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Reporting a Medication Error

Cuts on leg following EpiPen Jr use

0b242dd5a6f3b60d9c07a5d96a2bc449 MIf you keep an EpiPen Jr (epinephrine) auto-injector on hand in case a child has a severe allergic reaction, you need to know about the risk of cutting a child while the needle is under the skin if he or she moves during the injection. An EpiPen Jr auto-injector is a disposable automatic injection device filled with 1 dose of epinephrine. When the orange tip is pressed against a child's outer thigh until it "clicks" and then held there for 10 seconds, the dose is automatically delivered. Prompt treatment of severe allergic reactions in the home and community can be lifesaving and has resulted in better survival rates and less long-term effects. Most often, auto-injectors are used successfully without complications. But two children recently sustained cuts on their legs when using the EpiPen Jr.


 A 4-year-old boy at daycare had an allergic reaction. The staff gave him an injection of epinephrine using an EpiPen Jr. The child was standing, and a daycare staff member was standing behind him for support. Another staff member held the child's leg and gave the injection. The child kicked while getting the injection, and the needle moved while under the skin, leaving a cut along his leg. Believing the device had not been held in place long enough to give the drug (10 seconds recommended), the staff member attempted to re-inject the child using the same needle. This resulted in a second cut (Figure 1) when the child tried to get away again.

laceration

The child's symptoms improved without additional epinephrine. The two 3-inch cuts were closed with non-absorbable sutures and tissue adhesive. X-ray imaging and inspection of the needle showed it was bent, which likely prevented the needle cover from locking back in place when the needle was initially kicked free by the child (Figure 2).

2radiographic

In a very similar case, a 3-year-old boy having an allergic reaction while at daycare was given a dose of EpiPen Jr in his outer thigh. The child jerked his leg and got a 1½ inch cut on his leg. The daycare worker then restrained the child with her body weight and attempted to re-inject the medication using the same EpiPen Jr to complete the 10 seconds of holding the device in place and ensure the drug had been fully delivered. The child was taken to the emergency department, where his symptoms improved without additional medicine. The cut was repaired with eight non-absorbable sutures.

These cases highlight features of the EpiPen Jr and adult EpiPen design and instructions for use that contributed to the injuries. The instructions direct the user to hold the EpiPen firmly against the outer thigh, holding it in place for approximately 10 seconds. The needle stays under the skin until the EpiPen is pulled away from the thigh. Because of this, people may believe it takes 10 seconds for the medicine to be injected. However, the average time to inject the epinephrine is much shorter, less than 3 seconds in most cases.1 The instructions don't say, "Never reinsert the same needle," or, "Don't worry if the needle comes out in less than 10 seconds. The drug is still likely delivered." The instructions for EpiPen Jr also do not mention the need to restrain a child or the risk of injury if the child moves.

With a newer epinephrine device, the Auvi-Q (epinephrine) auto-injector, the medication is delivered quickly and the needle retracts automatically in less than 1 second. There is no risk of needle injury once the needle is back in the device.

→ Here's what you can do: Be sure to restrain a child when using an epinephrine auto-injector to prevent movement during the injection. This is particularly important for EpiPen Jr and other similar epinephrine auto-injectors where the needle should remain in the thigh for 10 seconds. If the needle is dislodged, reinsertion should never be attempted. If it was in place for at least 3 seconds, it is likely that the full dose of epinephrine was injected. Repeat doses should be determined by emergency medical professionals. This information should be relayed to caregivers, daycare workers, teachers, and anyone else who might administer epinephrine to a child.

ISMP thanks Julie Brown, MDCM, MPH, of Seattle Children's Hospital for providing the contents of this article based on errors that happened outside the facility in which she works.

Reference
1) Lieberman P. The 10-second rule and other myths about epinephrine and auto-injectors. Ann Allergy Asthma Immunol. 2011;107:189-90.

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