SOURCE: Xtalks

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April 11, 2016 15:00 ET

The Surprising Link Between Off-Label Prescribing Practices and Adverse Drug Events

TORONTO, ONTARIO--(Marketwired - April 11, 2016) - Prescribing drugs to treat a condition other than its US Food and Drug Administration (FDA) approved indication, is known as off-label drug use. It's estimated that around 12 to 20 percent of all prescription drugs are prescribed for uses other than those indicated on the label. This has the potential to present a significant risk of adverse drug events in patients, as clinical trials were never conducted to test the safety and efficacy of the pharmaceutical in treating the off-label condition.

Though the FDA tightly regulates the approval of new pharmaceuticals and medical devices, the agency does not -- and never has -- regulated the practice of medicine. This means that prescribing a drug for an off-label indication is not only legal, but actually quite common in clinical practice.

There are three common reasons why a medication may be prescribed for off-label usage:

  • The drug was tested and approved for use in adults, however the patient belongs to a group -- such as pediatric, pregnant or psychiatric patients -- often excluded from clinical trials.
  • The patient has a rare or advanced-stage disease for which no approved treatment exists, and the physician believes there is substantial evidence supporting the off-label use of the drug for this indication.
  • Based on a patient's needs, the pharmaceutical dosage or delivery method must be customized.

If physicians ensure that pharmaceuticals are only prescribed for off-label uses when compelling evidence supports it, these drugs can prove invaluable to some patients. For example, cancer patients are often prescribed off-label drugs designed to treat another form of cancer, because the drug could have an effect on other tumor types.

Once an off-label use of a drug becomes common, or even the standard of care for a given condition, one might wonder why the pharmaceutical company would not opt to file a supplemental drug application to get FDA approval for the new indication. After all, pharmaceutical companies are not permitted to advertise or otherwise market an indication for a drug, unless it is a so-called on-label use.

Much like applying for a new drug application, obtaining FDA approval for another indication can be very time-consuming and costly. Oftentimes this investment may not be recouped by sales of the drug, therefore it is usually more beneficial to continue to allow the drug to be prescribed for off-label uses.

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