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by Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist
The United States Pharmacopeia (USP) General Chapter 800 addresses the handling of hazardous drugs (HDs) to minimize the risk of exposure to patients, health care workers and the environment. It became compendially applicable in November 2023. USP 800 contains some key elements that specifically apply to employee safety and HD containment. Section 16, for example, discusses managing HD spills and retaining spill kits on site. This article addresses HD spills that occur in a compounding pharmacy; however, it can be adapted for handling of non-HD chemical spills as well.
Team members involved in HD spill cleanup must be properly trained in spill management and the use of appropriate personal protective equipment (PPE), including respirators. Team members qualified in spill control must be available whenever HDs are handled in the pharmacy. Spills must be contained and cleaned immediately by qualified personnel.
Standard operating procedures (SOPs) that address spill management must also be in place. SOPs should include:
Management and effective cleanup of HD spills require access to appropriate spill kits. Spill kits can be purchased from various vendors; however, it is often easier to make one by using PPE and cleaning materials already onsite. Doing so will allow your pharmacy staff to use properly fitted PPE and familiar cleanup materials.
Prepackaged spill kits often do not contain the correct sizes of PPE required by team members, nor do they have the correct N95 respirators that properly fit staff. Many prepackaged spill kits do not contain deactivating, decontaminating, cleaning and disinfectant cleaners (DDCD), nor do they contain the appropriate number of cleaners for containing a spill. In addition, your staff may not be familiar with the DDCD agents included in the spill kit and, therefore, may require additional training during a spill occurrence.
Creating a spill kit with materials already available in the pharmacy may make it easier, safer and less stressful for your staff to manage an HD spill, especially if HD spills seldom occur. Each spill kit should contain at least:
PPE sizes can be customized to the specific employees involved in spill management or based on the largest team member’s size.
The spill kit should be stored in a puncture-resistant container or bucket with a cover, so if broken glass or hard plastic fragments are within HD substance spills, all can go into the container for disposal. The container should be clearly labeled as a spill kit on the outside and placed in an easily identified area so all team members know where it’s located. At a minimum, spill kits should be located in areas where chemicals are received and prepared. Spill kits should also be labeled with the item of shortest expiration date on the outside of the kits; that item should be replaced as needed prior to expiration.
When a liquid or powder HD spill occurs, staff members may feel stressed and unsure of how to handle the spill due to infrequent occurrences.
It’s recommended that staff routinely practice and understand how to handle a spill to reduce stress and potential confusion. Recommendations include:
While USP 800 may not be enforceable in all states, it is important to note that federal agencies, such as the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH) and the FDA, are involved in protecting compounding pharmacy staff from potential exposure to HDs.
Additional information regarding USP 800 is available in the blog: USP 800: Is It Enforceable?
Members with clinical services access may contact our Clinical Services team for help with spill kits and other compounding questions.
These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.