H.12

Introduced by Representatives Knox of Northfield and Weiss of Northfield

Referred to Committee on

Date:

Subject: Health; electroconvulsive therapy; informed consent

Statement of purpose: This bill proposes to require that a patient receive essential information regarding electroconvulsive therapy to assure that the patient has given informed consent prior to receiving treatment.

AN ACT RELATING TO ELECTROCONVULSIVE THERAPY

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1. 18 V.S.A. chapter 180 is added to read:

CHAPTER 180. ELECTROCONVULSIVE THERAPY

§ 7551. FINDINGS

The general assembly finds that electroconvulsive therapy requires specific protections to ensure that voluntary informed consent has been given, and that the therapy is administered pursuant to established criteria.

§ 7552. DEFINITIONS

As used in this chapter:

(1) "Cognitive side effects" means specific anterograde and retrograde memory deficits, whether temporary or permanent.

(2) "Department" means the department of developmental and mental health services.

(3) "ECT" means electroconvulsive therapy, which is a medical treatment involving the use of electrodes to produce a current in the brain to stimulate seizures for therapeutic purposes in severe psychiatric, motor or seizure disorders.

(4) "Informed consent" means voluntarily agreeing to a medical treatment decision, while having the necessary mental capacity to make the decision, based on all relevant information, including the elements specified in subsection 7553(b) of this title, and any other information the department shall consider necessary to include in the standard written consent form adopted under subsection 7553(a) of this title.

(5) "Mental capacity" means a patient's ability to assimilate relevant facts and to appreciate his or her situation with regard to those facts, including the information listed in subsection 7553(b) of this title. It shall also include the ability to participate in treatment decisions by means of a rational thought process.

(6) "Minor" means a person who is under 18 years of age.

(7) "Voluntary" means the absence of any direct or indirect coercion or pressure on a patient with regard to the treatment decisions of a patient, including making a treatment choice a condition for any other patient rights, services or treatment options that would normally be available, including the discharge or transfer of a patient from any institution. However, advice or recommendations of physicians or members of a treatment team, made without such pressure, shall not be considered to interfere with a voluntary treatment decision.

§ 7553. INFORMED CONSENT

(a) ECT treatment shall not be administered to a patient unless the patient

has given informed consent as evidenced by execution of a witnessed and dated form.

(b) The consent form adopted by the department shall include all of the following:

(1) Information about ECT, its purpose, the method of its administration, the recommended range of dosages, anticipated benefits, possible routine side effects and methods, if any, to treat such side effects.

(2) That there exists a division of opinion as to the efficacy of the proposed treatment, why and how it works and its commonly known risks and extent of side effects.

(3) The nature, degree, duration and probability of cognitive side effects, especially noting the degree and duration of risks of memory loss, including its potential irreversibility, and how and to what extent they may be controlled, if at all. This shall include the information that research is incomplete regarding cognitive side effects, and that they can vary substantially based on treatment variations, number of treatments and unknown individual factors; and that in the case of a minor, due to the limited numbers, there exists minimal research on the effect of ECT on a developing brain.

(4) Information about relapse rates and the need for continued therapy to attempt to prevent relapse if the initial course of treatment is successful.

(5) Specific and up-to-date information regarding death rates from the use of anesthesia, and state or national statistics on deaths related to ECT.

(6) That the patient has the absolute right to refuse or accept the proposed treatment, and that if the patient does consent to ECT, the patient has the right to revoke his or her consent for any reason at any time prior to or between treatments.

(c) The treating physician shall attach to the consent form a completed

physician's form as provided for in subsection (d) of this section, and shall thoroughly and understandably review both forms with the patient and with the parent or guardian of a minor patient. The physician and patient shall sign the consent form. A parent or guardian shall sign for a minor patient. The physician shall also sign the physician's form. An identified second person of the patient's choice shall be present for the entire session, which shall be recorded on either audiotape or videotape. The recording shall be made part of the patient's record.

(d) The physician's form shall include all of the following:

(1) A brief history of the patient's diagnosis, severity, symptoms and length of illness, and the specific reasons ECT has been recommended as a course of treatment.

(2) The reasonable alternative treatments, and why the physician is recommending this particular treatment rather than such alternatives.

(3) The specific type of ECT to be used and projected number of treatments, including an explanation of seizure thresholds and the differences in side effects between unilateral and bilateral ECT, and specific information regarding any deviations from the American Psychiatric Association's recommended treatment protocols.

(4) Specific additional information about any individual risk factors, including the consulting advice of an obstetrician-gynecologist if the patient is or may be pregnant, and the consulting advice of the child specialists referenced in section 7555 of this title if the patient is a minor.

