Bill Text: GA SB346 | 2011-2012 | Regular Session | Introduced

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Bill Title: State Board of Pharmacy; prescription drugs by mail/other common carriers; provisions

Spectrum: Slight Partisan Bill (Republican 2-1)

Status: (Passed) 2012-07-01 - Effective Date [SB346 Detail]

Download: Georgia-2011-SB346-Introduced.html

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12 SB346/AP

Senate Bill 346

By: Senators Balfour of the 9th, Carter of the 1st and Henson of the 41st

AS PASSED

A BILL TO BE ENTITLED
AN ACT

To amend Code Section 26-4-60 of the Official Code of Georgia Annotated, relating to grounds for suspension, revocation, or refusal to grant licenses by the State Board of Pharmacy, so as to change certain provisions relating to selling, distributing, and delivering prescription drugs by mail or other common carriers; to amend Code Sections 26-4-5 and 26-4-80 of the Official Code of Georgia Annotated, relating to definitions and dispensing of prescription drugs, respectively, so as to authorize the use of remote order entry for hospital pharmacies; to provide for submission of policies; to provide for related matters; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

SECTION 1.

Code Section 26-4-60 of the Official Code of Georgia Annotated, relating to grounds for suspension, revocation, or refusal to grant licenses by the State Board of Pharmacy, is amended by revising paragraph (11) of subsection (a) as follows:

"(11) Regularly employing the mails or other common carriers to sell, distribute, and deliver a drug which requires a prescription directly to a patient; provided, however, that this provision shall not prohibit the use of the mails or other common carriers to sell, distribute, and deliver a prescription drug directly to:

(A) A patient or directly to a patient's guardian or caregiver or a physician or physician acting as the patient's agent for whom the prescription drug was prescribed if:

(i) Such prescription drugs are prescribed for complex chronic, terminal, or rare conditions;

(ii) Such prescription drugs require special administration, comprehensive patient training, or the provision of supplies and medical devices or have unique patient compliance and safety monitoring requirements;

(iii) Due to the prescription drug's high monetary cost, short shelf life, special manufacturer specified packaging and shipping requirements or instructions which require temperature sensitive storage and handling, limited availability or distribution, or other factors, the drugs are not carried in the regular inventories of retail pharmacies such that the drugs could be immediately dispensed to multiple retail walk-in patients;

(iv) Such prescription drug has an annual retail value to the patient of more than $10,000.00;

(v) The patient receiving the prescription drug consents to the delivery of the prescription drug via expedited overnight common carrier and designates the specialty pharmacy to receive the prescription drug on his or her behalf;

(vi) The specialty pharmacy utilizes, as appropriate and in accordance with standards of the manufacturer, United States Pharmacopeia, and Federal Drug Administration and other standards adopted by the State Board of Pharmacy, temperature tags, time temperature strips, insulated packaging, or a combination of these; and

(vii) The specialty pharmacy establishes and notifies the enrollee of its policies and procedures to address instances in which medications do not arrive in a timely manner or in which they have been compromised during shipment and to assure that the pharmacy replaces or makes provisions to replace such drugs; or

(B) An institution or to sell, distribute, or deliver prescription drug refills drugs, upon his or her request, to an enrollee in a health benefits plan of a group model health maintenance organization or its affiliates by a pharmacy which is operated by that same group model health maintenance organization and licensed under Code Section 26-4-110 or to a patient on behalf of a pharmacy. Any pharmacy using the mails or other common carriers to dispense prescriptions pursuant to this paragraph shall comply with the following conditions:

(i) The pharmacy shall provide an electronic, telephonic, or written communications mechanism which reasonably determines whether the medications distributed by the mails or other common carriers have been received by the enrollee and through which a pharmacist employed by the group model health maintenance organization or a pharmacy intern under his or her direct supervision is enabled to offer counseling to the enrollee as authorized by and in accordance with his or her obligations under Code Section 26-4-85, unless the enrollee refuses such consultation or counseling pursuant to subsection (e) of such Code section. In addition, the enrollee shall receive information indicating what he or she should do if the integrity of the packaging or medication has been compromised during shipment;

