The Perils of Off-Label Prescribing

Carolyn Buppert, CRNP, JD

Disclosures

Journal for Nurse Practitioners. 2012;8(7):567-568. 

In This Article

Abstract and Introduction

Introduction

Nurse practitioners (NPs) and other prescribing clinicians are in an odd position regarding off-label prescribing. Everyone seems to do it, and sometimes there is little choice but to do it, yet it is risky, and the messages to clinicians are decidedly mixed. Off-label prescribing does not violate FDA or state law. Except for the prescribing of physician-assisted suicide in Oregon, there is no legal requirement that clinicians write the intended use on a prescription.

Prescribing off-label is not malpractice. Case law supports clinicians' authority to do it. In the case of United States v Evers,[1] the court held that a physician could prescribe a drug for a different dose than recommended in the prescribing guides if it was not contraindicated. In one court case, the opinion read, "In some circumstances, the off-label use of a particular drug or device may even define the standard of care." However, the presumed standard of care is to prescribe "on label." If an adverse event occurs and a plaintiff's attorney finds out that a drug was prescribed off-label, he or she likely will make an issue of it.

One court case against a physician gives us an indication of how judges view off-label prescribing.[2] In that case, a physician used terbutaline sulfate, by infusion pump, to stop a woman's preterm labor at 35 weeks. Terbutaline sulfate has been used for this purpose for many years, though it is an off-label practice. The patient had a myocardial infarction and sued for malpractice. The appellate court held that the fact a drug was prescribed off-label could be introduced as evidence that the prescriber deviated from the standard of care. As this case and others became known, the FDA issued warnings against use of terbutaline for stopping preterm labor.

Off-label prescribing is an especially important issue for pediatric NPs and pediatricians. Approximately 75% of the drugs prescribed for children have not been tested in children, so the labeling approved by the FDA regarding dosing, indications, and precautions in the drug references are, for the most part, applicable to adults, not children. Prescribing drugs not approved for pediatric use is not the same as prescribing a drug for which there is a contraindication. In short, rather than saying, "We know there is a problem (contraindication)," the FDA is saying, "We just don't know."

In one case against a pediatric NP who prescribed off-label, a judge awarded a plaintiff $3,459,892.[3] In that case, an NP saw a 15-year-old girl in a clinic, 2 days after the patient had visited an emergency department for nausea, abdominal pain, and vomiting. The NP prescribed anti-nausea medications and also fluoxetine for depression. Three weeks later the girl hanged herself. Her parents sued the NP, and among the points the plaintiff made was that the FDA had issued a warning specifying that fluoxetine increases the risk of suicidal thinking and behavior in adolescents.

The bottom line is that off-label use may be 1 factor leading a judge or jury to a conclusion that a clinician breached the standard of care. Further-more, if a clinician does not inform a patient that he or she is prescribing off-label, that lack of information may lead a patient to claim that he has not given his informed consent to take the medication. Courts have ruled that physicians do not have to reveal that a proposed use is off-label during the informed consent process. However, it makes sense for clinicians to tell a patient that they are prescribing off-label in order to give the patient a chance to refuse or agree to take the medication.

In a Consumer Reports article[4] on off-label prescribing, the magazine advised consumers: "Although many doctors regularly discuss off-label drug use with their patients, your doctor is not obligated to do so. Ask your doctor when a prescription is written if the drug has been approved by the FDA to treat your condition. If the answer is 'no,' ask why he or she thinks it will work better than a drug that's already been approved for your condition. Also ask about the evidence that supports its use in your case and about the alternatives."

Prescribing off label requires a clinician to balance patient safety (protecting patient from unsafe or ineffective drugs) against the judgment of the clinician that the drug will benefit the patient. Any clinician prescribing off-label is taking on some risk, and is putting the patient at risk, as the clinician does not have benefit of the use, dosing and route information which is available when a medication is prescribed for an approved indication. And, the safety and efficacy of the drug may not have been established for the unapproved use. There is little or no opportunity for clinicians to share data on the successes or mishaps regarding their off-label use, as there are no requirements to keep or report such data.

When prescribing off-label, clinicians must weigh the risks to themselves and patients versus the benefits to the patient. And, if an NP is practicing under a protocol and off-label use is not covered by the protocol, the NP needs to avoid prescribing off-label.

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