Addressing Spills and Accidental Exposure to In Vivo Gene Therapy
An overview of the recommendations for dealing with the spillage of and accidental exposure to gene therapy products
Experts recommend that gene therapy products be treated as biohazardous drugs1–3
A clinical biosafety committee
should conduct risk assessments of potential hazards of each approved gene therapy product1–4
Standard operating procedures
should be established to deal with spills and accidental exposure1
Spills
Spill Kit
A spill kit and product information leaflet should be available during the storage, preparation, dispensing, transport, administration, and disposal of gene therapy products4
Figure adapted from Chart 6 in Vulto AG, et al. 20074.
*Disinfectant with proven virucidal activity, e.g. an oxidising/sterilising agent, such as 1000 parts per million (ppm) chlorine, 1–2% Virkon, or 6% hydrogen peroxide.
Procedure for Addressing Spills
Staff handling gene therapy products should be trained on decontamination procedures, and the ultimate responsibility for ensuring a spill is correctly decontaminated lies with the pharmacist4
Procedures for addressing spills differ depending on the spill location4
Spills Inside a BSC
Figure adapted from Chart 6 in Vulto AG, et al. 20074. *Note: Follow local legal and regulatory requirements regarding use of additional protective equipment, e.g. respirator; †Disinfectant with proven virucidal activity, e.g. an oxidising/sterilising agent, such as 1000 ppm chlorine, 1–2% Virkon, or 6% hydrogen peroxide.
BSC, biosafety cabinet; PPE, personal protective equipment.
Spills Outside a BSC
Figure adapted from Chart 6 in Vulto AG, et al. 20074. *Note: Follow local legal and regulatory requirements regarding use of additional protective equipment, e.g. respirator; †Disinfectant with proven virucidal activity, e.g. an oxidising/sterilising agent, such as 1000 ppm chlorine, 1–2% Virkon, or 6% hydrogen peroxide.
BSC, biosafety cabinet; PPE, personal protective equipment.
Accidental Exposure
While precautions should be put in place to prevent personnel being exposed to gene therapy products, accidental exposure may still occur
Risks associated with accidental exposure vary depending on the specific product; refer to the product information1,4
Here is the recommended process for dealing with different types of accidental exposure
Figure adapted from Chart 7 in Vulto AG, et al. 20074. *This refers broadly to agents that are Biosafety Level 2; those that are Biosafety Level 1 may require less stringent decontamination agents. See product information for specific procedures for decontamination.
References
- Petrich J, et al. J Pharm Pract 2020;33(6):846–855.
- Armitstead JA, et al. Hosp Pharm 2001;36(1):56–66.
- Blind JE, et al. Am J Health Syst Pharm 2019;76(11):795–802.
- Vulto AG, et al. EJHP Pract 2007;13(5):29–39.
- Central Michigan University. Biohazard Spill Kit Checklist. Available at: https://www.cmich.edu/office_provost/ORGS/Lab_Safety/Biological_Safety/Documents/cmuBiohazspill.pdf. Accessed 9 July 2020.
