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





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           California Healthcare Association (  Unless Amended  )


          Consultant:Bill Gage