Or. Admin. Code § 415-020-0065

Current through Register Vol. 63, No. 12, December 1, 2024

Section 415-020-0065 - Opioid Agonist Medication Administration

(1) The Opioid Treatment Program (OTP) shall meet the following standards for opioid agonist medication for administration:

(a) Methadone shall be administered only in oral form and shall be formulated in such a way as to reduce its potential for abuse by injection and accidental ingestion;

(b) Packaged for outpatient use in special packaging as required by 16 CFR Part 1700.14.

(2) Methadone Take-Out Doses: For take-out doses, the Poison Prevention Act (P.L. 91-601, 15 USC 1471 et seq.) must be followed. Any take-out medication must be in oral form, either liquid or diskette and shall be labeled with the OTP name, address, telephone number, and medical director. All labeling shall be in compliance with the Oregon Board of Pharmacy standards.

(3) OTPs shall maintain current procedures to ensure that each opioid agonist treatment medication used by the program is administered in accordance with its approved product labeling.

(4) Records: Accurate records traceable to specific patients shall be maintained showing dates, quantity, and any other Board of Pharmacy required identification for the drug administered and shall be retained for a period of seven years.

(5) Security: The program shall meet security standards for the distribution and storage of controlled substances as required by the Federal Drug Enforcement Administration, Department of Justice.

(6) Who May Administer Opioid Agonist Treatment Medications: Medications shall be administered by:

(a) A practitioner licensed or registered under appropriate State or Federal law to order narcotic drugs for patients; or

(b) A person licensed or approved by the State Board of Nursing or the State Board of Pharmacy, supervised by and pursuant to the order of the practitioner.

(7) Responsibility: The licensed practitioner is fully accountable and personally responsible for the amounts of opioid agonist treatment medications administered.

(8) Documentation: All changes in dosage schedule will be recorded and signed by the licensed practitioner.

(9) Medical Director: The medical director shall:

(a) Assume responsibility for the amounts of opioid agonist treatment medications administered; and

(b) Review each patient's dosage level at least once every 90 days.

(10) Initial Dose: The initial dose of methadone should not exceed 30 milligrams and the total dose for the first day should not exceed 40 milligrams unless the program medical director documents in the patient's record that 40 milligrams did not suppress opiate abstinence symptoms. The initial dose of opioid agonist treatment medication to a patient whose tolerance for the drug is unknown shall not exceed 40 milligrams.

(11) Maintenance Dose: The maintenance dose should be individually determined with careful attention to the information provided by the patient. The dose should be determined by a physician, nurse practitioner, or physicians' assistant experienced in addiction treatment and should be adequate to achieve the desired effects for 24 hours or more. The desired effects are;

(a) Preventing the onset of opioid abstinence syndrome;

(b) Reducing drug cravings or hunger; and

(c) Blocking the effects of any illicitly administered opioids.

(12) All changes ordered by a physician, nurse practitioner, or physicians' assistant in the opioid agonist treatment medication shall be documented in the patient record, and each change in the dosage schedule shall be recorded, dated, and signed in each patient's record.

(13) Methadone Take Out Schedule: A patient may be permitted a temporary or permanently increased take-out schedule if it is the reasonable clinical judgment of the program physician and documented in the records that:

(a) A patient is found to have a physical disability which interferes with the patient's ability to conform to the applicable take-out schedule; or

(b) A patient, because of critical circumstances such as illness, personal or family crises, or other hardship is unable to conform to the applicable takeout schedule; and

(c) The patient may not be given more than a 30-day supply of narcotic agonist medication at one time.

(14) Patient Treatment at Another Program: The patient shall report to the same OTP unless prior written approval is obtained from the program physician allowing the patient to receive treatment at another program. If permission is granted, the programs involved shall meet the following requirements:

(a) The program referring the patient shall notify and obtain, in writing, permission from the other program for the patient to attend;

(b) During attendance at another program the patient may not receive more opioid agonist treatment medication take-out doses than currently authorized by their regular program; and

(c) The program making the referral shall provide the patient with positive identification for presentation to the other program.

Or. Admin. Code § 415-020-0065

HR 4-1988, f. & cert. ef. 5-10-88; HR 17-1993, f. & cert. ef. 7-23-93, Renumbered from 410-006-0065; ADAP 3-1995, f. 12-1-95, cert. ef. 3-1-96; ADS 1-2003, f. 6-13-03, cert. ef. 7-1-03; ADS 2-2008, f. & cert. ef. 11-13-08; ADS 2-2021, temporary amend filed 09/21/2021, effective 10/01/2021 through 03/29/2022; ADS 3-2021, temporary amend filed 09/29/2021, effective 10/1/2021 through 3/29/2022, ADS 1-2022, amend filed 03/25/2022, effective 3/28/2022; ADS 2-2023, amend filed 04/07/2023, effective 4/7/2023

Statutory/Other Authority: ORS 430.256

Statutes/Other Implemented: ORS 430.010(4)(b) & 430.560 - 430.590