American College of Rheumatology Releases Position Statement on Patient Safety and Site of Service for Biologics

The American College of Rheumatology (ACR)’s Committee on Rheumatologic Care released an updated position statement regarding patient safety and the site of service for biologics for patients with rheumatic diseases. The full report is available on the ACR website.

1. The committee noted that the ACR strongly supports the use of biologic medications for the treatment of rheumatic diseases.

2. Biologics have substantial side-effect profiles, with up to 30% of clinical trial participants experiencing adverse reactions to these drugs. In addition, the delivery of biologics via subcutaneous (SC) and intravenous (IV) routes further increases the risk for complications; IV vs SC administration has been found to have more severe adverse drug reactions.

Known adverse effects include injection site reactions; infusion reactions; infections including tuberculosis; cytopenia; increased risk for skin cancer; demyelinating diseases; exacerbation of existing heart conditions; drug-induced systemic lupus erythematosus; anaphylaxis; and death. Serious infections reportedly affect 2% to 5% of patients per year receiving biologics, and regular screening for adverse events is an essential component of care.

3. Due to the substantial risk for serious side effects, the ACR maintains that biologics should only be administered in a supervised health care setting. Infusion should be monitored by a care team trained in biologics administration, by professionals who are involved in the patient’s care plan with access to their medical records.

4. The ACR “opposes policies that force patients to receive biologics at home,” particularly home-delivery options, as this may compromise on patient safety though it cuts costs. The ACR also recommends against infusion centers that do not have clinicians trained in biologics administration. Instead, delivery in a specialized clinical setting is strongly advised.

Infusion in a clinical environment allows for the prompt identification and treatment of adverse reactions. In addition, as biologics have specific storage and reconstitution instructions, a clinical setting increases the likelihood of efficacious delivery. Direct contact between clinician and patient allows for real-time treatment adjustment, depending on the patient’s condition and needs. However, for patients who strongly require a home infusion under extenuating circumstances, a shared decision-making process between the patient and provider should be initiated.

5. The ACR recommends that nurse practitioners and physician assistants who are involved in infusion centers have specialized training in the administration of biologic therapies. These professionals should work in a collaborative manner with the physician, as regulated by state law.

The ACR committee noted, “[T]he tremendous heterogeneity of patients and the diversity of autoimmune conditions treated with biologics multiplies the variety of responses and side effects associated with these medicines, necessitating oversight by highly trained, specialized physicians to ensure their safe and effective administration.”

Reference

American College of Rheumatology. Patient safety and site of service for biologics. Updated June 21 2021. Accessed July 15, 2021. https://www.rheumatology.org/Portals/0/Files/Biologics-Patient-Safety-and-site-of-Service.pdf