Hazardous Drug Management Policy

1. Policy Statement

It is the policy of this organization that the safe handling of hazardous drugs requires a comprehensive, multi-layered approach addressing all points in the chain of custody—from receipt and storage through preparation, administration, patient body fluid contact, and final disposal. There is no established safe threshold of exposure for many hazardous drugs. The organization shall implement controls at every stage of the hazardous drug lifecycle, prioritize the hierarchy of controls (elimination, substitution, engineering controls, administrative controls, and PPE), and ensure that all personnel who handle hazardous drugs are trained, competent, monitored, and supported.

2. Purpose

This policy exists to:

• Protect clinical and non-clinical personnel, patients, and the environment from unintentional exposure to hazardous drugs at every stage of handling.
• Establish and maintain a comprehensive institutional hazardous drug list, updated annually and upon formulary changes.
• Define the hierarchy of engineering and administrative controls and PPE requirements for hazardous drug handling.
• Mandate environmental monitoring, medical surveillance, and training programs that support early detection of exposure and sustained worker safety.
• Define spill management, exposure response, and waste disposal procedures that comply with applicable jurisdictional regulations.
• Address hazardous drug handling in home care settings.

3. Scope

This policy applies to:

• All clinical and non-clinical personnel who handle hazardous drugs or contaminated waste in any stage of the drug lifecycle, including receipt, storage, compounding, preparation, transportation, administration, and disposal.
• All settings where hazardous drugs are handled: inpatient units, intensive care, emergency departments, perioperative areas, pharmacy compounding areas, outpatient infusion centers, ambulatory clinics, home health, and physician offices.
• Pharmacy, Nursing, Physicians, Advanced Practice Providers, Occupational Health, Environmental Services, Supply Chain, and Biomedical Engineering insofar as they handle, manage, or clean areas where hazardous drugs are present.
• All hazardous drugs as defined by the current NIOSH Hazardous Drug List and the organization’s institutional hazardous drug list.

4. Policy Requirements

4.1 Hazardous Drug Identification and Classification

4.1.1 Institutional Hazardous Drug List. The organization shall prepare, distribute, and maintain a comprehensive list of all hazardous drugs used within the facility. This list shall be reviewed and updated at minimum annually and immediately when new drugs are introduced into the formulary before their first use.

4.1.2 The list shall be compiled in accordance with the current NIOSH Hazardous Drug List and supplemented by additional trustworthy sources to identify hazardous drugs excluded from NIOSH classification, including: radiopharmaceuticals, veterinary drugs used in human applications, and biologic products approved through FDA’s Center for Biologics Evaluation and Research (CBER).

4.1.3 For newly approved drugs with mechanisms of action suggestive of potential harm, a precautionary approach shall be adopted: these agents shall be handled as hazardous drugs until sufficient safety data is available to determine hazardous status definitively.

4.1.4 Risk Categorization. Hazardous drugs shall be categorized per NIOSH risk groups:

• Group 1: Drugs known to be or probably carcinogenic to humans (based on epidemiological studies or animal research). Stringent handling precautions are required.
• Group 2: Drugs meeting NIOSH hazardous criteria but not confirmed carcinogens; may exhibit reproductive toxicity, genotoxicity, or organ toxicity at low doses.

4.1.5 Labeling. All hazardous drugs shall be physically labeled at all times with the drug name and appropriate hazard warnings. Where technologically feasible, hazardous drugs shall be flagged electronically within the EHR, electronic medication administration record, and infusion pump drug libraries.

4.2 Exposure Control Program and Hierarchy of Controls

4.2.1 The organization shall implement a comprehensive exposure control program addressing every stage of the hazardous drug lifecycle, applying controls in the following order of priority (most to least effective):

Elimination. Removing the hazard entirely: avoiding unnecessary doses, discontinuing treatment when clinical benefit is no longer evident, or choosing non-pharmacologic alternatives when appropriate.

Substitution. Replacing a hazardous agent with a less hazardous alternative: switching from IV to oral administration when therapeutically equivalent, selecting drugs with lower toxicity when efficacy is comparable, or using ready-to-administer formulations that eliminate compounding-related exposure.

Engineering Controls. Physical containment systems that isolate healthcare workers from the hazard. The most critical engineering control is compounding within a Biological Safety Cabinet (BSC) or other containment primary engineering control (C-PEC). Additional engineering controls include: closed-system drug transfer devices (CSTDs), needleless connectors, and negative-pressure preparation rooms.

Administrative Controls. Organizational policies, standard operating procedures, restricted access, medical surveillance programs, and training that change how people interact with hazardous drugs.

Personal Protective Equipment (PPE). Physical barrier between the worker and the hazard. PPE is the least effective control but remains essential when used in combination with higher-level controls.

