In response to concerns about pharmaceutical companies’ undue influence on medical practice and research, in particular, drug prescribing practices, a growing number of academic medical centers have instituted policies restricting the activities of pharmaceutical sales representatives.
A range of concerns has led to the stricter policies, including extensive off-label prescribing of drugs, that is, prescribing a drug for uses not approved by the Food and Drug Administration (FDA), the Wall Street Journal reports. While a physician may prescribe an approved drug for any use, manufacturers are not permitted to market or promote a drug except for approved uses. But sales reps, in face-to-face interactions with doctors and other health professionals, may be able to influence off-label prescribing. Studies have shown that limiting contact between reps and medical residents may lower their later prescribing, but that research did not look specifically at how the policies affect off-label prescribing.
A new study examines the effect sales reps may have on prescribing and how prescribing practices change when restrictions are imposed on pharmaceutical reps. The researchers focused on antidepressants and antipsychotics prescribed to children from January 2006 to June 2009. Study co-author Dr. Aaron Kesselheim, of the Harvard Medical School, explains that these drugs have a history of being prescribed off-label, although there is limited evidence about their effectiveness in pediatric use, and some children have suffered serious side effects and increased risk for other diseases. The research showed an 11 percent drop in off-label prescribing once restrictive policies were in place, according to the WSJ. Kesselheim says the policies “should not affect off-label prescribing, unless there’s an association between what the rep does and prescribing.”
The researchers noted that prescriptions for approved uses fell by 34 percent. With less – or possibly no – interaction with sales reps, physicians wrote fewer prescriptions for these drugs over all, according to the WSJ. Prescriptions for generic versions of the drugs rose for both off-label use (35 percent) and approved uses (14 percent). Kesselheim says these changes in prescribing reflect the impact that sales reps can have on physicians. But, he cautions, physicians may need to turn to off-label use of a drug when an approved drug is ineffective in treating a particular condition.