Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
Volume 10, Issue 2, Pages 444-452Publisher
ELSEVIER
DOI: 10.1016/j.jaip.2021.10.057
Keywords
Allergen immunotherapy; Allergen extract; Extract shortage; Disruption of allergen immunotherapy; Immunotherapy extract; Venom immunotherapy; Allergen extract supply; Allergy extract supply; Allergen extract shortage; Allergy extract shortage
Categories
Funding
- AAAAI, Immunotherapy, Allergen Standardization and Allergy Diagnostics (IASAD) committy
- AAAAI, Practice, Diagnostics and Therapeutics (PDT) committy
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Allergen immunotherapy is the only disease-modifying therapy for allergic diseases, but the manufacturing of extracts used in the therapy is complex and subject to regulatory oversight, making the supply vulnerable to disruptions and potentially impacting patient care.
Allergen immunotherapy (AIT) is the only disease-modifying therapy indicated for treatment of allergic asthma, rhinitis, conjunctivitis, and Hymenoptera hypersensitivity. Manufacturing of the extracts used in AIT involve multistep complex processes as well as regulatory oversight. Furthermore, some source materials are vulnerable to unexpected events of nature. Given these circumstances, allergen extract supply can be disrupted with a potential to adversely impact patient care. A group of members from the American Academy of Allergy, Asthma, and Immunology (AAAAI) Immunotherapy, Allergy Standardization and Allergy Diagnostic Committee formed a workgroup to assess the frequency and effects of allergen extract shortages and associated factors. This workgroup developed a survey that was distributed to a random 20% of the AAAAI membership. In addition, the group also performed a review of the scientific literature on allergen extract supply and shortage. Based on the findings of the survey study and literature review, the workgroup reports frequency and extent of shortages, potential ways to improve communication with suppliers, and need for further guidance in patient care during times of shortage. (C) 2021 American Academy of Allergy, Asthma & Immunology
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