Philadelphia, PA—The Institute for Safe Medication Practices (ISMP) has some recommendations to help pharmacists and other healthcare professionals avoid the most common errors associated with administration of COVID-19 vaccines.

“Millions of doses of the COVID-19 vaccines will be administered over the next few months,” the group states in a report. “As we work toward expanding vaccinations to all, we must also learn from the vaccine errors that have already happened and implement strategies to minimize the risk of making these same vaccine errors.”

In January, ISMP had published an analysis of early vaccine errors occurring in the first month of administering the Pfizer-BioNTech and Moderna vaccines.

“Now that the US has been administering COVID-19 vaccines for about 4 months, we have analyzed more than 160 COVID-19 vaccine errors voluntarily reported to ISMP between December 14, 2020, and April 15, 2021.”

Early on, according to the authors, most reports were associated with dilution errors involving the Pfizer-BioNTech vaccine, wasted vaccine doses, administration to the wrong age group, and errors associated with scheduling second doses.

“While these error types continue to be reported, we are now receiving a wide variety of different error report types,” according to the article. “During our analysis, each COVID-19 vaccine error report was categorized into one of four broad categories: general error types, errors specific to the two-dose vaccines, dilution errors with the Pfizer-BioNTech vaccine, and errors specific to the single-dose vaccine.”

Errors reported to ISMP include:
• The wrong dose, either lower or higher than authorized, in 20 cases
• Too young for the vaccine (less than age 16 years for Pfizer-BioNTech or age 18 years for the Moderna/Janssen vaccines) in 17 cases
• Wrong administration technique, either reuse of empty syringe and needle or causing shoulder injury in eight cases
• Wasted vaccine due to leakage, contamination, or insufficient dose left in vial in five cases
• Incorrect storage and handling related to temperature excursions outside of recommendations or administration of expired vaccine in four cases, or
• Contraindicated coadministration within 14 days of a non-COVID-19 vaccine or within 90 days of monoclonal antibodies in two cases.

In terms of errors specific to the mRNA vaccines, ISMP says there were 11 incidents of incorrect mRNA vaccine being administered for the second dose and nine cases of the second dose administered at the wrong interval, or a third dose being administered.

Because of its requirement for dilution, use of the Pfizer-BioNTech vaccine was related to errors in volume of diluent in 11 cases, no diluent in three cases, or wrong diluent in three cases.

As to the single-dose viral vector vaccine from Johnson & Johnson (Janssen), there was a situation where two-dose vaccine cards were shipped with single-dose vaccines.

A key issue is staff competency, according to ISMP, which emphasizes that vaccinators must be trained in the proper dilution of only the Pfizer-BioNTech vaccine; correct dose-withdrawal technique overall, choosing the appropriate injection site to prevent shoulder injury related to vaccine administration, and timing and scheduling of a second vaccine dose.

The group adds that all staff who check-in and screen patients for vaccination need to be knowledgeable about age indications for each vaccine; timing and scheduling of a second vaccine dose (if needed); screening patients for allergies, prior vaccinations, prior administration of monoclonal antibodies used to treat COVID-19, and other health indicators, and verifying the first vaccine (date, manufacturer) via the state/local immunization-information system, medical record, and/or the patient’s vaccine card for patients requiring a second dose.

Vaccination sites are urged to schedule patients for a second dose (if needed) before they leave the vaccination site after receiving their first dose and to establish a vaccination-scheduling system that does not allow patients younger than age 16 years to obtain an appointment, and schedules appointments for patients who are aged 16 and 17 years only for administration of the Pfizer-BioNTech vaccine.

The report also urges that, during the check-in process, patients are asked age-related screening questions, including their date of birth. Strictly comply with vaccine age restrictions. Staff also must verify receipt of the first dose among those seeking a second one. One way to do that, according to the guidance, is to require all patients who arrive for a second dose to present their vaccine card and have them carry the card throughout the process so the vaccinator can verify the information.

While prefilled, labeled syringes of the vaccine are preferred, according to ISMP, pharmacies should stock vials of sterile water in a different location than 0.9% sodium chloride, separate the preparation of each brand of vaccine, withdraw doses from one vaccine vial at a time before accessing the next vial, label vaccine syringes immediately after preparation, and remove syringes from their packaging one at a time immediately before drawing up diluents or doses.

The report strongly advises that syringe packages should not be opened ahead of time and/or syringes filled with air in preparation for later dose or diluent withdrawal. 

Other recommendations include:
• Stock each vaccination station with a sharps container for syringe/needle disposal.
• Before administration of any dose, check the syringe for the correct dose volume, air bubbles, and a tight fit between the needle hub and the syringe.
• Before administration of a second dose, visually check the patient’s vaccine card to verify the correct time interval and manufacturer.
• If preparing the Pfizer-BioNTech vaccine outside of the pharmacy, require an independent double-check of the dilution process (if staffing permits).
• After administration, immediately engage the needle safety device and dispose of the syringe in a sharps container (do not leave the used syringe on the table).
• Report any syringe or needle malfunctions to the pharmacy.
• After administration, complete the patient’s vaccine card. For single-dose COVID-19 vaccines, cover all references to a second dose (front and back of the card) with a note that only a single dose is required.
• Stock the vaccination site with epinephrine autoinjectors instead of prefilled syringes to visually differentiate the emergency agent from vaccine syringes.

The ISMP also emphasizes that errors should be revealed to patients and reported to authorities.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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