Clinical Trial and Therapeutics
Clinical Pharmacology & Therapeutics (1996) 60, 332–340; doi:
Cost-effectiveness analysis of serum vancomycin concentration monitoring in patients with hematologic malignancies*
Ma del Mar Fernández de Gatta PharmD1, Ma Victoria Calvo PharmD1, Jesus M. Hernández MD1, Dolores Caballero MD1, Jesus F. San Miguel MD1 and Alfonso Domínguez-Gil PharmD1
1Department of Pharmacy, Faculty of Pharmacy, University of Salamanca, and the Pharmacy Service and Department of Hematology, University Clinical Hospital of Salamanca, Salamanca, Spain
Correspondence: Ma Victoria Calvo, PharmD, Servicio de Farmacia, Hospital Clinico, Paseo San Vicente 57-133 37007, Salamanca, Spain.
*Supported by the University Clinical Hospital Pharmacy Service and carried out as a part of our routine practice.
Received 18 October 1995; Accepted 16 May 1996.
Abstract
Objective: This study evaluates the cost-effectiveness of vancomycin serum concentration monitoring in patients with hematologic malignancies.
Methods: The study was designed as a prospective randomized study. Seventy immunocompromised febrile patients with hematologic malignancies were randomly assigned to either a vancomycin therapeutic drug monitoring group (TDM group; n = 37) or to a control group (n = 33). Intervention in the TDM group involved patient follow-up by a clinical pharmacist to obtain and pharmacokinetically interpret serum vancomycin concentrations for dosage individualization.
Results: Evaluation of all patients included global clinical response and nephrotoxicity, as well as the economic costs and effectiveness derived from the vancomycin monitoring program. There were no significant differences between the TDM and control groups in the outcome measures, except for the incidence of nephrotoxicity: the rates of minor nephrotoxicity were 33.3% and 13.5% in the control and TDM groups, respectively. The corresponding figures for moderate nephrotoxicity were 9.1% and 0%. Logistic regression analysis confirmed that TDM independently reduced the incidence of nephrotoxicity in this patient population. On the basis of this reduced nephrotoxicity, a incremental cost of $435 per case of nephrotoxicity prevented was found for vancomycin serum concentration monitoring.
Conclusions: A decreased incidence of nephrotoxicity provides evidence of a real clinical benefit to patient management in patients with hematologic malignancies. The TDM for vancomycin therapy in this highrisk population has been shown to be a cost-effective procedure.
