What are you planning to learn?
I am planning to understand to use of Epipen past it’s expirary date. The reason for this is because the MHRA is advocating patients with severe allergies use Epipen devices outside of the normal expirary date due to the severe shortages of stock. This is the first time since my practice that the MHRA have advocated such a drastic approach. The news article by the BBC entitled, ‘Epipen users told they can use some devices past normal expirary date’ was worth exploring before I advised patients to take such an action.
understand which pens we could advocate use outside of expirary date and for how long.
Understand the scientific rationale to justify use outside of expirary date
How are you planning to learn it?
I plan to read the guidance from the
- DOH guidance
- Explore other countries regulator views i.e. FDA
Exploring other countries views (FDA) and MHRA guidance
The director of the FDA:
“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” saidJanet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Based on the above research, it can be concluded that the scientific rational for date modification beyond the approved 20-month shelf life was based on an FDA review of product stability data submitted by Mylan which demonstrated that the product was still stable for at least 4 months past the expirary date. A list of the epipens and their new expirary date was published by Mylan.1 The MHRA also published a similar list in its guidance2
The MHRA guidance was particularly useful in ensuring the importance of calm, pharmacist and other healthcare professional had a key role to play by ensuring people do not panic and request for extra supplies of epipen which would only further exacerbate the shortage. It was important to be able to speak with consumers in a calm and reassuring tone. It also advocated a closer relationship between prescribers and pharmacies to ensure we are aware of what product is available locally.
Give an example of how this learning has benefited the people using your services.
The knowledge obtained above has been useful as it allowed me to be able to speak confidently to patients during my locum shifts, when they are concerned about the safety of using an expired epipen. I am able to show them the MHRA guidance and the extended expirary date of their product. I am able to speak to them in a calm manner, the consumers feel comfortable been able to see the data. And, so also do the staff I work alongside during locum shifts, they also feel able to communicate effectively with consumers as a result of this learning.
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- Department of Health (2018). Supply disruption alert. Issued 28th September 2018. Available at: cas.mhra.gov.uk%2FViewandAcknowledgment%2FViewAttachment.aspx%3FAttachment_id%3D103102&h=AT3drzbswzk8i7dcnCXmFQFGG0ZFjTpZFxdypJVZGEmD7MAUPh6zi7Rz_yh3cD9gOfO-QIV7LF5p2BLI7OxaO6K7zD2-EBzoIJwbVvMX9CT7HDhu7AiXYO9bREyZ93FzaA