Who Does USP<797> Apply To? What About Oncology Offices?
So WHO does USP <797> apply to? Officially, USP<797> applies to the following types of sterile preparations:
“ Compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including…dosage forms that must be sterile when they are administered to patients: aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.”
USP<797> also applies to all persons who prepare compounded sterile products (CSPs) and all places where CSPs are prepared, stored or transported. Hospitals, pharmacies, doctor’s offices, oncology offices, long term care facilities…etc. Although the chapter is considered one of the ‘enforceable’ chapters of the USP NF, the actual enforcement has traditionally been left to the states with few states actually enforcing the requirements for sterile compounding. Even then, when enforced by the state, historically only certain state boards were found to be enforcing <797>. For example, in many states, the State Pharmacy Board may be actively enforcing <797>; however the state’s medical board (which typically oversees oncology offices and other private physician practice settings where sterile compounding may take place) is not. Unfortunately, in many states that declare to be enforcing <797>, the extent to which officials are surveying facilities for compliance may be reduced to simply checking to make sure that any sterile compounding hoods display a sticker that they have recently been certified.
The irony is that oncology offices are amongst the least enforced health care settings when it comes to USP <797>, however, the immunocompromised patients seen in these clinics may benefit the most from utilizing the principles set forth in USP<797>. In addition, staff that compound chemotherapy in these clinics benefit from the safety measures put forth in <797>. The hazardous drug compounding requirements in USP<797> seek to decrease the cumulative risk of exposure to hazardous drugs (such as chemotherapy) over time. It was written with the following in mind: that a one-time exposure from a chemotherapy spill may not pose as much of a threat as the cumulative exposure to small amounts over long periods of time. Cumulative exposure is the type of exposure chemotherapy compounding staff will most likely be exposed to.
Often staff at oncology offices will be following the standards set forth by the Oncology Nursing Society (ONS) and perhaps the National Institute for Occupational Safety and Health (NIOSH). However, many experts do not feel the standards set forth by these two organizations provide enough detail in the areas of garbing, cleaning, certification, competency, equipment and clean room design to properly protect patient and employee health.
There are trends taking place that may shape the picture of compliance with USP<797> in the future. Facilities who prepare CSPs should be aware of these trends and may benefit from taking steps toward compliance sooner than later. Infection rate reporting and reimbursement trends may be a couple of ways an incentive to comply with USP<797> may be provided….Read more
About the author: Christi Larson, Pharm. D. is the owner and Chief Consultant of I.V. Insights. Dr. Larson is committed to helping clients improve patient care through the implementation of best sterile compounding practices within the healthcare system.
