Or. Admin. Code § 415-050-0155

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

Section 415-050-0155 - Management of Medications

Each Program must have:

(1) A written order signed by a physician, a physician's standing order, or a physician's order received by phone and signed by the physician at the earliest opportunity before any medication is administered or dispensed to or self-administered by any patient.

(2) The program must have a policy that requires, at a minimum, each of the following:

(a) Assurances that medications prescribed for one patient must not be administered to or self-administered by another patient or employee;

(b) All prescription drugs stored in the program must be kept in a locked container. Only those medications requiring refrigeration must be stored in a refrigerator;

(c) Stored not yet prescribed controlled substance including records and maintain inventories in conformance with 21 U.S.C. Section 827; 21CF R 1304.02 through 1304.11; 1304.21 through 1304.26; 1304.31 through 1304.33; except that a written inventory of all controlled substances must be taken by registrants annually within 365 days of the last written inventory. All such records must be maintained for a period of three years;

(d) In the case where a patient self-administers their own medication, self-administration must be recommended by the Program, approved in writing by the Medical Director, and closely monitored by the medical treatment staff;

(e) No unused, outdated, wasted or recalled medications, confiscated substances or objects used for substance consumption must be kept by the program or in the facility;

(f) All unused, outdated, wasted or recalled medications, and confiscated substances and objects must be disposed of in a manner that assures that they cannot be retrieved within 21 days of identifying need for destruction;

(g) A written record of all disposals of medications, substances and objects must be maintained in the Program and must include:

(A) A description of the drug, medication or substance including the amount;

(B) The patient for whom the medication was prescribed, or from whom the medication, substance or object was confiscated from;

(C) The reason for disposal; and

(D) The method of disposal including:

(i) Medications that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other medications until they are destroyed or returned to their supplier; and

(ii) Controlled substances which are expired, deteriorated or unwanted must be disposed of in conformance with 21 CFR 1307.21.

(E) The destruction must be documented and signed by the witnesses and the document retained at the facility for a period of at least three years. Destruction must be jointly witnessed on the premises by any two of the following:

(i) The consultant pharmacist or registered nurse designee;

(ii) The Director of Nursing Services or supervising nurse designee;

(iii) The administrator of the facility or an administrative designee; or

(iv) A Registered Nurse employed by the facility.

(h) Documentation of each prescription medication dispensed, administered to, or self-administered by any patient. This written record must include, at a minimum:

(A) A copy or detailed written description of the signed prescription order, including;

(i) Patient's name;

(ii) The date medications were prescribed, reviewed, or renewed;

(iii) Prescribing physician's name and credential;

(iv) Description of the medication, including the medication name and prescribed dosage; and

(v) Method of administration.

(B) Known allergies to medication(s);

(C) Verification in writing by medical treatment staff that the medication was taken, and the times and dates the medication was dispensed, administered, or self-administered;

(D) Observed side effects including laboratory findings;

(E) Any adverse reactions to the medication; and

(F) Continuing evaluation of the patient's ability to self-administer the medication.

Or. Admin. Code § 415-050-0155

MHD 15(Temp), f. 1-16-74, ef. 2-1-74; MHD 45, f. & ef. 7-20-77; MHD 15-1983, f. 7-27-83, ef. 10-25-83, Renumbered from 309-052-0000(6); ADAP 3-1993, f. & cert. ef. 12-6-93, Renumbered from 309-050-0045; ADS 2-2008, f. & cert. ef. 11-13-08; ADS 3-2013(Temp), f. & cert. ef. 2-4-13 thru 8-2-13; ADS 6-2013, f. & cert. ef. 8-1-13; ADS 1-2023, renumbered from 415-050-0045, filed 01/20/2023, effective 1/20/2023; ADS 3-2023, amend filed 04/07/2023, effective 4/7/2023

Statutory/Other Authority: ORS 413.042 & 430.256

Statutes/Other Implemented: 430.345 - 430.375 & ORS 430.306