Medium NAPLEX USP 800 Practice Questions

Mastering USP 800 standards is essential for any pharmacist candidate, as these regulations ensure the safety of healthcare workers handling hazardous drugs. This guide provides Medium NAPLEX USP 800 Practice Questions designed to test your knowledge of containment, personal protective equipment (PPE), and facility requirements. For a comprehensive overview of all exam topics, visit our NAPLEX Prep hub.

Concept Explanation

USP Chapter 800 provides practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Hazardous drugs include those that exhibit carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity, as defined by the National Institute for Occupational Safety and Health (NIOSH). Key requirements include the use of specific engineering controls, such as Biological Safety Cabinets (BSCs) or Compounding Aseptic Containment Isolators (CACIs), which must be vented to the outside and maintained in negative pressure rooms. Personnel must adhere to strict PPE protocols, including double-gloving and chemotherapy gowns, when compounding or administering these agents. Understanding these standards is just as critical as knowing oncology therapeutics, as many hazardous drugs are used in cancer treatment.

Solved Examples

1. Question: A pharmacy is designing a new cleanroom for compounding hazardous sterile preparations. According to USP 800, what is the minimum number of air changes per hour (ACPH) required for the buffer room?
   Solution:
   1. Identify the room type: Hazardous sterile compounding buffer room.
   2. Recall USP 800/797 standards: Sterile HD compounding requires a minimum of 30 ACPH.
   3. Confirm pressure requirements: The room must also maintain a negative pressure of $0.01$ to $0.03$ inches of water column relative to adjacent areas.
   4. Answer: 30 ACPH.
2. Question: A technician is preparing to compound a dose of IV cyclophosphamide. How many pairs of gloves should they wear, and what type?
   Solution:
   1. Reference USP 800 PPE standards for compounding HDs.
   2. Identify the requirement: Two pairs of chemotherapy-rated gloves are mandatory.
   3. Determine placement: The inner glove should be under the gown cuff, and the outer glove should be over the gown cuff.
   4. Answer: Two pairs of chemotherapy-rated gloves.
3. Question: An Assessment of Risk (AoR) is being performed for a hazardous drug that the pharmacy only intends to dispense in its final unit-dose package. How often must this AoR be reviewed?
   Solution:
   1. Recall the frequency for AoR documentation.
   2. Standard requirement: Documentation of the AoR must be reviewed at least every 12 months.
   3. Answer: Every 12 months (annually).

Practice Questions

1. Which of the following engineering controls is required for compounding hazardous sterile preparations (C-SAPs)?
2. A nurse is administering a hazardous drug from a pre-filled syringe. According to USP 800, what is the minimum PPE required for administration?
3. A pharmacy receives a shipment containing a damaged carton of a hazardous drug. Where should the technician move the damaged package for further inspection?

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4. What is the required pressure relationship for a C-SCA (Containment Segregated Compounding Area) relative to the surrounding areas?
5. When decontaminating a BSC used for hazardous drugs, which agent is typically used first to oxidize the drug residue?
6. A pharmacist is checking a hazardous drug label. Which statement must be included on the outer wrap of a hazardous drug container?
7. Personnel who handle HDs must be trained before independently handling them. How often must their competency be reassessed?
8. A spill of 20 mL of a liquid hazardous drug occurs on the floor of the negative pressure room. What is the first step the staff should take?
9. Which type of respiratory protection is required when cleaning a large spill that cannot be contained by a standard spill kit?
10. True or False: A CACI (Compounding Aseptic Containment Isolator) used for HDs can be placed in a positive pressure cleanroom if it is externally vented.

Answers & Explanations

1. Answer: A C-PEC (Containment Primary Engineering Control) such as a Class II BSC or CACI. These devices provide an ISO Class 5 environment and are externally vented to protect the operator and the environment.
2. Answer: One pair of chemotherapy gloves and a gown. While compounding requires double gloves, administration of HDs only requires a single pair of chemotherapy gloves unless otherwise specified by the institution or if a spill is likely. You can practice more clinical scenarios with our AI Question Generator.
3. Answer: A negative pressure room (C-SEC). Damaged HD containers must be handled in a way that prevents the spread of contamination, typically within a designated containment area or a C-PEC.
4. Answer: Negative pressure (between $0.01$ and $0.03$ inches of water column). This ensures that air flows into the room, preventing hazardous particles from escaping into non-HD areas.
5. Answer: Sodium hypochlorite (bleach). Decontamination involves moving the drug from a hazardous state to a non-hazardous state, often using an oxidizer like bleach, followed by a neutralizer like sodium thiosulfate or a detergent.
6. Answer: "Caution: Hazardous Drug." USP 800 requires that all HD containers and those containing HD waste be clearly labeled with appropriate cautionary statements.
7. Answer: At least every 12 months. This is consistent with the review cycle for the Assessment of Risk and other safety protocols. For more on regulatory requirements, check out our guide on antimicrobial stewardship for similar compliance topics.
8. Answer: Restrict access to the area and post signs. Safety first involves containing the risk to personnel before attempting cleanup with a spill kit.
9. Answer: A full-facepiece, chemical cartridge-type respirator or a powered air-purifying respirator (PAPR). Standard N95 masks do not provide protection against gases or vapors and are insufficient for large HD spills.
10. Answer: False. USP 800 requires that the C-SEC (the room housing the C-PEC) must be maintained at negative pressure to ensure containment, even if the isolator itself is used.

1. Which organization maintains the list of antineoplastic and other hazardous drugs used in healthcare settings?

• AFDA
• BOSHA
• CNIOSH
• DASHP

Frequently Asked Questions

What is the difference between USP 797 and USP 800?

USP 797 focuses on the sterility of the compounded preparation to protect the patient, while USP 800 focuses on the handling of hazardous drugs to protect the healthcare worker and the environment. When compounding sterile hazardous drugs, both chapters must be followed simultaneously.

Can hazardous and non-hazardous drugs be stored together?

No, hazardous drugs must be stored separately from non-hazardous drugs in a dedicated room with negative pressure and at least 12 air changes per hour. Refrigerated HDs must also be kept in a dedicated refrigerator in a negative pressure area.

Is a Closed System Drug Transfer Device (CSTD) mandatory?

Under USP 800, CSTDs are mandatory for the administration of hazardous drugs when the dosage form allows. While they are highly recommended for compounding, they are not strictly mandatory for that stage, though many facilities require them as an extra layer of safety.

Are N95 masks sufficient for handling hazardous drug spills?

No, N95 masks only protect against particulates and do not filter out the vapors or gases that may be released during a hazardous drug spill. A NIOSH-certified respirator with appropriate chemical cartridges or a PAPR is required for spill management.

What drugs are covered under USP 800?

USP 800 covers all drugs identified as hazardous by NIOSH, including antineoplastics like methotrexate, progestins like medroxyprogesterone, and certain antivirals like ribavirin. Facilities must maintain their own list based on the NIOSH criteria.

How should hazardous drug waste be disposed of?

Hazardous drug waste must be placed in specially marked containers, usually yellow for trace chemotherapy waste and black for bulk chemotherapy waste. These must be handled according to federal, state, and local regulations for hazardous waste disposal.