Medication
Formulary System
Introduction
Overview:
A formulary system is a
method for the medical staff of BHCS to evaluate, appraise, and select
from the numerous available drug entities and drug products that those
are considered most useful for care of our patient population. Only
those selected drugs will be routinely available for prescribing from
the community pharmacies.
Components of the formulary system include a method for requesting drug
placement onto and withdrawal from the formulary, evaluating the role of
new medications released to the market, programs to monitor drug use and
adverse events, as well as provision of drug information and education
related to optimizing patient care and outcomes. A formulary is not a
restrictive list of medications; it is a flexible and dynamic system
that reflects the current clinical judgment of the medical staff and
BHCS, and needs constant evaluation and revision.
Purpose:
A formulary system has
three purposes and associated benefits for Alameda County Behavioral
Health Care Services:
1. The principle purpose is to ensure the quality and
appropriateness of medication provision within BHCS. New drug
evaluations, dosing guidelines, drug use evaluations, and
adverse drug reaction reporting are some of the ways to support
this principle.
2. The second purpose is to teach appropriate drug therapy to
staff through education. Drug monographs, treatment guidelines,
and in-service educational programs all provide staff benefit.
3. Finally, a formulary system
provides cost-effective drug therapy, not simply drug
cost reductions. With a limited formulary, the pharmacy network
can maintain a more efficient control on drug costs, while
focusing on the quality of care.
Medication Classification:
1. Formulary
Medication can be prescribed
by authorized BHCS clinicians
2. Application/Approval
Necessary Prior to Dispensing
-clozapine (Clozaril)
Candidates must be approved by
Clozapine Monitoring Committee through a prior application
process (see
Clozapine Monitoring Committee section). As part of this
application, both the
AIMS and
PANSS
(including Negative Subscale) are necessary prior to
therapy, and quarterly for the initial 6 months of
treatment.
3.
AIMS/PANSS Required Prior to Dispensing
a) aripiprazole (Abilify)
Candidate must
have both AIMS and PANSS (including Negative Subscale)
scores written on the flip side of the Alameda County BHCS
Prescription form (see Atypical Antipsychotic section).
These scores are necessary prior to the first
prescription, and at 6 months of treatment (at initiation,
and 180 days).
4.
Non-Formulary – Psychotropic Medication
Medications from one of the
following therapeutic categories:
a)
Antipsychotic Agent
b)
Antidepressant
c)
Mood Stabilizer
d)
Antiparkinsonian/Antidyskinetic Agent
e)
Antianxiety/Hypnotic
f)
Psychostimulant
are only available if two
prior medication trials of formulary agents in the same
therapeutic class were unsuccessful. The medications,
doses, and outcomes need to be documented on the flip side
of the Alameda County BHCS Prescription form.
5.
Non-Formulary – Non-psychotropic Medication
Medications
not belonging to one of the above therapeutic
categories must be approved by the Office of the BHCS
Medical Director (567-8110) prior to prescribing, or the
medication will not be dispensed. Information
necessary includes patient name, PSP#, medication name and
specific justification.
Formulary Revisions:
Medication addition/deletions
to the Alameda County BHCS Formulary will be made in writing
to the Office of the Medical Director. All proposed
changes will be discussed in the Psychiatric Committee (PPC),
and an action recommendation made to the Medical Director.
The Medical Director will make the final decision.
TARs:
All Medi-Cal eligible patients
prescribed non Medi-Cal covered medication must have the
flip side of the Alameda County BHCS Prescription form
completed. This information is necessary for the
network pharmacy to complete a TAR for submission to Medi-Cal.
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Clozapine Monitoring Committee
I. Background/General
Information
Clozapine is a
dibenzodiazepine derivative indicated for the treatment of psychotic
disorders. Numerous studies have demonstrated the
effectiveness of this drug for treatment-resistant patients
unresponsive to standard antipsychotics, with fewer incidences of
troubling extrapyramidal reactions, neuroleptic malignant syndrome,
and tardive dyskinesia. However, due to the 1% to 2% incidence
of agranulocytosis associated with use of the medication as well as
the high cost, special protocols have been developed for prescribing
and distributing the drug.
