FLORIDA STATE HOSPITAL STATE OF FLORIDA OPERATING PROCEDURE DEPARTMENT OF NO. 150-34 CHILDREN AND FAMILIES CHATTAHOOCHEE, October 6, 2017 Health PSYCHOTHERAPEUTIC MEDICATION PRESCRIPTION STANDARDS 1. References: a. Children and Families Operating Procedure 155-1, Guidelines for Psychiatric, Medical and Nursing Responsibilities with the Use of Psychotherapeutic Medications in State Mental Health Treatment Facilities b. Drug Facts and Comparisons c. Clinical Pharmacology: Gold Standard d. Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers e. Florida State Hospital Operating Procedure 151-23, Informed Consent and Emergency Treatment Orders for Psychotherapeutic Medications 2. General Information: For the purpose of this operating procedure, the terms “psychiatrist” and (medical/primary care) “physician” shall also mean the appropriate Advanced Registered Nurse Practitioner or Physician Assistant. a. The use of psychotherapeutic medications shall be part of an individualized comprehensive psychiatric treatment plan. b. Psychotherapeutic medications are prescribed to treat specific target symptoms; are prescribed in a graduated manner for a reasonable length of time that will allow a therapeutic response; and that they are only changed when the change can be justified and documented. Justification shall display clinical judgment supported by evidence-based or currently acceptable clinical practice. c. Prior to the initiation of any psychotherapeutic medication, an informed consent (CF Form 1630, Informed Consent for Psychotherapeutic Medications, see Attachment 1) must be obtained from the resident, guardian, or guardian advocate as appropriate; or a court order obtained. In emergency situations where an informed consent cannot be obtained, an emergency treatment order may be instituted; or treatment may be provided where it is expressly permitted by Florida Statute to treat without consent. d. All information concerning and surrounding the prescription, administration, modification or discontinuation of any medication MUST be documented along with the medical reasoning supporting that order. Documentation may be in the ‘Rationale’ section of the Physician’s Order, in the psychiatric monthly progress notes (Form 220) and/or in the ‘Indication’ section of the ‘Medication Orders’ in Health Care Systems (HCS)/electronic medical records. This Operating Procedure supersedes: Operating Procedure 150-34 dated May 6, 2016 OFFICE OF PRIMARY RESPONSIBILITY: Clinical Services DISTRIBUTION: See Training Requirements Matrix
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FLORIDA STATE HOSPITAL STATE OF FLORIDAOPERATING PROCEDURE DEPARTMENT OFNO. 150-34 CHILDREN AND FAMILIES
a. Children and Families Operating Procedure 155-1, Guidelines for Psychiatric, Medical andNursing Responsibilities with the Use of Psychotherapeutic Medications in State Mental HealthTreatment Facilities
b. Drug Facts and Comparisons
c. Clinical Pharmacology: Gold Standard
d. Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
e. Florida State Hospital Operating Procedure 151-23, Informed Consent and EmergencyTreatment Orders for Psychotherapeutic Medications
2. General Information:
For the purpose of this operating procedure, the terms “psychiatrist” and (medical/primary care)“physician” shall also mean the appropriate Advanced Registered Nurse Practitioner or PhysicianAssistant.
a. The use of psychotherapeutic medications shall be part of an individualized comprehensivepsychiatric treatment plan.
b. Psychotherapeutic medications are prescribed to treat specific target symptoms; areprescribed in a graduated manner for a reasonable length of time that will allow a therapeutic response;and that they are only changed when the change can be justified and documented. Justification shalldisplay clinical judgment supported by evidence-based or currently acceptable clinical practice.
c. Prior to the initiation of any psychotherapeutic medication, an informed consent (CF Form1630, Informed Consent for Psychotherapeutic Medications, see Attachment 1) must be obtained fromthe resident, guardian, or guardian advocate as appropriate; or a court order obtained. In emergencysituations where an informed consent cannot be obtained, an emergency treatment order may beinstituted; or treatment may be provided where it is expressly permitted by Florida Statute to treatwithout consent.
d. All information concerning and surrounding the prescription, administration, modification ordiscontinuation of any medication MUST be documented along with the medical reasoning supportingthat order. Documentation may be in the ‘Rationale’ section of the Physician’s Order, in the psychiatricmonthly progress notes (Form 220) and/or in the ‘Indication’ section of the ‘Medication Orders’ in HealthCare Systems (HCS)/electronic medical records.
This Operating Procedure supersedes: Operating Procedure 150-34 dated May 6, 2016OFFICE OF PRIMARY RESPONSIBILITY: Clinical ServicesDISTRIBUTION: See Training Requirements Matrix
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e. The physician will monitor and document the use of psychotherapeutic medication;documentation shall be in the psychiatric progress notes that shall be completed at least monthly andwhenever there is a change in the resident's status. Documentation shall include assessment of theresident and the effect(s) and side effects of the psychotherapeutic medication.
f. The physician will document discussion of the risks and benefits of psychotherapeuticmedication treatment with the resident or his/her legal representative and their perspective(s) regardingtreatment and their progress in achieving the goal.
g. Health Care Systems (HCS) is the facility’s newly implemented electronic medical recordssystem.
For the purpose of Florida State Hospital, all Informed Consents for PsychotherapeuticMedications shall list each medication in its generic name, include all forms available (i.e., oral,intramuscular) and ‘up to’ the recommended maximum dose.
h. For all resident internal transfers (within Florida State Hospital):
(1) It is the transferring psychiatrist’s responsibility to ensure that all psychotherapeuticmedications have a valid Informed Consent or Court approval.
(2) All continued medications shall be electronically reviewed and reordered in ‘HCSClinicals.’
(3) For residents on a ‘24/48-Hour Observation’ status in MSU/ER, the MSU/ERphysician may indicate “continue unit medications” in ‘HCS Clinicals’ with the changes if indicated (e.g.add, increase, decrease, discontinue or hold).
(4) For residents discharged back to home unit from MSU: After regular work hours,weekends and holidays, the MSU/ER physician shall indicate “continue home unit medications” in theHCS Clinical with the changes if indicated (e.g. add, increase, decrease, and discontinue).
