BILL ANALYSIS Ó SENATE COMMITTEE ON HUMAN SERVICES Senator McGuire, Chair 2015 - 2016 Regular Bill No: SB 253 ----------------------------------------------------------------- |Author: |Monning | ----------------------------------------------------------------- |----------+-----------------------+-----------+-----------------| |Version: |March 23, 2015 |Hearing |April 21, 2015 | | | |Date: | | |----------+-----------------------+-----------+-----------------| |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sara Rogers | |: | | ----------------------------------------------------------------- Subject: Dependent children: psychotropic medication SUMMARY This bill provides that an order of the juvenile court authorizing psychotropic medication shall require clear and convincing evidence of specified conditions, including a requirement that the prescribing physician attest under penalty of perjury that he or she has conducted a comprehensive evaluation of the child, as specified. It also prohibits the authorization of psychotropic medications without a second independent medical opinion under specified circumstances. Furthermore, this bill prohibits the authorization of psychotropic medications unless the court is provided documentation that appropriate lab screenings, measurements, or tests have been completed, as specified. Finally, this bill requires the court, no later than 45 days following an authorization for psychotropic medication, to conduct a review to determine specified information regarding the efficacy of the child's treatment plan. ABSTRACT Existing law: 1) Establishes the criteria by which a child who has suffered, or is at risk of suffering, significant abuse or harm shall be within the jurisdiction of the juvenile court which may adjudge that person to be a dependent child of SB 253 (Monning) PageB of? the court. (WIC 300) 2) Permits the court to make any and all reasonable orders for the care, supervision, custody, conduct, maintenance, and support of an adjudged dependent child, including medical treatment, subject to further order of the court. (WIC 362) 3) Permits the court to order that a social worker may authorize the medical, surgical, dental or other remedial care for a dependent child that has been placed by the court under the custody or supervision of a social worker if it appears there is no parent or guardian capable of authorizing or willing to authorize medical, surgical, dental or other remedial care. (WIC 369 (c)) 4) Permits a minor who is 12 years of age or older to consent to mental health treatment or counseling services if, in the opinion of the attending professional person, the minor is mature enough to participate intelligently in the mental health treatment or counseling services. (HSC 124260) 5) Provides that only a juvenile court judicial officer shall have authority to make orders regarding the administration of psychotropic medications for a minor who has been adjudged a dependent of the court and removed from the physical custody of his or her parent. (WIC 369.5) 6) Requires court authorization for the administration of psychotropic medication to be based on a request from a physician, indicating the reasons for the request, a description of the minor's diagnosis and behavior, the expected results of the medication, and a description of any side effects of the medication. Requires the Judicial Council to adopt rules of court and develop appropriate forms. (WIC 369.5) SB 253 (Monning) PageC of? 7) Requires, within seven court days from receipt, the juvenile court judicial officer to either approve or deny in writing a request for authorization for the administration of psychotropic medication, or to set the matter for hearing. (WIC 369.5) This bill: 1) Provides that an order of the juvenile court authorizing psychotropic medication shall require clear and convincing evidence of the following, and requires the requesting agency to bear the burden of proof of the following: The medication is not being used as punishment, for the convenience of staff, as a substitute for less invasive treatments, or in quantities or dosages that interfere with the child's treatment program. Written consent for a child that is over the age of 12 has been obtained, after being advised of alternative treatments, informed of the benefits and risks of the medication, and understanding of his or her right to refuse the medication. The prescribing physician has testified under penalty of perjury that a comprehensive examination has been conducted, that takes into account the child's history of trauma and medication use and is based on multiple sources, as specified. Additionally requires the physician to attest that the dosage is appropriate for the child. The short and long-term risks associated with the use of psychotropic medications by the child do not outweigh the reported benefits. There are no less invasive and effective treatment options available to meet the needs of the child. 