Skip to main content
SpringerLink
Log in

Improving Adverse Drug Reaction Reporting in Hospitals

Results of the French Pharmacovigilance in Midi-Pyrénées Region (PharmacoMIP) Network 2-Year Pilot Study

  • Original Research Article
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Background: Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting.

Objective: The aim of this pilot study was to assess the effect of regular visits of a Clinical Research Assistant (CRA) on the improvement of ADR reporting in non-university hospitals.

Methods: We set up an ADR report collecting system that involved regular visits by a CRA to non-university hospitals, which was similar to a system that already existed in university hospitals in Toulouse, France. Two areas in our region were chosen: Haute Garonne and Gers. We compared firstly the reporting rate (number of reports/number of beds) of total ADRs (i.e. spontaneously reported ADRs plus solicited ADRs collected by the CRA) and secondly, the percentage of serious ADRs reported by non-university hospitals in these two areas, in 2005 (the year prior to CRA visits) and after the start of CRA visits (2006 until the end of December 2008). We also compared the reporting rate of total ADRs in Haute Garonne and Gers non-university hospitals with those reported during the same period with a control group (the Ariège area, which has a similar number of beds to Gers and that was not visited by the CRA). The characteristics of ADRs collected by the CRA were also described.

Results: A total of 687 reports were collected by the CRA: 40% were classified as serious, including two deaths. The number of ADRs and the reporting rate increased significantly between 2005 and 2008 in non-university hospitals of Haute-Garonne and Gers, but not in Ariège. In Gers, the reporting rate was 3% in 2005 and 25% in 2008. In Haute-Garonne, the reporting rate was 11% in 2005 and 40% in 2008. The difference between the number of spontaneous and solicited reports also increased.

Conclusions: This study shows that regular visits by a CRA increases the number of ADRs collected by a Regional Pharmacovigilance Centre. Another interesting consequence was the rise in spontaneous reporting by healthcare professionals following the set-up of this system. Further assessment of this procedure is necessary for the long-term evaluation of its effectiveness.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II
Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Pouyanne P, Haramburu F, Imbs JL, et al. Admissions to hospital caused by adverse drug reactions: cross sectional incidence study [letter]. French Pharmacovigilance Centres. BMJ 2000; 320: 1036

    Article  PubMed  CAS  Google Scholar 

  2. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 admissions. BMJ 2004; 329: 15–9

    Article  PubMed  Google Scholar 

  3. Moore N, Kreft-Jais C, Dhanani A. Spontaneous reporting: France. In: Mann RD, Andrews E, editors. Pharmacovigilance. 2nd ed. Chichester: John Wiley and Sons, Ltd, 2007: 217–26

    Google Scholar 

  4. Décret n∘95-278 du 13 mars 1995 relatif à la pharmacovigilance et modifiant le code de la santé publique. J Officiel du 14 mars 1995: 3935–8

  5. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255–9

    Article  PubMed  CAS  Google Scholar 

  6. Figueiras A, Tato F, Fontainas J, et al. Influence of physicians’ attitudes on reporting adverse events. Med Care 1999; 37: 809–14

    Article  PubMed  CAS  Google Scholar 

  7. Eland IA, Belton KJ, Van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623–7

    Article  PubMed  CAS  Google Scholar 

  8. Irujo M, Beitia G, Bes-Rastrollo M, et al. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf 2007; 30: 1073–82

    Article  PubMed  Google Scholar 

  9. Herdeiro MT, Figueiras A, Polonia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28: 825–33

    Article  PubMed  Google Scholar 

  10. Herdeiro MT, Figueiras A, Polonia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2006; 29: 331–40

    Article  PubMed  Google Scholar 

  11. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32: 19–31

    Article  PubMed  CAS  Google Scholar 

  12. Bateman DN, Lee A, Rawlins MS, et al. Geographical differences in adverse drug reactions reporting rates in the northern region. Br J Clin Pharmacol 1991; 31: 188–9

    Article  PubMed  CAS  Google Scholar 

  13. Sacilotto K, Bagheri H, Lapeyre-Mestre M, et al. Adverse drug effect notifications by nurses and comparison with cases reported by physicians. Thérapie 1995; 5: 455–8

