Health Canada has released its Draft Guidance Document for Industry, Reporting Adverse Reactions to Marketed Health Products

2008 ◽  
Vol &NA; (1186) ◽  
pp. 2
Author(s):  
&NA;
2019 ◽  
Vol 32 (2) ◽  
pp. 91
Author(s):  
Ana Teresa Fróis ◽  
Teresa Cardoso

Introduction: Anaphylaxis is significantly underdiagnosed, and the medical community’s knowledge about it is precarious. The aim of this study is to characterize the patient population and the Emergency Department approach of anaphylaxis.Material and Methods: Retrospective study of adult patients attending the Emergency Department of a tertiary care Portuguese hospital, over a year, with anaphylaxis. Data were obtained from each patient’s clinical records and anonymized. A questionnaire evaluating knowledge about the notification of anaphylaxis was applied to Emergency Department physicians.Results: The study included 69 patients. Cutaneous (97%) and respiratory features (80%) were most prevalent; 22% of patients presented with shock or related symptoms. There were no reported biphasic reactions or deaths. The likely allergen was identified in 73%, most commonly food; 12% of reactions were related to a previously known allergen. Epinephrine was administered to 15%. Referral to an Immunoallergologist was done in 36% of patients, and 10% received or already possessed an epinephrine autoinjector. Among six parameters recommended for auditing clinical practice, 70% of cases fulfilled less than half. Only 13% of physicians knew it was mandatory to register all cases in the Portuguese Catalogue of Allergies and Other Adverse Reactions, and only 4% knew how to do it; regarding notification to the National Authority of Medicines and Health Products results were slightly better.Discussion: Many patients with anaphylaxis present to the Emergency Department every year, and their clinical approach is not in agreement with national guidelines. Conclusion: An educational program to increase medical awareness of the national guidelines and mandatory notification of all anaphylactic reactions should be implemented.


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