Editor’s note: This article has been updated since original publication to delete a mention of oxytocin, which was made in error. See further comment below. *
We are less than three months away from Dec. 1—the day that USP<800> will go into effect. Created by the United States Pharmacopeia (USP), USP<800> is designed to educate and enforce the safe handling of hazardous drugs to protect healthcare workers and patients. It is an important set of standards, as unsafe exposure to hazardous drugs poses health risks, ranging from short-term reactions (e.g., nausea or skin rashes) to long-term effects (e.g., infertility or cancer).
Whereas past standards like USP<797> only covered sterile preparations in facilities where compounding occurs, USP<800> will encompass the end-to-end handling process: receiving, transport, storage, compounding, dispensing, administration, patient care, cleaning, disposal and waste management. Therefore, practically all types of medical practices handling and dispensing hazardous drugs will need to meet compliance.
Does USP<800> matter to skilled nursing and long-term care?
In skilled nursing and long-term care, a common drug like warfarin is administered to patients regularly. Yet it too is considered hazardous by the Centers for Disease Control and Prevention and National Institute for Occupational Safety and Health. (* There are several examples of hazardous drugs that can pass through a senior living facility, including spironolactone to treat high blood pressure and letrozole to treat breast cancer among postmenopausal women. The key is for all facilities to review the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings—which NIOSH updates regularly—to see if they handle any of the listed drugs in order to conduct a comprehensive risk assessment.)
Further, it is common practice to crush or split medication tablets in long-term care and assisted living facilities for convenience and to assist residents with swallowing. For drugs which are hazardous if altered by crushing, breaking, splitting, or other manipulation from their intended dosage form, you need to consider potential exposure, surface contamination and medication errors. In fact, it is estimated that 10 percent of all medication is not suitable for splitting or crushing.
Where will enforcement of these standards come from?
Enforcement of USP<800> will initially come from the state boards of pharmacy. The Food and Drug Administration (FDA) may also carry out enforcement through the 2013 Drug Quality and Safety Act. The Joint Commission can enforce the standards during accreditation surveys. Further, the Occupational Safety and Health Administration (OSHA) already has authority wherever worker safety is concerned. It is up to each skilled nursing and long-term care facility to ensure they have the proper policies and procedures in place ahead of Dec. 1.
How can you prepare your facility for USP<800>?
USP<800> outlines guidelines to mitigate risks from exposure, including personnel responsibilities for hazardous drug handling, the use of protective equipment, decontamination and cleaning for spills, and safe disposal. It may seem daunting at first, but there are proactive steps that you can take to prepare and meet compliance:
- Review NIOSH’s list of hazardous drugs
Since 2004, NIOSH has continued to update the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings.” NIOSH has made the list available online so healthcare workers always have access to the most current list. Before Dec. 1, facilities should review this document to see if they handle any of the listed drugs. Nurses and other staff members should also plan to download the <800> HazRx™ Mobile App. Released by USP itself, the app enables you to select any drug, your activity and access handling instructions in accordance with USP<800> standards to minimize on-the-job risk.
- Appoint a compliance leader
Given the vast number of USP <800>requirements, it is a good idea to appoint one experienced individual to serve as a compliance leader. They may be an on-site pharmacist, nurse, or administrative staff member. The compliance leader should know all USP <800> guidelines so that they can serve as a single point of contact for accountability and dissemination of information.
- Perform an initial risk assessment
An initial risk assessment helps to identify areas of potential exposure within your facility so that you can revise current policies and procedures. An assessment should include documentation of all hazardous drugs by type and dosage, and analysis of how they are packaged, stored, manipulated and moved throughout a facility. Due to the frequency of splitting and crushing medications in long-term care and assisted living facilities, the assessment should include a review of whether certain drugs can be split or crushed, as well as if equipment and safeguards are in place or need to be.
The assessment should also include a list of all staff members who may encounter hazardous drugs while performing their job duties—even non-medical staff, such as those in shipping and receiving and housekeeping.
- Invest in online tools and education
USP <800> mandates that everyone handling hazardous drugs must understand the requirements and how to properly perform their job function. For instance, a housekeeper will need to know how to recognize a dangerous spill and the appropriate steps for escalation so that the issue is contained. The level of competency across a facility should be assessed every 12 months, as well as when a new hazardous drug is introduced. Online toolkits are now available to help facilities and employees with compliance.
These toolkits include resources for risk assessments, up-to-date hazardous drug lists, customizable safety data sheets and policy templates. Policy templates are particularly beneficial as they enable you to custom create electronic policy manuals, detailing everything from floor plans and diagrams for how drugs move throughout the facility, to instructions for equipment use and maintenance. By making policy manuals available in a digital format, it is easier to track who has received them and ensure everyone has the most up-to-date information.
Online training courses can help to educate staff on the hazardous drug handling guidelines. Online education provides the added benefit of being able to monitor and report on who has completed the required training. Moreover, staff members can take the courses on their own time so they don’t have to take time out of their schedule for lengthy seminars. External resources for toolkits and training can simplify compliance greatly for skilled nursing and long-term care facilities, in the days leading up to December and thereafter.
Brian Williams is Director of Compliance and Regulatory Affairs at MedTrainer.