Investigational drug practices in Michigan hospitals

Abstract

All 188 acute-care hospitals in Michigan with licensed pharmacies were surveyed to assess compliance with recommendations of ASHP, FDA, and the Joint Commission on Accreditation of Healthcare Organizations related to investigational drug use; other practice issues related to investigational drugs but not covered in those guidelines were also studied. Pharmacy directors were questioned about their practices for approving, prescribing, procuring, storing, and labeling investigational drugs; preparation, content, and use of investigational drug data sheets; record keeping; personnel issues; and other investigational drug services provided by the pharmacy department. The response rate was 84.5% (159 completed questionnaires returned), but only 44 respondents (27.7%) indicated that investigational drugs were currently used in their institutions. Written investigational drug policies and procedures were available in 116 (73.0%) of the responding pharmacy departments. Respondents currently handling investigational drugs had high rates of adherence for the following practice guidelines: preparation of data sheets (75.0%), storage (97.7%), monitoring of investigational drug use and stock levels (79.5%), and maintaining perpetual inventories (79.5%). Areas with relatively poor adherence rates included pharmacy department preparation of investigational drug patient-information sheets (20.5%), maintaining information within the pharmacy on minimum stock levels (53.9%), mode of shipment (30.8%), time to receive investigational drugs after order placed (38.5%), acceptance of nursing transcriptions of oral orders (56.8%), including "investigational drug" on the dispensing label (55.8%), and approval of data sheets by the investigator and the institutional review board (40.5% and 37.8%, respectively). Pharmacy departments, regardless of hospital size, should improve their adherence to ASHP, FDA, and Joint Commission guidelines for handling investigational drugs.