration of Psychoactive Medication.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on May 28, 2004.
TRD-200403628
Rodolfo Arredondo
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: July 11, 2004
For further information, please call: (512) 206-4516
Subchapter I. CONSENT TO TREATMENT WITH PSYCHOACTIVE MEDICATION--MENTAL HEALTH SERVICES
25 TAC §§414.401 - 414.415
The Texas Department of Mental Health and Mental Retardation
(TDMHMR) proposes new §§414.401 - 414.415 of Chapter 414, Subchapter
I, governing consent to treatment with psychoactive medication--mental health
services. The new sections would provide updated requirements for obtaining
consent to treatment with psychoactive medications from patients receiving
services in inpatient mental health programs in Texas. The new subchapter
would replace Chapter 405, Subchapter FF, governing consent to treatment with
psychoactive medication, which is contemporaneously proposed for repeal in
this issue of the
Texas Register
.
The new subchapter would continue most of TDMHMR's existing policies with
respect to obtaining consent to treatment with psychoactive medication from
patients receiving inpatient services in mental health facilities. Significant
changes to the existing policies include the following: The term "psychiatric
emergency" would be used in place of "emergency situation." The term "medically
appropriate treatment" would not be defined. Informed medication consent would
not be obtained by medication class but would be required to be obtained by
individual medication. The definition of "psychoactive medication" would be
based on the functional effect of medication as opposed to its inclusion in
a specified class of medications. The new subchapter requires the treating
physician or ancillary personnel to provide the patient with an explanation
of the risks, benefits, and related matters for each medication prescribed.
If the explanation is provided by ancillary personnel the treating physician
must confirmation the explanation within two days. The new subchapter would
establish that a list of medication classes will be made available by the
Office of the Medical Director, TDMHMR, and will be updated and posted on
the TDMHMR web site, www.mhmr.state.tx.us (Office of the Medical Director).
The new subchapter describes conditions under which a medication order by
the court will designate a specific medication and not a class of medications.
The new subchapter clarifies that a brief physical hold is not considered
restraint provided that the individual currently exhibits behavior that meet
the definition of a psychiatric emergency, the individual is currently under
a court order allowing the facility to administer court-approved medication
without the consent of the individual; the purpose of administering medication
is to provide active treatment to reduce symptoms of a diagnosed mental illness;
using medication to reduce specified symptoms of a diagnosed mental illness
is standard clinical practice; the specific medication and dosage ordered
can be clinically justified as in keeping with standard clinical practice
and are appropriate for reduction of specified target symptoms; and the physical
hold is terminated as soon as the medication is administered.
The new subchapter would include a section (§414.413, relating to
Monitoring Compliance with Policies and Procedures) that requires facilities
to document self-monitoring of compliance. Self-monitoring of compliance would
include procedures to audit records for compliance, analyze and report audit
results to staff responsible for the informed consent process, improve the
performance of individual employees, contractors, and agents, and improve
overall facility performance. Facilities would be required to collect information
related to obtaining consent to treatment with psychoactive medication and
the use of psychoactive medication in psychiatric emergencies as requested
by the medical director of TDMHMR.
Pursuant to House Bill 2679 of the 78th Texas Legislature, Regular Session,
it would be clarified that if an adult under a protective custody order as
provided by THSC Chapter 574, Subchapter B, is a ward, the guardian of the
person of the ward may consent to the administration of psychoactive medication
as prescribed by the ward's treating physician regardless of the ward's expressed
preferences regarding treatment with psychoactive medication. Also pursuant
to House Bill 2679, the new subchapter would stipulate that psychoactive medications
will not be administered to a patient committed to a mental health facility
under an order for temporary or extended mental health services if the patient
refuses medication except when the patient is a ward who is 18 years of age
or older and the guardian of the person of the ward consents to the administration
of psychoactive medication regardless of the ward's expressed preferences
regarding treatment with psychoactive medication.
Kevin Nolting, Acting Chief Financial Officer, has determined that for
each year of the first five-year period that the proposed new sections are
in effect, enforcing or administering the sections does not have foreseeable
implications relating to costs or revenues of state or local governments.
It is not anticipated that the proposed new sections will have an economic
cost to small businesses or micro-businesses which are required to comply
with the new sections. It is not anticipated that the sections will affect
a local economy.
