BILL ANALYSIS
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|Hearing Date:April 22, 2002 |Bill No:SB |
| |1290 |
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SENATE COMMITTEE ON BUSINESS AND PROFESSIONS
Senator Liz Figueroa, Chair
Bill No: SB 1290Author:Haynes
As Amended:April 2, 2002 Fiscal: Yes
SUBJECT: Psychotropic drugs: prescriptions for children.
SUMMARY: Requires a physician to obtain written consent
from a child's parent or legal guardian before prescribing
or dispensing a psychotropic drug to a child for treatment
of a behavioral disorder, and for the written consent form
to include information from the latest version of the
Physicians Desk Reference concerning adverse effects of the
drug.
Existing law:
1)Provides for the licensure and regulation of physicians
by the Medical Board of California.
2)Governs the prescribing, dispensing, or furnishing of
dangerous drugs by physicians.
3)Requires physicians to perform a "good faith prior
examination" and have appropriate medical indications
before prescribing, dispensing, or otherwise furnishing
dangerous drugs.
4)Requires physicians and surgeons under specified
circumstances to provide informed consent to patients
before performing certain medical procedures and failure
to do so could subject physicians to unprofessional
conduct by the Medical Board.
5)Requires that a physician obtain verbal and written
consent, and to provide certain additional information,
before performing a hysterectomy or sterilization
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procedure, before treating a patient with dimethyl
sulfoxide, before removal of sperm or ova from a patient,
and prior to delivery of health care via telemedicine.
6)Requires a physician to provide specific information
regarding alternative treatments for breast and prostate
cancer, the availability of appropriate diagnostic
procedures for prostate cancer, symptoms and appropriate
diagnosis for gynecological cancers, and information
regarding silicone implants and collagen before used in
cosmetic or plastic surgery.
7)Authorizes the parent or guardian of a minor (i.e.,
anyone under the age of eighteen years) to give informed
consent for most medical decisions on behalf of a child.
8)Allows a minor under the age of 18 to consent to medical
treatment who has obtained a certain status including if
married, on active service in armed forces, emancipated
by a court order, or 15 years or older and is living
separate and apart from their parents or guardian.
9)Allows a minor who 12 years of age or older to consent to
mental health treatment on an outpatient basis if certain
requirements are met including maturity, the minor is an
alleged victim of incest or child abuse, or there is a
danger of serious physical or mental harm to the minor or
others without such treatment, but requires the consent
of the minor's parent or guardian before psychotropic
drugs may be provided.
10) Defines psychotropic drug as any drug that has the
capability of changing or
controlling mental functioning or behavior through direct
pharmacological
action, such as antipsychotic, antianxiety, sedative,
antidepressant, and
stimulant drugs, and also includes drugs that have a
mind-altering and
behavior altering effect.
11) Classifies certain psychotropic drugs, such as
Ritalin, as Schedule II
controlled substances that are considered to have a high
abuse and
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dependence potential.
12) Requires informed consent and specific information to
be provided to a
person who is detained in a mental health facility,
regarding the effects that
antipsychotic medications may have on them, the
likelihood of improving or
not improving without the medications, and the reasonable
alternatives
available.
13) Requires informed consent of a resident of a skilled
nursing facility or for an
interested family member to be notified before
antipsychotic medication is
provided by the attending physician.
14) Specifies that if a child is adjudged a dependent of
the court and removed
from physical custody of the parent, that only a juvenile
court judge shall
have authority to make orders regarding the
administration of psychotropic
medications for a child.
15) Requires development of a treatment plan for children
placed in foster care
to address among other things the use of psychotropic
medication.
16) Requires the Department of Youth Authority, in
consultation with the
Department of Mental Health, to establish standards and
guidelines for
administration of psychotropic medications to any person
under its
jurisdiction.
This bill:
1)Requires a physician before prescribing, dispensing, or
furnishing a psychotropic drug to obtain a properly
signed informed consent form from the child's parent or
legal guardian.
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2)Specifies that the informed consent form shall include
information from the latest version of the Physicians
Desk Reference (PDR) concerning adverse effects of the
psychotropic drug.
