Updated ACR position statement on patient safety and site of service for biologics released

The American College of Rheumatology (ACR) has released an updated position statement on patient safety and site of service for biologics outlining several reasons why the ACR strongly believes infusions should be administered in a monitored health care setting with onsite supervision by a provider with appropriate training in biologic infusions.

It is becoming more frequent that rheumatologists are having insurers mandate the location of infusions. Requiring patients to do infusions at home for the sole purpose of cost-cutting jeopardizes their safety. Biologics are complex therapies often used when patients have failed to respond to less potent medications, and they can cause adverse reactions that must be promptly evaluated and treated. Effective clinical monitoring and mitigation of risk is best accomplished when these drugs are infused in medical facilities supervised by on-site trained physicians."

Dr. Marcus Snow, MD, Chair of the ACR's Committee on Rheumatologic Care (CORC)

Biologics can be highly effective in treating patients with rheumatic diseases. Early aggressive therapy with a range of drugs, including biologics, has been shown to reduce joint damage, deformities and improve function which can reduce work absenteeism, disability, death, costly procedures/surgeries, and hospitalizations. However, they can cause reactions that range in severity from a mild rash and myalgia to hypertension, shortness of breath, headaches, and even life-threatening anaphylaxis, and can occur during or after the infusion.

The position statement also explains home infusions do not allow for rigorous maintenance of conditions such as recommended temperature, storage away from sunlight, and proper reconstitution or dosing. The ACR believes having patients monitored in a healthcare facility by a provider who is actively involved in their care with access to their medical record helps ensure patients' safety.

"Making sure our patients are getting their medication in the safest environment is a big concern. While the risk of infusion reaction is small overall, it can be severe. We feel that if infusions are given where the patient is known by health care providers who understand the drugs given, the risk of adverse event to the patient is lower," said Dr. Snow. "Experienced providers, available on site, can decide whether it is safe to continue therapy if mild reactions occur and provide prompt treatment for moderate or severe reactions."

The position statement strengthens the ACR's stance that the decision on where to infuse should be left up to the patient and the provider. The full statement is available at: https://www.rheumatology.org/Portals/0/Files/Biologics-Patient-Safety-and-site-of-Service.pdf.

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