The Unexpected Drug That Can Mitigate the Opioid Crisis
Facing pressure from healthcare professionals, voters and media, lawmakers are struggling to address the opioid crisis which claims 91 lives in the U.S. every single day. Despite their efforts in drafting legislation, proposing initiatives, formulating strategies and coming up with lofty proposals, well-meaning lawmakers are missing a key solution to mitigating the opioid crisis: Making a less-addictive opioid—buprenorphine (CIII)—more widely available by expanding insurance coverage for it.
All opioid products carry the potential for drug abuse. The Drug Enforcement Administration’s (DEA) Controlled Substance Act categorizes drugs into five schedules. Schedule I drugs, like heroin and marijuana, are considered the most dangerous and have the greatest potential for addiction. Schedule III drugs, like buprenorphine, are defined as having “a potential for abuse less than the drugs or other substances in Schedules I and II and abuse may lead to moderate or low physical dependence or high psychological dependence.” Therefore, Schedule III drugs are considered to be less likely to be abused. The commonly prescribed opioids such as morphine, oxycodone, hydromorphone and others are Schedule II drugs. Many Schedule II opioids are available in generic formulations. While these generic Schedule II opioid analgesics are less expensive, they are more associated with abuse than Schedule III opioids.
Regardless of the established DEA categorizations, insurance providers routinely steer patients and prescribers toward these less expensive Schedule II opioids, although these are among the most frequently abused prescription opioids in the country. Oxycodone, for example, is one of the most abused prescription opioids in the U.S. Schedule III drugs are potentially more expensive and are typically not reimbursed unless there are specific and documented reasons. This is also true for the newer abuse-deterrent formulations of opioid analgesics. Thus, insurance directives drive both prescribers to prescribe and their patients to take a riskier category of drug with known higher abuse potential—even when there are effective analgesics readily available that carry less risk of abuse.
Buprenorphine is an important drug to consider in this connection. It is a potent opioid and has been shown to be an effective pain reliever. It has a “ceiling effect” for respiratory depression, a potentially life-threatening side effect of opioid therapy. This “ceiling effect” means that the potential risk for respiratory depression—after a certain point—does not increase as the dose of the drug is increased. Furthermore, buprenorphine has no ceiling effect on pain control. Despite its strength as a pain reliever, it is considered to be less associated with opioid abuse and thus has earned a Schedule III ranking with the DEA.
In the U.S., buprenorphine for pain control has mainly been available as a transdermal system (skin patch) but it was available only in a few sizes which limited dosing options. Last year, a new Food and Drug Administration (FDA) approved formulation of buprenorphine became available as a thin film that dissolves in the mouth (Belbuca). This expands the potential for buprenorphine by allowing for more dosing versatility.
Unfortunately, buprenorphine in either form is not covered by many insurance policies, which compels prescribers to provide their pain patients with generic versions of Schedule II opioids. It seems logical, at least from a medical point of view, to consider the Schedule III opioids first for pain patients and advance to the riskier Schedule II analgesics only if there are valid reasons. The issue at play is cost, but the cost argument is short-sighted particularly in view of the current public health crisis of opioid overdose, which costs the U.S. billions of dollars every year in terms of rehabilitation, treatment, law enforcement costs, lost productivity and emergency healthcare services for opioid overdoses.
Buprenorphine may also be familiar to some individuals as a drug sometimes used for the rehabilitation of patients with opioid use disorder. In buprenorphine maintenance, buprenorphine combined with naltrexone (an opioid antagonist) is administered in small doses under medical supervision in a medically supervised rehabilitation program. Its role in opioid rehabilitation is secured because buprenorphine is not associated with the powerful psychoactive effects –the high, the rush– that make many other opioids appealing to potential abusers.
Individuals with substance use disorder taking opioids deserve our help and compassion, but our society must also recognize the role it is playing in perpetuating the cycle of addiction by guiding patients toward higher-risk, less-expensive, generic Schedule II opioids when less-risky Schedule III opioids are available and offer equivalent safe and effective pain control. Our legal, insurance, employer and healthcare systems must work together (and not at cross purposes!) in effective ways in order to combat this public health problem. It is time to shift and proactively adopt products and technologies that are directed towards helping prevent potential opioid prescription related addiction. This can only be done by treating pain with the safest effective pain relievers available. This should include an expanded role of buprenorphine for pain control.
Dr. Joseph Pergolizzi is a Senior Partner with the Naples Anesthesia and Pain Associates in Southwest Florida.