Infusions of Monoclonal Antibodies in New York State

In the past 12 years, we have seen an increase in new monoclonal antibodies approved by the FDA for numerous indications as treatment options for cancer, neurologic disorders, immunologic,  and autoimmune diseases, to name a few. These monoclonal antibodies are administered either subcutaneously, usually self administered by patients or administered intravenously by a registered nurse and/or other health care professionals. The place of service where these monoclonal antibodies are infused and who administers the infusion varies. Infusions of monoclonal antibodies can be administered in an in-patient hospital setting; ambulatory/out patient setting; infusion centers; physician’s offices; endoscopy centers; and even in the patient’s home.

In 2009, the New York State Board of Nursing issued a practice alert and guidelines on “intravenous monoclonal antibodies”. For details of this position statement, refer to this link.

I do not live and I’m not licensed to practice in the state of New York so why do I care? I applaud their efforts in releasing a position statement on who can infuse monoclonal antibodies, the education/ training requirements; and nursing assessment parameters. I care because aside from this statement, I have not found any specific, detailed guidelines or standards of practice on who can infuse monoclonal antibodies. Designating the RN and specifically stating the administration of these agents by LPN’s is not within their scope of practice provided a clear and defined guidelines in the state of New York. What about the other states? We can only assume that the RN should be the designated person, however, not all states have clear delineation. In some states, infusions of monoclonal antibodies are provided by non-RN’s or unlicensed assistive personnel such as medical assistants. It may come as a shock to many of you, but that is reality. (read my previous blog, Can vs. Should) Oh, by the way, regardless of what clinical settings the infusions of monoclonal antibodies are provided in the state of New York, the position statement applies.