Steven P. Shon, TDMHMR Medical Director, has determined that for each year
of the first five years the proposed new sections are in effect, the public
benefit will be the promulgation of updated requirements for obtaining patient
consent to treatment with psychoactive medications. It is not anticipated
that there will be any additional economic cost to persons required to comply
with the new sections because the new sections do not impose additional requirements
on persons required to comply.
Comments concerning the proposed new sections may be submitted in writing
to Linda Logan, Director, Policy Development, Texas Department of Mental Health
and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668; by fax to
(512) 206-4750; or by e-mail to policy.co@mhmr.state.tx.us within 30 days
of publication.
A hearing to accept oral and written testimony from members of the public
concerning this and other related proposals has been scheduled for Thursday,
June 17, 2004, 9:00 a.m., in the TDMHMR Central Office Auditorium, Building
2, 909 West 45th Street, Austin, Texas. Persons requiring an interpreter for
the deaf or hearing impaired should contact the department's Central Office
operator at least 72 hours prior to the hearing at TDD (512) 206-5330. Persons
requiring other accommodations for a disability should notify Sharayla Jones
at least 72 hours prior to the hearing at (512) 206-5283 or at the TDY phone
number of Texas Relay, (800) 735-2988.
The new sections are proposed under Texas Health and Safety Code
(THSC), §532.015(a), which provides the Texas Mental Health and Mental
Retardation Board with broad rulemaking authority; THSC, §571.006, which
provides the board with the authority to adopt rules as necessary for the
proper and efficient treatment of persons with mental illness; THSC, §577.010,
which provides the board with the authority to adopt rules and standards for
the proper care and treatment of patients in private mental health facilities,
community-based crisis stabilization services, and crisis residential services;
and THSC, §534.052(a), which provides the board with the authority to
adopt rules and standards necessary to ensure adequate provision of community-based
mental health services through the local mental health authority.
The proposed new sections affect THSC, §§241.001 et seq., 534.052,
567.024, 571.006, 574.101 et seq., 576.024, 577.001 et seq., and Texas Probate
Code, §770A.
§414.401.Purpose.
The purpose of this subchapter is to provide procedures for obtaining
consent for treatment with psychoactive medications from patients receiving
voluntary or involuntary mental health services.
§414.402.Application.
This subchapter applies to the following facilities providing inpatient
mental health services:
(1)
a state hospital or state center operated by the Texas
Department of Mental Health or Mental Retardation (TDMHMR);
(2)
a psychiatric hospital licensed under Texas Health and
Safety Code (THSC), Chapter 577, and Chapter 134 of this title;
(3)
an identifiable mental health service unit of a hospital
licensed under THSC, Chapter 241, and Chapter 133, Subchapter A of this title;
(4)
a crisis stabilization unit (CSU) licensed under THSC,
Chapter 577, and Chapter 134 of this title; and
(5)
facilities operated by local mental health authorities
or under contract to local mental health authorities
§414.403.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise:
(1)
Capacity--A patient's ability to:
(A)
understand the nature and consequences of a proposed treatment,
including the benefits, risks, and alternatives to the proposed treatment;
and
(B)
make a decision whether to undergo the proposed treatment.
(2)
Imminent--Ready to take place within seconds.
(3)
Informed consent--Consent given by a person or the person's
legally authorized representative when each of the following conditions have
been met:
(A)
Comprehension of information. The person giving the consent
has been provided the information outlined in §414.404 of this title
(relating to Information Required To Be Given) and has the capacity to give
consent; and
(B)
Voluntariness. The consent has been given voluntarily.
(4)
Legally authorized representative (LAR)--A person authorized
by law to act on behalf of an individual with regard to a matter described
in this subchapter, and may include a parent, guardian, managing conservator
of a minor individual, a guardian of an adult individual, or legal representative
of a deceased individual.
(5)
Medication class--A group of medications with similar actions
and indications for use, as outlined in the department's most recent "Classes
of Psychoactive Medications Determined by the Texas Department of Mental Health
and Mental Retardation." A copy of which may be obtained by contacting TDMHMR,
Office of Office of the Medical Director, P.O. Box 12668, Austin, TX 78711-2668,
or the TDMHMR website, www.mhmr.state.tx.us.
