HOPA Publishes Investigational Drug Service Best Practice Standards

We are pleased to announce the HOPA Standards Committee has completed the HOPA Investigational Drug Service Best Practice Standards, the first of its kind that provides the best practice standards and guidance for pharmacists and institutions that conduct clinical trials. The HOPA Investigational Drug Service Best Practice Standards emphasizes the critical role of the pharmacist in the investigational drug service from protocol concept to close-out. This document provides a foundation for pharmacy to be involved very early in protocol development and review, to ensure that the trial meets institutional medication guidelines, is executed efficiently, and adheres to all regulations and standards. In addition, the guidelines provide an outline for the role of the pharmacy technician which is unique to this document. These guidelines address various best practices for pharmacy operations and provide ancillary information about the different mechanisms for obtaining investigational drugs for a single patient, and provide a concise summary of and reference source for the procedures for obtaining investigational drugs on a “compassionate” basis. This best practice guideline should be used in conjunction with other applicable state and federal guidelines.

HOPA wishes to thank the following members for their valuable contributions: 

Editor

Barry Goldspiel, PharmD BCPS BCOP 

Lead Authors

Sapna Amin, PharmD BCOP

Joyce Lee, PharmD BCOP BCPS

Authors

Jorge Avila, PharmD BCOP

Matthew Boron, RPh 

Stefanie Conley, PharmD RPh 

Robert Enos, RPh MBA 

Kathy Galus, PharmD BCOP 

Theresa Mays, PharmD BS BCOP FASHP

Gopal Patil, PhD MBA RPh 

Jennifer Thompson, PharmD BCOP CCRP 

Peer Reviewers

Linda Bressler, PharmD BS

Michael Kane, RPh BCOP 

Jennifer LaFollette, PharmD BCOP

Susan Rogers, RPh 

You can access the HOPA Investigational Drug Service Best Practice Standards on HOPA’s website.