4.3 Personal Protective Equipment

4.3.1 Selection and Use. Healthcare workers shall wear PPE appropriate to the route of exposure risk and the procedures being performed. All PPE shall be removed immediately upon leaving the hazardous drug handling area. Contaminated PPE shall be disposed of as hazardous waste.

4.3.2 Donning and Doffing. Organizational policies shall include detailed, step-by-step instructions for proper donning and doffing of PPE, including goggles, face shields, head covers, fit-tested respirators (when required), chemotherapy gloves, and protective gowns. Correct doffing sequence is critical to prevent self-contamination.

4.3.3 Competency. Competency in PPE donning and doffing shall be assessed and documented for all employees who may experience environmental exposure to hazardous drugs at initial hire and at minimum annually thereafter.

4.3.4 Barrier Removal. The organization shall proactively identify and remove barriers to PPE compliance, including: inadequate product availability at the point of use, uncomfortable or poorly fitting equipment, time pressure, inadequate training, poor understanding of exposure risks, and absence of accountability for non-compliance.

4.4 Special Populations: Reproductive Health

4.4.1 Healthcare workers who are actively trying to conceive, currently pregnant, or breastfeeding shall be allowed to refrain from exposure to hazardous drugs and contaminated waste.

4.4.2 The organization shall develop clear policies addressing reproductive health concerns and shall provide work reassignment options that do not create career penalties for workers who choose to avoid hazardous drug exposure.

4.5 Environmental Monitoring

4.5.1 The organization shall conduct environmental wipe sampling at minimum every six months to identify surface residue of hazardous drugs in areas where compounding, preparation, and administration occur. Sampling locations shall include: pharmacy compounding areas, patient treatment areas, medication storage, transport containers, infusion pumps, and work surfaces.

4.5.2 When surface contamination is detected, the organization shall: identify and document the source, perform thorough deactivation and decontamination, and adjust engineering or administrative controls to prevent recontamination.

4.6 Medical Surveillance

4.6.1 Healthcare workers for whom hazardous drug handling is a regular part of their job assignment shall participate in a medical surveillance program. The program shall include: baseline health assessment, periodic health monitoring, reproductive health counseling, and exposure documentation.

4.6.2 Individuals who experience acute hazardous drug exposure (significant spills, direct skin contact with concentrated drug solutions) shall undergo clinical evaluation, indicated laboratory testing, incident documentation, and follow-up assessment for delayed health effects.

4.7 Training and Competency

4.7.1 Pre-Independent Handling. Training and competency assessment shall be completed and documented before any clinician handles hazardous drugs independently. Initial training shall cover: the institutional hazardous drug list and associated risks, applicable policies and procedures, PPE use, exposure incident management, spill management, and waste disposal.

4.7.2 Annual Competency. Competency in hazardous drug handling shall be reassessed and documented at minimum every 12 months for all personnel who regularly handle hazardous drugs.

4.8 Compounding and Preparation

4.8.1 Closed-System Drug Transfer Devices. CSTDs shall be used during sterile compounding of hazardous drugs wherever possible. CSTDs mechanically prevent environmental contaminants from entering the system and hazardous drug or vapor from escaping. When selecting CSTDs, priority shall be given to devices with containment reduction demonstrated by independent, peer-reviewed studies.

4.8.2 CSTDs do not eliminate the need for biological safety cabinets or PPE; they function as an additional layer of protection within a comprehensive safety program.

4.9 Administration Procedures

4.9.1 Protective devices—including needleless connectors and CSTDs—shall be used for administration of all hazardous drugs when the dosage form allows. CSTD selection shall be based on independent, peer-reviewed evidence of containment performance.

4.9.2 Priming. Spiking the administration set and priming shall be performed within the containment primary engineering control (C-PEC) whenever possible to minimize aerosolization risk. If priming must occur outside the C-PEC, back-priming using a CSTD with proven dry-connection capability shall be employed.

4.9.3 Pre-Infusion Inspection. Healthcare workers shall perform a visual inspection of the solution container, administration set, and vascular access device connections before starting a hazardous drug infusion to identify any loose connections or damaged components.

4.9.4 Post-Administration Disposal. After hazardous drug administration, the drug container shall be disposed of with the administration set still attached to eliminate exposure from aerosolization during disconnection. A new administration set shall be used for each hazardous drug dose.

4.10 Spill Management

4.10.1 Spill Kit Availability. Spill kits containing all necessary materials shall be available wherever hazardous drugs are prepared, transported, or administered. Spill kits shall include: chemotherapy-resistant gloves, protective gowns, eye protection, shoe covers, absorbent materials, hazardous waste disposal bags, signage to restrict access, and appropriate deactivating agents.

4.10.2 Spill Response. Written spill response protocols shall specify: appropriate deactivating agents, required dilutions, documentation and reporting requirements, responsible personnel, and proper use of spill kit materials by surface type (hard surfaces, carpet, BSC). Response sequence: containment → deactivation → decontamination → cleaning.

