Vaccine Protocol Agreements

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  1. As used in this Code section, the term:
    1. "Administer" means the provision of a unit dose of vaccine by a pharmacist or nurse pursuant to a vaccine order contained in a vaccine protocol agreement with a physician.
    2. "Adverse event" means an event that is a negative consequence of the administration of 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.
    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 engaged in the active practice of medicine.
    5. "Pharmacist" means an individual licensed under Chapter 4 of Title 26 to engage in the practice of pharmacy in the State of Georgia.
    6. "Pharmacy intern" means a pharmacy intern as defined in paragraph (19) of Code Section 26-4-5.
    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.
    8. "Vaccine" means a specially prepared antigen which upon administration to a person will result in immunity to influenza, pneumococcal disease, shingles, or meningitis. No live attenuated virus shall 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.
    9. "Vaccine order" means a prescription drug order, contained in a vaccine protocol agreement, for 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. A vaccine order shall also mean a prescription drug order, contained in 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 vaccine provided that the vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.
    10. "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 a vaccine and epinephrine, if determined appropriate by the physician, by means of a vaccine order for administration by a pharmacist or a nurse.
  2. A physician engaged in the active practice of medicine may prescribe a vaccine for a group of patients via a vaccine order contained in a vaccine protocol agreement to be administered by a pharmacist, provided the physician resides in Georgia and 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 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 Georgia State Board of Pharmacy; and the pharmacist completes a training program recognized by the Centers for Disease Control and Prevention in the basics of immunology which focuses on practice implementation and legal and regulatory issues, composed of: (1) at least 12 hours of self-study and an assessment exam; (2) at least eight hours of live seminar with a final exam; and (3) a hands-on assessment of intramuscular and subcutaneous injection technique. A physician who is a party to a vaccine protocol agreement may also prescribe epinephrine via a vaccine order contained in a vaccine protocol agreement for administration by a pharmacist upon the occurrence of an actual or perceived anaphylactic adverse reaction to the administered vaccine, provided that the vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.
  3. A physician engaged in the active practice of medicine may prescribe a vaccine for a group of patients via a vaccine order contained in 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 a vaccine protocol agreement may also prescribe epinephrine via a vaccine order contained in a vaccine protocol agreement for administration by a nurse upon the occurrence of an actual or perceived anaphylactic adverse reaction to the administered vaccine provided that the vaccine protocol agreement sets forth the signs and symptoms that warrant the administration of epinephrine.
  4. 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 vaccine protocol agreement;
    3. Require the pharmacist or nurse to take an appropriate case history and determine whether the patient has had a physical examination within the past year and shall not administer a vaccine to a patient with any condition for which such vaccine is contraindicated;
    4. Require the pharmacist or nurse to provide the vaccine recipient with the appropriate and current Vaccine Information Statement as provided by the Centers for Disease Control and Prevention;
    5. Require the pharmacist or nurse to provide written information to the vaccine recipient to be developed by the Department of Public Health on the importance of having and periodically seeing a primary care physician;
    6. Require the pharmacist or nurse to provide each new vaccine recipient with a personal immunization card on card stock paper containing the vaccine recipient's name, the pharmacist's or nurse's name and phone number, the name and dosage of the vaccine, the location of injection on the vaccine recipient, and the date of the administration of the vaccine in legible writing or printed type in a format made available by the Department of Public Health. The patient shall produce such card when he or she has subsequent vaccines and the pharmacist or nurse shall update such card, unless the patient does not have such card, in which case, a new card shall be provided. The written information required pursuant to paragraph (5) of this subsection may be included on the card provided pursuant to this paragraph;