3)Provides that it is unprofessional conduct for the
physician if the informed consent is not obtained and the
information from the PDR is not provided.
FISCAL EFFECT: Unknown.
COMMENTS:
1.Purpose. This bill is sponsored by the author.
According to the author, this bill would set forth a
standard level of information for the prescription of
psychotropic medication to minors. It would give a
specific list of topics such as side effects and
treatment options that a physician should discuss with a
parent before a child can be prescribed a psychotropic
medication.
As stated by the author, current law only requires
"informed consent" a term that is left up to the doctors
personal judgement as to what a parent or guardian "needs
to know" or "can handle" before that requirement is met,
and the parent or guardian is asked to sign the consent
form. Due to the dramatic side-effects and potential
damage caused by psychotropic medications, as explained
by the author, this bill would give a specific list of
information that a doctor must give to a parent before
that parent is asked to sign the consent form. As
indicated by the author, side effects from psychotropic
medications commonly prescribed to children include
serious stomach problems, migraine headaches, outbursts
of extreme violence, suicidal levels of depression, as
well as sudden cardiac death. Also, many of these
medications, such as Ritalin, fall into the same Drug
Enforcement Agency class of drugs as cocaine (Schedule II
drugs). These are not drugs where consent should be
taken lightly.
2.Background. It appears as if the primary focus of this
bill is to deal with the ever-increasing use of
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psychotropic medications, such as Ritalin, for treating
minors who are diagnosed as having
Attention-Deficit/Hyperactivity Disorder (ADHD). Both
the proponents of this bill, and others, have voiced
growing concern over the increased reliance of these
drugs, and whether children are receiving important
information about the effects of these medications along
with possible alternative treatments that may be
available for treating ADHD.
a) What is ADHD? Attention-Deficit/Hyperactivity Disorder
(ADHD) is the most commonly diagnosed behavioral disorder
of childhood, estimated to affect 3 to 5 percent of
school-age children. According to the National Institute
of Mental Health, ADHD refers to a family of related
chronic neurobiological disorders that interfere with an
individual's capacity to regulate activity level
(hyperactivity), inhibit behavior (impulsivity), and
attend to tasks (inattention) in developmentally
appropriate ways. The core symptoms of ADHD include an
inability to sustain attention and concentration,
developmentally inappropriate levels of activity,
distractibility, and impulsivity. Children with ADHD
generally exhibit functional impairment across multiple
settings including home, school, and peer relationships.
ADHD has also been shown to have long-term adverse
effects on academic performance, vocational success, and
emotional development. Children with ADHD experience an
inability to sit still and pay attention in class and the
negative consequences of such behavior. They experience
peer rejection and engage in broad array of disruptive
behaviors. Their academic and social difficulties have
far-reaching and long-term consequences. These children
have higher injury rates. As they grow older, children
with untreated ADHD, in combination with conduct
disorders, experience drug abuse, antisocial behavior,
and injuries of all sorts. For many individuals, the
impact of ADHD continues into adulthood.
b) Problems Associated with Diagnosis of ADHD. According
to the National Institutes of Health (NIH), primary care
and developmental pediatricians, family practitioners,
(child) neurologists, psychologists, and psychiatrists
are the health care professionals responsible for
assessment, diagnosis, and treatment of most children
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with ADHD. As indicated by the NIH, there is wide
variation among types of practitioners with respect to
frequency of diagnosis of ADHD. Data collected by the
NIH indicates that family practitioners diagnose more
quickly and prescribe medication more frequently than
psychiatrists or pediatricians. This may be due in part
to the limited time spent making the diagnosis. "The
quickness with which some practitioners prescribe
medications may decrease the likelihood that more
educationally relevant interventions will be sought."
The NIH expressed concern that diagnoses may be made in an
inconsistent manner with children sometimes being
"overdiagnosed" (being diagnosed with ADHD when they do
not have it) and "under diagnosed" (those having ADHD but
not being diagnosed and treated). This is due in part to
a number of factors including inadequate and fragmented
communication between the diagnostician and those who
more readily observe children within the school or home
setting. Other factors include a lack of skilled mental
health practitioners in this area, lack of insurance
coverage for psychiatric evaluations, and the inability
to use other assessment tools to provide a more complete
and accurate diagnosis within a managed care environment.
