Do reps push drugs off-label? Yes, a study suggests. Does it work? Also yes.

Aaron Kesselheim

Studies have shown that cutting down on face time between pharmaceutical reps and healthcare providers can cut down on expensive brand prescribing. But now, new data suggest that scaling back rep visits can also lower off-label prescribing.

Does that mean reps are pushing drugs for unapproved uses? Maybe, the study's authors say. But it also suggests sales folks may have a bigger impact on docs' habits than they might think.

Researchers looked at 31 academic medical centers that began to restrict pharma sales-rep visits. After hashing over the data on rep detailing and prescribing behavior, they estimated the effects of limiting rep contact. Specifically, they looked at pediatricians' and child psychiatrists' prescribing of antidepressants and antipsychotics--meds that are often prescribed off-label--between January 2006 and June 2009.

The result? No-detailing policies sank off-label use of promoted drugs by 11%. And that suggests reps were actually touting drugs for unapproved uses, the study authors say.

"Theoretically, if the rep isn't talking about off-label use and a center makes changes that affect marketing, it should not affect off-label prescribing, unless there's an association between what the rep does and prescribing," co-author Aaron Kesselheim said, as quoted by The Wall Street Journal's Pharmalot blog.

Additional data showed that the latter could actually be at play, however. Prescriptions for FDA-approved uses also fell 34%, suggesting that in the absence of rep interaction, physicians simply wrote fewer scripts for branded drugs, period. Prescriptions for the drugs' generic rivals rose, too, for both off-label and unapproved uses, climbing 35% and 14%, respectively. And Kesselheim said that difference reflects the impact reps have on healthcare providers, the WSJ notes.

So if nixing rep visits can lower off-label drug use, does that mean more hospitals should restrict detailing? Not necessarily. As the WSJ points out, reasons for prescribing can vary wildly, and doctors often turn to an off-label therapy when a drug approved for a certain use, like depression, fails to get the job done.

"A lot of important drugs are prescribed off label and patients may benefit from that. So it should be case by case," Kesselheim said, as quoted by the newspaper. "In areas where there is less controversy, the considerations may be different."

- read the study abstract
- get more from The Wall Street Journal (sub. req.)