Iowa Admin. Code r. 657-22.5 - Patient med paks
In lieu of dispensing prescribed drug products in conventional prescription containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or the prescriber, provide a customized patient medication package (patient med pak) pursuant to the requirements of this rule.
(1)
Definition. A patient
med pak is a customized patient medication package prepared for a specific
patient which comprises a series of immediate containers containing prescribed
solid oral dosage forms, each container being labeled with the time or the
appropriate period for the patient to take its contents. A patient med pak
includes but is not limited to a strip pack prepared utilizing an automated
medication distribution system (AMDS).
(2)General procedures. The
following shall apply when patient med paks are employed:
a. The pharmacist shall be responsible for
determining the classification, as directed by USP General Chapter 671, for
containers used by the pharmacy to repackage nonsterile drugs into patient med
paks.
b. Packaging for all
nonsterile solid oral dosage forms stored and dispensed in patient med paks
shall:
(1) Preserve and protect the identity
and integrity of the drug from the point of packaging to the point of
administration, and
(2) Be clean
and free of extraneous matter when the drugs are placed into the
package.
c. Drugs
dispensed in patient med paks to patients may not be returned to the pharmacy
stock and reissued except to the same patient as provided in subrule
22.5(4).
d. 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, shall 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 shall be obtained.
(3)Reuse of containers.
Notwithstanding requirements that all prescription drugs be dispensed in a new
container conforming with standards established in the official compendia, a
pharmacist may dispense and refill a prescription for nonliquid oral products
in a clean patient med pak provided:
a. A
patient med pak is reused only for the same patient; and
b. No more than a one-month supply is
dispensed at one time.
(4)Repackaging of patient med
paks. In the event a drug is added to or discontinued from a patient's
drug regimen, the pharmacist may repackage the patient's med pak and either add
to or remove from the patient's drugs packaged as ordered by the prescriber.
Drugs returned by the patient for repackaging may be reused by the pharmacist
in the design of the new patient med pak, and any drug removed from the new
drug regimen shall either be disposed of in compliance with board rules or
returned, properly labeled, to the patient. Under no circumstances shall a drug
within a container of a patient med pak be returned to the pharmacy stock or
returned to an automated medication distribution system (AMDS) component unless
the drug was dispensed as a single dose and was not commingled with other
patient medications in a single package or container.
(5)
Labeling requirements.
a. Except as provided in subrule 22.5(6), the
patient med pak shall be labeled with the following:
(1) The name of the patient;
(2) The unique identification number for the
patient med pak itself and a separate unique identification number for each of
the prescription drug orders for each of the drug products contained
therein;
(3) The name, strength,
dosage form, and total quantity of each drug product contained
therein;
(4) The directions for use
for each drug product contained therein;
(5) The name of the prescriber of each drug
product;
(6) The date of
preparation of the patient med pak and the beyond-use date assigned to the
patient med pak;
(7) The name,
address, and telephone number of the pharmacy; and
(8) The initials or unique identification of
the responsible pharmacist.
b. The patient med pak shall be accompanied
by a patient package insert, in the event that any drug contained 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 pharmacist for the total patient med
pak.
c. If the patient med pak
allows for the removal or separation of the intact containers therefrom, each
individual container shall bear a label identifying the patient, the unique
identification number for the patient med pak, and the name and telephone
number of the dispensing pharmacy.
d. If a pharmacist selects a generically
equivalent drug product for a brand name drug product prescribed by a
practitioner, the label must identify the generic drug and may identify the
brand name drug for which the selection is made. The dual identification
allowed under this paragraph must take the form of the following statement on
the label: "(generic name) Generic for ( brand name product)". If a pharmacist
selects an interchangeable biological product for the biological product
prescribed by a practitioner, the label shall identify the interchangeable
biological product dispensed and may identify the biological product prescribed
by the practitioner, such as "(interchangeable biological product) for
(biological product)".
(6)
Alternate labeling. If
the patient med pak container is not of sufficient size to accommodate the
label information as required in subrule 22.5(5) in a legible font, a patient
package insert shall be prepared and delivered with the patient med pak. The
patient package insert shall contain all label information required in subrule
22.5(5). In such case, the label affixed to the patient med pak shall minimally
include:
a. The name of the
patient;
b. The unique
identification number for the patient med pak;
c. The beyond-use date assigned to the
patient med pak;
d. A statement
directing the patient or patient's caregiver to the patient package insert;
and
e. The name and telephone
number of the dispensing pharmacy.
(7)
Expiration/beyond-use
dating. Beyond-use date or period of time shall be not longer than the
shortest recommended beyond-use date for any dosage form included therein or
not longer than 60 days from the date of preparation of the patient med pak,
whichever is shorter. In no event shall the beyond-use date exceed the shortest
expiration date on the original manufacturer's bulk containers for the dosage
forms included in the patient med pak. Alternatively, the package label shall
state the date of the prescriptions or the date of preparation of the patient
med pak, provided the package is accompanied by a record indicating the start
date and the beyond-use date.
(8)
Recordkeeping. The record of each patient med pak shall
contain, at a minimum:
a. The name and
address of the patient;
b. The
unique identification number for each of the current prescription drug orders
for each of the drug products contained therein;
c. A unique identification number for the
patient med pak;
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,
unique identification, or initials of the responsible pharmacist. This rule is
intended to implement Iowa Code sections
126.10,
126.11,
and
155A.28.
Notes
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