6.4 Hazardous Drug Handling & Safety (USP 800)

Hazardous Drug Handling & Safety (USP 800)

Introduction to USP Chapter 800 and Hazardous Drugs

While USP 795 and 797 are primarily concerned with protecting the patient from contaminated or improperly formulated medications, the primary focus of the United States Pharmacopeia (USP) Chapter 800 is entirely different: its purpose is to protect healthcare workers, patients, and the environment from the profound dangers of exposure to Hazardous Drugs (HDs). Hazardous drugs include antineoplastic (chemotherapy) agents, potent antivirals, certain hormones, and immunosuppressants. The National Institute for Occupational Safety and Health (NIOSH) maintains a comprehensive list of these drugs, categorized based on their toxicity. Exposure to these drugs, even in minute quantities through inhalation, dermal absorption, or accidental ingestion, can cause severe health consequences for pharmacy personnel, including carcinogenicity, teratogenicity (fetal abnormalities), reproductive toxicity, organ toxicity, and genotoxicity. The Georgia Board of Pharmacy rigorously enforces USP 800 to ensure that every pharmacy that receives, stores, compounds, or administers HDs maintains an environment that strictly contains these toxins. For the MPJE, candidates must possess a deep understanding of negative pressure requirements, specialized Containment Primary Engineering Controls (C-PECs), mandatory Personal Protective Equipment (PPE), closed-system drug-transfer devices (CSTDs), and emergency procedures such as spill management and medical surveillance programs.

Facility Design: Containment and Negative Pressure

The fundamental engineering principle for handling hazardous drugs is containment. This is achieved primarily through the use of negative pressure environments. Unlike non-hazardous sterile compounding (USP 797), which utilizes positive pressure to push clean air out, hazardous drug facilities use negative pressure to pull air into the room, ensuring that any toxic aerosols or dust generated during compounding are trapped inside the designated area and safely exhausted to the outside of the building.

Containment Primary Engineering Control (C-PEC): The workstation where HDs are actively handled and compounded is known as a C-PEC. For sterile hazardous compounding, this must be a Class II Biological Safety Cabinet (BSC) or a Compounding Aseptic Containment Isolator (CACI). These devices provide ISO Class 5 air quality to protect the sterile product, while simultaneously using a specialized airflow design and HEPA filters to protect the worker from drug exposure. The C-PEC must run continuously (24/7) and must be externally vented, meaning the exhausted air is sent directly outside the building, never recirculated into the pharmacy.

Containment Secondary Engineering Control (C-SEC): The room housing the C-PEC is the C-SEC. This room must be physically separated from all other preparation areas. It must maintain a continuous negative pressure relative to all adjacent areas. Furthermore, the C-SEC must maintain a specific rate of ventilation, measured in Air Changes Per Hour (ACPH). For a room used to compound sterile hazardous drugs, the C-SEC must maintain a minimum of 30 ACPH. If the room is used solely for storing HDs or compounding non-sterile HDs, it must maintain a minimum of 12 ACPH.

Receiving, Unpacking, and Storage

The protection of personnel begins the moment a hazardous drug shipment arrives at the pharmacy. HDs must be unpacked in an area that maintains neutral or negative pressure relative to surrounding areas; they must never be unpacked in positive pressure areas or in sterile compounding anterooms. Personnel unpacking HDs must wear appropriate PPE, including chemotherapy gloves, to protect against potential contamination on the outside of the shipping containers.

Storage of HDs also requires strict controls. Antineoplastic HDs and all HD APIs (Active Pharmaceutical Ingredients) must be stored separately from non-hazardous drugs in a designated, negative-pressure room with at least 12 ACPH. This room must be externally vented. Storing hazardous drugs in the same refrigerator as non-hazardous drugs is strictly prohibited; a dedicated refrigerator located within the negative pressure HD storage area is required.

Personal Protective Equipment (PPE) Requirements

Rigorous garbing and the use of specialized Personal Protective Equipment (PPE) are mandatory to prevent dermal and inhalation exposure to HDs. Standard compounding garb is insufficient. When compounding hazardous drugs, personnel must adhere to the following PPE requirements:

• Double Gloves: Two pairs of sterile, powder-free, chemotherapy-rated gloves must be worn. The inner glove goes under the cuff of the gown, and the outer glove goes over the cuff of the gown, creating a sealed barrier. Gloves must be changed every 30 minutes during compounding or immediately if torn, punctured, or contaminated.
• Gowns: Personnel must wear a disposable, impermeable gown specifically tested to resist permeability by hazardous drugs. These gowns must close in the back, have long sleeves with tight-fitting cuffs, and lack seams or closures that could allow drugs to pass through. Gowns must be changed every 2-3 hours or immediately after a spill or splash.
• Head, Hair, and Shoe Covers: Two pairs of shoe covers are required when entering the HD compounding area. The outer pair must be removed before exiting the C-SEC to prevent tracking hazardous residue into the rest of the pharmacy.
• Respiratory Protection: If there is a risk of airborne exposure (e.g., attending to a spill outside the C-PEC, or cleaning the C-PEC), an appropriate fit-tested N95 respirator or a powered air-purifying respirator (PAPR) must be utilized.

Administration and Closed-System Drug-Transfer Devices (CSTDs)

While nurses typically administer IV hazardous drugs, pharmacists must ensure the drugs are prepared safely for administration. USP 800 highly recommends the use of Closed-System Drug-Transfer Devices (CSTDs) during compounding and absolutely mandates their use during the administration of antineoplastic HDs (when the dosage form allows). A CSTD is a specialized device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. These devices add a crucial layer of protection for the nurses administering the chemotherapy.

Spill Management and Medical Surveillance

Despite stringent controls, accidents can happen. Every pharmacy handling HDs must have explicit, written Standard Operating Procedures (SOPs) detailing spill management protocols. Specialized HD spill kits must be readily available in all areas where HDs are received, stored, compounded, or transported. Personnel must be trained annually on the proper procedures for containing and cleaning up an HD spill, and any spill must be immediately documented and reported.

Furthermore, USP 800 emphasizes the importance of a Medical Surveillance Program. This program involves the proactive monitoring of healthcare workers who routinely handle HDs to identify any early signs of adverse health effects related to exposure. While USP 800 recommends rather than strictly mandates medical surveillance, it is considered a vital best practice for employee health and liability mitigation. A comprehensive program includes baseline health assessments prior to the employee handling HDs, periodic follow-up examinations, and an established protocol for addressing acute exposure events.

Table: USP 800 Facility Requirements Summary