Our partner Food Allergy Italia has just launched a petition to ensure everywhere in Italy the availability of auto-injector adrenaline, a life-saving drug in cases of anaphylactic shock caused by food and non-food allergies.
We ask all our readers to sign this petition, on Change.org, in order to put an end to the recurrence of tragedies that can be predicted and avoided. Here’s how and why.
1) Allergies and anaphylactic shock. Foreword
The World Allergy Organization (WAO) defines anaphylaxis as ‘a severe, systemic hypersensitivity reaction, usually rapid onset, that can cause death.’ (1) Anaphylactic shock is characterized as follows:
- lawsuit. Allergic reactions to food, drugs, hymenoptera stings (e.g., wasps, yellowthroats, hornets, bees), (2)
- effects. The most acute reactions can cause permanent damage (e.g., cerebral ischemia, myocardial infarction), up to and including death.
2) Adrenaline with auto-injector, the only lifesaver.
Prompt administration of adrenaline, intramuscularly, is indicated in international guidelines as first-aid drug treatment in cases of anaphylaxis. And the auto-injector facilitates its use, as well as shortening execution time and reducing error margins. (3)
The European Medicines Agency (EMA), in 2015, recommended that the medical community:
- Instruct allergic patients on the use of adrenaline with self-injector, while at the same time
- Prescribe two adrenaline auto-injectors, to patients at risk of anaphylaxis, to mitigate any possible risk of ineffectiveness of the first administration.
3) Two indispensable self-injectors
A single self-injector of adrenaline may not be enough in cases of anaphylactic shock in the hypotheses of:
- Incorrect use or error in administration,
- Absence of clinical improvement or worsening.
A second adrenaline auto-injector , in such cases, can save the life of the allergic patient. Its availability is therefore indispensable.
4) Fragmented rights
The prescription of two adrenaline auto-injectors, recommended by EMA in 2015 (see supra, para. 2), has also been formally implemented by AIFA (Agenzia Italiana del Farmaco). But the rights of allergy patients are fragmented and asymmetrical, in the various regions and ASLs of Italy.
Self-injectable adrenaline, introduced in Italy in 1995, was classified by AIFA in 2005 as a band H (hospital) drug. Accordingly, it:
- can be used in the hospital, or
- distributed at hospital center pharmacies on prescription from the hospital allergist (or general practitioner, in some regions).
5) Inaccessibility of the drug
Therefore, the life-saving medication is often inaccessible due to the lack of allergy services that can quickly manage the treatment plan, i.e., long waiting lists that do not allow the prescription to be obtained quickly.
Instead, the response to anaphylactic shock must be immediate and cannot be constrained to the often biblical time frames of the National Health System. Nor to the proximity and ease of reaching a hospital emergency room in a few moments.
6) Petition. Our instances
It is necessary and urgent:
- classify adrenaline with auto-injector as a life-saving drug (Band A) and thus make it available in every pharmacy,
- Include anaphylactic reaction in the Essential Levels of Care (EAA),
- Ensure the provision of the two self-injectors certain and free of charge for allergic patients,
- Activate a specific training campaign for specialists, pediatricians, general practitioners and primary care physicians.
#Égalité
Dario Dongo
Notes
(1) Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Sanchez Borges M, Senna G, Sheikh A, Tanno LK, Thong BY, Turner PJ, Worm M. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020 Oct 30;13(10):100472. doi: 10.1016/j.waojou.2020.100472
(2) Allergy Verona (2020). Study of Hymenoptera venom allergy. https://www.allergyverona.it/studio-dellallergia-a-veleno-di-imenotteri/ Simple Departmental Unit of Allergology, Integrated University Hospital Company
(3) Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, Riggioni C, de Silva D, Angier E, Arasi S, Bellou A, Beyer K, Bijlhout D, Bilò MB, Bindslev-Jensen C, Brockow K, Fernandez-Rivas M, Halken S, Jensen B, Khaleva E, Michaelis LJ, Oude Elberink HNG, Regent L, Sanchez A, Vlieg-Boerstra BJ, Roberts G; European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022 Feb;77(2):357-377. doi: 10.1111/all.15032
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
