ArticleDrug safety2015
Assessment of a new instrument for detecting preventable adverse drug reactions.
Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Serious adverse drug reactions in sub-Saharan Africa in the era of antiretroviral treatment: A systematic review.Pharmacology research & perspectives · 2021Pooled it
- Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Overlay Associated with Self-Medication of Sulfadoxine-Pyrimethamine Overdose in a Patient with HIV/AIDS Infection: A Case Report.International medical case reports journal · 2025Article
- Adverse drug reactions of Rituximab in patients suffering from autoimmune neurological diseases.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022Observational
- Article
- Construction and analysis of a database for medication errors in a pharmacovigilance centre-the Moroccan experience.European journal of clinical pharmacology · 2021Article
- Preventable Cases of Oral Anticoagulant-Induced Bleeding: Data From the Spontaneous Reporting System.Frontiers in pharmacology · 2019Article
- Medication Errors Associated With Adverse Drug Reactions in Iran (2015-2017): A P-Method Approach.International journal of health policy and management · 2018Article
- Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Article
- Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients.Pharmacy (Basel, Switzerland) · 2018Article
- Observational
- Mobile App Design, Development, and Publication for Adverse Drug Reaction Assessments of Causality, Severity, and Preventability.JMIR mHealth and uHealth · 2017Article
- Campania Preventability Assessment Committee (Italy): A Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs' Adverse Drug Reactions.Frontiers in pharmacology · 2017Article
- Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance.International journal of obesity (2005) · 2016Article
- The monitoring medicines project: a multinational pharmacovigilance and public health project.Drug safety · 2015Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPharmacovigilance 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).
objectiveTo present the PM and to evaluate its inter-rater reliability.
methodsThe 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.
resultsThe 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).
conclusionThe 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.
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