Drug Safety

, Volume 32, Issue 1, pp 77–83 | Cite as

An Intervention to Improve Spontaneous Adverse Drug Reaction Reporting by Hospital Physicians

A Time Series Analysis in Spain
  • Consuelo Pedrós
  • Antoni Vallano
  • Gloria Cereza
  • Gemma Mendoza-Aran
  • Antònia Agustí
  • Cristina Aguilera
  • Immaculada Danés
  • Xavier Vidal
  • Josep M. Arnau
Original Research Article


Background: Spontaneous reporting of adverse drug reactions (ADRs) in hospitals is scarce and several obstacles to such reporting have been identified previously.

Objective: To assess the effectiveness of a multifaceted intervention based on healthcare management agreements for improving spontaneous reporting of ADRs by physicians in a hospital setting.

Methods: In 2003, the spontaneous reporting of ADRs was included as one of the objectives of hospital physicians at the Vall d’Hebron Hospital, Barcelona, Spain, within the context of management agreements between clinical services and hospital managers. A continuous intervention related to these management agreements, including periodic educational meetings and economic incentives, was then initiated. We carried out an ecological time series analysis and assessed the change in the total number of spontaneous reports of ADRs, and the number of serious ADRs, unexpected ADRs, and ADRs associated with new drugs between a period previous to the intervention (from 1998 to 2002) and the period during the intervention (from 2003 to 2005). A time series analysis with ARIMA (Auto-Regressive Integrated Moving Average) models was performed.

Results: The median number of reported ADRs per year increased from 40 (range 23–55) in the first period to 224 (range 98–248) in the second period. In the first period, the monthly number of reported ADRs was stable (3.47 per month; 95% CI 1.90, 5.03), but in the second period the number increased progressively (increase of 0.74 per month; 95% CI 0.62, 0.86). In the second period, the proportion of reported serious ADRs increased nearly 2-fold (63.1% vs 32.5% in the first period). The absolute number of previously unknown or poorly known ADRs increased 4-fold in the second period (54 vs 13 in the first period). There was also an increase in the absolute number of suspected pharmacological exposures to new drugs (97 vs 28) and in the number of different new drugs suspected of causing ADRs (50 vs 19).

Conclusion: A continuous intervention based on healthcare management agreements with economic incentives and educational activities is associated with a quantitative and qualitative improvement of spontaneous reporting of ADRs by hospital physicians.


Economic Incentive Spontaneous Reporting ARIMA Model Hospital Physician Multifaceted Intervention 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors would like to thank the hospital physicians who participated in this study for their collaboration. No sources of funding were used to assist in the development of this study. The authors have no conflicts of interest that are directly relevant to the content of this study.


