European Journal of Clinical Pharmacology

, Volume 71, Issue 5, pp 631–636 | Cite as

The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses’ reporting

  • Sofia A. Karlsson
  • Ingela Jacobsson
  • Marit Danell Boman
  • Katja M. Hakkarainen
  • Henrik Lövborg
  • Staffan Hägg
  • Anna K. Jönsson
Pharmacoepidemiology and Prescription
First Online:
Received:
Accepted:

Abstract

Purpose

In March 2007, a legislative amendment was issued in Sweden compelling nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. The aims of this study were to describe the status of ADR reporting, before and after the implementation of the legislative changes, and to describe the general characteristics of suspected ADRs reported by nurses.

Methods

The Swedish pharmacovigilance system during the study period constituted six regional centres responsible for the handling of all spontaneous ADR reports within their region. In this study, we identified all individual ADR reports from 2005 and 2010, analysed in depth the ADR reports from two regional centres and collated information about the reporter and the nature of the reported ADR.

Results

From the two regional centres, a total of 898 and 1074 reports were submitted in 2005 and 2010 respectively. Nurses submitted 31 % (275 reports) of the reports in 2005 and 24 % (260 reports) in 2010. Nurses’ reporting of serious ADRs was 3 % (seven reports) in 2005 and 7 % (17 reports) in 2010 with reporting of unlabelled ADRs at 4 % (11 reports) in 2005 and 17 % (45 reports) in 2010. Most of the serious and/or unlabelled reactions were related to vaccine administration (14 reports in 2005 and 36 reports in 2010).

Conclusions

The overall ADR reporting by nurses did not appear to increase after the change in reporting legislation. The proportion of serious and/or unlabelled ADRs reported by nurses did however appear to increase during the same period. Taken together, our data suggests that further pro-active measures should be considered in order to involve nurses in the reporting of suspected ADRs.

Keywords

Adverse drug reaction Spontaneous reporting Pharmacovigilance Nurses 
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Notes

Acknowledgments

The authors would like to thank Camilla Rosenlund for assisting with data collection in 2005 and Padraig D’Arcy for the linguistic revision.

Contributors

AKJ was the principal investigator. IJ, MDB and SAK collected the data. SAK drafted the manuscript. All authors contributed to the study design and interpretation of the results and commented on the draft. All authors had full access to the data. AKJ is the guarantor of the study.

Ethical statement

All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the Helsinki Declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required by law.

