USP <800> and Other Hazardous Pharmaceuticals Standards and Regulations: Update 2020
USP’s standard on the safe handling of hazardous drugs (HD), General Chapter <800>, became official on December 1, 2019. For a USP chapter numbered below 1000 to become compendially required, it needs to either be referenced in General Notices, a monograph or another general chapter numbered below <1000>. Originally, USP <800> was referenced in USP <795> and <797> standards; however, these chapters are undergoing additional review. Until such a time as USP <800> meets the criteria for compendial applicability, it has the effect of being a recommendation rather than a requirement.
What does that mean for healthcare organizations that were very concerned about implementation of the USP <800> full chapter or providing evidence of an annual Assessment of Risk? It means that they can breathe a sigh of relief regarding not having to implement USP <800>, according to USP. However, the considerations contained within USP <800> offer insight and guidance into exposure risks beyond compounding.
HD Exposure Concerns
The intent of USP <800> definitely raised the awareness of how hazardous drugs can create unhealthy exposures for patients and anyone that receives, prepares, administers, transports or otherwise comes in contact with hazardous drugs and all the environments in which they are handled.
During the pre-implementation phase of USP <800> there were many concerns by healthcare professionals that were primarily administering HDs regarding potentially significant investments needed to implement engineering controls associated with HD compounding. It was later clarified that reconstituting or diluting HDs prior to administration were not considered compounding. 1
Another concern involved caregivers in a nursing home that needed to crush up an HD to mix it into a resident’s food or liquid to assist with swallowing the HD. Crushing or splitting medications for the purpose of administering the HD does not constitute compounding (or expensive engineering controls) but does increase risk of exposures and HD residues that can accumulate.
OSHA’s Hazardous Communication Standard (HCS) requires organizations to identify and communicate all hazardous chemicals and substance to staff. The HCS provides a limited exemption for HDs in solid, final forms for direct administration to the patient, i.e., tablets or pills, but more recent guidance from OSHA further limits the exemption. The act of crushing or counting pills and tablets may result in an HD exposure, and it therefore is not be exempt from the HCS. It also contains a statutory requirement for annual training and methods to mitigate potential exposures. 2
Managing HDs Within Your Facility
The National Institutes of Occupational Safety and Health (NIOSH) recently released an update to the 2016 List of Hazardous Drugs in Healthcare Settings. There have been substantial changes to the list — which has not been finalized but should be a priority to review as there have been many changes that healthcare organizations will need to incorporate into their Standard Operating Procedures (SOPs).
Although enforcement of USP standards is determined by each state and the respective Board of Pharmacy, the USP mentions that states may adopt all or some of the elements of USP <800>. For example, the California Board of Pharmacy released a statement on May 7, 2020, that although USP has indicated that Chapter <800> is informational and not compendially applicable unless and until Chapters <795> and <797> are revised to reference Chapter <800>, the Board’s current regulations on compounding hazardous drug preparations remain in effect. Like USP, the Board encourages utilization of Chapter <800> in the interest of advancing public health. 3
There are other important factors within current federal and state regulations, as well as accreditation standards, that reinforce the importance having a HD management plan. This includes an annual review of standard operating procedures, an annual assessment of risk to include any new HDs prior to entering the facility, staff training and methods to mitigate exposures.
The issues addressed by USP <800> are valid, especially the importance of knowing the hazards associated with all forms of HDs within a facility. Implementing measures to protect residents and staff from unintentional exposure to HDs is an integral part of safety and public health. I would not be at all surprised if it becomes an enforceable standard once the issues regarding USP <795> and <797> have been resolved.
Brian Williams, MHA, MBA, is the Vice President of Compliance & Regulatory Affairs – MedTrainer, Inc.