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A Focus on Protecting Healthcare Patients and Staff: Meeting USP 797 and 800 Standards Handling Hazardous Drugs

A refined set of standards significantly impacts hospital compounding practices in the ever-changing healthcare and pharmaceutical landscapes. Before we dive in – don’t forget to download our strategic insights and free checklists for seamless adaptation to new compliance regulations.  


The new USP 800 standards provide detailed specifications for handling hazardous drugs to protect patients and pharmacy staff from health risks associated with harmful compounds. Hazardous drug compounds are identified by the National Institute for Occupational Safety and Health (NIOSH) based on criteria including carcinogenicity, teratogenicity, genotoxicity, and toxicity. NIOSH goes on to state, “Exposure to HDs can result in adverse health effects in health care workers. Published studies have shown that workplace exposure to hazardous drugs can cause both acute and chronic health effects. The health risk depends on how much exposure a worker has to these drugs and how toxic they are. Workers can be protected from hazardous drug exposure through engineering and administrative controls and proper protective equipment”. 


It is also essential to note Chapter 800 adds to the compounding standards already in place with the USP <795> and <797> regulations. The premise behind USP <800> is that no exposure to hazardous drugs is acceptable. Pharmacies that handle these dangerous drugs are often found in hospitals and are primarily regulated by the State Boards of Pharmacy. They may also be inspected by the U.S. Food and Drug Administration (FDA)


So, how do we, as architects and engineers, help healthcare staff mitigate exposure in these areas? By correctly designing spaces and utilizing proper engineering controls, we can help personnel by limiting the lowest possible level of hazardous exposure. 


As a result of regulatory updates, many pharmacies in hospitals and cancer clinic settings may require significant modifications to comply with the safety requirements. An overview of the requirements below shows the standards that address the sequence and types of spaces required; appropriate finishes for floors, counters, and ceilings; necessary components, such as a sink and an emergency eyewash station; and environmental controls. This includes negative pressure spaces for unpackaging, storing, and compounding the hazardous drugs in a manner that minimizes exposure risk. In many cases, pharmacies may need to expand or reconfigure their space and modify their HVAC strategy to accommodate the prescribed standard. 


Pharmacies may need to renovate their facilities in order to accommodate new USP 800 standards.


Creating a Safe Process: Unpack, Prepare, and Store

Pharmacists and hospital facility administrators must focus on three primary functions in handling hazardous drugs to comply with USP 800: unpacking, preparation (compounding), and storage. 


Delivery and Storage 

First, the rules call for hazardous drugs to be unpacked and stored separately in unfavorable pressure rooms, which are externally vented with a minimum of 12 air exchanges per hour (ACH) to mitigate exposure to residues and gases of harmful chemicals in the containers.  The only exception is unit-dose or unit-of-use packaging, if not altered. As such, Pharmacy staff will no longer be able to unpack or store the drugs in general pharmacy spaces or non-hazardous storage areas often designed with positive pressurization. This may require converting an existing space into a storage area meeting USP requirements. 


Anterooms 

Second, USP 800 requires the use of Anterooms. Often referred to as Air Locks, these rooms are the buffer between a “clean room” and a “non-clean” space to allow for the transition of air pressure differentials and help prevent cross-contamination between rooms. The anterooms should have a handwashing sink near the entrance and a line of demarcation for gowning and PPE. They must also meet ISO Class 7 cleanroom requirements, have HEPA-filtered supply grilles, and have negative pressure relative to adjacent spaces.  


Hazardous Compounding Rooms 

Third, Hazardous and non-hazardous compounding must now be performed in separate rooms per USP <800>.  Often known as secondary engineering control (C-SEC) rooms, the compounding room must meet ISO Class 7 cleanroom requirements, operate at negative pressure relative to adjacent spaces, be 100% exhausted to the outside, have HEPA-filtered supply grilles, and have a minimum of 30 air changes per hour (ACH).  To assist with proper air flows, low wall exhaust grills are to be installed in the direction of airflow with pressurization continuously maintained and monitored, even when unoccupied. Temperature and humidity requirements for the C-SEC room are lower than before. These requirements are addressed in USP 797 with revisions that call for a standard of a continuously maintained temperature of 20°C (68°F) and 60% humidity. Consider keeping your compounding room at lower conditions to allow some buffer in the temperature to avoid having to shut down operations in the case of a higher fluctuation.  

Pressurization and ISO requirements for a typical USP 800 pharmacy.


Additionally, the flooring must be smooth and waterproof with sealed seams, resistant to disinfectant agents, and easy to clean. Wall protection features, including corner and wall guards, help protect against wear and tear from carts and hand trucks. Counters must also be made of waterproof, nonporous materials with integral sinks for durability and to maximize infection controls. Modular casework storage systems should be considered for flexibility and integration during space planning. Sprinkler heads must be flush-mounted and concealed for cleanroom use, and lights must be sealed, as well as cleanroom-style fixtures.


Within the hazardous compounding room(s), both sterile and non-sterile compounding of dangerous drugs are to be performed in a type of containment primary engineering control (C-PEC) called a Class II B biosafety cabinet or compounding aseptic containment isolator, which provides an ISO Class 5 cleanroom environment. These must be exhausted to the outside for the safety of the staff working with these hazardous drugs and run continuously with emergency power available. 


Compounding hazardous drugs must take place in a biological safety cabinet (C-PEC). 


Other Considerations  

While retrofitting pharmacy spaces to meet USP 800 requirements, pharmacists and facility administrators may want to explore options to incorporate dispensing and conveyor system technologies. New material handling technologies are critical in reducing errors and improving staff efficiency regarding how drugs are stored, filled, and delivered. Other technological measures must be addressed, including security, which is an essential concern in protecting controlled substances. Security gates, cameras, card readers, access-controlled cabinets, and staff lockers with glass fronts are all necessary pharmacy security measures. 




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