1. (1) Opioid Drugs. Facilities shall develop and implement written policies and procedures for prescribing, dispensing, and administration of medications and their security. No standardized routines or schedules of increases or decreases of medications may be established or used. These policies and procedures shall include the following:

   1. (a) Administration.

      1. 1. A program provider shall perform a medical assessment to determine the service recipient’s initial dose and schedule. The provider shall communicate the initial dose and schedule to the person supervising medication and document the dose in the service recipient’s medical record.
      2. 2. A program provider may assign such dose and schedule by verbal order only on an emergency basis. If a verbal order is given, the program provider shall examine the service recipient within seventy-two (72) hours of the verbal order. Both the verbal order and the results of the physical examination shall be documented in the service recipient’s medical record.
      3. 3. The initial dose of methadone shall be based on the clinical judgment of the program provider and in compliance with relevant federal rules and regulations. A transferring service recipient may receive an initial dosage of no more than the last daily dosage authorized at the former Facility unless in the clinical judgment of the medical director, there are extenuating circumstances documented in the service recipient’s medical records which justify an initial dosage that is greater than the last daily dosage authorized at the former Facility.
      4. 4. Subsequent doses shall be authorized by a program provider. Additional dosage may be dispensed on the first day where the program provider documents that the initial dose does not suppress withdrawal symptoms. Service recipients are stabilized on methadone when they are receiving a therapeutic dose that is sufficient to stop opioid cravings and misuse and sufficient to keep the service recipient comfortable for at least twenty-four (24) hours.
      5. 5. No dosage increases shall occur on the days that the Facility is closed.
      6. 6. No methadone may be administered unless the service recipient has undergone all of the screening and admission procedures required, unless there is an emergency situation that is fully documented in the service recipient’s medical record. In that case, intake procedures shall be completed on the next working day. No take-home medication may be given in such an emergency. OPIOD TREATMENT PROGRAM FACILITIES
      7. 7. No dose of methadone in excess of one hundred eighty (180) milligrams per day may be ordered or administered without the prior approval of the SOTA. Except provided:
   2. (i) Service recipients transferring to the Facility who are already established on doses greater than one hundred eighty (180) milligrams per day may continue their previously established dose, at the program provider’s discretion, for up to one (1) week to allow for sufficient time to receive SOTA approval; and

   3. (ii) Service recipients that are guest-dosing at the Facility and receiving a dose of greater than one hundred eighty (180) milligrams per day will not require SOTA approval.

      1. 8. Benzodiazepine Use. If a service recipient has a positive benzodiazepine screen:
   4. (i) The treatment team shall meet with the service recipient, either in person or via video conferencing platform, within fourteen (14) days of receiving the results of the screen, to develop a benzodiazepine action plan in the service recipient’s medical record. The plan shall be reviewed and signed by the medical director or designated program provider;
   5. (ii) If the plan requires the service recipient to become abstinent from benzodiazepines, a time period for supervised withdrawal shall be established. Coordination, or the attempt to coordinate with the benzodiazepine prescriber must be documented in the service recipient’s medical record;
   6. (iii) The Facility shall provide benzodiazepine gradual dose reductions or tapering services either directly or through referral to another provider. Any referrals must be documented in the service recipient’s medical record;
   7. (iv) If the plan calls for the continued use of benzodiazepines, the Facility shall coordinate the care with a qualified provider and document this coordination in the service recipient’s medical record;
   8. (v) The Facility shall document any follow-up action to any deviation from the benzodiazepine action plan; and
   9. (vi) The benzodiazepine action plan and subsequent progress notes about plan implementation shall be documented in the service recipient’s medical record.

   10. (b) Any opioid drug ordered and administered shall be documented on an individual medication administration record. The record shall include:

       1. 1. Name of medication;
       2. 2. Date prescribed;
       3. 3. Dosage;
       4. 4. Frequency of administration; OPIOD TREATMENT PROGRAM FACILITIES
       5. 5. Route of administration;
       6. 6. Date and time administered; and
       7. 7. Documentation of staff administering medication or supervising self- administration.

   11. (c) Take-home doses of methadone or buprenorphine shall comply with the following requirements:

       1. 1. Take-home doses of methadone or buprenorphine shall not exceed what is permitted by the applicable rules of the Substance Abuse and Mental Health Administration or other applicable federal agency. Except provided:
   12. (i) Service recipients that provide an unfavorable drug screen but otherwise demonstrate treatment stability, as determined and documented by the program provider, shall receive not more than thirteen (13) take-homes at a time (i.e., presenting to the Facility once every other week) for a minimum of twenty-eight (28) days beginning the day the service recipient first receives the reduced number of take-homes;
   13. (ii) Service recipients that provide an unfavorable drug screen and demonstrate treatment instability, as determined and documented by the program provider, shall receive not more than four (4) take-homes per week (i.e., presenting to the clinic three (3) nonconsecutive days per week) for a minimum of twenty-eight (28) days beginning the day the service recipient first receives the reduced number of take-homes; or
   14. (iii) Service recipients that pose a high risk of diversion, including presenting an inappropriate amount of medication for a diversion control call-back, or otherwise demonstrating noncompliance with the service recipient’s responsibilities of the Facility’s diversion control plan, shall receive not more than four (4) take-homes per week (i.e., presenting to the clinic three

2. (3) nonconsecutive days per week) for a minimum of twenty-eight (28) days beginning the day the service recipient first receives the reduced number of take-homes.

