FDA Safety Communication – Caution Urged When Using Pen Needles

PUBLISHED: Sep 27, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Home Health, Hospitals, Long Term Care, Medical Office, Pharmacy, Rural Health Clinics

The U.S. Food and Drug Administration (FDA) has received reports of patients using standard pen needles to inject insulin without removing the inner needle cover. In these cases, the inner cover stopped the needle from entering the skin and the patients did not get the insulin. Some patients developed hyperglycemia because the inner needle cover stopped them from getting insulin. One patient was hospitalized and died because of having blood sugar that was too high for too long.

According to the FDA, it is possible that patients learned to use one type of pen needle, then received the other type later. This could cause confusion about how to use the pen needle correctly and may prevent the patient from getting the medicine they need.

Device Specifications:

  • Common types of pen needles include standard pen needles and safety pen needles.
    • Standard pen needles often have an outer cover and a removable inner needle cover, which are both removed before an injection.
    • Safety pen needles are different: they have an outer cover that is removed, and a fixed inner needle shield that is not removed before an injection.

In their safety communication the FDA provides recommendations for patients and caregivers, link provided below. The FDA also provides the following recommendations for health care providers and health care educators:

  • Train and educate patients and caregivers:
    • Show patients how to use the pen needle for their medication.
    • Ensure patients can demonstrate correct technique to verify proper use of their pen needles.
    • Be sure patients are aware of the different types of pen needles, and patients know which type they use.
    • Explain the signs and symptoms of under-dose (and over-dose) of medication prescribed to be used with the pen needle, how to monitor their medical condition (for example, blood glucose levels), and when to contact their health care provider.
  • Prescribers: Consider whether there could be a problem with an injection or medication administration technique before changing a medication dose.
  • Pharmacists: When dispensing a new box of pen needles, consider asking the patient if they know how to use the type of pen needles being dispensed. For example, remind patients that:
  • For standard pen needles with an outer cover and an inner needle cover, remove both covers before use.
  • For the safety pen needle, remove only the outer cover, as the fixed inner needle shield remains in place.
  • Pharmacists should be available to answer questions from patients and caregivers or refer them to their applicable health care provider.

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