Bill Text: GA SB180 | 2011-2012 | Regular Session | Introduced

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Bill Title: Controlled Substances; authorize the use of remote automated medication systems; definitions; requirements

Spectrum: Partisan Bill (Republican 4-0)

Status: (Introduced - Dead) 2011-03-02 - Senate Read and Referred [SB180 Detail]

Download: Georgia-2011-SB180-Introduced.html

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11 LC 33 4015ER

Senate Bill 180

By: Senators Carter of the 1st, Goggans of the 7th, Butterworth of the 50th and Grant of the 25th

A BILL TO BE ENTITLED
AN ACT

To amend Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled substances, so as to authorize the use of remote automated medication systems; to provide for legislative findings; to provide for definitions; to provide for requirements; to provide for the establishment of rules and regulations by the State Board of Pharmacy; to amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and pharmacies, so as to authorize pharmacists to dispense prescriptions through a remote automated medication system; to provide that a remote automated medication system shall not be considered a vending machine for certain purposes; to provide for related matters; to provide for an effective date; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

SECTION 1.

The General Assembly finds that:

(1) The cost of health care services is increasing at a rate that requires constant review and adoption of better and more efficient delivery systems;

(2) Technology is constantly improving the efficiency of the delivery of health care services;

(3) Georgia law must be revised from time to time to permit the adoption of new technology to enable that increase in efficiency;

(4) There is a national pharmacist shortage and current pharmaceutical practices utilizing remote automated medication systems have demonstrated reduction of human error, improvements to patient safety, and the effective provision of pharmacist care services to patients from a distance;

(5) Those systems permit the remote dispensing of prescriptions in a way that is safe, accurate, effective, and efficient, and permits the control necessary to avoid improper dispensing, while substantially reducing the cost of getting those prescriptions to the patient and reducing the amount of unused medications needing return or other disposition;

(6) Such systems have been endorsed by the Centers for Medicare and Medicaid Services ("CMS"), the federal agency which administers medicare, Medicaid, and the Children's Health Insurance Program, and are in use in other states;

(7) The ability of the State Board of Pharmacy to regulate the dispensing, pre-packaging, and repackaging of medications to residents in this state is of vital importance;

(8) There is a need for the State Board of Pharmacy to regulate remote automated medication systems for residents in this state while being flexible enough to adapt future technologies and the economic and efficiency benefits such technologies provide in the health care setting;

(9) Additional structure and guidance will improve pharmaceutical services for residents in health care facilities utilizing remote automated medication systems; and

(10) This Act will enable the use of such systems subject to the provisions of this Act and rules and regulations of the State Board of Pharmacy adopted pursuant to this Act.

SECTION 2.

Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled substances, is amended in Code Section 16-13-21, relating to definitions relative to regulation of controlled substances, by adding a new paragraph to read as follows:

"(26.1) 'Remote automated medication system' means an automated mechanical system that is located in an institution, as defined in paragraph (18.1) of Code Section 26-4-5, that does not have an on-site pharmacy and in which medication may be dispensed in a manner that may be specific to a patient."

SECTION 3.

Said chapter is further amended in Code Section 16-13-41, relating to prescriptions, by adding a new subsection to read as follows:

"(i)(1) Pharmacists may dispense prescriptions from a remote location for the benefit of an institution that uses a remote automated medication system in accordance with the requirements set forth in this subsection and rules and regulations adopted by the State Board of Pharmacy pursuant to paragraph (8) of this subsection. As used in this subsection, the term 'institution' means any licensed hospital, nursing home, personal care home, hospice, health clinic, or prison clinic.

(2)(A) 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 an institution that does not have a pharmacy present on site.

(B) If a pharmacist is not physically present where the remote automated medication system is located in an institution, 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, labeling, and accountability for all medications in the system.

(3) If an institution uses a remote automated medication system, a pharmacist shall review for accuracy, completeness, and appropriateness all medication orders after being entered in the system.

