INFORMED CONSENT

Chapter 13

LPS recognizes that patients may be involuntarily committed yet nevertheless remain capable of giving informed consent. Riese, at 1319, 271 Cal. Rptr. 199.

A. The General Principles of Informed Consent.

1. The right to informed consent.

California law provides that all people, including those who receive mental health services, have the right to give or refuse informed consent to treatment. All mental health patients have a right to: 1) an explanation of their diagnosis; 2) information about their treatment; and 3) give or refuse to give consent for treatment.

This right assures that mental health clients are given good information and the opportunity for participation in the treatment process. The purposes of informed consent include:

  • To educate clients about the risks and benefits of and alternatives to, medication.
     

  • To involve clients in an important and significant part of their treatment.
     

  • To certify that the client has been offered an explanation of the antipsychotic medication and has received a copy of the specific drug information.
     

  • To serve as the legal record of the client's agreement or disagreement with the administration of antipsychotic medication.

2. Limits on the right.

The principles of informed consent apply to all forms of treatment, including hospitalization, placement, services and medication. It applies to medical and psychiatric treatment. This right may only be limited when:

  • There is a statutorily-defined emergency where it is immediately necessary to give medication for the preservation of life or the prevention of serious bodily harm; or
      

  • It has been determined in a hearing (called a Riese hearing or "capacity" hearing) that a person does not have capacity to consent; or
      

  • The person is on LPS conservatorship with a specific judicial determination of incapacity.

B. Physical Health Care.

1. Legal Basis of right to make medical decisions.

a. Statutory and regulatory standards.

Adults, including those receiving mental health treatment, have the right to give or refuse consent to medical diagnostic or treatment procedures. California Health and Safety Code § 7185.5(a) states that "the legislature finds that adult persons have the fundamental right to control the decisions relating to the rendering of their own medical care..." California Code of Regulations, Title22 § 70707(b)(6) provides that a patient has a right to "participate actively in decisions regarding medical care. To the extent permitted by law, this includes the right to refuse treatment." Commitment for involuntary psychiatric treatment does not confer authority to give medical treatment without consent unless an emergency exists or a judicial decision specifically confers that authority.

b. Case (Common) law.

The right to give or withhold consent to medical treatment is well established in California. This right is grounded in the constitutional right to privacy and in the common law. Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972). Cobbs held that a person may bring an action for battery in absence of informed consent. Furthermore, the California Supreme Court recently reaffirmed the basic and "fundamental right" even when a refusal of the proposed medical treatment may cause or hasten death. Thor v. Superior Court, 5 Cal. 4th 725, 855 P.2d 375, 21 Cal. Rptr. 2d 357 (1993) (dealing with a quadriplegic prisoner could refuse gastrostomy tube for feeding and medication). Likewise, persons committed for involuntary psychiatric treatment under the LPS Act have the same legal rights and responsibilities guaranteed all other persons by the Federal Constitution and laws and the Constitution and laws of the State of California, including the fundamental right to determine the scope of one's own medical treatment. (Cal. Welf. & Inst. Code 5325.1).

2. Court Authorized Medical Treatment (Probate Code 3200 et seq.).

The procedure for obtaining court authorization of non-emergency physical health care to which a patient will not consent is outlined in Cal. Probate Code Section 3200 et. seq. Pursuant to this law, a Court can determine that a patient is not competent to consent to certain medical procedures or treatments and therefore, order such procedures or treatments be authorized without the patient's consent.

3. "Medical emergency" exception.

In the case of a medical emergency, medical treatment may be provided without the patient's consent if no evidence exists to indicate that the patient would refuse the treatment. The law implies consent in these circumstances on the theory that if the patient were able, the consent would be given. A psychiatric hold does not give the facility authority to provide medical care without consent.

California law defines a medical emergency as a situation where:

  • immediate services are required for the alleviation of severe pain, or
     

  • immediate diagnosis and treatment of unforeseeable medical conditions are required, if such conditions would lead to serious disability or death if not immediately diagnosed and treated,

Only the emergency condition may be treated. Treatment which exceeds that needed for the emergency may not be rendered without the patient's consent.

