Quality assurance program for a hospital investigational-drug service

The development and implementation of a quality-assurance (QA) program for a pharmacy-based investigational-drug service are described. The objective of the QA program was to assess the quality of the activities in the areas of drug acquisition, inventory control, availability of drug data sheets and dispensing guidelines, provision of a quarterly drug accountability report, and documentation of drug dispensing to patients and decentralized pharmacy areas. The audit criteria were based on hospital policies and procedures and federal regulations for the handling of investigational drugs. Audits of four randomly selected protocols are conducted quarterly by a pharmacist who is not affiliated with the investigational drug service. The results of the first two audits have identified several areas for improvement, including the need for additional pharmacy staff education regarding study protocols, the importance of maintaining complete and accurate drug accountability records by decentralized pharmacists, and the need to provide a centralized source of study protocol information. The QA program has enabled the investigational-drug service to establish and enforce the policies and procedures for the appropriate handling of investigational drugs in this institution.