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Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark

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Objective To explore the organisational structure and processes of the Danish and Australian spontaneous ADR reporting systems with a view to how information is generated about new ADRs. Setting The Danish and Australian spontaneous ADR reporting systems. Method Qualitative analyses of documentary material, descriptive interviews with key informants, and observations were made. We analysed the organisational structure of the Danish and Australian ADR reporting systems with respect to structures and processes, including information flow and exchange of ADR data. The analysis was made based on Scott’s adapted version of Leavitt’s diamond model, with the components: goals/tasks, social structure, technology and participants, within a surrounding environment. Results The main differences between the systems were: (1) Participants: Outsourcing of ADR assessments to the pharmaceutical companies complicates maintenance of scientific skills within the Danish Medicines Agency (DKMA), as it leaves the handling of spontaneous ADR reports purely administrative within the DKMA, and the knowledge creation process remains with the pharmaceutical companies, while in Australia senior scientific staff work with evaluation of the ADR report; (2) Goals/tasks: In Denmark, resources are targeted at evaluating Periodic Safety Update Reports (PSUR) submitted by the companies, while the resources in Australia are focused on single case assessment resulting in faster and more proactive medicine surveillance; (3) Social structure: Discussions between scientific staff about ADRs take place in Australia, while the Danish system primarily focuses on entering and forwarding ADR data to the relevant pharmaceutical companies; (4) Technology: The Danish system exchanges ADR data electronically with pharmaceutical companies and the other EU countries, while Australia does not have a system for electronic exchange of ADR data; and (5) Environment: The Danish ADR system is embedded in the routines of cooperation within European pharmacovigilance network while the Australian system is acting alone, although they communicate with other systems. Conclusion The two systems differ with regard to reporting requirements, report handling, resources being spent and information exchange with the environment. In Denmark, learning about ADRs primarily takes place in the safety divisions of the pharmaceutical companies and the authorities have no control over the knowledge creation process. In Australia, more learning and control of the knowledge is present than in Denmark.

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  1. Lenz W. Malformations caused by drugs in pregnancy. Am J Dis Child. 1966;112:99–106.

    PubMed  CAS  Google Scholar 

  2. Mann RD. Modern drug use. Lancaster: MTP Press; 1984. ISBN: 978085200717–4.

    Google Scholar 

  3. Wardell WH, Velo GP, Jarocha NM. Drug development, regulatory assessment and postmarketing surveillance. New York: Plenum; 1981. ISBN: 9780306408229.

    Google Scholar 

  4. About the Uppsala Monitoring Centre [Online]. 2007 Feb [cited 2007 Aug 28]; Available from URL:

  5. Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. BMJ. 2004;329:44–7.

    Article  PubMed  Google Scholar 

  6. Dukes G. The law and ethics of the pharmaceutical industry. Amsterdam: Elsevier; 2006. ISBN: 0444518681.

    Google Scholar 

  7. Aagaard L, Soendergaard B, Andersen E, Kampmann JP, Hansen EH. Creating knowledge about adverse drug reactions: a critical analysis of the Danish reporting system from 1968 to 2005. Soc Sci Med. 2007;65:1296–309.

    Article  PubMed  Google Scholar 

  8. Scott Morton MS (ed) The corporation of the 1990s. Oxford: Oxford University Press; 1991. ISBN: 0195063589.

    Google Scholar 

  9. Roberts AS, Hopp T, Soerensen EW, Benrimoj SI, Chen TF, Herborg H et al. Understanding practice change in community pharmacy: a qualitative research instrument based in organisational theory. Pharm World Sci. 2003;25:227–34.

    Article  PubMed  Google Scholar 

  10. Boyd IW. The role of the Australian adverse drug reactions advisory committee (ADRAC) in monitoring drug safety. Toxicology. 2002;181:99–102.

    Article  PubMed  Google Scholar 

  11. Australian guideline for pharmacovigilance responsibilities of sponsors of registered medicines regulated by Drug Safety and Evaluation Branch. [Online] 2007 Feb 12 [cited 2007 Feb 31]; Available from URL:

  12. Volume 9A–Pharmacovigilance for medicinal products for human use, version April 2007 [Online] 2007 Feb [cited 2007 Feb 31]; Available from URL:

  13. TGA Adverse Drug Reactions [Online] 2007 Feb [cited 2007 Feb 15]; Available from URL:

  14. Australian Therapeutic Goods Act 1989 [Online] 2007 Feb [cited 2007 Feb 15]; Available from URL:

  15. Reporting of adverse drug reactions to medicines/vaccines [Online] 2007 Feb [cited 2007 Feb 15]; Available from URL:

  16. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–6.

    Article  PubMed  CAS  Google Scholar 

  17. WHO programme on official member countries and their year of entering the Programme [Online] 2007 Sep [cited 2007 Sep 18]; Available from URL:

  18. The Danish Board of Health’s circular of 1 May 1968 on setting up a National Committee of Adverse Drug Reactions associated with the Licensing Committee [Online] 2007 Feb [cited 2007 Sep 18]; Available from URL:*&s20=1968&s22=%7c10%7c/

  19. Executive Order No. 1238 of 12 December 2005 on ADR surveillance of drugs. The Danish Ministry of the Interior and Health [Online] 2007 Feb [cited 2007 Sep 18]; Available from URL:

  20. Executive Order No. 1213 of 7 December 2005 on the business procedure for the Council for Adverse Drug Reactions. The Danish Ministry of the Interior and Health [Online] 2005 Dec 12 [cited 2007 Feb 15]; Available from URL:

  21. EudraVigilance [Online] 2007 Feb [cited 2007 Feb 15]; Available from URL:

  22. Nonaka I, Takeuchi H. The knowledge-creation company: how Japanese companies create the dynamics of innovation? New York: Oxford University Press; 1995. ISBN: 0195092694.

    Google Scholar 

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We thank the Therapeutics Goods Administration and the Danish Medicines Agency for access to documents, meetings and interviews.


The study was funded by the Danish Medicines Agency.

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We declare that we have identified no conflicts of interest.

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Correspondence to Lise Aagaard.

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Aagaard, L., Stenver, D.I. & Hansen, E.H. Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark. Pharm World Sci 30, 563–570 (2008).

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