(5) For Full Admits to Medical Service Unit, the MSU physician shall electronicallytransfer (i.e., ‘continue) home medications in ‘HCS Clinicals’ and additional changes such as newmedical and psychiatric orders as indicated.
i. ‘Discontinue previous orders’ in addition to words such as “increase, decrease, change, add,”etc. shall be used in writing medication orders to improve the clarity of the order and help to ensureaccuracy. The physician shall ‘discontinue the previous order’ when a new order is given for a changedifferent form or strength.
j. Laboratory baseline tests and monitoring shall be ordered and completed as recommended inthe Psychotherapeutic Medication Prescription Monitoring Guidelines. Laboratory reports will bereviewed, dated, and signed by a physician prior to filing in the medical record. One signature by aphysician may suffice; however, for laboratory results that are primarily medical in nature, as in Cultureand Sensitivity or Prostate-Specific Antigen (PSA), etc., the ’medical’ physician shall sign. Forlaboratory tests that psychiatrists order, i.e., Clozaril complete blood count (CCBC) or lithium levels, thepsychiatrist shall sign.
k. Laboratory staff will immediately report any critical Lab values to the Dorm Nurse by phone, inaddition to the hard copy to the appropriate Attending Physician. (Please refer to Florida State HospitalGuidelines/Procedures on Critical Values Reporting.)
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l. Side effects/adverse effects shall be identified and managed by the physician. Persistent sideeffects will be added to the resident’s problem list and management of persistent side effects will bemonitored at least monthly by the recovery team. Adverse or side effects of psychotherapeuticmedications must be described, identified, and their management documented. Adverse drug reactionsand allergies to medications must be reported by completing the Adverse Drug Event Report (ADER)and following FSHOP 151-24 Adverse Drug Reaction (ADRs) and Allergies to Medications.
m. For the purpose of this procedure:,
(1) Side effects are defined as actions or effects of a drug other than the therapeuticeffect it is prescribed for, whether it is intrinsically harmful or not. Some side effects may be commonand/or minor annoyances and may go away when the drug is discontinued; some may be rare, serious,or potentially life threatening. Serious side effects are called adverse drug reactions.
(2) An adverse drug reactions (ADR) is a serious, undesired or unexpected side effect,including an allergy, toxicity or even death. The onset may be sudden or take days to develop.Adverse drug reactions may require discontinuation of the medication, modification of the dosage,hospitalization, and/or supportive treatment.
(a) Adverse drug reactions carry a special reporting requirement on FSH Form160, Adverse Drug Reaction Report.
(b) All adverse reactions are to be reported to Florida State Hospital Risk Management.
(3) Team members, nurses, and direct care staff will receive annual competency basedtraining to identify potential side effects and Adverse Drug Reactions of psychotherapeutic medications.
n. The preferred dosage form for administration is the tablet or capsule. Liquid and depot formsare prescribed to ensure compliance or when the resident has swallowing difficulties. A resident on anoral disintegrating or liquid formulation shall be re-evaluated by the prescribing psychiatrist and therationale for their continued use shall be documented in the psychiatrist’s monthly progress notes or inthe ‘Rationale’ section on the Physician’s Order form.
o. A resident on two (2) or more atypical antipsychotics shall be evaluated by the psychiatristand a rationale for the continuance of current regimen shall be documented in the psychiatrist’s monthlyprogress note.
p. A number of residents’ records will indicate “allergy” to specific medications. It is important todistinguish a true allergy, a side effect or a hypersensitivity to the drug, or a mere dislike of a particularmedication.
q. The ‘routine’ use of anticholinergics and anti-Parkinson medications is discouraged for thefollowing reasons:
(1) They worsen symptoms of schizophrenia and worsen cognitive impairment.
(2) They lower the effective levels of antipsychotic drugs; they delay the neurolepticeffect.
(3) They do not alleviate the symptoms of tardive dyskinesia; in some instances, mayaggravate and/or increase the risk of tardive dyskinesia.
(4) Constipation is common and in this population, may lead to severe gastrointestinalcomplications including bowel obstruction.
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(5) They increase the risk of hyperthermia, blurred vision, dry mouth, and urinaryretention.
r. While on psychotherapeutics, and unless specifically ordered by the attending physician:
(1) Food products containing caffeine shall be restricted.
(2) Personal supplies of nutrients, vitamins and similar products is not allowed.
s. Except for Specialty Care Unit Dorm A where the therapeutic response to thepsychotherapeutic medication must be reviewed and documented weekly for eight (8) weeks aftertreatment is initiated, changed, or added, and monthly thereafter; all other units shall document weeklyfor four (4) weeks, and monthly thereafter.
t. “Clozaril Clinic”, which consists of the appropriate Medical Service Director, clinical pharmacistand a nurse representative, will be responsible for reviewing the appropriateness of therapy and assistthe psychiatrist in the management of residents on clozapine and issues arising from the use ofclozapine. The results of the pre-Clozaril workup and a referral to the “Clozaril Clinic” will be submittedto the Pharmacy by the treating psychiatrist.
u. On admission, a baseline Abnormal Involuntary Movement Scale (AIMS) Evaluation shall becompleted; then quarterly on individuals receiving 1st generation antipsychotics and semi-annually onindividuals receiving atypical antipsychotics, including clozapine. The completed AIMS evaluation isfiled in the Psychotherapeutic Section of the dorm chart.
v. Antipsychotics Switch/Transition: When residents are transitioned from one antipsychotic toanother, a transition dosing may be prescribed as clinically appropriate or in some cases bothmedications may be maintained until stabilization occurs. Generally, the original agent should betapered slowly and safely, as tolerated, to prevent decompensation; however, in certain circumstancesthe transition/switch may need to be quicker or immediate.
w. Upon discharge from the hospital, a resident may receive up to a thirty-day supply ofmedications or hard copy prescription in some cases may be provided in place of a supply ofmedications.
3. Background: State of the Art. Contemporary standards require that the utilization of medications bemanaged in a prudent manner that is consistent with the current state of the art. Drug Facts andComparisons and Clinical Pharmacology: Gold Standard is nationally accepted, periodically updated,compendia and will constitute our contemporary standards.
