According to a new report in the Mayo Clinic Proceedings, many patients who are being treated with "off-label" drugs are unaware that the medications they have been prescribed by their doctor aren't being used in ways that would meet U.S. Food and Drug Administration approval, research shows.
"Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one,” says study lead author Dr. Christopher Wittich, an internal medicine physician at the Mayo Clinic in Rochester, Minn.
While this report states the obvious, the more important question is what are physicians telling their patients about the medicines they prescribe … and where is that information coming from.
Now that industry detailers are getting the cold shoulder and many inveigh against industry supported CME – wither knowledge about off label or, for that matter, on label indications?
It’s time for pharma detailers to start detailing the label – with such a detail aid being developed and approved by the FDA at launch.
The researchers also surmise that the high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication,.