Study finds high rates of off-label prescribing
By Andrew M. Seaman
NEW YORK (Reuters Health) - More than 10 percent of prescriptions in one Canadian province were for drugs not approved to treat the patient's condition, a new study finds. And many times, there was little evidence the drugs would work.
A medication is being used "off label" if a doctor prescribes it to treat a condition other than the one(s) Health Canada, the U.S. Food and Drug Administration or similar national regulatory agencies approved it for based on tests of safety and efficacy.
Dr. Tewodros Eguale, who led the new study, said doctors typically prescribe medications off-label when their patients fail to respond to other popular approved drugs or when they have a rare condition with few available treatments.
Eguale, from McGill University in Montreal, and his colleagues used data on every prescription written by Quebec physicians participating in an electronic health record network. The network is unusual in that it requires a doctor to state what the prescribed drug is intended to treat.
Between 2005 and 2010, 113 primary care doctors wrote more than 250,000 prescriptions for just over 50,000 patients.
Eleven percent of those prescriptions were considered off-label by the standards of the Health Canada drug database.
The researchers didn't have information on how well those drugs ended up working for the patients who took them. But they determined that four out of five off-label prescriptions didn't have strong evidence suggesting they were likely to be effective.
"Strong evidence" in this case included at least one controlled clinical trial -- considered the "gold standard" of medical research - showing the drug could help the patient's disorder. Continued...