The American Psychiatric Association states, “Given the current state of knowledge, it is our opinionthat the new generation of antipsychotic medications (except clozapine) need to be made available asfirst-line treatments for appropriate individuals throughout all systems of care.”
4. Pro Re Nata (PRN) Order. Pro Re Nata (PRN) Order is an individualized treatment order based onthe presence of predetermined specific criteria established by the prescribing practitioner which isadministered by the nurse who has, by means of an assessment, determined the need for themedication.
There will be NO standing orders or pro re nata (PRN) orders for psychotherapeutic medications.
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5. The Psychotherapeutic Medication Treatment Plan. A treatment plan developed after evaluation ofthe resident by the psychiatrist. This plan includes specific psychotherapeutic medications, dosages,frequency of administration, target symptoms for each psychotherapeutic medication ordered andexpected outcomes. The Psychotherapeutic Medication Treatment Plan is part of the monthlypsychiatric progress note (Form 220).
6. Medication Exception Request (MER) (CF Form 1582, see Attachment 3). A standardized systemfor providing exception for use of psychotherapeutic medications beyond standards identified innationally recognized pharmacology compendia such as “Drug Facts and Comparisons”; based onacceptable practice in current literature; and approved by the facility’s Pharmacy and TherapeuticsCommittee.
a. Medication Exception Request is not needed when:
(1) Unlabeled use of a medication is recognized as acceptable practice in currentliterature and has been approved by the facility’s Pharmacy and Therapeutics Committee to be exemptfrom the Medication Exception Request process.
(2) The switch/transition from one atypical antipsychotic medication to another atypicalantipsychotic medication is completed within thirty (30) days.
b. A Medication Exception Request is required when:
(1) The dose of the medication ordered is above the recognized range as stated innationally recognized pharmacology compendia relative to indication for use and specific population.For atypical antipsychotic medication dose variances, the following daily doses will be utilized asrecommended by the Medical Executive Directors of the state facilities: Abilify > 30; Abilify Maintena˃400 mg/month IM; Clozaril > 900; Fanapt > 24; Geodon > 240; Invega ˃ 12 mg, Invega Sustenna > 234; Latuda > 160; Risperdal > 8, or > 16 for schizophrenia spectrum disorders; Risperdal Consta ˃ 37.5 mg IM; Saphris > 20; Seroquel > 800; Symbyax > 18/75); Zyprexa > 30; and Zyprexa Relprevv ˃ 300 mg/2 weeks or ˃ 405 mg/4 weeks. (Recommended dose is 300 mg per 2 weeks or 405 mg per 4 weeks.)
(2) The prescription is an unlabeled use for that particular medication (e.g. use ofLamictal for weight loss), unless the unlabeled use is recognized as acceptable practice in currentliterature and has been approved by the facility’s Pharmacy and Therapeutics Committee to be exemptfrom the Medication Exception Request process.
(3) The psychotherapeutic medication is not on the individual facility’s formulary.
(4) The psychotherapeutic medication regimen consists of:
(a) Five (5) or more psychotherapeutic medications (long acting antipsychoticinjections and oral doses of the same drug count as one);
(b) Three (3) or more antipsychotic medications;
(c) Three (3) or more mood stabilizers;
(d) Two (2) or more atypical antipsychotics. A Medication Exception Request isnot needed if the resident is being transitioned from one atypical antipsychotic to another atypicalantipsychotic, and the transition does not last longer than thirty (30) days.
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c. Exceptions to this procedure shall be granted by the Medical Executive Director or designee,on the basis of the clinical needs of the resident, the medical justification for the proposedpsychotherapeutic regimen, acceptable clinical practice, and after consideration of risks and benefits.
d. Medication Exception Requests will be reviewed and processed in as expedient a manner aspossible. However, this procedure does not preclude the physician’s prerogative or responsibility totreat residents with an appropriate regimen while awaiting Medication Exception Request approval.
e. Submission and disposition of requests:
(1) Medication Exception Requests including clear explanation/rationale/justification forthe request, will be completed by the physician, reviewed by a clinical pharmacist and reviewed by theMedical Executive Director for final disposition.
(2) Medication Exception Requests screened out or disapproved will be returned to thephysician with recommendations for reconsideration.
f. Override--This is an auxiliary mechanism which allows the on-duty physician to temporarilyoverride the provisions of this procedure, so that the urgent needs of residents will not be unnecessarilydelayed. This procedure only applies to prescriptions by the on-duty physician. A MedicationException Request form will be completed by the prescribing/on-duty physician and reviewedretrospectively by the Medical Executive Director or designee on the next regular workday, which mustbe within 72 hours (except Thanksgiving holiday weekend which must be within 96 hours).
7. Psychotherapeutic Medication. Any drug prescribed with the primary intent to stabilize or improvemood, mental status, behavioral symptomatology, or mental illness. The medications include, but arenot limited to the following major categories:
a. Antipsychotics
b. Antidepressants
c. Anxiolytics
d. Mood stabilizers
e. Cerebral or psychomotor stimulants
f. Other medications commonly used which may include, but are not limited to beta blockers,anticonvulsants, antihistamines, and opiate blockers. These medications will only be consideredpsychotherapeutic medications when used to stabilize or improve mood, behavior, or mental illness, orto induce sleep.
g. Cognitive enhancers and medications used solely for the treatment of dementia shall not beconsidered psychotherapeutic medications and shall not require an informed consent.
h. Diphenhydramine and melatonin, being over the counter medications, shall be specificallyexcluded from the requirements for psychotherapeutic medications when used for sleep.
8. Intramuscular Psychotherapeutic Medication:
a. The use of rapid-onset, intramuscular (IM) psychotherapeutic medications may be employedonly when the resident is doing poorly AND after oral route of administration and behavioral
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interventions have been carefully considered and deemed inadequate/insufficient for the resident’simmediate needs.
For continued oral medication refusals, the psychiatrist will discuss with the individual and therecovery team and a plan to address this concern will be included in the Recovery Plan.
b. When a rapid-onset, intramuscular (IM) psychotherapeutic medication order is needed:
(1) The physician will clearly define and document the parameters/specific criteria forwhich the medication may be administered, the frequency of administration and the duration of theorder.