(4)(A) If an institution uses a remote automated medication system, the pharmacy license holder that manages the system and the institution where the system is located shall meet the following requirements:

(i) An institution 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; and

(ii) A remote automated medication system may allow simultaneous access to multiple drug strengths, dosage forms, or drug entities if contained within a patient-specific package.

(B) A remote automated medication system shall at a minimum:

(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 in this state, provide:

(I) A picture of the medication if available; or

(II) If a picture is not available, either a written report that describes the medication or a description of the medication on a label affixed to the patient-specific pouch containing the medication.

(C) The institution where the remote automated medication system is located shall have at a minimum:

(i) A pharmacist available for consultation by telephone or other appropriate communications technology 24 hours per day;

(ii) Technical assistance regarding operation of the system available by telephone or other appropriate communications technology 24 hours per day; and

(iii) A quality assurance program as described under paragraph (5) of this subsection.

(D) The pharmacy license holder that manages a remote automated medication system shall provide a comprehensive training program to all persons with access to the system.

(5)(A) A pharmacist that operates a remote automated medication system, in consultation with the institution where the system is located, shall develop and implement a quality assurance program in accordance with rules and regulations adopted by the State Board of Pharmacy.

(B) The quality assurance program developed pursuant to this paragraph shall include:

(i) Policies and procedures at both the pharmacy where the system receives an order and the institution 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 State Board of Pharmacy and set forth in rules and regulations.

(6)(A) 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.

(B) A record shall be kept of each transaction containing user identification information.

(7)(A) A pharmacist who operates a remote automated medication system shall maintain maintenance logs and repair records for the system.

(B) In a power outage or otherwise unforeseen situation, a pharmacist shall ensure that:

(i) A backup power source for the system is available by a connection with the institution's generator; and

(ii) Only a registered professional nurse or a licensed practical nurse has access to the medications contained within the system.

(8) No later than December 31, 2011, the State Board of Pharmacy shall establish rules and regulations to implement the requirements of this subsection. Such rules and regulations may be periodically revised and updated as appropriate."

SECTION 4.

Said chapter is further amended in Code Section 16-13-75, relating to drugs to be kept in the original container, as follows:

"16-13-75.

(a) Possession and control of controlled substances or dangerous drugs by anyone other than the individuals specified in Code Section 16-13-35 or 16-13-72 shall be legal only if such drugs are in the original container in which they were dispensed by the pharmacist or the practitioner of the healing arts and are labeled according to Code Section 26-3-8.

(b) The possession, filling, and use of canisters for remote automated medication systems pursuant to subsection (i) of Code Section 16-13-41 shall not be considered a violation of this Code section."

SECTION 5.

Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and pharmacies, is amended in Code Section 26-4-5, relating to definitions, by adding a new paragraph to read as follows:

"(37.1) 'Remote automated medication system' means an automated mechanical system that is located in an institution that does not have an on-site pharmacy and in which medication may be dispensed in a manner that may be specific to a patient."

SECTION 6.

Said chapter is further amended in Code Section 26-4-80, relating to dispensing prescription drugs, by adding a new subsection to read as follows:

"(p) Pharmacists dispensing prescriptions from a remote location for the benefit of an institution that uses a remote automated medication system in accordance with the requirements of subsection (i) of Code Section 16-13-41 and in rules and regulations adopted by the State Board of Pharmacy pursuant to such subsection shall be considered in compliance with this Code section."

SECTION 7.

Said chapter is further amended in Code Section 26-4-89, relating to the prohibition on selling drugs in vending machines, as follows:

"26-4-89.

(a) Any person who shall sell or dispense drugs by the use of vending machines shall be guilty of a misdemeanor.

(b) A remote automated medication system shall not be considered a vending machine for purposes of this Code section."

SECTION 8.

This Act shall become effective upon its approval by the Governor or upon its becoming law without such approval.

SECTION 9.

All laws and parts of laws in conflict with this Act are repealed.