Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 35 No. 43, October 30, 2009 issue of the Florida Administrative Weekly.
65C-35.001 Definitions.
(1) “Assent” when used in this cChapter means a process by which a provider of medical services helps the patient achieve a developmentally appropriate awareness of the nature of his or her condition; informs the patient of what can be expected with tests and treatment; makes a clinical assessment of the patient’s understanding of the situation and the factors influencing how he or she is responding; and solicits an expression of the patient’s willingness to accept the proposed care.
(2) No change.
(3) “Caregiver” means, for purpose of this chapter, a person who is approved in writing by the Department as responsible for providing for the child’s daily needs, or any other person legally responsible for the child’s welfare in a residential setting the person or persons with whom the child resides or who is responsible for providing the child’s daily needs.
(4) “Chemical Restraint” means the use of a medication psychotropic drug as a restraint to control behavior or restrict freedom of movement that is not an accepted standard treatment for the person's medical or psychiatric condition.
(5) “Children’s Legal Services” is a statewide law firm focusing on children’s issues within the Department of Children and Families.
(6) “Child Protective Investigator” means an authorized agent in a professional position within the Department or designated sheriff’s office with the authority and responsibility of investigating reports of child abuse, neglect, or abandonment received by the Florida Abuse Hotline, as defined in Section 39.01(62)(58), F.S.
(7) through (9) No change.
(10) “Express and Informed Consent” means, for the purposes of this chapter; voluntary written consent from a competent person who has received full, accurate, and sufficient information and explanation about a child’s medical condition, medication, and treatment to enable the person to make a knowledgeable decision without being subjected to any deceit or coercion. Express and informed consent for the administration of psychotropic medication may only be given by a parent whose rights have not been terminated, or a legal guardian of the child. Sufficient explanation includes but is not limited to the following information, provided and explained in plain language by the prescribing physician to the consent giver: the medication, reason for prescribing it, and its purpose or intended results; side effects, risks, and contraindications, including effects of stopping the medication; method for administering the medication, and dosage range when applicable; potential drug interactions; alternative treatments; and the behavioral health or other services used to complement the use of medication, when applicable consent from a child’s parent or legal guardian as defined in Section 394.455(9), F.S. and as described in Section 394.459(3)(a), F.S. See those sections for further details.
(11) No change.
(12) “Guardian ad Litem” is defined in Section 39.820(1), F.S.
(13)(12) “Lead Agency” means the not-for-profit or governmental community-based care provider responsible for the provision of support and services for eligible children and their families who have been abused, abandoned, or neglected.
(14)(13) “Legal Guardian” means a permanent guardian as described in Section 39.6221, F.S., or a “guardian” as defined in Section 744.102, F.S., or a relative with a court order of temporary custody under Chapter 751, F.S. Dependency case managers and Guardians aAd Litems do not meet the definition of legal guardian.
(15)(14) “Medical Report” means a report prepared by the prescribing physician that includes information required by Section 39.407(3)(c), F.S. The form for the medical report is “Medical Report” (form CF-FSP 5339 dated October 2009), which is hereby incorporated by reference and is available by contacting the Family Safety Program Office at 1317 Winewood Boulevard, Tallahassee, Florida 32399-0700, or at http://www.dcf.state.fl.us/DCFForms/Search/DCFFormSearch.aspx.
(16)(15) “Out-of-Home Care” means the placement of a child, arranged and supervised by the Department of Children and Families or its agent, outside the home of the child’s custodial parent or legal guardian. This includes placement in licensed shelter, foster home, group home, Residential Treatment Center (including Statewide Inpatient Psychiatric Programs), and non-licensed relative/non-relative settings.
(17)(16) “Prescribing Physician” is a physician licensed under Chapter 458 or 459, Florida Statutes.
(18)(17) “Psychotropic Medication” means, for the purpose of this rule, any chemical substance prescribed with the intent to treat: psychiatric disorders; disturbances of reality testing, cognitive impairment, mood disorders or emotional dysregulation; and those substances, which though prescribed with the intent to treat other medical conditions have the effect of altering brain chemistry or involve any of the medications in the categories listed below. The medications include, without limitation, the following major categories:
(a) through (i) No change.
(19)(18) “Residential treatment center” means a 24-hour residential program which provides mental health services to emotionally disturbed children or adolescents as defined in Section s. 394.492(5) or (6), F.S. that is licensed by the Agency for Health Care Administration. For purposes of this rule, therapeutic group homes are not considered a residential treatment center.
