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Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital

  • Pharmacoepidemiology and Prescription
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European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The aim of the study was to detect adverse drug reactions (ADRs) in pediatric inpatients using the medical administrative database “Programme de Médicalisation des Systèmes d′Information” (PMSI) and to compare these cases ADRs with those spontaneously reported to a regional PharmacoVigilance (PV) Centre.

Methods

The study was conducted from January 2008 to December 2011 in the Children University Hospital of Toulouse (Midi-Pyrénées, South-west France). From PMSI database, all discharge summaries including selected ICD-10 codes (10th International Classification of Diseases) were analyzed. All ADRs spontaneously reported by the Children Hospital of Toulouse and registered in the French PV Database (FPVDB) were included. The capture–recapture method was applied to estimate the incidence of ADRs.

Results

During the study period, we identified 60 reports from the PMSI database and 200 from the FPVDB. The rate of “serious” ADRs was higher in PMSI reports (74.6 % vs 38.9 %, p < 0.0001). The most frequent ADRs reported were musculoskeletal (12.4 %) and central (11.3 %) ADRs in PMSI database versus cutaneous (22.4 %) and general (17.5 %) ADRs in FPVDB. The most frequently suspected drugs were antineoplastic drugs (31.1 %) in PMSI database versus anti-infectives (38.2 %) in FPVDB. The estimated number of ADRs was 717 [95 % confidence interval (CI) 513, 921], and the incidence of ADRs among admissions was 0.6 % (95 % CI 0.4, 0.8).

Conclusions

Use of PMSI database improves from around 30 % detection of ADRs in children. In comparison with classical pharmacovigilance database, it also allows to detect different ADRs and drugs, thus enhancing safe medicine use for pediatric patients.

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Acknowledgments

We would like to thank Charlotte Benzina, Lucie Cantaloube, and Caroline Rossard for data collection.

Conflict of interest

The authors declare that they have no conflict of interest

Author contributions

Dr Durrieu conceptualized and supervised the study, drafted the initial manuscript, and reviewed and revised the manuscript. Dr Batz designed the study and carried out the initial data analysis. Dr Rousseau carried out the final analysis and reviewed the manuscript. Dr Bondon-Guitton contributed to the concept and the design of the study and reviewed the manuscript. Dr Petiot contributed to the concept of the study, extracted data from the administrative hospital database, and reviewed the manuscript. Pr Montastruc reviewed and revised the manuscript. All authors approved the final manuscript as submitted.

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Authors and Affiliations

  1. Department of Medical and Clinical Pharmacology, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d′Informations sur les Médicaments, Toulouse University Hospital, Toulouse, France

    G. Durrieu, A. Batz, V. Rousseau, E. Bondon-Guitton & J. L. Montastruc

  2. U1027 INSERM Pharmacoepidemiology Unit, Faculty of Medicine, University of Toulouse, Toulouse, France

    G. Durrieu, A. Batz, V. Rousseau, E. Bondon-Guitton & J. L. Montastruc

  3. Département d’Information Médicale, University Hospital of Toulouse, Toulouse, France

    D. Petiot

Authors
  1. G. Durrieu
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  2. A. Batz
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  3. V. Rousseau
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  4. E. Bondon-Guitton
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  5. D. Petiot
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  6. J. L. Montastruc
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Corresponding author

Correspondence to G. Durrieu.

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Durrieu, G., Batz, A., Rousseau, V. et al. Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital. Eur J Clin Pharmacol 70, 1519–1526 (2014). https://doi.org/10.1007/s00228-014-1763-1

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  • DOI: https://doi.org/10.1007/s00228-014-1763-1

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