(2) The IM order will be time limited not to exceed seven (7) days and with an approvedMER.
(3) The administering nurse will document in a progress note, their assessment of theindividual, specific parameters/behavioral criteria observed, the time of administration, and the effect ofthe medication on the individual’s presentation/symptoms.
c. If an individual withdraws consent for an oral medication, continued consent from theindividual for the IM route shall be confirmed and documented by the administering nurse each time theoral medication is refused. In an emergency situation, an Emergency Treatment Order (ETO) can beutilized if there is an imminent and substantial risk of danger to the individual or others.
d. The use of rapid onset IM psychotherapeutic medications, including patterns and trends ofuse, will be reported to the Pharmacy and Therapeutics Committee for review and inclusion in thequarterly psychotherapeutic medication review report.
9. Liability. The physician is the responsible professional in prescribing psychotherapeutic medications.The Florida Statute (F.S. 768.45) directs these professionals to be prudent. The principles of ethics ofthe American Medical Association instruct these professionals to seek assistance in all cases of doubtor difficulty. It is very strongly suggested that all physicians follow the procedures closely, requestreview by the Medical Service Director(s) when indicated, and utilize the Medication Exception Requestto advise, protect and assist.
10. Additional Protection. In addition to the protections offered by the Medication Exception Request,the external peer reviewer and internal Medical Staff Peer Review are separate review processes thatexamine the broad scope of medical management. These additional protections will best serve theresident if all staff members participate in and utilize the processes fully and in a timely manner.
a. Internal monitoring will be completed by the Pharmacy and Therapeutics (P&T) Committeeand Quality Improvement processes.
b. The Program Office Facility Section will monitor the facility’s progress, provide technicalassistance when requested by the facility, validate corrective actions should external reviews indicate aneed for follow-up of identified concerns, and facilitate and maintain contemporary Department clinicalpolicies, procedures, and protocols.
11. The Pharmacy and Therapeutics (P&T) Committee. An advisory group that considers all mattersrelated to the use and safe handling of medications in a facility. When necessary, they shall develop,review, and update all procedures or guidelines relating to psychotherapeutic medications. Thecommittee shall further make periodic review of psychotherapeutic medication selection and usage;shall analyze the Medication Exception Request forms (CF Form 1582) and shall offer generalsurveillance of psychotherapeutic medications. In addition to the general support in the proper, safe
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and cost effective utilization of psychotherapeutic medications as described above, the Pharmacy andTherapeutics Committee will also, on a continuing basis, review and keep updated the attachmentswhich form part of this procedure. This committee is composed of physicians, pharmacists and otherhealth care professionals and essential staff selected according to the Florida State HospitalProfessional Clinical Staff Bylaws, Rules and Regulations.
12. Common Clinically Significant Medication Interactions:
a. Medication and Substances Interacting with Antipsychotics:
(1) Anticholinergics—delay neuroleptic effect, worsening of schizophrenic symptoms;worsening of cognitive impairment, increase risk of hyperthermia, tardive dyskinesia, blurred vision, drymouth, constipation, urinary retention
(6) Epinephrine—augments hypotension, phenothiazines may reverse the action ofepinephrine
(7) Alcohol—may potentiate, alter or obscure effects of psychotherapeutics, i.e., additiveCentral Nervous System (CNS) depression, extrapyramidal syndrome (EPS)
(8) Serotonin Reuptake Inhibitors—increase the chance of extrapyramidal syndrome(EPS), do not use with Tegretol® or monoamine oxidase (MAO) Inhibitor
(9) Lithium—may induce disorientation, unconsciousness, and extra-pyramidalsyndrome (EPS)
(10) Methyldopa—combination may produce psychosis, and may produce elevations inblood pressure
(11) Propranolol—may result in increased plasma levels of both drugs, hypotensiveepisode
(12) Phenytoin—may increase or decrease phenytoin levels
(13) Valproic Acid—clearance may be decreased increasing toxicity
b. Medication Interaction with Antidepressants: (monoamine oxidase inhibitors (MAOIs) interactextensively with food and other drugs)
(4) Theophylline—effects of both drugs may be decreased
(5) Serotonin Reuptake Inhibitors—may result in a toxic serotonin syndrome
13. Use of Clozaril® (Clozapine):
a. Florida State Hospital will comply with any national data gathering and reporting systemrequired by the manufacturing company.
b. Clozapine is indicated for treatment-resistant schizophrenia; and in the reduction in the risk ofrecurrent suicidal behavior in schizophrenia or schizoaffective disorders.
c. Clozapine is contraindicated in patients with previous hypersensitivity to clozapine or anyother component of this drug, in patients with myeloproliferative disorders, uncontrolled epilepsy,paralytic ileus, or a history of severe neutropenia or clozapine-associated severe neutroppenia, or insevere central nervous system depression or comatose states from any cause.
d. Clozapine should be used with extreme caution when prescribed simultaneously with otheragents having a known potential to suppress bone marrow function.
e. Residents admitted on clozapine shall be continued on their current dose of medication solong as the last dose received has not exceeded 48 hours and the laboratory data is current andacceptable. Re-initiation after discontinuance of 48 hours or more requires restarting dose at Day 1.
f. Guidelines to the use of clozapine: Prior to prescribing clozapine at Florida State Hospital:
(1) The Psychiatrist will submit a consultation to the ‘Clozaril Clinic’ (thru Pharmacy)along with copies of the most current Monitoring of Side Effects Scale (MOSES) – completed by anurse, and most current Abnormal Involuntary Movement Scale (AIMS) Examination & Rating –completed by a psychiatrist.
(2) The ‘Clozaril Clinic’ shall meet with the referring psychiatrist to:
(a) Discuss appropriateness for clozapine treatment and ensure that eachcandidate for clozapine therapy fully meets pre-established indicators/’criteria’ in compliance with theFood and Drug Administration's approved labeling.
