Development and validation of an algorithm to identify drug-induced anaphylaxis in the Beijing Pharmacovigilance Database.

International Journal of Clinical Pharmacy
Ying ZhaoTiansheng Wang

Abstract

Background Pharmacovigilance databases are utilized to identify serious adverse drug events (ADEs). In China, very few studies have evaluated the validity of using pharmacovigilance databases to identify drug-induced anaphylaxis (DIA). Objective We aimed to develop and validate an algorithm to identify DIA using the Beijing Pharmacovigilance Database (BPD). Setting ADEs from the BPD mainly spontaneously reported from 94 hospitals in Beijing, China. Method Using the diagnoses, we developed an algorithm to identify potential DIAs from the BPD between January 2004 and December 2014. A sample of 500 patients was randomly selected for chart abstraction. Two physician adjudicators assessed whether DIA occurred using the published clinical criteria as the gold standard. Main outcome measure Positive predictive values (PPVs) and 95% confidence intervals of the algorithm and algorithm criteria components were calculated. Results 500 patients (53.2% female; the mean age 48.2 years) with potential DIA were selected using the algorithm. 444 were adjudicated as having anaphylaxis by physicians. The PPV of the overall algorithm was 88.8% (95% CI 86.0-91.6%). PPV for the algorithm only using specific diagnoses of "anaphylactic shock", "anaphy...Continue Reading

References

Jul 1, 1996·Clinical Pharmacology and Therapeutics·N J BrownM R Griffin
Nov 3, 2001·The Journal of Allergy and Clinical Immunology·A F BrownK Chu
Mar 10, 2004·The Journal of Allergy and Clinical Immunology·Kari BohlkeUNKNOWN Vaccine Safety Datalink Team
Aug 19, 2004·The Journal of Allergy and Clinical Immunology·Simon G A Brown
Aug 19, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Catherine B JohannesGerald Faich
Jan 22, 2008·The Journal of Allergy and Clinical Immunology·Marianne Phelan RossStefano Luccioli
Apr 17, 2008·Hypertension·Donald R MillerDavid E Lillienfeld
May 22, 2010·Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology·Carlos IribarrenMark D Eisner
Nov 30, 2011·British Journal of Clinical Pharmacology·Pernille WarrerLise Aagaard
Dec 27, 2011·Journal of Clinical Epidemiology·Jessica ChubakNoel S Weiss
Jun 30, 2012·Pharmacoepidemiology and Drug Safety·Sarah L CutronaJerry H Gurwitz
Aug 24, 2012·European Journal of Clinical Pharmacology·Inês Ribeiro-VazEva Rebelo Gomes
Feb 1, 2011·The World Allergy Organization Journal·F Estelle R SimonsUNKNOWN World Allergy Organization
Feb 14, 2013·BMJ : British Medical Journal·F Estelle R Simons, Aziz Sheikh
Sep 17, 2013·Pharmacoepidemiology and Drug Safety·Kathleen E WalshSusan Andrade
Jun 10, 2014·Allergy·A MuraroUNKNOWN EAACI Food Allergy and Anaphylaxis Guidelines Group
Oct 5, 2014·The Journal of Allergy and Clinical Immunology·Elina JerschowAileen P McGinn
May 20, 2015·Journal of Research in Pharmacy Practice·Pernille WarrerEbba Holme Hansen
Nov 4, 2015·The World Allergy Organization Journal·F Estelle R SimonsAziz Sheikh
Nov 7, 2015·The American Journal of Emergency Medicine·Damian V BaalmannRonna L Campbell
Nov 8, 2016·The Journal of Allergy and Clinical Immunology. in Practice·Megan S MotosueRonna L Campbell
May 16, 2017·International Archives of Allergy and Immunology·Tiansheng WangSuodi Zhai
Aug 2, 2017·The Journal of Allergy and Clinical Immunology. in Practice·Megan S MotosueRonna L Campbell
Sep 25, 2017·The Journal of Allergy and Clinical Immunology. in Practice·Megan S MotosueRonna L Campbell
Nov 1, 2017·International Journal of Clinical Pharmacy·Ying ZhaoTiansheng Wang

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Aug 23, 2018·International Journal of Clinical Pharmacy·Linda Gore MartinVibhu Paudyal
Jul 28, 2018·International Journal of Clinical Pharmacy·Ying ZhaoShusen Sun

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Anaphylaxis

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.