By Jerri Lynn Ward, J.D., Garlo Ward, P.C.
Posted July 3, 2002
A new rule, 19.1207, in Chapter 40 of the TAC has been added to require informed consent for psychoactive medications starting July 1st, 2002.
Definition of Psychoactive Medications
The rule defines a psychoactive medication as any medication prescribed for the treatment of symptoms of psychosis or other severe mental or emotional disorders and used to exercise an effect on the central nervous system to influence and modify behavior, cognition, or affective state when treating the symptoms of mental illness. The term includes the following categories when used as described by this subdivision:
- anti-psychotics or neuroleptics;
- antidepressants;
- agents for control of mania or depression;
- anti-anxiety agents;
- sedatives, hypnotics, or other sleep-promoting drugs; and
- psychomotor stimulants.
Conditions Not Requiring Consent
A person may not administer a psychoactive medication to a resident who does not consent to the prescription unless:
- the resident is having a medication-related emergency; or
- the person authorized by law to consent on behalf of the resident has consented to the prescription
An emergency is defined as a situation in which it is immediately necessary to administer medication to a resident to prevent:
- Imminent probable death or substantial bodily harm (physical or emotional) to the resident, or
- Imminent physical or emotional harm to another because of threats, attempts, or other acts the resident overtly or continually makes or commits
Obtaining Consent
Consent to the prescription of psychoactive medication given by a resident, or by a person authorized by law to consent on behalf of the resident, is valid only if:
- the consent is given voluntarily and without coercive or undue influence;
- the person who prescribes the medication, or that person’s designee, provides the resident and, if applicable, the person authorized by law to consent on behalf of the resident, with the following information in a single document identified as being for the purpose of consent to treatment with psychoactive medication:
- the specific condition to be treated;
- the beneficial effects on that condition expected from the medication;
- the probable clinically significant side effects and risks associated with the medication, as reported in widely available pharmacy databases or the manufacturer’s package insert; and
- the proposed course of the medication.
Consent can be obtained in two ways:
- Residents or their legal representatives give written consent after being given the required information on the medication (described above), or
- The person who prescribes the medication or his/her designee obtains consent of the resident or legal representative, and documents in the chart that the required information (described above) was discussed, and the consent given under which circumstances. Telephone consents are permitted.
Consent is valid until consent is withdrawn, or the practitioner has discontinued the medication.
Facilities have 7 days upon admittance of a resident who is already taking psychoactive medication to obtain consent. Attempts to obtain consent must be documented.
Residents do not need to re-obtain consent for residents taking psychoactive medications who are transferred to a hospital and then readmitted to the facility taking the same prescriptions.
Discontinuation of Medication
For purposes of this rule, a medication will be considered to be discontinued if therapy has been suspended for more than 70 days. If the suspended therapy is resumed within the 70-day period, an oral explanation of side effects should be documented in the clinical record.
The Health and Safety Code, Chapter 313, Consent to Medical Treatment, provides guidance on treatment decisions when a resident is comatose, incapacitated, or otherwise mentally or physically incapable of communication. An ethics committee also may prove helpful in such situations.
Refusal to Give Consent
A resident’s refusal to consent to receive psychoactive medication must be documented in the resident’s clinical record.
If a person prescribes psychoactive medication to a resident without the resident’s consent because the resident is having a medication-related emergency:
- the person must document the necessity of the order in the resident’s clinical record in specific medical or behavioral terms, and
- treatment of the resident with the psychoactive medication must be provided in the manner, consistent with clinically appropriate medical care, least restrictive of the resident’s personal liberty.
Liability
A physician, or a person designated by the physician, is not liable for civil damages or an administrative penalty and is not subject to disciplinary action for a breach of confidentiality of medical information for a disclosure of the information provided under subsection (c)(2) made by the resident, or the person authorized by law to consent on behalf of the resident, that occurs while the information is in the possession or control of the resident or the person authorized by law to consent on behalf of the resident.
All information in this article is informational only and is not legal advice. Should you have any questions or a situation requiring advice, please contact an attorney.
Copyright 2004 by Garlo Ward, P.C., all rights reserved
Austin, Texas 78752-3714 USA
Telephone: 512-302-1103
Facsimilie: 512-302-3256
Email: Info@Garloward.com