(b) Review resident’s most recent Clozaril pre-treatment laboratory work-up andcoexisting medical conditions if any; and
(c) Discuss any complications regarding dosing strategies. Residents shall bereviewed in ‘Clozaril Clinic’ prior to exceeding 600mg/day and every six (6) months thereafter.
(3) Current oral antipsychotic medication(s) shall be carefully weaned off with an overlapin clozapine therapy when clinically appropriate. If possible, the overlap shall begin during theworkweek (Monday-Thursday) as an extra precautionary measure in case any adverse effects occurfrom the initiation of clozapine therapy.
(4) Current depot antipsychotics shall be switched to the oral form of the medication priorto the initiation of clozapine.
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(5) Daily dosing of clozapine should be in increments of 25 to 50 mg/day, if well toleratedto achieve a target dose of 300 to 450 mg/day by the end of 2 weeks. Subsequent dose incrementsshould be made no more than once or twice weekly, in increments not to exceed 100 mg.
(6) Cautious titration and a divided dosage schedule are necessary to minimize the risksof hypotension, seizure and sedation. Daily doses greater than 450 mg may require three times daily(TID) dosing.
(7) Dosing should not exceed 900 mg/day because of the increased risks of adverseeffects.
(8) Dosage initiation and schedule recommendation is as follows:
Week I AM (mg) HS (mg) Week 2 AM (mg) HS (mg)
Day 1 12.5 qd or BID Day 8 50 100
Day 2 25 --- Day 9 100 100
Day 3 25 25 Day 10 100 100
Day 4 25 50 Day 11 50 200
Day 5 50 50 Day 12 50 200
Day 6 50 75 Day 13 100 200
Day 7 50 100 Day 14 100 200
(9) Maintenance treatment for responding patients shall be continued at the lowesteffective dose to maintain remission.
(10) Re-initiation of clozapine treatment:
(a) Restart of clozapine after discontinuance of 48 hours or more requiresrestarting the dose titration at Day 1.
(b) If the dose at Day 1 is well tolerated, it may be feasible to titrate patients backto a therapeutic dose more quickly than is recommended for initial treatment except in cases withprevious severe adverse reactions during initial treatment.
(11) Monitoring while on clozapine:
(a) An Informed Consent must include a discussion with the resident/legalrepresentative regarding clozapine information along with the monitoring mandate (blood tests); andshould these requirements be unmet, the medication will have to be discontinued.
(b) Each resident receiving clozapine will be evaluated by a Psychiatrist andprogress notes shall be completed at least monthly and whenever there is a change in the resident'sstatus. Documentation shall include assessment of the resident’s response to treatment and theeffect(s) and side effects of clozapine, if any.
(c) The Medical Executive Director or designee will be responsible for registeringthe resident with the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program.
(d) The Laboratory will promptly report critical lab values to the Nurse by phoneso that timely medical interventions can be instituted.
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(e) The drug protocol for regular monitoring will include, but not be limited to,hematological, cardiovascular, neurological, hepatic, gastrointestinal and urinary functioning, and mustbe implemented according to Clinical Management Guidelines.
(f) The Recommended Monitoring Frequency and Clinical Decisions by ANCLevel is based on the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program as follows:
ANC Level Treatment Recommendation ANC Monitoring
Normal Range for a NewPatient
GENERAL POPULATION
ANC ≥ 1500/ µL
BEN POPULATION
ANC ≥ 1000/ µL Obtain at least 2 baselineANC levels before initiatingtreatment
Initiate treatment If treatment interrupted: < 30 days, continue monitoring as before ≥ 30 days, monitor as if new patient
Discontinuation for reasons other thanneutropenia
Weekly from initiation to six months Every 2 weeks from 6 to 12 months Monthly after 12 months
Mild Neutropenia
(1000 - 1499/µL)*
GENERAL POPULATION
Continue treatment
GENERAL POPULATION
Three times weekly until ANC ≥ 1500/µL Once ANC ≥ 1500/µL return to patient’s last “Normal Range” ANC monitoringinterval if clinically appropriate
BEN POPULATION
Mild Neutropenia is normal range for BENpopulation, continue treatment Obtain at least two baseline ANC levels beforeinitiating treatment If treatment interrupted: < 30 days, continue monitoring as before ≥ 30 days, monitor as if new patient
Discontinuation for reasons other thanneutropenia
BEN POPULATION
Weekly from initiation to six months Every 2 weeks from 6 to 12 months Monthly after 12 months
Moderate Neutropenia
(500 - 999/µL)*
GENERAL POPULATION
Recommend hematology consultation Interrupt treatment for suspected clozapine-induced neutropenia Resume treatment once ANC normalizes to ≥ 1000/µL
Daily until ANC ≥ 1000/µL then Three times weekly until ANC ≥ 1500/µL Once ANC ≥ 1500/µL check ANC weekly for 4 weeks, then return to patient’s last“Normal Range” ANC monitoring interval ifclinically appropriate
BEN POPULATION
Three times weekly until ANC ≥ 1000/µL or ≥ patient’s known baseline Once ANC ≥ 1000/µL or patient’s known baseline, check ANC weekly for 4 weeks,then return to patient’s last “Normal Range”ANC monitoring interval if clinicallyappropriate
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Severe Neutropenia
(<500/µL)*
GENERAL POPULATION
Recommend hematology consultation Interrupt treatment for suspected clozapine-induced neutropenia DO NOT RECHALLENGE unless prescriberdetermines benefits outweigh risks
BEN POPULATION
Recommend hematology consultation Interrupt treatment for suspected clozapine-induced neutropenia DO NOT RECHALLENGE unless prescriberdetermines benefits outweigh risks
GENERAL POPULATION
Daily until ANC ≥ 1000/µL Three times weekly until ANC ≥ 1500/µL If patient is re-challenged, resumetreatment as a new patient under “NormalRange” ANC monitoring once ANC ≥ 1500/µL
BEN POPULATION
Daily until ANC ≥ 500/µL Three times weekly until ANC ≥ patient’s established baseline If patient is re-challenged, resumetreatment as a new patient under “NormalRange” ANC monitoring once ANC ≥ 1000/µL or at patient’s baseline
* Confirm all initial reports of ANC less than 1500/µL (ANC < 1000 ANC for BEN patients) with a repeat ANC measurementwithin 24 hours.