A. Clozapine
Monitoring Committee
No patient
will be started on clozapine within the outpatient clinics of
Alameda County BHCS without prior approval by the Clozapine
Monitoring Committee. When patients are referred to a
county outpatient clinic from an inpatient facility, the
referring psychiatrist is to complete the Clozapine Monitoring
Committee Application Form prior to initiating clozapine.
If a patient
who is already receiving clozapine is admitted to any Alameda
County outpatient clinic, and that patient does not meet the
Clozapine Patient Criteria below, the patient will be reviewed
by the assigned physician and the Clozapine Monitoring Committee
for possible change to another clinically appropriate treatment.
II. Clozapine Patient
Criteria
Patients who meet
the following criteria will be considered for clozapine initiation:
A. Documented
history of one of the following diagnoses:
1.
Severe schizophrenia
2. Severe schizo-affective
disorder
3. Bipolar disorder unresponsive to treatment with
lithium, carbamazepine, and
valproic acid (divalproex)
B.
Be over the age of 16
C.
A history of trials with at
least two different (atypical) antipsychotics which were titrated
to the
maximum dose, and were maintained for at least 2 months before
discontinuation due to inadequacy
of symptom response or adverse effects.
|
|
Drug |
Dose |
| |
risperidone |
4 -
8 mg |
| |
olanzapine
|
15
- 20 mg |
| |
quetiapine
|
400
- 800mg |
| |
ziprasidone |
120 - 160mg |
| |
aripiprazole |
10 - 15mg |
D. None of the following
complications or contraindications are present:
1. History of clozapine-induced
leukopenia, agranulocytosis or granuloctyopenia
2. Medical condition or drug associated with
myeloproliferative disease or immunosuppression
3. Severe medical condition, or other illnesses causing
central nervous system depression or concurrent organic state
4. Poor medical compliance and/or poor compliance with lab
testing
5. Initial WBC < 3500/mm3 (or neutrophil < 2000/mm3)
6. History of hypersensitivity to a clozapine related drug
(amoxapine, loxapine)
7. History of significant physical illness in the prior
month
8. History of blood disorders
E. The following potential concerns and complications have been
addressed, if applicable:
1. Presence of concurrent active substance abuse
2. History of seizure disorder or neurological illness
i. Finnish or
Jewish background, especially Ashkenazi Jew
ii. Laboratory or
clinical evidence of significant hepatic, renal, or cardiopulmonary
disease
iii.
Unexplained abnormalities in laboratory tests within the preceding
four weeks
iv. Prostatic
enlargement or narrow angle glaucoma
v. Need for continued
use of heterocyclic or MAOI-type antidepressants
vi. Concomitant
use of (see
Table #1-Drug Interactions):
a. Bone marrow suppressants
b. Antihypertensive agents
c. CNS depressants
d. Highly protein bound drugs
e. Substrates/inhibitors/inducers of CYP 1A2, 2D6, and 3A4
vii. History of
orthostatic hypotension
F. Clozapine
Monitoring Committee Application Form (attachment #1)
completion and approval.
III. Initiation
of Clozapine Treatment
The following must be
completed if the patient is approved for clozapine administration:
1.
Physician must be registered as a provider with the National Registry by
calling the National Registry or providing the completed forms to the
registry.
2.
Physician will explain medication to the patient and have patient sign
Informed Consent for Clozapine.
3.
Physician calls the National Registry to obtain rechallenge clearance
authorization. A patient number is received from the National
Registry, and documented in the client Medical Record.
Telephone Numbers
Clozaril (Novartis) Patient Registry
(800) 448-5938
FAX (800) 648-6015
Clozapine (IVAX) Patient Registry
(800) 507-8334
FAX (800) 507-8339
IV. Clozapine
Treatment Requirements:
A. The following
items must be performed prior to initiation of clozapine:
-
WBC with differential
-
Electrolytes, serum
creatinine, total protein and albumin, liver function panel
-
Drug screen
-
Pregnancy test, if
possibly pregnant (Pregnancy Category B)
-
An assessment of the
patient’s physical condition
-
Vital signs
(including orthostatic BP, pulse) and weight
-
Geriatric patients or
patients with history of cardiovascular disease: ECG or evaluation
by internist
-
Patients with history
of seizures, recent head trauma or intracranial disease:
EEG or evaluation by internist
-
Registration with the
Clozapine National Registry
B.
