Rule Summary and Fiscal Analysis (Part A)
Department of Job and Family Services
Agency Name
Division of Social Services Michael Lynch
Division Contact
OFC- 4200 E. 5th Ave., 2nd fl. J6-02 P.O. Box 183204 Columbus OH 43218-3204
614-466-4605 614-752-8298
5101:2-5-13
Rule Number
AMENDMENT
TYPE of rule filing
Rule Title/Tag Line Required agency policies, plans and procedures.
RULE SUMMARY
1. Is the rule being filed consistent with the requirements of the RC 119.032 review? Yes
2. Are you proposing this rule as a result of recent legislation? No
3. Statute prescribing the procedure in accordance with the agency is required to adopt the rule: 119.03
4. Statute(s) authorizing agency to adopt the rule: 5103.03, 5103.0316
5. Statute(s) the rule, as filed, amplifies or implements: 5103.02, 5103.03, 5103.0316, 5103.0319, 5103.032
6. State the reason(s) for proposing (i.e., why are you filing,) this rule:
This rule is proposed for amendment as a result of the five year review.
7. If the rule is an AMENDMENT, then summarize the changes and the content of the proposed rule; If the rule type is RESCISSION, NEW or NO CHANGE, then summarize the content of the rule:
Page 2 Rule Number: 5101:2-5-13
This rule provides guidance to agencies regarding policies a foster care agency must have in order to operate. Paragraph (A)(2) was amended to remove the two year update timeframe for the completion of the Multiethnic Placement Act (MEPA) plan. The MEPA plan can remain as written until an update occurs.
Paragraph (A)(10) was amended for clarity. No substantive changes were made. Paragraph (A)(16) was added to require an agency that operates a residential facility to have a policy for admissions. Paragraphs (A)(24) and (A)(25) were removed because they are duplicative and can be found in rule 5101:2-48-05 of the Administrative Code. A new paragraph (A)(28) was added to require an agency to have a policy for monitoring the appropriate use of psychotropic medications for children and youth in foster care. This was added due to a federal mandate in section 422(b) (15)(A) of 42 U.S.C. 622.
8. If the rule incorporates a text or other material by reference and the agency claims the incorporation by reference is exempt from compliance with sections
121.71 to 121.74 of the Revised Code because the text or other material is generally available to persons who reasonably can be expected to be affected by the rule, provide an explanation of how the text or other material is generally available to those persons:
This rule incorporates one or more references to another rule or rules of the Ohio Administrative Code. This question is not applicable to any incorporation by reference to another OAC rule because such reference is exempt from compliance with ORC 121.71 to 121.74 pursuant to ORC 121.76(A)(3).
This rule incorporates one or more dated references to an ODJFS form or forms. Each cited ODJFS form is dated and is generally available to persons affected by this rule via the inner-web at http://innerapp.odjfs.state.oh.us/forms/inner.asp or on the inter-net at http://www.odjfs.state.oh.us/forms/inter.asp in accordance with RC 121.75(E).
This rule incorporates one or more dated references to a federal act or acts. This question is not
applicable to any dated incorporation by reference to a federal act because such reference is
exempt from compliance with RC 121.71 to 121.74 in accordance with RC 121.75(C)
9. If the rule incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material electronically, provide an explanation of why filing the text or other material electronically was infeasible:
Page 3 Rule Number: 5101:2-5-13
Not applicable
10. If the rule is being rescinded and incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material, provide an explanation of why filing the text or other material was infeasible:
Not Applicable.
11. If revising or refiling this rule, identify changes made from the previously filed version of this rule; if none, please state so. If applicable, indicate each specific paragraph of the rule that has been modified:
The rule is being refiled to enter a new revision date to JFS form 01682 in paragraph (A)(29).
12. 119.032 Rule Review Date: 4/4/2014
(If the rule is not exempt and you answered NO to question No. 1, provide the scheduled review date. If you answered YES to No. 1, the review date for this rule is the filing date.)
NOTE: If the rule is not exempt at the time of final filing, two dates are required: the current review date plus a date not to exceed 5 years from the effective date for Amended rules or a date not to exceed 5 years from the review date for No Change rules.
FISCAL ANALYSIS
13. Estimate the total amount by which this proposed rule would increase / decrease either revenues / expenditures for the agency during the current biennium (in dollars): Explain the net impact of the proposed changes to the budget of your agency/department.
This will have no impact on revenues or expenditures. 0.00
This will have no impact on the current budget.
14. Identify the appropriation (by line item etc.) that authorizes each expenditure necessitated by the proposed rule:
Not applicable.
Page 4 Rule Number: 5101:2-5-13
15. Provide a summary of the estimated cost of compliance with the rule to all directly affected persons. When appropriate, please include the source for your information/estimated costs, e.g. industry, CFR, internal/agency:
No new costs.
16. Does this rule have a fiscal effect on school districts, counties, townships, or municipal corporations? No
17. Does this rule deal with environmental protection or contain a component dealing with environmental protection as defined in R. C. 121.39? No
S.B. 2 (129th General Assembly) Questions
18. Has this rule been filed with the Common Sense Initiative Office pursuant to
R.C. 121.82? Yes
19. Specific to this rule, answer the following:
A.) Does this rule require a license, permit, or any other prior authorization to engage in or operate a line of business? Yes
Certification by ODJFS requires the agency to comply with the rule.
B.) Does this rule impose a criminal penalty, a civil penalty, or another sanction, or create a cause of action, for failure to comply with its terms? Yes
Lack of compliance can result in revocation of the certificate.
C.) Does this rule require specific expenditures or the report of information as a condition of compliance? Yes
Expenditures related to the agency complying with the requirements of the rule to create agency policies.
