Pharmacy Departments Prepare for New & Revised Compounding Standards

Pharmacy leaders have had more than three years to prepare for new standards surrounding the compounding of hazardous drugs. USP 800, Hazardous Drugs—Handling in Healthcare Settings, the newest chapter from U.S. Pharmacopeia governing drug handling, was publicized in February 2016 and is scheduled to go into effect on Dec. 1, 2019.

Complicating the transition is the fact that sweeping revisions to USP 797, Pharmaceutical Compounding—Sterile Preparations, are also going into effect on the same day. Because these revisions were just released on June 1, 2019, not everyone is ready.

Mark Walsh, PharmD

“Most people should have had a clear runway for how to implement USP 800 standards, but one of the issues is that USP 797 revisions will go live the same day and were just released at the beginning of summer 2019,” says Mark Walsh, director of clinical pharmacy strategy at HealthTrust. “The competing timelines of implementation have created challenges.”

In some cases, changes required for compliance with 800 and the revised 797 involve overlapping requirements, so it would seem prudent and logical to handle both at the same time. However, even for those who are still trying to determine whether 797 revisions will affect their pharmacies, it’s best to take broad steps to become compliant with USP 800.

Erika Anderson, CPhT, CSPT

“Complying with the USP 800 standards is the responsible thing to do for the safety of your staff and patients,” says Erika Anderson, CPhT, CSPT, division program manager of pharmacy compounding at CHI Franciscan’s Pacific Northwest Division in Tacoma, Washington. “USP 797 is about protecting the products, and USP 800 is all about protecting people.”

Implement Engineering Controls

For most facilities, the most urgent change required by USP 800 involves the new specifications for engineering controls in the locations where pharmacists compound and where hazardous drugs are stored. For instance, for facilities to manipulate National Institute for Occupational Safety and Health (NIOSH) Table 1 drugs, they must have at least a containment segregated compounding area that meets certain specifications, such as at least 12 air changes per hour, specific temperatures and a containment primary engineering control.

In most cases, complying with the new requirements means undertaking expensive, lengthy construction projects. “Even retrofitting existing spaces is expensive and time sensitive,” Anderson says.

Each state’s Board of Pharmacy has a different approach to the new guidelines. In Washington state, for instance, pharmacies are required to follow USP compounding requirements. “On Dec. 1, if we’re not compliant, we can’t handle hazardous drugs,” Anderson says.

Healthcare facilities in states that require compliance should have the new engineering controls in place or be working toward them. USP 800 applies not only to pharmacies, but also to any healthcare entity that handles hazardous drugs, including doctor’s offices administering chemotherapy drugs.

Assess the Risks

At CHI Franciscan’s Pacific Northwest Division, Anderson and her team started working on compliance a couple of years ago. They started by developing a checklist of requirements based on the new standards, then visiting each facility and measuring it against their compliance checklist. From that exercise, the team was able to develop a list of gaps where the system was not yet compliant with USP 800, she says.

After updating facilities to comply with engineering controls, the next priority was to develop the hazardous drug list and assessments of risk for each applicable drug. Anderson and her team made a list of every applicable hazardous drug and dosage form used in their facilities, and they established an individual Assessment of Risk (AOR) document for each one.

“These documents detail how you will protect people when shipping, handling, unpacking, storing, manipulating, removing, administering and disposing of the drug,” she explains. “By including strategic processes for keeping everything contained, you can create alternative ways of avoiding risk.”

Different drugs present different levels of risk, so the AOR explains how to handle a particular drug, including engineering requirements, personal protective equipment (PPE) and other requirements. The team relied on information available from the NIOSH and other resources to develop their strategies and AOR documents. Writing thoughtful, well-researched AORs for each drug based on its individual level of risk took the team about 16 months, Anderson says.

When the AORs were completed, the team created a chart that categorizes drugs with similar handling instructions. They also created easy handling guides for hospital personnel to refer to when handling different types of drugs. With a quick glance, a nurse, pharmacist or other healthcare worker can easily review how to handle a drug such as a chemotherapy agent, as well as which PPE to use and other requirements.

Keep Staff Informed

A final crucial component of USP 800 compliance involves training staff on the new policies and procedures. As with any rollout, it’s important for frontline staff to be informed about the level of protection the changes offer, Walsh says.

“You can have the greatest facility with all the proper engineering controls and available PPE, but if people aren’t trained to use it effectively, safety and compliance goes out the window,” Anderson adds. “Training needs to be robust, so that people understand the ‘why’ behind the changes.”

Because USP 800 covers all aspects of hazardous drug handling, from receiving products through administration and disposal, individuals working at all stages of the process must be included in the training. For example, when it comes to intravenous administration of chemo, USP 800 requires a closed-system drug transfer device (CSTD) when the dosage form allows. This ensures safer connection and disconnection.

“When using CSTDs during administration, the risk of unintentional disconnection or a hazardous drug spill is significantly reduced,” Anderson explains. “But they must be trained effectively and understand why they need to use the devices.

“The easier you make it, the more likely people are to comply,” she adds. The easy-to-access handling guides mean that staffers don’t have to remember every detail of how to handle each drug. And, the reference guides offer a quick refresher without losing too much time on the job.

As the guidelines’ deadline approaches, HealthTrust’s Pharmacy Services team urges members to be proactive.

“Even if you’re waiting to get confirmation on some USP 797 changes, USP 800 is coming,” Walsh says. “Its recommendations, such as policy changes and training, should be worked on now. These are foundational components that are important to put in place.”

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