CME: Pharmacology in the Clinical Lab: Therapeutic Drug Monitoring and Pharmacogenomics

Number of Credits

1.5 CME





This course provides CME credit and is only for individuals that are eligible for CME credit (physicians, nurse practitioners, nurses). All others should register for the course under the Laboratory Training category where the course is offered for
P.A.C.E. credit.

Course Details:

Therapeutic drug monitoring and pharmacogenomics are both pharmacy-related areas within the clinical laboratory. Although each is considered a sub-discipline within laboratory medicine, the two fields overlap significantly. In this course, we will provide an overview of each of these laboratory sub-disciplines and discuss the utility, rationale, and practice of each one.

Therapeutic Drug Monitoring (TDM) is a branch of clinical chemistry that specializes in the measurement of medication levels in serum. TDM requires that the laboratory make quantitative measurements of drugs and/or their metabolites.

Pharmacogenomics (usually abbreviated PGx) is the study of how variations in the human genome affect a given individual’s response to medications. It refers to how administered drugs will be handled by a specific person given specific genetic mutations and polymorphisms they may have.

Intended Audience: The target audience for this course is laboratory professionals eligible for CME credit (Physician Laboratory Directors, Pathologists, nurses, who are responsible for prescribing and administering therapeutic medications.

Learning Objectives

  • Define therapeutic drug monitoring (TDM) and explain the rationale for this testing.
  • Explain the concept of elimination half-life.
  • List the criteria and attributes of commonly monitored drugs.
  • Discuss three methods that are used for the measurement of therapeutic drugs in serum.
  • Define pharmacogenomics, polymorphism and CYP450; explain what is meant by ‘individualized medicine’ or ‘personalized medicine’.
  • Explain the usefulness of CYP450 testing as well as its shortcomings.
  • List the four classifications of metabolizers and explain the clinical relevance of each.

This CME activity has been designed to change learner competence and focuses on the American Board of Medical Specialties areas of patient care, practice-based learning and systems-based practice.

This Enduring Material activity, Laboratory Director Continuing Education Program, has been reviewed and is acceptable for credit by the American Academy of Family Physicians. Term of approval begins 08/01/2019. Term of approval is for one year from this date. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Approved for 1.5 AAFP Prescribed credits.


AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award.  When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as Category 1.

This course will take 1.5 hours to complete and there are no prerequisites. A credit certificate will be issued upon completion of the course evaluation and post-test with a score of 80% or better.

Release Date: 8/1/2017
Expiration Date: 8/1/2018

  • Welcome
  • General
  • Procedural
  • Proficiency Testing
  • Quality Control
  • Personnel
  • Conclusion
  • Graded Exam
  • Resources

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It is the policy of the AAFP and COLA Resources, Inc. that the faculty, authors, planners, and other persons who may influence content of this CME activity disclose all relevant financial relationships with commercial interests* in order to allow CME staff to identify and resolve any potential conflicts of interest. Faculty must also disclose any planned discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s). For this educational activity all conflicts of interests have been resolved and detailed disclosures are listed below:

Activity Planner and Course Reviewer: Verlin K. Janzen, MD, FAAFP

No relevant financial relationships to disclose, No discussion of unlabeled/unapproved uses of drugs/devices during presentation.

* The ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients The ACCME does not consider providers of clinical service directly to patients to be commercial interests.

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