Also, pressure from parents and teachers to "fix the
problem" by making a diagnosis of ADHD and prescribing
medication.
c) Multidisciplinary Treatment Approach. It has been
argued that the best approach to treating children with
ADHD is a multidisciplinary method, which includes both
psychosocial and pharmacological treatments. Medications
such as dextroamphetamine (Dexedrine) and methylphenidate
(Ritalin) are the primary choice in use of medications to
treat ADHD. However, there has been a growing use of
other drugs such as Adderall and Concerta. The increase
in the use of these medications has been substantial. In
just the past five years there has been a 37% increase in
prescriptions written for these medications according to
IMS Health, and marketing of these drugs has been
extremely aggressive.
Psychosocial treatment primarily focuses on the parents,
the child and the school in attempting to modify the
child's behavior. Parents and educators are encouraged
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to actively participate in helping the child's
development with positive reinforcement, supervision,
management and encouragement. Strategies such as
contingency management (reward systems, etc.), clinical
behavior therapy (teaching parents and teachers to use
contingency management techniques) and
cognitive-behavioral treatment (self-reinforcement,
problem-solving strategies, etc.) are used as a part of
psychosocial treatment. Other alternative treatments
include dietary management, herbal and homeopathic
treatments, biofeedback, mediation, and perceptual
stimulation/training.
As indicated by the NIH, of these treatment strategies, use
of medications and psychosocial interventions have been
the major focus of research. Overall, these studies have
continued to support the efficacy of using these
medications and psychosocial treatments for ADHD and the
superiority of these medications to psychosocial
treatments. However, the NIH also pointed out that no
long-term studies testing psychotropic drugs or
psychosocial treatments have been completed, and there
are no long-term outcomes of medication-treated ADHD
individuals in terms of educational and occupational
achievements.
d) Practice Guidelines for the Diagnosis and Treatment of
ADHD. On October 2001, the American Academy of
Pediatrics released clinical practice guidelines for the
treatment of ADHD. Clinical practice guidelines for the
diagnosis of children with ADHD were released a year
earlier. The pediatrician's guidelines for diagnosis
included the following recommendations: 1) in a child 6
to 12 years old who presents with inattention,
hyperactivity, impulsivity, academic underachievement, or
behavior problems, primary care clinicians should
initiate an evaluation for ADHD; 2) the diagnosis of ADHD
requires that a child meet Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition criteria; 3)
the assessment of ADHD requires evidence directly
obtained from parents or caregivers regarding the core
symptoms of ADHD in various settings, the age of onset,
duration of symptoms, and degree of functional
impairment; 4) the assessment of ADHD requires evidence
directly obtained from the classroom teacher (or other
school professional) regarding the core symptoms of ADHD,
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duration of symptoms, degree of functional impairment,
and associated conditions; 5) evaluation of the child
with ADHD should include assessment for associated
(coexisting) conditions; and 6) other diagnostic tests
are not routinely indicated to establish the diagnosis of
ADHD but may be used for the assessment of other
coexisting conditions (e.g., learning disabilities and
mental retardation).
e) Increased prescribing of psychotropic drugs. As
already indicated, new prescriptions for drugs to treat
ADHD have increased more than 37% over the past five
years, with 20 million prescriptions written in 2000.
What is of greater concern for the proponents of this
bill, is that a February 23, 2000, study in the Journal
of American Medical Association (JAMA) reported a two to
three-fold increase in the use of stimulants such as
Ritalin and anti-depressants such as Prozac in children 2
to 4 years old between 1991 and 1995. Researchers also
found a 20-fold increase in the use of clonidine, a blood
pressure medicine used to control insomnia in children
diagnosed with ADHD. Experts expressed concern that
mind-altering drugs are providing a quick fix for
families of youngsters with behavioral problems before
much is known about the long-term effects of such drug
use.
