Guidelines for Writing a Prescription for Buprenorphine

There are no special guidelines for writing a prescription for Suboxone® and giving it to a patient to get filled at the pharmacy of his/her choice. However, all prescriptions should have your DEA number plus the "X" DEA number (which denotes buprenorphine prescriber status) written on them or the pharmacy may not fill it.

Also note that under the Code of Federal Regulations Title 42 Part 4 (Confidentiality of Alcohol and Drug Abuse Patient Records) - you must receive full permission from the patient before you can fax the prescription to a pharmacy. Buprenorphine is a Schedule III drug and and so DEA guidelines as well as state guidelines for Schedule III drugs must be followed; the stricter guideline always applies.

Instructions should be provided with the prescription for the specific formulation prescribed, as they can vary.

Paper prescriptions should be manually signed, whether filled out with indelible ink, typed on a typewriter, printed on a computer, or faxed (DOJ, 2010). The DEA recommends making a copy of each prescription (Gallagher, 2010).

All states currently allow e-prescribing of Schedule 2 narcotics, but the software to support these prescriptions may need to be upgraded in order to meet DEA standards before prescriptions can be sent by providers or accepted by pharmacies (Lowes, 2015). Additionally, there is no requirement that a provider must utilize e-prescribing in their practice, nor that pharmacies must accept e-prescriptions (DOJ, 2010).

Electronic prescribing requires a two-step verification process (DOJ, 2010):

  1. send the prescription for fulfillment
  2. apply a digital signature when the prescription is sent

The Department of Justice suggests the following, or an equivalent statement:

“By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.”

The Department of Justice has created some General Questions and Answers that may be helpful in learning more about the regulations surrounding e-prescribing of narcotics. This information can be found in the resources section.

Additional considerations:

  • Providers who have their patients get their prescription filled and return to the office for induction are NOT subject to the same recordkeeping guidelines as providers who store and dispense the tablets or film in-office.
  • Buprenorphine tablets and film (like other Schedule III medications) can be refilled up to 5 times. Most providers begin by prescribing limited initial quantities of medication and then write prescriptions for larger quantities and refills when the patient achieves stability (negative urines, psychosocial treatment adherence, etc.)
  • If a buprenorphine prescription is written for an off-label use (i.e. not for opioid dependence), then no "X" number should appear on the prescription. Also, patients who are treated for with buprenorphine for pain are not considered to be part of the patient limit.
  • The patient is considered to be under your care and is part of your roster for the duration of the last prescription issued. For example, if you write a prescription for a month's supply of buprenorphine then the patient will remain on your roster even if he/she misses all appointments and seems to have dropped out of treatment. When the last prescription that you wrote terminates, then you may remove the patient from your roster.
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FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. FSMB Website http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_treatment_opioid_addiction.pdf Accessed on: 2013-10-11.
Gallagher C. What Waivered Physicans Need to Understand About DEA Requirements. PCSS-B Web Seminar . 2010. Available at: https://www.psychiatry.org/File%20Library/Psychiatrists/Practice/Professional-Topics/Addiction-Psychiatry/PCSMAT/Webinar-Slides-What-Waivered-Physicians-Need-to-Understand-About-DEA-Requirements.pdf Accessed on: 2011-04-11.
Lowes R. e-Prescribing Controlled Substances Now Legal Nationwide. MedScape. 2015. Available at: http://www.medscape.com/viewarticle/850268 Accessed on: 2016-08-10.
US Department of Justice. Title 21 Code of Federal Regulations: PART 1306 — PRESCRIPTIONS. US Department of Justice - Office of Diversion Control. 2010. Available at: http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm Accessed on: 2015-05-04.
US Department of Justice. Title 21 Code of Federal Regulations: PART 1311 —REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS. US Department of Justice - Office of Diversion Control. 2010. Available at: http://www.deadiversion.usdoj.gov/21cfr/cfr/1311/subpart_c100.htm Accessed on: 2015-05-04.
Related Resources: 
Description: 
This document, first published in 2004 and revised in July 2013, is a model policy for state medical boards to use in developing their guidelines for use of opioids in treating chronic pain. These Model Guidelines provide the FSMB's policy on proper treatment of pain and the use of opioids when necessary to manage pain. Source: Federal State Medical Boards (FSMB)
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FSMB
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Description: 
The questions and answers are intended to summarize and provide general information regarding the Drug Enforcement Administration (DEA) Interim Final Rule with Request for Comment "Electronic Prescriptions for Controlled Substances" (21 CFR Parts 1300, 1304, 1306 and 1311; October 19, 2011) [Docket No. DEA-360].
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DEA
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