0940-05-35-.13
Medication Management
Cite as Tenn. Comp. R. & Regs. 0940-05-35-.13
(1)
Opioid Drugs. Facilities shall develop and implement written policies and procedures for the
prescription of opioid drugs. Any changes to these policies and procedures shall be done in
consultation with the Facility’s medical director. These policies and procedures shall include
the following:
(a)
Prescribing.
1.
The proper initial dose, medication type, and dosage form shall, in consultation
with the patient, be based on the clinical judgment of the program provider who
has examined the patient and who has considered all available relevant patient-
specific information including, but not limited to, drug screens, initial screenings,
and medication availability and cost.
2.
No standardized routines or schedules of increases or decreases of medication
doses may be established or used.
3.
Facilities shall comply with requirements for prescribing higher doses of
buprenorphine, pursuant to Tennessee Code Annotated § 53-11-311(d)(1). For
purposes of these rules, a patient dose greater than sixteen milligrams (16mg),
or its equivalent, per day, shall be considered a high dose.
4.
A patient dose of thirty-two milligrams (32mg), or its equivalent, per day shall be
considered a maximum dose. Doses greater than the maximum dose may only
be used with prior written approval from the State Opioid Treatment Authority.
Documentation of this approval shall be kept in the patient’s medical chart or
otherwise be readily retrievable upon request or Facility inspection.
5.
A copy of all prescriptions for a patient at the Facility shall be documented in the
patient’s medical chart.
6.
The program provider shall demonstrate to the patient appropriate techniques for
administering the particular prescribed treatment medication.
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL
CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES
(b)
Dispensing. An office-based opiate treatment facility without dispensing authorization is
prohibited from dispensing buprenorphine-containing products.
(c)
Protocols for initiating or switching a patient to a high dose of the treatment medication
used at the Facility.
1.
The patient’s medical chart shall include documentation of rationale that it is
clinically appropriate for the patient to receive a high dose of the treatment
medication.
2.
The program provider shall have a discussion with the patient and the patient
shall provide written consent acknowledging that the patient will receive a high
dose of the treatment medication and associated risks. The program provider
shall document that this discussion included an assessment of the patient’s
administration technique and that the patient is using the appropriate technique
for the prescribed medication.
3.
The program provider shall not establish or use standardized routines or
schedules of increases or decreases of treatment medication doses for the
patient. Decisions about dosing should be individualized with documentation of
reasons for choice of dosing.
(d)
Program Provider-Initiated-and-Led Tapering Discussions. Program provider shall
initiate and lead a discussion with the patient regarding patient readiness to taper down
or taper off treatment medications employed in the patient’s treatment with each patient
at any time upon the patient’s request but no later than one (1) year after initiating
treatment and then every six (6) months thereafter. Documentation of this discussion
shall be placed in the patient’s medical chart.
(2)
CSMD Check. The Facility shall check the CSMD upon every visit of the patient with a
program provider. The patient’s medical record shall include documentation of the check of
the CSMD and the date upon which it occurred.
(3)
Benzodiazepine Use. Benzodiazepines should only be prescribed to a patient after careful
evaluation while utilizing caution and good judgment. Benzodiazepines may be prescribed to
a patient on buprenorphine or a buprenorphine and naloxone combination under the following
conditions:
(a)
Benzodiazepines shall not be initiated with a patient with opioid use disorder or the
disease of addiction who has never been prescribed these products or has a history of
misusing these products. Notwithstanding, in rare circumstances:
1.
Patients who present with a longstanding prescription for benzodiazepines for a
medical condition from another prescriber may be prescribed buprenorphine
products by a program provider. Contact should be initiated with the prescriber of
the benzodiazepine to coordinate care and clear documentation should be
recorded in the patient’s medical record.
2.
A program provider at an OBOT may assume management of a patient’s
benzodiazepine prescribing from another physician if the patient is willing to
initiate a program of tapering.
3.
If a patient presents at an OBOT with a dual diagnosis of opioid use disorder and
a clear history of benzodiazepine use disorder, the duration and extent of the
misuse should be clearly documented in the medical record. A program provider
MINIMUM PROGRAM REQUIREMENTS FOR NONRESIDENTIAL
CHAPTER 0940-05-35
OFFICE-BASED OPIATE TREATMENT FACILITIES
at an OBOT may prescribe a long-acting benzodiazepine, such as clonazepam
or its equivalent, under the following conditions:
(i)
A patient may continue on benzodiazepine therapy as medically indicated
as long as there is an ongoing effort to taper the patient to the lowest
effective dose in order to prevent benzodiazepine withdrawal syndrome
and clear documentation of this effort is made in the patient’s medical
record.
(I)
Prescribing more than two (2) milligrams of clonazepam or its
equivalent daily is considered “high dose therapy.”
(II)
Patients receiving high dose therapy should have justification for the
dosing clearly documented in the patient’s medical record.
(III)
Patients receiving high dose therapy should be tapered as rapidly as
tolerable to two (2) milligrams or less of clonazepam, or its
equivalent, daily. If the taper is unsuccessful, the reason(s) shall be
clearly documented in the patient’s medical record.
(IV) Patients receiving high dose therapy for a period of longer than six
(6) weeks shall be managed by a physician who is board certified in
addiction medicine or who is board certified or fellowship trained in
addiction psychiatry, or by a physician who has obtained a formal
consult from a physician who is board certified in addiction medicine
or who is board certified or fellowship trained in addiction psychiatry.
The formal consult shall be clearly documented in the patient’s
medical record.
(4)
The Facility shall have a policy and procedure developed for reviewing prescriptions from
other providers, including:
(a)
Procedures to ensure that a patient’s prescriptions from outside providers will be
reported to the medical staff and reviewed by the program provider at admission and
annually thereafter;
(b)
Procedures describing the Facility’s response when information about prescriptions
from outside providers is not reported to ensure compliance with this rule; and,
(c)
Documentation of the Facility’s efforts to obtain information about prescriptions from
outside providers in the patient’s medical record, if a Facility is unable to acquire
information about a patient’s prescriptions.