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Can Pharmaceutical Sales Reps Influence Prescribing For Unapproved Uses?

After academic medical centres began instituted policies that restricted sales reps from having access to physicians, prescribing antidepressants and anti-psychotics for unapproved uses declined.

In recent years, a growing number of academic medical centres in the U.S. have adopted policies that restrict the activities of pharmaceutical sales reps. The shift, which typically involves limiting access reps have to physicians, has come in response to growing concern about undue influence on medical training, practice and research.

One justification for adopting tighter policies has been the extent to which medicines are prescribed off-label, or for uses not approved by the FDA. Studies have shown that limiting contact between reps and medical residents may lower prescribing later. But there have not been any studies examining how these new policies affect off-label prescribing, in particular.

So a group of researchers ran a study to gauge the effect that sales reps may have had on prescribing and what, if any, changes were caused by the medical centre policy restrictions. The thinking was that if restrictions did affect off-label prescribing, it would suggest that reps engaged in off-label promotion, according to co-author Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School.

The researchers focused specifically on prescribing for antidepressants and anti-psychotics in the belief these types of medicine would make a good test case for placing limits on direct marketing to physicians. The reason, he explains, is that these drugs have been regularly prescribed off-label to children and remain controversial due to limited evidence for paediatric use.

What did they find?

After examining prescribing patterns between January 2006 and June 2009, prescriptions for off-label use fell by 11 percent following the introduction of more restrictive policies. “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,” he says.

In addition, prescriptions for uses approved by the FDA fell 34 percent. Why? Kesselheim suggests that the lack of interaction with sales reps simply prompted physicians to write fewer prescriptions for these drugs at all. The implication is that the restrictive policies essentially lessened the affect that marketing had overall.

Not all patients were prescribed brand-name pills, though. And interestingly, prescriptions for lower-cost generic versions of the drugs rose for both off-label and approved uses – by 35% and 14%, respectively. Again, Kesselheim suggests that the difference in prescribing reflects the impact that sales reps can have on physicians.

Of course, there are varied reasons for prescribing, including instances where a drug approved for treating a given malady – such as depression – is ineffective, prompting physicians to turn to off-label remedies. “A lot of important drugs are prescribed off label and patients may benefit from that. So it should be case by case,” he says. “In areas where there is less controversy, the considerations may be different.”

Nonetheless, the study underscores the potential for restrictive policies to alter prescribing patterns even more than FDA approval, at least for these classes of medicines.

By Ed Silverman
Harvard medical

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