Dr. George J. Hruza discusses proposed changes to sterile pharmaceutical compounding preparations and the ongoing advocacy efforts to ease regulations.
George J. Hruza, MD, MBA, FAAD, is Adjunct Professor of Dermatology, St. Louis University, and Candidate, Missouri State Senate, 24th District, St. Louis, Missouri
“When we anesthetize patients, we buffer the lidocaine… putting [in] a little bit of bicarbonate helps to make it less painful. And it’s been used safely pretty much for at least 30 years that I’ve been in practice. The problem is, it’s considered compounding now. And because of that, it comes under all kinds of rules and regulations,” said George J. Hruza, MD, MBA, FAAD, who presented “Legal Considerations in Compounding and Mixing Drugs” at the 41st ASLMS Annual Conference.
“The issue of compounding… started with the Aspergillus meningitis outbreak from compounded corticosteroids, which led to 53 deaths and many other serious illnesses from that. And out of that arose this legislation which requires the FDA… to regulate pharmacies and anybody who compounds.”
That includes dermatologists, said Dr. Hruza.
While the FDA has released regulatory guidance, the FDA is not enforcing it in physicians’ offices yet, he said.
“So that one is a little bit less of a threat. The problem is that USP—United States Pharmacopeia—has made changes to chapter 797, which deals with compounding of medications, primarily in pharmacies. However, it includes compounding in any location, including physician offices.”
The USP initially proposed that nonsterile pharmaceutical compounding preparations must be used within 1 hour after preparation. Advocation by dermatology organizations have won an extension to 4 hours, said Dr. Hruza.
“…in offices, we usually prepare buffered lidocaine in batches. And so you prepare a batch and traditionally we’ve been using it… for over a week. But now they say that, once this is fully implemented, you will have 4 hours to use it.”
In addition to that, you’ll have to label each syringe with the name of who prepared it, what’s in it, and what the expiration time is, he said.
To date, appeals have prevented these changes from becoming finalized, but because the States generally accept USP standards, changes are coming, said Dr. Hruza.
In fact, some states and facilities have already begun to implement them, he said.
“They kind of jumped the gun. Ohio actually went even before they finalized the rules. Also, if you work in a facility, like a hospital setting, then they also tend to apply those already.”
In those places that are already following these expected changes in compounding standards, pharmacies are preparing buffered local anesthetic, said Dr. Hruza.
“They have it prepared in the pharmacy, and they charge them $2 for each 3 mL syringe. So that is not very practical because it gets very, very expensive.”
Advocacy at Work
But changes won’t be finalized without a fight, said Dr. Hruza. The American Academy of Dermatology, American Society for Dermatologic Surgery, American College of Mohs Surgery, and American Society for Mohs Surgery are putting compounding standards to the test.
“What we’re doing is trying to get a first-ever monograph to make those requirements—the USP requirements—less onerous…”
Specifically, the aforementioned dermatology associations will be providing the USP with the results of three tests on buffered lidocaine with epinephrine asking the USP to extend the permitted shelf-life from 4 hours to at least 12 hours.
To date, two of the three testing requirements have been met.
“If we pass the third one, which has to do with stability…, then we’ll have the USP, hopefully, approve this monograph, which has never done before and will get us at least a 12-hour timeframe.”
“If you prepare it according to the monograph, you’ll be able to prepare lidocaine with epinephrine and buffer it and use it for the whole day. We probably won’t get a whole week but certainly getting a whole day would help a lot of practices.”
Other Issues
This will also concern the preparation of neuromodulators, said Dr. Hruza.
“The challenge is that if you prepare it on label… where you reconstitute with non-bacteriostatic single-use saline, then you can use it over 24 hours, but you’re supposed to use it only in one patient, which for the cosmetic world is very impractical.”
Historically, it’s been prepared with bacteriostatic saline. The benzyl alcohol content makes the injections more tolerable, said Dr. Hruza.
“The preservative is a mild anesthetic. It hurts less and, of course, using something that contains a preservative means that it can be used safely for weeks and on multiple patients.”
The problem is the 4-hour rule.
“I don’t have the answer for you yet because we are right now working on the [issue of] local anesthetic, and I’m hoping that once we get that through, then we can work on some of these other issues.”
Another of which is the preparation of intralesional corticosteroids, said Dr. Hruza.
“Some offices that are very busy will prepare those ahead of time…. They take the full-strength triamcinolone acetonide and dilute it with bacteriostatic saline based on patient needs. This is considered compounding and therefore if you prepare it ahead of time, you will be limited to 4 hours along with the various preparation restrictions and labelling.”
For now, most dermatologists don’t need to change what they’re doing. Wait until the guidance is finalized and until your state adopts it, said Dr. Hruza.
“…when this guidance is finally finalized, as the states take it up, we want the regulations to be promulgated by the boards of healing arts rather than pharmacy boards.”
This is because we consider in-office preparation part of the practice of medicine, not pharmacy, said Dr. Hruza.
“…what’s happening now in Ohio [is] the pharmacy regulators come into offices and slap heavy fines on practices that don’t follow those very restrictive guidelines…”
Advocacy will continue for dermatologists and patients, said Dr. Hruza.
“Our organizations will continue fighting as it’s finalized at the state level, as this is too onerous and really bad for patients.”
Case in point, if practices decide not to buffer lidocaine, it’s patients who lose, said Dr. Hruza.
“That patient now is going to be suffering because of this regulation. We are going to be fighting that state by state. What people can do is to support our organizations because they’re fighting on their behalf.”
For more information: https://www.aad.org/member/advocacy/priorities/drugs/compounding