Anaphylaxis is a medical emergency and can be fatal if not treated immediately.1,2 Adrenaline remains the only effective first-line treatment capable of reversing anaphylaxis in all settings, including in the community,1,2 and should be administered without delay. However, more than a century after the therapeutic effect of adrenaline was first described——and decades after the development of devices for its self-administration——the majority of the world's population still lacks access to these potentially life-saving tools.3,4
Recent global surveys, including those conducted under the auspices of the World Allergy Organization (WAO), reveal an unpleasant reality: only about one-third of countries provide consistent access to any form of adrenaline device for self-administration.3 In the remaining countries, people at risk of anaphylaxis, including children, are forced to rely on improvisation, or worse, be entirely without protection. Even in those countries where adrenaline auto-injectors are available, only 44% of patients have a standardized action plan to guide its use to treat anaphylaxis.5
This situation represents a profound global health inequity, and one that must become an urgent priority for allergy organisations, health authorities, and policymakers worldwide.
Adrenaline devices: a global standard not yet global
Current devices for self-administration of adrenaline include auto-injectors and now an intranasal device. Other non-injectable formulations (eg, sublingual, transcutaneous) are under development. All of these are designed to ensure timely treatment outside of medical settings.6, 7, 8, 9 They are compact, user-friendly, and endorsed by all major guidelines. Their appropriate use reduces the morbidity associated with anaphylaxis, and provides a level of protection that is particularly important in schools and other public spaces.
Nevertheless, their availability remains limited almost exclusively to high-income nations.3 In many low- and middle-income countries, these devices are neither licensed nor included in national formularies. Where they are available, prohibitive pricing, lack of reimbursement, and fragile supply chains further restrict access.
This is not a technological failure. Rather, it is a failure of healthcare systems to ensure equitable access to essential medicines.
Improvisation is not a solution
In settings where adrenaline devices are not available, clinicians often attempt to bridge the gap by providing ampoules of adrenaline alongside syringes and dosing instructions. Some resort to prefilled syringes. While this may offer a temporary solution, it introduces unacceptable risks: errors and delays in dose and administration, degradation of medication, and difficulties during high-stress emergencies.
These strategies must be recognized as attempts to support a population at risk, but they are clearly inferior to approved devices designed specifically for self-administration. More importantly, they are a symptom of systemic neglect. Patients at risk of anaphylaxis, including in low-resource settings, deserve better than improvised kits and complex instructions in moments when every second can matter.
The inequity affects the most vulnerable, namely children
Children are particularly affected by this injustice. Food allergy, insect venom allergy, and idiopathic anaphylaxis often manifest early in life. The inability to access self-administered adrenaline places them at unacceptable risk. School staff and caregivers, who are often poorly trained to recognize an allergic reaction, face even greater challenges when required to prepare doses manually, under pressure, and without proper equipment.
This disparity is compounded by the absence of adrenaline emergency protocols in many school systems globally. Without the necessary medication and training, even well-prepared action plans become meaningless.10
The promise, and the danger, of innovation
The development of non-injectable adrenaline delivery systems is an important technological advance.9 These devices will overcome concerns over using an injection device, and are likely to be used earlier as a result. They are especially promising for paediatric and school-based settings.
However, innovation that fails to reach those in need will reinforce inequity. Without deliberate strategies to ensure availability and affordability worldwide, these new technologies risk repeating the same cycle: available in high-income settings only, priced beyond reach, and invisible in most national systems.
Progress in delivery methods must not obscure the larger problem: the global failure to guarantee access to adrenaline in any form.
Structural barriers demand systemic change
The continued absence of adrenaline for self-administration in two-thirds of the world stems from a combination of regulatory, economic, and structural barriers:
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Regulatory inertia delays the approval of devices in countries lacking robust pharmacovigilance frameworks or where regulatory reliance is underutilized.
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Lack of inclusion in essential medicines lists means national procurement systems do not prioritize these products.
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No local production or licensing models results in fragile supply chains and total dependence on imports.
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High out-of-pocket costs, even in countries where devices are licensed, mean that patients may be prescribed adrenaline devices but are unable to obtain them.
These challenges are most acute in regions such as Sub-Saharan Africa, Latin America, and parts of South and Southeast Asia, regions where allergic diseases are on the rise, but systems remain under-resourced.