Psychotropic Medication Toolkit for Public Children Services Agencies
PCSAO Behavioral Health Leadership Group
Table of Contents
Introduction........................................................................................................ 2
About the Toolkit................................................................................................ 4
Sections............................................................................................................. 5
I. Policy Development................................................................................. 5
II. Psychotropic Medication Practices and Guidelines.......................................... 6
III. Procedures........................................................................................... 8
IV. Orientation and Training........................................................................ 12
V. Ongoing Monitoring and Evaluation.......................................................... 12
VI. Information-Sharing Mechanisms............................................................ 13
PCSAO Reference Table for Psychotropic Medication Dosage Thresholds in Children........ 14
Appendix 1: Toolkit Chart Psychotropic Medication Policy Guidelines for
Children in the Care of PCSAs...................................................................... 17
Appendix 2: Medication Documentation Psychotropic Medication Checklist
for Youth in Care...................................................................................... 27
Appendix 3: Committee Membership PCSAO Behavioral Health Leadership Group........... 29
Introduction
The Fostering Connections to Success and Increasing Adoptions Act of 2008 required state child welfare agencies develop a plan for oversight and coordination of health care services for children in foster care, including prescription medications. This work was to be completed in consultation with the state Medicaid agency, pediatricians, other experts in health care, and experts in and recipients of child welfare services. On September 30, 2011, the Child and Family Services Improvement and Innovation Act enhanced these requirements by mandating additional provisions to the health care plan that specifically delineate "protocols for the appropriate use and monitoring of psychotropic medications."
Due to their histories of maltreatment and trauma, children in foster care frequently demonstrate symptoms of behavioral health conditions for which psychotropic medications commonly are prescribed. While such prescriptions often are necessary, national and statewide data show a high prescription rate of poly-psychopharmacology among children and youth in the custody of the child welfare system. The data includes the following:
· 23 percent of children age 17 and younger who have experienced maltreatment have behavior problems requiring clinical intervention. Clinical-level behavior problems are almost three times as common among this population as among the general population.
· 35 percent of children age 17 and younger who have experienced maltreatment demonstrate clinical-level problems with social skills. This rate is more than twice that of the general population.1
· Children in foster care are more likely to have a mental health diagnosis than other children. In a study of foster youth between the ages of 14 and 17, 63 percent met the criteria for at least one mental health diagnosis at some point in their lives. The most common diagnoses were Oppositional Defiant Disorder/Conduct Disorder, Major Depressive Disorder/Major Depressive Episode, Attention Deficit/Hyperactivity Disorder, and Post-Traumatic Stress Disorder.
· According to one study, by the time youth in foster care reach age 17, 62 percent will exhibit both the symptoms of a mental health disorder and the symptoms of trauma.2
· Although they make up only 3 percent of the Medicaid population under age 18, children in foster care account for 32 percent of the recipients of behavioral health services in this age group. 3
1. White, CR; Havalchak, A; Jackson, L; O'Brien, K; & Pecora, PJ. (2007). Mental Health, Ethnicity, Sexuality, and Spirituality among Youth in Foster Care: Findings from The Casey Field Office Mental Health Study. Casey Family Programs.
2. Griffin, G; McClelland, Holzberg, M; Stolbach, B; Maj, N; & Kisiel, C (In Press). Addressing the impact of trauma before diagnosing mental illness in child welfare. Child Welfare.
3. Center for Health Care Strategies, Inc. (Forthcoming). Analysis of Medicaid Claims Data for 2005.
· Children in foster care receive antipsychotic medications at a rate of almost nine times that of other Medicaid-eligible children, though they represent only 3 percent of that population.4
· Of children in foster care taking psychotropic medication,
o 21.3 percent take one class of medication;
o 41.3 percent take three or more;
o 15.4 percent take four or more; and
o 2.1 percent take five or more.5
When used appropriately, psychotropic medications often are an essential treatment component to effectively address the multiple needs of children in care. Given the complexity of pharmacological interventions, consistent oversight and monitoring of medication use are critical. As the custodians for children in care, public children services agencies (PCSAs) have a profound responsibility to focus not only on safety and permanency, but also on improving the well-being of children in care. Ultimately, PCSAs are required to authorize use of medication if birth or adoptive parents are unavailable to consent. This responsibility requires knowledge of specific medications, effective interventions, best practices, policies, procedures and practice guidelines.
To better address this issue, the Public Children Services Association of Ohio (PCSAO) established the Behavioral Health Leadership Group (BHLG) in February 2012. BHLG membership includes state and local child welfare entities, as well as public and private providers. Representatives include 15 PCSAs, including both rural and urban jurisdictions; the Ohio Association of County Behavioral Health Authorities; the Ohio Association of Child Caring Agencies; the Ohio Council of Behavioral Health and Family Service Providers; and the Ohio Departments of Job and Family Services, Mental Health and Addiction Services, Youth Services, Education, Health, and Developmental Disabilities. Technical assistance is provided by Vorys Health Care Advisors.
The BHLG developed this toolkit to guide the oversight of psychotropic medication use by children and youth in the custody of Ohio's child welfare system. The recommendations put forth have been selected following review of other published works, including Guidelines on Managing Psychotropic Medications from the American Academy of Child and Adolescent Psychiatrists, other state plans (for example, Connecticut and Texas) and local Ohio child welfare agencies' policies (for example, those in Lucas and Summit counties).
4. Crystal, S; Olfson, M; Huang, C; Pincus, H; & Gerhard, T. (2009). Broadened use of atypical antipsychotics: Safety, effectiveness, and policy challenges. Health Affairs, 28(5):770.
