Why Safety is Crucial in Hazardous Drug Compounding

When performing pharmacy compounding with hazardous drugs, both facility design and sterile work practices are key to ensuring safety. This is why the United States Pharmacopeia created the USP <800> General Chapter, which “provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.”¹

Drug Topics sat down with Lisa McCabe, PharmD, MBA, BSN, director of Health System Pharmacy at Cardinal Health, at the American Society of Health-System Pharmacists (ASHP) 2023 Midyear Clinical Meeting and Exhibition, to discuss best practices when working with hazardous drugs, key features of compounding facilities, and how compounders can work with leadership to balance needs around safety, efficacy and cost. McCabe and her colleague Patricia Kienle, MPA, BCSCP, FASHP, director of accreditation and medication safety at Cardinal Health, presented a session focused on USP <800> compounding at this year’s ASHP Midyear Clinical Meeting.

Drug Topics: For those in our audience who are not as familiar with compounding, can you briefly touch on the differences between USP <797> and USP <800>?

Lisa McCabe, PharmD, MBA, BSN: USP <797> is related to sterile compounding as a whole—so, all of your compounding practices for compounding sterile products—whereas USP <800> is the applications of that to hazardous drug compounds. So, your antineoplastic drugs, as well as drugs that may have other kinds of risks to you, including reproductive toxicity, and that is specific to the handling and administration of those hazardous drugs.

Drug Topics: When you're working with hazardous drugs in a compounding setting, what are some of the most important best practices that compounders need to adhere to?

McCabe: The biggest thing is safety; safety of workers and people who are handling the hazardous drugs. That's probably the key—protection—because you're not going to remove that hazard. You have to make those drugs for patient care and to help people get better and get their therapy. Since we can’t completely eliminate the hazard, we need to protect ourselves and make sure that we're working in the right environment. We have our clean room spaces that we're working in and our engineering control, so where we're compounding those drugs is protecting us from those products, as well as what we're wearing. We're always wearing double gloves, a gown, all of our personal protective equipment (PPE), when we're around those drugs.

Drug Topics: What are some key features of the facilities where these hazardous drugs are being compounded? What do those facilities need to look like?

McCabe: In general, anywhere where you're doing sterile compounding, you're going to be in a controlled environment. When you're entering into that space, that's usually a restricted area. Only personnel who are familiar with handling those drugs would be permitted to go in. But with your hazardous drugs in particular, what I would really hope to see is some kind of alert that hazardous drugs are there in the area. Because as pharmacists, yes, we know [how to handle these drugs], but somebody might be coming in, a nurse [for example]. We want them to be aware that those hazards exist. You're going to see those controlled spaces, signage, people are going to be in their PPE protecting themselves. Those are all key features.

Drug Topics: How can compounders work with leadership at their institutions to balance needs around safety, efficacy, and cost when it comes to compounded drugs?

McCabe: The key thing is safety and regulatory requirements. That's usually key for when I'm working with my leadership. If you're saying it's something that's regulatory, and you have to do it, that's going to make [leadership] pay attention. I think another the key too is the Joint Commission; we will be surveyed for these new regulations as well come January. Your organization is definitely going to want to avoid any negative implications. So, the key is now pushing patient safety and worker safety, as well as [safety] for all of us, in the environment.

Drug Topics: Are there any other key points or takeaways that you wanted to touch on?

McCabe: We want to make sure that we're not just involving pharmacists. [Compounding] is multidisciplinary in nature. In our presentation today we'll be talking about administration as well as the compounding part. [It’s] really important to involve all the key stakeholders because everybody's involved, including the patients and their caregivers. Information is key.

Reference

1. Hazardous drugs—handling in healthcare settings. United States Pharmacopeia. Accessed December 5, 2023. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare