Easy NAPLEX Hazardous Drug Practice Questions

Concept Explanation

Hazardous drugs (HDs) are medications that pose a significant health risk to healthcare workers and patients due to their potential for carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, or genotoxicity. For the NAPLEX, understanding the management of these agents is primarily guided by USP General Chapter 800, which provides standards for the safe handling of HDs to minimize the risk of exposure to personnel and the environment. This includes specific requirements for personal protective equipment (PPE), engineering controls like biological safety cabinets, and rigorous cleaning protocols. This foundational knowledge is a core component of NAPLEX Prep, as candidates must ensure safety in both sterile and non-sterile compounding environments.

The National Institute for Occupational Safety and Health (NIOSH) maintains a list of antineoplastic and other hazardous drugs used in healthcare settings. Drugs on this list are categorized based on their risk profile. For instance, while many hazardous drugs are oncology therapeutics, the list also includes non-antineoplastic drugs such as certain hormones, transplant medications, and antivirals. When handling these substances, pharmacists must employ primary engineering controls (PECs) such as Class II Biological Safety Cabinets (BSCs) or Compounding Aseptic Hazardous Drug Isolators (CAHDIs), which must be housed in a negative-pressure secondary engineering control (SEC).

Key safety requirements for handling hazardous drugs include:

• Personal Protective Equipment (PPE): Two pairs of chemotherapy-rated gloves are required for compounding and administering injectable HDs. Gowns must be disposable and shown to resist permeability by HDs.
• Negative Pressure: The compounding area must be maintained at a negative pressure of $0.01$ to $0.03$ inches of water column relative to surrounding areas to prevent contaminated air from escaping.
• Deactivation and Decontamination: Surfaces must be regularly treated with agents such as sodium hypochlorite (bleach) to deactivate HD residue, followed by cleaning and disinfection.

Solved Examples

1. Calculating Air Changes: A pharmacy is designing a new buffer room for hazardous drug compounding. According to USP 800, what is the minimum number of air changes per hour (ACPH) required for this room?
   1. Identify the requirement: USP 800 specifies that the secondary engineering control (the room) for sterile HD compounding must have a minimum of 30 ACPH.
   2. Identify non-sterile requirements: For non-sterile HD compounding, the requirement is at least 12 ACPH.
   3. Final Answer: 30 ACPH for sterile compounding; 12 ACPH for non-sterile.
2. Gloves and Gowns: A technician is preparing a dose of intravenous cyclophosphamide. How many pairs of gloves should they wear, and how often should they change their gown?
   1. Reference USP 800 PPE standards: Two pairs of chemotherapy-rated gloves are mandatory for sterile HD compounding.
   2. Gown frequency: Gowns should be changed every 2 to 3 hours or immediately if contaminated or torn.
   3. Final Answer: Two pairs of gloves; change gown every 2-3 hours.
3. Spill Kit Readiness: A 50 mL vial of a hazardous antiviral breaks in the pharmacy receiving area. What is the first step the pharmacist should take?
   1. Safety first: The immediate priority is to restrict access to the area and obtain a hazardous drug spill kit.
   2. PPE: Before cleaning, the pharmacist must don appropriate PPE, including a respirator if there is a risk of aerosolization.
   3. Final Answer: Restrict the area and utilize a spill kit with proper PPE.

Practice Questions

1. Which organization is responsible for maintaining the list of antineoplastic and other hazardous drugs?
2. What is the minimum negative pressure required (in inches of water column) for a hazardous drug buffer room?
3. How often must a pharmacist or technician undergo competency assessment for handling hazardous drugs?

