ISMP Issues Recommendations To Help Avoid COVID-19 Vaccine Administration Errors
With the U.S. healthcare system preparing to immunize hundreds of millions of individuals nationwide after the first COVID-19 vaccines are approved, a group of drug safety experts has issued a series of recommendations for safe vaccine administration, which will help avoid errors and potential injuries.
The Institute for Safe Medication Practices (ISMP) issued the new recommendations November 20, to help prepare the medical community and avoid COVID-19 vaccine administration errors.
Currently, there are two anticipated mRNA vaccines from Pfizer and Moderna designed to reduce the risk of COVID-19 infections. Both vaccines are in Phase 3 clinical trials, and have petitions pending for Emergency Use Authorization from the Food and Drug Administration (FDA), which may be issued in the next few weeks.
The Pfizer vaccine requires two doses administered 21 days apart, and the Moderna vaccine requires two doses administered 28 days apart, meaning it will require nearly 700 million vaccine injections to protect the entire U.S. population.
Following an analysis of vaccine errors associated with influenze or flu shots, the ISMP warns that many underlying causes of these problems could also lead to problems during COVID-19 vaccine administration.
To help healthcare providers anticipate the vaccine administration risks and prepare for one of the largest vaccination efforts in U.S. history, the group provided a description of factors associated with recent flu vaccine problems and a series of recommendations for the delivery of COVID-19 vaccines:
Plan ahead
Healthcare providers should focus on infection control measures, storage capacity needs and potential storage issues. Issues included staffing levels and language barriers. Healthcare facilities should also use the first phase of distribution to essential workers as an exercise on how to complete administration for next phases.
Safe Storage
Healthcare providers should ensure their facilities have sufficient cold chain capacity so the vaccines can be stored separately from other medications. Additionally, monitoring storage temperatures and expiration dates should be a priority.
Staffing and training
Additionally, vaccine administration staff should know how to search vaccine registries and properly document immunizations. Staff should be trained for read back/repeat back oral communications while wearing a mask or face shield.
Safe dispensing
Facilities should use commercially available pre-filled syringes when possible, use auxiliary labels or highlight important information on vials, and establish a process to keep two component vaccines together if storage requirements for the two do not differ. Facilities should also use barcode technology for tracking if available.
Safe administration
All syringes should be labeled, barcode verification should be used, and administration should be documented, logged and registered. Details should be reported to local, state and public health authorities.
Patient education
Health care providers should provide vaccine information statement to recipients before administering, as well as providing a completed vaccine record card to every vaccine recipient.
Side effects
Adverse events must be reported and a safety monitoring system must be established to ensure vaccine side effects and errors are communicated to appropriate health authorities. Side effects must be reported to the CDC’s Vaccine Adverse Event System (VAERS) and the ISMP National Vaccine Errors Reporting Program.