Conflict of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Hallas J (1996) Drug related hospital admissions in subspecialities of internal medicine. Dan Med Bull 43:141–155PubMedGoogle Scholar
  2. 2.
    Pouyanne P, Haramburu F, Imbs JL, Bégaud B (2000) Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. Br Med J 320:1036CrossRefGoogle Scholar
  3. 3.
    Smith CC, Bennett PM, Pearce HM, Harrison PI, Reynolds DJM, Aronson JK, Grahame-Smith DG (1996) Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. Br J Clin Pharmacol 42:423–429CrossRefPubMedCentralPubMedGoogle Scholar
  4. 4.
    Stausberg J, Hasford J (2011) Drug-related admissions and hospital-acquired adverse drug events in Germany: a longitudinal analysis from 2003 to 2007 of ICD-10-coded routine data. BMC Health Serv Res 11:134CrossRefPubMedCentralPubMedGoogle Scholar
  5. 5.
    von Euler M, Eliasson E, Öhlen G, Bergman U (2006) Adverse drug reactions causing hospitalization can be monitored from computerized medical records and thereby indicate the quality of drug utilization. Pharmacoepidemiol Drug Saf 15:179–184CrossRefGoogle Scholar
  6. 6.
    Hazell L, Shakir SAW (2006) Under-reporting of adverse drug reactions: a systematic review. Drug Saf 29:385–396CrossRefPubMedGoogle Scholar
  7. 7.
    Talbot J, Waller P (2004) Stephens’ detection of new adverse drug reactions. John wiley & sons Ltd, the Atrium, Southern Gate, Chichester, West sussex PO19 8SQ, EnglandGoogle Scholar
  8. 8.
    Conforti A, Opri S, D'Incau P, Sottosanti L, Moretti U, Ferrazin F, Leone R (2012) Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database. Pharmacoepidemiol Drug Saf 21:597–602CrossRefPubMedGoogle Scholar
  9. 9.
    Ekman E, Petersson G, Tågerud S, Bäckström M (2012) Awareness among nurses about reporting of adverse drug reactions in Sweden. Drug Healthc Patient Saf 4:61–66CrossRefPubMedCentralPubMedGoogle Scholar
  10. 10.
    Hall M, McCormack P, Arthurs N, Feely J (1995) The spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol 40:173–175CrossRefPubMedCentralPubMedGoogle Scholar
  11. 11.
    Ulfvarson J, Mejyr S, Bergman U (2007) Nurses are increasingly involved in pharmacovigilance in Sweden. Pharmacoepidemiol Drug Saf 16:532–537CrossRefPubMedGoogle Scholar
  12. 12.
    Morrison-Griffiths S, Pirmohamed M (2000) Specialist nurse reporting of adverse drug reactions. Prof Nurse 15:300–304PubMedGoogle Scholar
  13. 13.
    Bäckström M, Ekman E, Mjörndal T (2007) Adverse drug reaction reporting by nurses in Sweden. Eur J Clin Pharmacol 63:613–618CrossRefPubMedGoogle Scholar
  14. 14.
    The adverse drug reaction investigation (2003) http://www.lakemedelsverket.se/Alla-nyheter/NYHETER-2007/Aven-sjukskoterskor-far-rapportera-lakemedelsbiverkningar-/. Last accessed 19 Feb 2015 (In Swedish)
  15. 15.
    (2006) Act (LVFS 2001: 12) on regulations on pharmacovigilance, Swedish code of statues [Svensk författningssamling (SFS)]. (In Swedish)Google Scholar
  16. 16.
    World Health Organisation (1972) International drug monitoring: the role of the hospital. Technical report series 498 Geneva, SwitzerlandGoogle Scholar
  17. 17.
    (2009) WHO Collaborating Centre for Drug Statistics Methodology Guidelines for ATC classification and DDD assignmentGoogle Scholar
  18. 18.
    (2011) Medical Dictionary for Regulatory Activities. Introductory Guide MedDRA Version 14.0 MSSO-DI-6003-14.0.0 GenevaGoogle Scholar
  19. 19.
    Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–1259CrossRefPubMedGoogle Scholar
  20. 20.
    Hakkarainen KM, Gyllensten H, Jönsson AK, Andersson Sundell K, Petzold M, Hägg S (2014) Prevalence, nature and potential preventability of adverse drug events—a population-based medical record study of 4970 adults. Br J Clin Pharmacol 78:170–183. doi: 10.1111/bcp.12314
  21. 21.
    (2004) The Medical Products Agency’s desire for increased reporting of adverse drug reactions related to vaccines have yielded results. http://www.lakemedelsverket.se/Alla-nyheter/NYHETER---2004/Lakemedelsverkets-onskemal-om-okad-rapportering-av-vaccinbiverkningar-har-givit-resultat/. Last accessed February 19th 2015 (In Swedish)
  22. 22.
    (2007) Experiences of vaccination in year 4—adverse drug reaction reporting 2005/2006. http://www.lakemedelsverket.se/Alla-nyheter/NYHETER-2007/Erfarenheter-av-vaccination-i-ak-4--biverkningsrapportering-20052006/. Last accessed February 19th 2015 (In Swedish)
  23. 23.
    Mendes D, Alves C, Batel Marques F (2014) Nurses’ spontaneous reporting of adverse drug reactions: expert review of routine reports. J Nurs Manag 22:322–330CrossRefPubMedGoogle Scholar
  24. 24.
    Ekman E, Bäckstrom M (2009) Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. Eur J Clin Pharmacol 65:43–46. doi: 10.1007/s00228-008-0564-9 CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Sofia A. Karlsson
    • 1
  • Ingela Jacobsson
    • 2
  • Marit Danell Boman
    • 3
  • Katja M. Hakkarainen
    • 4
    • 5
  • Henrik Lövborg
    • 2
  • Staffan Hägg
    • 2
    • 5
  • Anna K. Jönsson
    • 2
  1. 1.Department of Public Health and Community Medicinethe Sahlgrenska Academy at University of GothenburgGothenburgSweden
  2. 2.Department of Clinical Pharmacology, Department of Medical and Health SciencesLinköping UniversityLinköpingSweden
  3. 3.Division of Clinical PharmacologyUniversity Hospital of UmeåUmeåSweden
  4. 4.Nordic School of Public Health NHVGothenburgSweden
  5. 5.Futurum—Academy for Health and Care, Jönköping County CouncilJönköpingSweden

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