(12) Leave Of Absence (LOA) while on clozapine:
(a) Community liaisons/case managers shall contact a local community mentalhealth facility or a local health laboratory to do the required blood work as part of clozapine monitoringprotocol. These arrangements must be made and documented prior to the resident on Leave ofAbsence. Florida State Hospital Pharmacy Department requires a copy of the laboratory report byTuesday of each week.
(b) Residents may be allowed up to a 30-day supply of clozapine when theirleave begins depending upon the required laboratory monitoring schedule. If the leave extends beyondthe resident's supply of medication, a new supply will be mailed overnight pending compliance ofmonitoring requirements and following receipt of most recent blood work.
(c) Residents admitted to community hospitals may take up to a 14-day supply ofclozapine. The community hospital shall be responsible for abiding by the monitoring requirements andproviding Florida State Hospital with a copy of the laboratory results each time. If needed, a newsupply will be mailed overnight pending compliance of monitoring requirements and following receipt ofmost recent blood work.
(13) Discharge of Resident on Clozapine:
(a) Community liaisons/case managers shall participate in the pre-discharge anddischarge planning to help ensure compliance with treatment and monitoring requirements.
(b) The Psychiatrist must notify the Medical Service Director and a ClinicalPharmacist as soon as the Recovery Team is preparing to discharge a resident on clozapine.
(c) The Recovery Team will document in the resident’s Discharge Plan who andwhere in the community, will be treating the monitoring the resident on clozapine.
(6) salivation – trihexyphenidyl (Artane®), benztropine (Cogentin®), or clonidine(Catapres®) patch
(7) seizure - reduce clozapine dose by half and institute Valproic Acid/Divalproex
(8) hypertension - beta blocker (atenolol)
(9) weight gain - consult with Food Services Department
IN ALL CASES OF DOUBT, GET A SECOND OPINION
14. Use of Intramuscular (I.M.) Ativan® (lorazapam) in Psychiatric Emergencies:
a. An emergency treatment order may be instituted in the following cases:
(1) severe agitation in a resident who is at imminent risk for injury to self or others, andfor whom oral form of medication is refused, or impractical or will not provide the needed immediateeffects; or
(2) severe agitation in a resident requiring a life-saving or necessary medical, diagnosticor treatment procedure.
b. It is NOT to be used to substitute for behavioral programs; as a punishment; to suppresspersonality-related behavior; for the convenience of the staff; or for experimental purposes.
c. Sedation usually lasts an average period of four hours.
d. Dosage administration must be consistent with Drug Facts and Comparisonsrecommendation as follows:
(1) A dose of 0.05 mg/kg of body weight up to a maximum of 4mg per dose.
(2) One to 2mg as the starting dose for debilitated residents.
15. Use of Intramuscular (I.M.) Geodon® (ziprasidone) in the Management of Acute AgitationAssociated with Psychosis:
a. DO NOT administer Geodon oral or IM if the QTc interval is greater than 500 milliseconds(msec.)
b. Reassess the resident two (2) hours post 10mg IM injection and 4 hours post 20mg IMinjection.
c. In the event the IM dose is administered and the next scheduled oral dose of Geodon is due,wait at least one (1) hour after the injection before administering the scheduled oral dose of Geodon.
October 6, 2017 FSHOP 150-34
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d. The maximum dose of Geodon IM is 40mg/day; 20mg IM per injection (except for elderly andmedically-compromised individuals where a 10mg IM dose may be given) for up to 3 days.
e. A Medication Exception Request (MER) will be required if an additional 20mg IM injection isneeded (i.e., three-20mg IM injections/day); or when a resident requires treatment beyond 3 days.
f. Geodon IM may be given for the refusal of any atypical or typical oral antipsychotic agent, withthe exception of thioridazine (Mellaril®), mesoridazine (Serentil®), and chlorpromazine(Thorazine®).
g. When Geodon IM is used for Geodon oral refusal, the total Geodon oral dose for that dayshall not exceed 120mg/day.
16. Use of Intramuscular Zyprexa® (olanzapine) for the Management of Acute Agitation Associatedwith Schizophrenia and Bipolar Mania:
a. Use caution while using Zyprexa IM with Ativan IM due to a potential increase in somnolenceand respiratory depression.
b. After reconstituting the vial, the injection must be given immediately or up to one (1) hourfollowing reconstitution.
c. The entire reconstituted Zyprexa IM 10mg vial shall be administered (elderly, the medically-compromised and any resident unable to tolerate this dose are excluded).
d. If subsequent IM Zyprexa is/are necessary, the second injection shall be administered after atleast two (2) hours post initial injection; and a third IM Zyprexa shall be administered after at least four(4) hours post second injection.
e. In the event IM Zyprexa is administered and the next scheduled oral dose is due, wait at leastone (1) hour and observe the resident for side effects such as drowsiness and dizziness. If these sideeffects are observed, the next scheduled oral dose should be held.
f. Zyprexa IM may be given for the refusal of any atypical or typical oral antipsychotic agent.
17. Use of Divalproex/Valproic Acid (Valproate):
a. Hepatic fatalities generally occur within the first 3-6 months.
b. Monitor plasma levels of valproate.
(1) A rising level of liver enzymes after three (3) consecutive measurements plus clinicalsigns and symptoms of hepatic dysfunction are indications to discontinue valproate.
