Investigational Drug Service (IDS) Internship

By Meenakshi Shelat, 2013 Pharm.D. candidate, University of Michigan College of Pharmacy

As a student pharmacist, I am thankful for my two-year experience as an intern in Investigational Drug Service (IDS) at the University of Michigan Health System (UMHS). As a designated section of the Department of Pharmacy Services within the UMHS, IDS handles the experimental drugs used for patients enrolled in clinical trials. IDS is responsible for the pharmacy-related tasks of both hematology/oncology and nonhematology/ oncology studies. This includes drug accountability, meticulous record-keeping, proper storage and disposal of medications, and compounding. The pharmacists, in addition to verifying every drug order or prescription, have many responsibilities. These include drafting and verifying dispensing guidelines, amendments and opening study procedures. Also, they are active members of several Committees and Task Forces, including the Institutional Review Board (IRB).

During my first year, the internship was focused on a basic understanding of regulatory procedures and the drug development process. I gained pharmacy technician skills, including dispensing inpatient and outpatient study drugs, preparation of sterile admixture and chemotherapy, and drug compounding. The second year transitioned to more professional-level activities, including project coordination, drug information writing and study support documentation for opening studies, and other IDS-pharmacist activities, such as drafting dispensing guidelines and prescription templates. As interns, we were also in charge of ensuring accuracy in our records and inventory in advance of audits and monitoring visits. A highlight of my second year was helping to design and pilot a new institutional Advanced Pharmacy Practice Experience (APPE), or P4, clerkship experience.

There was never a routine day during my two years in IDS. As of this past summer, we crossed the mark of handling 400 active investigational drug trials. This was an accomplishment for our dedicated team of pharmacists, technicians and interns. With the experience of both technical and professional aspects of IDS operations, I have been able to help train students while working on my daily to-do lists. What I loved about IDS and this internship was the autonomy in my responsibilities and the ability to work on a variety of projects. The work accomplished in IDS is critical for patients and for data that the Food and Drug Administration will analyze when evaluating investigational agents for approved indications.