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.
OncLive: What are some of the current challenges that community practices and infusion centers are facing with USP <800> and <797>?
: 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.
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.
Would RTU overcome some of these challenges?
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.
What do you think the role of RTUs will be in the future of cancer care?
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.
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