Introduced in 2016, USP <800> Hazardous Drug – Handling in Healthcare Settings, aims to address alarming statistics related to hazardous drug exposure—equating to approximately 8 million healthcare workers annually, according to the Centers for Disease Control and Prevention. Pharmacy directors recognize the urgency, yet many lack the resources needed to ensure ongoing, sustainable compliance.
There are many challenges that hospitals are facing with the upcoming enforcement of USP and it can be difficult to navigate it all. Simplifi 797 presented a webinar, Preparing for Enforcement: USP Readiness Checklist, and the following are some key insights from that webinar.
Because of the proven dangers of exposure from handling medications, establishing a robust hazardous drug safety program is key. Studies have shown that there is a significant association between occupational exposure during a normal workday and increases in chromosomal aberration in healthcare workers. It is essential to comply with USP <800> in order to protect the patients and staff exposed to hazardous drugs in your facilities.
Five key areas of focus when evaluating USP <800> preparedness
1. Standards and regulations
Standards and regulations exist to promote patient safety, worker safety, and environmental protection when handling hazardous drugs. Be sure to read all the standards and regulations requirements because these requirements affect all healthcare personnel who handle hazardous drugs as well as any healthcare entities that store, prepare, transport, or administer hazardous drugs. As you are researching these regulations, USP must be the “source of truth” used for adherence to requirements as it will become enforceable as of December 2019. If you don’t know where you stand currently with these requirements, explore utilizing a gap analysis tool and assessments available from companies such as CriticalPoint.
2. Drug hazards and regulations
The drug is the linchpin to decide which strategy to focus on. If the drug is a hazard or not determines which regulations must be considered. If the drug requires compounding, additional controls need to be put in place. If not, then normal safe handling is required. One resource for knowing which drugs are affected by USP <800> is the NIOSH hazardous drug list, tables 1, 2, and 3. This list also helps identify drugs that have additional handling requirements.
3. Engineering containment controls
There are three different areas of containment controls that should be considered.
- C-PEC (Containment Primary Engineering Control) such as a ventilated device to minimize worker and environmental exposure. Examples are biological safety cabinets (BSCs) and Containment Aseptic Compounding Isolators (CACIs)
- C-SEC (Containment Secondary Engineering Control) which is the room in which the C-PEC is placed. Examples are a cleanroom, suite (ISO classified rooms) and containment segregated compounding area (C-SCA)
- Supplemental Engineering Control, an example of this type of control is CSTD (Closed System Drug Transfer Devices) which offers additional levels of protection for compounding staff, nurses and the patient.
Minimum room requirements are a room with ventilation that exhausts the room air outside of the building with at least 12 air changes per hour (30 for a buffer room).