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FDA Advise-ERR: Pen injectors need pen needles!

Autoinjectors and pen injectors are commonly used for patient self-administration of medications. Autoinjectors, which already have an attached needle, provide a single medication dose for onetime use prior to disposal. Autoinjectors help some patients overcome the hesitation with injecting themselves. EPIPEN and AUVI-Q (both EPINEPHrine), and BYDUREON BCISE (exenatide) are examples of medications available in autoinjectors. Unlike autoinjectors that already have a needle attached, pen injectors require patients to manually attach a pen needle. Some pen injectors, including OZEMPIC (semaglutide), come with a supply of disposable needles. HUMALOG KWIKPEN (insulin lispro) and FORTEO (teriparatide) are examples of pen injectors that require the purchase of pen needles separately. Some states require a prescription to obtain pen needles, which are available in multiple lengths and gauges. When pen needles need to be purchased separately, the US Food and Drug Administration (FDA) encourages manufacturers to include a statement, “Needles not included,” on the carton (Figure 1).

Figure 1. FDA recommends that manufacturers of pen injectors include the statement, “Needles not included,” on the outside carton as a reminder to provide pen needles.
Figure 1. FDA recommends that manufacturers of pen injectors include the statement, “Needles not included,” on the outside carton as a reminder to provide pen needles.

FDA and ISMP have received reports of missed doses and reuse of needles when the correct pen needles were not prescribed and/or dispensed to patients. Most of these errors were attributed to not prescribing the required pen needles, not offering patients pen needles (if allowed in some states), dispensing the incorrect type of pen needles, unfamiliarity with the pen injector, and patients with an inadequate supply of pen needles.

To help prevent errors associated with pen injectors, FDA recommends the following:

  • Check your state laws to determine if a prescription is required to dispense pen needles.

  • Work with your information technology and electronic medical record vendors to create order sets that include a prescription for pen needles when ordering pen injectors.

  • Prescribers who provide samples of pen injectors should consider maintaining a supply of the correct pen needles to dispense with the samples. 

  • Educate patients to pick up BOTH the pen injector and pen needles from the pharmacy.

  • If there is no prescription for pen needles or it is unclear in the patient’s profile if they have received pen needles, enter a counseling note in the pharmacy computer system (or on the prescription receipt) to trigger patient education when the patient picks up the prescription. Ask the patient if they have an adequate supply of pen needles without reusing them.

  • Use the teach-back method to educate patients regarding how to correctly use the pen injector, including setting up the device, using the pen needle (standard pen needle or safety pen needle), changing the needle with each injection, administering the medication, and disposing of the pen needle safety.

  • Educate patients not to share their pens, even when the needle has been changed.

  • Educate patients to never use the pen injector cartridge as a vial.

This FDA Advise-ERR was provided by the FDA Division of Mitigation and Medication Error Surveillance (DMAMES), Postmarket Medication Error Team (PMET): BarbraKaryne N. Nchinda Fobi, PharmD, MPH, CPPS, FISMP; Niloofar Rezvani, PharmD; and LCDR Zachary Oleszczuk, PharmD, MSPharm, BCGP.

Editor’s note: A hospital pharmacist reported that a patient was discharged from another hospital with a U-500 insulin pen, but no pen needles. She used a U-100 insulin syringe to withdraw “70 units” of insulin from the U-500 pen, not realizing she had actually withdrawn 350 units. The patient’s children found her unresponsive and called for emergency care. Fortunately, the patient recovered.


Suggested citation:

Institute for Safe Medication Practices (ISMP). FDA Advise-ERR: Pen injectors need pen needles! ISMP Medication Safety Alert! Acute Care. 2022;27(11):5.