USP 800 Compliance Integration
According to the CDC, nearly 8 million U.S. Health Care workers are potentially exposed to hazardous drugs, including pharmacy, lab and nursing personnel, physicians, operating room personnel, environmental services workers, and more. This exposure can result in both acute and chronic health effects, depending on the exposure length and toxicity.
Exposure of hazardous drugs can take place in any healthcare setting including hospitals, pharmacies, surgical centers, home health centers, skilled nursing facilities and even veterinary hospitals/clinics. To provide guidance on reducing and preventing exposure, the United States Pharmacopeial (USP) Convention recently released their newest chapter, 800 Hazardous Drugs – Handling in Healthcare Settings. The standard applies to all health care personnel and facilities where hazardous drugs are handled, compounded, stored and distributed.
The deadline to meet compliance set by these standards has been extended to December 1, 2019. In addition to USP 800, all facilities that are responsible for compounding drugs, whether sterile, non-sterile or hazardous, must comply with USP 795 – Pharmaceutical Compounding – Non-Sterile Preparations as well as 797 Pharmaceutical Compounding – Sterile Preparations. Chapter 797 is currently undergoing revisions and will be released concurrently with USP 800.
Under the new guidelines in chapter 800, hazardous drugs must be stored, unpacked and prepared separately from non- hazardous drugs. In regards to the built environment and space planning, this impacts the design of workspaces, storage and HVAC accommodations within the pharmacy, medical oncology or other clinical areas where such drugs are present. Designated areas must be available for the following areas:
- Receipt and Unpacking
- Hazardous Drug Storage
- Compounding, Buffer and Ante Rooms
Receipt + Unpacking
During receiving and unpacking, Hazardous Drugs (HDs) much be removed from external shipping containers in an area with neutral/normal or negative pressure areas (relative to the surrounding areas). Unpacking should not be performed in sterile compounding areas or those with positive pressure.
Hazardous Drug Storage
The guidelines specify that hazardous drugs must be stored in a manner to mitigate spillage or breakage should the container fall. Applicable safety precautions regarding shelving must be taken for facilities located in areas prone to natural disasters, such as an earthquake. Storage on the floor must also be avoided.
Storage for various types of hazardous drugs are further defined in the chapter. Hazardous Drugs must be stored in an externally ventilated, negative-pressure room (12 ACPH) as well as separately from non-hazardous drugs. Based on the entity’s policies, non-antineoplastic, reproductive risk only, and final dosage forms on antineoplastic HDs may be stored
with other inventory. Dedicated refrigerators placed in a negative pressure area (with 12 ACPH) should be utilized for antineoplastic hazardous drugs requiring refrigeration. It is important to note that sterile and nonsterile hazardous drugs can be stored together.
Compounding, Buffer and Ante Rooms
In general, compounding of any hazardous drug must take place in a containment primary engineering control (C-PEC), or hood, located in a dedicated secondary engineering control (SEC) room, or buffer room, that is externally ventilated, physically separated from other areas and maintained at a negative pressure. If the C-PEC supplies some or all of the negative pressure or is used for sterile compounding, it must operate continuously.
Under the current regulations (USP 795, USP 797), compounding pharmacies can process both hazardous and non- hazardous drugs in the same room. For those facilities to meet requirements for USP 800, a negative buffer room for hazardous drug compounding will need to be added. This addition will assist in associated challenges with maintaining required ISO ratings.
For facilities that process both non-hazardous and hazardous drugs, two buffer rooms will be required; negative for HDs and positive for sterile non-hazardous drugs.
Additionally, a sink for handwashing must be readily available along with an eyewash station and/or other emergency precautions that meet applicable laws and regulations in a positive ante room.
Due to the amount of airflow and system pressure needed to sustain requirements, modifications to existing systems may be needed. These alterations could include adding equipment, such as fan filter units, or increasing fan motor sizes if the system cannot support being rebalanced.
The extensiveness of infrastructure modifications needed to meet the new requirements will depend upon the age and capacity of mechanical systems, facility/department location and current exhaustion methods. Construction costs can also be significantly impacted by the current rating of walls and ductwork. Discussions with facility staff to minimize duct routing can assist in limiting this financial impact on existing facilities.
Developing a Solution
The conceptual floor plan below serves to illustrate a possible solution for integrating USP 800. Each facility affected by these standards should be evaluated on a case-by-case basis to develop an optimal and cost-effective solution that aligns with regulations set by your local authorities. Modifications, which can be identified by a design professional, will vary depending on existing conditions and the types of drugs that are handled. This planning should be completed early to help identify and budget capital expenditures required for compliance.
For guidance and/or to perform an assessment on your facility’s compliance to USP standards, contact TEG Architects.
About TEG Architects
TEG is an internationally recognized firm focusing on comprehensive facility planning, architecture, visualization and interior design services. Understanding the client’s business, mission, challenges and competitive landscape forms the basis by which TEG delivers its menu of services. The firm specializes in health care, wellness, educational, municipal and commercial facilities.