5. Zito, JM; et al., (2008). Psychotropic medication patterns among youth in foster care. Pediatrics. 121(1): e157.
About the Toolkit
This toolkit is comprised of six sections:
· Policy Development
· Practice: Guidelines and Definitions
· Procedures
· Orientation and Training
· Ongoing Monitoring and Evaluation
· Information Sharing
In recognition that community needs and available resources vary, three levels of recommendation are offered under each section, where applicable. Basic recommendations serve as the foundation for practice; enhanced and ideal categories illustrate additional options for consideration.
Throughout this document, the following definitions are used:
· Psychotropic medication - medications used to treat mental health conditions; medications that affect the mind, emotions and behavior.
· Antipsychotic medications - a class of psychotropic medications used to treat serious mental disorders (for example, psychosis, schizophrenia and other disorders that may lead to psychosis, including bipolar disorder).
· Polypharmacy - the use of multiple medications at the same time.
A list of reference documents concerning frequently prescribed medications and dosage thresholds can be found at the end of the toolkit recommendations.
Sections
I. Policy Development
A. Involving stakeholders to define the issue and generate practical suggestions for implementing informed consent/approval process. Stakeholders include the following:
1. Foster parents or other substitute caregivers (Basic)
2. Caseworkers, supervisors and administrators (Basic)
3. Main provider agencies (Basic)
4. Inpatient units and psychiatrists(Basic)
5. Biological parents of children in agency custody (Enhanced)
6. Children (Enhanced)
7. Other physicians and nurses (Enhanced)
8. Judges and attorneys (Ideal)
9. School personnel (Ideal)
B. Determining ultimate authority, designees and medical consultations:*
* Obtain legal consultation for parameters of authority.
1. Authority for final informed consent for medication:
a. Executive director or designee (Basic)
b. PCSA case worker or supervisor (provides informed consent for continuation of maintenance level-of-medication or dose adjustment when dose remains within accepted prescribing timelines) (Basic)
c. Executive director or designee with medical background (Enhanced)
d. Executive director with psychiatric consultation (Ideal)
2. After hours/emergency approval:
a. "On-call" child welfare staff give preliminary approval within prescribing guidelines (Basic)
b. "On-call" child welfare supervisor gives approval within prescribing guidelines
(Enhanced)
c. Executive director or designee with medical background gives approval following psychiatric consultation (Ideal)
3. Parental consent:
a. Notification given, consent not required when medications are within prescribing guidelines (Basic)
b. Consent requested when prescribed medications are not within guidelines
(Basic)
c. Consent required for changes in type of medication (Enhanced)
d. Consent required for any medication change (Ideal)
4. Assent from youth:
a. Risks benefits explained, no assent requested or required (Basic)
b. Assent from children age 15 or older when not clinically contraindicated
(Enhanced)
c. Assent from any school-age child when not clinically contraindicated (Ideal)
5. Consultation from medical or psychiatric authority:
a. Required prior to finalizing policy (Basic)
b. Required when medications do not fall within prescribing guidelines
(Enhanced)
c. All of the above, with periodic random review of psychotropic database
(Ideal)
C. Use of a "Preferred Provider" list:
1. Consider (Basic)
2. Develop (Enhanced)
3. Consistently implement (Ideal)
II. Psychotropic Medication Practices and Guidelines
A. Definition of covered medications:
1. Non-psychiatric medications used for symptoms related to a behavioral health diagnosis (Basic)
2. All over-the-counter medications used to treat behavioral health symptoms/conditions (Basic)
3. All known substances used by the youth, including alcohol, tobacco and other drugs (Basic)
4. Items one through four, plus nutritional supplements used on a regular basis
(Enhanced)
5. Items one through five, plus over-the-counter medications used on an as-needed basis (Ideal)
B. Prescriber criteria:
1. Approved prescribers:
a. Any clinician licensed to prescribe medication (Basic)
b. Any clinician licensed to prescribe medication who is specially trained
(Enhanced)
c. Board-certified or -eligible child/adolescent psychiatrists and developmental behavioral pediatricians (Ideal)
2. Medication management for a stable child on maintenance doses of medications:
a. Any clinician licensed to prescribe medication (Basic)
b. Any clinician licensed to prescribe medication, with major changes overseen by clinicians who are specially trained (Enhanced)
c. Child/adolescent psychiatrists (Ideal)
C. Informed consent parameters and medical consultation:
1. Informed consent procedure:
a. Initial informed consent by executive director or designee for a medication; continued informed consent for changes in same medication by child welfare manager or supervisor when changes are within prescribing parameters (Basic)
b. Initial and continued informed consent always the responsibility of executive director or designee (Enhanced)
2. Approval timeline for informed consent:
a. Within one business day (Basic)
b. On the same business day (Enhanced)
c. Executive director or designee with approving authority is present at the medical appointment, either in person or via conference call, and participates in the informed consent discussion (Ideal)
3. Informed consent in psychiatric emergencies:
a. Covered by the consent for treatment form (Basic)
b. "On-call" child welfare staff give approval if request is within prescribing parameters (Enhanced)
c. Executive director or designee with medical background gives approval following psychiatric consultation (Ideal)
4. Medical expert consulted if prescribing is not within prescribing parameters
(Enhanced)
a. When medication doesn't "match" diagnosis
b. When dosages are not within recommended prescribing parameters
c. When polypharmacy is used without a pretrial of monopharmacy
d. When four or more psychotropics are used concurrently
e. For two or more concurrent antidepressants
f. For two or more concurrent antipsychotics
g. For two or more concurrent stimulants
h. For three or more concurrent mood stabilizers
i. For all children under 6 years of age
j. For children with three or more mental health hospital admissions during any one-month period
k. When executive director or designee is not satisfied by the prescriber's justification for medication use.