    7. Require the pharmacist or nurse or his or her employer to retain documentation of each dose of vaccine administered. Such documentation shall include, but not be limited to:
      1. The administering pharmacist's or nurse's name, address, telephone number, and professional license number;
      2. The name, dose, manufacturer, and lot number of the vaccine;
      3. The vaccine recipient's name, address, date of birth, and telephone number;
      4. The date of administration and injection site;
      5. A signed and dated consent form by which the vaccine recipient acknowledges receipt of the Vaccine Information Statement, consents to the administration of the vaccine, and authorizes the pharmacy or nurse to notify the vaccine recipient's primary care provider of the vaccine administered to the vaccine recipient; and
      6. Any adverse events or complications that occur;
    8. Require the pharmacist or nurse to make documented reasonable efforts to obtain the name of the vaccine recipient's primary care provider and to notify such primary care provider of the vaccine administered by the pharmacist or nurse within 72 hours of administration;
    9. Require the pharmacist or nurse to administer the vaccine to a patient in a private room, area with a privacy screen, or other interior area in which the patient's privacy can be maintained. In no event shall a pharmacist or nurse administer a vaccine to a patient in a manner that is designed so that the patient can be served while remaining in his or her personal vehicle. This paragraph shall not apply to mass immunizations in the event of a public health emergency or for purposes of training in which vaccinations are administered to large groups of people at one or more locations in a short interval of time;
    10. Require the pharmacist or nurse to enter the patient's 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. The Georgia Drugs and Narcotics Agency shall have the authority to impose sanctions in accordance with subsection (r) of this Code section on any person subject to the requirements of this paragraph who does not submit the information required by this paragraph and to notify the delegating physician and the applicable licensing board for such person of violations of this paragraph;
    11. Require, as a condition of administration of the vaccine, the 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 vaccine;
    12. Contain procedures to follow up on the occurrence of an adverse event or complication including, if prescribed via a vaccine order contained in a vaccine protocol agreement, the administration of epinephrine;
    13. Provide for prioritization of vaccine recipients in the event the supply of a vaccine is limited;
    14. Require the pharmacist or nurse to maintain individual liability insurance coverage or be individually covered by his or her employer's liability insurance coverage in an amount not less than $250,000.00 to cover claims arising from administration of vaccines by the pharmacist or nurse pursuant to a vaccine protocol agreement and to provide proof of such coverage to the physician for submission to the board with the vaccine protocol agreement. The pharmacist or nurse shall also retain a copy of the proof of insurance coverage, including the name of the insurer and policy number, onsite at his or her primary location for inspection by the Georgia Drugs and Narcotics Agency, upon request;
    15. Require the pharmacist or nurse to post proof of the vaccine protocol agreement, including a list of the vaccines authorized by such protocol, in a conspicuous location within the pharmacy, local health department, or other setting in which the vaccine is being administered;
    16. Require the pharmacist or nurse to submit a signed and notarized affidavit to the physician attesting to the following:
      1. Compliance with paragraph (14) of this subsection regarding maintenance of liability insurance;
      2. Verification that the pharmacist or nurse holds current certification in Basic Cardiac Life Support as required by subsections (b) and (c) of this Code section and, for pharmacists, verification of completion of immunology training as required by subsection (b) of this Code section;
      3. The pharmacist or nurse has a copy of the vaccine protocol agreement and agrees to comply with its requirements; and
      4. Identification of the pharmacist's or nurse's location or locations in which he or she will be administering vaccinations pursuant to the vaccine protocol agreement.

