- Classification: Medication Assisted Treatment |
- Category: Medication Assisted Treatment
Term/Topic: Opioid Treatment
Federal Guidelines for Opioid Treatment - Draft - 2013
New Federal Guidelines for Opioid Treatment - Draft Version - April 2013
See Attached PDF for entire guidelines. Table of contents and Introduction only in text format.
Table of Contents
- I. Introduction..................................................................................................................... 3
- II. Opioid Treatment Standards.......................................................................................... 5
- A. Administrative Organization and Responsibilities................................................... 5
- B. Management of the Facility and Clinical Environment............................................ 6
- C. Risk Management and Continuous Quality Improvement......................................... 7
- D. Diversion Control.................................................................................................... 12
- E. Professional Staff Credentials and Development.................................................... 14
- F. Patient Admission Criteria...................................................................................... 15
- G. Informed Consent..................................................................................................... 17
- H. Screening, Assessment, and Evaluation................................................................... 18
- I. Pregnant and Postpartum Patients.......................................................................... 23
- K. Neonatal Abstinence Syndrome............................................................................... 25
- L. Treatment Planning, Evaluation of Patient Progress in Treatment, and Continuous
Clinical Assessment................................................................................................. 25
- M. Detoxification, Tapering, or Medically Supervised Withdrawal............................ 29
- N. Medically Supervised Withdrawal from Medicationk............................................. 29
- O. Administrative Withdrawal and Discharge............................................................. 31
- P. Continuing Care....................................................................................................... 32
- Q. Additional Treatment Planning Considerations...................................................... 32
- R. Concurrent Services................................................................................................. 39
- S. Testing and Screening for Drug Use....................................................................... 43
- T. Record Keeping and Documentationp...................................................................... 45
- U. Guidelines for Therapeutic Dosageq....................................................................... 48
- V. Unsupervised Approved Use (Take-Home Medication).......................................... 52
- W. Patient Rights and Program Responsibilitiesw........................................................ 55
Endnotes................................................................................................................................ 60
Appendix A. References........................................................................................................ 70
Appendix B. Guideline Panel................................................................................................ 71
Appendix C. Frequently Asked Questions............................................................................ 73
- I. SMA-162................................................................................................................... 73
- II. Detoxification Programs.......................................................................................... 76
- III. Take-Home Privileges.............................................................................................. 78
- IV. Treatment................................................................................................................. 79
- V. Medication............................................................................................................... 81
- VI. State-Specific Questions.......................................................................................... 82
- VII. Drug Testing............................................................................................................. 83
- VIII. Miscellaneous 84
Appendix D. Standard and Example Forms.......................................................................... 85
Appendix E. Mid-Level Practitioners Authorization by State............................................. 91
I. Introduction
The Center for Substance Abuse Treatment (CSAT) developed the original Guidelines for the Accreditation of Opioid Treatment Programs (OTPs) between 1996 and 1999 using a Treatment Improvement Protocol (TIP) type process involving two expert panels, field reviews, and clearances from other Federal agencies and the Office of Management and Budget. These guidelines were established to serve as a guide to accreditation organizations in developing accreditation standards that conform to the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Federal Opioid Treatment Standards, found in Title 42 of the Code of Federal Regulations (CFR), Part 8. The guidelines also provide guidance to OTPs, elaborating on and providing examples of ways in which programs can achieve and maintain compliance with Federal regulations.
OTPs must be certified by SAMHSA before they may dispense opioid drugs in the treatment of opioid addiction. To become certified, an OTP must meet the Federal opioid treatment standards in section 8.12 of the regulation, must have current valid accreditation status from a SAMHSA-approved accreditation body, and must comply with any other conditions for certification established by SAMHSA. Under Title 42 of CFR Part 8 (42 CFR Part 8), which became effective in May 2001, an accreditation organization or State governmental entity that wants to participate in SAMHSA’s OTP certification program must apply to become a SAMHSA-approved accreditation body. Among the numerous application requirements, potential accreditation bodies are required to submit a set of accreditation elements and a detailed discussion showing how these ensure that each OTP surveyed is qualified to meet the Federal opioid treatment standards set forth in section 8.12 of the regulation.
Accordingly, these guidelines will inform accreditation elements and assist accreditation organizations in interpreting the Federal opioid treatment standards.
In accordance with good guideline practice, SAMHSA has periodically updated the OTP Guidelines. To update the 2007 version of the Guidelines, SAMHSA convened a Stakeholder panel in January 2012. The panel included Federal and State regulatory authorities, addiction treatment medical practitioners and counselors, accreditation organizations, patient advocates, and others. The panel was charged with revisiting and revising the Guidelines in light of new scientific research findings; advancements in the field; and state-of-the-art, evidence-based practices. Expert panel members were selected based on their knowledge and expertise of the following content areas:
- Most recent developments in opioid addiction treatment
- New regulations
- The prevention and treatment of infectious diseases, such as HIV and hepatitis viruses
- Best practices and standards of practice
- Addition of new addiction treatment products to the armamentarium of available treatment medications
- The growing problem of prescription drug abuse
- Issues relating to diversion control
- Medication for unsupervised or take-home use
- Methadone-associated mortality
- Planning and acting in emergencies
- Detoxification from drugs of abuse
- Medically supervised withdrawal from opioids
- Community or State resistance to medication-assisted treatment
- Cardiac complications
- Management of co-occurring disorders, including chronic pain
- Third-party reimbursement
- Physician and staff education
- Office-based treatment
OTPs should be aware of their obligation to protect the confidentiality of patients’ substance abuse records, as set forth in Federal regulations in Title 42 of the Code of Federal Regulations, Part 2. Patient privacy becomes especially important with the national movement toward electronic health records. Additional information about privacy and substance abuse treatment is available at http://www.samhsa.gov/HealthPrivacy/.
To understand some of the guidelines, the reader may need a more complete explanation of the issue or rationale underlying the standard, as well as some examples to clarify meaning. Superscript letters guide the reader to that information in the Endnotes section (pages 60–69). Additionally, text boxes below each relevant section in the guidelines directly excerpt the text from 42 CFR so that the reader may reference both the guidelines and the regulations concurrently.
Should there be any questions or issues not covered in this guidance document, please contact CSAT’s Division of Pharmacologic Therapies (DPT) at 1-240-276-2700.
Related Publications
Footnotes
| Date Published | 08/18/2013 |
|---|---|
| Posting Date | 08/18/2013 |