III. Procedures
A. Approvals for youth on medication prior to policy/procedure implementation
1. Identify information needed immediately at the time of screening (recommend using the Psychotropic Medication Information Checklist - Appendix 2) and document the checklist data in the psychotropic medication file for each child. Checklist data includes:
a. Name, age, height and weight of child (Basic)
b. Name of provider (Basic)
c. Psychotropic medications, dosage, route and times (Basic)
d. Diagnostic assessment with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis, if available (Enhanced)
e. Individualized service plan, if available (Ideal)
f. Medication history (may be part of diagnostic assessment) (Ideal)
g. Most recent progress note from a medical doctor (Ideal)
B. Documentation:
1. Consistent filing of information in the Statewide Automated Child Welfare Information System (SACWIS) record (Basic)
2. Create and maintain a Psychotropic Medication Information Checklist and spreadsheet for each child for easy access to current information (see Appendix 2); checklist/spreadsheet should include the following: (Enhanced)
a. Child name, age, height and weight
b. Provider name and credentials
c. DSM-IV diagnosis
d. Symptoms addressed by prescribed medication
e. Risks and benefits of medication
f. Other interventions ordered (for example, therapies and behavioral interventions)
g. Accept provider's informed consent form (when above data elements are included).
C. Procedure for youth on psychotropics when taken into custody: (Basic)
1. Consider "preliminary approval" status if current medications "match" DSM-IV diagnosis and are within recommended dosage parameters.
2. Establish timelines for medication review and approval process with the following steps:
a. PCSA caseworker obtains Psychotropic Medication Information Checklist data and documents it in the Psychotropic Medication File and SACWIS.
b. PCSA caseworker notifies the behavioral health provider of agency approval process (if not on "Active Provider" list).
c. PCSA caseworker ensures that the prescriber provides information contained in the Medication Authorization Form.
d. PCSA caseworker reviews agency policy/procedure with the out-of-home care provider and obtains/documents provider's input about the use of specified psychotropic medications.
e. Process for executive director or designee to have questions answered by the provider.
f. PCSA caseworker or PCSA nurse, as assigned by the executive director, communicates informed consent for the psychotropic medications by doing the following:
1. Notifies the caregiver to continue medication without interruption.
2. Consults with medical advisers if there are questions or concerns about the psychotropic medication, or whenever the prescribed medication is not within recommended medication parameters.
3. Submits the request for executive director's or designee's authorization after all information is obtained and reviewed and notifies the substitute caregiver and the physician if informed consent is not granted.
4. Documents all the information in SACWIS and the Psychotropic Medication Information Checklist.
5. Regularly monitors medication adherence and child's and caregiver's roles in adherence.
D. Procedure for youth identified as possibly benefitting from psychotropics after being taken into custody: (Basic)
1. Establish timelines for each of the following steps, to be conducted by a PCSA caseworker unless otherwise noted:
a. Conducting a screening to identify possible behavioral health concerns, especially trauma.
b. Securing diagnostic, psychological and/or psychiatric assessments, or any referral to behavioral health providers as deemed appropriate by the child's team.
c. Informing the substitute caregiver or nurse that an assessment is requested.
d. Making an appointment with a behavioral health provider and communicate appointment date and time to the substitute caregiver.
e. Informing the behavioral health provider of agency policies on psychotropic medications before or during the appointment .
f. Attending the initial appointment, and any other appointments during which a psychotropic medication may be prescribed. For youth placed out of county, the caseworker must attend psychiatric appointments at least quarterly.
g. Documenting diagnosis, symptoms to be addressed with medications, potential risks, expected benefits, medication name, route, dose and time(s) to be administered (PCSA caseworker or PCSA nurse as assigned by the executive director).
h. Communicating the name, benefits and risks of the medication to the child (as developmentally appropriate) and to the caregiver; obtaining and documenting the child's and caregiver's inputs.
i. Communicating the child's response to the medication to the behavioral health provider, PCSA nurse and substitute caregiver; documenting the child's response to the medication in the record.
j. Ensuring that the prescriber provides information as contained on the Medication Authorization Form and faxes or emails it to the executive director or designee.
k. Reviewing information and providing informed consent for the psychotropic medications; communicating the decision to the PCSA caseworker (executive director or designee).
1. If the executive director or designee cannot provide informed consent, the provider must be contacted to share concerns.
2. If the executive director or designee still is not able to provide informed consent following discussion with provider, he or she shall contact the agency's medical expert.
3. The caseworker communicates the final decision to the behavioral health provider, out-of-home care provider, child and/or nurse.
l. Filling and administering the medication after approval is received (out-of- home care provider).
m. Contacting the pharmacy if the prescription was electronic and the informed consent was not given (PCSA caseworker or PCSA nurse as assigned by the executive director).
n. Documenting all the information in SACWIS and on the Psychotropic Medication Information Checklist (PCSA caseworker or PCSA nurse as assigned by the executive director).
E. Emergency procedures:
1. Agencies must:
a. Define "psychiatric emergency." For example, a psychiatric emergency exists when a person needs to be treated by emergency healthcare providers for conditions, symptoms or behaviors that are causing or might cause a danger to self or others and are or might be related to a diagnosable behavioral health condition.
b. Determine whether general phone consent for emergency treatment includes a blanket authorization for use of psychotropic medications as determined by an emergency room physician during the course of emergency treatment.
c. Determine whether the consent for psychotropics administered during the course of emergency psychiatric care extend to any prescriptions written by the emergency room physician for administration until the child can be seen by an outpatient behavioral health provider.
2. The PCSA caseworker must obtain a list of all psychotropic medications used during the course of emergency psychiatric treatment, document them in SACWIS and on the Psychotropic Medication Information Checklist, and forward it to the executive director or designee.