1) Prohibits the authorization of psychotropic medications without a second independent medical opinion under the following circumstances. SB 253 (Monning) PageD of? The request is for a child five years of age or younger. The request would result in the child being administered three or more psychotropic medications concurrently. The request is for the concurrent administration of any two drugs from the same class, unless the request is for medication tapering and replacement, and is limited to 30 days. The request is for a dosage that exceeds the amount recommended for children. The request is for the administration of a psychotropic medication for a use not FDA-approved for children or adolescents. 1) Prohibits the authorization of psychotropic medications unless the court is provided documentation that all of the appropriate lab screenings, measurements, or tests have been completed, no more than 30 days prior to the submission of the request. 2) Requires the court, no later than 45 days following an authorization for a new psychotropic medication, or at the next review hearing scheduled, whichever is earlier, to conduct a review to determine the following: Whether the child is taking the medication or medications. To what extent the symptoms warranting the authorization have been alleviated. What, if any adverse effects the child has suffered. Any steps taken to address those effects. The date or dates of follow-up visits with the prescribing physician since the authorization. 1) Requires the court to reconsider, modify, or revoke its authorization if it determines that the proffered benefits of the medication have not been demonstrated or that the SB 253 (Monning) PageE of? risks of the medication outweigh the benefits. FISCAL IMPACT This bill has not been analyzed by a fiscal committee. BACKGROUND AND DISCUSSION Purpose of the bill: According to the author, nearly one in four children placed in foster care receive powerful psychotropic drugs, and that of these children, 52 percent are given antipsychotics, drugs that include risk factors that can lead to life-long disabilities such as tremors, obesity, and diabetes. Additionally the author states that 48 percent of foster children are given antidepressants that include an FDA black box warning for use by children. The author states that frequent monitoring of children given psychotropic medications is required as part of the health care guidelines of the American Psychiatric Association, the American Diabetes Association and the American Association of Child and Adolescent Psychiatrists. However, the author cites findings from the California Drug Use Review Board indicating that the required baseline lab and blood tests were completed for fewer than four in ten children administered the psychotropic drug. California Child Welfare System The California Department of Social Services (CDSS) supervises the 58 county-administered Child Welfare Services systems that investigate approximately 32,000 reports of abuse and neglect of children annually. According to CDSS, as of January 2015, there were nearly 63,000 children in foster care placement, with nearly one in three residing in Los Angeles County. Following a court order to remove a child from parental custody, existing law requires the court to order the care, custody, control and conduct of the child to be under the supervision of the social SB 253 (Monning) PageF of? worker.<1> Existing law also provides that only a juvenile court judicial officer has authority to make orders for the administration of psychotropic medications for a dependent child. Psychotropic Medication Use in Children Concern over the use of psychotropic medications among children has been well-documented in research journals and the mainstream media for more than a decade. The category of psychotropic medication is fairly broad, intending to treat symptoms of conditions ranging from ADHD to childhood schizophrenia. Some of the drugs used to treat these conditions are FDA-approved, including stimulants like Ritalin for ADHD, however only about 31 percent of psychotropic medications have been approved by the U.S. Food and Drug Administration (FDA) for use in children or adolescents. It is estimated that more than 75 percent of the prescriptions written for psychiatric illness in this population are "off label" in usage, meaning they have not been approved by the FDA for the prescribed use, though the practice is legal and common across all manner of pharmaceuticals.<2> Anti-psychotic medications, used to treat more severe mental health conditions, include powerful brand-name drugs such as Haldol, Risperdal, Abilify, Seroquel and Zyprexa. They have very limited approval by the FDA for pediatric use beyond rare and severe conduct problems that are resistant to other forms of treatment, such as Tourette's syndrome, behavioral symptoms associated with autistic disorder, childhood schizophrenia, and bipolar disorder.<3> However, the off-label use of these anti-psychotics among children is high, particularly among foster children. According to a study published in 2011, children who took antipsychotic medications were likely to --------------------------- <1> WIC 361.2 <2>https://www.magellanprovider.com/mhs/mgl/providing_care/clinic al_guidelines/clin_monographs/psychotropicdrugsinkids.pdf <3> Harrison, et al, Antipsychotic Medication Prescribing Trends in Children and Adolescents, Journal of Pediatric Health care, March 2012. SB 253 (Monning) PageG of? suffer ill health effects including "cardiometabolic and endocrine side-effects" as well as significant weight gain.