Q&A: What you need to know about compounding medicine

Briefings on Accreditation and Quality, August 1, 2017

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Editor’s note: The Joint Commission unveiled a new Medication Compounding Certification (MCC) program in January with the goal of reducing the harm stemming from drug compounding and ensuring compliance with U.S. Pharmacopeial Convention (USP) and Joint Commission standards. All compounding pharmacies are eligible to enroll in the program, including organizations not accredited by The Joint Commission. Meanwhile, USP Chapter <800> goes into effect on December 1, 2019 and contains major changes aimed at protecting healthcare workers from exposure to hazardous drugs and materials.

The following is an edited Q&A with Kurt Patton, MS, RPh, a former director of accreditation services for The Joint Commission and founder of Patton Healthcare Consulting in Naperville, Illinois. He spoke with BOAQ on the details surrounding medication compounding.

Q: What are some of the benefits of compounding medications?
Not everything doctors want to give to patients is available commercially. Sometimes you might want to mix two products together so you can give it in one IV instead of having two IVs attached to the patient—makes it a little bit more convenient. And other times it’s pretty routine that you have to mix things and put into a large-volume solution in order to give it to the patient.

It’s really just for ease of administration and the fact that not everything comes prepared from the manufacturer exactly the way you want to give it to the patient. It is also very common that, for clinical reasons, the patient cannot take fluids by mouth.

Q: Are there any cost benefits to compounding?
No. If the product comes commercially available, most hospitals will buy it commercially packaged and ready to go. But if it’s not commercially available, you just make it.

Q: Is medication compounding safety compliance an area where hospitals and clinics struggle? Or are most pretty good at following USP and Joint Commission regulations?
Medication compounding is an issue that hospitals struggle with due to the complexity of the regulations. These regulations touch on the physical environment, including air handling, exits, entries, pass-through, cleaning, employee health, receiving, spill management, competency, product validation, employee attire, and more.

Usually with new requirements you are talking more about just changing a process, requiring some education. There are many facets to these compounding requirements. 

Q: Do you think the new USP <800> Chapter will help reduce that complexity at all? And if not, is there anything that could provide simplification?
I don’t think the new USP <800> will reduce complexity. Actually, it adds a new chapter of complexity to things.

The main advantage, though, is that it’ll make product preparation safer for the employees involved in either preparing or administering these medications. These medications are by themselves sometimes toxic to the healthcare worker. The USP <800> regulations are designed to help protect the healthcare worker while at the same time ensuring delivery of a sterile product. 

I think they are inherently complex. To try and make a sterile product you can deliver intravenously is not as easy as making an oral product. Keeping or maintaining sterility is the difficult challenge, but it’s essential when you’re talking about a product going directly into the bloodstream. If you or I ate a product that contained some contamination, once it got into the GI tract, to a large extent, our GI tract helps protect us. But if you deliver that same bacteria into the bloodstream, you don’t have that same level of protection.

This is an excerpt from a member only article. To read the article in its entirety, please login or subscribe to Briefings on Accreditation and Quality.

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