Patient Safety & Site of Service for Biologics
Although emphasizing its strong support for the use of biologic agents as necessary treatments for rheumatic diseases, the ACR Board of Directors continues to be concerned about the safe delivery of these agents, given the potential for associated adverse events and infusion reactions. In a position statement on patient safety and site of service for biologics, the Board says that it supports the standard of care for the delivery of these agents by a trained provider.1
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“We favor supervision of biologic infusions by providers trained in the administration of these complex agents in a setting that maximizes patient safety, such as a physician’s office, hospital outpatient infusion center or free-standing infusion center with proper supervision,” says Sean Fahey, MD, chair of the Insurance Subcommittee and a member of the Committee on Rheumatologic Care (CORC).
Because of the potential for serious drug reactions and the need for clinical monitoring and mitigation of this risk by trained professionals, Dr. Fahey emphasizes that the Board opposes policies that mandate home infusions, which undermine patient safety, solely to cut costs.
The Issue of Compounding
Addressing a separate issue concerning compounding of pharmacologic agents, Donald Miller, PharmD, professor of pharmacy practice, College of Health Professionals, North Dakota State University, says that the ACR has looked carefully at the issue of pharmaceutical compounding and is lobbying the appropriate agencies for positions favorable to rheumatology.
As the lead author of the ACR’s position statement on compounding of pharmacologic agents, Dr. Miller highlighted two main issues addressed in the statement:2 1) allowing physicians to do limited sterile compounding (i.e., admixing two different sterile drugs in one syringe) in the office without additional precautions; and 2) allowing continued pharmacy compounding of quinacrine for patients who do not respond well to hydroxychloroquine.
The position statement highlights the importance of allowing rheumatologists to follow the standard of care in compounding and administering medications in the office setting, such as for performing joint and soft tissue injections, using a combined local anesthetic and corticosteroid. “This procedure must be protected,” the ACR says in its position statement.2
In addition, the statement emphasizes the need for continued permission to compound quinacrine via addition to the Food and Drug Administration’s (FDA’s) bulk substances list. The ACR emphasizes that only drugs compliant with the use of bulk substances should be permitted for compounding. “For the time being, the FDA is not taking action on this issue until it makes a final decision on which drugs have sufficient evidence of efficacy to add to the list,” the ACR notes in its statement.
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.
- American College of Rheumatology Position Statement. Patient Safety and Site of Service for Biologics. http://www.rheumatology.org/Portals/0/Files/Biologics-Patient-Safety-and-site-of-Service.pdf.
- American College of Rheumatology Position Statement (Draft). Compounding of Pharmacologic Agents. http://www.rheumatology.org/Portals/0/Files/ACR-Position-Statement-Compounding-Pharmacologic-Agents.pdf.