Precision Dosing Technology Poised to Spread Beyond Academic Medical Centers

Published October 2020 | Critical Care Medicine

For many years, the ability to employ model-informed precision dosing in real-world clinical settings has been limited to a select set of medications for a limited menu of health conditions managed almost exclusively by specialists working at the largest academic medical centers.

Applications have focused on preventing rejection of transplanted organs, walking the tightrope between effective cancer chemotherapy and dangerous side effects, constantly re-calculating doses for younger patients receiving off-label drug treatments for rare diseases, and so forth.

More recently, however, a convergence of improved precision dosing models, wider use of electronic medical records, and more user-friendly decision support software suggests that once-theoretical concepts like pharmacogenetics are becoming increasingly ready for day-to-day clinical practice. That’s the conclusion drawn from a wide-ranging review article produced by five scientists at Cincinnati Children’s. The paper details four successful implementations of model-informed precision dosing (MIPD):

• Customizing doses for children ranging from newborns to teens in clinical trials evaluating the drug sirolimus in multiple conditions.
• Helping doctors find the maximum tolerated dose of hydroxyurea within days instead of months for children coping with sickle cell anemia.
• Managing toxicity risk when cancer patients receiving high-dose methotrexate experience delays clearing the drug from their bodies.
• And introducing a decision support tool called NeoRelief that helps care teams more precisely manage morphine doses for neonates experiencing pain.

“Our overarching vision is that integrating a pharmacokinetics and pharmacodynamics (PK/PD) profile or prediction into prescribing clinicians' workflows will improve the safety and efficacy of many medications,” the co-authors state.

Steps involved in PK/PD-Informed Precision Dosing

Model-informed precision dosing uses multiple patient factors to identify the optimal starting dose. Subsequent dose adjustments are made based on clinical feedback.