title: A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.
abstract: The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies.
  
  
  
  Our objective was to explore the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; to explore gaps and inconsistencies in the reporting process; and to identify the causes of under-reporting ADEs in these settings.
  
  
  
  The Tufts Center for the Study of Drug Development (Tufts CSDD) interviewed 11 thought leaders and conducted a survey between May and August 2014 among US-based healthcare providers (HCPs) in diverse settings to assess their experiences with, and processes for, reporting ADEs.
  
  
  
  A total of 123 individuals completed the survey (42 % were pharmacists; 27 % were nurses; 15 % were physicians; and 16 % were classified as 'other'). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously (66 % of respondents); that HCPs lack sufficient time to report ADEs (63 % of respondents); poor integration of ADE-reporting systems (53 % of respondents); and uncertainty about reporting procedures (52 % of respondents).
  
  
  
  The results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies.
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts Medical School, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA. stella.stergiopoulos@tufts.edu.
authors.forename: Stella
authors.identifier: 0000-0001-6868-0493
authors.initials: S
authors.lastname: Stergiopoulos
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts Medical School, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA.
authors.forename: Carrie A
authors.initials: CA
authors.lastname: Brown
authors.affiliation: Amgen Inc., Washington, DC, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Felix
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Gustavo
authors.initials: G
authors.lastname: Grampp
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts Medical School, 75 Kneeland Street, Ste 1100, Boston, MA, 02111, USA.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Getz
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001291:Attitude of Health Personnel; D006761:Hospitals; D006801:Humans; D009726:Nurses; D010594:Pharmacies; D010595:Pharmacists; D010820:Physicians; D010865:Pilot Projects; D011331:Private Practice; D011795:Surveys and Questionnaires; D014481:United States