At a recent meeting, I was asked by an RN what her liability is if she administered an approved intravenous drug for an non-labeled indication prescribed by a physician to her patient and does she have the right to refuse to give the treatment even with the patient consent? A very interesting question and one that I had research to see what I find.
Medications in the United States cannot be marketed without an FDA determination that they are safe and effective for the intended use. Hence, pharmaceutical companies submit their products to rigorous scrutiny and present the subsequent data to the FDA. FDA approval comes with specific labeling requirements for the product, including the approved indications for use, the appropriate dosing, and the specific population for its use. This is termed “FDA Approved Drug” and “FDA Approved Labeling“. Drug uses that are not included in the indications or dosage regimens listed in the drug’s FDA labeling are defined as “unlabeled uses“. Some refer to this as “off label uses“. Unlabeled uses include the use of a product in doses, patient populations, indications, or routes of administration that are not reflected in the FDA approved drug labeling. This is very different from an investigational drug, which is a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical investigators and then by practicing physicians using subjects who have given informed consent to participate.
The use of FDA approved drugs for off label indications is very common among physicians in many different specialties – pediatrics, oncology, psychiatry, orthopedics, to name a few. This practice is increasing and in certain situations, the “off label ” use is the most appropriate therapy for the patient. The FDA cannot approve or disapprove physicians prescribing practices of legally marketed drugs. Once a medication is FDA approved, physicians can prescribe the medication even for indications not on the labeling. However, the FDA does regulate what manufacturer may recommend about uses in their products’ labeling and what manufacturers can include in advertising and promotion. There is also the issue related to reimbursement, which might not be allowed for “unlabeled use” by insurance companies.
In my research, I found that the FDA, ASHP and several other organizations have issued statements and position papers on the use of medications for unlabeled uses. All agree that unlabeled uses may be appropriate and rational in certain circumstances, and may, in fact reflect approaches to drug therapy that have been extensively reported in medical literature. None of these organizations are related to nursing, hence, there are no statements or position that addresses the nursing role and responsibilities on administering medications for unlabeled use that I could find. The closest thing I found is the Infusion Nurses Society standard on the “administration of parenteral investigational drug” which isn’t the same as “unlabeled use” .
So back to the question – what her liability is if she administered an approved intravenous drug for an non-labeled indication prescribed by a physician to her patient and does she have the right to refuse to give the treatment even with the patient consent? These are tough questions with no suitable answers as the potential for unexpected adverse effects should always be a concern when drugs are used in an off label manner. In situations like this, it is best for the organization to develop policies and procedures addressing the prescribing, dispensing and administration of drugs for unlabeled uses specific to their work settings. It should address the documentation of scientific support, adherence to accepted medical practice standards or a description of medical necessity. From a liability standpoint, the patients should be informed that a drug being prescribed is for an unlabeled use and informed of the rationale for the suggested treatment.The decision to use drugs for unapproved treatments should be based on the understanding of the risks and benefits to the patients. The nurse must be well informed about the drug and the treatment protocol prescribed. As always, documentation is of utmost importance in this case.
2. KR Rapkin: Pediatric Off Label Prescribing: What every APN should know. The Internet Journal of Advanced Nursing Practice. 1999 Vol 3 Number 1
3. Pfister DG: Off label Use of Oncology Drugs:l The need for more data and then some. JCO February 20, 2012 vol. 30no. 6 584-586
4. Infusion Nurses Society 2011 Standards of Nursing Practice : Standard 68 Administration of Parenteral Investigational Drugs.