The Department intends to (1) Change the term “prescribing practitioner” to “prescribing physician,” and amend the terminology throughout the rules and in form CF-FSP 5339, Medical Report; (2) Amend the definition of “psychotropic medication” to ...

 

DEPARTMENT OF CHILDREN AND FAMILIES

Family Safety and Preservation Program

RULE NOS.:RULE TITLES:

65C-35.001Definitions

65C-35.002Behavioral Health Services

65C-35.003Parent or Legal Guardian Involvement

65C-35.004Caregiver Involvement

65C-35.005Child Involvement in Treatment Planning

65C-35.006Taking a Child Into Custody Who Is Taking Psychotropic Medication

65C-35.007Authority to Provide Psychotropic Medications to Children in Out-of-Home Care

65C-35.011Medication Monitoring and Administration

65C-35.012Requests for Second Opinions and Pre-Consent Reviews

65C-35.013Medical Report

65C-35.014Training on Psychotropic Medication

PURPOSE AND EFFECT: The Department intends to (1) Change the term “prescribing practitioner” to “prescribing physician,” and amend the terminology throughout the rules and in form CF-FSP 5339, Medical Report; (2) Amend the definition of “psychotropic medication” to include substances, though prescribed with the intent to treat other medical conditions, have the effect of altering brain chemistry; (3) Amend the age of children whose cases are required to have a pre-consent review; and (4) Clarify from whom child protective investigators, case managers, and other caregivers will receive training.

SUMMARY: “Prescribing Physician” will be defined as a physician licensed under Chapter 458 or 459, F.S. The definition of “psychotropic medication” will be expanded to include substances, though prescribed with the intent to treat other medical conditions, have the effect of altering brain chemistry. The child protective investigator or case manager shall be required to seek a pre-consent review when the child is age birth to 17 years.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Department used a checklist to conduct an economic analysis and determine if there is an adverse impact or regulatory costs associated with this rule that exceeds the criteria in section 120.541(2)(a), F.S. Based upon this analysis, the Department has determined that the proposed rule is not expected to require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 39.0121, 39.01305, 39.407(3)(g), FS.

LAW IMPLEMENTED: 39.01305, 39.407(1)-(3), FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jodi Abramowitz. Jodi can be reached at [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

65C-35.001 Definitions.

(1) through (11) No change.

(12) “Express and Informed Consent” means 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 the following information, provided and explained in plain language by the prescribing physician or designee practitioner 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.

(13) through (16) No change.

(17) “Medical Report” means a report prepared by the prescribing physician that includes information required by Section 39.407(3)(c), F.S. The “Medical Report” form, CF-FSP 5339, December 2017 2015, is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XX.

(18) through (19) No change.

(20) “Prescribing Physician Practitioner” means a physician practitioner licensed under Chapter 458 or 459, F.S.

(21) “Psychotropic Medication” means any medication prescribed with the primary intent to stabilize or improve mood, mental status, behavioral symptomatology, or mental illness and those substances, though prescribed with the intent to treat other medical conditions, have the effect of altering brain chemistry, including any medications in the following categories.

(a) Antipsychotics;

(b) Antidepressants;

(c) Sedative Hypnotics;

(d) Lithium;

(e) Stimulants

(f) Non-stimulant Attention Deficit Hyperactivity Disorder medication;

(g) Anti-dementia medications and cognition enhancers; and

(h) Anticonvulsants.

(22) through (23) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1), (2), (3) FS. History–New 3-17-10, Amended 4-20-17, 6-29-17, ______.

 

65C-35.002 Behavioral Health Services.

(1) Behavioral health services shall be provided to children in out-of-home care once the need for such services is identified. Prior to prescribing a psychotropic medication, the physician or designee practitioner must consider other treatment interventions that may include medical, mental health, behavioral, counseling, or other services. All decision-making shall be guided by the principle that it is important to comprehensively address all of 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) No change.

(3) Prior to prescribing a psychotropic medication, the physician or designee practitioner 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.

(4) No change.

Rulemaking Authority 39.407(3)(g), 39.0121 FS. Law Implemented 39.407(1), (3) FS. History–New 3-17-10, Amended 4-20-17, _____.

 

65C-35.003 Parent or Legal Guardian Involvement.

