Drug Adherence: The Impact of Off-Label Prescribing

Imagine you’re a professional musician who starts experiencing stage fright. You make an appointment with your doctor, explain the situation, and expect to be prescribed an anti-anxiety drug. Instead, the physician prescribes a beta blocker medication designed for cardiac patients. It’s a prescription error, right?

Probably not. Using medication off-label may seem risky and counterintuitive, but the practice occurs in doctor offices and hospitals across the nation with striking regularity. According to Consumer Reports, “One in five prescriptions in the U.S. is for a use not approved by the FDA [U.S. Food and Drug Administration].”

It’s not surprising. Just as pharmaceuticals can have negative side effects on more than one part of the body, they can hold therapeutic benefits for more than one part. It so happens that beta blockers can banish stage fright by the same action they use to manage cardiac arrhythmias: blocking epinephrine and norepinephrine adrenergic beta receptor sites.

What is surprising is another statistic from Consumer Reports regarding off-label prescribing: Most [off-label prescriptions] (about 75 percent) are for a use that lacks any evidence or rigorous

studies to back it up.” For some patients, this aspect of off-label prescribing negatively impacts drug adherence.

Off-Label Prescribing and Drug Adherence

If most off-label prescriptions are dispensed without persuasive scientific backing, does that mean they’re prescribed on anecdotal evidence alone?

Not necessarily. Returning to the example of the musician, doctors know that reducing the excitatory effects of epinephrine and norepinephrine can induce calmness. This is what makes a beta blocker like propranolol a good option for treating stage fright, which ignites the body’s fight-or-flight response that is driven by the interaction of epinephrine and norepinephrine.

Doctors may know this information like the back of their hand, but most patients don’t. On the prescription label, they witness an appropriate use of an off-label medication. But if they take time to read the prescription flyer, they find nothing about using the prescription to treat their condition. The result?

Some patients trust their doctor and comply. Others resist adhering to the medication. Pharmaceuticals are based on science, and they want scientific proof that a drug is therapeutic for their ailment before swallowing a single pill. Among the patient population that holds this view, off-label prescribing can negatively affect drug adherence in a profound way.

Because the FDA prohibits drug companies from advertising medications for off-label use, the burden of improving off-label drug adherence falls mainly to physicians and pharmacists.

With the help of drug adherence resources — particularly informational prescription labeling and brief but informative drug counseling at the doctor’s office and pharmacist’s window — doctors and pharmacists can promote adherence and the positive health outcomes it predicts.

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