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APPENDIX G: Serum Drug Concentration Monitoring Protocol
UWHC Protocol For Inpatient Serum Drug Concentration Monitoring By Clinical Pharmacists
Protocol developed by UWHC Center for Drug Policy (CDP)
Author: Cindy Gaston, RPh
Coordination: Lee Vermeulen, MS, RPh, FCCP, Director, CDP
Reviewed by: Pharmacokinetics Committee
Approved By P&T: July 2001
Last Reviewed: April 2007
Next Scheduled Review Date: April 2009
A. Background
This protocol outlines the procedure of therapeutic monitoring of serum drug concentrations
(SDC) by clinical pharmacists and gives the authority to the pharmacist to order serum drug
concentrations as necessary. Serum drug concentrations are useful to identify the causes of
unwanted or unexpected responses, improve clinical outcomes, and prevent unnecessary
diagnostic testing. Monitoring concentrations is important when pharmacologic and toxic effects
correlate with SDC and therapeutic endpoints are difficult to assess clinically. Abnormalities in
absorption, distribution, or elimination can be detected by SDC monitoring. A serum drug
concentration may be necessary to evaluate an inadequate response to treatment, toxicity, and
the impact of drug interactions. However, SDC should not be the only means for determining
appropriate dose regimens. Accurate assessment and clinical judgment must be used to evaluate
SDCs and determine appropriate dosing regimens.
Timing of the SDC is important. Route of administration, dosage regimen, dosage form,
pharmacokinetic characteristics of the drug, drug interactions, and alterations in elimination will
determine the optimum time to obtain the serum sample. The drug should be allowed to distribute
thoroughly throughout the body before samples are obtained. Concentrations obtained during the
distributive phase are variable and do not correlate with the usual therapeutic range. To obtain
the most useful information SDC should be obtained at steady state. Steady state is reached in 4
to 5 half-lives for drugs following first order kinetics. If a concentration is not at steady state, then
the SDC does not reflect the drug’s clearance. It may be necessary to obtain a SDC before
steady state if toxic or sub-therapeutic concentrations are a concern at that time. Improper
sampling times can lead to misleading SDC and incorrect therapeutic adjustments.
B. Policy and Procedure
1.0 Policies
1.1 Only SDC that can accurately and readily be measured and be correlated with
therapeutic or toxic effects will be ordered.
The clinical pharmacist is responsible for reviewing each patient’s drug therapy and
the need for SDC, and if appropriate, ordering a serum drug concentration. In
advance of ordering serum drug concentrations, the pharmacist will consider the
therapeutic goal of the specific medication.
Indications for SDC include:
1.3.1 Questionable drug efficacy
1.3.2 Patient exhibiting signs of possible drug-related toxicity
1.3.3 Noncompliance is suspected
1.3.4 Concomitant disease states that can alter drug elimination
1.3.5 Drug-drug interactions
1.3.6 Establishing a baseline value after a patient exhibits a therapeutic
response to drug therapy
1.3.7 Changing dosage formulations or regimens