Fee structure for investigational drug studies

The development and implementation of a fee structure for a pharmacy-coordinated investigational drug service is described. A pilot task and time study established specific time and cost elements for investigational drug services provided by the pharmacy department. To fully assess the costs in dispensing investigational drugs, each research study that used the investigational drug service was broken down into five phases of service. Each phase was further categorized by specific tasks or activities, and a time element to perform each activity or task was determined. Since some studies could require more elaborate randomization of patients, more extensive review of protocols, or more individualized dispensing procedures than others, a range of charges was derived: $2800 for standard protocols to $5700 for more complicated studies. An institutional drug therapy newsletter describing the services and costs was distributed to all medical staff members and principal investigators. The development of a fee structure for an investigational drug service coordinated by the pharmacy department has ensured that pharmacy services are adequately reimbursed and has allowed the department to allocate appropriate personnel to provide the services.