440 IAC 10-4-26 - Self-administered medication
Authority: IC 12-23-1-6; IC 12-23-18
Affected: IC 12-23-18-5
Sec. 26.
(a) An OTP
shall do the following:
(1) Comply with the
requirements in this section for a patient's self-administration of opioid
treatment medication.
(2) Implement
practices in accordance with the principle that obtaining unsupervised doses of
opioid treatment medication is a privilege given only to a patient who:
(A) will benefit from obtaining unsupervised
doses; and
(B) has demonstrated
responsibility in taking opioid treatment medication as prescribed and toward
the patient's overall recovery program.
(3) Not provide an enrolled patient with any
dose of opioid treatment medication for self-administration until the clinical
staff has observed the patient's ingestion of opioid treatment medication for
at least five (5) days.
(b) Treatment program decisions regarding the
administering of opioid treatment medications to patients for unsupervised use,
beyond the requirement in subsection (d), shall be determined by the medical
director. In determining which patients may be permitted unsupervised use, the
medical director shall consider the take-home criteria in subsection
(e).
(c) The determinations made
under subsection (b) and the basis for the determinations, consistent with the
criteria under subsection (e), shall be documented in the patient's medical
record.
(d) An OTP may provide
unsupervised opioid treatment medication based on the patient's time in
treatment pursuant to 42 CFR
8.12(i)(3) unless the
patient does not qualify under, and subject to the provisions of, the
following:
(1) Subsection (a)(3).
(2) Subsection (k).
(3) Section 22(f)(4) of this rule.
(e) In determining whether a
patient may be permitted the unsupervised use of opioid treatment medication,
the medical director shall consider the following take-home criteria in
determining whether a patient is responsible in handling opioid treatment
medication for unsupervised use:
(1) The
absence of recent abuse of drugs (opioid or non-narcotic), including
alcohol.
(2) Regularity of clinic
attendance and compliance with the patient's treatment plan.
(3) The absence of serious behavioral
problems at the clinic.
(4) The
absence of known recent criminal activity, for example, drug dealing.
(5) Stability of the patient's home
environment and social relationships.
(6) The length of time in opioid
treatment.
(7) Assurance that
take-home medication can be safely and securely stored within the patient's
home.
(8) Whether the patient will
derive a benefit from decreasing the frequency of clinic attendance that
outweighs the potential risks of diversion.
(f) Before self-administration privileges are
granted:
(1) an OTP shall educate the patient
regarding:
(A) the safe transportation of
opioid treatment medication;
(B)
storage requirements for opioid treatment medication; and
(C) emergency procedures in case of the
accidental ingestion of opioid treatment medication; and
(2) the patient is required to provide:
(A) an opaque, childproof locked container
for transportation of opioid treatment medication; and
(B) safe and secure home storage.
(g) The OTP shall
prepare bottles for the self-administration of medication with labels
containing the following information:
(1) The
patient's name.
(2) The name of the
program physician.
(3) The
medication name.
(4) The medication
dose.
(5) The date the bottle was
filled.
(6) The date or dates when
the medication is to be ingested.
(7) Directions for ingesting the
medication.
(8) The name, address,
and telephone number of the OTP.
(9) Appropriate cautionary statements,
including "Caution: Federal law prohibits the transfer of this drug to a person
other than the patient for whom it was dispensed".
(h) The OTP shall have written policies
addressing the responsibilities of patients who are granted privileges for the
self administration of opioid treatment medication, including the following:
(1) Methods of assuring a patient's
appropriate use and storage of medication in the home.
(2) The return of self-administered
medication bottles, including a policy and procedure that:
(A) requires bottles to be returned:
(i) immediately upon request; and
(ii) with labels intact;
and
(B) addresses the
consequences of a failure to return bottles as requested.
(i) Regardless of a patient's time
in treatment, the medical director may deny or rescind, if clinically
appropriate, a patient's privileges to receive opioid treatment medication for
self-administration.
(j) Exceptions
for self-administered medication may be requested, consistent with the federal
requirements in 42 CFR Part 8, and submitted to the following:
(1) The SOTA.
(2) The federal Center for Substance Abuse
Treatment, Division of Pharmacologic Therapy.
(k) An OTP shall submit exception requests to
the SOTA for all self-administered opioid treatment medication for more than
seven (7) days.
(l) Any OTP request
under subsection (j) or (k) for an exception to the federal regulations for
self-administered medications shall include the following:
(1) The dates and results of the patient's
drug tests within the past three (3) months.
(2) The patient's progress toward treatment
plan goals.
(3) Documentation, as
appropriate, of a private physician's recommendation that the patient is unable
to travel to the OTP due to a medical condition.
(4) Documentation of employment travel
hardship, as appropriate.
(5)
Documentation of other travel hardship, as appropriate.
(6) For a temporary exception request due to
travel, documentation that interim services are not available at the location
to which the patient is temporarily traveling.
Notes
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