  1. 1.
    Edwards R, Olsson S, Lindquist M, et al. Global drug surveillance: the WHO programme for international drug monitoring. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Chichester: Wiley, 2005: 161–83Google Scholar
  2. 2.
    Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385–96PubMedCrossRefGoogle Scholar
  3. 3.
    McGettigan P, Feely J. ADR reporting: opinions and attitudes of medical practitioners in Ireland. Pharmacoepidemiol Drug Saf 1995; 4: 355–8CrossRefGoogle Scholar
  4. 4.
    Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union: the European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997; 52: 423–7PubMedCrossRefGoogle Scholar
  5. 5.
    Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of ADR. Br J Clin Pharmacol 1999; 48: 623–7PubMedCrossRefGoogle Scholar
  6. 6.
    Cosentino M, Leoni O, Oria C, et al. Hospital-based survey of doctor’s attitudes to adverse drug reactions and perception of drug-related risk for adverse reaction occurrence. Pharmacoepidemiol Drug Saf 1999; 8: S27–35PubMedCrossRefGoogle Scholar
  7. 7.
    Bäckström M, Mjorndal T, Dahlqvist R, et al. Attitudes to reporting ADR in northern Sweden. Eur J Clin Pharmacol 2000; 56: 729–32PubMedCrossRefGoogle Scholar
  8. 8.
    Figueiras A, Tato F, Fontainas J, et al. Physicians’ attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 2001; 7: 347–54PubMedCrossRefGoogle Scholar
  9. 9.
    Hasford J, Goettler M, Munter KH, et al. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for ADR. J Clin Epidemiol 2002; 55: 945–50PubMedCrossRefGoogle Scholar
  10. 10.
    Vallano A, Cereza G, Pedrós C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol 2005; 60: 653–8PubMedCrossRefGoogle Scholar
  11. 11.
    Herdeiro MT, Figueiras A, Polónia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 2005; 28: 825–33PubMedCrossRefGoogle Scholar
  12. 12.
    Chatterjee S, Lyle N, Ghosh S. A survey of the knowledge, attitude and practice of adverse drug reaction reporting by clinicians in Eastern India. Drug Saf 2006; 29: 641–2PubMedCrossRefGoogle Scholar
  13. 13.
    Kimelblatt BJ, Young SH, Heywood PM, et al. Improved reporting of adverse drug reactions. Am J Hosp Pharm 1988; 45: 1086–9PubMedGoogle Scholar
  14. 14.
    Fincham J. A statewide program to stimulate reporting of adverse drug reactions. J Pharm Pract 1989; 2: 239–44CrossRefGoogle Scholar
  15. 15.
    Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA 1990; 263: 1785–8PubMedCrossRefGoogle Scholar
  16. 16.
    Nazario M, Feliu JF, Rivera GC. Adverse drug reactions: the San Juan Department of Veterans Affairs Medical Center experience. Hosp Pharm 1994; 29: 244–50PubMedGoogle Scholar
  17. 17.
    McGettigan P, Golden J, Conroy RM, et al. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Br J Clin Pharmacol 1997; 44: 98–100PubMedCrossRefGoogle Scholar
  18. 18.
    Figueiras A, Herdeiro MT, Polonia J, et al. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006; 296: 1086–93PubMedCrossRefGoogle Scholar
  19. 19.
    Bracchi RCG, Houghton J, Woods FJ, et al. A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme. Br J Clin Pharmacol 2005; 60: 221–3PubMedCrossRefGoogle Scholar
  20. 20.
    Castel JM, Figueras A, Pedrós 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: 1049–55PubMedCrossRefGoogle Scholar
  21. 21.
    Feely J, Moriarty S, O’Connor P. Stimulating reporting of adverse drug reaction by using a fee. BMJ 1990; 300: 22–3PubMedCrossRefGoogle Scholar
  22. 22.
    Bäckström 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: 381–5PubMedCrossRefGoogle Scholar
  23. 23.
    Armadans L, Carné X, Laporte JR. Detection of adverse reactions to drugs from the hospital admission diagnosis: method and results. Med Clin (Barc) 1988; 91: 124–7Google Scholar
  24. 24.
    Ibañez L, Laporte JR, Carné X. Adverse drug reactions leading to hospital admission. Drug Saf 1991; 6: 450–9PubMedCrossRefGoogle Scholar
  25. 25.
    Capellà D, Laporte J-R. La notificación espontánea de reacciones adversas a medicamentos. In: Laporte J-R, Tognoni G, editors. Principios de epidemiología del medicamento. 2nd ed. Barcelona: Masson-Salvat, 1993: 147–70Google Scholar
  26. 26.
    Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/ 319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Official Journal of the European Communities 10.6.2000: L139/28-L139/30 [online]. Available from URL: [Accessed 2008 Oct 22]
  27. 27.
    Meyboom RHB, Royer RJ. Causality classification at pharmacovigilance centres in the European Community. Pharmacoepidemiol Drug Saf 1992; 1: 87–97CrossRefGoogle Scholar
  28. 28.
    Real Decreto 1344/2007, de 11 de octubre, por el que se regula la farmacovigilancia de medicamentos de uso humano. Boletin Oficial de Estado 1/11/2007: 44631–4460 [in Spanish; online]. Available from URL: [Accessed 2008 Oct 22]
  29. 29.
    Box GEP, Jenkins GM, Reinsel GC. Time series analysis: forecasting and control. 3rd ed. Englewood Cliffs (NJ): Prentice Hall, 1994Google Scholar
  30. 30.
    Edwards IR. Adverse drug reactions: finding the needle in the haystack. BMJ 1997; 315: 500PubMedCrossRefGoogle Scholar
  31. 31.
    Pirmohamed M, Darbyshire J. Collecting and sharing information about harms. BMJ 2004; 329: 6–7PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2008

Authors and Affiliations

  • Consuelo Pedrós
    • 1
    • 2
  • Antoni Vallano
    • 1
    • 3
    • 4
  • Gloria Cereza
    • 1
    • 2
  • Gemma Mendoza-Aran
    • 1
    • 2
  • Antònia Agustí
    • 1
    • 3
    • 4
  • Cristina Aguilera
    • 1
    • 3
    • 4
  • Immaculada Danés
    • 1
  • Xavier Vidal
  • Josep M. Arnau
    • 1
    • 3
    • 4
  1. 1.Fundació Institut Català de FarmacologiaBarcelonaSpain
  2. 2.Catalan Centre of PharmacovigilanceBarcelonaSpain
  3. 3.Clinical Pharmacology ServiceHospital Universitari Vall d’HebronBarcelonaSpain
  4. 4.Department of Pharmacology, Therapeutics and ToxicologyUniversitat Autònoma de BarcelonaBarcelonaSpain

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