Subject to the hearing provisions of § 12–315 of this title, for a violation of this subtitle, Subtitle 6C of this title, or any regulation adopted under Subtitle 6C of this title, the Board may:
Deny a permit to an applicant;
Reprimand a permit holder;
Place a permit holder on probation; or
Suspend or revoke a permit.
A person aggrieved by a final action of the Board under this subtitle or Subtitle 6C of this title may appeal as provided under Title 10, Subtitle 2 of the State Government Article.
In this section the following words have the meanings indicated.
“Dialysis drugs and devices” means:
Dialysate and dialysis solutions;
Dialyzers, delivery systems, and their accessory equipment necessary to administer these products;
Heparin;
Local anesthetics and any other drugs and devices approved by the Board under subsection (g) of this section;
Needles;
Syringes; and
Sterile sodium chloride and sterile potassium chloride.
“Home dialysis distribution permit” means a permit issued by the Board to distribute dialysis drugs and devices to the homes of dialysis patients.
Except as provided under this subsection, a person shall hold a home dialysis distribution permit issued by the Board before the person may distribute dialysis drugs and devices to the home of a dialysis patient.
A licensed pharmacist may distribute dialysis drugs and devices under this section without the home dialysis distribution permit otherwise required by this section.
To qualify for a home dialysis distribution permit, an applicant shall satisfy the Board that the applicant will distribute dialysis drugs and devices in compliance with subsection (h) of this section.
To apply for a home dialysis distribution permit, an applicant shall:
Submit an application to the Board on the form that the Board requires; and
Pay to the Board a fee set by the Board.
The Board shall issue a home dialysis distribution permit to any applicant who meets the requirements of this section.
A home dialysis distribution permit issued under this section authorizes the home dialysis distribution permit holder to distribute dialysis drugs and devices to the home of a dialysis patient while the home dialysis distribution permit is effective.
The Board may approve local anesthetics and other drugs and devices for distribution as dialysis drugs and devices under this section.
The Board may adopt rules and regulations to assure safe, proper, and uninterrupted distribution of dialysis drugs and devices, including rules and regulations as to:
Maintaining facilities that are adequate to assure proper security and control of dialysis drugs and devices;
Keeping records;
Labeling dialysis drugs and devices;
Receipts and returns from patients for dialysis drugs and devices;
Reports to the Board; and
Restrictions on specific dialysis drugs or devices, including limitations on the amounts that may be distributed.
A person authorized to distribute dialysis drugs and devices under this section may distribute only dialysis drugs and devices:
That the Board, after consultation with the State Commission on Kidney Disease, has approved as effective and safe for their intended use;
Under supervision of a person who the Board considers qualified to safeguard and protect the public health;
To an individual:
Who has irreversibly lost function of the individual’s kidneys and requires regular treatment; and
Who has completed a full course of training in providing the individual’s own dialysis treatment given by:
A home dialysis training facility; or
An end stage renal disease clinic certified under Medicare; and
In compliance with the rules and regulations adopted by the Board under this section.
Subject to the Administrative Procedure Act, the Board may suspend or revoke the home dialysis distribution permit of any home dialysis distribution permit holder who fails to comply with subsection (h) of this section.
The Secretary, the Board, or the agents of either, during business hours, may:
Enter any place where drugs, devices, diagnostics, cosmetics, dentifrices, domestic remedies, or toilet articles are manufactured, packaged, stocked, or offered for sale; and
Inspect the drugs, devices, diagnostics, cosmetics, dentifrices, domestic remedies, and toilet articles there.
A pharmacy in this State issued a permit by the Board and subject to inspection under subsection (a) of this section shall be inspected annually.
A nonresident pharmacy:
Is subject to inspection under subsection (a) of this section by the Secretary, the Board, or the agents of either; and
On application for and renewal of a pharmacy permit in this State, shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located.
A person may not hinder an inspection conducted under this section.
In this section the following words have the meanings indicated.
“Health care facility” means a related institution as defined in § 19–301 of the Health – General Article.
“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.
“Starter dose” means a dose of medication removed from a remote automated medication system within the first 24 hours after it is ordered.
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.
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.
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.
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:
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;
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
A system may allow simultaneous access to multiple drug strengths, dosage forms, or drug entities if contained within a patient–specific package.
A remote automated medication system shall at least:
Use bar code technology to ensure accuracy in loading and selection of medications in the system;
Have electronic reporting capability regarding the identity of all persons with access to the system and regarding all medications removed from the system; and
Before administration of a medication to a patient by an individual authorized to administer medication under this article, provide:
A picture of the medication if available; or
If a picture is not available, a written report that describes the medication.
The health care facility where the system is located shall have at least:
A pharmacist available for consultation 24 hours per day;
Technical assistance regarding operation of the system available 24 hours per day; and
A quality assurance program as described under subsection (e) of this section.
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.
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.
The quality assurance program developed under this subsection shall include:
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;
Daily inspection of the integrity of the system;
A plan for addressing medication errors;
A plan for reviewing incidents regarding inappropriate use and access to the system;
Proper labeling procedures that comply with applicable State and federal laws;
Policies and procedures for the safe handling and return of unused medications; and
Any other requirements determined by the Board and set forth in regulations.
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.
A record shall be kept of each transaction containing user identification information.
A pharmacist who operates a remote automated medication system shall maintain maintenance logs and repair records for the system.
In a power outage or otherwise unforeseen situation, a pharmacist shall ensure that:
A back–up power source for the system is available by a connection with the health care facility’s generator; and
Only a registered nurse or a licensed practical nurse has access to the medications contained within the system.