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11 Articles in Volume 7, Issue #4
Cervical-Medullary Meningioma
CES in the Treatment of Depression
Deep Penetration Therapeutic Laser
Fibromyalgia Patient Insights
Invoking the Placebo Effect
Multidimensional Ultrasonography
Paradigm Shift in Cancer Pain Management
Prolotherapy for Low Back Pain
Sedation Levels for Intraspinal Injections
Self-Protection Against “Off-label” Lawsuits
Viewpoint: Methadone Successes and Cautions

Self-Protection Against “Off-label” Lawsuits

The current medico-legal climate is hampering the long-standing medical prerogative to prescribe a particular drug for a therapeutic effect deemed beneficial to the patient.

“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.

Table 1. Some Common Off-Label Uses of Drugs in Pain Treatments
  • Use of B-blockers and epilectic agents for migraine prophylaxis.
  • Use of NSAID’s and Cox-2 inhibitors for dysmennorhea and headaches.
  • Use of epileptic agents and antidepressants for neuropathic pain.
  • Use of attention deficit disorder agents and appetite suppressant drugs for daytime sedations and analgesic potentiation.
  • Use of some benzodiazepines, antihistamines, antidepressants, and muscle relaxants for sleep
  • Use of some liquid opioids, muscle relaxants, and clonidine in intrathecal administration.
  • Use of fentanyl transmucosal for non-cancer pain.
  • Use of oral analgesics for topical use.

Case in Point: the Transmucosal Fentanyl Problem

The issue of off-label prescribing has resurfaced to national attention due to the use of Transmucosal Fentanyl (TMF) for non-cancer pain. The PI is for cancer breakthrough pain in opioid- tolerant individuals. A recent Wall Street Journal article claimed this off-label use contributed to the opioid diversion problem. Passik and Kirsh1 rightly castigate this claim and called for an open discussion of the common practice of off-label use in pain practice. This is a most timely call to action for all physicians.

Of great concern to physicians is the recent newspaper advertisements by some law firms soliciting non-cancer patients who have been prescribed TMF. The ads focus on patients who have had TMF complications, including “addiction," to join lawsuits presumably to sue the prescribing physician and manufacturer.

This development could prove to be most hurtful for all pain patients and physicians, because it could conceivably promote a bandwagon effect to stop all off-label use in pain treatment. Consequently, all physicians must immediately become better informed about this issue and educate all patients and families about it.

The Fallacy of the TMF Claims

Any claim that TMF used in non-cancer pain is a misuse of the drug or malpractice is no more justified than with any other opioid. TMF was initially restricted to breakthrough cancer pain by the FDA since it was an innovative (“lollipop”) formulation which was new to adult pain practice. While the cancer restriction was undoubtedly a prudent one for labeling several years ago, this restriction is unjustified today because the TMF “lollipop” has proven itself over several years of use to be as safe and non-abusable as injectable or transdermal fentanyl.2,3 Physicians should clearly and strenuously object to any claim that sub-lingual or buccal drugs such as TMF have some inherent abuse, diversion, and death potential above and beyond that of opioid injections, oral, transdermal, and suppository routes of administration. In fact, TMF may be safer and less abusable than other formulations.

How to Self-Protect

As in many cases where misinformation and opportunistic lawsuits abound, the antidote is accurate information and disclosure: to the patients, their families, and the medical community at large.

  • Step One: Educate Patients and Families The author highly recommends that this issue be immediately brought to the attention of all pain patients and their families. Physicians practicing in a group should discuss this issue among themselves. Be clearly advised that the vast majority of malpractice suits involving pain issues known to this author have been brought about by family members, not the patient.
  • Step Two: Use a Special Off-Label Consent Form Almost all pain treatment physicians today who use opioids require a contractual consent agreement which sets out rules and requires patients to only take opioids as prescribed. It is highly recommended that pain treatment physicians add a special, off-label consent form to existing contracts. Shown in Table 2 is the off-label consent the author has used for approximately five years. It has apparently been successful in that there has been no claims or questions about off-label use. Any physician who reads this article is welcome to copy and use this consent form in part or in full.
“Quality and effective pain treatment relies heavily on off-label use of numerous drugs. Any physician may prescribe any marketed drug for an indication or in a dosage that he/she deems appropriate even though it may not be listed in the PI.”


Quality and effective pain treatment relies heavily on off-label use of numerous drugs. Any physician may prescribe any marketed drug for an indication or in a dosage that he/she deems appropriate even though it may not be listed in the PI. Some law firms are currently recruiting patients who have used TMF off-label to sue the prescribing physicians and manufacturer. Although the PI for TMF shows an indication for cancer, breakthrough pain, this labeled indication is several years old. Since being marketed, TMF has been extensively studied and numerous, peer review studies clearly show it is as safe and effective for any pain problem that is appropriate for any other potent opioid drug. In the interest of self-protection, physicians should educate all current and future patients and their families about the essential necessity for off-label prescribing. In addition, the author highly recommends the use of an “Off-Label Consent” for pain patients as illustrated in Table 2.

Last updated on: December 27, 2011
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