Sec. 10.34.28.05. Usage Requirements for Decentralized Automated Medication Systems

A. A decentralized 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 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 decentralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and

(c) The decentralized 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:

(1) The pharmacist reviews the order within 24 hours of removal from the decentralized automated medication system; or

(2) The prescriber reviews the patient medical history and authorizes the administration of the dose to the patient.

C. Decentralized automated medication systems shall operate in a manner which:

(1) Limits simultaneous access to multiple:

(a) Drug strengths;

(b) Dosage forms; or

(c) Drug entities;

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

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

D. The requirements listed in §C(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.

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

(1) Whether the permit holder operates a decentralized automated medication system; and

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