title: Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy.
abstract: OBJECTIVE
  Adverse drug reaction (ADR) reporting by patients has a fundamental role in pharmacovigilance. The main objectives of the present study were to assess the impact of a pharmacist-based intervention in promoting direct patient reporting, to evaluate patient ability to identify and report ADRs and to determine their pattern.
  
  
  METHODS
  The study involved 96 pharmacists in the Campania region of Italy, who interviewed their customers and asked them whether they had experienced an ADR. Patients who had experienced an ADR were invited to complete an ADR reporting form. The quality of completed ADR reporting forms was evaluated before their entry into the Italian Spontaneous Reporting System (Rete Nazionale di Farmacovigilanza [RNF]) and, once entered, their pattern was determined.
  
  
  RESULTS
  A total of 18,677 patients were interviewed, and 10.88% had experienced an ADR. After quality control, 54.32% of all reporting forms were entered into the RNF so that patient contribution to spontaneous reporting, null over the years, reached ∼7%. Patients reported mainly non-serious (91.28%) and expected (94.62%) ADRs, and NSAIDs or antibiotics were the most frequently reported drugs.
  
  
  CONCLUSIONS
  The study shows that pharmacists can have an important role in promoting patient reporting and adds new information on how a patient reporting form should be structured.
authors.affiliation: Second University of Naples, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Faculty of Medicine and Surgery , Via De Crecchio, 7, 80138 Naples , Italy +39 0815667652 ; +39 0815667652 ; elisabetta.parretta@unina2.it.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Parretta
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.forename: Lara
authors.initials: L
authors.lastname: Magro
authors.forename: Anna
authors.initials: A
authors.lastname: Coggiola Pittoni
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.forename: Carmen
authors.initials: C
authors.lastname: Ferrajolo
authors.forename: Annamaria
authors.initials: A
authors.lastname: Mascolo
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sessa
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D003157:Community Pharmacy Services / Q000458:organization & administration*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010595:Pharmacists / Q000458:organization & administration*; D060735:Pharmacovigilance; D024382:Professional Role; D057566:Self Report; D055815:Young Adult
keywords: direct patient reporting; pharmacist; pharmacovigilance; spontaneous reporting