(2) Increased ammonia levels may be early signs of liver toxicity. The manufacturerrecommends discontinuation of valproate if clinically significant signs and symptoms of elevatedammonia levels occur.
c. Use valproate with caution in residents with the following:
(1) pre-existing liver disease;
(2) family history of childhood hepatic disease;
October 6, 2017 FSHOP 150-34
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(3) or if resident is receiving other medications that may be potentially hepatotoxic.
d. Avoid concomitant administration with salicylates or topiramate.
e. Therapeutic plasma levels are:
(1) For Seizure disorder: 50-100mcg/ml
(2) For Bipolar disorder: 50-125mcg/ml
18. Use of Stimulants:
a. Two (2) FDA-approved indications Attention Deficit/Hyperactivity Disorder and Narcolepsy.
b. Other uses of stimulants are:
(1) to potentiate the action of antidepressant medications;
(2) for HIV-or AIDS-related affective syndromes; and
(3) severe lethargy and psychomotor retardation.
c. Administer stimulants at the lowest effective dosage and adjust individually. Be mindful of itsabuse potential and resulting insomnia.
d. Stimulants are metabolized in the liver.
e. Contraindications: advanced arteriosclerosis; symptomatic cardiovascular disease; moderateto severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to thesympathomimetic amines; glaucoma; agitated states; history of drug abuse; during or within 14 daysfollowing administration of MAO inhibitors (hypertensive crises may result).
f. Adverse Reactions: more common are: palpitations, tachycardia, increased blood pressure,decrease in heart rate, arrhythmias, restlessness, dizziness, insomnia, dyskinesia, euphoria, dysphoria,tremor, headache, dry mouth, unpleasant taste, diarrhea, constipation, anorexia, weight loss, urticaria,and impotence.
g. Abrupt cessation following prolonged use in high doses may result in extreme fatigue,depression, and changes in sleep EEG.
h. Amphetamines may exacerbate psychotic symptoms, tics and Tourette’s syndrome.
19. Metabolic Monitoring: See separate Metabolic Syndrome Information sheet (Attachment 4). Pleaseprovide the resident with a copy.
20. Training Requirements: A check in the box below indicates which employees within the departmentare required to read this operating procedure and when they will receive training at Florida StateHospital. Employees within identified departments will also be required to review the policy each time itis updated.
October 6, 2017 FSHOP 150-34
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DepartmentWorksite
Education
NewEmployeeOrientation
DisciplineSpecificTraining
AnnualUpdate
All EmployeesClerical/Administrative SupportDentalDieticians, Laboratory, SpecialTherapy, X-Ray Techs
Signed Original on file in Quality Improvement Program
ROBERT QUAM Attachments:Chief Hospital Administrator 1. Florida State Hospital Psychotherapeutic
Medication Dosage Guide2. Metabolic Syndrome Information Sheet3. Psychotherapeutic Medication Prescription
Standards Laboratory Testing
SUMMARY OF REVISED, ADDED OR DELETED MATERIAL
This policy was revised to include the new process of electronic medical records (Health Care Systems/ ‘HCS Clinicals’). The guidelines from the Clozapine Risk Evaluation and Mitigation Strategy (REMS)were updated.
Florida State HospitalPSYCHOTHERAPEUTIC MEDICATION DOSAGE GUIDE
REFERENCESFacts and Comparisons Drug InformationClinical Pharmacology
LAMICTAL Escalation Regimen* for Bipolar DisorderFor Patients Not Taking Carbamazepine,Phenytoin, Phenobarbital, Primidone, or
Rifampin and Not Taking ValproateFor Patients Taking Valproate
For Patients Taking Carbamazepine, Phenytoin,Phenobarbital, Primidone, or Rifampin and Not
Taking ValproateWeeks 1 and 2 25mg daily 25mg every other day 50mg dailyWeeks 3 and 4 50mg daily 25mg daily 100mg daily, in divided dosesWeek 5 100mg daily 50mg daily 200mg daily, in divided dosesWeek 6 200mg daily 100mg daily 300mg daily, in divided dosesWeek 7 200mg daily 100mg daily Up to 400mg daily, in divided doses*To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of LAMICTAL should not be exceeded.
Adjustments to LAMICTAL Dosing for Patients with Bipolar DisorderFollowing Discontinuation of Psychotherapeutic Medications
Discontinuation of Psychotherapeutic Drugs(excluding Carbamazepine, Phenytoin,Phenobarbital, Primidone, Rifampin, or
Valproate
After Discontinuation of ValproateAfter discontinuation of Carbamazepine,Phenytoin, Phenobarbital, Primidone, or
RifampinCurrent LAMICTAL dose (mg/day)
100Current LAMICTAL dose (mg/day)
400Week 1 Maintain current LAMICTAL dose 150 400Week 2 Maintain current LAMICTAL dose 200 300Week 3 ondorm Maintain current LAMICTAL dose 200 200REFERENCE: LAMICTAL Prescribing Information
Attachment 1Page 5 of 5
Operating Procedure 150-34
Florida State HospitalMETABOLIC MONITORING
GOAL: To Minimize Metabolic Risks and Improve Patients' Overall Health
Height (m.) x Height (m.) ≥ 50mg/dL in women Normal triglycerides < 150 mg/dL
For people who develop worsening glycemia ordyslipidemia while on antipsychotic therapy, the panelrecommends considering switching to an atypicalantipsychotic that has not been associated with significantweight gain or diabetes. Consensus DevelopmentConference on Antipsychotic Drugs and Obesity andDiabetes.J Clin Psychiatry 2004; 65(2):270.
Atypical Antipsychotic Agents' Risk of Metabolic Abnormalities
Tier 1. Abilify or Geodon →No association Tier 2. Risperdal or Seroquel →Discrepant results for metabolic riskTier 3. Zyprexa or Clozaril →Increase effect for metabolic risk If the patient has 1 or more of the 7 metabolic risk factors, start with a Tier 1 atypicalantipsychotic agent until failure, then proceed to a Tier 2 atypical antipsychotic agent untilfailure before proceeding to a Tier 3 atypical antipsychotic agent.
Attachment 2Page 1 of 2
Operating Procedure 150-34
METABOLIC SYNDROME INFORMATION SHEET
What is metabolic syndrome?
Metabolic Syndrome is a combination of medical conditions of the body’s metabolism that increases the risk ofheart disease, stroke, and diabetes. Having Metabolic Syndrome means you have several of these medicalconditions occurring at the same time. These conditions can include:
Over-weight, especially around the waist (greater than 40 inches for men and greater than 35inches for women). Some call this having an “apple shape” or a “pot belly”. Elevated level of blood fat called triglycerides (blood level of 150 mg/dl or more). Low level of high-density lipoprotein (HDL) cholesterol (levels below 40mg/dl or men and below50mg/dl for women). HDL cholesterol is known as the “good” cholesterol. Elevated blood pressure of 130/85 mm Hg or higher. Resistance to insulin, a hormone that helps to regulate the amount of sugar in your body. This isalso known as pre-diabetes (fasting blood sugar between 100 and 125 mg/dl). Type II Diabetes (afasting blood sugar greater than 125 mg/dl) is a greater concern.
