Self-Protection Against "Off-Label" Lawsuits
by Forest Tennant MD, DrPH
 “Off-label” use of pharmaceuticals refers to a usage or
dosage other than that specifically listed in the package insert (PI). When a drug is
approved for commercial marketing by the US Food and Drug Administration (FDA), it does so
after the maker of the drug prepares a PI listing the drug’s recommended indications
and dosage, as well as possible complications. PI’s are routinely published in the
Physician’s Desk Reference (PDR), and they accompany all bulk shipments of the drug
which are stocked in pharmacies. The actual label on a prescription bottle will only
contain a fraction of the PI—typically, just the normal dosage.
Federal laws and regulations clearly allow physicians to prescribe any marketed drug in
any dosage and indication they deem appropriate. The use of drugs in so-called
“off-label” fashion is commonplace in medical practice and is, in fact, so
common and routine that physicians and hospitals may not even recognize that off-label
prescribing is taking place. Common examples include prescribing antidepressants and
antihistamines for sleep, antibiotics for acne, seizure drugs for migraine, and
anti-hypertensives for drug withdrawal. The FDA and US Drug Enforcement Agency (DEA) are
cognizant of this practice and are aware that it has been a tradition in medical practice
for decades.
“Off-Label” Use In Pain Treatment
Physicians who treat pain problems extensively use numerous drugs “off-label.”
In fact, off-label use is so common that it is difficult to imagine whether pain treatment
would be very effective if such prescribing were not possible. Table 1 lists some of the
common off-label prescribing practiced in pain treatment. Review the Table and ask
yourself what would happen to pain practice if off-label use were suddenly banned.
Please refer to the May 2007 issue for the complete text. In the event you need to order a back issue, please click here.
— May 2007
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