Title 12 . Professional and Vocational Regulations

Chapter 52 . Big Game Guides and Transporters

Section 520. Customized patient medication package (patient med-pak)

12 AAC 52.520. Customized patient medication package (patient med-pak)

(a) Instead of dispensing one or more prescribed drug products in separate containers, a pharmacist may, with the written consent of the patient, patient's caregiver, or prescribing practitioner, provide a customized patient medication package or patient med-pak).

(b) A patient med-pak is a series of containers prepared by a pharmacist for a specific patient containing one or more prescribed solid oral dosage forms and designed or labeled to indicate the day and time, or period of time, when the contents within each container are to be taken.

(c) The pharmacist shall prepare a label for a patient med-pak that includes

(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 the drug products in the patient med-pak;

(3) the name, strength, physical description or identification, and total quantity of each drug product in the patient med-pak;

(4) the directions for use and cautionary statements, if any, contained in the prescription drug order for each drug product in the patient med-pak;

(5) any other information, statements, or warnings required or appropriate for any of the drug products in the patient med-pak;

(6) the name of the prescribing practitioner of each drug product in the patient med-pak;

(7) the date of preparation of the patient med-pak and the expiration date assigned to the patient med-pak; the expiration date may not be more than 60 days from the date of preparation of the patient med-pak;

(8) the name, address, and telephone number of the pharmacy; and

(9) the initials of the dispensing pharmacist.

(d) If the patient med-pak allows for the removal or separation of the intact containers from the patient med-pak, the pharmacist shall label each individual container of the patient med-pak to identify each of the drug products contained in the patient med-pak.

(e) When preparing a patient med-pak, the dispensing pharmacist shall take into account any applicable compendium requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container in the med-pak and any therapeutic incompatibilities that may attend the simultaneous administration of the drugs.

(f) In addition to any individual prescription filing requirements, the pharmacist shall make and file a record of each patient med-pak. Each record must contain

(1) the name and address of the patient;

(2) a unique identification number for the patient med-pak itself and a separate, unique, identification number for each of the prescription drug orders for each drug product contained in the patient med-pak;

(3) information identifying or describing the design, characteristics, or specifications of the patient med-pak that is sufficient to prepare an identical patient med-pak for the patient;

(4) the date of preparation of the patient med-pak and the expiration date assigned;

(5) any special labeling instructions; and

(6) the name or initials of the pharmacist who prepared the patient med-pak.

History: Eff. 1/16/98, Register 145

Authority: AS 08.80.005

AS 08.80.030

AS 08.80.480