<4> The authors recommended that collaboration between child and adolescent psychiatrists, general practitioners and pediatricians is essential to "reduce the likelihood of premature cardiovascular morbidity and mortality." Compounding the potential for unintended side effects is the use of combinations of psychotropic medications, which foster youth are particularly likely to be prescribed, despite limited evidence of clinical efficacy.<5> Protecting the health and well-being of children who are taking one or more psychotropic medication requires extensive and ongoing health and metabolic screenings to identify potential adverse effects quickly, however in practice many children many fail to receive ongoing screenings and adverse effects may go undetected causing permanent injury or death. Drugging our Children Media Series A recent series of stories published in the San Jose Mercury News<6> and most recently in the Los Angeles Times, highlighted growing concerns that psychotropic medications have been relied on by California's child welfare and children's mental health systems as a means of controlling, instead of treating, youth who suffer from trauma-related behavioral health challenges. The series detailed significant challenges in accessing pharmacy benefits claims data held by the California Department of Health Care Services (DHCS), eventually overcome through a Public Records Act request and lengthy negotiations, and it demonstrated that prescribing rates were far higher than had been anticipated by child welfare system experts. --------------------------- <4> DeHert, Dobbelaere, Sheridan, et al "Metabolic and endocrine adverse effects of second-generation antipsychotics in children and adolescents: A systematic review of randomized, placebo controlled trials and guidelines for clinical practice," European Psychiatry, April 2011, pgs 144-58. <5> http://www.ncbi.nlm.nih.gov/pubmed/25022817 <6> Drugging our Kids. Karen De Sa. San Jose Mercury News. SB 253 (Monning) PageH of? Court oversight mechanisms SB 543 (Bowen, Chapter 552, Statutes of 1999) mandated that, once a child has been adjudged a dependent of the state, only the court may authorize psychotropic medications for the child, based on a request from a physician that includes the following:<7> The reasons for the request; A description of the child's diagnosis and behavior; The expected results of the medication; A description of any side effects of the medication. Under the statute, psychotropic medications are defined as those "administered for the purpose of affecting the central nervous system to treat psychiatric disorders or illnesses. These medications include, but are not limited to, anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, anti-Parkinson agents, hypnotics, medications for dementia, and psychostimulants." In accordance with this statute, the Administrative Office of the Courts established a series of court documents generally referred to as "the" JV 220, which includes a statement completed and signed by the prescribing physician that includes the child's diagnosis, relevant medical history, other therapeutic services, the medication to be administered, and the basis for the recommendation. In addition, a form must be included indicating notice has been provided to the parents or legal guardians, their attorneys of record, the child's attorney of record, the child's guardian ad litem, the child's current caregiver, the child's Court Appointed Special Advocate, if any, and if a child has been --------------------------- --------------------------- <7> WIC 369.5 SB 253 (Monning) PageI of? SB 253 (Monning) PageJ of? determined to be an Indian child, the Indian child's tribe.<8> The procedure for notification varies by county - the responsibility may fall primarily to the child welfare agency, or it may be shared with the juvenile court clerk's office that may be responsible for notifying the attorney and the Court Appointed Special Advocate. Within four court days after notification, a parent or guardian, the child, the attorney for either, the guardian ad litem, or the Indian child's tribe may file an objection to the application. Following this period, the court files a final order. Oversight Concerns Stakeholders have expressed widespread concerns about the efficacy of the current oversight mechanisms, given that in many counties the court lacks access to medical experts to assist in evaluating medical information. Child welfare advocates and clinicians report that in many instances a prescribing physician who fills out the JV 220 form may not have a history of treating the child, and thus may not be aware of prior medications or alternative treatments that have (or have not) been tried. Such information is frequently left blank on the JV 220. Additionally, as noted by the author, the California Drug Use Review recently found that fewer than four in ten children had received the required baseline laboratory