The following items must be obtained during clozapine treatment:
-
Review of
weekly WBC count and ANC during the initial 6 months of
treatment, biweekly for the next 6 months, and every 4 weeks
thereafter, if client meets the criteria outlined below (see
Monitoring Requirements for Clozapine).
-
Vital signs
taken at each visit (including orthostatic BP and pulse).
C.
Prescription of Clozapine
-
No PRN use of clozapine shall be prescribed.
-
The medication will be prescribed weekly for the first 6 months
of therapy. If patient meets the requirements for biweekly
blood draws (see
Monitoring Requirements for Clozapine), on a biweekly basis.
V. Monitoring
Requirements for Clozapine:
A. On an
ongoing basis the physician will monitor patient outcomes, medication
dosing, and adverse effect development, notifying the Clozapine
Monitoring Committee of any critical adverse effects, including:
-
Agranulocytosis – Agranuloytosis has been estimated to occur in
association with clozapine therapy in ~1-2% of patients. Risk
is highest during the first 6 months of clozapine therapy, during
which weekly blood count monitoring must be performed.
-
Seizure/myoclonus – Dose-related seizures have been associated
with the use of clozapine. At doses below 300 mg/day seizure
risk is comparable to other antipsychotic drugs (~1-2%). At
doses between 300-600 mg/day seizure risk is increased to 3-4%,
while in patients receiving 600-900 mg/day the risk is 5%.
Caution should be used when using clozapine for patients having a
history of seizures or other predisposing factors.
-
Myocarditis
– Analyses of postmarketing safety databases suggest that
clozapine is associated with an increased risk of fatal myocarditis,
especially during, but not limited to, the first month of therapy.
Signs and symptoms of myocarditis may include: unexplained
fatigue, dypnea, tachypnea, fever, chest pain, and palpitations,
other signs/symptoms of heart failure, tachycardia, ST-T wave
abnormalities on EKG, or arrhythmias. In patients in
whom myocarditis is suspected, clozapine treatment should be
promptly discontinued, and a re-challenge should not be attempted.
-
Marked hypotension – Orthostatic hypotension with or without
syncope can occur with clozapine treatment and may represent a
continuing risk in some patients. It is more likely to occur
during initial titration in association with rapid dose escalation
and may even occur on first dose. Rarely, collapse can be
profound and be accompanied by respiratory and/or cardiac arrest.
-
Respiratory depression – see above section “Marked
hypotension.” Also, some of the cases of collapse/respiratory
arrest/cardiac arrest during initial treatment occurred in patients
who were being administered benzodiazepines, caution is advised when
clozapine is initiated in patients taking a benzodiazepine.
-
Increased glucose, lipids and/or weight – hyperglycemia,
hyperlipidemia, and weight gain have been reported in patients
treated with atypical antipsychotics including clozapine.
Patients with established diagnoses of diabetes mellitus,
hyperlipidemia, or obesity who are started on clozapine should be
monitored regularly for worsening of glucose or lipid control, or
for further weight gain. Patients with risk factors for the
above disorders who are starting clozapine therapy should undergo
fasting blood glucose and lipid testing, along with weight
monitoring, at the beginning of treatment and periodically during
treatment (see Alameda County BHCS Psychotropic Medication Practice
Guidelines).
-
Fever or other possible clozapine-induced side effects –
During clozapine therapy, patients may experience transient
temperature elevations above 100.4F, with the peak incidence within
the first 3 weeks of treatment. While this fever is generally benign
and self-limiting, it may necessitate discontinuing patients from
treatment. On occasion, there may be an associated increase or
decrease in WBC count. Patients with fever should be carefully
evaluated to rule out the possibility of an underlying infectious
process or the development of agranulocytosis. In the presence
of high fever, the possibility of Neuroleptic Malignant Syndrome
must be considered.
B. Patients who are being treated with clozapine must have a baseline
white blood cell and differential count before initiation of treatment
and a WBC/ANC every week thereafter for the first 6 months. If
acceptable WBC counts (WBC>3500/mm3 with ANC>2000/mm3) have been
maintained during the first 6 months of continuous therapy, WBC/ANC can
be monitored every other week for the next 6 months. Thereafter,
if acceptable WBC/ANC (WBC>3500/mm3 with ANC>2000/mm3) have been
maintained during the second 6 months of continuous therapy, WBC/ANC may
be monitored every 4 weeks. WBC counts must be monitored weekly
for at least 4 weeks after the discontinuation of clozapine.
