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Clinical
Procedures
Verbal
Notification
CPRP
Forensic
Aftercare
Authorization
Documentation
Progress
Notes and
Progress
Notes
Instructions
mGAF
Scale
AIMS
Medications
Formulary
Medication
Assistance
Benzodiazepines
Antipsychotics
Lab
Services
Authorization
Form
Claims
Processing
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Recommendations
Identify High-Risk Patients -- Obtain a risk profile for each patient
- Medical Factors -- Obesity, dyslipidemia, hypertension, hyperglycemia, diabetes
- Behavioral and Lifestyle -- Poor diet, smoking, physical inactivity, high stress
- Genetic Factors -- Ethnicity, metabolic or cardiovascular illness
Treatment Selection -- Select antipsychotic based on the patient risk profile
- Discuss risk factors and side effects with patient and family
- For a high-risk patient, choose an agent with fewer metabolic side effects
Baseline Assessments and Monitoring -- Obtain baseline values and monitor regularly
- Blood pressure, weight, BMI, waist circumference
- Serum lipids, fasting plasma glucose
Management -- When treatment-emergent metabolic abnormalities are observed
- Change medication regimen or switch to another agent
- Initiate behavioral or medical intervention
- Refer to a specialist for further evaluation
Clozapine Protocol
BJCBH & BHP promote appropriate use and monitoring of Clozapine and its side effects. This includes prevention of premature use of Clozapine and detection of leukopenia and rapid medical intervention should it occur.
Physicians use these guidelines from the DMH Comprehensive Psychiatric Services (DMH CPS) Clozapine Treatment Protocol (third edition) to identify candidates for Clozapine.
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Diagnosis -- Patient has a primary DSM-IV Axis I diagnosis where psychosis is prominent
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Non-Responsive to Medicine or Experienced Side Effects -- Patient has been non-responsive to other antipsychotic medicine or experiences tardive dyskinesia or extra pyramidal symptoms because of these meds; at least two trials of other antipsychotic medications -- one must be an atypical at the optimum dose -- has to be documented
The physician:
- Discusses the risks and benefits of Clozapine treatment with the patient, acquires the patient's informed consent to initiate Clozapine treatment and records this in a progress note
- Completes mylan form
- Notifies the patient's case manager/community support worker of decision to initiate Clozapine treatment
- Orders pre-treatment white blood count (WBC), differential counts, and other pre-treatment assessments -- EEG and EKG -- as indicated on a case-by-case basis
The BJCBH & BHP case manager and community support worker:
- Assists the patient with completing pre-treatment assessments
- Reviews the plan with the patient and physician to support Clozapine treatment
- Notifies the BJCBH & BHP site nurse of Clozapine referral, and identifies lab and pharmacy preferences
The BJCBH & BHP nurse:
- Contacts the physician and verifies the start-date for Clozapine treatment, and lab and pharmacy choices
- Contacts designated pharmacy and lab to verify arrangements related to communicating weekly WBC results
To initiate Clozapine treatment, the physician:
- Reviews pre-treatment assessment results to check for contraindications for initiating Clozapine treatment -- refers to mylan guidelines
The pharmacist:
- Dispenses one week supply of Clozapine
- Processes mylan's prescription access system form
For continued Clozapine treatment, the physician:
- Determines routine methods for ongoing lab work, and appointments with patient and case manager
- Documents WBCs have been performed routinely and notes abnormal WBCs, notes responsive actions or unusual circumstances related to Clozapine treatment in quarterly progress reports
- After six months of uninterrupted Clozapine treatment regimen with no WBC below 5,000 -- lab work may be reduced to every two weeks
The case manager and community support worker:
- Ensures the patient completes weekly or bi-weekly lab work
- Maintains physician appointment
- Accesses medications from the pharmacy
This protocol is used for abnormal WBC results:
- When a WBC is 5,000 or lower, the physician contacts the BJCBH & BHP site nurse and advises a course of action; the site nurse reviews the case with BJCBH & BHP medical director and case manager/community support worker
- When a WBC is below 4,000, the physician contacts the BJCBH & BHP site nurse and increases the lab work to twice weekly; the site nurse reviews the case with the BJCBH & BHP medical director, patient and case manager/community support worker
- When a WBC is lower than 3,500 -- and lower than the previous lab work -- the physician discontinues the Clozapine and repeats the lab work within 48 hours
- When a WBC is below 3,000, the provider arranges hospitalization with a hematological consult and notifies BJCBH & BHP
To discontinue Clozapine treatment, the physician:
- Notifies the patient, case manager/community support worker, and designated pharmacy of the decision to terminate Clozapine treatment
- Orders WBCs for four weeks following the discontinuation of Clozapine treatment; documents the results of weekly WBCs
Note
- If the patient or physician is out of town, arrangements should be made to ensure Clozapine treatment is continued without disruption
- If a patient misses his or her treatment for two or more days, a physician should be consulted before the medication is reinitiated
- Physicians may authorize one unit per week during the initial months until a stable regimen is established
Recommendations for Routine Laboratory Studies for Clinically Stable Patients
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Child (under 18) |
Adult (18-65) |
| Lithium |
Serum level
Renal function
Thyroid function |
q 3-6 months
q 3-6 months
q 3-6 months |
q 12 months
q 6-12 months
q 12 months |
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| Valproate |
Serum Level
Hepatic function
CBC |
q 3-6 month
q 3-6 months
q 3-6 months |
q 12 months
q 6-12 months
q 6-12 months |
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| Carbamazepine |
Serum level
Hepatic profile
CBC |
q 3-6 months
q 3-6 months
q 3-6 months |
q 6-12 months
q 6-12 months
q 6-12 months |
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| Antipsychotics |
Fasting Blood
Glucose |
q 3-6 months |
q 12 months |
Note
- These recommendations may be useful for routine monitoring when a patient's stable clinical condition has resulted in a stable dose of medication; they do not apply to initiating or adjusting treatment
- These recommendations do not replace clinical judgment for monitoring during changes in dosage or changes in a patient's condition
- Older adults may need to be monitored more closely
- It is recommended that fasting blood glucose be monitored with higher frequency during the first months of olanzapine and Clozapine treatment, and monitored thereafter consistent with other risk factors for the development of diabetes mellitus
- It is recommended patients on antipsychotics be weighed at every appointment and BMI tracked routinely
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