Complex pain

Recently Approved Opioid Implant Comes with Big Risks

The Food and Drug Administration (FDA) recently approved the opioid Probuphine for the treatment of opioid dependence and opioid use disorder. The implanted buprenorphine delivery formulation consists of four matchstick-sized rods implanted under the skin for time-released dosages lasting six months. It is not an approved pain treatment.

Advocates for the drug buprenorphine like it because it appears to have less respiratory depression (a frequent cause of death in overdose) and has a ceiling effect above a certain dose beyond which there is no additional effect (i.e. it maxes out). It also may block the effects of other potentially harmful opioids (such as heroin) when taken together. However, buprenorphine is a powerful opioid in its own right with a morphine equivalent dose somewhere between 20 to 75 times that of morphine. It can be abused and diverted to unintended users, and does not offer protections from other drugs that substance abusers may take concurrently, such as alcohol or benzodiazepines.

For motivated people with substance use disorder, buprenorphine, and Probuphine in particular, adds an important treatment option. Yet, for injured workers who are dependent due to the treatment of pain, the medical and payor community must appreciate that this is a strong opioid, and as long as an injured worker takes this medication, he remains opioid-dependent and vulnerable to most of the known risks and side effects of opioids.

When the Addiction is the “Cure”

Probuphine is a form of opioid maintenance treatment, or medication-assisted treatment, meaning that it maintains the user by providing a more “favorable” opioid to replace another opioid. Methadone is another example of a maintenance opioid. The treatment is in contrast to abstinence approaches that foster weaning off opioids entirely. Medication-assisted treatment can be in intermediate step to stabilize people on their way to abstinence, but it is not always easy to wean off the maintenance medications.

The Probuphine implant contains buprenorphine, an opioid with a stronger affinity to the body’s opioid receptors than other opioids. Though this may mean patients don’t get as high as they would using other prescription or illicit opioids, the body is still reliant on an opioid to feel “normal.”

When the FDA approved Probuphine, it lauded the treatment as part of an opioid action plan rolled out last February. Advocates of Probuphine argue that medication-assisted treatment options such as this may improve compliance with treatment plans while decreasing withdrawal symptoms and the experience of pain. Compliance is achieved in part by the fact that the implant is not easily accessible. This design makes it difficult to remove or skip doses in order to take other opioids. It also seems to affect the brain stem respiratory less, so it becomes harder, though not impossible, to take a fatal drug overdose. But are these improvements really a “cure” for opioid addiction?

There is quite a bit of irony to the epidemic of opioid use, overuse and addiction over the last 20 years. Today, many recognize that some in the pharmaceutical industry created the crisis. And now, in response to public concern, the industry is releasing products that claim to “fix” opioid addiction via the use of an addictive opioid.

The Preferred Biopsychosocial Approach

Abstinence as an option is being sidelined in favor of the idea that fewer people may fatally overdose. This is a treatment, not a cure to opioid dependence. We must keep this fact in mind because if more and more opioid dependents continue to be created by liberal opioid prescribing for pain, we will have millions more Americans on some opioid who should never have been on any.

Paradigm Outcomes advocates for an evidence-based, biopsychosocial approach to pain management through support and care for the whole individual. Probuphine and other buprenorphine preparations for substance use disorders should not be confused as a treatment for pain. Despite billions of dollars spent, the long-term use of opioids has not proven effective in improving function in chronic pain.

Titan Pharmaceuticals developed the product and recommends Probuphine be offered as part of a larger treatment plan including support and counseling that should last at least six months (the lifespan of the patch). While any use of the drug should correspond to a full treatment plan, including therapy and follow up visits, these tools should be used first, with Probuphine a last resort.

Probuphine/buprenorphine use risks prolonged periods of opioid addiction treatment for many injured workers and the continued sense that they have no control over their pain or lives. In addition, workers’ compensation plans may wind up paying an estimated $825 per month for a single drug treatment in addition to the costs for counseling, physical therapy and follow-up visits that in themselves can constitute a successful treatment regimen for chronic pain.

To learn more about Paradigm Outcomes and strategies for complex pain management, visit our website or follow us on LinkedIn, Twitter, and Facebook.