(6)
Mental health facility--A facility that can provide 24-hour
residential and psychiatric services and that is:
(A)
a TDMHMR mental health facility that is a state hospital
or state center operated by the Texas Department of Mental Health or Mental
Retardation (TDMHMR);
(B)
a psychiatric hospital licensed under Texas Health and
Safety Code, Chapter 577, and Chapter 134 of this title;
(C)
an identifiable mental health service unit of a hospital
licensed under Texas Health and Safety Code, Chapter 241, and Chapter 133,
Subchapter A of this title;
(D)
a crisis stabilization unit (CSU) licensed under THSC,
Chapter 577, and Chapter 134; or
(E)
a facility operated by a local mental health authority
or under contract to a local mental health authority.
(7)
Minor--A person under 18 years of age who is not and has
not been married or who has not had his or her disabilities of minority removed
for general purposes.
(8)
Order for temporary or extended mental health services--A
court-ordered commitment to mental health services Texas Health and Safety
Code, §574.034 or §574.035.
(9)
Psychiatric emergency--A situation in which, in the opinion
of the physician, it is immediately necessary to administer medication to
ameliorate the signs and symptoms of a patient's mental illness and to prevent:
(A)
imminent probable death or substantial bodily harm to the
patient because the patient:
(i)
is threatening or attempting to commit suicide or serious
bodily harm; or
(ii)
is behaving in a manner that indicates that the patient
is unable to satisfy the patient's need for nourishment, essential medical
care, or self-protection; or
(B)
imminent physical or emotional harm to others because of
threats, attempts, or other acts the patient makes or commits.
(10)
Psychoactive medication--Medication whose primary intended
therapeutic effect is to treat or ameliorate the signs or symptoms of mental
disorder, or to modify mood, affect, perception, or behavior, consistent with
THSC, Chapter 574, Subchapter G, §574.101.
(11)
Refusal to consent to administration of psychoactive medication
(refusal)--Actions which include the following behaviors:
(A)
The patient or legally authorized representative communicates
orally, through sign language, or in writing that he or she refuses psychoactive
medication.
(B)
The patient communicates through behavior that he or she
refuses psychoactive medication, e.g., refusing to swallow oral medication
or refusing to submit to hypodermic injection of psychoactive medication.
(C)
The patient pretends to swallow oral psychoactive medications,
and the attending physician determines that the pretending behavior is due
to an unwillingness to take the medication.
(D)
The patient gives either no response or a noncommittal
response after he or she has received the standard risk-benefit explanation.
(12)
Service Setting--A state mental health facility, state
mental retardation facility, a local authority (LA) site, or a service site
contracted to one of these entities.
(13)
TDMHMR mental health facility--A state hospital or state
center operated by the Texas Department of Mental Health and Mental Retardation.
(14)
Ward--A person for whom a guardian has been appointed.
§414.404.Information Required To Be Given.
(a)
The treating physician, registered nurse (RN), licensed
vocational nurse (LVN), physician's assistant (PA), or registered pharmacist
(RPh) will explain to the patient and to the patient's legally authorized
representative, the information in paragraphs (1) - (10) of this subsection
in simple, nontechnical language in the person's primary language, if possible.
If the explanation is not provided by the treating he or she must confirm
the explanation with the patient and the patient's legally authorized representative,
within two working days, not including weekends or legal holidays:
(1)
the nature of the patient's mental illness and condition;
(2)
the name of the medication and the beneficial effects on
the patient's mental illness or condition expected as a result of treatment
with that medication;
(3)
the probable health and mental health consequences to the
patient of not taking the medication, including the occurrence, increase,
or reoccurrence of symptoms of mental illness;
(4)
the existence of generally accepted alternative forms of
treatment, if any, that could reasonably be expected to achieve the same benefits
as the medication and why the physician rejects the alternative treatment;
(5)
a description of the proposed course of treatment with
medication including any necessary evaluations and lab work;
(6)
the fact that side effects of varying degrees of severity
are a risk of all medication;
(7)
the relevant side effects of the medication, including:
(A)
any side effects which are known to frequently occur in
most persons;
(B)
any side effects to which the particular patient may be
predisposed; and
(C)
the nature and possible occurrence of the potentially irreversible
symptoms of tardive dyskinesia;
(8)
the need to advise mental health facility staff immediately
if any of these side effects occur;
(9)
an instruction that the patient may withdraw consent at
any time without negative actions on the part of staff; and
(10)
the patient's rights under this section.
