Display options
Cite
Crescioli G, Boscia E, Bettiol A, et al. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals (Basel). 2021;14(7)doi: 10.3390/ph14070678.
Crescioli, G., Boscia, E., Bettiol, A., Pagani, S., Spada, G., Vighi, G. V., Bonaiuti, R., Venegoni, M., Vighi, G. D., Vannacci, A., Lombardi, N., & On Behalf Of The MEREAFaPS Study Group. (2021). Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals (Basel, Switzerland), 14(7), . https://doi.org/10.3390/ph14070678
Crescioli, Giada, et al. "Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments." Pharmaceuticals (Basel, Switzerland) vol. 14,7 (2021). doi: https://doi.org/10.3390/ph14070678
Crescioli G, Boscia E, Bettiol A, Pagani S, Spada G, Vighi GV, Bonaiuti R, Venegoni M, Vighi GD, Vannacci A, Lombardi N, On Behalf Of The MEREAFaPS Study Group. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals (Basel). 2021 Jul 15;14(7). doi: 10.3390/ph14070678. PMID: 34358104; PMCID: PMC8308702.
Copy Download .nbib Format: NLM
Share it on

Pharmaceuticals (Basel). 2021 Jul 15;14(7). doi: 10.3390/ph14070678.

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments.

Pharmaceuticals (Basel, Switzerland)

Giada Crescioli, Ennio Boscia, Alessandra Bettiol, Silvia Pagani, Giulia Spada, Giuditta Violetta Vighi, Roberto Bonaiuti, Mauro Venegoni, Giuseppe Danilo Vighi, Alfredo Vannacci, Niccolò Lombardi, On Behalf Of The MEREAFaPS Study Group

Affiliations

  1. Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50139 Florence, Italy.
  2. Tuscan Regional Center of Pharmacovigilance, 50122 Florence, Italy.
  3. Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
  4. Internal Medicine, Medical Department, Vimercate Hospital, ASST di Vimercate, 20871 Vimercate, Italy.
  5. Joint Laboratory of Technological Solutions for Clinical Pharmacology, Pharmacovigilance and Bioinformatics, University of Florence, 50139 Florence, Italy.
  6. Pharmacology Unit, Department of Diagnostics and Public Health, University of Verona, 37100 Verona, Italy.

PMID: 34358104 PMCID: PMC8308702 DOI: 10.3390/ph14070678

Abstract

This post hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visits and hospitalization in women and men. During the study period (January 2007-December 2018), 61,855 reports of ADEs leading to ED visits were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13-176), antidepressants (ROR 1.12, CI 1.03-1.23) and antidiabetics (ROR 1.13, CI 1.02-1.24). Among men, only vitamin K antagonists (ROR 1.28, CI 1.09-1.50), opioids (ROR 1.30, CI 1.06-1.60) and digitalis glycosides (ROR 1.32, CI 1.09-1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidities were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing an adverse event following immunization (ROR 0.36, CI 0.27-0.48 and 0.83, 0.42-0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

Keywords: clinical pharmacology; emergency department; female; male; pharmacovigilance

References

  1. Front Pharmacol. 2020 Apr 06;11:412 - PubMed
  2. BMJ Open. 2018 Feb 22;8(2):e020203 - PubMed
  3. Eur Heart J Cardiovasc Pharmacother. 2017 Jul 1;3(3):163-182 - PubMed
  4. Gerontologist. 1996 Feb;36(1):88-99 - PubMed
  5. Intern Emerg Med. 2021 Apr;16(3):741-748 - PubMed
  6. Psychiatry Res. 2019 Oct;280:112506 - PubMed
  7. Am J Psychiatry. 2004 Aug;161(8):1324-33 - PubMed
  8. J Am Geriatr Soc. 2018 Jan;66(1):133-139 - PubMed
  9. Front Pharmacol. 2020 May 06;11:564 - PubMed
  10. Risk Manag Healthc Policy. 2020 Jan 29;13:63-71 - PubMed
  11. J Allergy Clin Immunol. 2014 Jan;133(1):16-26 - PubMed
  12. Adv Ther. 2020 Jan;37(1):61-82 - PubMed
  13. Eur J Clin Pharmacol. 2005 Mar;61(1):47-53 - PubMed
  14. Br J Clin Pharmacol. 2019 Jul;85(7):1507-1515 - PubMed
  15. Front Pharmacol. 2021 Jan 29;11:611102 - PubMed
  16. Intern Emerg Med. 2020 Oct;15(7):1291-1302 - PubMed
  17. Front Pharmacol. 2019 Aug 30;10:948 - PubMed
  18. Clin Pharmacokinet. 1998 Mar;34(3):203-18 - PubMed
  19. Sci Rep. 2020 Oct 16;10(1):17545 - PubMed
  20. Obstet Gynecol. 2013 Nov;122(5):1077-1081 - PubMed
  21. Neuropsychopharmacology. 2019 Jan;44(1):140-154 - PubMed
  22. Br J Clin Pharmacol. 2012 Dec;74(6):1045-52 - PubMed
  23. BMC Pharmacol Toxicol. 2018 Apr 16;19(1):16 - PubMed
  24. Adv Drug Deliv Rev. 2021 Aug;175:113804 - PubMed
  25. PLoS One. 2020 Apr 23;15(4):e0231564 - PubMed
  26. J Clin Pharmacol. 1998 Nov;38(11):1003-9 - PubMed
  27. Crit Care Clin. 2021 Jul;37(3):501-516 - PubMed
  28. Br J Clin Pharmacol. 2011 Jan;71(1):95-104 - PubMed
  29. Pharmacology. 2009;84(6):333-9 - PubMed
  30. J Clin Med. 2021 Apr 01;10(7): - PubMed
  31. Br J Pharmacol. 2014 Feb;171(3):580-94 - PubMed
  32. Eur J Intern Med. 2017 Oct;44:e30-e31 - PubMed
  33. Diabetes Metab Syndr Obes. 2014 Sep 16;7:409-20 - PubMed
  34. J Racial Ethn Health Disparities. 2015 Dec;2(4):527-36 - PubMed
  35. Addict Behav. 2021 Jan;112:106608 - PubMed
  36. Trials. 2012 Aug 20;13:138 - PubMed
  37. Expert Opin Drug Saf. 2016 Jan;15(1):1-4 - PubMed
  38. Medicine (Baltimore). 2014 Oct;93(17):309-317 - PubMed
  39. Diabetes Care. 2009 Dec;32(12):e148 - PubMed
  40. Lancet. 2000 Oct 7;356(9237):1255-9 - PubMed
  41. EClinicalMedicine. 2019 Oct 25;17:100188 - PubMed
  42. J Antimicrob Chemother. 2016 Jul;71(7):1800-6 - PubMed
  43. Biol Sex Differ. 2021 May 3;12(1):34 - PubMed
  44. Sci Rep. 2020 Nov 3;10(1):18964 - PubMed
  45. Clin Pharmacokinet. 2003;42(2):107-21 - PubMed
  46. Front Pharmacol. 2018 Sep 04;9:1003 - PubMed

Publication Types

Grant support