screenings prior to being administered a psychotropic medication. In theory, a health and education passport - a paper file of the youth's medical history - is supposed to be provided to a new caregiver - who might provide important information to a prescribing physician; however it is common for a child to move between placements without the requisite records, leaving the foster parent also unaware of the child's medical history. DHCS and CDSS have drafted, but not finalized, a report Guidelines for the Use of Psychotropic Medication with Children and Youth in Foster Care, which states that "the use of psychotropic medication for children and youth is considered a --------------------------- <8> See also 25 U.S.C. § 1903(4)-(5); Welf. and Inst. Code, §§ 224.1(a) and (e) and 224.3. SB 253 (Monning) PageK of? non-routine intervention, used under specified circumstances and as only one strategy within a larger, more comprehensive treatment plan to provide for that child's safety and well-being." The JV 220 form offers little opportunity for input from the community of representatives and caregivers involved with the youth except to offer a short window of opportunity to formally object. Furthermore, the form does not include information related to baseline or ongoing screening, it does not require consideration of alternative treatments (though it provides a field inquiring about them), nor does it offer substantive opportunities for relevant parties to weigh in with important information that may be worthy of consideration by the court. Currently, CDSS and DHCS, are collaborating on the Quality Improvement Project: Improving the Use of Psychotropic Medication among Children and Youth in Foster Care which is intended to improve oversight and monitoring of psychotropic medication use and to develop data tools to identify "quality concerns" described as overutilization of medication, inappropriate prescribing, gaps of service including insufficient monitoring or not basing decisions on evidence based care. Together, DHCS and CDSS hold quarterly and monthly meetings with various stakeholders to negotiate the parameters of the data for use in agreed-upon indicators. For this purpose, foster care data from the Child Welfare System/Case Management System is matched with a dataset containing fee-for-service and Medi-Cal managed care pharmacy paid claim records for psychotropic medication for children in foster care to identify prescribing patterns. Related legislation: SB 238 (Mitchell, 2015) requires specified certification and training programs for group home administrators, foster parents, child welfare social workers, dependency court judges and court appointed council to include training on psychotropic medication, trauma, and behavioral health, as specified, for children receiving child welfare services. This bill requires SB 253 (Monning) PageL of? the Judicial Council to update court forms pertaining to the authorization of psychotropic medication, and requires CDSS to develop an individualized monthly report, a form to share information and an alert system, used by county child welfare agencies, regarding the administration of psychotropic medication for a foster youth. SB 484 (Beall, 2015) requires the CDSS to publish and make available to interested persons specified information regarding the administration of psychotropic medication in residential facilities serving dependent children. Additionally, it requires CDSS to inspect facilities at least once per year, as specified, if the facility is determined to have a higher than average rate of psychotropic medication authorization rate for children residing in the facility and to monitor corrective action plans, as specified. SB 319 (Beall, 2015) expands the duties of the foster care public health nurse to include monitoring and oversight of the administration of psychotropic medication to foster children, as specified. It also requires counties to provide child welfare public health nursing services by contracting with the community child health and disability prevention program established by the county. COMMENTS This bill has considerable overlap with SB 238 (Mitchell) which would enact specified changes to the court authorization process also referenced in this bill. Staff notes that this bill provides more specificity regarding changes to the court authorization process while the direction of SB 238 is to provide general direction to the Judicial Council. Should both bills pass this committee, staff recommends the authors and sponsors of the two bills work to eliminate apparent conflicts between the two bills. Staff notes that, as currently drafted, this bill applies a "clear and convincing" evidentiary standard to numerous court findings that may have the practical effect of preventing the court from authorizing psychotropic medications, regardless of SB 253 (Monning) PageM of? the needs of the child. Staff recommends the following amendments. POSITIONS Support: Advokids AFSCME Alameda County Board of Supervisors Alameda County Foster Youth Alliance California Court Appointed Special Advocates (CASA) California Youth Connection Children's Advocacy Institute