This measure requires a physician and surgeon to obtain written consent from a child's parent or legal guardian before prescribing, dispensing or furnishing a psychotropic medication, that is primarily used to treat Attention Deficit/Hyperactivity Disorder (ADHD) and is classified as a Schedule II medication. The doctor must provide information, as specified in the bill, to a parent or legal guardian and obtain a signed consent form. Violation of these requirements would constitute unprofessional conduct on the part of the physician and surgeon.
Existing statutory and case law:
1. Authorizes the prescribing, dispensing, or furnishing of medications by physicians and surgeons, and requires the physician to perform a "good faith prior examination" and determine that the patient has appropriate medical indications for a medication before prescribing, dispensing, or otherwise furnishing a medication.
2. Requires physicians, as specified in court decisions, to provide informed consent to patients or their parents or legal guardians before prescribing medications. 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 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 patient's 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.
3. Requires physicians and surgeons, under specified circumstances, to provide additional information to patients before performing certain medical procedures and failure to do so could subject physicians to a finding of unprofessional conduct by the Medical Board. For example, requires that a physician obtain verbal and written consent, and provide certain additional information, before performing a hysterectomy or sterilization procedure, before treating a patient with dimethyl sulfoxide, etc.
4. Requires a physician to provide specific information regarding alternative treatments for breast and prostate cancer, and information regarding silicone implants and collagen before used in cosmetic or plastic surgery.
5. 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. However, also allows a minor under the age of 18 to consent to medical treatment if the minor is married, on active service in armed forces, emancipated by a court order, or is 15 years or older and living separate and apart from his/her parents or guardian.
6. Allows a minor who is 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 medications may be provided.
7. Defines, psychotropic medications as medication administered for the purpose of affecting the central nervous system to treat psychiatric disorders or illnesses. There medications include, but are not limited to, antidepressants, antipsychotics, anti-Parkinson's agents, psycho-stimulants, etc.
8. Classifies a number of medications, including some pain medications and certain psychotropic medications, as Schedule II controlled substances. Doctors prescribing these medications must meet special requirements, including the requirement that the doctor fill out a "triplicate" form and send a copy to the Dept. of Justice for review. Also, the prescription must be filled within a limited number of days of the date the prescription is written, etc.
9. Requires informed consent and specific information to be provided to a person who is detained in a mental health facility on an involuntary basis, 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. 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.
10. 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 the child. Further, 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. (Both of these existing statutes apply to all psychotropic medications).
This bill:
1. Requires a physician and surgeon, before prescribing, dispensing, or furnishing a "psychotropic drug" that is "used primarily to treat Attention Deficit/Hyperactivity Disorder" and is a Schedule II medication, to inform the child's parent or guardian of their right to accept or refuse the medication.
2. Requires a physician and surgeon, before prescribing, dispensing, or furnishing a psychotropic drug that is used primarily to treat Attention Deficit/Hyperactivity Disorder and is a Schedule II medication, to provide the child's parent or guardian with information, as specified in the bill, including:
3. Requires the physician to provide the above information in the parent's or legal guardian's "native language, if possible".
4. Requires that the physician and surgeon, before prescribing Schedule II medications that are primarily used for the treatment of ADHD, obtain a "signed consent form" from the child's parent or legal guardian that includes all the information specified in (1) and (2) above.
5. Provides that it shall constitute "unprofessional conduct" for a physician to prescribe Schedule II medications used primarily for the treatment of ADHD if all of the informed consent requirements described in (1), (2) and (3) above, are not met. Also, provides that a physician whose failure to comply with the requirements of SB 1290 constitutes unprofessional conduct would not be subject to Business and Professions Code Section 2314 (i.e., would not be a misdemeanor).
6. Provides that a physician and surgeon may prescribe, dispense, or furnish any psychotropic medication to a child who has been judged a dependent or ward of the court, pursuant to a judge's order, as provided in existing Welfare and Institutions Code Section 369.5.
Unknown at this time.
1. Background--Attention-Deficit/Hyperactivity Disorder (ADHD)
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 and developmentally (i.e., age) appropriate 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.
In addition, children with ADHD have higher rates of physical injury than other children their age. As they grow older, children with untreated ADHD, especially those with the co-existing mental health disorder "conduct disorder", experience higher rates of drug abuse, antisocial behavior, and injuries of all sorts. For many individuals, the impact of ADHD continues into adulthood.
