Investigational drug service advanced pharmacy practice experience (APPE)

Abstract

Although the Accreditation Council for Pharmacy Education (ACPE) and the American College of Clinical Pharmacy (ACCP) provide standards and guidelines for required APPEs (community pharmacy, hospital or health system pharmacy, inpatient/acute care general medicine, and ambulatory care) and there are some published descriptions of other elective APPEs, there is little information regarding the provision of an elective APPE focusing on Investigational drug service (IDS) and/or clinical research. The purpose of this paper is to describe the IDS APPE that was developed by the University of Michigan Health System (UMHS) IDS pharmacists in conjunction with the University of Michigan College of Pharmacy (UM COP). The IDS APPE is a four-week full-time program consisting of interaction with various IDS team members, topic discussions, opportunities for writing, and participation in IDS operations. Each week of the IDS APPE features a specific central theme, which includes both discussion topics and hands-on activities. While IDS practices may vary in size and scope, they all fulfill core regulatory requirements related to management of drugs used in clinical trials. Therefore, the IDS APPE description can be adapted and applied to other IDS practices in an effort to provide structure and foundation to the education of pharmacy students on an IDS APPE rotation. Further, it can be adapted into a general clinical research rotation with emphasis on the role of the pharmacist in the management of clinical trials and conduction of research for institutions that do not have a dedicated pharmacy service for clinical research (i.e., IDS).