(b)
The patient and his or her LAR must also be provided a
summary of this information in writing, along with an offer to answer any
questions concerning the treatment. If the LAR is not present, the information
must be mailed to the representative (via certified letter) within 24 hours,
except on weekdays and legal holidays when the information will be mailed
on the next business day.
§414.405.Documentation of Informed Consent.
(a)
Informed medication consent must be obtained for each individual
medication, not by medication class.
(b)
Informed consent for the administration of each psychoactive
medication will be evidenced by a completed copy of the department's form,
Consent to Treatment with Psychoactive Medication (MHRS 9-7 form (or other
format including the same information)) executed by the patient or his or
her LAR. A copy of which may be obtained by contacting TDMHMR, Office of Policy
Development, P.O. Box 12668, Austin, TX 78711-2668.
(1)
Any time the medication regimen is altered in a way that
would result in a significant change in the risks or benefits for the patient,
an explanation of the change will be provided to the patient and the patient's
legally authorized representative. The explanation will include notification
of the right to withdraw consent at any time.
(2)
A new consent will be obtained if a change to a different
medication is prescribed.
(c)
If the patient or his or her LAR consents to the administration
of psychoactive medication but refuses or is unable to execute the form, a
witness to the consent will be obtained. The consent and its witnessing will
be documented in the patient's medical record or on the MHRS 9-7 form (or
other format including the same information) and placed in the medical record.
The witness will confirm this consent by signing the consent form.
(d)
If the RN, LVN, PA, or RPh gives the initial explanation
of the consent information to the patient, then the treating physician must
confirm the explanation and the consent and sign the MHRS 9-7 form (or other
format including the same information) within two working days, not including
weekends or legal holidays.
(e)
A patient's refusal or attempt to refuse to receive psychoactive
medication, whether given verbally or by other indications or means, will
be documented in the progress notes of the patient's clinical record or on
the consent form (MHRS 9-7 form (or other format including the same information)).
(f)
An LAR's refusal to consent for the patient's treatment
will be documented in the patient's medical record.
(g)
All consents will be reviewed with the patient and his
or her legally authorized representative at least every 90 days. The review
will include a discussion of the information outlined in §414.404 of
this title (relating to Information Required To Be Given) as well as a discussion
of the patient and his or her legally authorized representative's wishes regarding
continuation of the medication.
§414.406.Patients Admitted under Texas Statutes.
(a)
Psychoactive medications will not be administered to patients
admitted to a mental health facility under the voluntary provisions of the
Texas Health and Safety Code (THSC) or detained at a mental health facility
under the THSC emergency detention or order of protective custody (OPC) provisions
without informed consent from the patient or the patient's legally authorized
representative unless the patient is in an psychiatric emergency and medication
is administered as provided in §414.410 of this title (relating to Psychiatric
Emergencies).
(b)
If an adult under a protective custody order as provided
by THSC, Chapter 574, Subchapter B, is a ward, the guardian of the person
of the ward may consent to the administration of psychoactive medication as
prescribed by the ward's treating physician regardless of the ward's expressed
preferences regarding treatment with psychoactive medication.
§414.407.Patients Committed to Mental Health Facilities under Provisions of the Texas Health and Safety Code.
Psychoactive medications will not be administered to patients committed
to a mental health facility under an order for temporary or extended mental
health services if the patient or the patient's legally authorized representative
refuses the medication unless:
(1)
the patient is in a psychiatric emergency and medication
is administered as provided in §414.410 of this title (relating to Psychiatric
Emergencies);
(2)
the patient does not have a legally authorized representative
and the administration of the medication, regardless of the patient's refusal,
is authorized by an order as outlined in THSC §§574.101 - 574.110;
or
(3)
the patient is a ward who is 18 years of age or older and
the guardian of the person of the ward consents to the administration of psychoactive
medication regardless of the ward's expressed preferences regarding treatment
with psychoactive medication.
§414.408.Patients Committed to Mental Health Facilities under Provisions Other than Those Found in the Texas Health and Safety Code (i.e., Code of Criminal Procedure, Family Code).
(a)
The decision to administer medication to a patient committed
to a TDMHMR mental health facility under provisions other than THSC §574.034
or §574.035 is consistent with the holding in Sell v. United States,
123 S.Ct. 2174 (2003).
(b)
Nothing in this section is intended to preclude the administration
of psychoactive medication to any patient in a psychiatric emergency as provided
for in §414.410 of this title (relating to Psychiatric Emergencies).