C. Patients
with interrupted therapy (flowchart
for Interrupted Therapy):
-
Patients on clozapine < 6 months with no abnormal blood work and a
break in therapy <1 month: continue the weekly blood work
from where client has left off for the duration of the six months
using the initial start date, before transitioning to biweekly
draws.
-
Patients on clozapine < 6 months with no abnormal blood work and a
break in therapy >1 month: restart the weekly blood draws
for another 6 months, before transitioning to biweekly draws.
-
Patients on clozapine for 6-12 months with no abnormal blood work
and a break in therapy <1 month: restart weekly blood
draws for 6 weeks, then continue with biweekly blood draws
for another 6 months, before transitioning to every 4 weeks draws.
-
Patients on clozapine for 6-12 months with no abnormal blood work
and a break in therapy >1 month: restart weekly blood
draws for 6 months, then continue with biweekly blood draws
for another 6 months, before transitioning to every 4 weeks draws.
-
Patients on clozapine for > 12 months with no abnormal blood work
and a break in therapy <1 month: restart weekly blood
draws for 6 weeks, then return to every 4 weeks blood draws.
-
Patients on clozapine for > 12 months with no abnormal blood work
and a break in therapy >1 month: restart weekly blood draws for
6 months, then continue with biweekly blood draws for 6
months, before transitioning to every 4 weeks draws.
D.
Abnormal blood draws (also see
Blood Monitoring
Requirements – Section VI):
-
Regardless of length
of clozapine treatment, if a patient experiences an abnormal blood
count (WBC <3500/mmj3 or ANC <2000/mm3), but remains rechallengeable
(WBC >2000/mm3 and/or ANC >1000/mm3), the following must occur:
a.
Daily blood draws until WBC >3000/mm3 and ANC >1500/mm3
b.
Twice-weekly blood draws until WBC >3500/mm3 and ANC >2000/mm3.
c.
May rechallenge when WBC >3500/mm3 and ANC >2000/mm3.
d.
If rechallenged, perform weekly blood draws for 1 year, then biweekly
for 6 months, then every 4 weeks thereafter.
e.
Note: data suggest that patients who have an initial episode of
moderate leucopenia (3000/mm3 > WBC=2000/mm3) have up to a 12-fold
increased risk of having a subsequent episode of agranulocytosis (ANC
≤500/mm3) when rechallenged, compared to the full cohort of patients
treated with clozapine. Although clozapine may be resumed once a
patient is deemed to be rechallengeable, prescribers are strongly
advised to reconsider the risks vs benefits of continuing clozapine
therapy.
E.
Obtain an EKG if cardiovascular sequelae are observed.
F. Obtaining a clozapine blood level may be
warranted if (a) noncompliance is suspected or if (b) there is an
unexpected outcome (either inadequate efficacy or clinical evidence of
toxicity) resulting from a normally therapeutic dose.
-
There are currently
no established guidelines which identify a specific target range of
blood levels for clozapine. However, therapeutic response to
clozapine has been associated with blood levels of 300-450 ng/mL.
Clinical evidence of toxicity has generally been associated with
blood levels of ~800 ng/mL or higher.
VI.
Blood Monitoring Requirements (see
Table #2):
A.
Within the week prior to each prescription, a WBC/ANC will be
obtained, with results forwarded to the pharmacy working with the
individual client. The pharmacy will submit these results to the
National Registry.
B.
Clozapine should not be initiated if WBC count is <3500/mm3.
When the WBC is greater than 3500/mm3, the WBC will be done weekly,
biweekly, or every 4 weeks, based upon history of clozapine therapy (see
Monitoring Requirements for Clozapine).
C.
If the total WBC count is above 3500/mm3 but there has been a
single drop or a cumulative drop within 3 weeks of over 3000/mm3,
perform a repeat WBC/ANC. If repeat values are 3000/mm3=WBC ≤
3500/mm3 and ANC >2000/mm3, then monitor twice weekly. Clozapine
treatment may continue but with twice a week WBC & differentials until
WBC >3500/mm3 and ANC >2000/mm3. Then return to previous
monitoring frequency.
D.
