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Assessment of a New Instrument for Detecting Preventable Adverse Drug Reactions

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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).

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.

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Acknowledgments

The authors would like to thank their colleagues from the national pharmacovigilance centres for their valuable contributions to this work: Luciana Soubihe and Eliane Gil Rodrigues de Castro from Brazil; Gloria Shalviri and Naghmeh Javidnikou from Iran; Uchenna Elemuwa, Cassandra A. Elagbaje, Desirée Kunac and Michael Tatley from New Zealand; Mariano Madurga and Cristina Fernandez from Spain; Alexandra Raetz Bravo and Wolfgang Renftl from Switzerland; Pattreya Pokhagul and Watcharee Rungapiromnan from Nigeria; Mohamed lakhal and Sihem El Aïdli from Tunisia; and Fatima Abadi, Driss Soussi Tanani and Souad Skalli from Morocco. The authors would also like to thank Wendy Shepherd for proofreading the text.

Funding

This project was funded by the EU-FP7 Monitoring Medicines Project (grant number 223566). The funding organization (the European Commission) had no role either in the conduct of the present study or in the writing of the present manuscript.

Conflicts of interest

Raja Benkirane, Rachida Soulaymani-Bencheikh, Asmae Khattabi, Ghita Benabdallah, Loubna Alj, Houda Sefiani, Khedidja Hedna, Lahcen Ouammi, Sten Olsson and Shanti N. Pal have no conflicts of interest that are directly relevant to the content of this study.

Theme issue

This article is part of a theme issue co-edited by Elliot G. Brown, Shanthi Pal and Sten Olsson. No external funding was used to support the publication of this theme issue.

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Authors and Affiliations

  1. Moroccan Pharmacovigilance Centre, Rabat, Morocco

    Raja Benkirane, Ghita Benabdallah, Loubna Alj, Houda Sefiani & Lahcen Ouammi

  2. Faculty of Medicine, Mohamed V, Rabat, Morocco

    Rachida Soulaymani-Bencheikh

  3. Institut National Administration Sanitaire, Rabat, Morocco

    Asmae Khattabi

  4. Department of Drug Research/Clinical Pharmacology, Linköping University, Linköping, Sweden

    Khedidja Hedna

  5. World Health Organization Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden

    Sten Olsson

  6. Quality Assurance and Safety of Medicines, World Health Organization, Geneva, Switzerland

    Shanti N. Pal

  7. Centre AntiPoison et de Pharmacovigilance, Rue Lamfedel Cherkaoui, BP 6671, Madinate Al Irfane, 10100, Rabat, Morocco

    Raja Benkirane

Authors
  1. Raja Benkirane
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  2. Rachida Soulaymani-Bencheikh
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  10. Shanti N. Pal
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Corresponding author

Correspondence to Raja Benkirane.

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Benkirane, R., Soulaymani-Bencheikh, R., Khattabi, A. et al. Assessment of a New Instrument for Detecting Preventable Adverse Drug Reactions. Drug Saf 38, 383–393 (2015). https://doi.org/10.1007/s40264-014-0257-5

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