USP Chapter 800 is on the Horizon: Are You Ready?
Posted on February 3, 2016
Now that USP Chapter 800 Hazardous Drugs: Handling in Health Settings has been published, there is no reason to delay taking steps to prepare for the substantial changes that will be required for compliance. The tasks required for preparation will take time and commitment and that means that hospitals should start preparing now.
USP 800 will increase protection for pharmacy personnel and other healthcare workers who come in contact with hazardous drugs, including all the antineoplastic and other hazardous drugs on the National Institute for Occupational Safety and Health (NIOSH) list. It will be an enforceable chapter like USP Chapters 795 and 797, but will be wider in scope than other compounding chapters as it applies to both sterile and nonsterile compounding practices, as well as the administration of these hazardous drugs to patients.1
The chapter will require every facility to maintain a list of antineoplastic and other hazardous drugs it uses. Healthcare organizations can start developing their lists today while recognizing that the list will need to be updated whenever the facility adds a new dosage or new agent.
Facilities that want to be prepared for Chapter 800 can take six actions now:
- Make a list: USP 800 outlines the responsibilities of personnel and specifies the personnel protective equipment required for handling hazardous drugs. It establishes requirements for receiving, storing, compounding, administering and disposing of hazardous drugs, for cleaning and ensuring environmental controls, and for medical surveillance of individuals who may come in contact with hazardous drugs.2
- Review procedures: To be prepared for implementation, hospitals can start by examining operating procedures and administrative controls to see what needs to change in terms of handling hazardous drugs. USP 800 incorporates many existing guidelines contained in USP 797, so updating internal processes to meet the higher standards in already published recommendations will help organizations prepare for the next steps.
- Think about storage space: Facilities may need to think about ways to create additional storage space for hazardous drugs or expand their existing negative pressure room(s). Organizations can refer to the NIOSH list to identify which drugs they currently stock that will require additional storage space. As currently written, Chapter 800 requires hospitals and outpatient facilities to keep antineoplastic drugs that require manipulation beyond simple counting to be kept in a negative-pressure room with at least 12 air changes each hour. Refrigerated antineoplastics must be stored in a separate, dedicated refrigerator within a negative pressure room with a minimum of 12 air changes per hour.
- Consider compounding location options: Chapter 800 provides an option for compounding low- and medium-risk sterile preparations that include hazardous drugs in a containment segregated compounding area (C-SCA), which it defines as a negative pressure room with at least 12 air changes per hour. When an aseptic containment isolator is used within such a room, compounded preparations will have a beyond-use date as stipulated in Chapter 797. Sterile products compounded in a biological safety cabinet within a C-SCA have a beyond-use date of just 12 hours. The new option will give facilities with limited space a way to comply with the chapter without having to invest in major renovations to create an ISO Class 7 compliant cleanroom, the standard required under Chapter 797.
- Stock up on gloves: Chapter 800 requires double gloving for administering and disposing of hazardous drugs. Two pairs of gloves will also be needed to dispose of personal protective equipment used in handling of hazardous drugs or cleaning areas where hazardous drugs are used or prepared.
- Conduct a risk assessment: Facilities that choose to employ alternative containment strategies for the handling of nonantineoplastic hazardous drugs must document how their strategies will minimize healthcare workers’ exposure.
- Traynor K. Prepare Now for USP Standard on Handling Hazardous Drugs. Pharmacy News. ASHP. April 1, 2015.
- USP Publishes Standard on Handling Hazardous Drugs In Healthcare Setting. US Pharmacopeial Convention. February 1, 2016.