(1) The child protective investigator (CPI) or case manager shall facilitate the attendance of the child’s parent (where parental rights are intact) or legal guardian at all medical appointments. The CPI or case manager shall make the following minimum efforts to assist the prescribing physician practitioner in obtaining expressed and informed consent from the child’s parent or legal guardian:

(a) No change.

(b) Facilitate telephone or tele-medicine participation between the prescribing physician practitioner and the parent or legal guardian when unable to attend in person.

(2) If the parent or legal guardian is unable to attend medical appointments, the CPI or case manager shall:

(a) Attempt to contact the parent or legal guardian upon learning of the recommendation for psychotropic medication by the prescribing physician or designee practitioner and provide specific information on how and when to contact the physician or designee practitioner; and,

(b) Provide a copy of the Medical Report, incorporated by reference in Rule 65C-35.001, F.A.C., to the child’s parent or legal guardian, which includes the prescribing physician’s practitioner’s contact information.

(3) When the court has authorized the provision of psychotropic medication, the CPI or case manager must continue to try to involve the parent or legal guardian in the child’s ongoing medical treatment planning, and shall continue to facilitate the parent or legal guardian’s communication with the prescribing physician or designee practitioner so that the parent or legal guardian has the opportunity to consider whether to authorize the provision of any new medications or dosages, unless the parent or legal guardian’s rights have been terminated.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3) FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.004 Caregiver Involvement.

(1) through (2) No change.

(3) The caregiver shall monitor the child and report to the prescribing physician or designee practitioner and the CPI or case manager any behavior or other incident that could indicate an adverse reaction or side effect. The caregiver must seek emergency medical care for the child if the presence of an adverse reaction or side effect to the medication is affecting the child’s health or safety.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3) FS. History–New 3-17-10, Amended 4-20-17, _____.

 

65C-35.005 Child Involvement in Treatment Planning.

(1) The prescribing physician or designee practitioner must discuss the proposed course of treatment with the child, in developmentally appropriate language the child can understand. The physician or designee practitioner must explain the risks and benefits of the prescribed medication to the child.

The physician or designee practitioner will discuss with the child the following:

(a) through (j) No change.

(k) The physician or designee’s practitioner’s plan to reduce and/or eliminate ongoing administration of the medication.

(2) The prescribing physician practitioner must ascertain the child’s position with regard to the medication and consider whether to revise the recommendation based on the child’s input. The child’s position must be noted in the Medical Report, incorporated by reference in Rule 65C-35.001, F.A.C. The child protective investigator (CPI) or case manager shall provide the child with a copy of the Medical Report if the child is of sufficient maturity and intellectual capacity to understand the report.

(a) It is the physician or designee’s practitioner’s responsibility to inform the child as clearly as possible and as fully as is appropriate. However, the child’s failure to understand or assent to treatment is not, by itself, sufficient to prevent the administration of a prescribed medication. Likewise, the child’s assent to the treatment is not a substitute for expressed and informed consent by a parent or legal guardian or a court order. Children are more likely to be successful in treatment if they fully understand and participate in treatment decisions.

(b) Pursuant to Section 39.01305, F.S., Tthe CPI or case manager shall request that Children’s Legal Services file a motion for the appointment of an attorney for the child when the child declines to assent or the prescribing physician practitioner determines that the child is not developmentally able to provide assent, or when the child has a diagnosis of a developmental disability as defined in Section 393.063, F.S.

(3) Whenever the child requests the discontinuation of the psychotropic medication, and the prescribing physician practitioner refuses to order the discontinuation, the CPI or case manager shall request that Children’s Legal Services request an attorney be appointed for the child. Children’s Legal Services will notice all parties and file a motion with the court, presenting the child’s concerns, the physician’s practitioner’s recommendation, and any other relevant information, pursuant to Section 39.407(3)(d)1., F.S.

Rulemaking Authority 39.01305, 39.407(3)(g) FS. Law Implemented 39.01305, 39.407(3) FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.006 Taking a Child Into Custody Who Is Taking Psychotropic Medication.

(1) When a child protective investigator (CPI) takes a child into custody he or she must ascertain whether the child is taking psychotropic medications. If so, the CPI must determine the purpose of the medication, the name and phone number of the prescribing physician practitioner, the dosage, instructions regarding administration (e.g., timing, whether to administer with food), and any other relevant information.

