Navigant Healthcare expert Martin Trautmann contributes to a Compass Newsletter study on the impact of laboratory practices on inter-laboratory variability in therapeutic drug monitoring of immunosuppressive drugs.
The immunosuppressant drugs utilized for the prophylaxis of organ rejection in solid organ transplantation are in many cases narrow therapeutic index drugs, and as such require therapeutic drug monitoring (TDM). Administration of these agents, within the suggested therapeutic range, is critical to patient care [1-4]. Long term graft survival, especially in renal transplant patients, due to the inherent nephrotoxicity of immunosuppressant drugs such as cyclosporine and tacrolimus, is dependent on the proper administration of these immunosuppressive agents.
The aim of this study was to systematically document current practices utilized for immunosuppressant drug TDM in clinical laboratories and identify methodological and practical differences which may be the basis for the variability observed between laboratories. Multiple aspects of the design, development, validation, implementation, and quality control of immunosuppressant drug TDM methods were assessed.