Georgia-2011-HB1149-Introduced

To amend Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to physicians, so as to authorize the administration of vaccines by pharmacists or nurses pursuant to vaccine protocol agreements with physicians; to provide for definitions; to provide requirements for the content of vaccine protocol agreements; to provide that a party to a vaccine protocol agreement shall not delegate his or her authority; to limit the number of vaccine protocol agreements into which a physician may enter at any one time; to prohibit certain entities from entering into vaccine protocol agreements; to provide for rules and regulations; to provide for limited liability; to provide for applicability; to provide for statutory construction; to provide for related matters; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to physicians, is amended by revising Code Section 43-34-26.1, relating to influenza vaccine protocol agreements, as follows:

(a) As used in this Code section, the term:

(1) 'Administer' means the provision of a unit dose of influenza vaccine by a pharmacist or nurse pursuant to an influenza a vaccine order contained in an influenza a vaccine protocol agreement with a physician.

(2) 'Adverse event' means an event that is a negative consequence of the administration of influenza a vaccine by a pharmacist or nurse that results in an unintended reaction, injury, or illness, which may or may not have been preventable.

(3) 'Board' means the Georgia Composite Medical Board.

(7)(4) 'Nurse' means a registered professional nurse as defined in paragraph (9) of Code Section 43-26-3. The term shall also mean a licensed practical nurse as defined in paragraph (5) of Code Section 43-26-32 who is regularly employed by a physician who actively engaged in the private active practice of medicine.

(8)(5) 'Pharmacist' means an individual licensed under Chapter 4 of Title 26 to engage in the practice of pharmacy in the State of Georgia.

(9)(6) 'Pharmacy intern' means a pharmacy intern as defined in paragraph (19) of Code Section 26-4-5.

(10)(7) 'Physician' means an individual licensed to practice medicine and surgery pursuant to this article and whose principal place of practice is located in this state.

(4)(8) 'Influenza vaccine Vaccine' means an inactivated virus administered by injection or a live attenuated virus administered by nasal spray that is prepared for the applicable season and that is administered to produce or increase immunity to the influenza virus; provided, however, that a live attenuated virus shall not be administered pursuant to this Code section to any individual younger than 13 or older than 49 years of age; and provided, further, that a live attenuated virus shall not be administered pursuant to this Code section unless the patient or his or her parent, if a minor, has signed an informed consent that he or she does not have a contraindication to this vaccine. The informed consent form shall list the contraindications to the vaccine.

(5)(9) 'Influenza vaccine Vaccine order' means a prescription drug order, contained in an influenza a vaccine protocol agreement, for influenza a vaccine issued by a physician for a group of patients who meet certain criteria and to be administered by a pharmacist or a nurse. An influenza A vaccine order shall also mean a prescription drug order, contained in an influenza a vaccine protocol agreement, for epinephrine issued by a physician for a group of patients who meet certain criteria and to be administered by a pharmacist or a nurse only upon the occurrence of an actual or perceived anaphylactic adverse reaction to the administered influenza vaccine provided that the influenza vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.

(6)(10) 'Influenza vaccine Vaccine protocol agreement' means a written document mutually agreed upon and signed by a physician and a pharmacist or by a physician and a nurse, by which document the physician prescribes influenza a vaccine and epinephrine, if determined appropriate by the physician, by means of an influenza a vaccine order for administration by a pharmacist or a nurse.

(b) A physician engaged in the active practice of medicine may prescribe influenza a vaccine for a group of patients via an influenza a vaccine order contained in an influenza a vaccine protocol agreement to be administered by a pharmacist, provided the physician is registered with the vaccination registry established by the Department of Public Health pursuant to Code Section 31-12-3.1, commonly known as the Georgia Registry of Immunization Transactions and Services, the pharmacist is located within the county of the physician's place of registration with the vaccination registry or a county contiguous thereto, and the pharmacist holds current certification in Basic Cardiac Life Support and has completed a course of training accredited by the Accreditation Council for Pharmacy Education or similar health authority or professional body approved by the State Board of Pharmacy. A physician who is a party to an influenza a vaccine protocol agreement may also prescribe epinephrine via an influenza a vaccine order contained in an influenza a vaccine protocol agreement for administration by a pharmacist upon the occurrence of an actual or perceived anaphylactic adverse reaction to the administered influenza vaccine provided that the influenza vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.

(c) A physician engaged in the active practice of medicine may prescribe influenza a vaccine for a group of patients via an influenza a vaccine order contained in an influenza a vaccine protocol agreement to be administered by a nurse, provided the physician is registered with the vaccination registry established by the Department of Public Health pursuant to Code Section 31-12-3.1, commonly known as the Georgia Registry of Immunization Transactions and Services, the nurse is located within the county of the physician's place of registration with the vaccination registry or a county contiguous thereto, and the nurse holds current certification in Basic Cardiac Life Support. A physician who is a party to an influenza a vaccine protocol agreement may also prescribe epinephrine via an influenza a vaccine order contained in an influenza a vaccine protocol agreement for administration by a nurse upon the occurrence of an actual or perceived anaphylactic adverse reaction to the administered influenza vaccine provided that the influenza vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.