(20)(19) “Resource Record” means the child’s standardized record that contains copies of all available and accessible medical and psychological information (including behavioral health information) pertaining to the child as described in subsections 65C-30.001(24) and 65C-30.011(18)(17), (4)-(6), F.A.C.
(21)(20) “Statewide Inpatient Psychiatric Program” or “SIPP” means those residential mental health treatment programs selected and contracted by the Agency for Healthcare Administration to participate in the Institution for Mental Disease waiver.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1), (2), (3) FS. History–New________.
65C-35.002 Behavioral Health Services.
(1) Behavioral health services shall be provided to children in out-of-home care without delay once the need for such services is identified. Prior to prescribing a psychotropic medication, the physician must consider other treatment interventions that may include, but are not limited to, medical, mental health, behavioral, counseling, or other services. All decision making should be guided by the principle that it is important to comprehensively address all the concerns in a child’s life – family, legal, health, education, and social/emotional issues – as well as to provide behavioral supports and parent training, so that a child’s behavioral and mental health issues can be addressed in the least restrictive setting and in a comprehensive treatment plan.
(2) through (3) No change.
(4) The Medical Report must include recommendations for medical, behavioral health, or other services that will be used in conjunction with the psychotropic medication, will be used in adjunct to as required by Section 39.407(3)(c)(g)5., F.S.
(5) Prior to prescribing a psychotropic medication, the physician must consider the child’s history for conditions that may indicate the presence of brain injury (for example, blows to head, fetal alcohol syndrome, loss of consciousness, head scars, fever above 104°) and document any follow-up assessments or referrals on the Medical Report.
(6)(5) The administration of psychotropic medication for the sole purpose of chemical restraint is strictly prohibited.
Rulemaking Authority 39.407(3)(g), 39.0121 FS. Law Implemented 39.407(1), (3), 39.6 012(2), 409.1671 FS. History–New________.
65C-35.003 Parent or Legal Guardian Involvement.
(1) The dependency case manager or child protective investigator shall facilitate make reasonable efforts to ensure that the child’s parent (where parental rights are intact) or legal guardian attendings of medical appointments, and obtains the parent or legal guardian obtaining of information about medications, possible side effects, and other details about treatment listed in (2) of this section etc.
(2) No change.
(a) through (e) No change.
(f) Possible side effects of stopping the medication; and
(g) Alternative treatment options;
(h)(g) How treatment will be monitored.; and
(i)(h) The physician’s plan to reduce and/or eliminate ongoing administration of the medication.
(3) No change.
(4) The dependency case manager or child protective investigator shall make the following minimum efforts to enable the prescribing physician to obtain express and informed consent from the child’s parent or legal guardian:.
(a) Attempt to invite the parent or legal guardian to the doctor’s appointment and to offer them transportation to the appointment, if necessary;.
(b) Attempt to contact the parent or legal guardian as soon as possible upon learning of the recommendation for psychotropic medication by the prescribing physician and provide specific information to them on how and when to contact the physician.; and
(c) No change.
(5) No change.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3), 409.1671 FS. History–New________.
65C-35.004 Caregiver Involvement.
(1) The child’s caregiver must make every effort to attend medical appointments and obtain the information about medications, possible side effects, and other information as listed in (2) of this section etc. Caregivers do not have the authority to provide express and informed consent for psychotropic medication. However, nothing in this rule prohibits caregivers from expressing their concerns regarding prescribing psychotropic medication to children.
(2) No change.
(a) A copy of the Medical Report;
(b)(a) The method of administering the medication;
(c)(b) An explanation of the nature and purpose of the treatment;
(d)(c) The recognized side effects, risks and contraindications of the medication;
(e)(d) Drug-interaction precautions;
(f)(e) Possible side effects of stopping the medication;
(g)(f) Alternative treatment options;
(h) How treatment will be monitored; and
(i)(g) The physician’s plan to reduce and/or eliminate ongoing administration of the medication.
(3) The caregiver shall monitor the child, and report to the prescribing physician and the dependency case manager any behavior or other incident that could indicate an adverse side effect.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3) History–New________.
65C-35.005 Child Involvement in Treatment Planning.
No change.
65C-35.006 Taking a Child Into Custody Wwho Iis Taking Psychotropic Medication.
(1) No change.
(a) The child protective investigator must seek written authorization from the parent or legal guardian to continue administration of currently prescribed psychotropic medications. This authorization is good for the first 28 calendar days the child is in shelter.
