A practical approach to assess the hazardous exposure potential of investigational drugs.

PURPOSE: A method to evaluate the hazardous exposure potential of investigational drugs was developed in order to comply with hazardous drug handling standards. SUMMARY: New nationwide standards require health-system pharmacies to recognize potential occupational risks and protect employees from any hazardous exposure. United States Pharmacopeia general chapter 800 (USP<800>) provides recommendations on handling precautions for commercial hazardous drugs. Recommendations for investigational drugs are less clear, with USP<800> suggesting more widespread protections when information is deemed insufficient to assess the risk. The investigational drug services pharmacy at a freestanding pediatric hospital developed a method to evaluate the hazardous potential of investigational drugs in order to determine the likelihood that a drug held an occupational handling risk. The goal of the project was to ensure compliance with hazardous drug handling standards and provide adequate employee protection while minimizing the financial burden on the health-system pharmacy. CONCLUSION: Investigational drugs that meet any of 4 defined criteria should be subject to hazardous drug handling precautions until adequate safety data are available.

Biosafety Practices for In Vivo Viral-Mediated Gene Therapy in the Health Care Setting.

Introduction: Gene therapy encompasses a diverse array of genetically engineered products in biomedical research. As novel products continue to gain regulatory approval, institutions will be challenged by translating research processes into the clinical environment. This article will provide a summary of the 5 in vivo viral-based therapies that have been approved or are under review in the United States or European Union and discuss the development of biosafety handling practices in the clinical setting. Discussion: Commercially approved gene therapies utilize adeno-associated viral vectors, lentiviruses, and modified herpes simplex viruses for genetic manipulation. Health care personnel must understand the location of the genetic manipulation, ex vivo or in vivo, in order to develop safe work practices when handling the products. Occupational exposure to a viral agent could lead to risks of infection or acquired immunity. Institutions must merge biosafety and hazardous drug handling standards in order to develop safe handling procedures for clinical care. Conclusion: As biotechnology continues to advance, so will the challenges of incorporating novel therapies into the clinical setting. Health systems must educate themselves on the current recommendations and maintain competency of this evolving science to ensure the safety of patients, families, and staff in the clinical environment.

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

PURPOSE: 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. SUMMARY: 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. CONCLUSION: 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.