Application of population approach to TDM services and educational programs

Ken-ichi Sako , Kimikazu Shinozaki

Division of Therapeutic Drug Monitoring, Center for Clinical Pharmacy and Clinical Sciences, School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane Minato-ku, Tokyo 108-8641, Japan.

Introduction: Division of TDM has been established from April 1996 and located in Kitasato Institute Hospital from May 1999. We have applied population pharmacokinetic models (abbreviated to pop.PK models) to TDM services and studied on pop.PK models to make safe and effective dosing regimens. Additionally, we applied pop.PK models to TDM educational programs.

Methods: We have cooperated with hospital staffs in providing TDM services. We are always carrying out TDM services, education and researches based on the concept of target concentration interventions. Educational programs in practices were arranged to educate pop.PK models intensively.

Results and discussions: There are two important steps in the concept; one is a parameter estimation step by using a pop.PK model and another is a dosing regimens step. In these steps, it is very important to use appropriate pop.PK models. However, there were few pop.PK models which had been evaluated completely in Japan. Therefore, we firstly examined predictabilities of serum drug concentrations of pop.PK models reported in other countries on digoxin, flecainide, vancomycin, lithium, etc. and if necessary, we secondarily tried to establish some new pop.PK models by using NPEM or NONMEM. During serial examinations, we recognized that it is essential for providing TDM services including determinations of initial dose, sampling time and maintenance dose to establish appropriate pop.PK models for dosing regimens. Comparing of predicted values with measured values on serum drug concentrations was a simple and effective method to examine predictability of models. On the other hand, pharmacy students could understand actual TDM easily by using pop.PK models. Intensive application of pop.PK model was important for evaluating or making dosing regimens in clinical setting. We think that for the purpose to provide still higher quality TDM services, we have to establish appropriate models in other drugs by using the simple method and pop.PK analysis.

Reference: PAGE 9 (2000) Abstr 123 [www.page-meeting.org/?abstract=123]

Poster: poster