If the WBC count is between 2000-3000/mm3, or the ANC is between
1000 and 1500/mm3, interrupt clozapine therapy and begin daily WBC
counts until WBC >3000/mm3 and ANC >1500/mm3 (see
Table 2).
E.
If the WBC is <2000 or the ANC <1000, discontinue clozapine
therapy and do not attempt a re-challenge.
VII.
Discontinuation of Clozapine:
A.
Generally clozapine will be tapered and discontinued for patients who
have not experienced substantial benefit from it after a trial period of
no longer than 24 weeks. At least 12 of those 24 weeks should be
at a therapeutic dose. Exceptions may occur on a case-by-case
basis with the approval of the Clozapine Monitoring Committee.
B. The pharmacy will be notified of a patient’s discontinuation of
clozapine.
C.
The Clozapine Monitoring Committee will be notified of a patient’s
discontinuation.
D.
Patients must receive weekly blood tests for four weeks following the
d/c of clozapine
E. The case manager will be informed of the clozapine discontinuation
and the need for subsequent blood tests in the event that the patient
needs assistance.
Clozapine Application
Interrupted Therapy
Drug Interactions
& Clozapine Blood Monitoring Parameters
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Atypical Antipsychotic
Requirements
Atypical Antipsychotics
Requirements
Aripiprazole (Abilify)
Alameda County Behavioral Health Care Services
requires three patient symptom assessment scores to be completed by the
patient’s physician, and recorded on the flip side of the Alameda County
Behavioral Health Care Services Prescription form in order to process
the prescription. The scales are the AIMS (Abnormal Involuntary
Movement Scale), and PANSS (Positive and Negative Syndrome Scale),
including the separate score for the Negative Subscale. WITHOUT THE
PRESENCE OF THESE SCORES ON THE PRESCRIPTION, THE MEDICATION CANNOT BE
DISPENSED. These objective assessment scales will provide Behavioral
Health Care Services with the data to monitor patient outcomes,
medication efficacy, and its impact on system costs. After the
initial pretreatment score, these scores need to be repeated at
six months, and documented on the prescription backside.
Risperidone long-acting depot IM (Consta)
Risperdal Consta is non-formulary and NOT covered
by Medi-Cal (it is only available through the Medi-Cal TAR process). Due
to the potential cost impact (see below), current County budget crisis,
and no coverage by Medi-Cal, only patients with an approved Medi-Cal
TAR or approved through the Janssen Cares Patient Asst. Program will be
eligible to receive Risperdal Consta. An application for that
program is available from the Office of the Medical Director or at the
Risperdal website.
http://www.janssen.com/active/janus/en_US/assets/common/company/pap_app.pdf
| |
|
Per
Inj
|
Per Month |
|
Risperdal Consta |
25mg IM |
$ 278 |
$ 556 |
| |
37.5mg IM |
$ 416 |
$ 832 |
| |
50mg IM |
$ 555 |
$1,110 |
Pharmacoeconomic Study
1. All
patients started on Long-acting IM Risperidone will be entered in the
study. This includes both MediCal (through approved TAR) and indigent
clients (through approved PAP).
2. The
PANSS score (overall and negative subscale) would be required upon
initiation and again after 6 months treatment.
3. The
use of anticholinergic agents, concurrent atypical antipsychotics and
impact on metabolic parameters would additionally be monitored.
4. Compliance with 2 week injection schedule will be tracked, as well
as dose titration.
ALAMEDA COUNTY BEHAVIORAL HEALTH CARE SERVICES
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Adult-Attention Deficit Hyperactivity Disorder
(ADHD)
BHCS does not treat patients with a primary diagnosis of Adult ADHD.
But patients with a secondary diagnosis of Adult ADHD may be
treated along with their primary psychiatric diagnosis. Please refer to
the BHCS Adult ADHD Assessment & Rating Guidelines, which can
assist in both diagnosis and treatment.
At a minimum, the 30-item Conners’ Adult ADHD Rating Scale (CAARS)
Self Reporting & Screening Version needs to be scored at both assessment
and again after 30 days of medication treatment. These four scores (A
thru D) need to be documented in the BHCS patient chart. If a
non-formulary medication is requested, then these scores must be written
on the backside of the BHCS prescription, or called into BHCS Pharmacy
Services.
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