BILL ANALYSIS
SENATE JUDICIARY COMMITTEE
Senator Ellen M. Corbett, Chair
2009-2010 Regular Session
SB 303
Senator Alquist
As Amended April 27, 2009
Hearing Date: April 28, 2009
Health & Safety Code
GMO:jd
SUBJECT
Nursing Facility Residents: Informed Consent
DESCRIPTION
This bill would codify certain regulations promulgated by the
Department of Public Health relative to the right of a skilled
nursing or intermediate care facility resident to information
that is material to the resident's decision to accept or refuse
a proposed treatment or procedure. Specifically, the bill would
make the resident's attending physician or the prescribing
physician responsible for disclosing the material information
and for obtaining the resident's informed consent, as defined,
prior to prescribing, ordering, or increasing an order for an
antipsychotic medication for the resident.
The bill would also require the facility staff to verify with
the resident whether the resident voluntarily agreed to accept
the proposed treatment or procedure after receiving the
information from the attending physician and to document this
verification in the resident's medical record.
The bill contains findings and declarations relating to the
protection of residents of California nursing facilities, about
60 percent of whom are prescribed psychoactive drugs and 20
percent of whom receive powerful antipsychotic drugs that are
not intended or approved for the resident's underlying
condition.
BACKGROUND
Long-term health care facilities, including skilled nursing
(more)
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facilities (SNFs), intermediate care facilities, congregate
living facilities, nursing facilities, and pediatric day health
and respite facilities, are licensed and strictly regulated by
responsible state agencies. Skilled nursing facilities (SNFs)
are facilities that provide skilled nursing care and supportive
care to patients whose primary need is for the availability of
skilled nursing care on an extended basis, and are licensed and
certified by the Department of Public Health (DPH).
The Department of Public Health is required to conduct periodic
inspections of SNFs to ensure compliance, and to assess
penalties, including citations which may result in monetary
fines, against SNFs that have violated federal or state law.
According to the author and the California Advocates for Nursing
Home Reform (CANHR), enforcement of the laws relating to
informed consent of residents for the administration of
psychotherapeutic drugs in nursing homes has been spotty. The
result, they state, is that drug manufacturers have taken full
advantage of the lax oversight to market the use of
antipsychotic drugs to sedate and control residents with
dementia.
Pscyhotherapeutic drugs are medications meant to control
behavior or to treat thought disorder processes.
Psychotherapeutic drugs, such as anti-depressants, are widely
used in nursing facilities to treat residents for various
conditions. According to data provided by the Centers for
Medicare and Medicaid Services (CMS) On-Line Survey,
Certification, and Reporting (OSCAR) system, approximately 58
percent of California nursing facility residents were
administered psychotherapeutic drugs in 2007.
Antipsychotic drugs are a group of psychotherapeutic drugs that
are primarily designed to treat severe conditions such as
schizophrenia. Studies show that the use of antipsychotic drugs
in nursing homes throughout California and the nation has
increased during recent years, as more and more physicians
prescribe these drugs, for "off-label" use, to patients with
Alzheimer's disease and other forms of dementia. According to a
2008 CMS report, approximately 20 percent of California nursing
facility residents were administered antipsychotic drugs.
Antipsychotic drugs are known to have major side effects and
risks, including increased risk of heart attack, stroke, and
death among elderly patients, thereby prompting the federal Food
and Drug Administration (FDA) to require black box warnings on
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their labels, informing patients of the health risks associated
with their use.
In February 2009, the Attorney General arrested a nurse,
physician, and pharmacist who worked for a skilled nursing
facility in Kern County, for forcibly administering high doses
of antipsychotic drugs to patients with Alzheimer's disease and
dementia who were noisy, uncooperative, or otherwise disruptive.
As a result of the forced administration of these drugs, three
residents died and one resident suffered great bodily injury.
When the case was discovered, the Department of Public Health
immediately sent an investigative team to the facility, where
the team discovered 22 residents had been given high doses of
antipsychotic drugs to control and quiet their behavior. DPH
issued a "certificate of immediate jeopardy" to the facility and
turned the case over to the Department of Justice.
This bill would codify existing regulations relevant to the
disclosure of information that is material to a resident's
decision to accept or refuse psychotherapeutic drug treatment.
CHANGES TO EXISTING LAW
1. Existing law requires an attending physician of a skilled
nursing facility (SNF) resident, who has the capacity to make
decisions concerning his or her own health care, to obtain the
informed consent of the resident when prescribing, ordering,
or increasing an order for an antipsychotic medication.
(Health & Saf. Code Sec. 1418.9.)
Existing law also requires the attending physician, with the
resident's consent, to notify the resident's family member, as
designated within the resident's medical record, within 48
hours of the prescription, order, or increase of an order of
an antipsychotic medication, as specified. (Health & Saf.
Code Sec. 1599.3.)
This bill would provide that a resident shall have the right
to receive all information that is material to an individual's
decision concerning whether to accept or refuse any proposed
treatment or procedure, and would require certain disclosures
for administration of psychotherapeutic drugs.
