Although rheumatology providers carry the responsibility of obtaining informed consent for the use of off-label treatments, nurses should help educate patients, particularly the parents or guardians of juvenile patients, on the justification of off-label therapies, according to presenters at the Rheumatology Nurses Society Annual Conference.
“I’m going to use the FDA’s own words here: ‘Once the FDA approves a drug, health care providers generally may prescribe the drug for an unapproved use if they judge it is medically appropriate for the patient,’” Sandra J. Mintz, MSN, RN-BC, of Children’s Hospital Los Angeles, told attendees. “Safety plus efficacy equals appropriate off-label use – not experimental.”
According to Mintz and co-presenter Cathy Patty-Resk, MSN, RN-BC, PC, of the Children’s Hospital of Michigan, patients and guardians will often mistake off-label treatments for experimental therapies, and accuse nurses and providers of “experimenting on” them or their children. Providers, pharmacist and nurses should all be prepared to answer such questions, they noted, including “What is this medication normally used for?” and “Will my health insurance cover this?”
Nurses in particular have a key role in educating patients and guardians, and in identifying the education barriers regarding off-label treatments, including primary language, anxiety and illiteracy, according to Mintz.
In addition, nurses can help patients and guardians review the diagnosis, prognosis and treatment plan, as well as reinforce the purpose and use of the medication. They can also discuss potential side effects, when those effects may occur and how they can be managed, Mintz said.
Rheumatology nurses should also encourage patients and families to maintain a journal containing their questions, as well as the responses they have received to those questions. They should also inform the family of the authorization process, as well as any co-pay assistance opportunities or restrictions that may exist.
According to Patty-Resk, there is evidence for the safe and effective off-label use of rituximab for systemic lupus erythematosus, pamidronate and sodium thiosulfate for calcinosis, pamidronate and infliximab for chronic recurrent multifocal osteomyelitis, and tocilizumab for systemic scleroderma. Researching these treatments means reviewing scientific literature, understanding the specific disease pathway and the drug’s mechanism for action, and discussing therapies with colleagues, she said.
Patty-Resk added that, although health care providers and nurses are accountable for negligence, evidence-based off-label treatments are neither incorrect nor investigational.
“When we go off-label, we are going off-label primarily because the on-label drugs are either not effective or unavailable,” Patty-Resk said. “Part of the off-label use we are doing is helping with research. We have to formulate rationale for why we are going off-label and choosing what we are choosing. In addition, you need to conduct a risk-benefit analysis for this drug, collaborate as a team on decision-making, discuss the options with patients and families, secure insurance authorization, prepare the infusion staff and then hopefully, ultimately, report in case studies.” – by Jason Laday
Mintz SJ, Patty-Resk C. Off-label successful treatments and how it is done. Presented at: Rheumatology Nurses Society Annual Conference; Aug. 8-11, 2018; Fort Worth, Texas.
Disclosure: Mintz and Patty-Resk report no relevant financial disclosures.