title: Language does not come "in boxes": Assessing discrepancies between adverse drug reactions spontaneous reporting and MedDRA® codes in European Portuguese.
abstract: BACKGROUND
  The description of adverse drug reactions (ADRs) by health care professionals (HCPs) can be highly variable. This variation can affect the coding of a reaction with the Medical Dictionary for Regulatory Activities (MedDRA(®)), the gold standard for pharmacovigilance database entries. Ultimately, the strength of a safety signal can be compromised.
  
  
  OBJECTIVE
  The objective of this study was to assess: 1) participation of different HCPs in ADR reporting, and 2) variation of language used by HCPs when describing ADRs, and to compare it with the corresponding MedDRA(®) codes.
  
  
  METHODS
  A retrospective content analysis was performed, using the database of spontaneous reports submitted by HCPs in the region of the Southern Pharmacovigilance Unit, Portugal. Data retrieved consisted of the idiomatic description of all ADRs occurring in 2004 (first year of the Unit activity, n = 53) and in 2012 (n = 350). The agreement between the language used by HCPs and the MedDRA(®) dictionary codes was quantitatively assessed.
  
  
  RESULTS
  From a total of 403 spontaneous reports received in the two years, 896 words describing ADRs were collected. HCPs presented different levels of pharmacovigilance participation and ADR idiomatic descriptions, with pharmacists providing the greatest overall contribution. The agreement between the language used in spontaneous reports and the corresponding MedDRA(®) terms varied by HCP background, with nurses presenting the poorer results than medical doctors and pharmacists when considering the dictionary as the gold standard in ADRs' language.
  
  
  CONCLUSIONS
  Lexical accuracy and semantic variations exist between different HCP groups. These differences may interfere with the strength of a generated safety signal. Clinical and MedDRA(®) terminology training should be targeted to increase not only the frequency, but also the quality of spontaneous reports, in accordance with HCPs' experience and background.
authors.affiliation: Clinical Pharmacy Group, Faculty of Pharmacy, University of Helsinki, Finland.
authors.forename: Pedro
authors.initials: P
authors.lastname: Inácio
authors.affiliation: Clinical Pharmacy Group, Faculty of Pharmacy, University of Helsinki, Finland.
authors.forename: Marja
authors.initials: M
authors.lastname: Airaksinen
authors.affiliation: iMed.ULisboa Research Institute for Medicines and Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon, Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal. Electronic address: acavaco@ff.ul.pt.
authors.forename: Afonso
authors.initials: A
authors.lastname: Cavaco
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards* / Q000706:statistics & numerical data; D016208:Databases, Factual / Q000592:standards / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D006282:Health Personnel / Q000706:statistics & numerical data; D006801:Humans; D007802:Language; D060735:Pharmacovigilance; D011174:Portugal
keywords: Adverse drug reactions; Drug safety; MedDRA; Pharmacovigilance; Portugal; Spontaneous reporting