Children's Partnership County Welfare Directors Association of California Dependency Legal Group of San Diego East Bay Children's Law Offices East Bay Community Law Center First Focus Campaign for Children Humboldt County Transition Age You Collaboration Legal Advocates for Children and Youth Peers Envisioning and Engaging in Recovery Services Youth Law Center 10 individuals Oppose: None. Amendments Mock-up for 2015-2016 SB-253 (Monning (S)) *********Amendments are in BOLD********* Mock-up based on Version Number 98 - Amended Senate 3/23/15 The people of the State of California do enact as follows: SECTION 1. Section 369.5 of the Welfare and Institutions Code is amended to read: SB 253 (Monning) PageN of? 369.5. (a) If a child is adjudged a dependent child of the court under Section 300 and the child has been removed from the physical custody of the parent under Section 361, only a juvenile court judicial officer shall have authority to make orders regarding the administration of psychotropic medications for that child. The juvenile court may issue a specific order delegating this authority to a parent upon making findings on the record that the parent poses no danger to the child and has the capacity to authorize psychotropic medications. Court authorization for the administration of psychotropic medication shall be based on a request from a physician, indicating the reasons for the request, a description of the child's diagnosis and behavior, the expected results of the medication, and a description of any side effects of the medication. On or before July 1, 2016, the Judicial Council shall adopt rules of court and develop appropriate forms for implementation of this section. Whenever the court authorizes the administration of a psychotropic medication, it shall ensure that the administration of the psychotropic medication is only one part of a comprehensive treatment plan for the child that shall include and specify the psychosocial services the child will receive in addition to any authorized medication. (b) (1) An order authorizing the administration of psychotropic medications pursuant to this section shall only be granted on clear and convincing evidence that administration of the medication is in the best interest of the child based on a determination that the anticipated benefits of the psychotropic medication outweigh the short- and long-term risks associated with the medications. (2) An order authorizing the administration of psychotropic medications pursuant to this section shall only be granted if the court determines the following: (A) The medication is not being used as punishment, for the convenience of staff, as a substitute for other, less invasive treatments, or in quantities or dosages that interfere with the child's treatment program. (B)If the child is 12 years of age or older, the child, after being advised of alternative treatments and informed of the benefits and risks of the medication, understands his or her right to refuse the medication, and has given his or her written SB 253 (Monning) PageO of? informed consent.The court is provided documentation confirming the child's caregiver has been informed, and the child has been informed in an age and developmentally appropriate manner, about the recommended medications, the anticipated benefits, the nature, degree, duration, and probability of side effects and significant risks commonly known by the medical profession, of psychosocial treatments to be considered concurrently with or as an alternative to the medication. (1) The documentation shall state that the child and the child's caregiver have been asked whether either have concerns regarding the medication, and if so, shall describe the nature of those concerns. The documentation shall confirm that the child has been informed of the right to request a hearing pursuant to (g). (2) The documentation shall include the written informed consent of a child who is 14 years of age or older, after being advised pursuant to (B). (C) The prescribing physician submitting the request for psychotropic medicationattests under penalty of perjuryconfirms that he or she conducted a comprehensive examination of the child based on the practice guidelines in compliance with Section 2242 of the Business and Professions Code and which is consistent with the Psychiatric Evaluation and Diagnosis provisions included in the Guidelines for the Use of Psychotropic Medication with Children and Youth in Foster Care issued by the state and which takes into account all of the following: (1) The child's trauma history. (2) The child's medical records, including medication history. (3) Multiple sources of information including, but not limited to, the child, the child's parents, relatives, teacher, caregiver or caregivers, past prescribers of psychotropic medication, or other health care providers. (D) The prescribing physician shall also confirm the following: (1) There are no less invasive and effective treatment options available to meet the needs of the child. (2) That the dosage or dosage range requested is appropriate for the child. (3) The short- and long-term risks associated with the use of psychotropic medications