U.S. Dept. of Health and Human Services (HHS) authorizes pharmacists to administer all ACIP recommended vaccines to children between the ages of 3 and 18 during the COVID emergency.
Today, August 18, HHS amended its declaration under the Public Readiness and Emergency Preparedness Act to authorize:
“State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their state board of pharmacy and acting under the supervision of a state-licensed pharmacist) to administer, any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule (ACIP-recommended vaccines).”
You can read the amendment here: https://www.hhs.gov/sites/default/files/third-amendment-declaration.pdf
This is exciting news as the federal government is recognizing the value of pharmacists and acting on it and GPhA applauds Secretary Azar for this action and is continuing to advocate for emergency action on the state level, particularly with regard to ACIP recommended vaccines as well as forthcoming COVID vaccines for children and adults. Below are the highlights of today’s amended declaration.
Preemption
- Preemption of state law for children between 3 and 18: Georgia law, which does not currently allow pharmacists to order and administer vaccines to children 3 through 12 without a prescription and 13 through 18 only in limited circumstances, is preempted under this declaration as to children between 3 and 18. As such there are no vaccine protocol requirements for children between 3 and 18 and pharmacists are authorized to administer any vaccine that ACIP recommends.
- Vaccine protocol requirements required for 18 and above remain in effect: The declaration does not preempt Georgia law with regard to administering a vaccine without a prescription to those older than 18. Remember, under Georgia law, pharmacists can administer vaccines without a specific prescription for influenza, pneumococcal disease, shingles, or meningitis pursuant to a vaccine protocol agreement and other requirements set forth in O.C.G.A. 43-34-26.1.
Requirements
The authorization applies to Georgia licensed pharmacists and their interns acting under their supervision (intern must be licensed or registered by the Georgia Board of Pharmacy) pursuant to the following requirements:
- The vaccine must be FDA-authorized or FDA-licensed.
- The vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
- The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
- The licensed or registered pharmacy intern must complete a practical training program that is approved by the ACPE. This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
- The licensed pharmacist and licensed or registered pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
- The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
- The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.
- The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
Note 1: Some of the above requirements are consistent with those under Georgia law and some are more stringent. By way of example in Georgia pharmacists have to report to GRITS but don’t have to check prior to administering. The above is more stringent, providing pharmacists must “review vaccine registry or other vaccination records prior to administering a vaccine.” In other words, don’t assume because you have met the requirements for a vaccine protocol agreement in Georgia you are good to go.
Note: 2: With regard to record-keeping and reporting, the authorization references complying with “record-keeping and reporting requirements of the jurisdiction.” Pharmacists would do well to comply with record-keeping and reporting requirements set forth in O.C.G.A. 43-34-26.1 in addition to any more stringent requirements set forth above.