A WAO call to action to the international community
As the global voice of allergists and immunologists, but also of the patients and several other health care providers, the WAO has a unique role in advocating for universal access to adrenaline self-administration. We propose the following priorities:11
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Promote the inclusion of devices for adrenaline self-administration in the WHO Model List of Essential Medicines, including intramuscular injection, intranasal, and other non-injectable options that may become available.
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Encourage national and international regulatory agencies to adopt reliance mechanisms and fast-track the approval of adrenaline delivery systems.
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Support public-private partnerships for the subsidized procurement and distribution of adrenaline devices in low-resource settings.
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Develop global educational campaigns targeting healthcare professionals, schools, and the public on the importance of timely adrenaline use.
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Work with governments to integrate adrenaline into universal health coverage frameworks, ensuring full or partial reimbursement and access without financial hardship.
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Expand data collection on anaphylaxis morbidity and mortality, and link outcomes to availability and use of adrenaline devices, highlighting the human cost of inaction.
Equity in emergency care is non-negotiable
Access to life-saving medication should not be dependent on where a person lives, what their income is, or whether their country's health system recognises adrenaline devices as essential. It should depend only on timely recognition and the availability of an effective treatment, which we already have.
We must stop accepting a world where resources, including innovation, benefits only the minority of the global population. Every child, every adult, in every region, must have access to self-administered adrenaline. Ensuring the availability, affordability, and integration of self-administered adrenaline into emergency care systems is not just a clinical responsibility; it is a moral and public health imperative.
Use of Generative artificial intelligence (AI) and AI tools
A generative AI tool was used for language review.
Funding
Not applicable.
Declaration of competing interest
Martin declares Speaker honorarium and advisory panel consultancy from Sanofi and Merck.
Turner declares grants from UK Medical Research Council, the UK Food Standards Agency, The Jon Moulton Charity Trust, NIHR/Imperial Biomedical Research Centre, outside the submitted work; personal fees from UK Food Standards Agency, UpToDate, Elsevier and ALK outside the submitted work.
Fiocchi has received Speaker honoraria and advisory panel consultancy outside the submitted work for Nutricia, Abbott, Danone, Stallergenes, DBV, Novartis. Funded research (Institution) from Sanofi, Novartis, Ferrero, DBV, GSK, Astrazeneca, Hipp GmBDH, Humana SpA.
Ebisawa reports personal fees from Viatris and SAB of ARS-Pharmaceuticals, Novartis, and Sanofi outside the submitted work.
Ansotegui reports personal fees from Bayer, Bial, Cipla, Eurodrug, Faes Farma, Gebro, Glenmark, Opella, Menarini, MSD, Roxall and Sanofi outside the submitted work.
Bernstein reports Investigator and consultant fees from Novartis, Genentech, Sanofi, Regeneron, Celldex, Cogent, Blueprint Medicine, Telios, Astra Zeneca, GSK, Takeda/Shire, CSL Behring, Pharming, Biocyrst, Astria, Intellia, Kalvista, Pharvaris, Amgen, Areteia, Allergy therapeutics, Apogee, Opella, Ajou University, Kyowa Kirin, ARS, Eli Lilly, Escient, Evommune, Jasper, TEVA, and Yuhan; and speaker fees from Pharming, Kalvista, CSL Pharming.
Fonacier has participated in the advisory board and/or consultant/speaker or received research grant paid to NYU Grossman Long Island School of Medicine from Regeneron, Sanofi, AstraZeneca, Dermavant, Blueprint.
Giavina-Bianchi declares speaker honoraria from Novartis.
Lang reports that he has served as a consultant for, carried out clinical research with, and/or has received honoraria from: AstraZeneca, Celldex, Genentech, Novartis, Sanofi-Regeneron.
Morita reports consulting/advisory board agreements with Sanofi, LEO Pharma, and Otsuka Pharmaceutical Co., Ltd.
Papadopoulos reports that he has served as a consultant for, carried out clinical research with, received grants from, and/or has received honoraria from: Abbott Nutrition, Berlin – Chemie AG, Danone, DBV Technologies, GSK, HAL Allergy, Hyproca Nutrition, MED Maps SRL, Menarini, Nestle Nutrition Institute, Numil, Regneron, Vianex, Vibrant America.
All other authors have no conflict of interest within the scope of the submitted work (Morais-Almeida, Wong, Al-Nesf, Chantaphakul, Chikovani, Fasano, Gómez, González-Díaz, Hossny, Ortega-Martell, Tanno).
Footnotes
Full list of author information is available at the end of the article.
References
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