Action | Ethical standards for practice |
Stage | Proposed |
Comment Period | Ended on 1/28/2005 |
I think it's bad legislation to restrict use of pharmaceutical agents only as labeled or to require 'informed consent' for off-label use in every instance. As the Board is likely aware, The AMA estimates that as many as 40% of prescriptions written are for off-label uses. To require 'informed consent' for pharmaceutical agents hogties prescribers, increases not only the cost of manufacture and sale of agents but the administration of agents by prescribers, pharmacists, and others. Further, it does not benefit the patient as in most uses, the ADE profile will be the same regardless of condition it's prescribed for. For instance, your chance of blood clots from Ortho-Evra doesn't change if you're taking it to prevent pregnancy or to treat irregular menses.
Prescribers are not stupid people. I've never seen one say "Hey, let's try Dilacor for that peptic ulcer you've got." They spend thousands of dollars and hours educating themselves on treatment protocols involvind the use of both labeled and off-label pharmaceutical therapy. Full prescribing information for both clinicians and patients is provided with every medication dispensed, with supplementary prescribing information provided online, in readily available publications such as the PDR and elsewhere. One need only to ask their prescriber 'Is this a labeled use for this drug?' to get not only the answer as well as their reasoning, if off-label, for prescribing.
Regina Brown