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CHDHP Interactive Case Studies
Certified Hazardous Drug Handling Pharmacist (CHDHP)
The Scenario: Managing a Large-Volume Hazardous Drug Spill
A pharmacy technician drops a 1-liter IV bag of cyclophosphamide (a NIOSH Table 1 hazardous drug) while transporting it from the cleanroom. The bag ruptures, spilling the entire contents onto the floor of the anteroom. As the CHDHP, you are the first pharmacist to respond and must direct the immediate response according to USP <800> standards.
Spill Details & USP <800> Requirements
Spill Details
- Drug: Cyclophosphamide 1000 mg / 1000 mL
- Location: Anteroom floor
- Exposed Personnel: One technician, wearing a gown and non-sterile gloves.
USP <800> Protocol (Excerpt)
- For large HD spills, immediately alert and evacuate personnel.
- Secure the area to prevent spreading contamination.
- Personnel cleaning the spill must wear full HD-appropriate PPE, including a respirator.
- Use a dedicated hazardous drug spill kit.
Your Task
Task 1: What are your first three immediate actions as the scene commander?
Answer:
- Secure the Area: Immediately restrict access to the anteroom and the connected cleanroom to prevent staff from walking through the spill and spreading contamination.
- Alert & Evacuate: Announce a hazardous drug spill to alert all staff and direct any unnecessary personnel to evacuate the immediate vicinity.
- Manage the Exposed Employee: Remove the technician from the area, have them immediately doff their contaminated garb, and instruct them to wash any exposed skin thoroughly. Initiate the employee exposure protocol.
Task 2: What is the minimum required Personal Protective Equipment (PPE) for the staff who will clean up this spill?
Answer:
The minimum PPE includes: two pairs of ASTM D6978-rated chemotherapy gloves, a disposable coated chemotherapy gown, eye protection (goggles or face shield), and an appropriate respirator (an N95 is the minimum, but a PAPR or respirator with chemical cartridges is preferred for large liquid spills).
Task 3: After the visible spill is cleaned, what is the three-step decontamination process required for the floor surface?
Answer:
The surface must undergo a three-step process: 1. Deactivation (using an agent like sodium hypochlorite to break down the active drug); 2. Decontamination (using a germicidal detergent to remove residue); and 3. Cleaning (rinsing with sterile water to remove any remaining chemicals).
Task 4: What is the most critical piece of documentation that must be completed after the incident?
Answer:
An employee exposure report for the technician must be completed. This document details the circumstances of the exposure, the hazardous drug involved, and the immediate actions taken. This is a critical legal and occupational health record for monitoring any potential long-term health effects from the exposure.
The Scenario: Applying PPE Requirements to Different Tasks
You are the CHDHP for a hospital pharmacy, conducting a safety audit. You observe several staff members performing tasks involving hazardous drugs. Your role is to determine if their Personal Protective Equipment (PPE) is appropriate for each specific task according to USP <800> standards.
Observations & USP <800> PPE Requirements
Observed Scenarios
- Receiving: A technician unpacks a tote containing intact, sealed bottles of methotrexate tablets. He is not wearing gloves.
- Compounding: A pharmacist compounds IV cyclophosphamide in a BSC, wearing one pair of sterile chemo gloves and a non-coated gown.
- Administering: A nurse prepares to administer IV paclitaxel, wearing one pair of standard nitrile exam gloves.
USP <800> PPE Requirements
- Receiving Intact HDs: Minimum of one pair of chemotherapy gloves.
- Sterile Compounding: Two pairs of sterile chemotherapy gloves and a coated chemotherapy gown.
- Administering IV HDs: Two pairs of chemotherapy gloves and a chemotherapy gown.
Your Task
Task 1: Is the technician in the receiving area compliant? If not, what is the minimum required PPE?
Answer:
No, he is not compliant. USP <800> requires personnel unpacking HDs to wear a minimum of one pair of ASTM D6978-rated chemotherapy gloves, as the exterior of the vials may be contaminated with drug residue.
Task 2: The compounding pharmacist is wearing incorrect PPE in two ways. What are they?
Answer:
1. She is only wearing one pair of gloves when two pairs of sterile chemotherapy gloves are required for sterile compounding. 2. She is wearing a non-coated gown, but USP <800> requires a disposable chemotherapy gown made of a material that is coated to be impervious to the chemicals.
Task 3: Is the nurse administering the IV paclitaxel compliant?
Answer:
No. She is wearing a single pair of standard exam gloves. Administering an injectable antineoplastic requires a minimum of two pairs of chemotherapy gloves and a chemotherapy gown to protect from potential leaks and sprays during the administration process.
Task 4: What specific ASTM standard must all chemotherapy gloves meet, and why is it important?
Answer:
They must meet the ASTM D6978 standard. This is critical because this standard specifically tests the glove's resistance to permeation by hazardous chemotherapy drugs over time. Standard nitrile exam gloves are not tested for this and offer no reliable protection against chemical exposure.
The Scenario: Conducting an Assessment of Risk (AoR)
A urology clinic that is part of your health system dispenses finasteride 5mg tablets. Finasteride is on NIOSH List 3 for reproductive risks. The clinic does not have a negative pressure room or full HD containment. As the CHDHP, you must conduct an Assessment of Risk (AoR) to determine if alternative containment strategies are permissible for this specific activity, as allowed by USP <800>.
Drug, Workflow, and USP <800> Rules
Drug & Workflow Details
- Drug: Finasteride 5 mg tablets (NIOSH Table 3)
- Dosage Form: Intact, film-coated tablets. Not scored.
- Workflow: Tablets are dispensed from a stock bottle into a vial using a dedicated counting tray. No splitting or crushing occurs.
USP <800> AoR Requirements
An AoR allows for alternative containment strategies for certain HDs if a documented assessment evaluates the:
- 1. Type of HD
- 2. Dosage Form
- 3. Risk of Exposure
- 4. Packaging
- 5. Manipulation
Your Task
Task 1: What is the purpose of an Assessment of Risk (AoR) under USP <800>?
Answer:
The purpose is to provide a formal, documented process for an entity to evaluate specific, lower-risk hazardous drug activities (e.g., handling intact tablets) and determine if they can be performed safely with alternative containment strategies and work practices, rather than the full, stringent requirements of the chapter (such as handling in a negative pressure room).
Task 2: Based on the five required elements, analyze the risk of handling finasteride tablets in this clinic.
Answer:
The overall risk is low: 1) Type: NIOSH Table 3 (reproductive risk only, not carcinogenic). 2) Dosage Form: Intact, film-coated tablet (low risk of aerosolization). 3) Risk of Exposure: Minimal. 4) Packaging: Secure manufacturer bottle. 5) Manipulation: Simple counting only; no splitting or crushing that would generate dust.
Task 3: Can this activity be performed without full USP <800> containment? Justify your answer.
Answer:
Yes. Because the drug is a NIOSH Table 3 agent handled in its final, intact dosage form without any manipulation that would create particles, a properly conducted AoR can justify handling it on the general pharmacy countertop with alternative containment strategies.
Task 4: What specific "alternative containment strategies and work practices" must be implemented and documented in your AoR?
Answer:
The AoR must specify, at a minimum: 1) PPE: Staff must wear one pair of chemotherapy gloves. 2) Designated Area: The counting must be done on a dedicated counting tray and spatula used only for hazardous drugs. 3) Decontamination: The counting tray and spatula must be immediately decontaminated and cleaned after use. 4) Staff Training: All staff handling finasteride must receive specific training on its reproductive risks, and this training must be documented.
