Unpacking USP 800
Healthcare workers who handle hazardous drugs, such as those used to treat cancer, are exposed to harmful chemicals that can pose some serious health risks: infertility, spontaneous abortions, congenital malformations, cancer, immune disorders—and the list goes on.
Since 1994, more than 100 studies related to hazardous drug handling from organizations including the Oncology Nurses Society, American Society of Clinical Oncology, and Occupational Safety and Health Administration have documented evidence that the work environment can become contaminated with hazardous drugs when these materials are handled without adequate precautions. Until now, there hasn’t been an authoritative standard for how spaces that store, prepare, transport, or administer hazardous drugs, including pharmacies, hospitals, patient treatment clinics, and physician’s practice facilities, should be designed to minimize this risk.
The United States Pharmacopeial (USP) Convention’s Chapter 800, “Hazardous Drugs—Handling in Healthcare Settings,” changes all of that. Released in February 2016, USP 800 provides guidance for personnel handling hazardous drugs, including the use of personal protective equipment and proper communication, training, transport, package labeling, and disposal. It also offers specifications for the built environment, including engineering controls. The national standard will become effective July 1, 2018, and many pharmacies in the U.S. will need to modify their spaces prior to that date to meet these new guidelines.
Before USP 800, pharmaceutical compounding was regulated by two standards, USP 795 and USP 797, which provide guidelines for nonsterile preparations and sterile preparations but don’t distinguish between hazardous and nonhazardous drugs.
USP 800 provides recommendations for hazardous drugs, specifically, and will have several implications for the space planning of new pharmacies. For example, the new guidelines require that hazardous drugs be unpacked, stored, and prepared in separate areas from nonhazardous drugs, which could require more square footage to accommodate these two workspaces. There are also new HVAC requirements that, depending on the type of drugs being compounded, will affect space planning.
Previously, pharmacies with compounding areas were required to be at positive pressurizations. Now, these spaces will need to be negatively pressurized, which necessitates dedicated exhaust ductwork to the exterior, impacting where pharmacies are located in a building to minimize the routing of exhaust equipment.
Existing pharmacies face tougher challenges, though, such as adapting existing wall systems to create new separations and accommodating new workflows and air-handling systems. Modifications will vary widely depending on existing conditions and the types of drugs the pharmacy prepares, ranging from executing minimal door or wall reconfigurations to relocating whole departments to maintain operations while new spaces are constructed. These types of projects will need to be evaluated on a case-by-case basis to determine the least impactful process. Collaboration between designers and pharmacy and facilities staff will be essential to develop the appropriate solution.
As facilities look to adopt these new guidelines, they should focus on three areas of concern: unpacking spaces, preparation/compounding spaces, and storage spaces.
- Unpacking spaces
The rule: Unpacking hazardous drugs from shipping containers can’t occur in an area that’s positively pressurized relative to surrounding areas.
What it means: Pharmacies are typically designed at a positive pressurization, and, currently, many pharmacies use their general pharmacy space to unpack hazardous drugs. This means they need to find a new place to unpack. Additionally, the containers used to ship hazardous drugs can contain harmful chemicals that present a risk to workers. In a positively pressurized environment, those residues and gasses may drift into adjacent areas. Unpacking in a negatively pressured or neutral environment prevents this.
- Identify an existing neutral area within the general pharmacy that can be designated for unpacking hazardous drugs.
- Unpack hazardous drugs in a negatively pressured hazardous drug storage room.
- Unpack in a neutral or negative area outside of the pharmacy (general shipping or receiving area).
- Preparation/compounding spaces
The rule: Hazardous-drug compounding must take place in a containment primary engineering control (C-PEC), or hood, located in a dedicated secondary engineering control (S-SEC) room, or buffer room, that’s externally ventilated, physically separated from other areas, and maintained at a negative pressure. In addition, sterile and nonsterile hazardous drugs need to be prepared in separate rooms, unless primary engineering controls (PEC) allow ISO Class 7 conditions, which relate to clean room design and correspond to the amount of particulate matter in room air, to be maintained continuously in the room where required.
What it means: There are two considerations at play here: separating hazardous drug preparation from nonhazardous drug preparation and separating sterile hazardous drug preparation from nonsterile hazardous drug preparation. Previously, compounding pharmacies could process sterile hazardous drugs and sterile nonhazardous drugs in the same room. However, USP 800 will require the same pharmacy to have two buffer rooms, one negative (hazardous) and one positive (nonhazardous). To access the buffer rooms, a positive-pressure ISO Class 7 anteroom is needed. (ISO Class 7 buffer rooms and anterooms aren’t required for lower-risk hazardous drugs, which are outlined in the USP 797 and 800 standards, but the more conservative approach is best here.) Although the processing of sterile and nonsterile hazardous drugs can theoretically occur in the same buffer room, the reality is that it would be impractical in most cases because it’s challenging to keep a room sterile while there are nonsterile processes occurring. Considering this, USP 800 recommends that the two be separated.
- Design around a shared positively pressurized anteroom to serve both a dedicated hazardous and a nonhazardous buffer room.
- Convert a space adjacent to the existing compounding room into a dedicated hazardous buffer room.
- Storage spaces
The rule: Hazardous drugs that require manipulation, such as those mixed with various drug components to create a specific prescribed drug combination or a reduced dosage of a manufactured drug for administering to a child, must be stored separately from nonhazardous drugs in an externally ventilated, negative-pressure room with a minimum of 12 air changes per hour (ACH), which is how many times the air within a defined volume of space is replaced through supply or exhausting of air.
What it means: USP 800 will have the biggest impact on pharmacies that prepare several different types of drugs, such as nonhazardous sterile drugs, hazardous nonsterile drugs, and hazardous sterile drugs. Currently, many pharmacies use the same room for storing hazardous drugs (both sterile and nonsterile) and nonhazardous drugs. USP 800 limits where hazardous drugs can be stored. Adding further complication, nonsterile hazardous drugs can’t be stored in the sterile buffer room.
- An existing storage room or office can be converted into a negatively pressurized storage area for both sterile and nonsterile hazardous drugs.
- The sterile hazardous-drug buffer room can double as storage for sterile hazardous drugs, but nonsterile hazardous drugs must be stored in a separate, dedicated hazardous drug storage room.
- As a rule of thumb, drug storage is initially estimated at 100 square feet per PEC. Local authorities may have stricter regulations than USP 800, though, and should be consulted on a project, ideally when a pharmacy is beginning to consider how to upgrade current facilities to the latest requirements.
Moving toward compliance
USP 800 will affect many existing pharmacy departments throughout the country. New policies and procedures regarding the handling of drugs, personal protective equipment, and spill control will be required, in addition to the physical building environment being reviewed to determine how the space is or is not complying and what potential upgrades must be made.
Facilities that can’t meet the July 2018 compliance date may be able to discuss waivers with their local pharmacy authority to have more time or to modify their process temporarily until compliance can be achieved. Some pharmacies with low hazardous drug compounding requirements may also choose, either temporarily or permanently, to outsource hazardous drug compounding to avoid facility upgrades.
A design professional can help identify potential space and infrastructure modifications needed for compliance. This planning should be done early to help identify and budget capital expenditures required for compliance. Another good step is to reach out to the local pharmacy authority to discuss the implementation of the new USP requirements and how these changes will be regulated locally.
For more information, go to www.ups.org.
Kim Cowman is senior associate and senior mechanical engineer at Leo A Daly in Omaha, Neb. She can be reached at email@example.com.