Liquid oral vaccine mistakenly given by injection. To protect children against rotavirus gastroenteritis, there are two oral live rotavirus vaccines available in the United States. These rotavirus vaccines are the only liquid oral vaccines given to children in the United States since use of live oral poliovirus vaccine was discontinued in 2000. Therefore, providers now have less experience administering oral vaccines and, on occasion, have accidentally injected oral rotavirus vaccine, making it ineffective.
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 the U.S. Food and Drug Administration (FDA) (Hibbs et al., 2014). There were 39 reports of accidental injection of the oral vaccine. ROTATEQ, a Merck product available as a liquid in a squeeze applicator (Figure 1), was involved in six of the errors. Most cases (33 out of 39) happened with the GlaxoSmithKline (GSK) product, ROTARIX, which requires reconstitution. This product comes with a prefilled oral applicator syringe that holds the diluent for reconstitution of the lyophilized vaccine vial (Figure 2). The reconstituted liquid vaccine is then supposed to be drawn back into the oral applicator via the transfer device and given orally. Errors have happened when the vaccine vial is thought to be a parenteral vial of 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 read.
We also have learned from other sources that the oral applicator, which doesn't properly connect to a needle, has been rigged by taping a needle to the syringe tip. In a case involving the GSK product reported to the Institute for Safe Medicine Practices (ISMP) National Vaccine Errors Reporting Program (VERP), operated in cooperation with the California Department of Public Health, the hospital stored the transfer devices and the oral applicator syringes separate from the vaccine vials, which were kept in a refrigerator. The nurse was unaware that the necessary transfer devices and oral applicators were in a cabinet a number of feet away from the refrigerator. The nurse assumed that all vaccines were given by injection, and she chose the intramuscular route of administration without checking the label.
Interestingly, the Rotarix product is available outside the United States, including Canada, as a ready-to-use liquid, so it's not clear why it isn't available in the United States this way. To best avoid this type of error, at least until a ready-to-use liquid Rotarix is available here, it seems reasonable to consider utilizing the Merck product RotaTeq (Figure 1) instead of Rotarix (Figure 2). Both CDC and ISMP have brought this type of error to the attention of the vaccine manufacturers and FDA.
Topical anesthetics for teething infants. Lidocaine viscous is indicated for use as a topical anesthetic for irritated or inflamed mucous membranes of the mouth and pharynx and to reduce gagging when taking X-rays of the mouth or performing dental impressions. The FDA has not approved this product for use in children who are teething. Nevertheless, we recently learned about a tragic event involving twin 1-year-old infants who were prescribed lidocaine viscous for that reason.
The first infant suffered a seizure at home, followed by cardiac arrest. She was successfully resuscitated by emergency medical services personnel and transferred to a hospital. Because the infant had been playing with toy beads, the initial impression was asphyxiation. Just 2 days later the second twin also had a seizure and arrested. Tragically, this twin could not be resuscitated. Upon hearing of the demise of the second twin, concern for toxic exposure and/or ingestion in the home was raised. Toxicology results for the first twin indicated toxic levels of lidocaine. It was learned that the infant's primary care provider had prescribed lidocaine viscous 2% for teething/irritability. Toxic levels of lidocaine were also identified in the second infant. It's unclear how the infants received an overdose of the medication.
Although many parents like to rub topical anesthetics on their baby's gums to treat the discomfort, the directions for use and potential for toxicity with these products are often not clear to parents and, sometimes, not even to their doctors. One issue is that the anesthetic effects may be short-lived, resulting in well-meaning parents using the product more often than recommended by the doctor or the product label. Parents have also been known to put the topical anesthetic into the infant's formula, or to soak a pacifier in the solution and then put that in the baby's mouth. This is a dangerous practice because it is difficult to determine the amount of medication the infant receives. Also, a portion of the medicine often ends up being swallowed. When that happens, the mucous membranes of the throat may become anesthetized (Cohen & Levinsky, 1976), which can affect the gag reflex and make it difficult to sense liquids during swallowing, increasing the risk of choking or aspiration.
As for anesthetic products like ANBESOL and ORAJEL that contain benzocaine, the same can occur, plus methemoglobinemia is a risk (Moore et al., 2004). Methemoglobinemia can occur within minutes after exposure, even the first time the product is used. It isn't very common overall, but children under 2 years of age appear to be at particular risk. In 2011, FDA issued an alert about the risks of over-the-counter benzocaine gels and stated that these products should not be used except under the advice and supervision of a healthcare professional. The American Academy of Pediatrics (n.d.) discourages topical anesthetic use and instead suggests using a rubber teething ring that's been chilled in the refrigerator (not the freezer). One can also gently rub or massage the child's gums with a finger. Pain medications like acetaminophen and ibuprofen can also be useful when given in conjunction with advice from a healthcare professional. The bottom line is, lidocaine viscous is not approved by FDA for use as a treatment for teething. For safety reasons, lidocaine viscous and benzocaine gels or liquids should not be used for this purpose.
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