Or. Admin. Code § 855-043-0630

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

Section 855-043-0630 - Correctional Facility - Drug Delivery and Control

(1) Policies and Procedures: The Pharmacist and the practitioner representing the facility are responsible for establishing written policies and procedures for medication management including, but not limited to, drug procurement, dispensing, administration, labeling, medication counseling, drug utilization review, medication records, parenterals, emergency and nonroutine dispensing procedures, stop orders, over-the-counter drugs, security, storage and disposal of drugs withing the facility. Policies and procedures must be reviewed and updated annually by the Pharmacist and the practitioner, maintained in the facility; and be made available to the board for inspection. The facility must submit to the board for approval, the name of any employee Pharmacist or a written agreement between the Pharmacist and the facility regarding drug policies and procedures. The facility must notify the board of any change of Pharmacist within 15 days of the change.

(2) Dispensing: Prescription drugs must be dispensed by a Pharmacist or by a practitioner authorized to dispense in either an individual container, medication card, or in a unit dose system.

(3) Unit Dose Dispensing System. The "Unit Dose Dispensing System" is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stock from patient care areas and enables the selection and distribution of unit dose packaging to be pharmacy based and controlled:

(a) A unit dose dispensing system must:

(A) By nature of the system;

(i) Provide for separation of medications by patient name and location; and

(ii) Provide for separating medications by day of administration.

(B) By means of an individual patient medication record:

(i) Record the drug and dosing regimen of those drugs dispensed by the pharmacy;

(ii) Record the actual doses dispensed and returned to the pharmacy;

(iii) Record the date of the original order and the date the order is discontinued;

(iv) Provide a means for the Pharmacist to verify the prescriber's original order;

(v) Provide a means for the Pharmacist to certify the accuracy of the selected medication before the dose is delivered for administration to the patient; and

(vi) Provide a mechanism to easily identify those drugs dispensed by pharmacy that are controlled substances.

(b) Each CF utilizing a unit dose dispensing system must establish written policies specifying the categories of drugs which will or will not be dispensed under the unit dose distribution system. Such policies must be available in the pharmacy for inspection by the board:

(A) Proper utilization of the unit dose system requires that, in as far as is practicable, all medications be in unit dose packaging when dispensed.

(B) Controlled substances may be included in the unit dose system if the methods of including such drugs in the system are in compliance with applicable federal and state laws and rules.

(C) Drugs not dispensed in unit dose packaging must be labeled in accordance with (4).

(c) The Pharmacist must certify the accuracy of the selected unit dose packages before the dose is delivered for administration to the patient.

(d) All medication must be stored in a locked area or locked cart.

(4) Labeling: Except as described in SB 450 (2023), prescription drugs dispensed in individual containers or medication cards must be labeled with the following information:

(a) Name and identifying number of the patient/inmate;

(b) Name, strength, and quantity of the drug dispensed. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;

(c) Name of the prescriber;

(d) Initials of the dispenser and the date of dispensing;

(e) Directions for use;

(f) Auxiliary labels and cautionary statements as required;

(g) Manufacturer's expiration date, or an earlier date if preferable; and

(h) Name of the pharmacy.

(5) Patient counseling:

(a) Upon receipt of a prescription drug order and following review by the Pharmacist of the patient's record, the Pharmacist must initiate and provide oral counseling to the patient or to the patient's agent or care giver in all ambulatory care settings and for discharge medications in institutions:

(A) Upon request; or

(B) On matters which a reasonable and prudent Pharmacist would deem significant; or

(C) Whenever the drug prescribed has not previously been dispensed to the patient; or

(D) Whenever the patient's medication record shows the drug has not been previously dispensed to the patient in the same dosage, form, strength or with the same written directions.

(b) When counseling is provided it must include information that a reasonable and prudent Pharmacist would deem necessary to provide for the safe and effective use of the drug. Such information may include the following:

(A) The name and description of the drug;

(B) The dosage form, dose, route of administration, and duration of drug therapy;

(C) The intended use of the drug and expected actions;

(D) Special directions and precautions for preparation, administration, and use by the patient;

(E) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(F) The possible dangers of taking the drug with alcohol, or taking the drug and then operating a motor vehicle or other hazardous machinery;

(G) Techniques for self-monitoring drug therapy;

(H) Proper storage;

(I) Prescription refill information;

(J) Action to be taken in the event of a missed dose; and

(K) Pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

(c) Patient counseling must be in person whenever practicable. Whenever the prescription is delivered outside the confines of the pharmacy by mail or other third party delivery, counseling must be in writing and by free access to the Pharmacist by phone.

(d) Subsections (a) and (b) of this section must not apply to those prescription drug orders for inpatients in hospitals or institutions where the drug is to be administered by a nurse or other individual authorized to administer drugs.

(e) Notwithstanding the requirements set forth in subsection (a), a Pharmacist is not required to provide oral counseling when a patient refuses the Pharmacist 's attempt to counsel, or when the Pharmacist, on a case by case basis and in the exercise of professional judgment, determines that another form of counseling would be more effective.

(f) Board rules for patient counseling must be observed for patient/inmates who self administer or who are given prescription drugs when they are released from the CF.

(6) Administration: Drugs must be administered to inmate/ patients by a practitioner or nurse, or by an unlicensed person who has been trained to administer drugs as defined by the Oregon State Board of Nursing in OAR 851-045-0060. Drugs selected by registered nurses from manufacturer's or Pharmacist's bulk drug containers must not be administered by unlicensed persons, except under certain emergency and nonroutine situations as described in the facility's policies and procedures.

Or. Admin. Code § 855-043-0630

PB 1-1996, f. & cert. ef. 4-5-96; Administrative correction 11-3-99; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 33-2020, minor correction filed 08/06/2020, effective 8/6/2020; Renumbered from 855-041-0177, BP 7-2012, f. & cert. ef. 12-17-12; BP 27-2023, amend filed 10/16/2023, effective 10/17/2023

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155 & 2023 SB 450