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TRANSPLANTATION

Immunosuppressant Drug Monitoring: Is the Laboratory Meeting Clinical Expectations?

Chief Medical Scientist, Clinical Pharmacology Laboratory, The Queen Elizabeth Hospital, Woodville SA, Australia; Affiliate Associate Professor, Department of Clinical and Experimental Pharmacology, The University of Adelaide, North Terrace, Adelaide SA, Australia

Reprints: Dr. Morris, Clinical Pharmacology Laboratory, The Queen Elizabeth Hospital, 28 Woodville Rd., Woodville SA 5011, Australia, fax 618 82226033

OBJECTIVE: To review the literature relating to immunosuppressant drug measurement as performed in therapeutic drug monitoring laboratories associated with transplantation centers and consider whether the assay methods widely used for patient dosage management achieve acceptable quality criteria in the context of other sources of variability with these drugs.

DATA SOURCES: Articles used were accessed primarily through MEDLINE, as well as references cited in related publications. Searches were restricted to organ transplantation in humans.

STUDY SELECTION AND DATA EXTRACTION: Emphasis was placed on the literature relating to the quality of immunosuppressant drug assays, their limitations, and evidence of clinical benefit in dosage individualization.

DATA SYNTHESIS: There is a dilemma evident between the quality of the analytical services offered by some diagnostic immunoassay manufacturers and the ability of a significant number of clinical laboratories globally to select only appropriate assay methods.

CONCLUSIONS: In many cases, clinical laboratories fail to meet the reasonable clinical expectations required for interpretation of immunosuppressant drug assay results as an adjunct to optimal dosage individualization and patient care.

Key Words: cyclosporine, mycophenolate, sirolimus, tacrolimus, therapeutic drug monitoring

Published Online, December 8, 2004. www.theannals.com, DOI 10.1345/aph.1E287

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