ASHP Midyear: Compounding Medications Provide Personalized Options for Patients

Compounding pharmacies serve an important function in the health care system, allowing pharmacists and technicians to create customized sterile preparations for patients with specific needs, such as allergies to certain ingredients or the requirement for tailored dosages. Annie Lambert, PharmD, BCSCP, clinical program manager of compliance solutions at Wolters Kluwer, emphasizes the clinical decision-making and safety checks involved in this compounding process, whether it's preparing large batches for many patients or individual doses for oncology treatments and parenteral nutrition. However, she notes that many patients are unaware of the complexities behind their medications, both from community pharmacies and in hospital settings. Lambert urges patients to ask questions about the origin and safety practices of compounding pharmacies, while also stressing that compounding facilities must adhere to the full breadth of regulations and standards.

Pharmacy Times: What is the role of the pharmacist in compounding, particularly for personalized and patient-centric care?

Annie Lambert: Pharmacists technicians, I think, both play a really important role in creating and producing compounded sterile preparations for patients. This is one of the areas that compounding actually supports, is that when patients have specific issues way that maybe that's an allergy to an excipient or a product that's part of a greater, maybe a commercially manufactured product, then that's where compounding is really unique, to help meet the patient's needs, but in a way a commercially manufactured product doesn't support certainly. From a hospital perspective, we're compounding medications for patients every day, whether that's in large quantities for many patients that we expect, or individual doses for patients like oncology patients that are going to be getting a dose that is specific based on their weight, their lab values. So all of that kind of both clinical decision making happens in preparation for that dose. Another example would be parenteral nutrition patients, where there's multiple ingredients that that patient needs all in one solution, and all of that is going to be tailored to their particular needs, and I think that's again, where thinking about that individual patient that is going to be receiving that preparation really helps connect why we go through all of these safety checks, all of these regulations on there to keep that patient safe.

Pharmacy Times: How can pharmacists ensure that patients understand the risks and benefits of compounded medications?

Lambert: This is a really important topic right now, with compounded medications being in the headlines and and a lot of patients, I think, don't think about what goes into their medicines, whether they pick them up from their corner drug store or their community pharmacy, or when they're in a health care setting like a hospital or emergency department. We don't want them to have to think about those medicines, that they're safe and effective, of course, but with compounded medications specifically being in the headlines a little bit more. It is important to ask a few questions. I would say, first is, "where is this coming from? Who is making this is this a licensed pharmacy? Is a state or was licensed in my state?" And it shouldn't really be the burden of the patient to figure that out, but that is what's coming to them. Maybe it's being mailed to their house, and so they actually don't have a face-to-face person that they're going to be talking to, and so they can look some things up on the internet. They can look up the pharmacy license number. There's things like that. The provider could also help with that, and sometimes providers have very good relationships with these compounding pharmacies, also just asking about some of their processes. Do they follow USP 797, when was their last State Board of Pharmacy inspection? What's the training involved? They shouldn't, again, have to ask all these questions. But if they're going to, you might as well start asking, have there been any safety concerns or recalls or FDA inspections, even on any of their products or their pharmacies? So those are things it is worth asking, and I know I have had family members and friends ask as they've been considering some of these compounded medications for various things that they're starting to get concerned, and as we talked about all these other things that can go wrong, it is important to know that your pharmacy is following all the right processes and regulations.

Pharmacy Times: Is there anything else you would like to add?

Lambert: I have been in the compounding industry and a pharmacist for over 20 years, and really, the evolution of these compounding standards has has taken place during the span of my career, and I have learned, many of us have learned we know better, so we're going to do better, yet, there really still are some detractors out there that don't want to follow the full breadth of the standards, or trying to find ways to kind of do the minimum, and I think there are definitely ways that you can find some shortcuts, and you can check some boxes, and you can still meet a regulatory inspection, but I think we need to keep those patients in mind and that are you doing the best that you can with what you have, whether that's a facility challenge or personnel challenge or financial issues. None of those are reasons to create an error or have a terrible outcome for a patient, and so I just wanted to keep that in mind that as we as we know better, we're going to do better, and the compounding industry will continue to evolve, and we have a lot more things that are coming, but these standards are here for a reason, and it's for those patients, and we want to keep them safe.