Having just one of these conditions would not result in a diagnosis of metabolic syndrome but it would contributeto your risk of having a serious illness. And, if you have one condition, you are more likely to have others. Themore conditions you have, the greater the risks are for your health.
Who is at risk for metabolic syndrome?
► People who have abdominal obesity (‘pot belly’) and insulin resistance.
► People with other medical conditions associated with the syndrome, like physical inactivity, aging, hormonal imbalance and genetic predisposition (or family history of medical conditions) are at risk.
► Hispanic and South Asian people (from the Indian subcontinent).
► People taking certain medications, specifically atypical antipsychotics, that have the potential to cause metabolic syndrome. Examples of these medications are Zyprexa, Risperdal, Clozaril, Geodon, Seroquel,Abilify, and Invega. Certain corticosteroids, antidepressants, protease inhibitors and antihistamines can alsocause metabolic syndrome.
What can I do to reduce risks and the potential health complications of Metabolic Syndrome?
Lose Weight. By losing 5 to 1- percent of your body weight, you can reduce the insulin level inyour body, reduce your blood pressure, and decrease your risk of diabetes.
Exercise. Doctors recommend getting 30 to 60 minutes of moderate-intensity exercise, such asbrisk walking, every day.
Eat a healthy diet – foods rich in fiber and unsaturated fats. Whole grains, beans, fruits, andvegetables have much dietary fiber. These foods can lower your insulin level. Limit fried foods,carbohydrates, and “empty calories” such as soda.
Stop smoking. Smoking worsens the health consequences of metabolic syndrome.
Schedule regular checkups after you leave the facility. Work with your doctor to monitor yourweight, blood pressure, cholesterol, and blood sugar level on a regular basis. Make additional lifestylemodifications if the numbers are not going in the right direction. Your doctor may prescribe certainmedications to reduce your risks (like medications to control your cholesterol level or medications toreduce your high blood pressure).
Even if you have none or only one of the medical conditions that make up the Metabolic Syndrome, somehealthy lifestyle changes will reduce your risk of heart disease, diabetes, and stroke.
(The information provided here is only a summary and does not cover all possible aspects of MetabolicSyndrome.)
NOTE: 1. Lab tests done within 30 days of admission to FSH may be utilized as ‘admissions lab tests’. Unless necessary, there is no need to repeat.2. For pre-treatment, lab tests done at Florida State Hospital within the last 3 months, including labs or tests done as part of the Annual Physical
Exam,may be used to comply with these guidelines.3. ALL THERAPEUTIC SERUM DRUG LEVELS SHOULD BE DRAWN AT THE TROUGH LEVEL.
ANTICONVULSANTS
BARBITURATES PRE-TREATMENT AT 2 MONTHS QUARTERLY SEMI-ANNUALLY ANNUALLY AS NEEDEDCBC CBC CBCHFP HFP CMP
ANTIDEPRESSANT PRE-TREATMENT AT 2 MONTHS QUARTERLY SEMI-ANNUALLY ANNUALLY AS NEEDEDCBC CBCHFP HFP
BUN, CreatinineTSHEKG EKG
ANTIMANIC/MOOD STABILIZER (Lithium)
WARNING: The risk of lithium toxicity is very high in residents with significant renal disease, cardiovascular disease, severe debilitation, dehydration,sodium depletion, or in residents receiving diuretics. Use extreme caution when treating ‘High Risk’ residents. Daily trough serum lithium levels are
recommended until the serum level and clinical condition are stabilized.
NOTE: 1. Blood draws for serum levels should be collected 8 – 12 hours after the last dose of lithium.2. Therapeutic lithium blood level is 0.6 – 1.2 mEq/L. If above 1.2 mEq/L, the dose must be held until reviewed by a physician. Discontinuation, or a
dosage reduction, then restarting at a lower dose after 24 – 24 hours may be necessary.
ANTIPSYCHOTICS (Excluding Clozapine®)ANTIPSYCHOTIC PRE-TREATMENT AT 1, 2 & 3
MONTHSQUARTERLY SEMI-ANNUALLY ANNUALLY AS NEEDED
CBC CBC CBC CBC*Metabolic
Assessment(includes FBS,Weight, Height,
BMI, Lipid Profile,
CMP withMagnesium
CMP CMP EKG
TSH Lipid ProfileEKG Weight Weight
Hgb A1c BMI BMI
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Eye Exams (forMellaril®&Seroquel®)
Blood Pressure,Family History &
WaistCircumference)AIMS (Abnormal
InvoluntaryMovement Scale)
AIMS (AbnormalInvoluntary
Movement Scale)for 1st Generation
Antipsychotics
AIMS (AbnormalInvoluntary
Movement Scale)for 2nd Generation
Antipsychotics*Metabolic
Assessment*Metabolic
Assessment
ANTIPSYCHOTICS – Special Monitoring Tool for Clozapine (Clozaril®)NOTE: 1. DURING TREATMENT: Do CCBC weekly for the first 6 months; then biweekly for 6 months. If WBC and granulocyte counts continue to be
within acceptable ranges, do CCBC every 4 weeks.2. UPON DISCONTINUING TREATMENT: Do CCBC weekly for at least 4 weeks after discontinuance or until WBC ≥3500/mm3 and ANC ≥2000/mm3
ANTIPSYCHOTIC –CLOZAPINE(Clozaril®)
PRE-TREATMENT AT 1 & 2 MONTHS QUARTERLY SEMI-ANNUALLY ANNUALLY AS NEEDEDCCBC CMP CMP EKG EEG
CMP (within 1month)
Weight Weight*Metabolic
Assessment(includes FBS,Weight, Height,
BMI, Lipid Profile,Blood Pressure,Family History &
