Pharmaceutical Compounding

How to Meet Guidelines for Sterile Prep & Safe Handling of Hazardous Drugs

The business of pharmaceutical compounding is becoming increasingly regulated. New standards from the United States Pharmacopeial Convention (USP)’s Chapter 800 (“Hazardous Drugs–Handling in Healthcare Settings) take effect in 2019. First, the USP released Chapter 795, which provides guidelines for non-sterile compounding, followed by Chapter 797, which focused on sterile compounding. USP 800 goes further to regulate the handling of hazardous drugs in healthcare settings.

“Because the standards included in USP Chapter 800 are enforceable, healthcare facilities must be vigilant about understanding the requirements and implementing them,” says Aigner George, director of pharmacy consulting at HealthTrust.

Expanding Regulations

USP 800 includes several sections of guidelines that directly affect the daily operations of a compounding pharmacy. For instance, under the new standards, pharmacies must control all the points at which there is a potential for exposure, including receiving the hazardous medications, transport of the medications through facilities, administration of medications and disposal of any hazardous waste from those medications, explains Bryan Mumaugh, PharmD, corporate manager, pharmacy quality and medication safety at Franciscan Alliance in Mishawaka, Indiana.

Appropriate personal protective equipment (PPE) must be used at any level of potential contact, George says. Team members will need to glove up when receiving and reviewing supplies and wear protective masks when necessary.

In addition to keeping track of the way hazardous drugs are being compounded, facilities “must now consider the design of physical space and its impact on our compounding activities,” Mumaugh says. Facility design considerations must include the areas where pharmacists compound as well as the space where hazardous drugs are stored. For example, a section of USP 800 focuses on engineering controls, laying out specifications regarding the sterile compounding hood, the room where compounding takes place and other stipulations about work areas.

Not only must pharmacy personnel work to meet the criteria outlined in USP 800, but they must also develop a written plan for how they’re meeting that criteria. “You should be able to refer to documents that show the hazardous drugs your facility uses and how you maintain them,” George says. “With USP 800, there’s an important focus on communication, such as having a standardized hazard communication program within the facility and/or across the IDN.”

Getting on Board

Franciscan Alliance started the compliance process by cataloging its entire medication formulary, identifying and arranging by risk, Mumaugh explains. Some medications that have not been considered hazardous in the past are now classified as such. Now these drugs are governed by USP 800 requirements and guidance for receiving, unpacking and storing; manipulating, compounding and administering; using PPE, including respiratory and eye/face protection; and engineering controls.

A corporate USP workgroup at Franciscan Alliance is leading the compliance charge for the health system. This group is composed of pharmacists and department leaders in nursing, risk management, infection control and construction program management. Mumaugh serves as corporate sponsor, and Chris Gregory, BSPharm, sterile compounding supervisor, serves as system champion. The group is working on new policies and procedures for an extensive USP 800 remodel of its more than 20 locations by 2019.

“We are working to ensure that all facilities are unified for compliance and success, completing programs for unified decontamination and cleaning,” Mumaugh says. “As we continue to move forward in the process, we will be doing the same for other facets of our operations.”

One important piece of the compliance program includes providing clear guidance to all healthcare team members regarding their handling or controlling of hazardous medications within the facility, Mumaugh says. Those team members include buyers, technicians, environmental services, building systems employees, pharmacists, nurses and physicians. The USP 800 team is providing guidance regarding processes for dealing with infrequent events like hazardous spills, as well as the day-to-day handling and disposal of medications that include hazardous drugs.

“As boards of pharmacy and governing and certifying entities become more familiar with these guidelines, USP 800 will also expand the need to educate, internally and externally, to ensure that all personnel are aware of the guidance,” Mumaugh adds.

How to Prepare for Compliance

USP 800 was originally scheduled to go live on July 1, 2018, but the deadline was pushed back to Dec. 1, 2019.

“Ideally, everyone was preparing for the earlier deadline, so they should be in good standing,” George says. “A number of facilities have already assessed the regulations and understand the budget impact. However, some facilities are further along than others, as some hospitals weren’t compliant with USP 797 and are having to do significant work to build to that compliance.”

For those facilities that still have work to do to become compliant with USP 800, George’s recommendations are simple enough in theory: Read the chapter over and over again, paying close attention to which standards are recommendations and which ones are requirements, signaled by words such as “shall” or “must.” Also, take advantage of online educational courses offered by USP. (Learn more about upcoming webinars and workshops here.)

Don’t forget to assess all the places where the USP 800 rules apply. “It’s not just in the hospital pharmacy,” George says. “Anybody dealing with hazardous drugs, such as urology clinics for instance, must comply with the new regulations.” The first step in the preparation and planning for USP 800 compliance is to get frontline staff on board, Mumaugh says. At Franciscan Alliance, a system champion helps ensure that expectations are realistic while workflow is being optimized.

“We want to ensure that the physical space is compliant. But, we also want to provide simple and concise policies and procedures to govern behavior within the newly remodeled sterile compounding facilities,” Mumaugh explains. “We can provide compliant structure, primary engineering control rooms and environmental controls, yet to be successful, we have to have corresponding procedures to ensure personnel operates within the guidelines to avoid contamination and minimize exposure to hazardous medications.”