Center for Behavioral Medicine
Clinical Pharmacist Collaborative Practice
Metabolic Monitoring and Therapeutic Drug Monitoring Protocol
PURPOSE
The purpose of this protocol is to allow the clinical pharmacist to order the pertinent laboratory
measures to safely and effectively monitor 1) patients who receive atypical (second generation)
antipsychotics for metabolic sequelae and 2) medication blood levels and appropriate laboratory
measurements for the safe use of the below specified medications that require therapeutic drug
monitoring.
CERTIFICATION AND QUALIFICATIONS
The pharmacist will be a graduate of an accredited school of pharmacy, hold an active pharmacist
license with the state of Missouri, have completed a post-graduate residency in psychiatric pharmacy or
possess equivalent experience. A psychiatric pharmacy resident may work within this protocol under
the supervision of his/her preceptor and the residency program director.
DESCRIPTION OF CLINICAL PRACTICE
1. METABOLIC MONITORING: The clinical pharmacist will order the following metabolic and
laboratory measures, according to the ADA guidelines below for any inpatient at CBM receiving
an atypical (second-generation) antipsychotic . The pharmacist may order the following
measures and HbA1c as often as clinically necessary (this frequency may vary from the table
referenced below). The pharmacist will follow the most recent published recommendations.
The 2004 published recommendations are included in the table below.
Recommended Schedule for Monitoring Patients on Second-Generation Antipsychotics
Baseline
Personal/Family
History
X
Weight (BMI)
X
Waist
Circumference
X
Blood Pressure
Fasting
Glucose
Fasting Lipid
4 wks
8 wks
12 wks
Quarterly
Annually
Every 5 yrs
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
J Clin Psychiatry 65:2, February 2004
2. THERAPEUTIC DRUG MONITORING: The clinical pharmacist may also order blood levels and the
relevant laboratory measures associated with each medication for any patient receiving one or
more of the below scheduled medications, when clinically indicated (e.g., signs or symptoms of
supra- or sub-therapeutic levels, at baseline, at steady-state following a dosage change, or
periodic monitoring):
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Collaborative Practice Agreement-Metabolic and Therapeutic Drug Monitoring 10-2009
Valproic acid/Divalproex:
Blood level (total and free), Liver Function Tests, Thyroid Panel,
Complete Blood Count with Differential (CBC), Serum Pregnancy
Test, Complete Metabolic Profile (CMP), serum ammonia level.
Lithium (any salt form):
Blood level, CMP, Thyroid Panel, Serum Pregnancy Test, EKG (if
clinically indicated, or annually), CBC, Urine Analysis
Clozapine:
Blood level, CBC, Serum Pregnancy Test, CMP, Thyroid panel,
HbA1C, EKG (if clinically indicated), Blood Pressure, Pulse,
Weight
Carbamazepine:
Blood level, CBC, Liver Function Tests, Thyroid Panel, CMP,
Serum Pregnancy Test
?Topiramate:
CMP , Liver Function Tests, Serum Bicarbonate, Serum
Pregnancy Test
Phenytoin:
Blood level (total and free), Liver Function Tests, Thyroid Panel,
CBC
SUPERVISION
The clinical pharmacist will work under the supervision of the Center for Behavioral Medicine’s Medical
Staff and Pharmacy Department. After initial approval by the Medical Staff, this protocol will be
reviewed annually for continued Medical Staff approval. Per the pharmacist’s clinical judgement, the
pharmacist may consult with the attending physician directly on-site and/or phone consultation.
ASSESSING COMPETENCY
?
DOCUMENTATION OF CLINICAL ACTIVITIES
The clinical pharmacist will document the purpose of each written order in the progress notes section of
the patient’s medical record. This documentation may include: medical and medication history,
assessment, recommendations, monitoring, educational interventions, and documentation of decisions
made including medications continued, modified, or discontinued.
The order written by the pharmacist on a physician’s order sheet should appear with the closing
statement, such as in the example below:
“Please obtain Depakote blood level tomorrow before AM dose…per the Pharmacy Protocol/Pharmacist
signature & credentials”
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Collaborative Practice Agreement-Metabolic and Therapeutic Drug Monitoring 10-2009