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.
Notes
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
