Hazardous+Medications

Definition and Categorization of Hazardous Drugs

  • Hazardous Drug Definition (NIOSH): Hazardous drugs (HDs) are defined by the National Institute for Occupational Safety and Health (NIOSH) as agents that exhibit one or more of the following toxicity characteristics:

    • Carcinogenicity

    • Teratogenicity

    • Reproductive Toxicity

    • Organ Toxicity

    • Genotoxicity

    • Structure and toxicity profiles that mimic existing hazardous drugs

  • Maintenance of the NIOSH List:

    • The entity must maintain and review its list of hazardous medications at least every 12 months12\,\text{months}.

    • The list must also be reviewed whenever a new agent or dosage form is introduced into use.

    • If available information regarding a drug's toxicity is insufficient, it must be considered hazardous until additional data becomes available.

  • Mandatory Requirements vs. Assessment of Risk:

    • Mandatory Compliance: Containment strategies and full requirements must be followed for:

      • Any Active Pharmaceutical Ingredient (API) defined as an HD.

      • Any Antineoplastic agent requiring HD manipulation.

    • Exemptions via Assessment of Risk: Certain dosage forms present a limited potential for contamination risk (e.g., solid intact medications, tablets, and capsules). Final dosage forms of HD preparations that do not require further manipulation may follow altered work practices if an Assessment of Risk is formally conducted and implemented.

    • Assessment of Risk Parameters: Must evaluate the type of HD, dosage form, exposure risk, packaging, and specific manipulation required. All altered work practices must be documented and reviewed at least every 12 months12\,\text{months}. If no Assessment of Risk is performed, full standard containment strategies must be enforced.

  • NIOSH Hazardous Drug Categories:

    • Group 1: Antineoplastic drugs known to be hazardous with repeated exposure. Most chemotherapy agents fall into this category and are cytotoxic. Cutting, crushing, or manipulating these agents significantly increases occupational exposure risk.

    • Group 2: Non-antineoplastic hazardous drugs that pose occupational hazard risks to males and females attempting to conceive.

    • Group 3: Medications presenting adverse effects specifically toward reproduction, though they may not carry the same degree of occupational risk as Group 1 or Group 2 agents.

    • Group 4: Deleted drug entries.

    • Group 5: PPE and Engineering Controls directives.

Occupational Exposure Routes and Risk Opportunities

  • Primary Routes of Exposure:

    • Skin contact

    • Inhalation

    • Ingestion

    • Injection

  • Specific Exposure Hazards for Pharmacy Technicians:

    • Spills generated during powder reconstitution and liquid dilution.

    • Air expelled directly from syringes during pressure equalization.

    • Direct contact with contaminated drug vials, work surfaces, or flooring.

    • Improper handling or disposal of hazardous waste materials.

  • Exposure Opportunities Across the Healthcare Handling Chain:

    • Receipt: Contacting hazardous drug residue present on outer packaging.

    • Dispensing: Direct contact during counting or repackaging of oral solids.

    • Compounding/Manipulation: Reconstituting powder or lyophilized HD formulations.

    • Cleaning/Deactivating: Interacting with contaminated surface areas.

    • Administration: Priming intravenous (IV) sets prior to patient infusion.

    • Patient Care: Handling patient excreta or body fluids containing metabolized HDs.

    • Spills: Spill generation, containment management, and subsequent cleanup disposal.

    • Transport: Moving HDs throughout the healthcare facility.

    • Waste Handling: Collecting, segregating, and disposing of hazardous waste containers.

Personal Protective Equipment (PPE) Requirements


PPE worn during various handling stages

  • General PPE Standards:

    • PPE serves to protect workers by reducing direct HD exposure during receipt, storage, transport, compounding, administration, deactivation, spill control, and waste disposal.

    • Reusable PPE must be thoroughly decontaminated before reuse.

    • Standard mandatory compounding attire includes disposable gowns, head/hair covers, sleeve covers, shoe covers, and two pairs of chemotherapy gloves.

    • Two pairs of chemotherapy gloves are mandatory when administering injectable hazardous preparations.

    • Standard Operating Procedures (SOPs) must explicitly outline the required PPE for every distinct activity.

  • Chemotherapy Gloves:

    • Must meet testing criteria established by the American Society for Testing and Materials (ASTM).

    • Must be powder-free, as powder particles