(5) The intended individual follow-up treatment plan, including whether maintenance ECT is being considered and what drugs are being recommended.

(6) The assessment, referral and treatment plan in place in advance in case of significant cognitive side effects, whether of memory or other cognitive functions.

(7) The treating physician's board certification, and dates of most recent retraining on the specific topic of research advances in uses and application of ECT.

(e) The treating physician shall have the burden of proof that the patient

was provided sufficient information to consent to treatment, as required by this chapter, should the patient report that a side effect of ECT was a loss of any memory of the consent review.

(f) A change in the number or type of treatments from the plan documented on the physician's form shall constitute a new course of treatment requiring repetition of the entire informed consent procedure.

(g) A person may revoke consent at any time during the course of treatment.

(h) If a person is found not to have capacity to give informed consent, but is not refusing consent, ECT treatment may be given in either of the following situations:

(1) That person has previously given clear advance consent in a valid

durable power of attorney for health care and the agent named in that document consents in accordance with the written consent procedure provided in this section.

(2) On application to the probate court, a guardian ad litem is named for the purpose of consent. An attorney shall be appointed to represent the patient. However, a guardian may only be named if the court determines by clear and convincing evidence the person's need for the treatment, the specific risks of treatment, the absence of reasonable alternative treatments, and that the person is likely to have consented to ECT if he or she had the capacity to give informed consent. The guardian may still exercise his or her independent judgment after appointment, in the best interests of the patient, and consent by the guardian must be informed consent in accord with the provisions of this chapter. All reasonable attempts must be made to provide the required information to the patient as well.

§ 7554. ADMINISTRATION OF ECT

(a) ECT may only be administered in a hospital or clinic that the department has certified as having appropriate equipment and emergency back up.

(b) ECT may be conducted on an inpatient or outpatient basis. The treating physician must document an assessment, to be placed in the patient's file, that a patient receiving outpatient treatment will not be at additional risk. Those receiving outpatient treatment may only be discharged to a responsible adult who has been made familiar with the side effects of ECT.

(c) ECT must be administered by an anesthesiologist and by a

board-certified psychiatrist who is not the patient's referring physician. The patient's regular physician must make the referral for consultation by the treating physician. If none exists, a patient must be referred to a consulting physician before referral to a clinic or hospital's treating physician.

(d) ECT treatments may not be used for psychiatric diagnoses or under circumstances that have not been approved by the American Psychiatric Association. When used for nonpsychiatric conditions, all provisions of this chapter shall remain in effect, except that the treatments may be used in addition for diagnoses and under circumstances approved by the American Medical Association.

(e) ECT may not be administered for any use classified as experimental.

(f) Any physician in the state of Vermont referring a patient to a facility outside Vermont for consultation regarding or treatment with ECT shall be required to follow the provisions for informed consent as established in this chapter in advance of the referral, unless it has been established that the facility potentially providing the treatment has in place equivalent or greater protections.

§ 7555. TREATMENT OF MINORS

(a) ECT may be administered to minors who are at least 14 years of age if all of the following conditions are met:

(1) An independent psychiatrist or licensed psychologist trained in adolescent psychiatry has determined that the minor has the mental capacity and the maturity of judgment to make an informed consent to ECT and that the minor has voluntarily consented to the treatment.

(2) Two consulting psychiatrists who specialize in adolescent psychiatry have independently reviewed the case and recommended ECT as the best and only reasonable course of treatment, and have determined that the minor's psychiatric illness is of a severe nature and cannot reasonably be treated by any other alternative. The psychiatrists shall place in the minor's file written evaluation and their recommendations.

(3) The minor's parents or legal guardian has given informed consent.

(4) All other requirements of this chapter have been met.

(b) ECT may be administered to a minor under the age of 14 if both the following conditions are met:

(1) The requirements of subdivisions (a)(2), (3) and (4) of this section have been met.

(2) An independent review panel established by the department has authorized treatment to proceed.

§ 7556. MEDICAL MALPRACTICE ACTIONS

This chapter specifically supercedes section 1909 of this title, as it pertains to a physician's administration of ECT treatments. Any additional questions asked by the patient are required to be reasonably answered, and such information may not be withheld, unless the physician decides to reverse his or her recommendation for ECT rather than provide information he or she believes might adversely affect the patient's condition.

§ 7557. RULES ADOPTION

The department shall adopt rules for the certification and decertification of ECT administration locations and the enforcement of the provisions of this chapter, as well as such other rules that are necessary to ensure the safety of the administration of ECT.

Sec. 2. EFFECTIVE DATE

This act shall take effect 30 days after passage.