(2) The CPI must seek written authorization from the parent or legal guardian to continue administration of currently prescribed psychotropic medications. The authorization shall be documented on the “Emergency Intake” form, CF-FSP 5314, May 2010, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-08063. This authorization is good for the first 60 calendar days the child is in shelter status.

(a) No change.

(b) If the medication is not in the original container, is not clearly marked, or is not the child’s current prescription, the child shall not be continued on the medication unless the prescribing physician or designee practitioner or the dispensing pharmacy confirms that the child is currently on the prescribed medication and provides a new prescription to be filled or refilled.

(b) If the CPI is informed that the child is currently taking prescribed psychotropic medication, however, the original container is unavailable or the label on the container provided is indiscernible, the child must be evaluated by a practitioner at the initial health screening to determine if the medication is needed and provided instruction on proper dosing.

(3) No change.

(4) Children’s Legal Services must file a motion requesting that continuation of the medication be determined at the shelter hearing.

(a) The motion must indicate the prescribing physician’s practitioner’s reasons for wanting to continue the medication and provide the court with any other available information relevant to the request.

(b) If the CPI is unable to obtain the reason for continuing the medication from the prescribing physician, he or she must document all efforts to obtain the information from the prescribing physician and file it with the court prior to the shelter hearing.

(5) No change.

(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 practitioner to determine whether it is appropriate to continue the medication.

(7) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(1), (2), (3) FS. History–New 3-17-10, Amended 4-20-17,______.

 

65C-35.007 Authority to Provide Psychotropic Medications to Children in Out-of-Home Care.

(1) through (2) No change.

(3) If the parents’ or guardians’ legal rights have been terminated, their identity or location is unknown, they decline to approve administration of psychotropic medication, or withdraw consent to the administration of psychotropic medication and any party to the dependency action believes that administration of the medication is in the best interest of the child and medically necessary, then authorization to treat with psychotropic medication shall be pursued as follows:

(a) The case manager shall consult with the prescribing physician practitioner within one (1) business day of being notified that the parent:

1. through 3. No change.

4. Is found by the prescribing physician practitioner to lack the ability to provide express and informed consent.

(b) If the prescribing physician practitioner determines that the medication is medically necessary for the child despite the lack of authorization, the case manager must obtain a completed Medical Report, incorporated by reference in Rule 65C-35.001, F.A.C., from the prescribing physician practitioner. If the parent or legal guardian withdraws consent that was previously provided or declines to consent to the administration of psychotropic medication, the parent or legal guardian’s decision, and any reason provided therefore, must be recorded by the prescribing physician or designee practitioner in the Medical Report. If the prescribing physician practitioner determines that the parent or legal guardian cannot provide express and informed consent, the basis for that determination must be recorded by the prescribing physician or designee practitioner in the Medical Report.

(c) Within three (3) business days of receiving the Medical Report from the prescribing physician or designee practitioner, the 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.

(d) No change.

(4) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(2), (3) FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.011 Medication Monitoring and Administration.

(1) The monitoring of the use of psychotropic medication provided to children will be the joint responsibility of the prescribing physician, physician’s designee practitioner, the caregiver, the child protective investigator (CPI) or case manager, and the CPI or case manager’s supervisor. Child protective investigator supervisors and case manager supervisors shall provide ongoing review and oversight of children prescribed psychotropic medications.

(2) The caregiver and CPI or case manager are responsible for implementing the medication plan developed by the prescribing physician practitioner. The case manager or child protective investigator shall ensure any additional medical evaluations and laboratory tests required are completed. The CPI or case manager shall add all information to the child’s Resource Record and report the results of evaluations and tests to Children’s Legal Services, all parties, and the prescribing physician or designee practitioner.

(3) Psychotropic medications will be administrated only by the child’s caregivers. Children who are age and developmentally appropriate must be given the choice to self-administer medication under the supervision of the caregiver or school personnel. Children assessed as appropriate to self-administer medication must be educated by the physician or designee practitioner or caregiver on the following:

(a) through (e) No change.

(4) No change.

