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Limiting Pharmaceutical Sales Reps’ Access Could Mean Fewer Drugs Prescribed for Off-Label Uses

Filed June 12th, 2014 Laurie

Sales of prescription drugs for off-label purposes can mean big money for the pharmaceutical industry, but they also mean injury and death for many patients.

This knowledge has prompted an increasing number of medical centers in the U.S. to limit the access that pharmaceutical sales reps have to their physicians. The concern is that these reps have undue influence on medical training, practice, and research.

One such example is the drug Seroquel. Introduced in 1997, Seroquel is approved by the FDA to treat psychotic disorders like schizophrenia and bipolar disorder. Lawsuits against the drug’s maker, AstraZeneca, have been piling up over the years, filed by patients who allege the company planned to broaden the use of Seroquel for approved and off-label purposes.

The Institute for Safe Medication Practices (ISMP) found in 2011 that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was used for off-label purposes, such as depression, sleep disorders and insomnia, according to CBSNews.com.

Concerns about the growing power and reach of sales reps were serious enough that a team of researchers decided to conduct a study to determine the effect that sales reps may have had on prescribing thus far, and what, if any, changes were caused by the medical center policy restrictions, according to the Wall Street Journal’s Pharmalot blog.

Past studies have shown that limiting contact between sales reps and physicians may actually lower prescribing later on. According to the study’s co-author, Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School, the researchers wanted to test their theory that if restrictions impacted off-label prescribing, it would suggest that sales reps participated in off-label promotion, Pharmalot explained.

Researchers focused on antidepressant and antipsychotic drugs, which are often prescribed for unapproved uses for children. They examined prescribing patterns between January 2006 and June 2009 and discovered that prescriptions for off-label uses fell by 11 percent after restrictive policies were introduced.

“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,” Kesselheim explained to Pharmalot.

During that time period, prescriptions for uses approved by the U.S. Food and Drug Administration (FDA) also decreased by 34 percent. Kesselheim told Pharmalot that number suggests that the lack of interaction with sales reps prompted doctors to write fewer prescriptions as a whole. Ultimately, the overall marketing of these drugs was clearly impacted by the restrictive policies.

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