Or. Admin. Code § 855-139-0355

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

Section 855-139-0355 - Dispensing: Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, an Oregon licensed Pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication package (patient med pak). A patient med pak is a package prepared by a Certified Oregon Pharmacy Technician or Pharmacy Technician and verified by a Pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed for each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken:

(1) Label:

(a) The patient med pak must bear a label stating:

(A) The name of the patient;

(B) A serial number for each patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;

(C) The name, strength, physical description or identification, and total quantity of each drug product contained therein;

(D) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;

(E) Any storage instructions or cautionary statements required by the official compendia;

(F) The name of the prescriber of each drug product;

(G) The date of preparation of the patient med pak and the beyond-use date assigned to the patient med pak (such beyond-use date must be no later than 60 days from the date of preparation);

(H) The name, address, and telephone number of the dispenser and the dispenser's registration number where necessary; and

(I) Any other information, statements, or warnings required for any of the drug products contained therein.

(b) If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container must bear a label identifying each of the drug products contained therein.

(2) Labeling: The patient med pak must be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the RDSP for the total patient med pak.

(3) Packaging:

(a) In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak must comply with the moisture permeation requirements for a Class B single-unit or unit-dose container. Each container must be either not reclosable or so designed as to show evidence of having been opened;

(b) There is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards must be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, must be obtained.

(4) Guidelines: It is the responsibility of the dispenser, when preparing a patient med pak, to take into account any applicable compendia requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications. In this regard, Pharmacists are encouraged to report to USP headquarters any observed or report incompatibilities.

(5) Recordkeeping: In addition to any individual prescription filing requirements, a record of each patient med pak must be made and filed. Each record must contain, as a minimum:

(a) The name and address of the patient;

(b) The serial number of the prescription order for each drug product contained therein;

(c) The name of the manufacturer or labeler and lot number for each drug product contained therein;

(d) Information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;

(e) The date of preparation of the patient med pak and the beyond-use date that was assigned;

(f) Any special labeling instructions; and

(g) The name or initials of the Certified Oregon Pharmacy Technician or Pharmacy Technician who prepared the med pak and the Oregon licensed Pharmacist who verified the patient med pak.

(6) Ensure an Oregon licensed Pharmacist visually verifies and documents each item required in OAR 855-139-0205 for each individual dosage unit in the med pak.

Or. Admin. Code § 855-139-0355

BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022; BP 4-2022, minor correction filed 01/03/2022, effective 1/3/2022; BP 26-2022, temporary amend filed 04/22/2022, effective 4/22/2022 through 10/18/2022; BP 36-2022, amend filed 06/15/2022, effective 6/16/2022

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034

Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034