PMID- 25537235
OWN - NLM
STAT- MEDLINE
DCOM- 20160125
LR  - 20220408
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 38
IP  - 4
DP  - 2015 Apr
TI  - Assessment of a new instrument for detecting preventable adverse drug reactions.
PG  - 383-93
LID - 10.1007/s40264-014-0257-5 [doi]
AB  - 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). CONCLUSION: 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.
FAU - Benkirane, Raja
AU  - Benkirane R
AD  - Moroccan Pharmacovigilance Centre, Rabat, Morocco, raja.benkirane@gmail.com.
FAU - Soulaymani-Bencheikh, Rachida
AU  - Soulaymani-Bencheikh R
FAU - Khattabi, Asmae
AU  - Khattabi A
FAU - Benabdallah, Ghita
AU  - Benabdallah G
FAU - Alj, Loubna
AU  - Alj L
FAU - Sefiani, Houda
AU  - Sefiani H
FAU - Hedna, Khedidja
AU  - Hedna K
FAU - Ouammi, Lahcen
AU  - Ouammi L
FAU - Olsson, Sten
AU  - Olsson S
FAU - Pal, Shanti N
AU  - Pal SN
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Drug-Related Side Effects and Adverse Reactions/*prevention & control
MH  - Humans
MH  - Internationality
MH  - *Pharmacovigilance
MH  - Risk Factors
MH  - World Health Organization/*organization & administration
EDAT- 2014/12/30 06:00
MHDA- 2016/01/26 06:00
CRDT- 2014/12/25 06:00
PHST- 2014/12/25 06:00 [entrez]
PHST- 2014/12/30 06:00 [pubmed]
PHST- 2016/01/26 06:00 [medline]
AID - 10.1007/s40264-014-0257-5 [doi]
PST - ppublish
SO  - Drug Saf. 2015 Apr;38(4):383-93. doi: 10.1007/s40264-014-0257-5.