NCCN Pharmacy Directors Forum Publishes Recommendations for Safely Dispensing Investigational Medications for Clinical Trials

The National Comprehensive Cancer Network's Pharmacy Directors Forum created an Investigational Drug Services work group to share evidence-based safety recommendations.

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National Comprehensive Cancer Network

Mar 15, 2022, 08:37 ET

PLYMOUTH MEETING, Pa., March 15, 2022 /PRNewswire/ -- The National Comprehensive Cancer Network^® (NCCN^®) today announced the publication of new expert consensus recommendations to address routine problems that can occur during prescribing, receiving, storing, preparing, and delivering investigational drugs. These new recommendations come from an Investigational Drug Services (IDS) work group that arose out of the NCCN Pharmacy Directors Forum. They are intended to build on existing resources to help improve the safety and efficiency of research studies.

"Clinical trials provide vital treatment options for many of our cancer patients," said Stephen Polley, PharmD, Assistant Director - Cancer Pharmacy Services, The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Co-Lead for the NCCN Work Group. "Promoting standardization and establishing robust IDS policies and procedures will help improve the feasibility of opening and successfully operating clinical trials. We hope these recommendations will be a helpful resource for IDS pharmacy leaders and pharmacists when creating or updating their policies and procedures."

"Clinical trials are increasing in complexity and logistics," agreed NCCN Work Group Co- Lead Sapna Amin, PharmD, Manager, Investigational Pharmacy Services, The University of Texas MD Anderson Cancer Center. "Understanding pharmacy workflows and collaboration with sponsors is key to ensure their success. IDS plays a critical and intricate role in the clinical trial. Having a standardized approach across institutions benefits the patients, institutions, and the trial sponsors."

The IDS recommendations were published in the American Journal of Health-System Pharmacy. They focus on seven areas of need identified by the work group:

Investigational product (IP) labeling from supplier
Building and validating research-specific treatment plans in the medical record
Restrictions on retained IP materials
IDS technician roles and training
Hazardous drug handling, and use of closed-system transfer devices
IDS participation in interactive response technology (IRT)
Temperature monitoring while IP is stored in institutional assets

The work group also suggests involving IDS pharmacists earlier in the development of research to capitalize on their unique expertise in order to improve study design and planning and mitigate many potential issues that arise during study treatment.

"If these recommendations can help improve how quickly and safely we can set up a clinical trial at our local institutions, then everyone wins," said Polley.

The full, evidence-based recommendations can be found via NCCN.org/publications.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network^® (NCCN^®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients^® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation^®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and Twitter @NCCN.