European Journal of Clinical Pharmacology

, Volume 69, Issue 2, pp 237–244 | Cite as

Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia–Romagna region)

  • Chiara Biagi
  • Nicola Montanaro
  • Elena Buccellato
  • Giuseppe Roberto
  • Alberto Vaccheri
  • Domenico MotolaEmail author
Pharmacoepidemiology and Prescription



Underreporting is a major limitation of spontaneous reporting systems for suspected adverse drug reactions (ADRs). Several interventions to increase the ADR reporting rate have been proposed, but their efficacy remains poorly investigated.


This was a questionnaire study aimed at assessing the knowledge, attitudes, and behavior of general practitioners (GPs) regarding ADR reporting and at evaluating whether a monthly e-mail-based newsletter on drug safety could affect the rate and the quality of the ADR reports submitted by these GPs. Three local health authorities (LHAs) of the Emilia–Romagna region were chosen on the basis of their ADR reporting rate during the period preceding the study: Rimini (high), Ferrara (average), and Piacenza (low reporting rate). All GPs (n = 737) associated with these three LHAs were recruited. The pooled number of ADR reports sent by GPs in the remaining seven LHAs of the region was used as controls. The study covered a period of 3 years and was divided into: (1) identification of the reasons leading to underreporting through a questionnaire (Phase I); (2) the intervention, i.e., sending a newsletter for a 10-month period (Phase II); (3) evaluation of the intervention outcomes during the 10 months following the period in which the newsletter had been received (Phase III).


Among GPs involved, 22.8 % returned the questionnaire. Over 94 % of the respondents considered the spontaneous reporting of suspected ADRs to be part of their professional obligations, but only 6.5 % had submitted at least one report in the previous 6 months. Following the completion of Phase II, the overall number of reports coming from the LHAs subjected to the intervention rose by 49.2 % compared to 2009, while the number of reports coming from the control LHAs increased by 8.8 %. Rimini and Piacenza showed a 200 % increase in the number of ADR reports submitted by GPs, while the number of ADR reported submitted by the control group decreased by 25.5 %. In 2011, the number of overall ADRs reports from the LHAs subjected to the intervention decreased by 6.8 %; this decrease reached 50.0 % of the GPs. Control HLAs showed an overall decline of 4.3 %, while the total number of ADRs from GPs increased by 63.3 %. Ferrara was excluded from the analysis due to confounding factors.


The periodic e-mail update on the safety of drugs represents an effective and inexpensive way to raise the awareness of GPs on the importance of spontaneous ADR reporting. Since the outcome of the intervention seemed to disappear after the intervention was stopped, there appears to be a need to adopt a policy of regular updates and educational strategies for health professionals.


Pharmacovigilance ADR Underreporting General practitioners 



The study was supported by institutional funds from the Emilia–Romagna region for the developing of pharmacovigilance. We are very grateful to the Drug Policy Service, Emilia–Romagna Region Health Authority, Bologna, Italy and to the pharmacists and GPs of the participating Local Health Authorities (Ferrara, Piacenza and Rimini) for their invaluable contribution to the research.

Competing interest



  1. 1.
    Li C, Xia J, Deng J, Chen W, Wang S, Jiang J, Chen G (2009) A web-based quantitative signal detection system on adverse drug reaction in China. Eur J Clin Pharmacol 65:729–741PubMedCrossRefGoogle Scholar
  2. 2.
    van Puijenbroek E, Diemont W, van Grootheest K (2003) Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf 26:293–301PubMedCrossRefGoogle Scholar
  3. 3.
    Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LH (1998) Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 54:483–488PubMedCrossRefGoogle Scholar
  4. 4.
    Inman WH (1996) Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 41:434–435PubMedGoogle Scholar
  5. 5.
    Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ (2005) Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf 28:825–833PubMedCrossRefGoogle Scholar
  6. 6.
    Hazell L, Shakir SA (2006) Under-reporting of adverse drug reactions: a systematic review. Drug Saf 29:385–396PubMedCrossRefGoogle Scholar
  7. 7.
    Backstrom M, Mjorndal T, Dahlqvist R (2004) Under-reporting of serious adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf 13:483–487PubMedCrossRefGoogle Scholar
  8. 8.
    Castel JM, Figueras A, Pedros C, Laporte JR, Capella D (2003) Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads. Drug Saf 26:1049–1055PubMedCrossRefGoogle Scholar
  9. 9.
    Johansson ML, Brunlof G, Edward C, Wallerstedt SM (2009) Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports. Eur J Clin Pharmacol 65:511–514PubMedCrossRefGoogle Scholar
  10. 10.
    Motola D, Vargiu A, Leone R, Conforti A, Moretti U, Vaccheri A, Velo G, Montanaro N (2008) Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy. Drug Saf 31:609–616PubMedCrossRefGoogle Scholar
  11. 11.
    Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G (1997) Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res 35:85–88PubMedCrossRefGoogle Scholar
  12. 12.
    Bandekar MS, Anwikar SR, Kshirsagar NA (2010) Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf 19:1181–1185PubMedCrossRefGoogle Scholar
  13. 13.
    Passier A, ten Napel M, van Grootheest K, van Puijenbroek E (2009) Reporting of adverse drug reactions by general practitioners: a questionnaire-based study in the Netherlands. Drug Saf 32:851–858PubMedCrossRefGoogle Scholar
  14. 14.
    Hasford J, Goettler M, Munter KH, Muller-Oerlinghausen B (2002) Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 55:945–950PubMedCrossRefGoogle Scholar
  15. 15.
    Edward C, Himmelmann A, Wallerstedt SM (2007) Influence of an e-mail with a drug information attachment on sales of prescribed drugs: a randomized controlled study. BMC Clin Pharmacol 7:12PubMedCrossRefGoogle Scholar
  16. 16.
    Figueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ (2006) An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 296:1086–1093PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Chiara Biagi
    • 1
  • Nicola Montanaro
    • 1
  • Elena Buccellato
    • 1
  • Giuseppe Roberto
    • 1
  • Alberto Vaccheri
    • 1
  • Domenico Motola
    • 1
    Email author
  1. 1.Department of PharmacologyUniversity of BolognaBolognaItaly

Personalised recommendations