2023 Maryland Statutes › Health Occupations › Title 12 - Pharmacists and Pharmacies › Subtitle 6 - Board Regulation of Drugs, Medicines, and Other Products › Section 12-605 - Remote Automated Medication Systems

(a)    (1)    In this section the following words have the meanings indicated.
(2)    “Health care facility” means a related institution as defined in § 19–301 of the Health – General Article.
(3)    “Remote automated medication system” means an automated mechanical system that is located in a health care facility that does not have an on–site pharmacy and in which medication is stored in a manner that may be patient–specific.
(4)    “Starter dose” means a dose of medication removed from a remote automated medication system within the first 24 hours after it is ordered.
(b)    (1)    A pharmacist shall be responsible for the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in a remote automated medication system located in a health care facility that does not have a pharmacy present on–site.
(2)    If a pharmacist is not physically present where the remote automated medication system is located in a health care facility, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in the system.
(c)    If a health care facility uses a remote automated medication system, a pharmacist shall review for accuracy, completeness, and appropriateness all medication orders after being entered into the system.
(d)    (1)    If a remote automated medication system, the pharmacy permit holder that manages the system, and the health care facility where the system is located meet the requirements of this subsection:
(i)    A health care facility that uses a system does not need to have a pharmacist physically present to review the selection, packaging, or repackaging of medications by the system;
(ii)    If the starter dose is reviewed by a pharmacist within 24 hours of delivery from a system, a system may deliver a starter dose or a dose in response to an emergency without prior review by a pharmacist; and
(iii)    A system may allow simultaneous access to multiple drug strengths, dosage forms, or drug entities if contained within a patient–specific package.
(2)    A remote automated medication system shall at least:
(i)    Use bar code technology to ensure accuracy in loading and selection of medications in the system;
(ii)    Have electronic reporting capability regarding the identity of all persons with access to the system and regarding all medications removed from the system; and
(iii)    Before administration of a medication to a patient by an individual authorized to administer medication under this article, provide:
1.    A picture of the medication if available; or
2.    If a picture is not available, a written report that describes the medication.
(3)    The health care facility where the system is located shall have at least:
(i)    A pharmacist available for consultation 24 hours per day;
(ii)    Technical assistance regarding operation of the system available 24 hours per day; and
(iii)    A quality assurance program as described under subsection (e) of this section.
(4)    The pharmacy permit holder that manages a remote automated medication system shall provide a comprehensive training program to all persons with access to the system.
(e)    (1)    A pharmacist that operates a remote automated medication system, in consultation with the health care facility where the system is located, shall develop and implement a quality assurance program in accordance with regulations adopted by the Board.
(2)    The quality assurance program developed under this subsection shall include:
(i)    Policies and procedures at both the pharmacy where the system receives an order and the health care facility where the system administers the medication regarding operation of the system;
(ii)    Daily inspection of the integrity of the system;
(iii)    A plan for addressing medication errors;
(iv)    A plan for reviewing incidents regarding inappropriate use and access to the system;
(v)    Proper labeling procedures that comply with applicable State and federal laws;
(vi)    Policies and procedures for the safe handling and return of unused medications; and
(vii)    Any other requirements determined by the Board and set forth in regulations.
(f)    (1)    A pharmacist that operates a remote automated medication system shall limit access to the system to individuals authorized to access the system by requiring individual security codes for all functions.
(2)    A record shall be kept of each transaction containing user identification information.
(g)    (1)    A pharmacist who operates a remote automated medication system shall maintain maintenance logs and repair records for the system.
(2)    In a power outage or otherwise unforeseen situation, a pharmacist shall ensure that:
(i)    A back–up power source for the system is available by a connection with the health care facility’s generator; and
(ii)    Only a registered nurse or a licensed practical nurse has access to the medications contained within the system.