patient safety & quality
By J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , MSL-BC , CPPS , CPHQ , NREMT , CADS , FACDONA , FAAPM , FNAP
What is Our Responsibility With the COVID-19 Vaccine as Healthcare Providers ?
With the recent Emergency Use Authorizations ( EUA ) from the Food and Drug Administration ( FDA ) for two COVID-19 vaccines , there is finally true hope in curbing the transmission of the highly transmissible SARS-CoV-2 virus . FDA defines EUA as “ an expedited authorization and use of an unapproved product or the off-label use of an already approved product in a declared emergency involving a chemical , biological , radiological , or nuclear ( CBRN ) agent .” These medical countermeasures can include drugs , devices or biologics that have potential to “ diagnose , treat , or prevent serious or life-threatening diseases or conditions caused by a CBRN agent when there are no adequate , approved , and available alternatives . FDA established four criteria that must be met for an EUA to be granted which include :
➊ Presence of a serious or life-threatening condition
➋ Evidence of effectiveness
➌ Risk-benefit analysis for safety
➍ No other alternatives to address the life-threatening condition
While the FDA is the responsible federal agency for the regulation of drugs and vaccines , FDA scientists and career regulatory officials work extremely closely with the Centers for Disease Control and Prevention ( CDC ) to develop clinical recommendations for both healthcare providers and the general public related to vaccine prioritization and administration . Healthcare providers are in a unique position given their professional role in caring for likely immunocompromised patients . Published data from the CDC and other public health authorities has demonstrated that immunocompromised persons and those with significant comorbidities are at higher risk for experiencing elevated poor clinical outcomes . As such , healthcare providers need to serve as ambassadors for the COVID-19 vaccines not only within their healthcare institution but also in their community involvement in places of worship , athletics , etc .
By setting an example and being stewards of infection prevention and control , we can help build the needed community heard immunity to stop the widespread and ongoing community transmission that is plaguing communities across the globe . Infection preventionists must be trusted by the patients and also our colleagues , and with this trust comes a deep responsibility to advocate for public health including vaccines for all eligible patient candidates .
Healthcare leaders and infection preventionists should be properly trained and deemed competent on several core issues
• Published data from the CDC and other public health authorities has demonstrated that immunocompromised persons and those with significant comorbidities are at higher risk for experiencing elevated poor clinical outcomes .
related to vaccine safety , administration , and monitoring . The skills below are critical to ensuring the safety and efficacy of the vaccine :
● Storage and handling of vaccine
● Preparation of vaccine
● Administration of vaccine
● Emergency response preparedness
● Documentation
● Immunization Information System ( registry ) data entry
● Patient education
● Staff education
● Adverse event monitoring
Additionally , the vaccine manufacturers in collaboration with FDA and CDC have created vaccination information documents for both vaccine recipients and also healthcare providers administering the vaccine . These handouts provide answers to the most frequently asked questions , and can be helpful in answering questions from patients , healthcare colleagues , and family members regarding the vaccines . It is expected that additional vaccines will be issued an EUA in the first quarter of 2021 , which will allow for more widespread distribution of the vaccine to community settings .
As further data is collected , analyzed , and submitted to the FDA for review and approval , other groups of potential vaccine candidates such as pediatrics and pregnant women may be potentially added if the science supports the use of the vaccine in these unique patient populations . Vaccination , combined with a continued emphasis on infection control interventions , will help curb the tide of this pandemic and allow us to move forward .
J . Hudson Garrett Jr ., PhD , MSN , MPH , MBA , FNP-BC , IP-BC , PLNC , CFER , AS-BC , VA-BC , MSL-BC , CPPS , CPHQ , NREMT , CADS , FACDONA , FAAPM , FNAP , is president and CEO of Community Health Associates , LLC . He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine . Garrett is a frequent lecturer globally on patient safety , infectious diseases , and medical device reprocessing and safety . He may be reached at :
Hudson . garrett @ chaassociates . com