§414.409.Involuntary Administration of Medication to Patients Committed to Mental Health Facilities under the Texas Health and Safety Code or by Court Order.
(a)
The physician will order medications administered involuntarily
under §414.407 of this title (relating to Patients Committed to Mental
Health Facilities under Provisions of the Texas Health and Safety Code) or §414.411
of this title (relating to Order Authorizing Administration of Psychoactive
Medication) to be given by the method most acceptable to the patient, if clinically
appropriate.
(b)
When a patient is court ordered to receive medication involuntarily
and refuses all routes of administration that are consistent with community
standards of practice, e.g., intramuscular injection, an ethics committee
of the facility must be consulted for further guidance in the method of administration.
(c)
The authority to administer a medication involuntarily
to a patient under §414.407 or §414.411 of this title includes the
authority to obtain evaluations and laboratory tests necessary to safely administer
the medication.
§414.410.Psychiatric Emergencies.
(a)
Nothing in this subchapter is intended to preclude the
administration of psychoactive medication to any patient in a psychiatric
emergency.
(b)
If a physician issues an order to administer psychoactive
medication to a patient without the patient's consent because of a psychiatric
emergency, then the physician will document in the patient's clinical record
in specific medical or behavioral terms:
(1)
why the order is necessary:
(2)
other generally accepted, less intrusive forms of treatment,
if any, that the physician has evaluated but rejected; and
(3)
the reasons those treatments were rejected.
(c)
Treatment of the patient with the psychoactive medication
will be provided in the manner, consistent with clinically appropriate medical
care, least restrictive of the patient's personal liberty.
(d)
A brief physical hold is not considered restraint for purposes
of this subchapter provided that:
(1)
the individual currently exhibits behavior that meets the
definition of psychiatric emergency as defined in this subchapter, or the
individual is currently under a court order allowing the facility to administer
medication without consent of the individual and the medication ordered is
permitted by the court order;
(2)
the purpose of administering medication is active treatment
to reduce symptoms of a diagnosed mental illness;
(3)
using medication to reduce specified symptoms of a diagnosed
mental illness is standard clinical practice;
(4)
the specific medication and dosage ordered can be clinically
justified as in keeping with standard clinical practice and are appropriate
for reduction of specified target symptoms; and
(5)
the physical hold is terminated as soon as the medication
is administered.
(e)
When the psychiatric emergency is no longer imminent or
present, medication prescribed without consent on an emergency basis must
be safely discontinued. If continued use of medication is recommended on a
regular basis, the physician must comply with provisions outlined in §414.406
of this title (relating to Patients Admitted Under Texas Statutes), §414.407
of this title (relating to Patients Committed to Mental Health Facilities
Under Provisions of the Texas Health and Safety Code), or §414.408 of
this title (relating to Patients Committed to Mental Health Facilities under
Provisions Other than Those Found in the Texas Health and Safety Code (i.e.,
Code of Criminal Procedure, Family Code)), as appropriate.
(f)
In no case may inappropriate designation of a situation
as a psychiatric emergency be used to circumvent the process of obtaining
consent or applying to the court for an order authorizing administration of
psychoactive medication.
§414.411.Order Authorizing Administration of Psychoactive Medication.
(a)
Filing of Petition. A physician who is treating a patient
may petition a probate court or a court with probate jurisdiction for an order
to authorize the administration of a class or classes of psychoactive medication
regardless of the patient's refusal:
(1)
if the physician believes that the patient lacks the capacity
to make a decision regarding the administration of the psychoactive medication;
(2)
if the physician determines that the medication is the
proper course of treatment for the patient; and
(3)
if the patient is under an order for temporary or extended
mental health services under THSC §574.034 or §574.035 and the patient,
verbally or by other indication, refuses to take the medication voluntarily.
(b)
Hearing on petition. A hearing on a petition for an order
to authorize the administration of psychoactive medication regardless of the
patient's refusal will be held in accordance with provisions outlined in THSC §§576.104
- 574.106.
(c)
Issuance of order.
(1)
The court may issue an order authorizing the administration
of one or more classes of psychoactive medication only if the court finds
by clear and convincing evidence after the hearing that:
(A)
the patient lacks the capacity to make a decision regarding
the administration of the proposed medication; and
(B)
treatment with the proposed medication is in the best interest
of the patient.
