Need for Investigational Drug Services at a Tertiary Community Hospital

Signature Grand, Davie, Florida, USA

Introduction. Investigational drug services (IDS) include procurement, storage, dispensing, and disposal of investigational medications along with providing education, participating in research committees and maintaining protocol records. The investigational drug workload at our institution is expected to increase after increased participation in H. Lee Moffit Cancer Center & Research Institute protocols and pursuit of teaching facility status. Our institution lacks formal IDS, with limitations of the current system causing missed opportunities for proper nursing education, miscommunication regarding investigational medications, and lack of organization to ensure all study medications are dispensed through the pharmacy as required by JCAHO. Purpose. To evaluate the amount of time currently dedicated to investigational drug pharmacy services. The current system effectiveness will be evaluated with protocol log audits for completeness. A secondary analysis will be conducted to determine the financial feasibility of accommodating a full time position through the budgeted pharmacy funds. Methodology. There will be three parts evaluated during this study. Prospective analysis of investigational pharmacist’s additional workload from IDS will be performed via daily activity logs for three months. Retrospective audits of completeness of log records to assess the current system will be collected for the period of three months. Pharmacy budgets in protocols from the 2007 fiscal year will be evaluated. Descriptive statistics will be used to summarize data analyzed.