Hazardous And Nonhazardous Drugs - NAPLEX

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.

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.

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.

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

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

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

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

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

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.

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

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.

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.

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.

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.

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.

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

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

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

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

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

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

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.

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