Increasing the Number of Spontaneous ADE Reports in a Danish Region: A Retrospective Analysis

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Background: Spontaneous reporting of suspected adverse drug events (ADEs) by health professionals is a cornerstone in pharmacovigilance and an important source from which to generate new adverse drug reaction (ADR) signals. However, under-reporting is a major challenge. Objective: The aim of this study was to increase the number of spontaneous ADE reports from physicians in the Capital Region of Denmark and to explore the obstacles and initiatives of the reporting clinicians. Methods: We report the effect of the introduction of an adverse drug event manager (ADEM) offered by the Capital Region of Denmark and handled by a clinical pharmacology department in Copenhagen, Denmark. The ADEM is a telephone and email service manned by young medical doctors offering physicians assistance in reporting suspected ADEs to the Danish Health and Medicines Authority. After a successful pilot project at one hospital, the function was expanded to all hospitals in the Capital Region of Denmark. Furthermore, we conducted semi-structured interviews with the heads of section of the three departments reporting the most ADEs in order to identify initiatives increasing reporting by their employees. Results: The number of reported ADEs from the Capital Region increased by 59 % from 2012 to 2013. Out of 627 reports, 337 came from the ADEM. In 2014, the number of reports from the ADEM reached 488 (44 % increase). The three heads of section pointed out leadership and visibility, simplicity, awareness and flow of staff, information overload, learning opportunities and local ambassadors as the most important factors influencing reporting of ADEs in their departments. Conclusion: The number of reported ADEs can be increased by the introduction of an ADEM. However, the introduction of an ADEM needs to be supplemented by an on-going engagement by leaders in addition to educational efforts targeted at physicians to strengthen their awareness of, and interest in, spontaneous reporting of ADEs.

Original languageEnglish
JournalPharmaceutical Medicine
Issue number4
Pages (from-to)211-217
Number of pages7
Publication statusPublished - 31 Aug 2015

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© 2015, Springer International Publishing Switzerland.

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