On July 28, 2018, the USP will publish preliminary updates to existing drug compounding standards that could affect whether rheumatologists maintain the ability to mix, combine or otherwise customize medications in office for individual patient use.
The ACR, in concert with the American Medical Association (AMA) and others, is working to help ensure rheumatologists can continue to meet the needs of patients in a timely, affordable and appropriate way.1
Why the Change?
The revisions to USP Chapter 797, which generally serve as the federal policy basis for sterile compounding, follow a 2012 incident in which 750 people across 20 states developed infections after receiving a compounded steroid medication shipped from the Massachusetts-based New England Compounding Center. It was contaminated with fungal meningitis. More than 60 people died.2
Current standards were last updated in 2008 and lack clarity with respect to physician mixing.3
“After the fungal infection with the compounding center, everyone is taking a closer look at compounding activities,” says Colin Edgerton, MD, FACP, chair of the ACR’s Committee on Rheumatologic Care and a voting member of the AMA’s House of Delegates.
He adds, “What we saw with the compounding accident essentially represented errors in industrial scale processes, not what is done day to day in the rheumatologist’s office.”
Concerns
Dr. Edgerton and other rheumatologists are concerned new regulations could affect their ability to effectively treat patients, creating significant hardship and morbidity. “Patient access to these treatments is extremely important,” he says.
Each day, “hundreds of rheumatologists across the country give hundreds of shots,” says Christopher Adams, MD, FACP, FACR and chair of the ACR’s Affiliate Society Council. “No one dies or has a tragic outcome, and people feel better, so where’s the problem? The last thing we need is more government regulation to get in the way of taking care of patients when we are already facing terrible [staffing] shortages and [limited] access to care.”
The USP’s Chapter 797, which focuses on the compounding of sterile preparations, is already in effect, but revisions to be published in June 2019, following a period of public comment, could subject physicians to compounding rules more typical of larger operations. Currently, compounding is permitted by physicians for individual patient use with a prescription.
For example, rheumatologists often mix injectable medications with an analgesic to alleviate associated pain. This activity may be defined as compounding in the new USP regulations.
“For years and years, doctors have been mixing medications in a syringe and giving it to patients, like mixing steroids with lidocaine because it hurts less,” says Dr. Adams. “If I were a large manufacturer and I was making salsa, … you would want the health department to make certain I was preparing ingredients appropriately, but nobody in their right mind would suggest a health officer has to come to every single kitchen in U.S. to make sure grandmom is chopping up ingredients right to make homemade salsa.”
The new USP standards, without appropriate exceptions, may also prevent physicians from reconstituting in-office lyophilized preparations purchased from a manufacturer.
“I am a practicing rheumatologist in the largest single-specialty rheumatology group in the U.S., and … in my practice we have been concerned that if we fall under more stringent compounding regulations we would be unable to … provide these services to patients because of the burden of what are essentially rules and processes designed for industrial compounding, not the reconstitution of medications in accordance with FDA labeling that we have all been doing safely for years,” says Dr. Edgerton.
Exclude In-Office Mixing
He and Dr. Adams, along with the ACR, believe USP should exclude in-office mixing from the compounding definition.
“The ACR’s push right now is protect patient access and safety while allowing appropriate in-office treatment,” says. Dr. Edgerton. “In regard to compounding, this [means] excluding activities, such as immediate-use joint and soft-tissue injections, and reconstitution in accordance with FDA labeling, from the definition of compounding.”
Kelly April Tyrrell writes about health, science and health policy. She lives in Madison, Wis.
References
- Committee on Rheumatologic Care. American College of Rheumatology Position Statement. Compounding of Pharmacologic Agents. 2017 Feb.
- Food and Drug Administration. New England Compounding Center pharmacist sentenced for role in nationwide fungal meningitis outbreak. 2018 Jan 31. https://www.fda.gov/ICECI/CriminalInvestigations/ucm594800.htm.
- American College of Rheumatology. Position Statement. Committee on Rheumatologic care. 2017 Feb.