   1. 2. All requests for take-home exceptions shall be submitted to the SOTA and any other applicable federal agency for approval consideration.

      1. (i) The Facility shall check the PMP database prior to requesting any take- home or dosing exceptions and include this information with the exception request.
      2. (ii) The Facility shall provide counseling prior to providing take-home doses to any service recipient. Progress notes in the service recipient’s medical record shall document the counseling provided.
      3. (iii) The Facility shall include the service recipient’s Central Registry ID number, details regarding the service recipient’s treatment stability, details regarding the need for the exception request and why alternatives would not be appropriate.

   2. 3. The Facility shall document in the service recipient’s medical record the basis for determining treatment stability approving and “take-home” medication for the OPIOD TREATMENT PROGRAM FACILITIES service recipient. The following examples should be considered as a guide in determining the service recipient’s treatment stability and determining eligibility for “take-home” medications:

      1. (i) Cessation of illicit drug use;
      2. (ii) Regularity of program attendance;
      3. (iii) Length of time and level of treatment in medication therapy (ability to responsibly self-medicate);
      4. (iv) Absence of known recent criminal activity;
      5. (v) Absence of serious behavioral problems;
      6. (vi) Absence of misuse of drugs, including excessive use of alcohol;
      7. (vii) Other special needs of the service recipient, such as split dosing, physical health needs, pain treatment, etc.;
      8. (viii) Capacity to safely store “take-home” medication within the service recipient’s home;
      9. (ix) Stability of the home environment and social relationships;
      10. (x) Service recipient’s work, school, or other daily-life activity schedule; and
      11. (xi) Hardship experienced by the service recipient in traveling to and from the Facility.
      12. (d) Adverse drug reactions and errors shall be reported to a program provider immediately and corrective action shall be initiated. The adverse reaction or error shall be recorded in the service recipient’s medical record, the medication administration record, the nurse progress notes, and the ITP, and all persons who are authorized to administer medication or supervise self-medication shall be alerted.
   3. (e) All medications shall be stored in a locked safe when not being administered or self- administered.
   4. (f) Medication orders and dosage changes shall be written, printed, or provided electronically, on a form which clearly displays the program provider’s signature. The Facility shall maintain an accurate, perpetual inventory at all times. Every dose shall be recorded in the service recipient’s individual medication record at the time the dose is dispensed or administered. The perpetual inventory shall be totaled and recorded in milligrams daily. Any inventory variances shall be documented, including the reason for the variance and any follow-up actions, and be made available for inspection by the SOTA office.
   5. (g) No standardized routines or schedules of increases or decreases of medications may be established or used.

   6. (h) Computer-Based Recording.

      1. 1. Any such computerized system shall have the capability of producing a hardcopy printout of any medical or dosing order data which the Facility is responsible for OPIOD TREATMENT PROGRAM FACILITIES maintaining under the laws and/or regulations of this state and/or the federal government. Any computerized system shall, upon the request of the SOTA, send or provide such a printout within forty-eight (48) hours, excluding weekends.
      2. 2. In the event a Facility experiences system down-time, the Facility must have a written or readily retrievable auxiliary policy and procedure for documentation of all medical and dosing orders. The auxiliary procedure shall ensure that each medical or dosing order is authorized, and that all appropriate data are retained for on-line data entry as soon as the computer system is available for use again.

   7. (i) Guest Dosing.

      1. 1. Guest dosing shall be provided for a maximum of fourteen (14) days. Anything beyond fourteen (14) days shall be approved by the SOTA before dosing occurs.
      2. 2. Service recipients shall have been enrolled at the home clinic for a minimum of thirty (30) days before being eligible for a guest dose. Service recipients enrolled less than thirty (30) days at the home clinic shall be eligible for guest dosing only if approved by the SOTA.
      3. 3. Service recipients shall have two (2) consecutive favorable drug screens before being eligible for a guest dose unless the program provider determines that the benefits of guest dosing outweigh the risks and documents the justification for granting guest dosing privileges in the service recipient’s medical record.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, and 33-2- 404. Administrative History: Original rule filed September 20, 2012; effective December 19, 2012. Amendments filed June 6, 2025; effective September 4, 2025.