(b) The child protective investigator must take the following actions:
1. If the medication is in its original container, and clearly marked as a current prescription for the child, the medication must continue to be provided to the child. The protective investigator must notify or cause to be notified the parent or legal guardian that the medication is being provided to the child.
2. through 5. No change.
(2), through (4) No change.
(5) Authorization in a shelter order to continue the medication shall be valid only until the arraignment hearing on the petition for dependency, or for 28 calendar days following the date of removal, whichever occurs first.
(6) Within 28 calendar days of removal, or no later than the arraignment hearing on the petition for dependency, whichever occurs first, the child must be evaluated by a physician to determine whether it is appropriate to continue the medication.
(7) All actions taken by the child protective investigator will be entered into FSFN within three (3) business days of receipt of the parent or legal guardian authorization or court order approving the medication.
(8) No change.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1),(2), (3) FS. History–New________.
65C-35.007 Authority to Provide Psychotropic Medications to Children in Out-of-Home Care Placements.
(1) No change.
(2) If the parents’ or guardians’ legal rights have been terminated; their identity or location is unknown; or they decline to approve administration of psychotropic medication, and any party believes that administration of the medication is in the best interest of the child and medically necessary, then authorization to treat with psychotropic medication must be pursued through a court order. Children’s Legal Services must file a motion in court that will allow the court to “hear” the request and upon consideration of the facts, circumstances, and law, authorize the provision of the medication. Court authorization must occur before the psychotropic medication is administered to the child except in the circumstances described in Rule 65C-352.010, F.A.C.
(3) In no case may the dependency case manager, child protective investigator, the child’s caregiver, representatives from the Department of Juvenile Justice, or staff from Residential Treatment Centers provide express and informed consent for a child in out-of-home care to be prescribed a psychotropic medication unless permitted pursuant to a court order with specificity.
(4) No change.
(5) All details about prescribed psychotropic medications, updates, (including changes in dosage or physician prescribed cessation of the medication), and including all actions taken by the dependency case manager or child protective investigator, will be entered into FSFN by the dependency case manager or child protective investigator within three (3) business days of the action.
(6) No change.
(a) No change.
(b) The condition and purpose for which the medication is prescribed for the is child;
(c) through (k) No change.
(7) through (9) No change.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(2), (3), 409.1671 FS. History–New________.
65C-35.008 Parent or Legal Guardian Declines to Consent to or Withdraws Consent for the Provision of Psychotropic Medication.
(1) If the parent or legal guardian declines to authorize the provision of psychotropic medication, or withdraws consent that was previously provided, the parent or legal guardian’s decision, and any reason provided therefore, must be recorded in the Medical Report. If the prescribing physician determines that the parent or legal guardian cannot provide express and informed consent, the basis for that determination must be recorded in the Medical Report. In either event, the following steps must be taken:
(a) The dependency case manager shall consult with the prescribing physician within one (1) business day of being notified that the parent will not authorize the provision of psychotropic medication, withdraws consent, or is found by the prescribing physician to lack the ability to provide express and informed consent.
(b) If the prescribing physician determines that the medication is medically necessary for the child despite the lack of authorization,; the prescribing physician must include the reasons for recommending the administration of the medication in the Medical Report.
(c) The dependency case manager shall provide Children’s Legal Services with the information necessary to inform the court that psychotropic medication has been recommended but not authorized; the reasons the parent or legal guardian did not authorize the provision of the medication, and the prescribing physician’s position regarding the need to administer the medication. Children’s Legal Services shall file a motion to authorize medication within one business day of this consultation.
(2) If, after considering the parent or legal guardian’s position, the prescribing physician chooses to revise the recommended treatment, the prescribing physician must document this revision in the Medical Report.
(3) When the parent declines to provide express and informed consent, the Department must seek court approval for the administration of psychotropic medication. The following steps must be taken:
(a) The dependency case manager must obtain a completed Medical Report from the prescribing physician.
(d)(b) Within three (3) business days of receiving the Medical Report from the prescribing physician, the dependency case manager must submit the Medical Report and any supporting documentation to Children’s Legal Services, with a request for legal action to obtain a court order authorizing the administration of the prescribed medication.
(e)(c) Children’s Legal Services must file a motion in court that will allow the court to “hear” the request and upon consideration of the facts, circumstances, and law, determine whether to authorize the provision of the medication. Children’s Legal Services shall notify all parties. Court authorization must occur before the psychotropic medication is administered to the child.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1), (2), (3) FS. History–New________.