F. Inpatient psychiatric episodes:
1. Agencies must determine:
a. Whether a blanket emergency consent (if in agency's policy) extends through the first 24 hours of hospitalization if the child in care is admitted for inpatient psychiatric treatment.
b. Whether executive director or designee approval will be required prior to administration of psychotropic medication in hospital settings.
c. How recommended medications change requirements will be handled at night and on weekends.
d. Whether "pro re nata" (as necessary) medications can be approved for administration at the discretion of a registered nurse.
IV. Orientation and Training
A. Determine which of the following stakeholders need to be trained:
1. Substitute care caseworkers, out-of-home or foster care providers and behavioral health prescribers (Basic)
2. All PCSA caseworkers, child welfare supervisors and administrators, all behavioral health providers (including non-prescribers and administrators) (Enhanced)
3. Foster parents or other substitute caregivers; PCSA caseworkers, supervisors and administrators; provider agencies; biological parents; judges and attorneys; school personnel; children; behavioral health providers (including psychiatrists and inpatient staff); and other physicians and nurses (Ideal)
B. Determine training content:
1. Policy procedures and use of specific forms (Basic)
2. Procedure implementation, description of national and local issues, and related data analyses (Enhanced)
3. Procedure implementation; description of national and local issues; related data analyses; overview of commonly used psychotropics, including their intended uses, risks, benefits and side effects; and an overview of common psychiatric diagnoses in children and adolescents (Ideal)
V. Ongoing Monitoring and Evaluation
A. Data to be collected, aggregated and analyzed:
1. Approved prescriptions that exceed parameters, listed by medication, the reason why it's being administered and the name of the behavioral health provider (Basic)
2. Instances when consent is not granted and the reason (Basic)
3. Adverse medication reactions, including the name of the medication, dose, description of the reaction and the name of the behavioral health provider (Basic)
4. Approved prescriptions that exceed parameters, listed by medication, the reason why it's being administered and the name of the behavioral health provider; instances when consent is not granted and the reason; adverse medication reactions, including the name of the medication, dose, description of the reaction and the name of the behavioral health provider; and policy/procedure feedback from providers, caseworkers, out-of-home care providers and youth (Enhanced)
5. Approved prescriptions that exceed parameters, listed by medication, the reason why it's being administered and the name of the behavioral health provider; instances when consent is not granted and the reason; adverse medication reactions, including the name of the medication, dose, description of the reaction and the name of the behavioral health provider; policy/procedure
feedback from providers, caseworkers, out-of-home care providers and youth; behavioral health treatment outcomes, listed by child, behavioral health provider and service combination; data identical to that collected by the Ohio Psychotropic Medication Quality Improvement Collaborative; and quarterly state- and county-level reports regarding the rates and types of psychotropic medication used by children in care (Ideal)
VI. Information-Sharing Mechanisms:
A. Releases of information specific to the behavioral health provider (Basic)
B. Memoranda of understanding among providers working with the youth and family
(Enhanced)
C. Sharing of electronic health-related information among providers working with the youth and family (Ideal)
D. Establishment and maintenance of a website that provides ready access to pertinent policies and procedures governing psychotropic medication management by clinicians, foster parents and other caregivers. The website should include psycho- educational materials, consent forms, adverse effect rating forms and reports on prescription patterns for psychotropic medications (Ideal)
PCSAO Reference Table for Psychotropic Medication Dosage Thresholds in Children
This reference chart is to be used a guide to inform consumers about the most common drugs used by providers to treat mental health disorders in children and adolescents.
Important considerations:
· These medications are NOT recommended for children under 6 years old.
· Doctors usually start at the lowest dose, then increase the dose if needed. Maximum dose may not be necessary for your child to feel better.
· It is important that children do not self-medicate. The medication is to be taken as prescribed by the provider. Always talk to the provider or pharmacist if there are questions regarding the prescription.
Consider talking with your provider and/or pharmacist when:
· The dosage is greater those listed in tables A through F, and/or
· When the patient is prescribed:
o Four or more psychotropics (Tables A through E)
o Two or more antidepressants (Table C) o Two or more stimulants (Tables A, B) o Two or more mood stabilizers (Table E) o Two or more antipsychotics (Table D)
This reference chart lists name-brand and generic drug names. Some drugs are available in extended release formulations, allowing for once-a-day dosing, and are not listed individually.
Table A.
Stimulants for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Generic name
Brand name
Maximum dose (mg) Children 6-12 years
Maximum dose (mg) Adolescents 13-17 yrs
Amphetamine and Dextroamphetamine
Adderall
40
40
Dexmethylphenidate
Focalin
20
20
Dextroamphetamine
Dexedrine
40
40
Lisdexamfetamine
Vyvanse
70
70
Methylphenidate
Concerta
54
90
Methylphenidate Patch
Daytrana TD
30
30
Methylphenidate CD
Metadata CD
60
60
Methylphenidate
Metadate
60
60
Methylphenidate
Methylin
60
60
Methylphenidate
Ritalin
60
60
Table B.
Other (non-stimulant) ADHD treatments
Generic name
Brand name
Maximum dose (mg) Children 6-12 years
Maximum dose (mg) Adolescents 13-17 yrs
Atomoxetine
Strattera
? 100mg / day
? 100mg / day
Bupropion
Wellbutrin, Aplenzin, Forvivo
? 450mg
? 450mg
Clonidine
Catapres
0.4 mg
0.4 mg
Clonidine XR
Kapvay, Nexiclon
0.4 mg
0.4 mg
Guanfacine
Tenex
4 mg
4 mg
Guanfacine XR
Intuniv
4 mg
4 mg
Imipramine
Tofranil
? 300mg
? 300mg
Nortriptyline
Aventyl, Pamelor
? 150mg
? 150mg
Table C.