(5) Any person with information that questions the child’s health and safety, including the signs or symptoms of side effects or adverse reactions to the medication, shall as soon as possible bring that information to the attention of the prescribing physician or designee practitioner, CPI or case manager, the CPI or case manager’s supervisor, and emergency services shall be arranged to protect the child’s safety and well-being. The child’s CPI or case manager shall provide this information to Children’s Legal Services. Children’s Legal Services shall notify the court and all parties within three (3) business days of the reported concerns.

(6) No change.

(7) All details about prescribed psychotropic medications, updates (including changes in dosage or physician practitioner prescribed cessation of the medication) and all actions taken by the CPI or case manager will be entered into the Florida Safe Families Network (FSFN) by the CPI or case manager within three (3) business days of the action.

(8) through (11) No change.

(12) To ensure that the medication is continued as directed by the prescribing physician practitioner, the CPI or case manager shall provide the caregiver with the following information:

(a) through (b) No change.

(c) The prescribing physician’s practitioner’s name and contact information;

(d) through (i) No change.

(j) The physician’s practitioner’s plan to reduce and/or eliminate ongoing administration of the medication; and,

(k) No change.

(13) If the child is moved from an out-of-home placement and placed in another out-of-home placement and the medication is in an unlabeled container or prescription information is insufficient, the CPI or case manager shall contact the prescribing physician or designee practitioner, if available, and dispensing pharmacist to ensure the proper identification and labeling of the medication by examining the pills (if unlabeled) or to arrange for a medical evaluation in order that treatment not be interrupted.

(14) No change.

Rulemaking Authority 39.407(3)(g), 39.0121 FS. Law Implemented 39.407(2), (3) FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.012 Requests for Second Opinions and Pre-Consent Reviews.

(1) No change.

(2) Pre-Consent Reviews. The CPI or case manager shall seek a pre-consent review when:

(a) A physician practitioner proposes prescribing psychotropic medication or changing the dosage of prescribed psychotropic medication outside the dosage parameters documented in the Medical Report; and,

(b) The child is age birth through 17 10 years; and,

(c) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3)(d)1. FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.013 Medical Report.

(1) If the parent or caregiver is unable to attend the medical appointment, the prescribing physician practitioner must complete, if not previously completed by the physician’s designee, review, and sign the Medical Report form, incorporated by reference in Rule 65C-35.001, F.A.C. The physician or designee practitioner may submit a medical report on a form of their choice as long as the form includes all information required on the Medical Report that is incorporated by reference into Rule 65C-35.001, F.A.C.

(2) When the parent and caregiver are able to attend the medical appointment and the parent provides express and informed consent for the child to be administered psychotropic medications, the prescribing physician or designee practitioner must complete Section 5: Parental Consent of the Medical Report Form. The parent must sign this section of the form attesting to his or her consent.

(a) through (b) No change.

(3) When court authorization is needed to provide psychotropic medication, the CPI or case manager must document efforts made to enable the prescribing physician practitioner to obtain express and informed consent from the child’s parent or legal guardian on the Medical Report form. Efforts to enable the prescribing physician practitioner must include:

(a) Dates and times the CPI or case manager attempted to contact the parent or legal guardian by phone or other means upon learning of the recommendation for psychotropic medication by the prescribing physician practitioner;

(b) Dates, times, and methods used to attempt to contact the parent or legal guardian and provide them with specific information for how and when to contact the physician practitioner; and,

(c) Efforts to facilitate transportation arrangements to the appointment and/or telephone calls between the parent or legal guardian and the prescribing physician practitioner.

(4) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3)(c) FS. History–New 3-17-10, Amended 4-20-17,_____.

 

65C-35.014 Training on Psychotropic Medication.

(1) All child protective investigators and sheriff’s officers who conduct child investigations case managers shall receive Department-approved training from Department trainers or trainers with the Sherriff’s Office. Case managers and other caregivers (foster parents and relatives/non-relatives) shall receive training from the community-based care lead agency (CBC) or its contracted provider on medication management and administration. Training must be completed prior to assuming responsibility for a child who is prescribed psychotropic medication.

(2) through (4) No change.

Rulemaking Authority 39.407(3)(g) FS. Law Implemented 39.407(3)(d) FS. History–New 4-20-17, Amended_____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Courtney Smith

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Mike Carroll

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 6, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 8, 2018