Diagnosis of ADHD
On February 13, 2002, this Committee, jointly with the Senate Business and Professions Committee and the Senate Select Committee on Developmental Disabilities and Mental Health, held a hearing on the Status of Children's Mental Health. At that hearing, in a section devoted to research on ADHD, Dr. James McCracken, Child Psychiatrist at UCLA and Director of UCLA's Division of Child and Adolescent Psychiatry, testified that:
"To summarize this field, the diagnosis of ADHD can be made reliably and consistently, using well-researched interview and observational instruments. There is not magic to approaching the assessment of a child with suspected ADHD. However, as is the case for all other psychiatric disorders, at the present time there is no laboratory tests to confirm the diagnosis, so what is required is, in fact, a very extensive history-taking evaluation and collaboration, as has been mentioned, with other observers, professionals, parents, and teachers…
Currently, although brain imaging studies examining differences in the structure and function of the brain in individuals with ADHD represent an area of active research, and, indeed, brain differences can be demonstrated in individuals with ADHD versus nonaffected individuals, currently there is no role for the use of imaging tests in diagnosis…
Major reviews and consensus documents developed by professionals and researchers both in and outside of the field of ADHD research have come to the same solid conclusion; namely, that ADHD is one of the best validated mental disorders in medicine…
The benefits of psychostimulant medications for the short-term treatment of the core symptoms of ADHD are undisputed. Literally, hundreds of studies observing thousands of children with well-diagnosed ADHD show striking benefits of treatment and excellent safety. Besides dramatic improvement versus controlled treatments &endash; such as placebo &endash; more recent, major comparative studies &endash; such as the MTA study &endash; show that the stimulants are clearly more powerful treatments as compared to even intensive home and school behavioral treatments administered at least over a fourteen-month period…
That being said, however, it is very clear &endash; and consensus documents agree &endash; that added benefits for ADHD are found when medication treatment are combined with other modalities of treatment; that is to say, behavioral and educational approaches. These combined treatments yield greater parent satisfaction, increased academic achievement, and even overall response rates are increased.
Psychostimulant prescribing has shown rapid increases during the past decade. There's good data to support that from a variety of perspectives. This raises an important question: Are stimulants being overprescribed?…
Here, the data are contradictory, suggesting large variation in practice patterns by region, discipline, and practitioner. However, taking the broadest view, estimated rates of the numbers of children receiving psychostimulant medications has increased to a level close to that of the estimated prevalence of the disorder. Therefore, comparing the rate of prescription against the estimated rate of the disorder would leave one to believe that there is not a significant problem or cause for alarm."
According to the National Institutes of Mental Health (NIMH), primary care and developmental pediatricians, family practitioners, psychologists, psychiatrists, and (child) neurologists are the health care professionals responsible for assessment, diagnosis, and treatment of most children with ADHD. The NIMH has stated the concern that children are both 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).
ADHD treatment
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), historically, are the primary choice in use of medications to treat ADHD, and, there has been a growing use of other drugs such as Adderall and Concerta. As indicated by the National Institute of Mental Health, treatment strategies, including use of medications and psychosocial or behavioral interventions, have been the major focus of much research. Overall, these studies have continued to support the efficacy of using these medications and psychosocial treatments together for ADHD and, also, the superiority of medications to psychosocial treatments when only one treatment is used alone.
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 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 proposed alternative treatments include dietary management, herbal and homeopathic treatments, biofeedback, mediation, and perceptual stimulation/training.
American Academy of Pediatrics Practice Guidelines for the Diagnosis and Treatment of ADHD.
In 2002 and 2001, the American Academy of Pediatrics released clinical practice guidelines for both the diagnosis and treatment of ADHD. The pediatrician's guidelines for diagnosis included the following recommendations:
2. 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 by the doctor with either the patient, if an adult, or the parent of the patient:
Under current statues and case law, 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 patient's 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. Proponents of SB 1290 argue 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, pharmacists now have a duty to warn of potential dangers regarding the use of drugs. 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, and certain experimental procedures.
There also are exceptions to the general informed consent requirement, that apply to emergency situations, when patient requests not to be informed, and in 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 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 &endash; if the minor is 12 years or older.
3. Author's stated intent
According to the author, this bill would set forth a standard level of information for the prescription of Schedule II psychotropic medications to minors being treated for ADHD. 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 medication.
As stated by the author, current law only requires "informed consent", a term that is left up to the doctor's 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. According to the author, due to the dramatic side-effects and potential damage caused by psychotropic medications, 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), and he states these are not drugs where consent should be taken lightly.
4. Arguments in Support
The Sacramento Citizens Commission on Human Rights (CCHR), associated with the Church of Scientology, 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 the parents being fully informed of the negative side effects. The CCHR argues 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. Also of concern to 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. (Note that Clonidine is also a primary medication used to treat Tourette's Syndrome tics. Tourette Syndrome is a not uncommon co-existing condition with ADHD; identification and treatment of Tourette's Syndrome in children, with Clonidine, may not be separated out in the above statistics from those cases where Clonidine is being prescribed for ADHD alone.)
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. (However, these prescriptions appear to include prescriptions for pain medication, anti-seizure medications and many other medications in addition to medications used to treat ADHD.)
5. Support if amended
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. 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.
6. Arguments in opposition
The California Psychiatric Association (CPA) is opposed to the bill arguing:
The California Medical Association (CMA) is also opposed to this measure stating that this bill:
The American Academy of Pediatrics is opposed, stating this bill is unnecessary and inappropriate: "Doctors are already required to obtain informed consent before prescribing any medication to a minor, with limited exceptions such as emergencies. As such SB 1290 is unnecessary. Further, doctors should be permitted to dialogue with parent, providing and responding to requests for information that will best permit the parent, who has the final decision, to determine whether and what medication the child shall have."
