Md. Code Regs. 10.34.28.02

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.28.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Automated medication system" means a centralized, decentralized, or remote robotic or computerized device and that device's components designed to:

(a) 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; or

(b) Prepare medications for final dispensing by a licensed pharmacist.

(2) "Centralized automated medication system" means an automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient.

(3) "Decentralized automated medication system" means an automated medication system that is located outside of the pharmacy in a 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, with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.

(4) "Distribution" means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Annotated Code of Maryland, before the administration of the provided drug or device to a patient and pursuant to an order issued by an authorized prescriber.

(5) "Health care facility" means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(6) "Interim box" means a tamper evident and secure container or secure electronic storage system holding minimal quantities of medications agreed on by the health care facility intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.

(7) Remote Automated Medication System.

(a) "Remote automated medication system" means an automated medication system that is located in a 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, that does not have an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.

(b) "Remote automated medication system" does not include an interim box or other similar medication storage container that:

(i) Does not operate pursuant to the entry of a medication order;

(ii) Does not require a pharmacist's review before access to medication;

(iii) Is stocked with unit dose medications;

(iv) Has the sole purpose of providing a medication dosage pending the next pharmacy delivery to the health care facility;

(v) Is located in a patient care setting that does not have a pharmacy on site; and

(vi) Is stocked and controlled by a pharmacy providing services to a health care facility.

(8) "Responsible pharmacist" means a licensed pharmacist who ensures the safe and efficient dispensing, repackaging, delivery, control, positive drug identification including bar coding, transaction records, dispensation records, labeling, and accountability for medications in an automated medication system.

(9) "Starter dose" means a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.

(10) "Unit dose" means a medication container or package containing one discrete pharmaceutical dosage form labeled according to federal and State law.

Md. Code Regs. 10.34.28.02