Buprenorphine Hydrochloride for the Treatment of Opioid Dependence

Policy Category: Drug/Prescribing
Under Review: No
Approved by Council: September 2007
Reviewed and Updated: March 2012 (Note: Policy is under review)
College Contact: Quality Management Division

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Two formulations of buprenorphine hydrochloride – Subutex® and Suboxone® – have been approved by Health Canada for use in treating opioid dependence.

Buprenorphine hydrochloride (“buprenorphine”) is one of the first new treatment options for opioid dependence since methadone was introduced in Canada over 40 years ago. Physicians do not have to obtain a section 56 methadone exemption1 from Health Canada in order to prescribe buprenorphine.

While international clinical evidence indicates that buprenorphine is a much safer drug than methadone2, it is important to keep in mind that the opioid-dependent patient population presents special risks and challenges.

In particular, opioid-dependent patients are susceptible to health issues related to their dependency, and are at a higher risk for drug and alcohol misuse/abuse, including inappropriate mixing of alcohol or other drugs with prescribed medication, and prescription drug diversion.

This, taken together with the limited clinical experience with buprenorphine in Canada and reported abuse/misuse of buprenorphine in other countries, raises concerns about patient and public safety should this drug be improperly prescribed.

College Expectation

As with any new therapy or treatment, the College expects that all physicians who wish to use buprenorphine to treat opioid-dependent patients will have training/education in this drug, and addiction medicine generally, prior to initiating buprenorphine treatment.

Training and Education

The College recommends the following training/education:

  1. Successful completion of a prescribing course in buprenorphine that provides appropriate training for treating opioid dependency;
  2. Completion of a one-day clinical observership of an opioid-dependency practice (e.g., observership in a practice providing methadone and/or buprenorphine treatment); and
  3. Ongoing continuing medical education (CME) in opioid-dependency treatment and/or addiction medicine.

The College recognizes the importance of flexibility and accessibility of training/education in buprenorphine. Further specifics of training/education the College considers most appropriate are available from the CPSO Methadone Program at (416) 967-2661 or 1 800 268-7096 ext. 661.

Clinical Guidelines

Guidelines specific to buprenorphine practice in Ontario are available through the Centre for Addiction and Mental Health3. In addition, physicians who prescribe buprenorphine should be familiar with the current CPSO MMT Program Standards and Clinical Guidelines (2011) and should use these guidelines, as applicable.

Treatment Options

While a methadone exemption is not necessary to prescribe buprenorphine, the College also recommends that physicians who wish to treat opioid dependence should have or should obtain a section 56 methadone exemption permitting them to prescribe methadone for opioid dependence. Being able to prescribe both buprenorphine and methadone increases treatment options, and helps ensure patients can receive the most appropriate care for their dependency. Information about obtaining a methadone exemption is available from the CPSO Methadone Program, which can be reached at (416) 967-2661 or 1 800 268-7096 ext. 661.

Other Applicable Policies and Regulations

Physicians who prescribe buprenorphine are also reminded of the College’s policies on Prescribing Practices, Prescription Drug Abuse, and Delegation of Controlled Acts. As with any other drug, prescribing should occur in compliance with these policies.

Buprenorphine is a narcotic. Consequently, its prescription and use are also subject to the federal Controlled Drugs and Substances Act and regulations. Physicians are reminded that failure to comply with this legislation could result in revocation of their narcotic or controlled drug prescribing privileges by the federal government, and may give rise to allegations of professional misconduct.

Additional Useful Resources

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1Controlled Drugs and Substances Act (S.C. 1996, c. 16), section 56.

2See for e.g., Fiellin, DA. The First Three Years of Buprenorphine in the United States: Experience to Date and Future Directions. Journal of Addiction Medicine. June 2007; 1(2):62-67; Finch, JW. et. al., Two-year Experience with Buprenorphine-naloxone (Suboxone) for Maintenance Treatment of Opioid Dependence Within a Private Practice Setting. Journal of Addiction Medicine. June 2007; 1(2): 104-110.

3 Buprenorphine/Naloxone for Opioid Dependence: Clinical Practice Guideline

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