This bill would define "informed consent" for this purpose to
mean the voluntary agreement of a resident or resident's
representative to accept a treatment or procedure after
receiving information, as further specified.
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This bill would specify that the information required for
"informed consent" is all information that is material to the
individual's decision concerning whether to accept or refuse
any proposed treatment or procedure, and shall include, but
not be limited to, the following:
the reason for the treatment and the nature and
seriousness of the resident's illness;
the nature of the procedure to be used in the proposed
treatment, including probable frequency and duration;
the probable degree and duration, whether temporary or
permanent, of improvement or remission expected with or
without the proposed treatment;
the nature, degree, duration and probability of side
effects and significant risks associated with the
medication;
the reasonable alternative treatments and risks, and why
a particular treatment is recommended; and
that the resident has the right to accept or refuse the
proposed treatment, and, if the resident consents, that he
or she has the right to revoke the consent for any reason
at any time.
This bill would make the attending physician responsible for
determining what information a reasonable person in the
resident's condition and circumstances would consider material
to a decision to accept or refuse a proposed treatment or
procedure, and would provide that information that is commonly
appreciated need not be disclosed.
This bill would require the facility staff, prior to
administration of psychotherapeutic drugs ordered by an
attending physician, to inspect the resident's medical record
and verify that the record contains a notation by the
attending physician that he or she has obtained the informed
consent of the resident for the proposed treatment or
procedure.
The bill would require the facility staff to then verify with
the resident or the resident's representative that the
resident has voluntarily agreed to accept the proposed
treatment or procedure after receiving information from the
attending physician, and to document this verification in the
resident's health record.
This bill would also require the facility staff to ensure that
all decisions concerning the withdrawal or withholding of life
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sustaining treatment are documented in the resident's health
record.
This bill would provide that obtaining informed consent each
time a treatment or procedure is administered is not required,
unless material circumstances or risks change.
The bill would provide that nothing in the bill shall be
construed to impair or otherwise alter other non-conflicting
statutory or regulatory requirements related to requirements
for informed consent for the administration of
psychotherapeutic drugs.
2. Existing law governs the licensing of skilled nursing and
intermediate care facilities and requires the State Department
of Public Health periodically to inspect the facilities for
compliance with licensing laws and regulations.
This bill would require the State Department of Public Health
to inspect a facility for compliance with these informed
consent requirements during prescribed inspections.
COMMENT
1. Need for the bill
The author writes:
The law regarding informed consent for the administration of
psychotherapeutic drugs in nursing homes is actually fairly
well developed. The problem is not with the law but with
its enforcement. DPH (Department of Public Health) has been
slow to establish an inspection process and carry out
licensing inspections, and drug manufacturers have taken
full advantage of the lax oversight to market antipsychotic
drugs to nursing homes and physicians as the method of
choice to sedate and control residents with dementia.
Despite law and regulations that mandate that informed
consent be obtained before any treatment may be administered
to a nursing home resident, doctors and nursing home staff
members often order and distribute potentially dangerous
psychotherapeutic drugs without consulting with residents
or their representatives. As a result, California nursing
homes residents receive psychotherapeutic drugs at a rate
significantly higher than in other states.
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The bill also remedies a problem with communicating boxed
warning labels to nursing home residents. Often, residents
never see the FDA-mandated black box warnings that describe
the serious side effects and risks associated with
antipsychotic drugs. These risks include increased risk of
heart attack, stroke, and death, which are especially high
for those with Alzheimer's disease or dementia. Residents
do not receive their prescribed drugs in the original
packaging and thus never know about warning labels unless
they are specifically told by their health care providers.
By requiring doctors to convey warning label information,
residents will be assured that they are given this important
information before agreeing to take potentially dangerous
drugs.
2. Informed consent definitions and requirements are
consistent with existing law and regulations
As the author stated, the law on informed consent is well
developed, and that enforcement is the problem that this bill
seeks to remedy. Current law places the obligation on a
physician to obtain "informed consent" from a patient prior to a
treatment or procedure. First used in Salgo v. Leland Stanford
Jr. University Board of Trustees (1957) 154 Cal.App.2d 560 and
followed by Cobbs v. Grant (1972) 8 Cal.3d 229, the principle of
"informed consent" has been fine-tuned, but not varied, by more
recent cases. Thus, the obligation to ensure that the resident
is given material information about the nature, associated and
inherent risks, duration, and other important and material facts
about a proposed treatment or procedure (especially
psychotherapeutic drugs, as it relates to nursing facilities),
continues to be the responsibility of the attending physician or
the physician prescribing the drug treatment or procedure.
The SB 303 definition of informed consent, including the list of
information that is material to a resident's decision whether to
accept or reject a proposed treatment or procedure, is entirely
consistent with statutory, regulatory, and decisional law on
informed consent.
AB 894 (Alquist, Chap. 46, Stats. 2000) enacted the current
requirement that an attending physician of a skilled nursing
facility (SNF) resident obtain the informed consent of the
resident for the purpose of prescribing, ordering, or increasing
an order for psychoactive medication and, within 48 hours, to
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notify the resident's designated family member of the increase,
prescription, or order of antipsychotic medication, provided the
resident consents to the disclosure to the family member.
