Section 440IAC10-4-26. Self-administered medication

   (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.

(Division of Mental Health and Addiction; 440 IAC 10-4-26; filed Dec 30, 2009, 2:00 p.m.: 20100127-IR-440080412FRA; filed Feb 16, 2015, 1:02 p.m.: 20150318-IR-440140343FRA; readopted filed May 10, 2016, 11:24 a.m.: 20160608-IR-440160134RFA)