Md. Code Regs. 10.34.28.06

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.28.06 - Usage Requirements for Remote Automated Medication Systems

A. A remote automated medication system may only be used if:

(1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter;

(2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the remote automated medication system;

(3) Except for starter doses, a licensed pharmacist reviews each order for medication:

(a) After the order has been entered into the system; and

(b) Before the system permits access to the medication;

(4) The permit holder ensures that:

(a) Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland;

(b) The remote automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and

(c) The remote automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and

(5) It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland.

B. A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if the pharmacist reviews the order within 24 hours of removal from the remote automated medication system.

C. If a licensed pharmacist is not physically present where the remote automated medication system is located, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient operation of the system.

D. Remote automated medication systems shall operate in a manner which:

(1) Unless packaging and labeling for a specific patient, limits simultaneous access to multiple:

(a) Drug strengths;

(b) Dosage forms; or

(c) Drug entities;

(2) Prevents access to medication not ordered for the patient; and

(3) Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the remote automated medication system.

E. The requirements listed in §D(1) and (2) of this regulation do not apply to automated supply towers which contain:

(1) Noncontrolled medications that are:

(a) Refrigerated;

(b) Bulk; or

(c) Intravenous fluids; or

(2) Prescription devices.

F. A remote automated medication system may be used only if the system:

(1) Uses positive drug identification, such as bar code technology, to ensure accuracy in:

(a) Loading and selection of medications in the pharmacy for stocking and replenishment of the remote automated medication system; and

(b) Loading medications into the remote automated medication system where it is located;

(2) Has electronic reporting capability regarding the identity of persons with access to the system and regarding medications removed from the system;

(3) Restricts access to medications to a licensed pharmacist or an individual authorized to administer medication under Health Occupation Article, Annotated Code of Maryland; and

(4) Before administration of a medication to a patient, provides:

(a) A picture of the medication, if available; or

(b) If a picture is not available, a written description of the medication specifically by color, shape, and unique manufacturer markings.

G. The permit holder shall ensure that the health care facility where the remote automated medication system is located provides, at a minimum:

(1) A licensed pharmacist available for consultation 24 hours per day;

(2) Technical assistance regarding operation of the system available 24 hours per day; and

(3) A quality assurance program as set forth in Regulation .10 of this chapter.

H. A permit holder shall indicate on the initial, renewal, and reinstatement applications:

(1) Whether the permit holder operated a remote automated medication system; and

(2) Any other information regarding the system that the Board considers necessary to determine compliance with this chapter.

Md. Code Regs. 10.34.28.06