Proponent's also point out, that in California, according
to the Department of Justice Bureau of Narcotic
Enforcement, new prescriptions for Schedule II category
drugs totaled 461,636 in the year 2000. Of these
prescriptions, 108,244 were for children under 6 years
old. That is a ratio of 1 out of 3.2 new prescriptions
for kids under 6 years old.
3.Current Legal Requirements for Informed Consent. Since
the California Supreme Court's decision in Cobbs v. Grant
(1972) 8 Cal.3d 229, 104 Cal. Rptr. 505, physicians have
had a duty to obtain informed consent of patients before
performing certain medical procedures. Basically the
patient has a right to consent (or refuse to consent) to
any recommended medical treatment and a right to
sufficient information in lay terms to make a
knowledgeable decision regarding the recommended medical
procedure. The California Supreme Court has specifically
mentioned three areas which should be discussed: a) the
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nature of the recommended treatment; b) the risks,
complications and expected benefits of the recommended
treatment, including its likelihood of success; and c)
any alternatives to the recommended treatment, including
the alternative of no treatment, and the risks and
benefits.
A physician must also disclose all information which is
material to the patient's decision of whether to proceed,
that is, that information which the physician knows or
should know would be regarded as significant by a
reasonable person in the patient's position when deciding
to accept or reject the recommended procedure,
supplemented as necessary in cases in which the physician
knows or should know of a patients unique concern or lack
of familiarity with medical procedures. A physician is
generally cautioned that just having a consent form
signed by the patient may not satisfy the current legal
requirement of informed consent and that an informed
consent form should only be used in conjunction with
discussion of the treatment with the patient or their
representative.
Although the legal requirements for informed consent seem
clear in regards to most medical treatments provided by
the physician, they are not as clear regarding the need
of physicians to warn patients of potential drug side
effects. It is argued, that the doctrine of informed
consent may at least require physicians to warn patients
of potential side-effects, including the risk of motor or
sensory impairment and possible reaction with alcohol or
other drugs. Beyond this requirement, it appears as if
pharmacists now have a greater duty to warn of potential
dangers regarding the use of drugs than physicians.
Pharmacists are now authorized to provide clinical
advice, information or consultations regarding the drugs
they dispense.
The Legislature has determined that there are certain
procedures and treatments that should be governed by
specific informed consent statutes, as indicated under
the "Existing law" section of this analysis. For
example, special rules apply to sterilization,
hysterectomy, breast, prostate and gynecological cancers
and certain experimental procedures. There are also
specific informed consent requirements for administration
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of certain psychotropic drugs.
Generally, there are exceptions to the informed consent
requirement, but they only apply to emergency situations,
patient requests not to be informed, and in very rare
circumstances when it is reasonable for the physician to
believe that disclosure could so seriously upset the
patient, that they would not be able to make a rational
decision about the recommended treatment.
As indicated in the "Existing law" section of this
analysis, the law generally requires the parent or
guardian of a minor under the age of 18 to give informed
consent for most medical decisions on behalf of the
child. However, there are exceptions, and there are
certain types of medical care for which minors may
themselves consent. This includes the right of a minor
to consent to pregnancy related services at any age, and
for care of infectious or sexually transmitted diseases,
diagnosis or treatment of rape or sexual assault or drug
or alcohol-related problems, testing for HIV, and mental
health treatment - if the minor is 12 years or older.
4.Prior and Pending Legislation
a) Senate Bill 119 (Haynes): The issue of prescribing
psychiatric medications for children diagnosed as having
ADHD was first presented to the Senate Business and
Professions Committee by way of SB 119 (Haynes) last
year. This bill would have required that a physician, or
other person lawfully prescribing psychiatric
medications, to obtain informed consent from the minor's
parent or legal guardian before writing a prescription,
confirm that the minor had been examined by a
pediatrician, and provide to the parent or legal guardian
a list of all medications the minor is taking to submit
to the pharmacist. A list of all psychiatric medications
that have been prescribed by the minor would also have to
be submitted to the State Board of Pharmacy. The Board
would then be responsible for tracking the amount of
medications being provided. The impact of this bill on
both the medical and pharmacy profession was substantial.
