Mo. Code Regs. tit. 20 § 2220-2.145

Current through Register Vol. 49, No. 21, November 1, 2024.

Section 20 CSR 2220-2.145 - Minimum Standards for Multi-Med Dispensing

PURPOSE: This amendment would expand the authorized beyond-use date for patient med paks and would authorize inclusion of controlled substances as allowed by state and federal controlled substance laws.

(1) In lieu of dispensing two (2) 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).

(2) A patient med pak is a package prepared by a pharmacist for a specific patient comprising one (1) or more containers and containing two (2) 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.

(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 assigned to the patient med pak (such beyond-use date shall be not later than ninety (90) days from the date of preparation);

8. The name, address, and telephone number of the dispenser; and

9. Any other information, statements, or warnings required for any of the drug products.

(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.

(C) 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.

(D) 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. Each container shall be either not reclosable or so designed as to show evidence of having been opened.

(E) 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 United States Pharmacopeia (USP) headquarters any observed or reported incompatibilities.

(F) In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, at 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.

(G) 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.

(H) Once a patient med pak has been delivered to an institution or to a patient it shall not be returned to the pharmacy, unless the following requirements are met:

1. The med pak is returned to the pharmacy from which it was originally dispensed;

2. The med pak is modified/repackaged, per prescription order, for the same patient to whom it was originally dispensed;

3. The med pak is labeled in compliance with the requirements of this rule, provided the med pak shall retain the original beyond-use date assigned to the med pak before modification/repackaging;

4. The med pak is assigned a new serial number;

5. The medications removed from the med pak are destroyed in compliance with state and federal law. In no event shall medication removed from a med pak be returned to stock/inventory or dispensed to another patient; and

6. Licensees shall comply with all applicable record-keeping requirements.

(I) Multi-med paks may include controlled substances as allowed by, and in accordance with, state and federal controlled substance laws and regulations.

(J) Except as otherwise allowed in subsection (H) of this section, once a drug has been commingled with other drugs in a med pak the drug may not be returned to stock, dispensed, or distributed except for destruction purposes.

20 CSR 2220-2.145

AUTHORITY: sections 338.010 and 338.140, RSMo Supp. 2011, and section 338.059, RSMo 2000.* This rule originally filed as 4 CSR 220-2.145. Original rule filed March 15, 2000, effective Sept. 30, 2000. Moved to 20 CSR 2220-2.145, effective Aug. 28, 2006. Amended: Filed Jan. 3, 2012, effective June 30, 2012.

Amended by Missouri Register April 1, 2020/Volume 45, Number 7, effective 5/31/2020

*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011 ; 338.059, RSMo 1971, amended 1973, 1978, 1997; and 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011.