Antidepressants
Generic Name
Brand name
Maximum dose (mg) Children 6-12 years
Maximum dose (mg) Adolescents 13-17 years
Citalopram
Celexa
40
40
Escitalopram
Lexapro
20
20
Fluoxetine
Prozac, Sarafem, Selfemra
60
60
Fluvoxamine
Luvox
200
300
Paroxetine
Paxil
Not approved
Not approved
Sertraline
Zoloft
200
200
Desvenlafaxine
Pristiq
Not enough information
Not enough information
Duloxetine
Cymbalta
Not enough information
Not enough information
Venlafaxine
Effexor
Not enough information
Not enough information
Table D.
Antipsychotics
Note: Some can be given as an injection at the provider's office
Chlorpromazine Haloperidol
Thorazine Haldol
75
4
800
6
Perphenazine
Trilafon
6
64
Aripiprazole
Abilify
15
30
Asenapine
Saphris
Not enough info.
Not enough info.
Clozapine
Clozaril, Fazaclo
300
600
Iloperidone
Fanapt
Not enough info.
Not enough info.
Olanzapine
Zyprexa
12.5
30
Paliperidone
Invega
Not enough info.
Not enough info.
Quetiapine
Seroquel
300
600
Risperidone
Risperdal
6
6
Ziprasidone
Geodon
Not enough info.
160
Pimozide
Orap
Weight-based
10
Table E.
Mood and Behavior Disorder
Generic Name
Brand name
Maximum dose (mg) Children 6-12 years
Maximum dose (mg) Adolescents 13-17 years
*Carbamazepine
Carbitrol, Tegretol
800
1200
*Divalproex (sodium)
Depakote
Symptom Improvement
Symptom Improvement
*Lamotrigine
Lamictal
Symptom Improvement
Symptom Improvement
Lithium
Eskalith
blood level
blood level
Lithium
Lithobid
blood level
blood level
*Can also be used as an anticonvulsant/antiseizure medication.
Appendix 1: Toolkit Chart
Psychotropic Medication Policy Guidelines for Children in the Care of PCSAs
POLICY DEVELOPMENT
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Stakeholder Involvement
Foster parents or other substitute caregivers Caseworkers, supervisors and administrators Main provider agencies
Inpatient units and psychiatrists
Biological parents of children in agency custody
Children
Other physicians and nurses
Judges and attorneys School personnel
Authority to Provide Informed Consent
(Obtain legal
consultation for parameters of authority.)
Executive director or designee
Caseworker or supervisor for continuation of medication or dose adjustment when it remains within accepted prescribing parameters.
Executive director or designee who has a medical or behavioral health background
Executive director in conjunction with psychiatric consultation
After-Hours/ Emergency Approvals
"On-call" child welfare staff give preliminary approval within prescribing guidelines
"On-call" child welfare supervisor gives approval within prescribing guidelines
Executive director or designee with behavioral health or medical background in conjunction with psychiatric consultation
Parental Consent
Notification given, consent not required if prescribed medications are within prescribing guidelines
Requested if prescribed medications are not within prescribing guidelines
Required for changes in type of medication
Required for any medication change
Assent from Youth
Risks and benefits explained, no assent requested or required
Assent from age 15 or older when not clinically contraindicated
Assent from any school-age child when not clinically contraindicated
Consultation from Medical/Psychiatric Authority
Prior to finalizing policy
When medications do not fall within prescribing guidelines
Periodic random reviews of psychotropic database
Preferred Provider List
Is considered
Is developed
Is consistently implemented
PSYCHOTROPIC MEDICATION PRACTICE: GUIDELINES AND DEFINITIONS
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Definition of Covered Medications
Psychotropic medications used for symptoms related to a behavioral health diagnosis
Non-psychiatric medications used for symptoms related to a behavioral health diagnosis
All over-the-counter medications used on a regular basis
All known substances used by the youth, including alcohol, tobacco and other drugs
Nutritional supplements used on a regular basis
Over-the-counter medications used on an as-needed basis
Approved Prescriber Criteria
Any clinician licensed to prescribe medications
Any clinician with prescriptive authority who is specially trained
Board--certified or -eligible child/adolescent psychiatrists; developmental pediatricians
Medication Management
(For a stable child on maintenance doses)
Any clinician licensed to prescribe medication
Any clinician licensed to prescribe medication with major changes handled by clinician with prescriptive authority who is specially trained
Child/adolescent psychiatrists
Informed Consent
(Parameters and Medical Consultation)
Initial informed consent by executive director or designee for a medication
Continued informed consent for changes in same medication at manager or supervisor level if changes are within prescribing parameters
Informed consent is always the responsibility of executive director or designee
Informed Consent
(Timelines)
Within one business day
Within the same business day
Executive director or designee participates in the informed consent discussion (in person or via conference call)
Informed Consent
(Psychiatric Emergencies)
Covered by the consent for treatment form
Emergency/"n-call" child welfare staff approve if within prescribing parameters Executive director or designee approves when outside of prescribing parameters
Authority as defined in previous column is contacted in all psychiatric emergencies
PSYCHOTROPIC MEDICATION PRACTICE: GUIDELINES AND DEFINITIONS, Continued
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Consultation with Medical Expert
When Prescription Is Not Within Prescribing Parameters
When medication doesn't "match" diagnosis
When dosages are not within recommended prescribing parameters
When polypharmacy is used without a pretrial of monopharmacy
When four or more psychotropics are used concurrently
When two or more antidepressants are used concurrently
When two or more antipsychotics are used concurrently
When two or more stimulants are used concurrently
When three or more mood stabilizers are used concurrently
For all children under 6 years old
When child has had three or more mental health hospitalizations during any one- month period.
