Development and validation of an algorithm to identify drug-induced anaphylaxis in the Beijing Pharmacovigilance Database
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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”, “anaphylactic reaction”, and “anaphylactoid reaction [severe]” was 89.6% (95% CI 86.6–92.4%); this partial algorithm identified 387 (87.2%) DIAs. The diagnosis that identified the most DIAs (83.8%) was “anaphylactic shock”, with a PPV of 91.6% (95% CI 88.9–94.3%). Conclusion The overall algorithm identified a greater number of DIAs than the algorithm that only used specific diagnoses; however, its PPV was slightly lower. We were able to identify DIAs with the algorithm we developed.
KeywordsAlgorithm Anaphylaxis China Pharmacovigilance Pharmacoepidemiology Positive predictive value Validation
The authors would like to thank the Beijing Pharmacovigilance Database for providing data.
This research is partially supported by the Research Grant 892FY60221022 from School of Pharmaceutical Sciences, Peking University.
Conflicts of interest
The authors have no conflicts of interest to declare.
- 6.Baldo BA, Pham NH. Classification and descriptions of allergic reactions to drugs. In: Drug allergy: clinical aspects, diagnosis, mechanisms, structure–activity relationships. New York, Springer; 2013.Google Scholar
- 7.Motosue MS, Bellolio MF, Van Houten HK, Shah ND, Li JT, Campbell RL. Outcomes of emergency department anaphylaxis visits from 2005 to 2014. J Allergy Clin Immunol Pract. 2017.Google Scholar
- 8.Motosue MS, Bellolio MF, Van Houten HK, Shah ND, Bellamkonda VR, Nestler DM, et al. Temporal trends in epinephrine dispensing and allergy/immunology follow-up among emergency department anaphylaxis patients in the United States, 2005–2014. J Allergy Clin Immunol Pract. 2017;5(5):1272–9.CrossRefPubMedGoogle Scholar
- 14.West SL, D’Aloisio AA, Ringel-Kulka T, Waller AE, Clayton Bordley W. Population-based drug-related anaphylaxis in children and adolescents captured by South Carolina Emergency Room Hospital Discharge Database (SCERHDD) (2000–2002). Pharmacoepidemiol Drug Saf. 2007;16(12):1255–67.CrossRefPubMedGoogle Scholar
- 18.China Food and Drug Administration Department of Pharmacovigilance and National Adverse Drug Reaction Monitoring Center. Appendix3. Assessment Criteria of Common Adverse Drug Events. Handbook for Regulations on Adverse Drug Events Reporting and Monitoring. 2012. P47–48.Google Scholar
- 19.The World Health Organization-Uppsala Monitoring Center. What is WHO-ART? https://www.who-umc.org/vigibase/services/learn-more-about-who-art/. Accessed 11 May 2017.
- 20.The World Health Organization-Uppsala Monitoring Center. The use of the WHO-UMC system for standardized case causality assessment. https://www.who-umc.org/media/2768/standardised-case-causality-assessment.pdf. Accessed 11 July 2017.
- 22.Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, et al. Second symposium on the definition and management of anaphylaxis: summary report–second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. Ann Emerg Med. 2006;47(4):373–80.CrossRefPubMedGoogle Scholar