4. A technician is compounding a hazardous drug in a C-PEC. Where should the outer pair of chemotherapy gloves be removed?
5. Which specific type of respirator is required when cleaning a large hazardous drug spill that cannot be contained by a standard spill kit?
6. True or False: A plastic-backed absorbent pad should be placed on the work surface of the C-PEC during HD compounding.
7. What is the purpose of using a Closed System Drug Transfer Device (CSTD) during the administration of hazardous drugs?
8. Which agent is commonly used for the "deactivation" step in the cleaning process of hazardous drug areas?
9. According to USP 800, how often must environmental wipe sampling for HD surface residue be performed?
10. Which of the following drugs is classified as hazardous: Methotrexate, Lisinopril, or Metformin?

Answers & Explanations

1. NIOSH: The National Institute for Occupational Safety and Health (NIOSH) publishes and updates the list of hazardous drugs used in healthcare.
2. $0.01$ inches of water column: The room must maintain a negative pressure between $0.01$ and $0.03$ inches of water column to ensure air flows into the room, preventing drug particles from escaping.
3. Every 12 months: Personnel must be trained and their competency assessed at least annually (every 12 months) or whenever a new HD or piece of equipment is introduced.
4. Inside the C-PEC: The outer pair of gloves should be removed inside the C-PEC (or just outside the C-PEC) and placed in a yellow chemotherapy waste bin to prevent contaminating the rest of the buffer room.
5. Full-face piece, chemical cartridge-type respirator or PAPR: While an N95 is sufficient for most dust, large spills or respiratory risks require a Powered Air-Purifying Respirator (PAPR) or a full-face chemical cartridge respirator.
6. True: A plastic-backed absorbent pad helps contain small spills or droplets during the compounding process and should be replaced if contaminated.
7. To prevent the escape of HD vapor or liquid: CSTDs mechanically prevent the escape of the drug into the environment and protect the nurse or healthcare provider during administration.
8. Sodium Hypochlorite (Bleach): Bleach or other EPA-registered oxidizing agents are used to chemically alter the HD into a non-hazardous form.
9. Every 6 months: While USP 800 recommends it, most guidelines suggest wipe sampling should be done at least every 6 months to ensure containment measures are effective.
10. Methotrexate: Methotrexate is a classic hazardous drug (antineoplastic) due to its teratogenic and toxic profile. You can find more details on managing such agents in renal therapeutics contexts where dosing is critical.

1. Which color of waste bin is specifically designated for trace chemotherapy waste (e.g., empty vials, used gloves)?

• ARed
• BYellow
• CBlack
• DBlue

Frequently Asked Questions

What is the difference between USP 797 and USP 800?

USP 797 focuses on the sterile compounding process to protect the patient from contamination, whereas USP 800 focuses on handling hazardous drugs to protect healthcare workers and the environment. Both chapters must be followed simultaneously when compounding sterile hazardous drugs.

Can I use a horizontal laminar airflow workbench for hazardous drugs?

No, horizontal laminar airflow workbenches blow air toward the operator, which would result in direct exposure to hazardous drug particles. Hazardous drugs must be compounded in a C-PEC that provides vertical airflow and negative pressure, such as a Class II BSC.

Are two pairs of gloves required for all hazardous drug tasks?

Two pairs of chemotherapy-rated gloves are required for compounding sterile and non-sterile HDs and for administering injectable HDs. For other tasks, such as receiving or stocking, a single pair of chemotherapy gloves may be sufficient depending on the facility's assessment of risk.

What should be done if a hazardous drug is received in a damaged shipping container?

The damaged container should be sealed in a plastic bag and moved to a C-PEC if possible. The pharmacist should then use a spill kit to clean any leaked contents, ensuring they are wearing the appropriate PPE including respiratory protection if necessary.

Where can I find the NIOSH list of hazardous drugs?

The NIOSH list is available on the Centers for Disease Control and Prevention (CDC) website. It is periodically updated to include new drugs that meet the criteria for toxicity or occupational risk.

Do hazardous drugs require a dedicated refrigerator?

Yes, hazardous drugs that require refrigeration must be stored in a dedicated refrigerator located in a negative pressure area with at least 12 ACPH, such as the HD buffer room or a dedicated HD storage room.