The Future of Emergency Hydrocortisone Injections for Adrenal Crisis One of the most frequently asked questions we get from our members and the wider adrenal insufficiency community, is; "Why isn't there something like an 'epi-pen' for us to use to give ourselves a quick and easy emergency injection'? It is a very good and valid question, and we share the various considerations, as well as our thoughts on the answer, below. Device options currently available in the UK Potential future device options Why don't we have these options already? Postitive things on the horizon Product development How is the ADSHG driving improvement? Hydrocortisone powder (hydrocortisone sodium succinate), which requires mixing with water, is currently the only format of hydrocortisone available in the UK for use in an emergency injection to prevent or treat adrenal crisis, following the discontinuation of hydrocortisone sodium phosphate. The adrenal insufficiency community has valid and significant concerns. An injection with hydrocortisone powder and water necessitates a 10 - 13-step process (depending on how you break it down) to prepare and administer. People with adrenal insufficiency are expected to self-administer the injection whilst in adrenal crisis and whilst directly affected by severe symptoms such as vomiting, pain, drowsiness, confusion, uncontrollable shaking and loss of consciousness. We share your incredulity and intense frustration that there still isn't a more 'user-friendly' injection device available. The process urgently needs to be significantly simplified, made less daunting, and more accessible. Read on for updates and the work we are doing as a charity around this. What device options are currently available in the UK? Currently, there are just 2 options for UK residents: Separate Needles & Syringes Most of you will be familiar with the needles and syringes that are issued to you, or that you have purchased, for use in your emergency injection kit. These items are low cost to produce, and whilst they are widely available on the market, we know they can be surprisingly difficult to get hold of from your GP! (but I don't want to go off tangent... that is another story). To administer an emergency injection of hydrocortisone, the unwrapped needle must be firmly attached to the unwrapped syringe. Generally (though not always), the needle will have a 'safe slip' cap that can be flipped off to reveal the needle, and flipped back on over the needle after use, to help prevent needlestick injuries. Retractable Needle / Syringes combo Devices where the needle and syringe are all in one, have already been developed eg Vanishpoint Safety Syringe, and until recently have been available in the UK. However, at the time of publication, they are not available due to issues with the distributor importing them. We understand that they will soon be available again and are in touch with the distributor so we can keep you posted. These all-in-one devices save 1-2 steps in the injection process (unwrapping an additional item and connecting the separate needle and syringe), and have a spring-loaded needle that retracts into the device once you have completed the injection, which helps prevent needlestick injuries. We know from our community that some people favour this type of all-in-one safety syringe, whereas some people prefer the separate syringe and needle above. What device options might be available in the UK in the future? Dual-compartment vial system A dual-compartment vial system is a specialist packaging system designed to simplify the mixing (reconstitution) of 2 components needed for a single injection. It contains a powdered drug in one compartment and the sterile diluent (e.g. water) in another. As the doses are already ‘measured out’, it reduces preparation steps as well as ensuring drug stability and reducing the risk of contamination. The stored components are mixed by pressing on a plastic cap. A needle is then used to draw up the mixed liquid and inject it. This system is in use by Pfizer, manufacturers of ACT-O-VIAL® which contains 100mg hydrocortisone sodium succinate (powder) and 2ml water (dilulent). It is NOT LICENSED in the UK at the current time (only licensed in the EU and the US). Why isn’t there already a pre-filled syringe or auto-injector for adrenal crisis? Here, we note some of the reasons why we believe that there isn't a device of some sort already on the market. The rarity of the condition Our Clinical Advisory Panel estimated that there are around 20-25k people with Primary (Addison's and Congenital Adrenal Hyperplasia) and Secondary adrenal insufficiency (with a pituitary cause) in the UK. Theoretically, following the NICE Guidelines for the Identification and Management of Adrenal Insufficiency (2024), these are the groups that would be prescribed 1-2 emergency injection kit(s). At the ADSHG, we don't believe that MedTech and Pharmaceutical companies have seen the development of an ‘EpiPen’ type device as a priority for development, compared to devices for people on insulin therapy for diabetes, for example, or for people with a severe allergy who might need an EpiPen type device, due to the numbers of people affected. The numbers