(d) An influenza A vaccine protocol agreement between a physician and a pharmacist or a physician and a nurse pursuant to this Code section shall, without limitation:

(1) Contain the current names, addresses, telephone numbers, and professional license numbers of the physician and the pharmacist or nurse;

(2) Contain a provision for immediate consultation between the pharmacist or nurse and the physician. If the physician is not available, the physician for purposes of consultation may designate another physician who concurs with the terms of the influenza vaccine protocol agreement;

(3) Require the pharmacist or nurse to provide the influenza vaccine recipient with the appropriate and current Vaccine Information Statement (VIS) as provided by the federal Centers for Disease Control and Prevention;

(4) Require the pharmacist or nurse or his or her employer to retain documentation of each dose of influenza vaccine administered. Such documentation shall include, but not be limited to:

(A) The administering pharmacist's or nurse's name, address, telephone number, and professional license number;

(B) The name, dose, manufacturer, and lot number of the influenza vaccine;

(D) The date of administration and injection site;

(E) A signed and dated consent form by which the vaccine recipient acknowledges receipt of the VIS and consents to the administration of the influenza vaccine; and

(F) Any adverse events or complications that occur;

(5) Require the pharmacist or nurse to enter the patient's influenza vaccine information in the Georgia Registry of Immunization Transactions and Services within the registry's designated time frame, or as designated by the Department of Public Health;

(6) Require, as a condition of administration of the influenza vaccine, the influenza vaccine recipient to remain under the observation of the administering pharmacist or nurse for a period of not less than 15 minutes immediately subsequent to the administration of the influenza vaccine;

(7) Contain procedures to follow up on the occurrence of an adverse event or complication including, if prescribed via an influenza a vaccine order contained in an influenza a vaccine protocol agreement, the administration of epinephrine;

(8) Provide for prioritization of influenza vaccine recipients in the event the supply of influenza a vaccine is limited; and

(9) Be renewed and, if necessary, revised or updated biennially by the physician and the pharmacist or nurse. An influenza A vaccine protocol agreement that is not renewed biennially shall expire.

(e) A pharmacist who is a party to an influenza a vaccine protocol agreement pursuant to this Code section shall not delegate the administration of influenza a vaccine to any individual other than a pharmacy intern under the direct supervision of the pharmacist whether or not any such other individual is under the supervision, direct or otherwise, of the pharmacist.

(f) A nurse who is a party to an influenza a vaccine protocol agreement pursuant to this Code section shall not delegate the administration of influenza a vaccine to any individual, whether or not any such individual is under the supervision, direct or otherwise, of the nurse; provided, however, that notwithstanding the requirement of employment by a physician in paragraph (7)(4) of subsection (a) of this Code section, a registered professional nurse who is a party to an influenza a vaccine protocol agreement pursuant to this Code section may delegate the administration of influenza a vaccine to a licensed practical nurse under the direct on-site supervision of the registered professional nurse.

(g) Notwithstanding any law to the contrary, a nurse acting pursuant to an influenza a vaccine protocol agreement as provided in this Code section may possess and transport influenza such vaccine and epinephrine.

(h) A pharmacist or nurse administering influenza vaccines pursuant to an influenza a vaccine protocol agreement authorized by this Code section shall maintain policies and procedures for the handling and disposal of used or contaminated equipment and supplies.

(i) Nothing in this Code section shall be construed to authorize a physician to prescribe any other vaccines or other drugs pursuant to an influenza a vaccine protocol agreement or influenza vaccine order contained in an influenza a vaccine protocol agreement other than influenza those vaccines and epinephrine specifically authorized in such vaccine protocol agreement or vaccine order.

(j) A delegating physician may not enter into an influenza a vaccine protocol agreement with more than ten pharmacists or nurses, or any combination thereof, at any one time; provided, however, and notwithstanding the geographic limitations provided in subsections (b) and (c) of this Code section, a delegating physician may enter into an influenza a vaccine protocol agreement with more than ten pharmacists or nurses, or any combination thereof, at any one time so long as the pharmacists or nurses are in the same public health district as established pursuant to Code Section 31-3-15 and are employees or agents of the same corporate entity.

(k) It shall be unlawful for a physician who is employed by a pharmacist or nurse to enter into an influenza a vaccine protocol agreement or otherwise delegate medical acts to such pharmacist or nurse. It shall be unlawful for a physician who is employed by a pharmacy to enter into an influenza a vaccine protocol agreement or otherwise delegate medical acts to a pharmacist or nurse who is also employed by such pharmacy.

(l) The board shall have the authority to promulgate rules and regulations governing a physician who is a party to an influenza a vaccine protocol agreement in order to carry out the intent and purposes of this Code section. Further, the board shall:

(1) Require that the influenza vaccine protocol agreement be filed by the physician with the board and be made available by the board for public inspection; and

(2) Promulgate by rule an approved standard protocol template that may be utilized as an influenza a vaccine protocol agreement and make such template available on the board's website.

(m) Nothing in this Code section shall be construed to require a physician to enter into an influenza a vaccine protocol agreement. A public or private managed care system, health plan, hospital, insurance company, or similar entity shall not require a physician, pharmacist, or nurse to enter into an influenza a vaccine protocol agreement as a condition for participation in or reimbursement from such entity.

(n) No physician who complies with the provisions of this Code section shall be subject to criminal or civil liability or discipline for unprofessional conduct for:

(1) Entering into an influenza a vaccine protocol agreement with a pharmacist or nurse;

(2) Issuing an influenza a vaccine order contained in an influenza a vaccine protocol agreement with a pharmacist or nurse; or

(3) The acts or omissions of a pharmacist or nurse pursuant to an influenza a vaccine protocol agreement including the administration of influenza a vaccine or epinephrine.

Nothing in this subsection shall be interpreted as altering liability of an employer for acts of his or her employees.

(o) This Code section shall not apply to any activities conducted within a hospital or within any other facility or entity owned, operated, or leased by a hospital.

(p) This Code section shall not be interpreted as limiting the authority of any authorized person to dispense or administer influenza vaccine vaccines or other medications.

(q) No influenza vaccine protocol agreement entered into pursuant to this Code section shall permit a pharmacist or nurse to administer an influenza a vaccine to any child under the age of 13 without an individual prescription from a physician, and consent of the child's parent or legal guardian shall be a condition precedent to the administration of an influenza a vaccine to a child under the age of 18."