Investigational Drug Services —A Challenge and Opportunity for Pharmacists

Abstract

The opportunities and challenges in providing pharmacy coordinated Investigational Drug Services (IDS) have grown tremendously in the past 10-15 years. The evolution of the Investigational Drug Service at Rush Medical Center is described. The job of an investigational drug service pharmacist is multifaceted, and goes beyond inventory control and drug distribution. Before a clinical drug trial can be initiated, federal law requires that the study be reviewed by an Institutional Review Board. The IDS pharmacist can serve as a valuable member on this committee, providing expertise on the drug therapy and assure complete and accurate information is available. A major role of the IDS pharmacist is to review or complete summary documents called investigational drug data sheets. Each study is unique, and has its own requirements for procurement, distribution, preparation, and accountability. The IDS pharmacist should utilize the existing pharmacy system to develop protocol specific procedures for handling the investigational agent. The IDS pharmacist is frequently audited by sponsors and study monitors. Computerization and technology have also played a major role in the evolution of the IDS. In today's business environment, the IDS pharmacist must also be a skillful negotiator to guarantee funding for IDS services.