title: Assessment of a new instrument for detecting preventable adverse drug reactions.
abstract: BACKGROUND
  Pharmacovigilance centres (PVCs) in the World Health Organization (WHO) Programme for International Drug Monitoring have demonstrated their ability to detect preventable adverse drug reactions (ADRs) in their databases. In this field, there is no gold-standard method for detecting medication errors and evaluating ADR preventability. Therefore, we developed, from existing tools, a preventability assessment method: the 'P Method' (PM).
  
  
  OBJECTIVE
  To present the PM and to evaluate its inter-rater reliability.
  
  
  METHODS
  The PM includes 20 explicit criteria for assessing ADR preventability. This approach is based on identification of any potentially preventable risk factor that increases the likelihood of ADR occurrence. The outcome of the preventability assessment results in one of three possible scores: 'preventable', 'non-preventable' or 'not assessable'. The PM was tested in a multicentre study involving nine national PVCs. Two experienced reviewers at each participating PVC independently analysed the preventability of 183 ADRs, applying the PM.
  
  
  RESULTS
  The overall agreement between all reviewers for assessment of ADR preventability was 'fair', with a kappa value of 0.27 [95 % confidence interval (CI) 0.21-0.40]. The level of agreement between reviewer pairs ranged from 'slight', with a kappa value of 0.12 (95 % CI -0.03 to 0.27), to 'substantial', with a kappa value of 0.69 (95 % CI 0.48-0.89).
  
  
  CONCLUSIONS
  The analysis of the agreements and disagreements between reviewers highlighted where improvements might be made. Given that no standard assessment tool exists in the WHO Programme, the transparency of the assessment process in this method provides a substantial basis for further development and for support in signalling possible preventability.
authors.affiliation: Moroccan Pharmacovigilance Centre, Rabat, Morocco, raja.benkirane@gmail.com.
authors.forename: Raja
authors.initials: R
authors.lastname: Benkirane
authors.forename: Rachida
authors.initials: R
authors.lastname: Soulaymani-Bencheikh
authors.forename: Asmae
authors.initials: A
authors.lastname: Khattabi
authors.forename: Ghita
authors.initials: G
authors.lastname: Benabdallah
authors.forename: Loubna
authors.initials: L
authors.lastname: Alj
authors.forename: Houda
authors.initials: H
authors.lastname: Sefiani
authors.forename: Khedidja
authors.initials: K
authors.lastname: Hedna
authors.forename: Lahcen
authors.initials: L
authors.lastname: Ouammi
authors.forename: Sten
authors.initials: S
authors.lastname: Olsson
authors.forename: Shanti N
authors.initials: SN
authors.lastname: Pal
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D038622:Internationality; D060735:Pharmacovigilance; D012307:Risk Factors; D014944:World Health Organization / Q000458:organization & administration*