Rules, regulations and recordkeeping

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].
Source: 
DEA
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In addition to the specific federal recordkeeping guidelines for buprenorphine patients, it is recommended that you document the following information:

Related Resources: 
Description: 
This checklist provides a list of the forms that must be signed, the information that should be recorded for each patient (including current medications and allergies), and tests and labs that should be drawn during the intake assessment.
Source: 
Colleen LaBelle, RN/Boston Medical Center
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Medical Recordkeeping

Description: 
A description of what should be included in a buprenorphine patient's medical record.

Many portions of the medical record contain general information that is not specific to patients with substance use disorders or opioid dependence. An example of this is the history portion of the record.

The following sections of the medical record should be noted for all substance use patients:

  • Initial diagnosis and treatment plan information
  • History and physical examination
  • Comparisons with initial presentation
  • Assessment of pharmacological efficacy
  • Lab tests and results
  • Compliance with treatment plan
  • Urine and blood drug screening
  • Medications prescribed
  • Dispensing of controlled substances

Treatment Plan

The treatment plan portion of the medical record should be a natural continuation of the previous portions of the medical record. The following information should be carefully documented and shared with the patient:

  • Diagnoses and how determined
  • Treatment goals
  • Determination of medication to be used
  • How medication will be used
  • Psychosocial services required/recommended

When the practitioner reviews this information with the patient, he/she should include the patient in formulation of treatment goals. Following the patient-practitioner review, both parties should sign and date the information contained in the treatment plan. Information about buprenorphine -- such as its effects, what to expect, and what not to expect -- should be discussed with the patient, and this discussion should be documented as well. The practitioner must remember to put his or her DEA registration number on the patient's medical records, as well as the patient's prescriptions.

Beyond
HIPAA

In addition to standard HIPAA laws, federal regulations mandate strict confidentiality for information about patients being treated for substance use disorders (42 CFR Part 2). Additionally, the law requires written patient consent before information about substance abuse treatment can be disclosed to any other source. For buprenorphine treatment, this may include any communications with other physicians, treatment centers, significant others, or pharmacies.

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Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Treatment for Alcohol and Other Drug Abuse: Opportunities for Coordination. Rockville, Md: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration. Technical Assistance Publication Series, No. 11. 1994b. Available at: https://secure.addictioncounselorce.com/articles/102015/TAP-11-Treatment-for-Alcohol-and-Other-Drug-Abuse-Opportunities-for-Coordination-101-1-.pdf Accessed on: 2013-10-09.
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Description: 
Informational checklist designed to aid health care providers in making sure their practice is compliant with HIPAA regulations.
Source: 
Substance Abuse and Mental Health Services Administration (SAMHSA)
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Description: 
Comprehensive document detailing the HIPAA Privacy Rule and its implications for alcohol and substance abuse programs.
Source: 
Department of Health and Human Services (DHHS)
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Description: 
Analyzes the misconceptions that arise from the Health Insurance Portability and Accountability Act and discusses when health care providers should use their professional judgment in deciding whether a disclosure is necessary.
Source: 
Journal of the American Medical Association (JAMA) 2005 Apr 13;293(14):1766-71.
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Description: 
This document contains frequently asked questions and answers in reference to applying substance abuse confidentiality regulations
Source: 
Legal Action Center
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Description: 
An educational document from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services on the frequently asked questions in regard to substance abuse confidentiality regulations
Source: 
SAMHSA
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The U.S. Drug Enforcement Administration (DEA) and state DEA oversee office-based buprenorphine treatment and have the right to inspect physicians' buprenorphine practices at any time. Audits are random and usually unscheduled; a minority of buprenorphine practices are visited by the DEA annually. Physicians who comply with federal recordkeeping and treatment guidelines have no need for concern.

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Description: 
This log can be used to keep track of office inventories of buprenorphine medication.
Source: 
California Society of Addiction Medicine (CSAM)
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Description: 
This is the full text of Title 21, Chapter 13 of the US Code, which deals with drug abuse prevention and control.
Source: 
Drug Enforcement Administration (DEA)
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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.

View ReferencesHide References
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.
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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)
Source: 
FSMB
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Resource Type: 
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].
Source: 
DEA
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Resource Type: 

When buprenorphine was first approved by the FDA in October 2003, few pharmacies consistently kept the medication in stock and thus many physicians kept a supply of tablets on hand and dispensed them from their office. In-office buprenorphine dispensing is still a legal practice under DATA 2000.

However, physicians who wish to dispense buprenorphine from their office must adhere to strict federal recordkeeping guidelines.

Related Resources: 
Description: 
This page provides links to the full text, summary, and physician waiver requirements under DATA 2000.
Source: 
Substance Abuse and Mental Health Services Administration (SAMHSA)
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Physician stage in practice: 
Description: 
This log can be used to keep track of office inventories of buprenorphine medication.
Source: 
California Society of Addiction Medicine (CSAM)
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Resource Type: 
Commonly Used Forms: 
Physician stage in practice: 

Physicians who are conducting office-based buprenorphine treatment should adhere to specific DEA medical recordkeeping requirements. Note that some of these requirements go beyond the standard Schedule III requirements.

Related Resources: 
Description: 
This is the full text of Title 21, Chapter 13 of the US Code, which deals with drug abuse prevention and control.
Source: 
Drug Enforcement Administration (DEA)
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Description: 
Manual written by the DEA to assist physicians in understanding and complying with the Federal Controlled Substances Act. Topics covered include recordkeeping requirements, rules regarding prescription, and security requirements.
Source: 
US Drug Enforcement Administration (DEA)
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Description: 
A forum for sharing on Prescription Monitoring Programs
Source: 
Alliance of States with Prescription Monitoring Programs
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Description: 
The DEA revised regulations to allow electronic prescriptions for controlled substances.
Source: 
Drug Enforcement Administration and Department of Justice
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