As a general rule, if the patient has validly exercised his/her right to refuse a particular medical treatment, the treatment may not be provided. Since the emergency treatment exception is based on the theory of implied consent, it is not applicable when the patient has validly refused medical treatment.

C. Antipsychotic Medication

Voluntary patients have an explicit right to accept or refuse antipsychotic medication after being fully informed of the risks and benefits except in a statutorily-defined emergency. (9 C.C.R. §§ 850-856).

Involuntary patients may accept or refuse antipsychotic medication except in a statutorily- defined emergency and/or when there has been a legal finding of incapacity. (Cal. Welf. & Inst. Code § 5332, Riese v. St. Mary's Hosp. & Med. Ctr., 196 Cal.App. 3d 1388 (1988)).

Antipsychotic medication is defined as any drug customarily prescribed for the treatment of symptoms of psychoses and other severe mental and emotional disorders. (Cal. Welf. & Inst. Code § 5008 (I), 9 C.C.R. § 856).

1. The right to know.

Informed consent means that the patient, after being provided adequate information about their condition and proposed treatment, knowingly and intelligently, without duress or coercion, clearly and explicitly give their consent to the proposed treatment. Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (1972).

Before a patient decides to consent or not consent to treatment, the physician must explain the following:

  • The patient's right to refuse treatment with antipsychotic medications;
     

  • The patient's right to be medicated over their objection only if there is a legally defined emergency or a legal determination of incapacity;
     

  • A description of the nature and seriousness of the mental condition, disorder, or behavior;
     

  • An explanation of the reasons for the treatment;
     

  • The name and type, frequency, amount, and method of dispensing the treatment, and the probable length of time that the treatment will be taken;
     

  • A description of the likelihood of improvement and the probable degree and duration (temporary and permanent) of improvement or remission expected with (and without) the medication;
     

  • An explanation of the nature, degree, duration, and probability of the side effects and interactions (with other treatment), the risks and how and to what extent they may be controlled, if at all;
     

  • An explanation of the reasonable alternative treatments available (including other medications and nonmedication-oriented treatment) and why the doctor is recommending this particular treatment. (Cal. Welf. & Inst. Code §§ 5332(c),5213(b), 5332; 9 C.C.R. § 851).

2. Giving consent.

After receiving the above information, the doctor should ask the patient whether he/she agree or disagree to take the medication. If the patient consents to the medication, the facility must keep a written record of the patient's decision.

The patient may withdraw consent at any time by stating their intention to any member of the treatment staff. (9 C.C.R. § 854).

3. Withholding consent.

The patient has a right to refuse the medication and/or revoke the consent previously given.

a. Voluntary Patients. If the patient is on voluntary status, he/she must be allowed to refuse the medication unless there is an emergency. (9 C.C.R. § 851, § 853).

b. Involuntary Patients. If the patient is on a 72 hour hold or 14 day hold, they must be allowed to refuse. If the doctor believes that the patient does not understand the circumstances, including why the medicine was recommended and what alternatives exist, the doctor should continue to discuss this information with the patient. (Cal. Welf. & Inst. Code §§ 5332(b), 5008(m)).

4. Riese (or capacity) hearings.

If the treating physician believes that a patient who is refusing medications does not have the capacity to make such a decision, the physician may petition the Superior Court to request a hearing to determine whether the patient has the capacity to consent to or refuse the medication. Within two days (not including weekends) from the time the doctor requests the capacity hearing, the patient will be contacted by an attorney from the Public Defenders Office or, in some counties, a Patients’ Rights Advocate to prepare for the hearing. The patient shall then be scheduled for a hearing to occur before a hearing officer or judge from the Superior Court who will decide the issue of capacity to give or withhold consent to medical treatment. (Cal. Welf. & Inst. Code § 5333).

Unless there is an emergency (Cal. Welf. & Inst. Code § 5008(m)), the patient cannot be medicated without giving consent until the hearing takes place. Then, if the court decides that the patient is not capable of giving informed consent, the doctor will be given authority to medicate the patient despite his/her objections.

5. Changes in medication.

Complaints and questions that the patient has about his/her condition, the medication, the side effects and the alternative treatments should be answered to the patient's satisfaction by staff and brought to the attention of the treating physician as soon as possible. Adjustments in medication should be made when appropriate.

