Off-label prescribing—the practice of prescribing medication for a condition for which it is not indicated or approved—is very common in America, particularly in the treatment of psychiatric disorders. In 2001, an estimated 21% of prescriptions for the 160 of the most commonly-used drugs were off-label.  And 75% of those off-label prescriptions were written for conditions for which there is absolutely no scientific evidence to prove they work!

The law doesn’t prevent this practice, although it does prevent pharmaceutical companies from promoting off-label prescribing. Often, there’s no real harm in off-labeling, but equally so, there’s even more often no scientific proof that those off-label drugs are doing you any good. The only evidence is what’s called anecdotal – evidence that has been noted by doctors, but there has been no scientific study carried out to provide hard proof.

Doctors and law-makers know it’s a problem, but they say it’s such an extensive issue that they just don’t know how to even begin solving it. This December, however, that might be about to change, as a group of physicians will publish a paper in scientific journal Pharmacotherapy, about ways in which solutions to the off-labeling problem might be approached.

The researchers who studied the issue have identified a list of fourteen medications that are often prescribed for off-label uses. Many of the drugs on the list are antidepressants and anti-psychotics – drugs used to treat psychological problems. Six of the drugs on the list are used to treat bipolar disorder. All three of these represent categories of illness where both physicians and their patients are eager to try new solutions and off-label prescriptions.

Often, this can provide an effective means of treatment for people with psychological disorders – but the problem is, these drugs haven’t been FDA tested and approved for the uses to which they are put. That means a serious risk of unintended and unanticipated side effects, which in turn can endanger the life and safety of the patient.

An additional problem is that drug companies are reluctant to put their products through the testing required for off-label uses, not only due to the expense, but also because testing might prove the existence of undesirable side effects that might make the drugs less popular for off-label use.

The solution? The researchers and physicians who have studied the off-label issue have proposed that an extensive round of testing and surveying be conducted on the fourteen drugs identified as being most commonly used for off-label purposes. They also say that patients should be proactive and ask their doctors for more information about the medications they are prescribed.

photo credit: ragesoss