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.
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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.”
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.”