The USP <800> serves as one source of truth for protecting healthcare workers from the dangerous effects of HDs. However, the implications in terms of cost and time needed to comply can vary depending on the type of medical facility.
Here we’ll look at USP <800> guidelines affecting long term care facilities including nursing homes, adult foster care, assisted living facilities, intermediate care facilities (ICF/ID), group homes:
1. Start with an Assessment of Risk of HDs in Use at Your Facility
The USP <800> requires documentation of all HDs in use at your facility and an assessment of the potential exposure risks to healthcare workers. Keep in mind this begins with the staff that receives the drugs into your facility all the way to the janitorial staff that disposes of them and everyone in between. Identifying how HDs move throughout your facility and who interacts with them throughout the process is key. Then you can assess risk for each role and worker. The NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 and 2020 serve as primary resources for identifying HDs and their potential exposure risks.
One pitfall we’ve seen long term care facilities fall into is that they forget the language for the Assessment of Risk. For example, “Reason for exemption: Unit dose packaged by manufacturer/no manipulation required.”
Also, many long term care facilities do not document all of the OSHA SDS sheets, the NIOSH requirements, and the USP <800> requirements.
2. Ensure Thorough HD Training for All Healthcare Workers
Healthcare workers who should be trained and assessed at least once a year on HD exposure risks include those who receive, prepare, administer, transport, or otherwise come in contact with hazardous drugs. Training includes recommended PPE needed for certain classes of drugs; how drugs should be packaged, labeled, and transferred; safe administration of HDs; and procedures for disinfecting environments and spill control.
In addition to annual training and assessment, ongoing training should be provided prior to the introduction of new HDs or equipment or before new or significant changes in processes or safe operating procedures.
According to a Pharmacy & Therapeutics article, because some existing treatments have been recently added to the NIOSH list of HDs, it is vital that medical staff be trained on this expanded HD list and the new requirements for PPE and safe handling.
All training and assessments also must be documented for USP <800> compliance.
3. Conduct Ongoing Medical Surveillance
One guideline that is recommended but not yet mandatory is to take a baseline health assessment of all healthcare workers who have potential exposure to HDs. Also, USP <800> recommends ongoing surveillance of symptoms or test results to alert the worker and the facility of any possible exposure-related health conditions as early as possible. This is a process that can go further to protect your staff and your organization.
4. Evaluate and Update Your Compounding Pharmacy
Many long term care facilities include an on-site compounding pharmacy to provide chemotherapy, IV medication, pain management, and other treatments. These facilities will most likely incur the bulk of their USP <800> compliance costs in required pharmacy upgrades, including significant improvements to ventilation equipment, storage requirements, and the introduction of new compounding procedures.
One of the most anticipated changes is the requirement for cleanrooms or negative pressure environments where HDs are compounded. USP <800> now requires a negative pressure range between just 0.01 and 0.03 inch WC. Negative pressure basically requires that more air is removed than introduced over a set period of time. Because air naturally flows from high to low-pressure areas, the negative pressure ensures that harmful gases, noxious odors, and toxic compounds do not spread to adjacent areas when people enter or leave the space.
5. Designate An HD Expert
The USP <800> specifies that all facilities “designate” a staff member who will implement appropriate operating procedures, oversee regulatory compliance, ensure proper training, ensure proper environmental controls, maintain reports and documentation, and perform Corrective Action Preventive Action (CAPA) for any HD related incident.
We’ve seen long term care facilities identify a nurse, a pharmacist, or even human resources or environmental services professionals as their “designated person.”
USP <800> is specific in its requirements and recommendations, which makes it a useful tool in protecting the health of your staff. However, because the healthcare system is composed of many different care facilities, figuring out how to implement them into your unique organization may be difficult. The Rpharmy team works with many long term care facilities to achieve USP <800> compliance, and we’d be glad to share what we know with you.
Also, ICYMI, check out the top 5 ways USP <800> is beneficial to your health.
