Pharmacist cleaning the sterile compounding bins
HealthJune 07, 2019

5 Ways to Prepare for USP 800 Enforcement

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 <800> and it can be difficult to navigate it all. Eric Kastango, from the Kastango Consulting Group, recently presented Preparing for Enforcement: USP <800> 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.

Here are five key areas of focus as you are evaluating your preparedness for USP <800>

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 – 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 Controls – There are three different areas of containment controls that should be considered.

  1. 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)
  2. 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)
  3. 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).

4. Personal Protective Equipment (PPE) – PPE requirements in USP <800> include gloves, gowns, hair covers, shoe covers, eye and face protection, and respirators. All PPEs should be single use only and never reused. Table 5 of the NIOSH list provides guidelines for PPEs when working with hazardous drugs. Because the outside of drug containers has been found to be contaminated, PPEs must be used even when working in CACIs. A good rule to follow when working in a restricted access barrier system (RABS) is to have one compounding technician assigned for the day and a second as the staging technician.

5. Work Practices– Even though clinicians understand that drugs can be harmful, what they fail to realize is that they are potentially exposed when performing routine handling activities. And recent studies indicate nurses’ exposure to hazardous drugs is frequent enough to warrant concern. Retraining and enforcement of safe work practices may be necessary to comply with USP <800>.

Facilities must have a designated person who is qualified, trained, and responsible for overseeing compliance with USP <800>. This can be a pharmacist, technician, or nurse. Training is available from companies like CriticalPoint and organizations such as USP and ASHP as well as others. Responsibilities for this designated person include implementing procedures, assessing competency of personnel, ensuring environmental control of storage and compounding areas, and monitoring facility reports of testing and sampling performed.

Pharmacy directors recognize the need for elevating sterile compounding practices—especially with patient and staff safety and financial and reputational consequences on the line. Many just need a line of sight into the most effective strategies and solutions to elevate practice. These five focus areas are a start to establishing a hazardous drug safety program at your facility.

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