Hazardous And Nonhazardous Drugs - NAPLEX

1. Which PPE item is required when handling hazardous drugs and must be tested to ASTM D6978?

   Chemotherapy gloves (ASTM D6978 tested). These gloves are specifically tested for resistance to chemotherapy drugs, ensuring protection against permeation during handling.

2. What is the USP term for the room providing containment for hazardous drug compounding (negative pressure)?

   Containment secondary engineering control (C-SEC). C-SEC is an ISO Class 7 room with negative pressure and ventilation to contain hazardous aerosols during compounding activities.

3. What is the primary USP chapter that sets standards for handling hazardous drugs in healthcare?

   USP <800>. This chapter outlines comprehensive requirements for safe handling, storage, and disposal of hazardous drugs to protect healthcare personnel.

4. Which device mechanically prevents escape of hazardous drug aerosols and droplets during vial access and transfer?

   Closed-system drug-transfer device (CSTD). CSTDs create a sealed system to contain hazardous substances, reducing the risk of environmental contamination and worker exposure.

5. Which six NIOSH criteria are used to determine if a drug should be considered hazardous?

   Carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or similar to HDs. NIOSH evaluates drugs for these toxicity profiles to classify them as hazardous, ensuring appropriate safety protocols in handling.

6. What is the correct action if a tablet is labeled as hazardous and must be manipulated (crushed or split)?

   Treat as HD: use containment strategy and appropriate PPE; avoid manipulation if possible. Manipulation increases exposure risk, necessitating full hazardous drug protocols to protect personnel and avoid aerosolization.

7. Which NIOSH hazardous drug group includes reproductive-risk drugs that mainly affect fertility or pregnancy?

   Group 3: Reproductive-risk drugs. Group 3 focuses on drugs posing risks to reproductive health, such as fertility impairment or developmental toxicity, as defined by NIOSH.

8. Which USP chapter provides sterile compounding standards that integrate with hazardous drug handling?

   USP <797>. It establishes guidelines for sterile preparations, incorporating hazardous drug protocols to ensure both product integrity and worker safety.

9. What is the correct waste category for trace chemotherapy waste (items with only residues)?

   Trace hazardous drug waste (commonly RCRA empty/trace chemo waste per policy). Trace waste with residual amounts is managed under RCRA exemptions or policies to ensure safe disposal without bulk hazards.

10. What is the USP term for drugs posing risk to personnel from exposure during handling?

    Hazardous drugs (HDs). USP <800> defines these as drugs exhibiting at least one NIOSH criterion of hazard, requiring special handling to minimize exposure risks.

11. Which NIOSH hazardous drug group includes antineoplastic drugs?

    Group 1: Antineoplastic drugs. NIOSH categorizes these cancer-treating drugs in Group 1 due to their high potential for toxicity and occupational exposure risks.

12. What is the USP term for engineering control that protects the product from contamination (ISO-class air)?

    Primary engineering control (PEC). PEC maintains an ISO Class 5 environment, providing a controlled airspace to prevent microbial contamination during compounding.

13. What is the USP term for the ventilated cabinet used as a PEC for hazardous sterile compounding?

    Biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). These devices provide both product protection and personnel containment for hazardous materials in sterile compounding processes.

14. Which BSC type is commonly used for sterile hazardous drug compounding in pharmacies?

    Class II BSC. Class II BSCs offer HEPA-filtered airflow and containment suitable for biohazards and hazardous drugs in pharmacy settings.

15. What is the required gown characteristic for handling antineoplastic hazardous drugs per USP <800>?

    Disposable, lint-free, low-permeability chemotherapy gown. Such gowns are designed to resist permeation by hazardous drugs while preventing lint contamination in clean environments.

16. What pressure relationship is required for a hazardous drug buffer/compounding room relative to adjacent areas?

    Negative pressure to adjacent areas. Negative pressure prevents hazardous contaminants from escaping the room, protecting adjacent areas and personnel from exposure.

17. Identify the correct storage approach for antineoplastic hazardous drugs upon receipt in the pharmacy.

    Store separately in a designated HD area; use negative-pressure storage if required by policy. Separate storage in designated areas prevents cross-contamination, with negative pressure used for high-risk antineoplastics per guidelines.

18. Which dosage forms of hazardous drugs are generally lower risk when intact and may require less containment?

    Intact tablets/capsules (no crushing, splitting, or opening). Intact forms minimize dust or aerosol release, reducing exposure risks compared to manipulated or liquid hazardous drug forms.

19. Which respiratory protection is appropriate for hazardous drug spill cleanup when aerosols may be generated?

    N95 respirator (or elastomeric/PAPR per risk assessment). N95 respirators filter airborne particles, with higher protection options used based on aerosol generation risks during cleanup.

20. Which USP chapter provides nonsterile compounding standards relevant to hazardous drug handling?

    USP <795>. It sets standards for nonsterile compounding, including precautions for hazardous drugs to prevent contamination and exposure.

21. What is the authoritative U.S. list commonly used to identify hazardous drugs for practice policies?

    NIOSH List of Hazardous Drugs. NIOSH maintains this list based on hazard criteria, guiding pharmacies in implementing safe handling policies for identified drugs.

22. What is the USP term for a drug that is not classified as hazardous under USP <800>?

    Nonhazardous drug. Drugs not meeting NIOSH hazard criteria are classified this way, allowing standard handling without specialized containment measures.

23. What is the minimum glove practice commonly required for antineoplastic hazardous drugs during compounding?

    Double chemotherapy gloves. Double gloving provides an additional barrier layer to minimize skin exposure risks from hazardous drug permeation or tears.

24. Which waste category applies to bulk hazardous drug waste (vials/syringes with measurable drug remaining)?

    Bulk hazardous drug waste (hazardous pharmaceutical waste). Bulk waste with remaining drug qualifies as hazardous under EPA regulations, requiring specialized disposal to prevent environmental harm.

25. Which NIOSH hazardous drug group includes non-antineoplastics meeting HD criteria?

    Group 2: Non-antineoplastic hazardous drugs. Group 2 encompasses drugs with hazardous properties like toxicity but not primarily used for cancer treatment, per NIOSH classification.

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