Informed consent should be obtained for any change in the medication or dosage prescribed. For each change, the physician should provide the oral and written information and the patient must sign the consent form.

6. Emergency situations.

Voluntary and involuntary patients may be medicated without consent in an emergency situation if they meet the legal criteria. An emergency is defined as a situation in which action to impose treatment over the person's objection is immediately necessary for the preservation of life or the prevention of serious bodily harm to the patient or others, and it is impracticable to first gain consent. [Cal. Welf. & Inst. Code § 5008(m)].

The definition of an emergency for the administration of medication to a voluntary patient is slightly different. California Code of Regulations Title 9 § 853 states; "Nothing in this article is intended to prohibit the physician from taking appropriate action in an emergency. An emergency exists when there is sudden marked change in the patient’s condition so that action is immediately necessary for the preservation of life or the prevention of serious bodily harm to the patient or others, and it is impracticable to first obtain consent If antipsychotic medication is administered during an emergency, such medication shall be only that which is required to treat the emergency condition and shall be provided in ways that are least restrictive of the personal liberty of the patient."

An emergency situation allows for administration of medication only to the degree and for the duration needed to address that emergency situation. An emergency must be addressed in the least restrictive manner. This means administering smaller rather than larger dosage amounts, shorter acting medications, orally rather than by injection and medication without seclusion and restraint.

Emergency determinations should be contemporaneous with the administration of medication. If at any point the behavior justifying the emergency ends or it becomes practicable to gain informed consent, the justification for the emergency administration of medication no longer exists.

7. Documentation Requirements.

Documentation of consent: "For each patient receiving antipsychotic medications, the facility shall maintain a written record of the patient's decision to consent to such medications. That written record shall be a written consent form signed by the patient indicating that items (a) through (f) of Title 9, section 851 of the California Code of Regulations have been discussed with the patient by the prescribing physician." (9 C.C.R. § 852).

California Code of Regulations Title 9, sections 851 (a) to (f) requires that "...[i]n order to make an informed decision, the patient must be provided with sufficient information by the physician prescribing such medications (in the patient's native language) which shall include the following:

a. the nature of the patient's mental condition;

b. the reasons for taking such medication, including the likelihood of improving or not improving without such medication, and that consent, once given, may be withdrawn at any time by stating such intention to any member of the treating staff,;

c. the reasonable alternative treatment available, if any,

d. the type, range of frequency and amount (including use of PRN orders), method (oral or injection), and duration of taking the medication,

e. the probable side effects of these drugs known to commonly occur, and any particular side effects likely to occur with the particular patient,

f. the possible additional side effects which may occur to patients taking such medication beyond three months. The patient shall be advised that such side effects may include persistent involuntary movement of the face or mouth and might at times include similar movement of the hands and feet, and that these symptoms of tardive dyskinesia are potentially irreversible and may appear after medications have been discontinued."

(See also Cal. Welf. & Inst. Code §§ 5152(c), 5213(b))

In the event the patient has been shown but does not wish to sign the consent, the unsigned form must be placed in the chart with a notation that while the patient understands the nature and effect of antipsychotic medications and consents to their administration, the patient does not wish to sign the consent form. (9 C.C.R. § 852)

Documentation of changes in medications: Informed consent must be obtained for any change in the medication or dosage prescribed. For each change, the physician must provide the oral and written information and the patient must sign the consent form.

Documentation of refusal/withdrawal of consent: The patient's refusal to take the proposed medications must be clearly documented in the chart. Every subsequent unsuccessful attempt to obtain that patient's consent must also be fully documented; likewise, a patient may withdraw consent at any time for any reason and such withdrawal of consent

Must also be documented.

Documentation of changes in medication: Informed consent should be obtained for any change in the medication or dosage prescribed. For each change, the physician should provide the oral and written information and the patient must sign the consent form.

Documentation of emergency: Administration of medication under emergency situations must be fully documented with a complete factual description of the events and behavior making emergency necessary for the preservation of life or serious bodily injury and the impracticality of obtaining consent.

8. The Role of the Patients’ Rights Advocate.

a. Education

An important role of the Patients’ Rights Advocate is to assist patients in obtaining adequate information regarding a proposed treatment. Advocates should promote and assist patients to ask their doctors or nursing staff questions regarding their condition and any proposed treatment.

