What is USP 800?
USP 800 has many healthcare professionals on edge as to how it relates to their field and practice scope. This federal standard was implemented with the intention of protecting the environment as well as any and all health care personnel that are exposed to hazardous drugs in the workspace. With the new rules anticipated to become official on December 1, 2019, it is important to be knowledgeable about what is expected and how this can affect your practice.
Who is affected by USP 800?
ALL facilities that store, handle, compound, and/or administer hazardous drugs, including but not limited to hospitals, pharmacies, medical practitioners, veterinarians, outpatient oncology clinics, etc. must abide by the laws of USP 800.
What drugs are covered by USP 800 and the NIOSH drug list?
A complete drug list can be found at https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf. Common veterinary prescriptions that we provide include but are not limited to methimazole, zonisamide, voriconazole, fluconazole, topiramate, clonazepam, tacrolimus, spironolactone, phenytoin, phenoxybenzamine, mycophenolate, diethylstilbestrol, cyclosporine, and chloramphenicol. Please refer to the link above to see what medications you are currently using in your practice and if they are included.
What special equipment or environmental specifications are needed to comply with USP 800?
Multiple components of protective equipment are necessary to comply with USP 800 in the event of any manipulation is necessary for hazardous drugs. Manipulation would in this will ensure safety. The three main components include containment primary engineering control (C-PEC), containment secondary engineering control (C-SEC) and personal protective equipment (PPE). Any compounding of hazardous drugs must include a primary engineering control such as a powder hood with HEPA filtration that is externally ventilated. The secondary engineering control refers to the design of the facility. Hazardous drugs are to be enclosed and separated in an area different from any other nonhazardous drugs and in a room with negative pressure. This is to control the dissemination of hazardous drugs and ensure safety. Finally, the last protective measure is personal protective equipment, which includes items such as gloves, gowns, head and shoe covers. The personal protective equipment must be worn in all facets of hazardous drug use from receiving the drug, transportation, compounding, and disposal. In addition to protective equipment, storage of hazardous drugs and equipment being used for hazardous drug compounding must be separated from all nonhazardous drugs and equipment.
Is there special training and documentation required for USP 800?
All personnel handling hazardous drugs must be trained on the dangers of each drug and how to protect themselves specifically for their job function. Training also includes the appropriate use of PPE, engineering controls and spill management procedures. An assessment of risks must be documented and updated each calendar year on every hazardous drug stored, compounded and/or dispensed, even if it is given in the original state. All personnel must be trained on how to deactivate, decontaminate, clean and disinfect all areas and equipment used around the hazardous drugs when compounding.
Where to go from here?
There is still a lot more information to cover regarding USP 800 but the intention of this article is to inform health care personnel that USP 800 is coming whether we like it or not. It is up to each facility to do due diligence and be proactive rather than reactive since the deadline is quickly approaching. Facility redesign and implementation of some of these protocols may not be feasible for your practice. However, Pharmacy Solutions is here to fulfill the needs of many of these hazardous drugs that you and your clientele still need. We are currently taking actions in preparation of USP 800 and plan to be compliant well in advance of the December 2019 deadline. Feel free to contact us to see how we can help your practice and patients.
Connor, T.H., MacKenzie, B.A., DeBord, D.G., Trout, D.B. & O’Callaghan, J.P. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014 138).