A new report out of the University of Chicago (a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008) indicates there is confusion among physicans about what is or is not “on-label.”
According to the abstract, the average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use.
The study’s senior author, Dr. G. Caleb Alexander (assistant professor of medicine at the University of Chicago) said a concern was that off-label uses often did not have the same level of scientific scrutiny as FDA-approved uses.
All the more reason for the FDA and the pharmaceutical industry to jointly develop (as part of the agency's Safe Use initiative) better ways to make the PI more user-friendly – specifically the physician-user. Here’s an idea – how about FDA-approved PI detailing guides?
A good discussion topic for the Risk Communications Advisory Committee.
According to the abstract, the average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use.
The study’s senior author, Dr. G. Caleb Alexander (assistant professor of medicine at the University of Chicago) said a concern was that off-label uses often did not have the same level of scientific scrutiny as FDA-approved uses.
All the more reason for the FDA and the pharmaceutical industry to jointly develop (as part of the agency's Safe Use initiative) better ways to make the PI more user-friendly – specifically the physician-user. Here’s an idea – how about FDA-approved PI detailing guides?
A good discussion topic for the Risk Communications Advisory Committee.
