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Case Study 2

Anapen® 2a – The next generation of anaphylaxis auto-injectors

The Owen Mumford Challenge

Anaphylaxis is a serious and severe allergic reaction that affects the whole body; it is often life threatening and in severe cases the cardiovascular system can completely collapse. Severe allergic reactions are triggered by any chemical or allergen that can stimulate a rapid immune response; common allergens can range from food (such as peanuts or prawns) to material like latex. Although anaphylaxis is treated with an intramuscular injection of adrenaline into the thigh, it still kills 0.65–2.0% of patients who experience an episode.The main cause of anaphylactic fatalities is the late injection of adrenaline, which leaves symptoms to worsen, resulting in death.2

If patients use a device that consistently performs, this not only reduces wastage of medicine, but increases patient confidence

The Analysis

The slow response to administer adrenaline can happen if a patient does not have their auto-injector with them, or doesn’t know how to use the device correctly. Worryingly it’s not just patients that struggle to use auto-injectors, an unexpected 79% of primary and secondary healthcare professionals found auto-injectors confusing to use and were unable to perform a correct demonstration of injecting.Common mistakes patients make when injecting include: not removing the safety cap, operating the device upside down, injecting into the arm, and not pressing the device hard enough to deploy the needle and adrenaline.3

Due to the unpredictable nature of anaphylaxis it is not surprising injection mistakes can happen, especially if patients become panicked and forget how to inject properly. But training can increase the amount of correct injections performed. Before training, less than half of patients (44%) were able to correctly demonstrate injecting, compared with 88% of patients who performed a correct demonstration after watching a training video. But there are some aspects of poor injecting, that training can’t solve. Needle phobia can sometimes cause patients to leave injecting till the last minute, causing their symptoms to worsen. There is also the risk of using degraded adrenaline, as anaphylactic attacks can be infrequent an out-dated pen may be used.1

Engineering Design

The new Anapen® 2a was designed to solve the problems training alone could not. The Anapen® 2a is derived from the Owen Mumford Autoject® Mini platform – a flexible and reusable injection device. The Autoject® Mini has an established and trusted profile amongst clinicians and patients, and proved an ideal platform for the innovative Anapen® 2a. When designing this new device we asked ourselves: how can we retain the ease of our previous auto-injector,4 whilst addressing issues like needle phobia and outdated adrenaline? The Anapen® 2a was first designed to have a clear window so patients could check if the adrenaline was clear, colourless and in date. Next we made the safety cap and needle shield different colours, minimising confusion so patients instantly know which end is for injecting. A deployment window was also inbuilt that changes to red once the needle has been fully deployed. Additionally, the needle shield can now also be removed and be replaced over the protruding needle to reduce needle stick injuries and anxiety.

Our Insights

In order to reduce deaths from anaphylaxis, not only do patients need thorough training, but they also need intelligent devices that make injecting as easy and as simple as possible. The Anapen® 2a is a new generation of auto-injector that when combined with training can deliver adrenaline reliably, and in worst case scenarios notify the patient if something has gone wrong (like unsuccessful deployment of the needle). If patients use a device that consistently performs, this not only reduces wastage of medicine, but increases patient confidence. This allows them to manage their anaphylaxis more proactively by using their device and injecting as appropriate, rather than waiting for symptoms to worsen.

 

The devices described in this case study belong to companies which are not Owen Mumford.

References:

  1. Frew AJ. What are the ideal features of an adrenaline (epinephrine) auto-injector in the treatment of anaphylaxis? Allergy 2011; 66:15-24.
  2. Schwirtz A, Seegar H. Comparison of the robustness and functionality of three adrenaline auto-injectors Journal of Asthma and Allergy 2012;  5:39-49.
  3. Lombardelli S. (2010, June) Adrenaline auto-injectors: how effective are written patient instructions when used alone in a simulated self-administration test? Presented at Exhibition Hall, Hungerford, UK.
  4. Brown J et al. A randomized maternal evaluation of epinephrine autoinjection devices. Pediatric Allergy Immunology 2013; 24:173-177.