below are from the internet, but even accounting for some inaccuracies, they tell a story; People using insulin: In 2021 there were an estimated 3.6 million people over 16 years old in England with Type 2 diabetes. About 15% of people with Type 2 diabetes use insulin, which equates to 54,000 people. NHS Digital estimates that a further 227.5k people in the UK have type 1 diabetes. So, a low estimate of people in the UK on insulin therapy (daily injections) is 281.5k people. UK allergy statistics say that there are around 2.5 million people in the UK who experience severe allergic symptoms that require medical attention, and 1 in every 1,333 people in England experiences anaphylaxis in their lives. This, and the statistic that approximately 23,800 adrenaline auto-injectors were prescribed to children in the UK between 200 and 2012, gives us an idea of the scale of use of an EpiPen. The higher numbers of 'end-users' for medical devices will directly influence the economics of device production and distribution. As such, it seems that products have been developed for conditions where there are a higher number of people affected. This is a barrier to development for a patient group with a rare condition. We don't believe that the impact on patient safety and quality of life is sufficiently considered when the development of new products is considered. The frequency with which it will be used / shelf life It is estimated that around 8% of patients will have an adrenal crisis yearly and will need to use their emergency injection kit. This figure hides the fact that some people will have more frequent adrenal crises (especially perhaps whilst their medication regime is being optimised, or if they have complex other health needs in addition to their adrenal insufficiency). Others will never have an adrenal crisis or may have the one that led them to their diagnosis, but not have another once they are on replacement steroid medication. As such, your emergency kit needs to be ready to go and kept with you, but it may not be used (and we hope it won't need to be!). This means that the medication needs to have a good shelf life, so that it is not constantly needing replacement due to expiry, without having being used. The complexity of bringing a pre-filled syringe or auto-injector to market The process of bringing a device that contains medication to market is very complicated, lengthy and highly regulated. A pre-filled syringe counts as both a device and a medication, so it needs to fulfil criteria for both categories. Initially, of course, and as you would expect, proof of the effectiveness of a product is required (clinical trials). The process for bringing an effective product to market involves many stakeholders: pharmaceutical companies, distributors, licensing organisations, NICE, and the MHRA, to name but a few. If a licence is issued in one geographical region, it is only for that region; so a licence in the US (from the Food and Drug Administration - FDA) will not automatically be licensed in the UK. Currently (although there are improvements underway), licensed products in the EU are not automatically recognised in the UK and vice versa. As an organisation, we want to share your experiences and influence the industry. To this end, we are building relationships with Pharma companies where we can, to represent your needs. Understanding what is in development, or what might be developed in the future, is further hindered, however, by complex confidentiality and non-disclosure requirements. Unfortunately, the complexity equates to an expensive and lengthy timescale: years, not months, and the confidentiality can lead to a sense of 'no progress being made'. Positive things on the Horizon The Office for Life Sciences (OLS) is a UK government initiative aimed at supporting research, innovation and technology. By 2030, they state that the UK will be one of the top three fastest places in Europe for patient access to medicines & Medtech. They are sharing 6 'headline actions' to achieve their plan of which 4 are very relevant to the adrenal insufficiency community: Streamlining regulation and market access: supporting the MHRA to become faster and more agile and giving industry a clearer route to market through joint advice and parallel approval with NICE, alongside a route for international reliance for medicines and medical devices. Introducing low-friction procurement: streamlining the route to procurement, ensuring it is clearer and less bureaucratic, giving industry low-friction access to the NHS through a Rules-Based Pathway (RBP) for MedTech and an NHS 'Innovator Passport'. Faster access to new treatments and technologies: The government wants the UK to be one of the fastest places in Europe to get new medicines and medical technologies, whilst ensuring patient safety More personalised and preventative care: a big shift from treating illness to diagnosing and preventing it early. This is particularly relevant due to the significance of early hydrocortisone injections in preventing adrenal crisis. (DHSC MedTech Patient Engagement Forum, October 2025) Value-based procurement is being given increasing recognition in the NHS: which is where products are chosen