Tuesday, March 7, 2017

FDA Label Changes Found to Play Major Role in Prescribing Patterns

Despite the common practice of off-label prescribing, FDA-approved labeling changes still appear to play a major role in how providers select medications for specific conditions, a study in Psychiatric Services in Advance reports.

Peggy O’Brien, Ph.D., a researcher at Truven Healthy Analytics LLC and colleagues used the National Disease and Therapeutic Index (NDTI) to examine three major categories of psychotropic medications—antidepressants, antipsychotics, and anxiolytics. The NDTI is a survey of more than 4,000 randomly selected, office-based physicians, which specifically asks physicians about the condition for which they prescribed a medication. The authors compared “snapshots” of data collected at two points—in 2005 and 2013.

The analyses showed that many significant changes in the use of a class of drugs for certain indications coincided with labeling changes: the addition of new indications for a class of drugs was associated with increased prescribing, while the addition of black-box warnings and associated side effects were associated with decreased use. For example, the use of antipsychotics for depressive disorders increased from 5.3 percent in 2005 to 13.6 percent in 2013, as numerous antipsychotics gained approval for treating depression. In contrast, prescriptions of antipsychotics for delirium, dementia, and related indications dropped from 7.4 percent in 2005 (the year the FDA announced the boxed warning against this use) to 2.8 percent in 2013. The study also revealed that off-label use of antidepressants for attention-deficit and related disorders and anxiolytics for bipolar disorders increased by 1.1 and 1.3 percentage points, respectively.

O’Brien and colleagues noted that the findings raise questions about the incentives and barriers that influence whether pharmaceutical companies apply for labeling changes related to new indications.

“A number of factors may influence the decision to seek additional labeling for a medication, including whether it is already used off label and, particularly, if it is already [available in] generics,” O’Brien told Psychiatric News. “Each [supplemental] application and the research needed to support it can require considerable resources and expenditures.”

The authors concluded, “These findings highlight that labels are an important but imperfect guide for physicians to make prescribing decisions. … Tracking prescribing for labeled and off-label conditions is a useful tool for illuminating whether new labeled indications may be appropriate, whether research on new indications and contraindicated indications is needed, and whether physicians may benefit from additional education about the application of particular medications for particular clinical scenarios.”

For additional coverage on this report, see the Psychiatric News PsychoPharm article “What’s in a Label?

(Image: iStock/FangXiaNuo)


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