        The pharmacist or nurse shall keep a copy of the affidavit onsite at his or her primary location for inspection by the Georgia Drugs and Narcotics Agency, upon request. The Georgia Drugs and Narcotics Agency shall have the authority to impose sanctions in accordance with subsection (r) of this Code section on any person subject to the requirements of this paragraph who does not submit the information required by this paragraph and to notify the delegating physician and the applicable licensing board for such person of violations of this paragraph; and

    17. Be renewed and, if necessary, revised or updated biennially by the physician and the pharmacist or nurse. A vaccine protocol agreement that is not renewed biennially shall expire.
  5. A pharmacist who is a party to a vaccine protocol agreement pursuant to this Code section shall not delegate the administration of 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.
  6. A nurse who is a party to a vaccine protocol agreement pursuant to this Code section shall not delegate the administration of 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 (4) of subsection (a) of this Code section, a registered professional nurse who is a party to a vaccine protocol agreement pursuant to this Code section may delegate the administration of a vaccine to a licensed practical nurse under the direct on-site supervision of the registered professional nurse.
  7. Notwithstanding any law to the contrary, a nurse acting pursuant to a vaccine protocol agreement as provided in this Code section may possess and transport such vaccine and epinephrine.
  8. A pharmacist or nurse administering vaccines pursuant to 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.
  9. Nothing in this Code section shall be construed to authorize a physician to prescribe any other vaccines or other drugs pursuant to a vaccine protocol agreement or vaccine order contained in a vaccine protocol agreement other than those vaccines and epinephrine specifically authorized in such vaccine protocol agreement or vaccine order.
  10. A delegating physician may not enter into 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 limitation provided in subsection (c) of this Code section, a delegating physician may enter into a vaccine protocol agreement with more than ten pharmacists or nurses, or any combination thereof, at any one time so long as the nurses are in the same public health district as established pursuant to Code Section 31-3-15 and the pharmacists and nurses are employees or agents of the same corporate entity.
  11. It shall be unlawful for a physician who is employed by a pharmacist or nurse to enter into 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 a vaccine protocol agreement or otherwise delegate medical acts to a pharmacist or nurse who is also employed by such pharmacy.
  12. The board shall have the authority to promulgate rules and regulations governing a physician who is a party to 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 vaccine protocol agreement, along with the affidavit by the pharmacist or nurse submitted pursuant to paragraph (16) of subsection (d) of this Code section and the proof of insurance required pursuant to paragraph (14) of subsection (d) of this Code section, 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 a vaccine protocol agreement and make such template available on the board's website.
  13. Nothing in this Code section shall be construed to require a physician to enter into 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 a vaccine protocol agreement as a condition for participation in or reimbursement from such entity.
  14. 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 a vaccine protocol agreement with a pharmacist or nurse;
    2. Issuing a vaccine order contained in a vaccine protocol agreement with a pharmacist or nurse; or
    3. The acts or omissions of a pharmacist or nurse pursuant to a vaccine protocol agreement including the administration of a vaccine or epinephrine.

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

    1. This Code section shall not apply to any activities conducted within a hospital, physician's office, nursing home, or other health care facility designated by the department or conducted within any other facility or entity owned, operated, or leased by a hospital.
    2. Except as otherwise provided in paragraph (1) of this subsection, any activities conducted by a hospital or health system for the administration of the influenza vaccine shall not be subject to paragraphs (5) through (9), (15), or (16) of subsection (d) of this Code section as long as the following conditions are met:
      1. A signed and dated consent form by which the vaccine recipient consents to the administration of the vaccine is obtained;
      2. If the vaccine recipient is a patient within the hospital or health system, the administration of the influenza vaccine shall be noted in such patient's health record maintained by the hospital or health system, including, but not limited to, the administering pharmacist's or nurse's name, address, telephone number, and professional license number; the name, dose, manufacturer, and lot number of the vaccine; and the date of administration and injection site;
      3. If the vaccine recipient is not a patient within the hospital or health system, a personal immunization card on card stock paper containing the vaccine recipient's name, the pharmacist's or nurse's name and phone number, the name and dosage of the vaccine, the injection site on the vaccine recipient, the date of the administration of the vaccine in legible writing or printed type in a format made available by the Department of Public Health, and written information developed by the Department of Public Health on the importance of having and periodically seeing a primary care physician shall be provided to the vaccine recipient; and
      4. If requested by the patient, the influenza vaccine shall be administered in an area or location with portable screening, at a minimum.

        As used in this paragraph, the term "health system" means (i) a parent corporation of one or more hospitals and any entity affiliated with such parent corporation through ownership, governance, membership, or other means; or (ii) a hospital and any entity affiliated with such hospital through ownership, governance, membership, or other means.