based on their ability to improve health outcomes, not just their price. This can only be good news. (DHSC MedTech Patient Engagement Forum, October 2025) AND...product development is happening! As an organisation representing the adrenal insufficiency community, it is really important for us to actively keep in touch with the companies that are involved in the development of alternative (and improved) treatment options for adrenal crisis. As mentioned above, in some cases, we are prevented from sharing the details as to who is doing what (ie which pharmaceutical and MedTech companies), because of certain compliance and confidentiality considerations. However, we can share that hydrocortisone products for adrenal crisis are actively under development now (and have been for some time) by more than one company, with a view to look at launching in the UK market. How is the ADSHG supporting the drive for an improved injection? In November 2020, we granted the Professor John Wass Research Award (£10,000) to Julia Antony, CEO of SOLUtion Medical for her research project to develop a simple, easy to use device to reduce complexity and difficulties of injections, providing an EpiPen-like experience. Six years later, after much hard work by Julia and her team in seeking commercial investment, SOLUtion Medical are now at the forefront of product design for our community. Read about our grant to SOLUtion Medical, thanks to your support! We are keeping up to date with what is happening across various pharmaceutical companies to keep you informed and sharing this information with the other Patient Support Groups who work with people with adrenal insufficiency and are supporting this campaign. We are pushing for improvements with the Department of Health and Social Care, having had one meeting with them in April, and another scheduled in May. We are sharing this progress and the outcomes with the Patient Support Groups who are supporting this campaign, and will keep you regularly updated. We continue to build valuable relationships with pharmaceutical and MedTech organisations to better understand the context of their industry, and the considerations around bringing medication and devices to market. We are working hard to ‘ready the market’ to make clear the positive impact that these devices will have on the adrenal insufficiency community. We are doing this through advocacy and supporting you to contact your MPs to make your opinions heard. We are also directly contacting MPs who have reached out to us following your MP letters. In April 2026 we drew up a one-page summary of the situation around the discontinuation of liquid hydrocortisone, with clear requests for action: Action by the Department of Health & Social Care to work with the MHRA and Pfizer Pharmaceuticals to urgently facilitate the availability of ‘Act-o-vial’ to patients in the UK, given the discontinuation of liquid hydrocortisone . Action by the Department of Health & Social Care, MHRA and Office for Life Sciences to expediate the development of an improved injection method (pre-filled syringe or auto-injector) for an intramuscular injection of hydrocortisone to prevent and treat adrenal crisis. We invited the UK Patient Support Groups to join us with this campaign and are grateful for their collaboration. We are also leading on a vital multi-stakeholder project called 'The Real Story' which brings together people with lived experience, clinicians, researchers, Patient Support Groups and representatives from the Society for Endocrinology and the Royal College of Emergency Medicine. Together we can ensure we have the information needed to drive improvements in adrenal crisis management and care. Thank you to our fellow Patient Support Groups for their collaboration! We are only able to do this work thanks to the support of our members, donors and fundraisers. Every donation to the ADSGH helps us raise awareness, improve adrenal crisis care and save lives. Your support ensures more people with adrenal insufficiency, including Addison's disease, are aware, prepared and understood. What else can you do to support change and improvements? Directly influencing politicians and policymakers is essential for improving services. Your voice matters, and you sharing your thoughts and experiences can really help drive change. We have put together a letter template for you to use if you want to contact your local MP to let them know how you feel about the challenges around the emergency hydrocortisone injection to treat adrenal crisis management. MP Letter Templates You can also help by sharing your experience of adrenal crisis: both in terms of how you work to prevent an adrenal crisis, and the experience you have had with an adrenal crisis. In collaboration with Dr Sofia Llahana from City St Georges, University of London, we have launched an important study to gather missing information about the prevention and management of adrenal crisis in the UK. Share your experience to help improve adrenal crisis care Are you a member of our charity? Whether you're newly diagnosed or have lived with the condition for years, please join our community and support our cause! 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