Implementing standard practices in the safe handling of gene therapy and biohazardous drugs in a health-system setting.

Abstract

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Purpose: This publication outlines development of the infrastructure and standard operating procedures (SOPs) for handling of gene therapy drugs within an integrated health-system setting. These guidelines aim to fill the gap in occupational safety standardization, as current materials focus on precautions in a research laboratory setting and do not fully take into account occupational hazards for pharmacists, technicians, and other medical staff.

Summary: Pharmacists in a large integrated healthcare system recognized the gap in knowledge as well as lack of standard procedures in handling gene therapy drugs in the pharmacy setting and sought to establish updated best practices. The objectives were to implement the necessary infrastructure and SOPs for the handling, compounding, and cleanup of gene therapy drugs and to update existing resources such as spill kits to reflect the new SOPs. Critical milestones included establishing a new biohazardous drug risk classification and standardizing medication labeling. These steps were necessary to ensure consistent and safe handling across the enterprise.

Conclusion: With the increasing prevalence of gene therapy drugs, it is of paramount importance to establish best practices to ensure occupational safety. While existing regulations and literature outline basic handling guidelines for laboratory use, there is a limited amount of information in relation to pharmacy departments within healthcare groups. In establishing robust SOPs surrounding the handling, compounding, and management of gene therapy drugs, pharmacy groups can better ensure both patient and staff safety.