Vaccine Errors Leaving Recipients Unprotected, ISMP Reports

A new report suggests that vaccination administration errors may cause patients to suffer severe side effects, including death.

The Institute for Safe Medication Practices (ISMP) released a report this month that details frequent reports of medical problems that resulted from incorrect or incomplete vaccine administration.

Two specific types of vaccines and their administration practices are highlighted in the report. Some vaccines are packaged in a powdered form, requiring a separate vial of diluent to be mixed in before the vaccine can be given to a patient.

ISMP officials say this may place some patients at risk, because in certain cases doctors, nurses or other medical staff who administer the vaccines may not mix the powdered vaccine in first, causing the patient to only receive the diluent.

Another type of mistake occurs when a vaccine is a two-component vaccine. This requires both components to be administered for full effectiveness. The ISMP found patients are often given only one of the two components.

In each case, errors during vaccine administration leave patients unprotected against the very diseases the vaccines are designed to protect them from, including serious and sometimes fatal communicable diseases.

Using the ISMP National Vaccine Errors Reporting Program (ISMP VERP), established in 2012, the group said these incidents account for six percent of all vaccine error types reported.

Currently, there are 12 vaccines that require specific diluents and two other vaccines which must be administered in a two-component container. The ISMP noted errors with these vaccines typically involve multiple patients.

Errors administering vaccinations may cause patients to become vulnerable to diseases such as meningitis, pertussis and other serious illnesses, which may cause death in some at risk populations of patients.

Patients Do Not Know They Are Vulnerable

If a patient experiences an error of this type when receiving a vaccination, they may not be aware they are still susceptible to the disease. Often times the error remains unrecognized or goes unreported.

The ISMP is calling on manufacturers to improve vaccine product labeling to help mitigate these kinds of errors. The group suggests manufacturers change labeling to clearly distinguish vaccines which require two-components. They also advise staff to circle or highlight pertinent information on the vials which would distinguish the two-components must be administered together.

Another recommendation offered in the ISMP report includes packaging the components together, by either affixing a rubber band to tie the two together or by placing them together in a sealable plastic bag.

The ISMP advises those administering the vaccines to confirm the separate vaccine components before administering them by documenting the NDC number for each vial in the vaccine log prior to administration. Vaccine administration should then be confirmed afterward, by documenting the administration in the log following the event.

ISMP officials also recommend conducting ongoing training and education for staff members who dispense and administer vaccines. This may include discussing safety issues and the unique problem two-component vaccines offer to health care professions.

The ISMP is a nonprofit charitable organization that works with healthcare practitioners, regulatory agencies, consumers and educational institutions to provide education concerning medical errors and their prevention.