Ask the Expert: Can buprenorphine transdermal system (Butrans) be used in the treatment of opioid addiction? How can patients on Suboxone be converted to Butrans?
QUESTION: Can buprenorphine transdermal system (Butrans) be used in the treatment of opioid addiction? How can patients on Suboxone be converted to Butrans?
ANSWER: The Drug Addiction Treatment Act of 2000 (DATA 2000) was signed into law in October 2000. This act allows for patients with opioid addiction to be treated outside of opioid treatment programs (commonly referred to as methadone clinics). Per the law, which was amended in 2006, an individual physician may treat a maximum of 30 patients on addiction treatment at any one time during the first year and then may apply to treat up to 100 patients concurrently thereafter with a schedule III, IV, or V opioid medication that has specifically been approved by the FDA for treating opioid addiction.1
Currently, Subutex (buprenorphine sublingual tablets), Suboxone (buprenorphine and naloxone sublingual film and sublingual tablets), and their generic products are the only medications FDA approved for the treatment of opioid addiction. Subutex brand name tablets were discontinued in September 2011; however, generic formulations of the product are still available. Suboxone brand name tablets were discontinued in March 2013; however, the film formulation and generic formulations remain available. Buprenorphine is also available as Buprenex (buprenorphine injection) and Butrans (buprenorphine transdermal system). These formulations are FDA approved only for the treatment of moderate to severe chronic pain.2 Buprenex and Butrans are not FDA approved for the treatment of opioid addiction, and there may be serious legal consequences associated with their off-label use.3
Because Butrans and Suboxone are approved for different indications, initiation of dosing differs between the products.4,5 We were unable to find any studies that evaluated a conversion between these products. For example, Butrans is dosed based on oral morphine equivalents per day when converted from another opioid therapy. If the patient’s oral morphine equivalents per day were less than 30 mg, then the 5-mcg/hour patch should be initiated. If the patient’s oral morphine equivalents per day were between 30 mg to 80 mg, then the 10-mcg/hour patch should be initiated.4 Studies evaluating the equipotency ratio of oral morphine to transdermal buprenorphine have ranged from 1:70 to 1:115. Initiation of dosing of transdermal buprenorphine, as suggested in the prescribing information, is therefore likely conservative.6 Suboxone therapy is meant for maintaining patients who have been initially inducted with buprenorphine tablets.5 Sublingual buprenorphine 0.4 mg may be equivalent to 30 mg of morphine orally.6
Currently, Butrans may not be used for the treatment of opioid addiction per the DATA 2000 law because opioid addiction is not an FDA-approved indication for this agent. The law restricts approved physicians to treat a maximum of 100 patients concurrently with opioid medications for opioid addiction.1-3 No clear data were found regarding conversions between Butrans and Suboxone. Both have data suggesting equivalent dosing to oral morphine; however, the supporting data are limited and vary.
Erin M. Timpe Behnen, PharmD, BCPS
Southern Illinois University
Edwardsville Drug Information & Wellness Center
ANSWER: Off-label use of any drug for the treatment of addiction raises a whole host of legal issues, including: (a) proper licensing and registration of the user, and other scope of practice issues; (b) federal and state laws regarding proper licensing of narcotic treatment programs and DATA 2000 registration; and (c) many, many more questions that should be evaluated with qualified legal counsel. There is no intention in this “Ask the Expert” article to encourage or recommend the off-label use of Buprenex or Butrans for the office-based treatment of opioid addiction; such use is prohibited at this time by federal law.7 Given the focus on pain management and addiction treatment in our country, healthcare practitioners should be familiar with medico-legal issues in this area.
Jennifer Bolen, JD
Legal Side of Pain