This bill would build upon that legislation by providing a
definition of informed consent in statute. The bill also would
provide specific guidelines to the attending physician, in
statute, on what material information must be disclosed, thereby
creating more consistency.
The California Advocates for Nursing Home Reform (CANHR) states
that the nursing homes have increasingly turned to
psychotherapeutic drugs to sedate and control residents,
especially those who display confused or agitated behavior
caused by dementia. CANHR states that while these drugs are
sometimes appropriately prescribed to treat mental health
conditions, many of the psychotherapeutic drugs being used in
nursing homes, particularly antipsychotic drugs designed to
treat serious psychiatric disorders, are dangerous and used
without medical justification. This bill, CANHR states, would
address these concerns by codifying existing regulations that
establish a nursing home resident's right to informed consent,
especially concerning the use of psychoactive drugs,
strengthening requirements for informed consent verification,
and clarifying that the DPH shall inspect for compliance with
informed consent requirements.
3. Nursing facility staff to verify attending physician's
notation of informed consent
This bill would further enforcement of the informed consent
requirement by imposing a duty on the nursing facility staff,
prior to administration of psychotherapeutic drugs, to inspect a
resident's medical record and verify the attending or
prescribing physician's notation that he or she had obtained the
informed consent of the resident for the treatment proposed
(ordering, prescribing, or increasing antipsychotic drug
treatment). While a nurse or other staff would not be required
to second-guess the completeness of the disclosures made to the
resident or resident's representative, this bill would however
require the nurse or other staff to ask whether the resident
voluntarily agreed to accept the proposed treatment and note the
answer in the resident's medical record. By this simple
requirement, the author and supporters hope that the attending
physician will spend the time explaining the drug treatment to
the resident or the resident's representative and remember to
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notate the resident's medical records.
4. Savings clause will ensure non-conflicting existing
regulations to remain intact and effective
SB 303 will codify only some of the regulations relating to
administration of treatments and procedures for residents of
SNFs. In order to avoid an implication that those regulations
not codified are to be rendered ineffective by SB 303, the bill
has been amended to include a savings clause (page 9, line 16).
5. Supporters' arguments and opponents' concerns
The AARP and other advocates for the elderly support SB 303
because "it would protect vulnerable residents from
inappropriate use of dangerous antipsychotic drugs, many of
which have dangerous side effects. As much as 60% of California
nursing home residents are given psychotropic medications. Many
residents are given inappropriate, unnecessary treatments that
can actually lead to adverse outcomes, including increased risk
of heart attack, stroke, and death among elderly patients.
Patients or their delegates are often not aware of the warning
labels on the medications administered to them and are therefore
not aware of the increased risk to their loved ones because of
the administration of these drugs."
Other supporters, such as Advocacy Inc., the Long-Term Care
Ombudsman Program for Santa Cruz and San Benito Counties, and
that for Ventura County contend that they are keenly aware of
the misuse of psychotherapeutic drugs, which are often used for
the convenience of staff. They believe this bill will help
ensure that SNF residents or their representatives become better
informed and make the right choices.
Some opponents' concerns, such as those expressed by the
California Association of Health Facilities (CAHF) about the
burden on the nursing facility staff created by this new "right"
to informed consent, have been addressed by the latest
amendments to the bill. Others, such as California Association
of Long Term Medicine (CALTCM) contend that SB 303 duplicates
regulations already in place, and tells physicians how to
practice medicine. They state, "[p]roposing stiffer criminal
penalties in an area of care that is already highly regulated
and highly scrutinized will only serve to make the practice of
long-term care medicine less attractive to the already projected
undersupply of graduating residents in primary care disciplines,
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who would find such legislation and the predictable consequent
increase in litigation liability exposure to be significant
disincentives." The California Medical Association (CMA)
believes that, while informed consent is imperative for these
nursing home patients, SB 303 "appears to go well beyond
existing law and could have the opposite effect by creating
burdensome requirements that will actually inhibit communication
with patients."
Support : AARP; Advocacy Inc.; California Senior Legislature;
Ombudsman Services of Northern California; Dayle McIntosh
Center; Bet Tzedek Legal Services; Pathways Home Health and
Hospice; Gray Panthers Sacramento; Congress of California
Seniors; 17 individuals
Opposition : California Association of Health Facilities;
California Association of Long Term Care Medicine; California
Medical Association; California Hospital Association; Crestwood
Behavioral Health, Inc.; Aging Services of California
HISTORY
Source : California Advocates for Nursing Home Reform (CANHR) and
California Alliance for Retired Americans (CARA) (Cosponsors)
Related Pending Legislation : None Known
Prior Legislation :
AB 894 (Alquist, Ch. 246, Stats. 2000) enacted the current
requirement of informed consent by residents of skilled nursing
facility residents and the notification to the resident's family
or representatives within 48 hours of ordering, prescribing, or
increasing use of psychotherapeutic drugs by a resident.
Prior Vote : Senate Health Committee (Ayes 8, Noes 3)
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