Opioids, Off-Label Prescribing and the Road Not Taken
/By Lynn Kivell Ashcraft, Guest Columnist
So much of the conversation about the use of opioids and other medications to treat various conditions has made it sound like doctors are doing something wrong when they utilize a treatment in an off-label fashion.
Off-label prescribing is not a crime. The federal Agency for Healthcare Research and Quality (AHRQ) estimates that 1 in 5, or 20 percent, of all prescriptions are written for off-label use.
In fact, off-label use of a drug often represents the standard of care. The Food and Drug Administration never intended for its drug approval and labeling process to be the sole determining factor in how a drug is to be used in a clinical setting.
It is left to physicians themselves to determine the ultimate clinical utility of pharmaceuticals, biologicals and medical devices in treating their patients.
Epidural Steroid Injections Are Off-Label
Some off-label use, however, is controversial. Many accepted protocols for treating back and neck pain include the use of epidural steroid injections (ESIs), despite a lack of rigorous supporting clinical evidence. As many as 9 million ESIs are performed in the U.S annually, yet few patients are told the injections are an off-label use of both the medication (corticosteroids) and the route of administration (an injection into the epidural space of the spine).
In 2014, after hearing about serious neurological problems in patients who received ESIs, the FDA required a label warning that injections of corticosteroids into the epidural space may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."
Anxious not to lose a treatment that they believed in, professional societies of anesthesiologists, pain medicine physicians, rehabilitation specialists, neurosurgeons, surgeons, radiologists and interventional pain specialists wrote guidelines to prevent complications from ESIs that were published in the journal Anesthesiology in 2015.
A coalition of doctors also formed the Multisociety Pain Workgroup (MPW) to defend the use of ESI’s. The MPW called an AHRQ study “flawed” and “absurd” because its questioned the effectiveness of ESI’s for treating low back pain. It also lobbied unsuccessfully to have the FDA tone down its warning.
Since 2017, according to OpenSecrets.org, the American Society of Interventional Pain Physicians has spent nearly $1.5 million on campaign donations and lobbying — much of defending the use if ESIs.
Where was the same type of outcry from the medical profession defending the use of opioid medication when the 2016 CDC guideline was released? Why have so many doctors stood by silently while insurers, states and the DEA began implementing the guideline as policy?
Lynn Kivell Ashcraft is an analytic software consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project.
