A Word of Caution on Buprenorphine

The opinions and commentary expressed in “Perspectives” are the sole property of the author and do not necessarily reflect those held by EMS World, its staff members or affiliated organizations.

Last summer New Jersey became the first state to approve paramedic distribution of buprenorphine (also referred to as Suboxone) to mitigate the opioid crisis. The announcement of this bold new policy came from New Jersey’s commissioner of health, Shereef Elnahal, MD. The change was historic—never had a state put forth such a policy.

In the past several years, first responder use of naloxone became a widely accepted means of treating those having an opioid overdose. This rapid increase in naloxone utilization has been rightfully accepted in the first responder community because of its immediate action and relative safety. On that note naloxone is remarkably different than buprenorphine, due to the stark duration of its effect and decreased moderating concerns compared to buprenorphine.

Many of us know all too well the dramatic impact naloxone can have—and the severe withdrawal once it wears off. But this fast onset and known duration, augmented by a clear track record of thousands of cases supporting naloxone’s efficiency, are factors that distinguish buprenorphine and naloxone from a regulation and distribution perspective.

This article does not center around naloxone’s role in facilitating treatment for patients with opioid use disorder. The evidence has overwhelmingly shown the drug is livesaving.¹ It has a vital role in prehospital care. However, the move in New Jersey to allow paramedics to dispense the markedly different opioid deterrent buprenorphine should not be taken as a mere equivalent or minor step up.

There is not one adequate research study supporting—to any extent—the claims to efficacy and benefits this practice has provided.

Of course I acknowledge the clear benefits of the medication, but the safety and benefits of the drug have only been trialed and shown when the medication was provided under the treatment of a specialized physician who nearly always provided additional treatments as well:

Withdrawal precipitated by buprenorphine is often quicker in onset and more severe than spontaneous withdrawal. Complications can require hospitalization; even intensive care unit admissions have been described.² Severe nausea and vomiting with dehydration may require aggressive intravenous rehydration and correction of electrolyte abnormalities. Patients undergoing opioid withdrawal are at risk of suicide, driven by the distress and fear that often accompanies withdrawal and/or feelings of failure among patients unable to complete the process. Assess patients for suicidality throughout supervised withdrawal, with positive findings resulting in clinically appropriate increases in the level of observation and follow-up.”³

New Jersey has, from my perspective, offered a well-intentioned treatment for a problem that requires far more complex interventions. I fear this directive could represent a disservice to patients because of the uncertainty in how effective this practice truly is compared to physician administration. For example, providing buprenorphine might offer what a patient sees as a rare chance to get this treatment—and therefore feel compelled to take the medication before they are truly ready and committed to doing so.

The lack of availability from physicians who provide the medication should be the initial issue addressed before considering any alternative that does not adhere to what we know are best practices. To this end, not only does broad distribution present a possible increased likelihood of a lack of compliance, but more important, dispensing the medication without the interaction of an in-person physician circumvents the entire process of addiction treatment. Evidence-informed decisions need not be based solely on robust, decades-long research, but the total absence of evidence in favor of this directive directly challenges the proven standard of care for treating opioid use disorder—that is, a physician augmenting the medication with a multifaceted program also encompassing psychological interventions, communal support groups, and a host of evidence-informed practices. Some would suggest it’s a disservice to patients to deprioritize these other proven support measures for a medication with an incomplete treatment plan.

There is a reason, one can argue, that buprenorphine is strictly regulated on a national level. It requires physician oversight in a controlled and multifactorial decision-making process for a patient’s treatment plan.

New Jersey’s sought to promote buprenorphine as a means to allow overdose patients to begin a care plan immediately after their revival, compared to waiting to see a physician.⁴ In an interview shortly after he made the announcement, Elnahal said, “We had a lot of paramedics telling us someone would be in an ambulance, knocked out, and then receive naloxone, and they would run out of the ambulance.”⁵

Though many providers have experienced refusals of care from overdose patients, I am hesitant to justify a historic policy change for the sake of providing a singular treatment modality in an inappropriate setting.

This situation is analogous to a company building a self-driving vehicle. Even if the autopilot technology appears to have been programmed correctly, the car has never been driven a single mile on a road. With this in mind, would you welcome the chance to drive that car?

References

1. Chimbar L, Moleta Y. Naloxone effectiveness: A systematic review. J Addict Nurs, 2018 Jul–Sep; 29(3): 167–71.

2. Hassanian-Moghaddam H, Afzali S, Pooya A. Withdrawal syndrome caused by naltrexone in opioid abusers. Hum Exp Toxicol, 2014 Jun; 33(6): 561–7.

3. Sevarino KA. Medically supervised opioid withdrawal during treatment for addiction. UpToDate, www.uptodate.com/contents/medically-supervised-opioid-withdrawal-during-treatment-for-addiction.

4. New Jersey Department of Health. Addition of Suboxone to the Advanced Life Support Optional Formulary. Executive Directive No. 19-004, www.state.nj.us/health/news/2019/NJDOH%20Executive%20Directive%2019-004.pdf.

5. Khazan O. A Radical Way to Stop Heroin Overdoses. Atlantic, 2019 Jun 28; www.theatlantic.com/health/archive/2019/06/new-jersey-paramedics-opioids-buprenorphine/592954/.

Christopher Gaeta is a student at Swarthmore College.