You are here

Patient Safety Advisory: Georgia House Bill 504---Adult Vaccinations

July 9, 2015

practice

  • Evaluate
  • Mitigate
  • Manage
  • Restore
  • Improve

Georgia recently passed legislation which will make it easier for many adult patients to receive certain vaccinations.  HB 504, which becomes effective on July 1, 2015, allows pharmacists and nurses to administer vaccines for influenza, pneumococcal disease, shingles and meningitis if they have a vaccine protocol agreement with a physician.  The bill is not applicable to physician’s office or hospitals and does not limit the authority of any person authorized to administer vaccines.  A summary of some of the new requirements follows.

Physicians should note:

  • Like the prior influenza statute, a physician who is registered with the GRITS vaccine registry may prescribe a vaccine order contained in a vaccine protocol agreement to be administered by a pharmacist or nurse.  (Note – current influenza vaccine protocol agreements will need to be updated.)
  • The pharmacist or nurse must be located within the county of the physician’s place of registration with the vaccine registry or a contiguous county.
  • The delegating physician may not enter into a vaccine protocol agreement with more than 10 pharmacists or nurses or combination thereof at any one time. However, a physician may enter into an agreement with more than 10 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 and are employees or agents of the same corporate entity. 
  • Provides immunity from criminal and civil liability and discipline for unprofessional conduct for (1) entering into a vaccine protocol agreement; (2) issuing a vaccine order in a vaccine protocol agreement; and, (3) the acts or omissions of a pharmacist or nurse pursuant to a vaccine protocol agreement including the administration of the vaccine or epinephrine.
  • Physicians who are employed by a pharmacist or nurse may not enter into vaccine protocol agreements or delegate medical acts to that pharmacist or nurse.  If employed by a pharmacy, the physician may not enter into vaccine protocol agreements or delegate medical acts to pharmacists or nurses who are also employed by the pharmacy.
  • The protocol agreement, affidavit and proof of insurance must be filed by the physician with the Board.

The vaccine protocol agreement itself has numerous requirements under the new statute.  Vaccine protocols agreement must:

  • Be a written agreement signed by the physician and the pharmacist or nurse.  The vaccine order should also have a vaccine order for epinephrine for any potential anaphylactic reaction to the vaccine.
  • Contain a provision for immediate consultation between the pharmacist or nurse and the physician.
  • Require the pharmacist or nurse to take a complete case history and determine whether the patient has had a physical examination within the past year and not allow the administration of the vaccine if contraindicated.
  • Must provide the vaccine recipient with the current CDC Vaccine Information Statement and provide written information to be developed by the DPH on the importance of having and periodically seeing a primary care physician.
  • Require the pharmacist or nurse to provide each new vaccine recipient with a personal immunization card containing the vaccine recipient’s name, the pharmacist’s or nurse’s name and phone number, and the date of administration of the vaccine in a format to be made available by the DPH.
  • Require the pharmacist or nurse to retain documentation of each vaccine administered, including the administering pharmacist’s or nurse’s name; the name, dose, manufacturer, and lot number of the vaccine; recipient’s name, address, DOB and phone number; date of administration and injection site; any adverse events or complications; and, a signed and dated consent form which acknowledges receipt of the Vaccine Information Statement and authorizes the pharmacist or nurse to contact the recipient’s primary care provider regarding the vaccine administered.
  • Require the pharmacist or nurse to make documented reasonable efforts to obtain the name of the recipient’s primary care provider and to notify the primary care provider within 72 hours of administration.
  • 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 so that the patient’s privacy may be maintained.
  • Require the nurse or pharmacist to enter the vaccine information into GRITS within the registry’s designated time frame. 
  • Require the vaccine recipient to remain under the observation of the administering pharmacist or nurse for a period of not less than 15 minutes after administration.
  • Must contain procedures to follow up on the occurrence of an adverse event or complication (including epinephrine).
  • Must provide for prioritization of vaccine recipients in the even the supply of a vaccine is limited.
  • 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 to cover claims arising from the administration of vaccines pursuant to the vaccine protocol agreement and to provide proof of coverage to the physician for submission to the Board.
  • Require the pharmacist or nurse to post proof of insurance and proof of the vaccine protocol agreement in a conspicuous place within the pharmacy, local health department, or other setting in which the vaccine is being administered.
  • Require the pharmacist or nurse to submit a signed and notarized affidavit to the physician attesting that he or she is (1) compliant with the insurance requirement; (2) is currently certified in Basic Cardiac Life Support and for pharmacists verification of completion of immunology training; (3) he or she has a copy of the vaccine protocol agreement and agrees to comply with its requirements; and (4) identification of the location or locations in which he or she will be administering vaccines.  The affidavit must be kept onsite at his or her primary location for inspection by the Georgia Drugs and Narcotics Agency.
  • Vaccine protocol agreements may not permit the pharmacist or nurse to administer the following:
    • An influenza vaccine to any child under 13 without an individual prescription from a physician;
    • A pneumococcal vaccine to any child under 18 without an individual prescription from a physician;
    • Any vaccines containing a live or attenuated virus to a child under the age of 13; or,
    • A meningitis vaccine to any child under 18.

A complete copy of HB 504 may be found at:

http://www.legis.ga.gov/Legislation/20152016/153813.pdf

In addition, sample protocol agreements and affidavits may be found here:  http://medicalboard.georgia.gov/press-releases/2015-06-26/georgia-composite-medical-board-releases-new-vaccine-protocol-documents

If you have any questions regarding HB 504, please call the MagMutual Patient Safety Institute. at 800-282-4882.

 

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.

Footnotes