The California School Nurses Association argues in opposition that: "We are extremely concerned with the trend of recently proposed legislation that seems to be aimed at preventing, or making it extremely difficult for physicians to prescribe psychotropic medications for students diagnosed with ADHD…School nurses administer these medications to students every day. We know that many children are receiving these medications and benefiting from them. We question the need to single out this type of medication, above any other than potentially has exhibited side effects in some patients, and ask what is truly the reasoning behind this bill. If it is to protect patients, then it is unnecessary, as current law and legal precedent is already in place…".
The Sacramento Learning Disabilities Association, writing in opposition to SB 1290, states that, "We know from neurological research that brain function is different for those with ADHD issues. Medication can be an answer for many students who could not otherwise be able to concentrate or focus in school. Many parents are reluctant to go through more paperwork involving school issues…Adding more steps to provide proper medication may be reason to put off treatment."
The American Academy of Family Physicians states that providing informed consent to parents is already required for doctors under current law and in addition parents must sign at pharmacies for receipt of information of medication risks. The threat of an additional basis on which unprofessional conduct allegations could be brought, might discourage doctors from treating certain patients and, therefore, represent a barrier to care.
7. 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. The Association states that the phrase in the bill, "Except as otherwise provided by law" is not explicit enough to insure that in emergency situations, prior written consent would not be required.
8. Related legislation
1. Is this bill necessary, given the existing informed consent requirements required for medication and as doctors prescribing these Schedule II medications must already go through extra steps to write the prescriptions?
As noted by supporters, Ritalin has been prescribed for ADHDs symptoms in children for well over 30 years, has been researched thoroughly, and has been found to be a comparatively safe medication for use by children. Opponents point out that many other medications used by children have received less research and have more dangerous side effects. Also, as this bill applies only to Schedule II medications, extra steps including triplicate prescriptions already are required for these medications. These informed consent procedures would apply a third layer of requirements on doctor's treating ADHD, opponents argue this is discriminating against those who require treatment for ADHD as it would make it more difficult for them to access appropriate mental health care.
Also, proponents of SB 1290 have not provided the Committee with data indicating widespread problems with doctor's not providing informed consent to parent, especially as compared with the number of prescriptions written. Is the perceived problem with informed consent for these particular medications so compelling that doctors should be exposed to additional legal liability and charges of unprofessional conduct by imposing specific, detailed informed consent procedures for these medications and requiring the parent's written rather than verbal consent?
2. This bill appears to assume that all prescriptions for Schedule II medications for ADHD are written for children, requiring that before a prescription could be written "the parent or legal guardian" must give written consent. However, research now indicates that for many persons with ADHD the disorder continues into adult life; thus, a number of adults receive the medications described in this bill, such as Ritalin and Adderall. If it is not the author's intent to affect prescriptions written for adults, the bill should be amended to clarify this point.
3. The focus of this bill was changed in the Senate Business and Professions Committee to pertain not to all psychotropic medications prescribed for children, but to those Schedule II medications "used primarily for treatment of ADHD". Should the focus of the bill be on all psychotropic drugs prescribed for children, or all Schedule II medications prescribed for children, or should it be limited to those primarily used to treat ADHD? Some of the medications used to treat ADHD may be used for other conditions as well, such as narcolepsy. Yet because the bill is written to apply the additional informed consent procedures to certain medications used primarily to treat ADHD, regardless of the patient's actual diagnosis, the additional informed consent procedures would be required of parents and legal guardians in these cases as well.
4. The Senate Health and Human Services Committee has supported legislation to move the state's health policy toward "mental health parity", i.e., to provide equal treatment under health insurance for mental health disorders as for physical health disorders. For example, in 1999, this Committee passed both SB 468 and AB 88; these bills both required the co-pays, treatment length limits, hospital day limits, and other health insurance constraints should be the same for mental health and physical heath disorders. Is this bill, by imposing additional informed consent procedures for one mental health disorder, contrary to the concept of mental health parity?
5. NAMI, California, states "There is subtle discrimination in this bill against people with mental illness. Children are treated with much more powerful drugs, with more serious side effects for many other medical conditions", where written consent is not required of the parents. "ADHD and ADD are full-fledged medical conditions as physically based as heart conditions and diabetes. Like many other medical conditions, treatment for these brain-based disorders usually starts with a prescription…".
6. This bill contains some vague terms that would likely lead to concerns and possibly legal action regarding the interpretation of these terms. For example, the bill requires that the doctor provide information on the "nature of the child's mental condition"; would this be the same as the child's mental health disorder diagnosis or is this a different requirement? Also, as described earlier in this analysis, the terms "any particular side effects likely to occur with the particular child" and "reasonable treatment alternatives" are open to interpretation.
POSITIONS
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Support: |
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Oppose: |
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Oppose:(unless amended) |
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