The World Health Organization (WHO) defines gene therapy as “the introduction of genetic material into an individual, or the modification of the individual’s genetic material to achieve a therapeutic objective.”1 While, in general, genetic material cannot be inserted directly into an individual’s living cells, the material can be delivered using a vector. The most common vectors are viruses that have been altered to make them safe and/or improve their ability to recognize and enter the target cell. Other types of vectors being investigated include liposomes and nanoparticles.2
Multidisciplinary collaboration is essential for organizations considering gene therapy. Pharmacists, physicians, nurses, infection control specialists, environmental services specialists, and risk management specialists must conduct assessments and establish procedures for gene therapy products to ensure their safe storage, preparation, administration, decontamination, and disposal. Education of staff and ongoing performance monitoring are essential to the safe handling of gene therapy products.
The very nature of viral vectors mandates that they be handled as biologic agents and with the same precautions used for cytotoxic and infectious agents (eg, Bacillus Calmette-Guerin), including appropriate protective clothing, the proper biosafety devices for preparation (such as CSTDs and engineering controls), and prescribed methods for cleaning up spills and disposing of waste. Consult product-specific information for suitable storage conditions, disinfection practices, and procedures following accidental exposure.1 In the event of a spill or accidental exposure, consult occupational health personnel and the biosafety/infection control officer, and inform environmental services staff of the incident.1
Each gene therapy product may have unique requirements for safe handling. When new gene therapy products become available, consult the product prescribing information or full summary of product characteristics to ensure compliance with product handling procedures.1
Other Biotherapy Modalities
Cytokines, cancer vaccines, and oncolytic virus therapy are additional biological medications that may require unique safe handling practices.
Safe Handling Position
Gene therapy, cytokines, cancer vaccines, and oncolytic virus therapy are promising therapeutic options, but data related to their hazard potential are scarce. Hazard considerations associated with these therapies should include multidisciplinary collaboration for the establishment of safe handling procedures, the proper environment for the preparation and administration of the agents, staff education, and ongoing monitoring of all associated processes.
James R. Rinehart, RPh, MS, FASHP, is a health-system pharmacy management specialist and a consultant and principal of Winovation Associates, LLC.
James A. Jorgenson, RPh, MS, FASHP, is chief executive officer and chairman of the board of Visante, Inc, and Visante Limited.
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