Viral-mediated gene therapy and genetically modified therapeutics: A primer on biosafety handling for the health-system pharmacist.

Abstract

The guidance documents applicable to the manipulation of viral vectors in a health-system pharmacy are reviewed to provide recommendations for occupational safe drug handling. Biosafety handling principles should be drawn from 2 guidance documents essential in the manipulation of biological material: Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. and the National Institute of Health's NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Incorporating the biosafety guidance of these 2 documents into the pharmaceutical standards of United States Pharmacopeia chapter 800, "Hazardous Drugs-Handling in Healthcare Settings," will assist in the establishment of viral gene therapy handling guidelines in a health-system pharmacy. Novel gene therapies and genetically modified therapeutic products will expose health-system pharmacists to classes of medications with unique biological handling requirements. Occupational safety data on the handling of these medications will be limited. The health-system pharmacy will need to rely on published biosafety recommendations to evaluate the infectious and genotoxic risks of these products while determining the necessary containment strategies to ensure safe work practice.