The U.S. Department of Health and Human Services (HHS) has issued an amendment to the Public Readiness and Emergency Preparedness Act (PREPA) allowing pharmacies to perform vaccination to children ages three through 18 as per ACIP’s standard immunization schedule.
In July, 2020, Centers for Disease Control and Prevention (CDC) conducted a survey to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19. The survey showed that 21.3 percent of pediatric practices responded that they are unlikely to provide immunization or the practice was permanently closed or not resuming immunization services for all patients. Another 20 percent responded that they were unsure. In response to these troubling developments, CDC and the American Academy of Pediatrics have stressed: “well-child visits and vaccinations are essential services and help make sure children are protected.” More information on the survey.
As a result, the HHS issued an amendment to include pharmacists in the PREPA for provision of vaccination to children (above 3 years of age).
Many States already allow pharmacists to administer vaccines to children of any age. Such states are: Alabama, California, Georgia, Idaho, Indiana, Iowa, Louisiana, Michigan, Mississippi, Montana, Nebraska, Nevada, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Virginia, New Hampshire.
Other states permit pharmacists to administer vaccines to children depending on the age. Some states, however, restrict pharmacist-administered vaccinations to only adults.
But all states require children to be vaccinated against certain communicable diseases as a condition of school attendance. With a school season upon us, it is unclear where these children will obtain their necessary vaccination. Now, with this federal amendment, hopefully more pharmacists will start providing vaccines to children. According to the HHS, pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved.
Pharmacist vaccination should be performed 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.
These requirements are consistent with those in many states that permit licensed pharmacists to order and administer vaccines to children and permit licensed or registered pharmacy interns acting under their supervision to administer vaccines to children.
Please note, that the PREPA also provides immunity from tort liability claims (except willful misconduct) to individuals or organizations involved in the manufacture, distribution, or dispensing of medical countermeasures. This could incentivize pharmacists to perform vaccination.