Examples of questions patients should ask include:

- What is the diagnosis of my condition? Please explain what that means.

- What kinds of treatment, other than medication, could be used for this condition?

- What kind of medication are you prescribing?

- What other kinds of medication could be prescribed for my condition?

- Why are you prescribing this medication rather than others?

- How much medication are you prescribing?

- Why are you prescribing at this dosage?

- Is this the normal dosage?

- What are the common side effects of this medication? What are other possible side effects?

- What is the likelihood of improvement with the medication?

- What is the likelihood of improvement without the medication?

- What will happen to me if I do not take the medication? What will the symptoms be?

b. Gathering evidence of capacity.

Patients’ Rights Advocates have an important role to play in identifying evidence of capacity. Advocates should emphasize that in order to be considered to have capacity, a person need not be "rational" regarding every aspect of life. For instance, someone who "hears voices" may be perfectly capable of making a decision regarding medical or psychiatric treatment. If a person has a number of reasons, some of which are considered "rational", others not considered "rational", the person's decision may still be the product of a competent decision relying on some rational basis for decision-making.

Statements from care givers (doctors, therapists, social service workers, etc) that the individual understands their current circumstances, nature of the decision to be made, and considered various alternatives and their benefits and disadvantages, is persuasive that a decision regarding treatment is valid. Specific examples of behavior indicating that the individual is capable of making rational, reasoned decisions and showing the person's rational reasons for making a particular decision regarding treatment are also valuable.

c. Facility monitoring.

Last, Advocates should monitor the facility's compliance with the patients' right to informed consent and the right to refuse medication. Advocates should encourage facilities to make continuing and successive efforts to obtain the informed consent of the patients prior to filing a petition for a capacity hearing. However, although doctors may urge medication, they may not use any rewards or threats, implied or express, or any other form of coercion. Also, patients who exercise their rights shall not be penalized or retaliated against for exercising those rights.

Advocates should assure that services are not being denied or terminated, privileges are not being revoked, or that legal status is not being changed solely on the basis of a refusal or withdrawal of consent. A patient may not be secluded or restrained for refusing or withdrawing consent.

D. Electroconvulsive Therapy (ECT)

Electroconvulsive therapy is a treatment for severe mental illness which involves passage of an electric stimulus across the brain sufficient to induce generalized seizure. California Welfare and Institutions Code § 5326.7 states that convulsive treatment is to be administered to involuntary and voluntary patients only when specified conditions are met.

1. Procedures with Voluntary Patients (Cal. Welf. & Inst. Code § 5326.75):

a. The patient's treating physician must document in the patient's record the reasons for the choice of ECT as the treatment of last resort, that all other appropriate treatment modalities have been considered with ECT remaining as the best and least drastic alternative.

b. The patient must receive all of the information about ECT specific in the law.

c. No sooner than 24 hours after this explanation has been received, the patient must sign the consent form. This signature must be witnessed by someone other than the treating physician. The date must be carefully checked. The consent form must be in the patient's record.

d. To constitute voluntary informed consent, the following information shall be given to the patient in a clear and explicit manner:

i. The reason for treatment, that is, the nature and seriousness of the patient's illness, disorder or defect.

ii. The nature of the procedures to be used in the proposed treatment, including its probable frequency and duration.

iii. The probable degree and duration (temporary or permanent) of improvement or remission, expected with or without such treatment.

iv. The nature, degree, duration, and the probability of the side effects and significant risks of such treatment, especially noting the degree and duration of memory loss (including its irreversibility).

v. That there exists a division of opinion as to the efficiency of the proposed treatment, why and how it works and its commonly known risks and side effects.

vi. The reasonable alternative treatment, and why the physician is recommending this particular treatment.

vii. That the patient has the right to accept or refuse the proposed treatment, and that if he/she consent, has the right to revoke his or her consent for any reason, at any prior to or between treatments.

e. A responsible relative of the patient's choosing and with the patient's consent must be given an explanation of the treatment.

2. Procedures with Involuntary Patients and Conservatees.

All of the following criteria must be completed in order to perform ECT on an involuntary patient or someone on an LPS conservatorship.

