title: Subjective Reasons for Non-Reporting of Adverse Drug Reactions in a Sample of Physicians in Outpatient Care.
abstract: BACKGROUND
  Drug safety surveillance strongly depends on the spontaneous reporting of adverse drug reactions (ADRs). A major limiting factor of spontaneous reporting systems is underreporting (UR) which describes incorrectly low reporting rates of ADRs. Factors contributing to UR are numerous and feature country-dependent differences. Understanding causes of and factors associated with UR is necessary to facilitate targeted interventions to improve ADR reporting and pharmacovigilance.
  
  
  METHODS
  A cross-sectional questionnaire-based telephone survey was performed among physicians in outpatient care in a federal state of Germany.
  
  
  RESULTS
  From n=316 eligible physicians n=176 completed the questionnaire (response rate=55.7%). Most of the physicians (n=137/77.8%) stated that they report ADRs which they have observed to the competent authority rarely (n=59/33.5%), very rarely (n=59/33.5%) or never (n=19/10.8%); the majority (n=123/69.9%) had not reported any ADRs in 2014. Frequent subjective reasons for non-reporting of ADR were (specified response options): lack of time (n=52/29.5%), the subjective evaluation that the required process of reporting is complicated (n=47/26.7%) or requires too much time (n=25/14.2%) or the assessment that reporting of an ADR is needless (n=22/12.5%); within open answers the participants frequently stated that they do not report ADRs that are already known (n=72/40.9%) and they only report severe ADRs (n=46/26.1%).
  
  
  CONCLUSIONS
  Our results suggest a need to inform physicians about pharmacovigilance and to modify the required procedure of ADR reporting or to offer other reporting options.
authors.affiliation: Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg, Ulm, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Gahr
authors.affiliation: Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg, Ulm, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Eller
authors.affiliation: Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg, Ulm, Germany.
authors.forename: B J
authors.initials: BJ
authors.lastname: Connemann
authors.affiliation: Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg, Ulm, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Schönfeldt-Lecuona
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001291:Attitude of Health Personnel; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D010820:Physicians / Q000523:psychology*