When executive director or designee is not satisfied with the prescriber's justification for medication use
PROCEDURES
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Approvals for youth on medication Prior to
Policy/Procedure Implementation
*Identify information needed immediately at the time of screening and document the checklist data in the psychotropic medication file for each child (see Appendix 2 - Psychotropic Medication Information Checklist)
Name, age, height and weight of child
Name of behavioral health provider
Psychotropic medications, dosage, route and times
Obtain diagnostic assessment
with DSM-IV diagnosis (if available)
Obtain individualized service
plan if available
Obtain medication history (may be part of diagnostic assessment)
Obtain most recent medical doctor progress note
Documentation
Consistent filing of information in SACWIS record
Create and maintain a psychotropic medication file and spreadsheet for each child for easy access to current information
Create a Psychotropic Medication Information Checklist* that includes the following:
Child name, age, height and weight
Provider name and credentials DSM-IV Diagnosis
Symptoms addressed by prescribed medication
Risks and benefits of medication
Other interventions ordered (for example, therapy and behavioral interventions)
*Accept provider's Informed consent form if above is included.
PROCEDURES
COMPONENT
BASIC
Timelines for Medication Review and Approval Processes
· PCSA caseworker obtains Psychotropic Medication Information Checklist data and documents it in the system.*
· PCSA caseworker notifies the prescriber of agency approval process if not on "Active Provider" list (when applicable).
· PCSA caseworker ensures that the prescriber completes the Medication Authorization Form, if information is not contained within behavioral health care documents.
· PCSA caseworker reviews Agency Policy/Procedure with the out-of-home care provider; obtains and documents care provider's input regarding use of specified psychotropic medications.
· Executive director or designee establishes a process to have questions answered by the provider.
*All information is to be documented in SACWIS and on the Psychotropic Medication Information Checklist
Procedure for Youth on Psychotropics when Taken into Custody
Consider "preliminary approval" status if current medications "match" DSM-IV diagnosis and are within recommended dosage parameters.
COMMUNICATION OF INFORMED CONSENT:
· As assigned by the executive director, the PCSA caseworker or PCSA nurse (where available) notifies the caregiver to continue medication without interruption.
· The PCSA caseworker or PCSA nurse consults medical experts if there are questions or concerns about the psychotropic medication, or whenever the prescribed medication is not within recommended medication parameters.
· The PCSA caseworker or PCSA nurse submits request for executive director's or designee's authorization after all information is obtained and reviewed.
· Once initial informed consent for a medication is given by executive director or designee, the PCSA caseworker or PCSA nurse communicates the decision with the caregiver and child.
· The executive director or designee provides informed consent; the executive director or designee may choose to delegate authorization of adjustments to the caseworker or child welfare supervisor when within prescribing parameters.
· PCSA caseworker or PCSA nurse regularly monitors medication compliance and role of child and caregiver in adherence.
IF CONSENT IS NOT GRANTED:
The PCSA caseworker or PCSA nurse, as assigned by the executive director, notifies the substitute caregiver and physician of this decision.
*All information is to be documented in SACWIS and on the Psychotropic Medication Information Checklist.
PROCEDURES
COMPONENT
BASIC
Procedures for Youth Identified as Possibly Benefitting from Psychotropic Medication After Being Taken Into Custody
COMMUNICATION OF INFORMED CONSENT:
· The caseworker ensures that the prescriber provides information identified on the Medication Authorization Form and forwards (faxes or emails) it to the executive director or designee.
· Executive director or designee reviews medication recommendation and provides informed consent for the psychotropic medications to the prescriber/behavioral health provider.
· Executive director or designee communicates the decision to the PCSA caseworker.
· The PCSA caseworker communicates the final decision to the out-of-home care provider and the child.
· Out-of-home care provider fills prescription and administers medication after approval is received.
· PCSA caseworker documents the child's response to the psychotropic medications and communicates his/her response to the behavioral health provider, nurse (where available) and substitute caregiver.*
IF CONSENT IS NOT GRANTED:
· Executive director or designee contacts provider to share concerns.
· If still unable to provide informed consent following discussion with provider, executive director or designee contacts agency's medical expert.
· PCSA caseworker or PCSA nurse contacts the pharmacy if the prescription was filed electronically and informs them that consent is not given.
All required information is to be documented in SACWIS and on the Psychotropic Medication Information Checklist.
Each agency must decide whether subsequent adjustments to already approved medications require the same level of approval if within acceptable parameters.
PROCEDURES
COMPONENT
BASIC
Emergency Procedures
EACH AGENCY MUST :
· Define "psychiatric emergency." For example, a psychiatric emergency exists when a person needs to be treated by emergency healthcare providers for conditions, symptoms or behaviors that are causing or might cause a danger to self or others and/or might be related to a diagnosable behavioral health condition.
· Determine whether general phone consent for emergency treatment includes blanket consent for use of psychotropic medications as determined by an emergency room physician during the course of emergency treatment.
· Determine whether the consent for psychotropics administered during the course of emergency psychiatric care extends to any prescriptions written by the emergency room physician, and if such medications are to be administered until the child is seen by behavioral health provider on an outpatient basis.
The caseworker must obtain a list of all psychotropic medications used during the course of emergency psychiatric treatment, document them in SACWIS and on the Psychotropic Medication Information Checklist, and forward it to the executive director or designee.
Inpatient Psychiatric Episodes
Hospital Settings
EACH CHILD WELFARE AGENCY MUST DETERMINE:
· Whether a blanket emergency consent (if in policy) extends through the first 24 hours of hospitalization when a child in care is admitted for inpatient psychiatric treatment.
