Friday, July 31, 2015

Oral rotavirus vaccine is ineffective by injection

Rotavirus is a virus that causes a type of gastroenteritis (inflammation of the lining of the stomach and intestines) that can lead to severe watery diarrhea, vomiting, fever, and abdominal pain. The virus is a major cause of death in children around the world.

Oral rotavirus vaccine is ineffective by injection

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Rotavirus is a virus that causes a type of gastroenteritis (inflammation of the lining of the stomach and intestines) that can lead to severe watery diarrhea, vomiting, fever, and abdominal pain. According to the CDC, rotavirus gastroenteritis can also lead to dehydration (loss of body fluids) in babies and young children. This is a serious complication that may require hospitalization for administration of IV fluids. The virus is a major cause of death in children around the world.

Fortunately there are two oral live rotavirus vaccines available in the US that can protect children against rotavirus gastroenteritis. But since the use of live oral poliovirus vaccine was discontinued in the United States in 2000, other than rotavirus vaccines, no other oral vaccines are routinely given to children in the U.S. Therefore, providers now have less experience administering oral vaccines and, on occasion, by mistake they’ve accidentally injected oral rotavirus vaccine, making it completely ineffective.

Recently the Centers for Disease Control and Prevention (CDC) examined reports of accidental injection submitted to the Vaccine Adverse Event Reporting System (VAERS), operated jointly by CDC and FDA. There were 39 reports of injection overall. A Merck product, RotaTeq, is available as a liquid in a squeeze applicator. This was involved in only 6 out of 39 errors reported by CDC. Most cases (33 out of 39) happened with the Glaxo SmithKline (GSK) product, Rotarix, which requires mixing a dried out form of the vaccine into a liquid before giving it.

Interestingly, the GSK product comes with a prefilled oral applicator syringe that holds the diluent for making the vaccine into a liquid. After mixing, the liquid vaccine is supposed to be drawn back into the oral applicator syringe and given orally. Mistakes happen when the person giving the vaccine thinks it’s like every other vaccine that’s given by injection. Sometimes the Rotarix oral applicator syringe is confused with a syringe typically used for injection. These types of errors are most common when there is inadequate training and when the person giving the vaccine doesn’t read the label. Interestingly, the Rotarix product is available outside the US, including Canada, as a ready-to-use liquid, like the Merck product. So it’s not clear why this isn’t the case in the US.

To best avoid this type of error, at least until a liquid Rotarix product is available in the US, it seems reasonable for doctors to consider using the Merck RotaTeq product to prevent anyone from making the mistake. The CDC recommends that either can be given. They are equally effective. This is a critically important vaccine that every baby should have. Parents should be aware of the vaccines their child is getting. When it comes to rotavirus vaccine, it needs to be given orally. 

Figure 1. Merck product, Rotateq, is available as a liquid in a squeeze applicator.


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President, Institute for Safe Medication Practices
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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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