(2)
In making its finding, the court shall consider:
(A)
the patient's expressed preferences regarding treatment
with psychoactive medication;
(B)
the patient's religious beliefs;
(C)
the risks and benefits, from the perspective of the patient,
of taking psychoactive medication;
(D)
the consequences to the patient if the psychoactive medication
is not administered;
(E)
the prognosis for the patient if the patient is treated
with psychoactive medication; and
(F)
alternatives to treatment with psychoactive medication.
(3)
An order entered under this subsection shall authorize
the administration to a patient, regardless of the patient's refusal, of one
or more classes of psychoactive medications specified in the petition and
consistent with the patient's diagnosis. The order shall permit:
(A)
an increase or decrease in a medication's dosage;
(B)
reinstitution of medication authorized but discontinued
during the period the order is valid; or
(C)
the substitution of a medication within the same medication
class.
(4)
The issuance of an order authorizing administration of
psychoactive medication is not a determination or adjudication of mental incompetency
and does not limit in any other respect the patient's rights as a citizen
or the patient's property rights or legal capacity.
(d)
Appeal of order. A patient may appeal an order under this
subchapter in the manner provided by THSC §574.070 for appeal of an order
requiring court-ordered mental health services. The order authorizing the
administration of psychoactive medication remains effective pending the appeal.
(e)
Review and expiration of order.
(1)
An order authorizing the administration of psychoactive
medication expires on the expiration or termination date of the order for
temporary or extended mental health services in effect when the order for
psychoactive medication is issued.
(2)
An order authorizing the administration of medication shall
be reviewed by the court on an annual basis.
§414.412.Designation of Medication Classes.
(a)
TDMHMR will maintain an updated list of psychoactive medication
classes to be used by the court. The list will be revised and distributed
at least annually or more frequently as needed and will include the most common
psychoactive medications. The list will be available from the Office of the
Medical Director, TDMHMR, and on the TDMHMR website, www.mhmr.state.tx.us
(Office of the Medical Director).
(b)
As provided by §414.411(c)(1) of this title (relating
to Order Authorizing Administration of Psychoactive Medication), the court
will only approve classes of medications unless the specific medication appears
in the other category on the list or is not on the list and:
(1)
the medication is being used for a non-FDA approved indication;
or
(2)
the medication is a recently FDA approved psychiatric medication.
§414.413.Monitoring Compliance with Policies and Procedures.
(a)
Each service setting will implement policies and procedures
in accordance with this subchapter.
(b)
Self-monitoring of compliance will include the following
components:
(1)
procedures to audit records for compliance;
(2)
procedures to analyze and report audit results to staff
responsible for the informed consent process; and
(3)
procedures to improve the performance of individual employees,
contractors, and agents, and to improve overall facility performance.
(c)
Each service setting will collect information related to
obtaining consent to treatment with psychoactive medication and the use of
psychoactive medication in psychiatric emergencies as may be required by the
medical director of TDMHMR.
(d)
Each service setting will maintain a record of self-monitoring
of compliance and may present these records to licensing or oversight authorities
when requested.
§414.414.References.
The following statutes are referenced in this subchapter:
(1)
the Texas Health and Safety Code;
(2)
the Texas Code of Criminal Procedure; and
(3)
the Texas Family Code.
§414.415.Distribution.
This subchapter is distributed to:
(1)
members of the Texas Mental Health and Mental Retardation
Board;
(2)
executive, management, and program staff of Central Office;
(3)
CEOs and medical directors of all facilities and LAs;
(4)
CEOs of psychiatric hospitals and crisis stabilization
units;
(5)
advocacy organizations;
(6)
any person on request.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on May 28, 2004.
TRD-200403627
Rodolfo Arredondo
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Earliest possible date of adoption: July 11, 2004
For further information, please call: (512) 206-4516
Subchapter A. PRESCRIBING OF PSYCHOACTIVE MEDICATION
Subchapter B. PRESCRIBING OF PSYCHOTROPIC MEDICATION--MENTAL RETARDATION FACILITIES
Subchapter FF. CONSENT TO TREATMENT WITH PSYCHOACTIVE MEDICATION
Chapter 414.
PROTECTION OF CONSUMERS AND CONSUMER RIGHTS
Chapter 415.
PROVIDER CLINICAL RESPONSIBILITIES