The purpose of USP Chapter <800> is to describe the practice and quality standards for handling hazardous drugs in a healthcare setting and to help promote patient safety, worker safety, and environmental protection. This chapter defines the processes intended to minimize the exposure to hazardous drugs in a healthcare setting.
USP Chapter <800> was written to protect all workers, patients and the general public who may be accessing facilities where hazardous drugs (HDs) are prepared. This includes but is not limited to pharmacists, technicians, nurse, physicians, physician assistants, home healthcare workers, veterinarians and veterinary technicians. If any workers come in contact with HDs, they must receive HD training, and be assessed for an understanding of the training. All personnel who handle HDs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final HDs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.
- USP Chapter <800> was “officially” published February 1, 2016. Healthcare facilities, however will be given until July 1, 2018 to implement changes required by the new rule.
- Absolute Pharmacy implemented the new rules and requirements for USP Chapter <800> in September 2016.
- USP Chapter <800> has been created due to the fact that USP <797> did not sufficiently address the risks associated with handling “hazardous” drugs.
- “Hazardous” drugs are basically those drugs that appear on the “National Institute for Occupational Safety and Health” (NIOSH) list of drugs.
- These drugs are required to be handled differently than drugs not on the NIOSH list. The main reason for this is operator safety.
- Drugs on this list are based on having at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity and new drugs that mimic existing hazardous drugs in structure or toxicity.
- Some of the differences in handling NIOSH drugs, as opposed to USP Chapter <797> protocols include:
- Storage and compounding of NIOSH drugs are to be performed in “negative pressure” environment in order for any chemical particles to move away from the operator.
- Special chemical gloves (two pairs) are to be worn by the operator.
- Gowns are required to be impervious and not reused after compounding.
- Air in negative environment to be vented to the outside.
Absolute Pharmacy will continue to operate above the curve in implementing new processes and procedures that improve the health, well-being and safety of our employees and patients. You can download a copy of this document here