title: Nurses' reporting of suspect adverse drug reactions: a mixed-methods study.
abstract: OBJECTIVE
  To assess nurses' knowledge, attitudes and practices (KAP) towards spontaneous adverse drug reactions (ADRs) reporting.
  
  
  METHODS
  The mixed-method study was conducted following a quanti-qualitative sequential approach: a survey (using a KAP questionnaire) followed by a focus group was performed.
  
  
  RESULTS
  In the quantitative findings, responders (570 hospital nurses) declared that they were unaware of the pharmacovigilance system (58.1%, n = 331); where to find the reporting form (63.5%, n = 362); how fill it in (71.6%, n = 408); to whom and how to send it (65.8%, n = 375). Only 11.1% (n = 63) reported ADRs. The qualitative phase supported the quantitative findings and provided new information about other factors that condition ADR reporting: misinterpretation of the meaning of "reporting", unawareness of nurses' autonomy in ADR reporting and fear of consequences after ADR reporting.
  
  
  CONCLUSIONS
  Nurses are not fully aware of their role in ADR reporting. We recommend educational interventions and management changes.
authors.affiliation: Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma Tor Vergata, Rome, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: De Angelis
authors.affiliation: Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute, Istituto Superiore di Sanità, Rome, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Giusti
authors.affiliation: Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma Tor Vergata, Rome, Italy.
authors.forename: Sofia
authors.initials: S
authors.lastname: Colaceci
authors.affiliation: Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma Tor Vergata, Rome, Italy.
authors.forename: Ercole
authors.initials: E
authors.lastname: Vellone
authors.affiliation: Dipartimento di Biomedicina e Prevenzione, Università degli Studi di Roma Tor Vergata, Rome, Italy.
authors.forename: Rosaria
authors.initials: R
authors.lastname: Alvaro
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D009726:Nurses; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires; D000078329:Workforce