It is just common sense: As with most diseases, preventing opioid addiction is a lot better than treating it.
In May, Dr. Scott Gottlieb, the new FDA Commissioner, declared the opioid epidemic his first and highest priority. And on his official blog, he has cited data unequivocally establishing prescription opioids as the main cause of opioid addiction. These medications are also gateway drugs: Some 75 percent of heroin users in treatment began their addiction with prescription opioids. Prescription opioids are responsible for the majority of opioid-overdose deaths, responsible for about 22,000 of the 33,091 fatalities in 2015.
Unfortunately, moderate-to-severe chronic pain typically cannot be adequately controlled with non-opioids. The President's Commission on the Opioid Epidemic recently issued its interim report that made some very good suggestions, but it did not take into account how to provide relief to patients with chronic pain while reducing the risk of opioid addiction and overdose death.
One highly promising solution to this dilemma focuses on an underutilized treatment for chronic pain called buprenorphine ("bu-pren-or-fin"). It is the only opioid in the CIII schedule of drugs, a category recognized by the DEA and FDA as representing a reduced risk of addiction. All other opioids for pain are grouped in the riskier CII class.
Until recently, buprenorphine was only available as a once-a-week transdermal (skin) patch, which limited its efficacy and caused some doctors to avoid it. Early last year, however, the FDA approved a twice-daily formulation of buprenorphine that provides significant pain relief: a small, transparent film resembling a Listerine breath strip that dissolves against the inside of the cheek (transmucosal).
In this new transmucosal form, buprenorphine may play a key role in fighting the prescription-opioid epidemic. Buprenorphine is the least addicting of all the opioids used to treat chronic pain. It typically does not lead to withdrawal symptoms when stopped. Importantly, it reduces the risk of death due to overdose because of respiratory depression. While there is a "ceiling effect" on respiratory depression, there is no ceiling effect on pain relief.
The FDA has approved high-dose buprenorphine (generally, over ten times the amount approved for pain management) as a treatment for opioid addiction. The advantage of buprenorphine is that it can eliminate withdrawal symptoms without triggering euphoria. This is in stark contrast to the use of methadone to treat heroin addiction. The dual ability of buprenorphine to both manage pain and also addiction underscores its uniqueness.
The danger posed by CII opioids is real and immediate, yet physician prescribing habits are notoriously slow to change. In an analysis by the Centers for Disease Control and Prevention, the longer the exposure of opioid-naïve patients to CII opioids, the greater the risk of becoming a chronic user. A one-day supply is associated with a 6 percent risk of continuing the opioid for at least a year; a 30-day supply is associated with about a 35-percent risk of becoming a chronic user. A recent Citizens' Petition by a consortium of professional organizations submitted to the FDA suggests limiting the maximum daily dosage of these CII opioids in an effort to limit the risk of addiction and overdose death.
There are common-sense conclusions to be drawn here. For chronic-pain patients who are not getting adequate relief from non-opioids, prescribers should be encouraged to offer buprenorphine as a first-line therapy before resorting to a CII opioid. For patients who have been on a CII-opioid long-term, the goal should be to gradually replace the medication with buprenorphine.
The quickest and most effective way to encourage this change in prescribing habits is for pharmacy benefit-management (PBM) companies to adopt these requirements in their formularies nationally. The CDC and the VA system can update their opioid prescription guidelines for management of chronic pain uncontrolled by a non-opioid.
In addition, the FDA should mandate labelling changes for all CII opioids, placing in so-called black box warnings something to this effect: that for pain uncontrolled a non-opioid, a CIII opioid should be tried before resorting to the highly addictive and life-threatening CII opioid.
Frank E. O'Donnell is a medical doctor.
If you would like to write an op-ed for the Washington Examiner, please read our guidelines on submissions.