Jeffrey C. Lombardo, PharmD, BCOP, discusses the potential impact that ready-to-use formats for cytotoxic drugs might have in the oncology arena.
Jeffrey C. Lombardo, PharmD, BCOP
The availability of cytotoxic drugs in a premixed, ready-to-use (RTU) format provides another option for oncology specialists and their patients, according to Jeffrey C. Lombardo, PharmD, BCOP. Pharmacists have been administering prepackaged drugs for agents used in the infectious disease field, such as antibiotics and electrolyte supplements, and the benefits are multifaceted, Lombardo said.
The introduction of RTU chemotherapy in cancer care comes at a time when oncology practices are bracing for new requirements for hazardous drug management. The US Pharmacopeia (USP) Convention’s General Chapter <800> draft guidelines, which cover safe handling practices, and the USP <797> revision, which involves standards for compounding sterile preparations, are scheduled to take effect in December 2019.1
Lombardo, associate director of the Empire State Patient Safety Assurance Network and research assistant professor at the University at Buffalo in New York, discussed the potential impact that RTUs for cytotoxic drugs might have in the oncology arena in an interview with OncLive.Lombardo: The adoption of USP <800> is really posing some challenges for [healthcare providers]. If you look at USP <797>, those [recommendations] are really [centered] around sterility, but USP <800> focuses on the healthcare worker—those who receive the product, store the product, compound the product—how we administer the drug to the patient at the bedside or in the chair, and where we dispose of it. As you can see, this is an encompassing task with a lot of policy procedures. A lot of thought has to be put into this to make sure you have the right guidance documents in place.
One of the challenges for compounding pharmacists with USP <800> is understanding that using closed-system transfer devices is a recommendation for compounding, but really not mandated when you infuse those drugs into the patient in the bedside or in the chair. Under the USP <800> standard, utilizing closed-system transfer devices is going to be [necessary] in order to meet compliance and code. The financial burden, the outlay, and the selection of what closed- system transfer device you should be using is also a question for some of the practices.
My guess is that some practices will not take on this endeavor and decide to send their patients to an independent infusion center that is up to code and compliance. If this happens, some patients may end up driving long distances to be treated.New to the market are the ready-to-use, or ready-to-administer, chemotherapy products, which may be a solution that assists community oncologists to continue treating patients in the office and circumvent the compounding procedure.
As pharmacists, we’ve been using these agents in infectious disease and certain electrolyte replacements, and they have been adopted as a recommendation by the American Society of Health-System Pharmacists to reduce and minimize errors. These could be an alternative to use in community oncology or academic centers to help with workflow and also to help with time efficiency and getting prepped for the patient a little bit quicker in a sterile environment. It’s unique how the manufacturing process and the sterility in a truly closed system, called a bag system, is utilized to administer the product.As RTUs come to the oncology market, I think it promotes workflow advantages, such as being able to stage chemotherapy drugs ahead of time, prepare at those busy clinics, and prepare patients before they walk into the door.
I think it has advantages for sterility and stability as well. Sometimes, for a patient who is receiving chemotherapy, their bloodwork come backs and it might have some neutropenia or thrombocytopenia, and you might have already mixed that medication. You then have to waste that and it’s a financial burden to the practice. The RTUs have an extended shelf life. If for some reason the patient is not administered chemotherapy on that day, you can bring [the drug] back and possibly use it on another patient.
1. Updates on compounding standards. USP website. usp.org/compounding/updates-on-standards. Accessed November 9, 2018.