(ii) In accordance with clinical and professional standards, the State Board of Pharmacy shall promulgate a list of medications which may not be delivered by the mails or other common carriers. However, until such list is promulgated, the group model health maintenance organization shall not deliver by use of the mails or other common carriers Class II controlled substance medications, medications which require refrigeration, chemotherapy medications deemed by the federal Environmental Protection Agency as dangerous, medications in suppository form, and other medications which, in the professional opinion of the dispensing pharmacist, may be clinically compromised by distribution through the mail or other common carriers;

(iii) The pharmacy shall utilize, as appropriate and in accordance with standards of the manufacturer, United States Pharmacopeia, and Federal Drug Administration and other standards adopted by the State Board of Pharmacy, temperature tags, time temperature strips, insulated packaging, or a combination of these; and

(iv) The pharmacy shall establish and notify the enrollee of its policies and procedures to address instances in which medications do not arrive in a timely manner or in which they have been compromised during shipment and to assure that the pharmacy replaces or makes provisions to replace such drugs.

For purposes of subparagraph (B) of this paragraph, the term 'group model health maintenance organization' means a health maintenance organization that has an exclusive contract with a medical group practice to provide or arrange for the provision of substantially all physician services to enrollees in health benefits plans of the health maintenance organization; or

(C) A pharmacist or pharmacy to dispense a prescription and deliver it to another pharmacist or pharmacy to make available for a patient to receive the prescription and patient counseling according to Code Section 26-4-85. The State Board of Pharmacy shall adopt any rules and regulations necessary to implement this subparagraph."

SECTION 1A.
Code Section 26-4-5 of the Official Code of Georgia Annotated, relating to definitions relative to pharmacists and pharmacies, by adding a new paragraph to read as follows:

"(37.2) 'Remote order entry' means the entry made by a pharmacist located within the State of Georgia from a remote location indicating that the pharmacist has reviewed the patient specific drug order for a hospital patient, has approved or disapproved the administration of the drug for such patient, and has entered the information in the hospital's patient record system."

SECTION 1B.

Code Section 26-4-80 of the Official Code of Georgia Annotated, relating to dispensing of prescription drugs, is amended by revising paragraph (7) of subsection (c) as follows:

"(7)(A) The board shall promulgate rules and regulations which may provide specific exceptions under this Code section for institutional settings such as hospital pharmacies, nursing home pharmacies, clinic pharmacies, or pharmacies owned or operated directly by health maintenance organizations.

(B) The rules established pursuant to subparagraph (A) of this paragraph shall specifically authorize hospital pharmacies to use remote order entry when:

(i) The licensed pharmacist is not physically present in the hospital, the hospital pharmacy is closed, and a licensed pharmacist will be physically present in the hospital pharmacy within 16 hours; or

(ii) When at least one licensed pharmacist is physically present in the hospital pharmacy and at least one other licensed pharmacist is practicing pharmacy in the hospital but not physically present in the hospital pharmacy.

(C) Before a hospital may engage in remote order entry as provided in this paragraph, the director of pharmacy of the hospital shall submit to the board written policies and procedures for the use of remote order entry. The required policies and procedures to be submitted to the board shall be in accordance with the American Society of Health-System Pharmacists and shall contain provisions addressing quality assurance and safety, mechanisms to clarify medication orders, processes for reporting medication errors, documentation and record keeping, secure electronic access to the hospital pharmacy's patient information system and to other electronic systems that the on-site pharmacist has access to, access to hospital policies and procedures, confidentiality and security, and mechanisms for real-time communication with prescribers, nurses, and other care givers responsible for the patient's health care.

(D) If the board concludes that the hospital's actual use of remote order entry does not comply with this paragraph or the rules adopted pursuant to this chapter, it may issue a cease and desist order after notice and hearing."

SECTION 2.

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