Fast Focus: State and federal legislation have increasingly embraced the use of naloxone to treat opioid overdose, as well as drugs that treat opioid dependence, particularly buprenorphine. But when should these products be prescribed, and what do they signify when present in a patient’s profile?
There have been many developments in the fight against opioids, including the expansion of access to drugs that combat opioid dependence and overdose. Claims professionals could see these medications appear more frequently in patient profiles, especially as state and federal legislation make these drugs more readily available. It is important that claims professionals understand the appropriate use of these drugs, as well as the reasons for use in certain patient populations, the differences between formulations, and appropriate precautions to consider when these drugs are prescribed to patients.
Naloxone—the opioid overdose antidote
Naloxone blocks or reverses the effects of opioids and is used to counteract an opioid overdose. The presence of naloxone in a patient’s profile is concerning and warrants a closer look into the patient’s current opioid therapy. However, naloxone may be prescribed for various reasons.
Commercially, naloxone is available as Evzio® auto-injector and Narcan® nasal spray. Both products consist of naloxone hydrochloride and work within minutes of administration.
Congress passed the Comprehensive Addiction and Recovery Act (CARA), raising hundreds of millions of dollars to expand treatment for opioid addiction and overdose. CARA will award grants up to $200,000 to eligible entities to expand access to naloxone, with $5 million approved for these grants every year from 2017 to 2021.1
Forty-seven state governments have also passed various laws that expand layperson access to naloxone, making it easier for medical professionals to prescribe and dispense naloxone, and encouraging laypersons to administer naloxone without fear of legal repercussions.2 Meanwhile, 36 states encourage Good Samaritans to summon aid in the event of an overdose.2
Furthermore the Centers for Disease Control and Prevention (CDC) recommends co-prescribing naloxone along with opioid therapies 50
MME/day or higher3, which could lead to physicians prescribing naloxone more frequently.
Reasons naloxone may be prescribed to a patient
- Opioid therapy is 50 MME/day or higher (per CDC recommendations)
- Patients may be on rotating opioid regimens.4
- Patient may be taking extended-release or long-acting opioids.4
- Patients may be undergoing detox or opioid abstinence, which can lower a patient’s opioid tolerance, thereby making them susceptible to overdose.4
- Patients may have comorbidities such as chronic obstructive pulmonary disease (COPD), asthma, sleep apnea, and other breathing disorders that increase the odds of respiratory depression.
Treating opioid dependence versus pain
Buprenorphine is a partial opioid agonist indicated for the treatment of opioid dependence. Buprenorphine helps to reduce opioid withdrawal, but there are also formulations of buprenorphine indicated to treat pain, and it is important to ensure that buprenorphine products are prescribed for their respective FDA-approved indication.
Regardless of the indication, buprenorphine can produce euphoria and respiratory depression, though it is not as potent as full opioid agonists.5 Similar to full opioid agonists, buprenorphine can be abused, misused, and diverted. In Massachusetts prisons, buprenorphine accounted for 12 percent of contraband.6
Embracing buprenorphine for opioid dependence
The Department of Health and Human Services (HHS) allowed medical practitioners with special waivers to prescribe buprenorphine to up to 100 patients for a year or more, and a recent rule update now increases that limit to 275 patients.7 As this rule allows prescribers to treat more patients, the prevalence of buprenorphine may increase in workers’ compensation.
Furthermore, CARA now allows nurse practitioners and physician assistants to prescribe drugs, such as buprenorphine, for medication-assisted treatment of opioid dependence. Not only does this increase the number of people who can prescribe buprenorphine, but CARA will also allocate $5 million a year to expand the use of medication-assisted treatments for opioid dependence, which includes buprenorphine, from 2017 to 2021.1
Buprenorphine products for the treatment of opioid dependence
The following medications are FDA-approved for the treatment of opioid dependence and should not be used for the treatment of pain:
Subutex® is the first buprenorphine formulation for the treatment of opioid dependence; there are many generics available, though Subutex is primarily for patients who cannot receive naloxone, an opioid antagonist included in most modern formulations to deter abuse, due to intolerance, allergies, and possible drug-drug interactions if the patient is on another medication.
Suboxone® (buprenorphine and naloxone) is available as both a sublingual tablet and a sublingual film. Generics are only available for the tablets, though the film dissolves quicker, which may help with medication adherence efficacy.
Bunavail® (buprenorphine and naloxone) is a buccal film more efficient than suboxone, allowing lower doses of buprenorphine to achieve similar effects. The lower dosage levels decrease the potential for side effects, but no generics are currently available.
Zubsolv® (buprenorphine and naloxone) is a sublingual tablet also more efficient than Suboxone. Zubsolv dissolves in seconds, quicker than other products, with a mint flavoring that patients may find easier to tolerate. No generics are currently available.
Probuphine® (buprenorphine hydrochloride) is a subdermal implant of four one-inch rods placed under the skin of the upper arm, providing low, steady doses of buprenorphine for six months. Probuphine is a novel drug meant for patients currently stable on 8 mg or less of transmucosal buprenorphine. It is not a first-line treatment and requires special surgery, which may be difficult to facilitate, though it reduces the burden of medication adherence.
Buprenorphine products for the treatment of pain
The following medications are FDA-approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatments are inadequate.
BelbucaTM (buprenorphine hydrochloride) is a long-acting buccal film that adheres to the inside of the cheek and dissolves within 30 minutes. This drug was approved in October 2015, meaning no generics will be available in the near future.
BuTrans® (buprenorphine) transdermal system is a once-weekly topical patch. No generics are currently available, though the drug’s exclusivity status has expired, meaning generics could arrive in the future.
Dependence products should not be used to treat pain
In workers’ compensation, buprenorphine products only approved to treat opioid dependence are often prescribed off-label to treat pain, despite the fact that there is no peer-reviewed published data or clinical practice guidelines on how to safely do so.8
Patients who need treatment for pain but not addiction should be treated within the context of traditional drug therapy with FDA-approved agents for pain. Such drug therapy should also be carried out for a well-monitored duration based on treatment guidelines.
This article originally appeared in the Winter 2016 edition of RxInformer clinical journal, a Healthesystems publication.
- Comprehensive Addiction and Recovery Act of 2016. S.524—114th Congress (2015-2016). www.congress.gov/bill/114th-congress/senate-bill/524. 2016.
- Legal interventions to reduce overdose mortality: Naloxone access and overdose good Samaritan laws. The Network for Public Health Law web site. June 2016.
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49.
- Medication and counseling treatment—naloxone. Substance Abuse and Mental Health Services Administration. www.samhsa.gov/medication-assisted-treatment/treatment/naloxone. Accessed September 8, 2016.
- Medication and counseling treatment—buprenorphine. www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine. Accessed September 8, 2016.
- Goodnough A, Zezima K. When children’s scribbles hide a prison drug. New York Times. May 26, 2011. www.nytimes.com/2011/05/27/us/27smuggle.html. Accessed September 8, 2016.
- HHS announces new actions to combat opioid epidemic [press release]. Department of Health and Human Services. July 6, 2016.
- Gordon AJ, Sullivan MA. The off-label use of sublingual buprenorphine and buprenorphine/naloxone for pain. Providers’ Clinical Support System for Medication Assisted Treatment.