by the child does not outweigh the reported benefits to the child. SB 253 (Monning) PageP of? (4) All appropriate lab screenings, measurements, or tests for the child have been completed in accordance with accepted medical guidelines. (E) A plan is in place for regular monitoring of the child's medication and psychosocial treatment plan, the effectiveness of the medication and psychosocial treatment, and any potential side effects of the medication, by the physician in consultation with the child's caregiver, mental health care provider, and others who have contact with the child, as appropriate. (2) The person or entity submitting the request for authorization of the administration of psychotropic medication shall bear the burden of proof established in this section. (c) A court shall not issue an order authorizing the administration of psychotropic medications for a child unless a second independent medical opinion is obtained from a child psychiatrist or a psychopharmacologist if one or more of the following circumstances exist: (1) The request is for any class of psychotropic medication for a child who is five years of age or younger. (2) The request would result in the child being administered three or more psychotropic medications concurrently. (3) The request is for the concurrent administration of any two drugs from the same class unless the request is for medication tapering and replacement that is limited to no more than 30 days. (4) The request is for a dosage that exceeds the amount recommended for children. (5) The request is for the administration of a psychotropic medication that is subject to a federal Food and Drug Administration black box warning requirement or is for the administration of an antipsychotic medication for a use that is not approved by the federal Food and Drug Administration for children or adolescents. (d) The court shall not authorize the administration of the psychotropic medication unless the court is provided SB 253 (Monning) PageQ of? documentation that all of the appropriate lab screenings, measurements, or tests for the child have been completed in accordance with accepted medical guidelines no more than 30 days prior to submission of the request to the court. (e) (1) No later than4560 days after the authorization of a new psychotropic medication is granted or at the next review hearing scheduled for the child pursuant to Section 366, 366.21, 366.22, or 366.31, if scheduled no earlier than 45 days after the authorization of a new psychotropic medication,whichever is earlier, the court shall conduct a review hearing to determine all of the following: (A) Whether the child is taking the medication or medications. (B) Whether psychosocial services and other aspects of the child's treatment plan have been provided to the child. (C) To what extent the symptoms for which the medication or medications were authorized have been alleviated. (D) What, if any, adverse effects the child has suffered. (E) Any steps taken to address those effects. (F) The date or dates of follow-up visits with the prescribing physician since the medication or medications were authorized. (G) Whether the appropriate follow-up laboratory screenings have been performed and their findings. (2) If based upon this review, the court determines that the proffered benefits of the medication have not been demonstrated or that the risks of the medication outweigh the benefits, the court shall reconsider, modify, or revoke its authorization for the administration of medication. (f) (1) In counties in which the county child welfare agency completes the request for authorization for the administration of psychotropic medication, the agency is encouraged to complete the request within three business days of receipt from the physician of the information necessary to fully complete the request. SB 253 (Monning) PageR of? (2) Nothing in this subdivision is intended to change current local practice or local court rules with respect to the preparation and submission of requests for authorization for the administration of psychotropic medication. (g) Within seven court days from receipt by the court of a completed request, the juvenile court judicial officer shall either approve or deny in writing a request for authorization for the administration of psychotropic medication to the child, or shall, upon a request by the parent, the legal guardian, or the child's attorney, or upon its own motion, set the matter for hearing. (h) Psychotropic medication or psychotropic drugs are those medications administered for the purpose of affecting the central nervous system to treat psychiatric disorders or illnesses. These medications include, but are not limited to, anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, anti-Parkinson agents, hypnotics, medications for dementia, and psychostimulants. (i) Nothing in this section is intended to supersede local court rules regarding a minor's right to participate in mental health decisions. (j) This section shall not apply to nonminor dependents, as defined in subdivision (v) of Section 11400. SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. -- END SB 253 (Monning) PageS of?