    Google Scholar 

  14. Begaud B, Evreux JC, Jouglard J, et al. Imputation of the unexpected or toxic effects of drugs: actualization of the method used in France. Thérapie 1985; 40: 111–8

    PubMed  CAS  Google Scholar 

  15. Bürki F, Badie K, Bartoli P, et al. Reversible posterior leukoencephalopathy syndrome associated with bevacizumab/ doxorubicin regimen. Br J Clin Pharmacol 2008; 65: 793–4

    Article  PubMed  Google Scholar 

  16. Pedros C, Vallano A, Cereza G, et al. An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians. Drug Saf 2009; 32: 77–83

    Article  PubMed  Google Scholar 

  17. Herdeiro MT, Polonia J, Gestal-Otero JJ, et al. Improving the reporting of adverse drug reaction: a cluster-randomized trial among pharmacists in Portugal. Drug Saf 2008; 31: 335–44

    Article  PubMed  Google Scholar 

  18. Ekman E, Bäckström M. Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 2009; 65: 43–6

    Article  PubMed  Google Scholar 

  19. Castel JR, Figueras A, Pedros C, et al. Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads. Drug Saf 2003; 26: 1049–55

    Article  PubMed  Google Scholar 

  20. Feely J, Moriarty S, O’Connor P. Stimulating reporting of adverse drug reaction by using a fee. BMJ 1990; 300: 22–3

    Article  PubMed  CAS  Google Scholar 

  21. Bäckstrom A, Mjörndal T. A small economic inducement to stimulate increased reporting of adverse drug reactions: a way of dealing with an old problem? Eur J Clin Pharmacol 2006; 62: 381–5

    Article  PubMed  Google Scholar 

  22. Bäckström M, Ekman E, Mjörndal T. Adverse drug reaction reporting by nurses in Sweden. Eur J Clin Pharmacol 2007; 63: 613–8

    Article  PubMed  Google Scholar 

  23. Ranganathan SS, Houghton JE, Davies DP, et al. The involvement of nurses in reporting suspected adverse drug reactions: experience with the meningococcal vaccination scheme. Br J Clin Pharmacol 2003; 56: 658–63

    Article  PubMed  Google Scholar 

  24. Morrison-Griffiths S, Walley TJ, Park BK, et al. Reporting of adverse drug reactions by nurses. Lancet 2003; 9366: 1347–8

    Article  Google Scholar 

  25. Ramsay LE. Bridging the gap between clinical pharmacology and rational drug prescribing. Br J Clin Pharmacol 1993; 35: 575–6

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

The authors would like to thank the Regional Agency of Hospitalisations of Midi-Pyrénées who financially supported the project, as well as the Regional Commission for Coordination of Health Vigilances, who helped to organize the work.

The authors have no conflicts of interest to declare that are directly relevant to the content of this study.

Author information

Authors and Affiliations

  1. Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    Mireille Gony, Kattalin Badie, Agnès Sommet, Julien Jacquot, Jean Louis Montastruc &  Haleh Bagheri

  2. Laboratoire de Pharmacologie Médicale et Clinique, Unité de Pharmacoépidémiologie EA3696, Université de Toulouse, Faculté de Médecine, Toulouse, France

    Agnès Sommet, Jean Louis Montastruc &  Haleh Bagheri

  3. Commission de Coordination Régionale des Vigilances (CCREVI), Direction Régionale des Affaires Sanitaires et Sociales (DRASS) de Midi-Pyrénées, Toulouse, France

    Dominique Baudrin

  4. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA

    Pierre Gauthier

Authors
  1. Mireille Gony
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kattalin Badie
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Agnès Sommet
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Julien Jacquot
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Dominique Baudrin
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Pierre Gauthier
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Jean Louis Montastruc
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Haleh Bagheri
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Haleh Bagheri.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gony, M., Badie, K., Sommet, A. et al. Improving Adverse Drug Reaction Reporting in Hospitals. Drug-Safety 33, 409–416 (2010). https://doi.org/10.2165/11319170-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11319170-000000000-00000

Keywords

Search

Navigation