Pharmacy Based Immunization Certification and Covid-19 Vaccinations

By Sandra Canally, Founder and CEO

The pandemic has brought us challenges and opportunities. We identified a need for a separate immunization certification program for pharmacies that addresses front-end preparation, administration SOP’s ,follow-up, oversight of the CDC requirements, validation by a third party, and reinforcement of quality assurances.

Our Immunization Certification covers all types of vaccines, including the COVID-19 vaccines that many of our pharmacies are currently administering. Below are some of the highlights of our what our program addresses:

Compliance

• • Adherence to manufacture guidelines (guidelines my vary by manufacturer)
  • Compliance with CDC and CDC’s Advisory Committee on Immunization Practices (ACIP)
  • Compliance with US Food and Drug Administration regulations
  • State and territorial vaccination laws

Drug Administration

• • Emergency protocols and supplies
  • Moderate and severe adverse events following vaccination must be reported to the Vaccine Adverse Event Reporting System (VAERS)
  • Provision of an approved Emergency Use Authorization (EUA) fact sheet/Vaccine Information Sheet (VIS)

Storage and Handling (manufacturer guidance may vary by manufacturer)

• • Covid-19 vaccines must be stored and handled per manufacturer guidelines
  • Digital Data Logger (DDL) monitoring of temperature at all times
  • Vaccines expiration dates must be continuously monitored and stock rotated
  • Proper timing and preparation of vaccines prior to administration
  • Issues related to transport and handling under emergency conditions
  • Staff training

Key components

• • The vaccine must be recorded in the recipient’s record and information must be reported to the relevant state, local or territorial public health authority within 24 hours
  • Vaccine records must be preserved for a minimum of 3 years
  • Emergency preparedness

If you are currently administering vaccines or are considering adding vaccine administration to your services, please contact us for more information about our Immunization Certification program.

Having your facility verified and validated by a nationally recognized third-party accreditation organization gives you that Quality and Safety stamp of approval that can differentiate your pharmacy to customers and payers and reduce your organization’s risk of legal headaches and worrisome paperwork down the road.