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Policy Statement

Policy Statement 98-011: Policy on Customized Patient Packaging

Date: 01/27/1998
Organization: Board of Registration in Pharmacy
Referenced Sources: M.G.L. c. 112 § 42(A)

It is the policy of the Board that when a pharmacist dispenses prescription drugs in patient systems containing two or more drugs in the same compartment, that the pharmacist shall follow United States Pharmacopeia guidelines for "Customized Patient Medication Packages", except where otherwise prohibited.

Table of Contents

Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, a 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 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 or 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.
It is the responsibility of the dispenser to instruct the patient or caregiver on the use of the patient med pak.

Label

(A) The patient med pak shall bear a label stating:

  1. the name of the patient;
  2. a serial number for the patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;
  3. the name, strength, physical description or identification, and total quantity of each drug product contained therein;
  4. the directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;
  5. any storage instructions or cautionary statements required by the official compendia;
  6. the name of the prescriber of each drug product;
  7. the date of preparation of the patient med pak and the beyond-use date or period of time assigned to the patient med pak (such 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 and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein); alternatively, the package label shall state the date of the prescription(s) or the date of preparation of the patient med park, provided the package is accompanied by a record indicating the start date and the beyond-use date;
  8. the name, address, and telephone number of the dispenser (and the dispenser's registration number where necessary); and
  9. 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 shall bear a label identifying each of the drug products contained therein.

Labeling - The patient med pak shall 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 pharmacist for the total patient med pak.

Packaging - In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container (see Containers-Permeation <617>). Each container shall be either not reclosable or so designed as to show evidence of having been opened.

Guidelines - It is the responsibility of the dispenser, when preparing a patient med pak to take into account any applicable compendial 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 reported incompatibilities.

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

  1. the name and address of the patient;
  2. the serial number of the prescription order for each drug product contained therein;
  3. the name of the manufacturer or labeler and lot number for each drug product contained therein;
  4. 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;
  5. the date of preparation of the patient med pak and the beyond-use date that was assigned;
  6. any special labeling instructions; and
  7. the name or initials of the pharmacist who prepared the patient med pak.

<671> Containers - Permeation

The tests that follow are provided to determine the moisture permeability of containers utilized for drugs being dispensed on prescription. The section Multiple-unit Containers for Capsules and Tablets applies to multiple-unit containers (see Preservation, Packaging, Storage, and Labeling under General Notices). The section Single-unit Containers and Unit-dose Containers for Capsules and Tablets applies to single-unit and unit-dose containers (see Single-unit Containers and Unit-dose Containers for Nonsterile Solid and Liquid Dosage Forms under Containers <671>). As used herein, the term "container" refers to the entire system comprising, usually, the container itself, the liner (if used), the closure in the case of multiple-unit containers, and the lidding and blister in the case of single-unit and unit-dose containers.

Where the manufacturer's unopened multiple-unit, single-unit, or unit-dose packages are used for dispensing the drug, such containers are exempt from the requirements of this test.

It should be noted that 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.

Referenced Sources:
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