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

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Experts recommend that gene therapy products be treated as biohazardous drugs1–3

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A clinical biosafety committee

should conduct risk assessments of potential hazards of each approved gene therapy product1–4

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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

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Figure adapted from Chart 6 in Vulto AG, et al. 20074.
*Disinfectant with proven virucidal activity, e.g. an oxidizing/sterilizing 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 oxidizing/sterilizing agent such as 1000 ppm chlorine, 1–2% Virkon, or 6% hydrogen peroxide.

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 oxidizing/sterilizing agent such as 1000 ppm chlorine, 1–2% Virkon, or 6% hydrogen peroxide.

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

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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

  1. Petrich J, et al. J Pharm Pract 2020;33(6):846-855.
  2. Armitstead JA, et al. Hosp Pharm 2001;36(1):56–66.
  3. Blind JE, et al. Am J Health Syst Pharm 2019;76:795–802.
  4. Vulto AG, et al. EJHP Pract 2007;13:29–39.
  5. Central Michigan University. Biohazard Spill Kit Checklist. Available at: https://www.cmich.edu/office_provost/ORGS/Lab_Safety/Biological_Safety/Documents/cmuBiohazspill.pdf. Accessed July 9, 2020.