BILL ANALYSIS
SB 303
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Date of Hearing: August 19, 2009
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Kevin De Leon, Chair
SB 303 (Alquist) - As Amended: August 17, 2009
Policy Committee: Health Vote:13-3
Judiciary 7-3
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill clarifies and expands informed consent processes prior
to the administration of psychotherapeutic (ie: anti-psychotic,
anti-anxiety) medications in skilled nursing facilities (SNF,
nursing homes) and intermediate care facilities (ICF).
Specifically, this bill:
1)Requires attending physicians to obtain informed consent
pursuant to the specifications of this bill.
2)Defines informed consent to include codification of current
regulations that require the physician to:
a) Share with the patient or resident's representative
"material information" to make a decision about the
medication.
b) Indicate the reason, the nature, and the duration, side
effects, and alternatives to treatment.
3)Requires information about black box warnings issued by the
federal Food and Drug Administration (FDA) and off-label FDA
uses to be included in the obtaining of informed consent.
4)Requires, prior to initiating a course of psychotherapeutic
medication, the facility staff to document the informed
consent established by the attending physician in the patient
health record, verify that the patient or the patient's
representative has agreed to the patient voluntarily taking
the medication, and specifies steps required if a patient or
patient's representative do not accept the treatment.
5)Requires the California Department of Public Health (DPH) to
SB 303
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inspect facilities with respect to the requirements
established by this bill.
6)Authorizes DPH to issue a "B", "A", or "AA" citation for
violations of the informed consent requirements.
FISCAL EFFECT
Absorbable workload to DPH to continue oversight of patient
safety and facility compliance with health and safety standards
at nursing homes and ICF.
COMMENTS
1)Rationale . This bill is sponsored by the California
Association for Nursing Home Reform (CANHR) to help prevent
the excessive use of powerful psychotherapeutic drugs such as
anti-psychotic and anti-anxiety medications. These medications
are designed for altering mood and may include prescription
stimulants, sedatives, tranquilizers, and pain relievers.
According to federal data, the use of these drugs has doubled
from 30% of patients in 2000 to 60% of patients in 2007 in
California nursing homes. According to the author and sponsor,
drugs such as Zyprexa, Seroquel, Risperidal, and Haldol, which
are approved for use to relieve symptoms of schizophrenia and
bi-polar disorder, are also used frequently to control the
behavior of elderly patients with dementia.
2)Recent Amendments clarify which section of the bill is tied to
the informed consent definition and change "promptly" to
"immediately" with respect to staff follow-up with an
attending physician in order to avoid DPH needing to
promulgate regulations.
3)Medication Risks . The FDA has not approved the use of
anti-psychotic drugs for the treatment of dementia and the use
of these drugs may lead to illness and death. The author and
sponsor cite an incident in Kern County in February of this
year when the California Attorney General filed criminal elder
abuse charges against a nurse, physician, and pharmacist for
causing the death of three residents of a nursing home by for
forcibly administering anti-psychotic drugs to patients with
Alzheimer's disease or dementia. Following DPH investigation,
it was discovered that more than 20 other patients had also
been prescribed high doses of risky medication to control
behavior.
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4)Medications and Black Box Warnings . The FDA black box warning
appears on the package insert of certain drugs that have been
shown by medical studies to carry a significant risk of
serious or life-threatening patient impacts. Off-label uses of
FDA-approved medications means that the use is not approved by
the federal government. Recently Eli Lilly reached a $1.4
billion settlement with the federal government for off-label
marketing of Zyprexa for children, adolescents, and dementia
patients. California's Medi-Cal program will receive $112
million of this settlement.
Zyprexa's approved uses include treatment of schizophrenia and
bi-polar disorder. Side effects of Zyprexa may include
diabetes and hyperglycemia. Zyprexa currently carries the
following black box warning: "Elderly people with psychosis
related to dementia (a brain disorder that lessens the ability
to remember, think, and reason) are at increased risk of death
when taking certain mental health medicines compared with a
sugar pill. Zyprexa is not approved for these patients."
5)DPH Citations. AA citations are issued when a resident death
has occurred and deemed to be the responsibility of the
facility. AA citations carry a fine of $25,000 to $100,000.
Class A citations are issued when violations present imminent
danger to patients or the substantial probability of death or
serious harm, and carry fines of $2,000 to $20,000.
6)Concerns . The California Association of Health Facilities
(CAHF) and the California Hospital Association (CHA) both
oppose this bill due to concerns about scope of practice for
nurses in their facilities. CAHF represents free-standing SNF
and CHA represents SNF affiliated with acute care hospitals.
According to both groups, the provisions of this bill that add
requirements beyond current law regulations are problematic.
For example, they express concerns about nursing staff
inquiring about informed consent. They indicate this exchange
will require nurses to engage in professional conduct that is
prohibited in their practice act. In addition, the opposition
indicates that it may be both illegal and inappropriate to
have nursing staff second-guessing physician prescribing by
requiring a nurse to determine whether to administer or
withhold treatment.
Analysis Prepared by : Mary Ader / APPR. / (916) 319-2081