Important update – Extended use of EpiPen® 300mcg adrenaline auto-injectors beyond labelled expiry dates

Important update – Extended use of EpiPen® 300mcg adrenaline auto-injectors beyond labelled expiry dates

October 1, 2018

The Department of Health and Social Care (DHSC) has issued a Supply Disruption Alert for: EpiPen and EpiPen Junior adrenaline auto-injector devices (Mylan)

Date issued: 28th September 2018

Valid until: 31st December 2018

SDA number: SDA/2018/001

The Department of Health and Social Care (DHSC) has issued a Supply Disruption Alert for:

EpiPen and EpiPen Junior adrenaline auto-injector devices (Mylan)

EpiPen and EpiPen Junior auto-injectors will be subject to limited availability for the remainder of 2018 . Mylan is now out of stock of EpiPen Junior auto-injectors and interruptions in the supply are anticipated to continue for the coming months.

Mylan UK has obtained acceptance from the Medicines and Healthcare products Regulatory Agency (MHRA) to extend the use of specific lot (batch) numbers of EpiPen 300mcg auto‐injectors, beyond the labelled expiry date by four months. The affected lot numbers, which have labelled expiry dates between July 2018 and November 2018 can be found in the table below.

Please note: the extended use only applies to the lots of EpiPen 300mcg auto-injectors listed above. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen auto-injectors not covered by the lot numbers above.

Actions for all health care professionals

All health care professionals in primary, secondary or specialist healthcare services who prescribe, dispense or administer adrenaline auto-injectors, or who advise patients and their carers, should ensure that:

  • Adult and child auto-injectors are only prescribed and dispensed to those who truly need them, as any additional issuing to patients who are worried about the shortages could exacerbate the overall supply situation.
  • Repeat prescriptions and supply are managed diligently and patients advised of the following:
    • It is important to note that when validating the expiry date of an adrenaline auto-injector, the product expires on the last day of the month indicated e.g. a device labelled ‘April 2019’ does not expire until the end of April.
    • Certain batches of adult EpiPen auto-injectors can be safely used for four months after the expiry date has passed – please see further information about these batches above. Where possible, prescribers should not prescribe a replacement adult EpiPen auto-injectors whilst the original is within the extended use by date.
    • Patients should be advised not to dispose of their expired devices until they have replaced them.
  • Due to ongoing constraints affecting EpiPen 300mcg and EpiPen 150mcg auto-injectors, some adults and children may need to switch from their usual device to other alternative adrenaline auto-injector devices that may be more readily available. The different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices. See information on these alternative devices in the DHSC alert.
  • Junior adrenaline auto-injectors (150mcg) must only be dispensed in line with the existing established guidance i.e. to children under 30kg. Other children weighing more than 30kg need to be given adult auto-injectors (300mcg). See further guidance in the DHSC alert.
  • Prescribers should work in close collaboration with their local pharmacies to understand which devices are available. Prescribers and pharmacists should work together to ensure patients who are switched to an alternative device are trained appropriately and understand how to use the new device.
  • Prescribers and pharmacies should regularly check the following Specialist Pharmacy Services website for additional updates to supply and clinical guidance at: https://www.sps.nhs.uk/articles/shortage-of-epipen/

For more information, please read the DHSC alert on the Central Alerting system website.



Posted in: ,


More Latest News >

EPS Phase 4 piloting

NHS Digital continues to pilot EPS Phase 4. All pharmacy staff need to be aware that they could receive a...

PSNC Job Opportunity: Office Administrator

PSNC (the Pharmaceutical Services Negotiating Committee) represents England’s community (high-street) pharmacies, and is looking to recruit an Office Administrator to...