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Original Article
 

Quality Assurance of Allergen-Specific Immunotherapy During a National Outbreak of Anaphylaxis: Results of a Continuous Sentinel Event Surveillance System
 

F Madsen,1 L Frølund,2 M Christensen,3 A Frost,4 U Søes Petersen5

1 Allergy and Lungclinic Helsingør. Sct. Olai Gade 39 1, 3000 Helsingør, Denmark
2 Allergy and Lungclinic Hellerup, Bernstorffsvej 20, 2900 Hellerup, Denmark
3 Lung and Allergy Clinic Aabenraa, Madevej 11, 6200 Åbenrå, Denmark
4 Specialist Clinic Hellerup, Hans Edvard Teglersvej 9, 2920 Charlottenlund, Denmark
5 Roskilde Hospital, Department of Internal Medicine, Roskilde, Roskilde Sygehus Køgevej 7-13, 4000 Roskilde, Denmark

J Investig Allergol Clin Immunol 2009; Vol. 19(4): 253-259
 

 Abstract


Background and Objective: Subcutaneous allergen-specific immunotherapy (SCIT) is an effective treatment for patients with allergic asthma and rhinitis. SCIT may be performed in many different ways and good safety profiles have been published. Other studies, however, have reported high frequencies of severe adverse events (SAEs) but without identifying the causes. After an increase in SCIT-related SAEs in Denmark between 2003 and 2004, strict performance regulations were imposed by the authorities. Because safety data from national databases were not available, we implemented a surveillance system aimed at identifying the causes of SAEs.

Methods: We prospectively registered the number of injections and SAEs during SCIT. A slow up-dosing regimen was used and adherence to international standards was optimized.

Results: No SAEs were observed with 28 992 injections. The maximal risk per injection was calculated at <1.3 per 10 000 injections.

Discussion: Our results confirm the good safety profile of SCIT. We applied a sentinel SCIT surveillance system that may offer a means of guaranteeing safety by providing online feedback to all participating clinics when SAEs occur in order to explore their causes by root course analyses performed by all participants. Furthermore, such quality assurance documentation may facilitate wider acceptance of SCIT by health care administrators, clinicians, and patients.

Key words: Safety. Risk management. Allergen immunotherapy. Risk. Immunotherapies. Allergen. Sentinel surveillance