  16. This Code section shall not be interpreted as limiting the authority of any authorized person to dispense or administer vaccines or other medications.
  17. No vaccine protocol agreement entered into pursuant to this Code section shall permit a pharmacist or nurse to administer any of the following:
    1. An influenza vaccine to any child under the age of 13 without an individual prescription from a physician;
    2. A pneumococcal disease vaccine to any child under the age of 18 without an individual prescription from a physician;
    3. Any vaccines containing a live attenuated virus to a child under the age of 13; or
    4. A meningitis vaccine to any child under the age of 18.

      Consent of the child's parent or legal guardian shall be a condition precedent to the administration of a vaccine to a child under the age of 18.

    1. A pharmacist or nurse who knowingly does not comply with paragraph (14) of subsection (d) of this Code section may be assessed a fine of up to $2,500.00 by the board.
    2. A pharmacist or nurse who knowingly administers a vaccine without a vaccine protocol agreement as required by this Code section may be assessed a fine of up to $2,500.00 and may be prohibited from administering vaccines pursuant to this Code section for up to one year as determined by the board.
    3. A pharmacist or nurse who knowingly does not comply with paragraph (6) of subsection (d) of this Code section may be subject to the following sanctions by the board:
      1. Upon the first violation, the issuance of a warning:
      2. Upon the second violation, a fine of up $500.00; and
      3. Upon a third or subsequent violation, prohibited from administering vaccines pursuant to this Code section for up to one year.
    4. A pharmacist or nurse who knowingly does not comply with paragraph (15) of subsection (d) of this Code section may be subject to the following sanctions by the board:
      1. Upon the first or second violation, the issuance of a warning:
      2. Upon a third or subsequent violation, prohibited from administering vaccines pursuant to this Code section for up to six months.
    5. A pharmacist or nurse who knowingly does not comply with paragraph (10) or (16) of subsection (d) of this Code section may be subject to the following sanctions by the Georgia Drugs and Narcotics Agency:
      1. Upon the first violation, the issuance of a warning;
      2. Upon the second violation, a fine of up to $5,000.00; and
      3. Upon a third or subsequent violation, prohibited from administering vaccines pursuant to this Code section.
    6. The sanctions contained in this subsection shall be supplemental to any other sanctions or penalties to which a pharmacist or nurse may otherwise be subject.

(Code 1981, §43-34-26.1, enacted by Ga. L. 2009, p. 184, § 1/HB 217; Ga. L. 2010, p. 530, § 1/HB 1154; Ga. L. 2010, p. 878, § 43/HB 1387; Ga. L. 2011, p. 705, § 6-3/HB 214; Ga. L. 2011, p. 752, § 43/HB 142; Ga. L. 2015, p. 297, § 2/HB 504; Ga. L. 2016, p. 84, § 1/HB 1043; Ga. L. 2019, p. 515, § 3/SB 115.)

The 2015 amendment, effective July 1, 2015, rewrote this Code section.

The 2016 amendment, effective July 1, 2016, substituted "an appropriate" for "a complete" near the beginning of paragraph (d)(3); designated the existing provisions of subsection (o) as paragraph (o)(1); and added paragraph (o)(2).

The 2019 amendment, effective July 1, 2019, in subsection (b), in the first sentence, inserted "resides in Georgia and" preceding "is registered" and deleted "the pharmacist is located within the county of the physician's place of registration with the vaccination registry or a county contiguous thereto;" preceding "the pharmacist holds current"; and, in subsection (j), substituted "limitation provided in subsection (c)" for "limitations provided in subsections (b) and", deleted "pharmacists or" following "so long as the", and inserted "the pharmacists and nurses" near the end.

Cross references.

- Influenza vaccinations for discharged patients aged 65 and older, § 31-7-18.

Editor's notes.

- Ga. L. 2009, p. 859, § 1/HB 509, effective July 1, 2009, redesignated former Code Section 43-34-26.1 as present Code Section 43-34-23.

Law reviews.

- For article on the 2011 amendment of this Code section, see 28 Georgia St. U.L. Rev. 147 (2011). For article, "Liability for Vaccine Injury: The United States, the European Union, and the Developing World," see 67 Emory L.J. 415 (2018).


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