Authority: IC 12-23-1-6; IC 12-23-18

Affected: IC 12-23-18

Sec. 19. (a) An OTP shall use only opioid treatment medications approved by the Food and Drug Administration under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid addiction.

(b) An OTP may use any of the following medications as an alternative for methadone for opioid treatment:

1. (1) Buprenorphine.
2. (2) Buprenorphine combination products containing naloxone.
3. (3) Any other medication that has been approved by the federal Food and Drug Administration for use in the treatment of opioid addiction.

(c) An OTP shall maintain current procedures adequate to ensure that each treatment medication used by the program is administered in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures shall ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record.

(d) Before the patient may receive the initial dose of medication, the program physician shall document the following in the patient's record:

1. (1) Evidence of current addiction to an opioid drug or drugs, including, but not limited to, drug testing results.
2. (2) Length of history of addiction to opioid drug or drugs.
3. (3) Any exception to the criteria for admission under section 15 of this rule.

4. (4) The program physician checked INSPECT prior to initial medication administration to determine any potential contraindication of any schedule prescriptions. The program physician is in compliance with the requirements of this subsection when the program physician as follows:

   1. (A) Documents any potential contraindications in the patient's record prior to determining which opioid treatment medications to administer.
   2. (B) Documents that informed consent was provided to the patient in the patient's record prior to administering opioid treatment medications to the patient.
5. The program physician shall check INSPECT as frequently as clinically indicated.

(e) For patients deemed clinically appropriate for admission, medication is titrated to a dose with the rate of increase indicated based on a clinical assessment of the following:

1. (1) The patient's tolerance.
2. (2) The patient's withdrawal symptoms.
3. (3) The elimination of craving.

(f) The rate of titration and dose achieved shall be determined on a case-by-case basis through the course of multiple clinical assessments. These assessments shall also monitor for the following:

1. (1) To assure the optimum effective dose to prevent withdrawal.
2. (2) To adequately block euphoric effects of other opioid drugs.
3. (3) To minimize or eliminate craving and dosing regimens too high for a given patient that may result in a clinically significant level of intoxication.

(g) The initial dose of the following medications shall be as follows:

1. (1) For methadone, the program physician may order the following:

   1. (A) Up to thirty (30) milligrams of methadone as an initial dose for an incoming patient.
   2. (B) After at least one (1) hour observation, up to ten (10) milligrams of additional methadone for an incoming patient if the symptoms of withdrawal have persisted.
2. (2) For buprenorphine, an initial dose as determined in the reasonable medical judgment of the program physician in light of the patient's circumstances.

(h) Precautions shall be taken in the induction of the opioid treatment medication to assure that an individual can tolerate the dosage of medication prescribed.

(i) A patient's initial dose of opioid treatment medication shall be administered under the direction of a program physician.

(j) A patient admitted to an OTP shall not be provided with doses of opioid treatment medication for self-administration until clinical staff has observed the patient after the administration of medication at clinic visits for a minimum of five (5) days.

(Division of Mental Health and Addiction; 440 IAC 10-4-19; 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; readopted filed Nov 9, 2022, 4:31 p.m.: 20221207-IR-440220292RFA)