65C-35.009 Parent or L/legal Gguardian Rights Terminated; Parent or L/legal Gguardian Refuses to Participate; or Parent or L/legal Gguardian Location or /Identitfy Unknown.
(1) through (2) No change.
(3) Within three (3) one (1) business days of receiving the Medical Report from the prescribing physician, the dependency case manager or child protective investigator must submit the Medical Report and other documentation to Children’s Legal Services, with a request for court authorization to administer the prescribed medication.
(4) Children’s Legal Services must file a motion in court that will allow the court to “hear” the request and upon consideration of the facts, circumstances, and law, authorize the provision of the medication. Children’s Legal Services shall notify all parties. Court authorization must occur before the psychotropic medication is administered to the child.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3), 409.1671 FS. History–New________.
65C-35.010 Emergency Administration of Psychotropic Medication.
(1) Psychotropic medications may be administered in advance of a court order or parental authorization under two circumstances, as described in Section 39.407(3)(e), F.S.: at the time the child is admitted to any hospital, Crisis Stabilization Unit (CSU) or Psychiatric Residential Treatment Center if the prescribing physician certifies that delay in providing the prescribed psychotropic medication would more likely than not cause significant harm to the child.
(a) If the prescribing physician certifies that delay in providing the prescribed psychotropic medication would more likely than not cause significant harm to the child. This certification shall be in writing on the Medical Report form.
(b) If the child is in a hospital, Crisis Stabilization Unit (CSU), or Psychiatric Residential Treatment Center.
(2) No change.
(3) If express and informed consent has not been obtained, If the prescribing physician did not obtain express and informed consent from the parent or legal guardian, the dependency case manager or child protective investigator must obtain a completed copy of the Medical Report that is signed by a treating physician and provide it to Children’s Legal Services in time for a motion to be filed by Children’s Legal Services within three (3) business days of beginning the medication, as required in Section 39.407(3)(e)1., F.S. within two (2) business days after the medication is initiated. This report shall also be provided to the child’s Guardian Ad Litem, the child’s lawyer and all other parties within two (2) business days of initiation of the medication to the child.
(a) Children’s Legal Services shall submit a motion to the court within three (3) business days of the initiation of the medication, and shall schedule the motion to be heard at the next regularly scheduled court hearing, or within 30 calendar days after the date of the prescription, whichever occurs sooner. All parties shall be notified within three (3) business working days.
(b) If any party objects to the motion the court shall hold a hearing within seven (7) calendar days.
(c) Medication information will be entered into FSFN within three (3) business days of beginning the medication.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1), (2), (3) FS. History–New________.
65C-35.011 Medication Administration and Monitoring.
(1) through (2) No change.
(3) The monitoring of the use of psychotropic medication provided to children will be a joint responsibility among between the prescribing physician, caregiver, dependency case manager or child protective investigator, and the supervisor.
(4) through (8) No change.
(9) A statewide workgroup shall be appointed by the Secretary of Tthe Department may address the to give recommendations to the Department that will ensure the safety and efficacy of psychotropic medication through requirements in lead agency contracts, including but not limited to the utilization of pre-consent reviews or second opinions by child psychiatrists. These recommendations may be amended into the lead agency contracts at the discretion of the Secretary.
(10) Lead agencies shall develop and implement protocols which ensure collaboration among those responsible for a child’s care, specifically addressing the use of psychotropic medication and the need to share all relevant information with all parties involved in the child’s care.
Rulemaking Authority 39.407(3)(g), 39.0121 FS. Law Implemented 39.407(2), (3), 409.1671 FS. History–New________.
65C-35.012 Requests for Second Opinions.
(1) through (2) No change.
(3) The child protective investigator or dependency case manager must obtain the second opinion within twenty-one (21) calendar days of or receipt of the court order. If the second opinion is not obtained within the required timeframes, the reasons for the delay must be reported to the court and all parties.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3)(d) FS. History–New________.
65C-35.013 Medical Report.
(1) If a court order is required to obtain authorization to administer psychotropic medication, the prescribing physician must complete and sign the Medical Report form that is incorporated by reference into this Chapter 65C-35, F.A.C. and includes all requirements set forth in Section 39.407(3)(c), (1)-(5), F.S. The physician may submit a medical report on a form of their choice as long as the form includes all information required on in Section 39.407 (3)(c)(1)-(5), F.S. and the Medical Report that is incorporated by reference in Chapter 65C-35, F.A.C. is included.
Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3)(c) FS. History–New________.