Cases of children mistakenly injected with oral rotavirus vaccines on the increase

March 10, 2014

ISMP reports that a growing number of cases of oral vaccines intended to protect children against rotavirus gastroenteritis are mistakenly being injected.

There are a growing number of cases of oral vaccines to protect children against rotavirus gastroenteritis mistakenly being injected, according to the Institute for Safe Medication Practices (ISMP).

In fact, there were 39 reports of accidental injection of the oral vaccine, according to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System. Thirty-three of the cases occurred with the Rotarix vaccine (GlaxoSmithKline), while six cases were associated with RotaTeq (Merck).

The Rotarix vaccine comes with a pre-filled oral applicator syringe that holds the diluents for reconstitution of the lyophilized vaccine vial. Then, the reconstituted liquid vaccine is supposed to be drawn back into the oral applicator via the transfer device and given orally, according to ISMP.

“Errors have happened when the Rotarix vaccine vial is thought to be a vial of injectable medicine, the Rotarix oral applicator syringe is thought to be a parenteral syringe, there is inadequate training of staff, or the package insert is difficult to read or isn’t reviewed,” ISMP wrote in its February 2014 issue of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.

Unfortunately, the United States is the only country where Rotarix is not available as a ready-to-use liquid. To avoid this error – until it is available as a ready-to-use vaccine – ISMP suggests using the RotaTeq vaccine instead.

Of course, pharmacies that supply physician offices, clinics, and all ambulatory practices should make sure their staff is aware of this potential problem with using Rotarix. In addition, both the CDC and ISMP have brought the errors to the attention of the vaccine manufacturers and the FDA.