Education Session Track

New Therapies: Should They be Classified as Hazardous Drugs? A Stepwise Approach for Risk Management and Protection of Healthcare Workers

Activity Description : New Therapies are emerging and they require an evaluation as “hazardous drug” or “not” per your entity definition for “hazardous drugs”, so that you can define sterile compounding and handling protocols to ensure compliance with USP and protection of your staff. We will examine the NIOSH hazardous drug definition and identify criteria that should be considered for the initial “hazard” assessment and provide examples for a variety of therapies – small molecules, biologics and anti-body drug conjugates. Equipped with the “hazard” assessment we will progress through Assessment of Risk (AOR) exercises for each type of therapy and related work tasks/functions defining the layers of the control system in place. We will explore terms like “exposure potential” and “strength of the control system”. We will discuss industrial hygiene measuring tools that can be used to evaluate “exposure potential” and confirm the performance of “control systems”. All of these inputs in a stepwise progression can help inform and manage the risk of hazardous drug exposure for healthcare workers.

Handouts/Tools: Handouts will include an example Assessment of Risk (AOR) template/tool including the perspective of an industrial hygienist, and some commentary on key factors that may serve to increase or decrease exposure potential.

Activity Description : New Therapies are emerging and they require an evaluation as "hazardous drug" or "not" per your entity definition for "hazardous drugs", so that you can define sterile compounding and handling protocols to ensure compliance with USP and protection of your staff. We will examine the NIOSH hazardous drug definition and identify criteria that should be considered for the initial "hazard" assessment and provide examples for a variety of therapies - small molecules, biologics and anti-body drug conjugates. Equipped with the "hazard" assessment we will progress through Assessment of Risk (AOR) exercises for each type of therapy and related work tasks/functions defining the layers of the control system in place. We will explore terms like "exposure potential" and "strength of the control system". We will discuss industrial hygiene measuring tools that can be used to evaluate "exposure potential" and confirm the performance of "control systems". All of these inputs in a stepwise progression can help inform and manage the risk of hazardous drug exposure for healthcare workers.

Handouts/Tools: Handouts will include an example Assessment of Risk (AOR) template/tool including the perspective of an industrial hygienist, and some commentary on key factors that may serve to increase or decrease exposure potential.

Learning Objectives

  • Define criteria for the entity “hazardous drug, inclusive of the NIOSH definition and including other factors as appropriate.
  • Clearly delineate the terms “hazard assessment” and “exposure assessment” and explain how they are each used by toxicologists and industrial hygienists.
  • Conduct a “hazard assessment ” and an “Assessment of Risk” (AOR) for a new or emerging therapy with an example tool.
  • Speaker(s)

    Amy Snow CIH, CSP Senior Managing Industrial Hygienist
    SafeBridge-Trinity

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