· Whether executive director or designee approval will be required prior to administration of psychotropic medication in hospital settings.
· How recommended medication change requests be handled at night and on weekends.
· Whether PRN medications can be approved for administration at the discretion of a registered nurse.
ORIENTATION AND TRAINING
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Who?
Substitute care child welfare caseworkers Care providers
Behavioral health prescribers
All caseworkers
Child welfare supervisors and administrators
All behavioral health providers (including non-prescribers and agency administrators)
Foster parents or other substitute caregivers
Caseworkers, supervisors and administrators
Main provider agencies
Biological parents of children in agency custody
Judges and attorneys School personnel Children
Behavioral health providers, including psychiatrists and inpatient staff
Other physicians and nurses
What?
Policy implementation procedures and use of specific forms
Description of national and local issues and results of related data analyses
Overview of commonly used psychotropics, including their intended uses, risks and benefits, and side effects, with an overview of common psychiatric diagnoses in children and adolescents.
ONGOING MONITORING AND EVALUATION
COMPONENT
BASIC
ENHANCED (Basic, Plus)
IDEAL (Enhanced, Plus)
Data to be collected, aggregated and analyzed
Approved prescriptions that exceed parameters, listed by medication, the reason why they're approved and the name of the behavioral health provider
When consent is not granted and the reason
Adverse medication reactions, including the name of the medication, dose, description of reaction and the name of the behavioral health provider
Policy/procedure feedback from providers, caseworkers, out-of- home care providers and youth
Behavioral health treatment outcomes, listed by child, behavioral health provider and service combination; this may be obtained from some providers certified by the Ohio Department of Mental Health and Addiction Services .
Data identical to that collected by the Ohio Psychotropic Medication Quality Improvement Collaborative.
Quarterly state- and county- level reports regarding the rates and types of psychotropic medication used by children in care
INFORMATION SHARING
COMPONENT
BASIC
ENHANCED
IDEAL
Information Dissemination
Releases of information specific to behavioral health provider
Memoranda of understanding among behavioral health providers working with the youth and family
Sharing of electronic health- related information among behavioral health providers working with the youth and family
Establishment and maintenance of a website that provides ready access to pertinent policies and procedures governing psychotropic medication management by clinicians, foster parents and other caregivers
Website includes psycho- educational materials, consent forms, adverse effect rating forms and reports on patterns of psychotropic medication use patterns
Appendix 2: Medication Documentation Psychotropic Medication Checklist for Youth in Care
Name of Child
Caseworker
Date of Birth
Date of Custody
Height
Weight
Medication
Dose
Route
Times
Diagnoses:
Provider:
Clinician
Phone #:
Email:
Diagnostic Assessment Obtained?
YES
NO
Not Available
Individualized Service Plan Obtained?
YES
NO
Not Available
Medication History Obtained?
YES
NO
Not Available
Most Recent Provider Progress Note Obtained?
YES
NO
Not Available
Completed by:
Date:
Last Name
First Name
DOB
Height
Weight
Medication
Dosage
Route/Times
Start Date
Stop Date
Provider
Informed Consent Y/N
PCSA
Caseworker
Appendix 3: Committee Membership
PCSAO Behavioral Health Leadership Group*
Crystal Ward Allen
PCSAO
Mary Applegate, MD Ohio Department of Medicaid
Audrey Beasley Cuyahoga County Department of Child and Family Services
Angie Blakeman Athens County Children's Services
Scott Britton
PCSAO
Suzanne Delany Ohio Association of County Behavioral Health Authorities
Kythryn Carr Hurd Franklin County Children's Services
Patricia Clements
ODJFS
Marsha Coleman Richland County Children's Services
Maureen Corcoran Vorys Health Care Advisors
Jessica Foster, MD Ohio Department of Health
Sharon Geffken Summit County Children's Services
Bridget Hoff Ashtabula County Children's Services
Karen Hughes
Ohio Department of Health
Mark Hurst, MD Ohio Department of Mental Health and Addiction Services
Terry Jones
Ohio Department of Mental Health and Addiction Services
Jennifer Justice
ODJFS
Kim Kehl
Ohio Department of Youth Services
Teresa Lampl
Ohio Association of Behavioral Health and Family Service Providers
Mark Mecum
Ohio Association of Child Caring Agencies
Pam Meermans Clark County Department of Job and Family Services
Johanna Pearce Fairfield County Department of Job and Family Services
Kate Riznyk Ashtabula County Children's Services
Daphne Saneholtz Vorys Health Care Advisors
John Saros
Summit County Children's Services
Timothy Schaffner Trumbull County Children's Services
Karen Stormann Cuyahoga County Department of Child and Family Services
Sue Williams
ODJFS
Lisa Wiltshire
ODJFS
Sue Zake
Ohio Department of Education
* With special thanks to Michael Howcroft, Jill Griffith and Margaret Scott for their expertise and individualized technical assistance with psychotropic medications and related Medicaid issues.
29
John R. Kasich, Governor State of Ohio
Cynthia C. Dungey, Director
Ohio Department of Job and Family Services
Office of Communications JFS 01682 (2/2014)
An Equal Opportunity Employer and Service Provider
Document Information
- File Date:
- 2014-05-13
- Five Year Review:
- Yes
- CSI:
- Yes
- Rule File:
- 5101$2-5-13_PH_RF_A_RU_20140513_1517.pdf
- RSFA File:
- 5101$2-5-13_PH_RF_A_RS_20140513_1517.pdf
- Related Chapter/Rule NO.: (1)
- Ill. Adm. Code 5101:2-5-13. Required agency policies, plans and procedures