Writing prescriptions for off-label uses is a known and accepted practice. But more than 10% of the time?
A new study from Canada found that over a 5-year period, 11% of more than 250,000 prescriptions for just over 50,000 patients written by 113 primary care docs were for off-label uses, reports Reuters. That was based on the standards of the Health Canada drug database.
Physicians will usually prescribe a drug for conditions it is not approved for when a patient is not responding to medications designated for a condition, explains Dr. Tewodros Eguale, who headed the study. And experts point out that because of the costs involved, drug manufacturers are not always going to seek approvals for every possible treatment, even when studies suggest they may work well for those conditions in some cases.
Of course, some companies are known to push off-label uses, even in questionable situations. Risperdal comes to mind. Maker Johnson & Johnson ($JNJ) has been fighting, and losing or settling, a mountain of litigation for that drug, in part because of testimony that it aggressively pushed the antipsychotic drug for off-label use among children.
The information was gleaned from data put into an electronic medical record system in which the doctors stated the conditions for which drugs were being prescribed. The study can't report how well the drugs worked, but researchers point out that in 80% of the cases, there was no strong evidence the prescription would be effective for the off-label use.
- here's the Reuters story