After a meeting held by Senator Haynes with the
opposition, the author decided to make SB 119 a two year
bill, with the understanding that Senate Business and
Professions Committee would look into the broader issue
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of whether further protections or restrictions are
necessary to assure the appropriate prescribing of
psychiatric medications. This Committee had planned to
hold a hearing on January 8, 2002. However, because of
concerns raised by the Senate Committee on Health and
Human Services regarding the mental health aspects of
this issue, both committees agreed to hold a joint
hearing. There was one hour allotted by the Health
Committee for a discussion regarding the current
treatment of ADHD and what problems if any there are
regarding the use of psychotropic drugs. No findings or
recommendations were made by this Committee or the Health
and Human Services Committee regarding this issue.
b) Other Similar Legislation:
SB 543 (Bowen, Chapter 552, Statutes of 1999) provides that
only a juvenile court judge may approve the
administration of prescription psychotropic medication
for children in foster care and required that the court
order be based upon a request from a physician that
includes the foster child's diagnosis, and the expected
results and side effects of the medication.
SB 2098 (Hayden, Chapter 659, Statutes 2000) requires the
Department of Youth Authority, in consultation with the
State Department of Mental Health to establish by
December 31, 2001, standards and guidelines for the
administration of psychotropic medications to any person
under the jurisdiction of the Department of Youth
Authority, in a manner that protects the health and
short- and long-term well-being of those persons.
AB 681 (Mountjoy, 2001) would have required the Department
of Social Services to conduct a study of the number of
foster youth being prescribed psychotropic medications.
The bill, according to the author, was intended to gather
information regarding the pattern of use of psychotropic
medications among children in foster care to address the
concern that the existing system of judicial oversight of
the use of psychotropic medications in foster children is
not functioning as intended. There was concern raised
that foster children were receiving a higher proportion
of these medications in relation to the normal school
population. However, it was also argued that at least 22
percent of foster children have been diagnosed with ADHD
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as compared to the national estimate of between 3 - 5
percent of children in the general population, and that
there was actually an unmet need among foster children
for mental health assessment and treatment. This bill
was assigned to the Assembly Health Committee but was
never heard in committee.
AB 225 (Washington, 2001) would have defined
"unprofessional conduct" and make it a crime to
prescribe, dispense, or furnish psychotropic drugs to a
child in foster care without first obtaining a juvenile
court order. This bill was introduced but never heard by
the Assembly Health Committee and died this year.
c) Recent Legislation Introduced:
SB 1289 (Haynes, 2002) would prohibit employees of school
districts and county boards of education, except medical
personnel authorized to prescribe medicine, from
recommending the use by pupils of psychotropic drugs.
This bill was heard in the Senate Education Committee on
March 13, 2002. Testimony was taken but there was no
vote on the bill. There were several issues and
questions that the Chair of the Education Committee had
regarding this bill. It was decided to put off the vote
on this bill until such time those issues and questions
can be adequately addressed.
AB 2572 (Mountjoy) is similar to the bill above, and is
also similar to this measure, except it would not require
the written informed consent form to include information
from the latest version of the PDR concerning adverse
effects of the psychotropic drug prescribed, only that
known adverse side effects be disclosed.
d) Legislation in Other States: More than half of the
state legislature have had some type of legislative
proposals to regulate the prescribing of psychiatric
medications for children. Last year for example,
Minnesota became the first state to ban schools and child
protection services from telling parents they must put
their children on drugs to treat ADHD. In Connecticut a
new law took effect that prohibits school personnel from
recommending the use of psychotropic medications for
children. School personnel may only advise parents and
other "responsible parties" that a medical evaluation be
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completed. Other similar bills have been introduced in
Arizona, New Jersey, New York, Utah and Wisconsin. In
Georgia, a Commission on Psychiatric Medication of
School-Age Children was created to investigate the use of
such medications in their schools. Hawaii required their
departments of health and education to increase their
efforts to educate parents about ADHD, to study the use
and effectiveness of medication utilized to improve a
child's educational opportunities, and to make
recommendations about the use of non-medication
alternatives in the treatment of ADHD. And, in Virginia
a joint legislative committee was created to study the
effects of ADHD on student academic performance and on
public education programs. Several states have
introduced legislation requiring informed consent of
parents regarding the use of psychotropic drugs.