  • a. The attending or treating physician enters adequate documentation in the patient's treatment record of the reasons for the procedure, that all reasonable treatment modalities have been carefully considered, and that the treatment is definitely available for this patient at this time. Such treatment in the treatment record shall be signed by the attending and treating physician or physicians.

  • b. A review of the patient's treatment record is conducted by a committee of two physicians, at least one of whom shall have personally examined the patient. One physician shall be appointed by the facility and one shall be appointed by the local mental health director. Both shall be either board-certified or board-eligible psychiatrists or board-certified or board-eligible neurologists. This review committee must unanimously agree with the treatment physician's determination pursuant to subdivision (a). Such agreement shall be documented in the patient's treatment record and signed by both physicians.

  • c. A responsible relative of the person's choosing and the person's guardian or conservator, if there is one, is given the oral explanation by the attending physician as required by Cal. Welf. & Inst. Code § 5326.2. Should the person desire not to inform a relative or should such chosen relative be unavailable, this requirement is dispensed with.

  • d. The patient gives written informed consent as defined in Cal. Welf. & Inst. Code § 5326.5 to the convulsive treatment. Such consent shall be for a specified maximum period of time not to exceed 30 days, and shall be revocable at any time before or between treatments. Such withdrawal of consent may be either oral or written and shall be given effect immediately. Additional treatments in number or time not to exceed 30 days, shall require a renewed written informed consent.

  • e. The patient's attorney, or a public defender appointed by the court, agrees as to the patients' capacity or incapacity to give written informed consent.

  • f. If either the attending physician or the attorney believes that the patient does not have the capacity to give written informed consent, a petition shall be filed in superior court to determine the patient's capacity to give written informed consent. The court shall hold an evidentiary hearing after giving appropriate notice to the patient and within three judicial days after the petition is filed. At such hearing, the patient shall be present and represented by legal counsel. If the court deems the above mentioned attorney to have a conflict of interest, such attorney shall not represent the patient in this proceeding.

  • g. If the court determines that the patient does not have the capacity to give written consent, then treatment may be performed upon gaining the written informed consent as defined in Cal. Welf. & Inst. Code § 5326.2 and § 5326.5 from the responsible relative or the guardian or the conservator of the patient.

  • h. At any time during the course of treatment of a person who has been deemed incompetent, that person shall have the right to claim regained competency. Should he do so, the person's competency must be reevaluated according to subdivisions 5, 6, and 7.

  • .i. Minors. Convulsive treatment may not be performed on anyone under the age of 12. Those between 12 and 16 may be treated only in a life-threatening emergency and if 3 board-certified psychiatrists unanimously agree. (Cal. Welf. & Inst. Code § 5326.8). Sixteen and 17 year olds are treated as adults for purposes of this section.

    3. Psychosurgery.

    Voluntary and involuntary patients have the right to refuse psychosurgery. Psychosurgery includes lobotomy, psychiatric surgery, and behavioral surgery performed for the purpose of modifying or controlling thoughts, behavior, or normal brain function (Cal. Welf. & Inst. Code § 5325(g)). Under no circumstances may psychosurgery be performed on a person under 18 years of age. (9 C.C.R. § 845(a)). Special procedures govern informed consent to psychosurgery and are the same whether patients are voluntary or involuntary. These procedures are found at Cal. Welf. & Inst. Code § 5326.6

    4. Quarterly Reports.

    Each facility must report ECT to the county, which relays this report to the Department of Mental Health on a quarterly basis. Each physician who administers ECT in his/her office or clinic must also report quarterly. This procedure is outlined in Cal. Welf. & Inst. Code § 5326.15.

    5. Violations.

    All alleged or suspected violations of ECT rules should be report to the Department of Mental Health for investigation. The results of any investigation may be reported to the Board of Medical Examiners, who have the option of several courses of action (Cal. Welf. & Inst. Code § 5326.9).

    6. Role of Patients’ Rights Advocate.

    • Advocates should monitor the facility for compliance with informed consent procedure.
       

    • Advocates should monitor and analyze quarterly reports of ECT including private physicians and facilities.
       

    • Advocates should investigate complaints, and document noncompliance of ECT laws.

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