4.10.3 Spills exceeding standard spill kit capability shall be managed by personnel trained in hazardous waste management using a cartridge respirator or powered air purifying respirator (PAPR). Large spills may require environmental health and safety specialists or hazardous materials teams.

4.11 Exposure Management

4.11.1 Immediate Response. Upon any hazardous drug exposure:

• Skin exposure: Remove contaminated clothing; wash skin with soap and water for at least 15 minutes for significant exposures.
• Eye exposure: Flush with saline or water for at least 15 minutes; seek emergency medical evaluation for corneal assessment.
• Inhalation: Move immediately to fresh air; seek emergency treatment if symptoms are severe or persistent.
• Needlestick/skin puncture: Allow brief free bleeding to flush the wound; cleanse thoroughly with soap and water. Do not squeeze or aggressively manipulate the wound.

4.11.2 All hazardous drug exposures shall be reported to the organization’s Occupational Health and Safety department. Documentation of exposure incidents provides data for trend analysis, identifies areas requiring process improvement, and supports medical surveillance records.

4.12 Waste Management

4.12.1 Hazardous waste shall be disposed of and segregated in accordance with jurisdictional regulations. Contaminated materials (empty vials, syringes, drug containers, administration sets, gloves, gowns) shall be placed in sealable, leak-proof hazardous waste bags. Sharps (needles, open ampoules) shall be placed in puncture-proof hazardous waste containers.

4.12.2 Hazardous waste containers shall be clearly labeled with contents and required precautions. Color-coded containers shall be used to facilitate proper segregation. Hazardous waste shall never be placed in standard medical waste containers.

4.13 Patient Body Fluid Precautions

4.13.1 Healthcare workers shall employ safety precautions when handling patient body fluids for at least 48 hours after the patient receives a hazardous drug, and for the full known excretion duration for drugs that persist in body fluids longer than 48 hours. Pharmacy consultation shall provide guidance on metabolism and excretion times for specific drugs.

4.13.2 Disposable linens and leakproof pads shall be used when possible to contain contaminated body fluids. Patients shall be identified through posted signs or labels to alert staff and visitors when body fluid precautions are required.

4.13.3 Patients and caregivers shall receive education on safe body fluid handling following hazardous drug administration, including proper disposal of disposable materials and laundry procedures for contaminated linens.

4.14 Home Healthcare

4.14.1 Home Spill Kits. Spill kits shall be provided whenever hazardous drugs are administered in the home setting. Home spill kits may use simplified cleaning procedures (dishwashing or laundry detergent with disposable cloths/paper towels, followed by water rinse with disposable towels) while maintaining adequate patient and caregiver protection.

4.14.2 Home Waste Disposal. Patients and caregivers shall receive instruction on storing contaminated clothing or linens in plastic bags until washing. Contaminated laundry shall be machine washed twice—separate from other household laundry—using regular detergent. Disposable diapers from patients receiving hazardous drugs shall be discarded in plastic bags. Contaminated materials shall be stored away from pregnant individuals, children, and pets.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through: semi-annual environmental wipe sampling results, annual competency documentation audit rates, PPE compliance observation during clinical rounding, tracking of exposure incidents and spill events, medical surveillance participation rates, and waste disposal audit compliance.

5.2 Key Performance Indicators.

• Environmental wipe sampling completion rate (target: 100% bi-annually).
• Hazardous drug handling competency documentation rate (target: 100% annually).
• PPE compliance rate during hazardous drug handling observations (target: ≥95%).
• Exposure incident reporting rate and follow-up completion rate (target: 100%).

5.3 Enforcement. Handling hazardous drugs without documented competency or without required PPE is a serious policy violation. Non-compliance with environmental monitoring or waste disposal requirements shall be escalated to Occupational Health and the CNO for corrective action.

6. Exceptions

6.1 In emergent clinical situations requiring immediate administration of a hazardous drug where standard PPE is not immediately accessible, the clinician shall use whatever protective equipment is available and shall obtain appropriate PPE as soon as the immediate clinical need is addressed. The incident shall be documented and reported to Occupational Health.

6.2 Reproductive health work reassignment shall be provided without requiring disclosure of pregnancy status beyond what is minimally necessary to support the accommodation.

7. Related Documents

• USP General Chapter <800>: Hazardous Drugs — Handling in Healthcare Settings
• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings
• OSHA Hazard Communication Standard (29 CFR 1910.1200)
• ASHP Guidelines on Handling Hazardous Drugs
• POL-009: Patient Education in Infusion Therapy
• POL-003: Evidence-Based Selection and Clinical Monitoring Standards
• Organizational Occupational Health and Safety Policy
• Organizational Hazardous Waste Disposal Policy
• Hazardous Drug Spill Response Protocol
• Institutional Hazardous Drug List (maintained by Pharmacy)

8. Revision History