San Diego Revises Alert System in Wake of Administration of Compromised Flu Vaccine

By Annette M. Boyle

SAN DIEGO—In the fall, failure of a pharmacy refrigerator and its monitoring system resulted in 1,540 veterans and staff receiving potentially ineffective shots. Since then, the San Diego VAMC has made significant changes to its alert process to prevent a repeat of the problem.

The cascade of events started with a failing refrigerator, which was followed by a series of errors that resulted in a disconcerting but not harmful situation.

Former Marine James McKenzie receives his flu shot at the New Orleans VAMC drive-thru flu shot clinic. In San Diego, some veterans had to be reimmunized because of concerns about proper handling of the vaccine.VA photo

When a pharmacy refrigerator exceeds preset temperatures, an automated alert tells staff when a problem has occurred. That might happen on a very hot weekend with a weak air conditioning system, for instance. Typically, then, cooling systems would be fixed, and any negatively impacted product would be thrown out when staff returned.

In this instance, the initial part of the alert process worked as it should. “The equipment began going out of range on Oct. 2,” recounted Kathleen Kim, MD, MPH, chief of staff and medical director of the VA San Diego Healthcare system. The system sent an alert to the San Diego VA’s engineering and pharmacy groups.

“Though a number of people got the message that the refrigerator was out of temperature range, they were not the right people, and nobody took action,” Robert Smith, MD, director of the VA San Diego Healthcare System told the San Diego Union-Tribune.

Further, the system was not set to continue sending or escalate alerts, so after the initial threshold was passed, no one received additional notices. Staff pulling influenza vaccine doses out of the refrigerator did not register the change in temperature either, as it rose from the target of 36 to 46 degrees into the mid-50s.

Consequently, the problem was not discovered until Oct. 13, and vaccine doses from the refrigerator were administered through the entire period. During most of that time, however, the vaccine retained its potency.

“The vaccine is still good for seven days” after the temperature began to rise, Kim told U.S. Medicine. “Therefore, only vaccines delivered between Oct. 10 and Oct. 13 were considered ineffective.”

According to the U.S. Centers for Disease Control and Prevention (CDC), “exposure of vaccines to temperatures outside the recommended ranges can decrease their potency and reduce the effectiveness and protection they provide.”

During the four days that the vaccines were likely ineffective, 1,300 veterans and 240 VA staff members received immunizations. Kim noted “there would be no negative side effects with the ineffective vaccines, however.”

While the compromised vaccine itself poses no risk, the use of ineffective vaccines did have some negative consequences.

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