5.Arguments in Support. The Sacramento Citizens Commission
on Human Rights (CCHR) is in support of this measure.
They indicate that that these very strong medications are
being recommended to parents and in some cases
significant pressure is being put on the parents without
them being fully informed of the negative side effects of
these powerful drugs. And, that many parents are saying
if they had known of the side effects of the drugs they
would never have drugged their children. There is also
evidence, as pointed out by CCHR, to connect the use in
childhood of these Schedule II drugs with an increased
likelihood of addiction to cocaine later in life. Also,
the very diagnosis for which many of these drugs are
prescribed, ADHD, is itself the subject of intense debate
in the scientific and medical community. Scientific
evidence has yet to emerge confirming its existence as a
disease, its cause or causes, or a valid test for ADHD
that, as stated by CCHR, is all the more reason for
extreme caution and full informed consent. As argued by
CCHR, these drugs are not benign substances and when
risks have been proven to be serious and the diagnoses
themselves are questionable at best, there is even more
reason to develop clear public policy to ensure parents
really know what they are getting into when they agree to
a drug regimen for their child.
The Committee on Moral Concerns and the Capitol Resource
Institute are also in support, as well as numerous
individuals who have written to this Committee for
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similar reasons.
6.Support if Amended. The Protection & Advocacy, Inc.
(PAI) supports this bill with suggested amendments. As
indicated by PAI, the absence of a requirement that
written, informed consent be obtained by a child's parent
or legal guardian in California law is an anomaly given
that adults who are deemed capable of consent are
afforded the right to be given informed consent. As
argued by the PAI, the only protection a child has from
unnecessary or risky medications is her parent or
guardian, and if the parent or guardian is uninformed
about the child's condition, the type of medication
prescribed, the reason for the prescription, the
potential side effects, and alternative treatments
available, both the child's and the parent's or
guardian's rights are denied. However, the PAI believes
the informed consent for the prescription of psychotropic
medications for children should track the same informed
consent required for adults who receive antipsychotic
medications when staying in a mental health facility.
7.Arguments in Opposition. The California Psychiatric
Association (CPA) is opposed to the bill. They have
expressed a number of concerns with the bill. They argue
that there is already a common law duty to obtain
informed consent before prescribing any medication to a
minor and that the nature and scope of these duties is
well developed by the courts and do not need to be
modified or expanded by legislation. They also argue
that providing a form with information about the PDR may
not provide useful information to the patient since it
contains technical, medical terminology used by
physicians and pharmacists, and contains only general
information that may or may not apply to a particular
patient's circumstances. There is also a question as to
whether the PDR contains updated medical information
about medications that the physician may have knowledge
about. As indicated by CPA, there are already a variety
of information sheets available that educate parents and
patients about potential adverse effects of these
medications, and that the PDR would be a poor choice for
educating patients/parents. This bill would also create
an additional burden for physicians to obtain a signed
consent form from a parent or guardian when this may not
be practical, since another adult may bring the minor to
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the physician or the consent may be handled over the
phone, such as when a child is in juvenile hall.
The California Medical Association (CMA) is also opposed to
this measure for similar reasons. The CMA believes this
bill would negatively impact a physician's ability to
prescribe appropriate medications to a patient by
requiring this additional informed consent requirement
and use of specific, non-layman language from the PDR.
Additionally, they believe this bill simply is an
intrusion into the practice of medicine, which already
requires adequate informed consent and communication with
a patient. The American Academy of Pediatrics is opposed
for similar reasons and believes this bill is unnecessary
and inappropriate. By requiring a physician to detail
what resource shall be used (the PDR) and in what fashion
(written consent) borders on the Legislature trying to
practice medicine for the doctor.
8.Oppose Unless Amended. The California Healthcare
Association is opposed for similar reasons as already
stated, but suggest that the bill be amended to deal with
exceptions for informed consent in emergency situations
and conform to current law regarding informed consent for
minors. They also believe the PDR is not an appropriate
source to use for informed consent.
