Indiana Administrative Code
Title 440 - DIVISION OF MENTAL HEALTH AND ADDICTION
Article 10 - MINIMUM STANDARDS FOR THE PROVISION OF SERVICES BY OPIOID TREATMENT FACILITIES AND PROGRAMS
Rule 4 - Specific Approval of Opioid Treatment Programs
Section 4-19 - Initial opioid treatment medication
Current through March 20, 2024
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:
(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:
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:
(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:
(g) The initial dose of the following medications shall be as follows:
(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.