USP 800 and Hazardous Drugs

USP 800 Overview

• USP 800 regulates the safe handling of hazardous drugs (HD) in healthcare to ensure safety and environmental protection.

Hazardous Drugs

• Drugs classified as hazardous due to potential carcinogenic, teratogenic, reproductive, organ toxicity, or other harmful effects.

NIOSH List

• The National Institute for Occupational Safety and Health maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.

NIOSH Drug Categories

• Drugs are divided into three groups:
  • Antineoplastic drugs
  • Non-antineoplastic drugs
  • Drugs that pose reproductive risks

Common Hazardous Drugs

• Frequently found drugs on the NIOSH list include estrogens, clonazepam, phenytoin, and valproic acid, among others.

Pharmacy Practices

• Most pharmacies stock at least one medication from the NIOSH list, highlighting the prevalence of these drugs.

NIOSH List Updates

• The NIOSH list is not continuously updated, so facilities must routinely assess new hazardous drugs and their risks.

Evaluating Hazardous Potential

• Evaluate hazardous drugs by checking Safety Data Sheets (SDSs) and reviewing product labeling.

Routes of Unintentional Exposure

• Hazardous drugs can enter the body through:
  • Dermal/mucosal absorption
  • Inhalation
  • Injection
  • Ingestion

Contact Points for Hazardous Drugs

• Receipt of hazardous drugs may leave residues on containers, work surfaces, and floors.
• Dispensing activities can result in contact during tablet processing.
• Compounding or manipulation involves direct contact with hazardous drugs.
• Administration may involve IV setups or specialized aerosol procedures.
• Patient care activities include handling contaminated body fluids.

Spill Management

• Spills require effective management and disposal strategies to minimize exposure risks.

Drug Transport

• Healthcare settings must manage the transport of hazardous drugs carefully to prevent exposure.

Waste Disposal

• Safe collection and disposal of hazardous drug waste is critical for environmental safety.

Facility Responsibilities

• Each healthcare facility must identify hazardous medications and establish procedures for safe handling.

Risk Levels by Activity

• Dispensing a single, intact tablet or capsule is low risk (gloves recommended).
• Repeatedly counting, cutting, or crushing tablets increases risk, necessitating double gloves, gowns, and respiratory protection.
• Compounding IV hazardous drugs is very high risk and requires rigorous controls including double gloves and containment devices.

USP 800 Compliance

• Only hazardous drugs that are active ingredients in compounding or require manipulation are subject to USP 800.
• Final dosage forms that only require counting or repackaging do not need to follow USP 800.

Engineering Controls

• Containment Primary (CPEC) and Secondary (CSEC) Engineering Controls are essential to protect staff from hazardous exposure.

CPEC Definition and Function

• CPECs are ventilated devices designed to minimize worker and environmental exposure to hazardous drugs.

CSEC Definition

• CSEC is the designated room where CPECs are located, ensuring controlled environments for hazardous drug handling.

Supplemental Engineering Controls

• These provide additional protection, such as closed-system drug transfer devices, which minimize exposure during drug transfer.

HEPA Filtration

• High-Efficiency Particulate Air (HEPA) filters are crucial, capturing 99.97% of particles larger than 0.3 microns, creating sterile environments.

Sterile Compounding CPECs

• BSCs and CACIs are examples of CPECs for sterile compounding, ensuring protection against contamination.

Non-Sterile Compounding CPECs

• Examples include Containment Ventilated Enclosures (CVE) and Class I and II BSCs, providing protection for the compounder.

Importance of CSEC

• CSECs are necessary for containing CPECs and ensuring both sterile and non-sterile compounding safety.