9.Issues and Policy Concerns and Recommended Amendments.
a) Is the bill in conflict with current informed consent
requirements for minors? As indicated, there are
specified circumstances under which minors may consent
to medical treatment without parental consent and there
are circumstances under which informed consent may not be
necessary, such as in emergency medical situations. This
bill does not make any exceptions regarding parental
consent for the treatment of a minor with psychotropic
drugs. The author may want to consider allowing for
current exceptions under the law for informed consent
especially as it pertains to a minor .
b) Should the focus of the bill be on all psychotropic
drugs as defined under Section 3500 of the Penal Code, or
those primarily used to treat ADHD and classified as
Schedule II drugs? As argued by opponents of the bill,
the list of drugs considered "psychotropic" involve
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medications that may be used for different purposes, some
for simple depression or smoking cessation while others
for more serious conditions such as bipolar disorder or
psychotic episodes. Also, there are medications that are
considered as non-psychotropic, but whose side effects
are inherently no more common or dangerous than other
types of medications considered as psychotropic.
Opponents question the reason for why a physician should
have to follow one set of informed consent standards when
prescribing a medication for a "behavior disorder" and
different standards when prescribing drugs potentially as
dangerous for another purpose. The author may want to
consider attempting to narrow the definition of
psychotropic drugs under this bill to only those used for
the treatment of ADHD and which are classified as
Schedule II drugs, since these are the drugs with the
greatest potential for abuse and dependence according to
the DEA .
c) Is the Physicians Desk Reference (PDR) the best source
of information concerning adverse effects of psychotropic
drugs? The PDR provides a description of the drug, the
clinical pharmacology, indications for use,
contraindications, warnings about drug interactions,
adverse reactions, and the appropriate dosage for
administration of the medication. As argued by
opponents, and earlier indicated, the PDR is a technical
document written for clinicians and is a poor choice for
educating patients and parents. When it comes to side
effects, the PDR lists virtually every possible condition
that occurred in patients during testing of the drug,
including many that were probably not related to the drug
itself. Generally, when specific information has been
required to be provided to patients for certain medical
treatments or medications provided, the Legislature has
required either the Department of Health Services or the
Department of Mental Health to develop and promulgate
written materials or information to be used as part of
the informed consent or as part of the materials to be
provided to the patient. Rather than requiring use of
the PDR, the author may want to consider requiring the
Department of Mental Health to develop written
information on the effects of psychotropic drugs, to be
disseminated or required as part of the informed consent
provided by physicians before psychotropic drugs are
prescribed, addressing the probable effects and the
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possible side effects of the medications .
d) Should there be a specific informed consent requirement
before prescribing all psychotropic drugs or specific
information provided regarding effects of medications
provided and treatments available for ADHD? As earlier
indicated, the Legislature has decided for certain types
of medical procedures or treatments, and prior to
prescribing of certain medications, to specifically
require that particular information be provided, either
in the form of a pamphlet, or that the physician be under
a legal obligation to provide oral and written informed
consent regarding the medical treatment or medication
provided. In some instances, not providing this
information or informed consent would subject the
physician to unprofessional conduct. The author may want
to consider language similar to current law regarding the
information and informed consent required before certain
specified medications can be provided. An example of
this is in Section 5152 (c) of the Welfare and
Institutions Code and Title 9, Section 851 of the
California Code of Regulations that reflect the informed
consent requirements for providing antipsychotic
medications for those placed in mental health facilities .
NOTE: Referral back to Rules Committee and Possible
Referral to Senate Committee on Health and Human Services
for May 1, 2002 hearing.
SUPPORT AND OPPOSITION:
Support: Sacramento Citizens Commission on Human Rights
Committee on Moral Concerns
Capitol Resource Institute
Numerous Individuals
Protection & Advocacy, Inc. ( If Amended )
Opposition: California Psychiatric Association
California Medical Association
American Academy of Pediatrics
SB 1290
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California Healthcare Association ( Unless Amended )
Consultant:Bill Gage