Danish Medicines Agency's annual pharmacovigilance report 2011

01 August 2012

The annual pharmacovigilance report offers an insight into some of the pharmacovigilance work performed by the Danish Medicines Agency in 2011.

The work in 2011 was characterised by five major activities in particular:

  • The initial phase for implementing the new EU legislation on pharmacovigilance
  • The establishment of most of our new IT system for pharmacovigilance and analysis
  • Adoption and initiation of a new action plan for pharmacovigilance for 2011-2013
  • Evaluation of an information campaign targeted at hospital doctors and launch of an information campaign targeted at municipal nursing staff
  • Establishment of cooperation agreements with Aalborg Hospital Science and Innovation Center, Aalborg Hospital, North Denmark Region and the National Institute for Health Data and Disease Control (SSI).

You can read the entire annual pharmacovigilance report 2011 by clicking the link in the box to the right.     

Continued strong focus on making more people report side effects

The number of side effect reports in 2011 was more or less identical with that for 2010, but there are, however, indications that things are moving in the right direction. The number of side effect reports from the hospitals, for example, shows an increasing trend (see pages 12-16).

To further call attention to the importance of reporting side effects, the Danish Medicines Agency launched a nationwide campaign at the end of November 2011 targeted at nursing staff in all Danish municipalities. We will continue these efforts in 2012.

You can read more about the development in the number of side effect reports from 2009 to 2011 in the annual report (see page 5) and about the campaign 'Respond to side effects – an information effort towards healthcare professionals in the care sector' (see page 20).

Focus areas in 2011 – amongst others treatment of pregnant women with antidepressants

In 2011, another main focus area for the Danish Medicines Agency was antidepressants of the SSRI type, in particular in relation to a potential risk to the foetus and child when the medicine is used for treatment of pregnant women. The background for this was the significant increase in the consumption of antidepressants, especially of the SSRI type, witnessed in recent years. This increase in consumption also applies to pregnant women undergoing treatment, which has given cause for concern.

Read more about this and the other focus areas on pages 23-28 in the annual report.

New names as from 1 March 2012

The Danish Medicines Agency and the Danish National Board of Health merged into one authority on 1 March 2012 by the name of the Danish Health Authority.

The Statens Serum Institut merged on the same date with the Danish National e-Health.  This new agency now gathers the present Statens Serum Institut, the Danish National e-Health and the documentation tasks of the Danish National Board of Health and the Danish Medicines Agency and Diagnosis Related Grouping (DRG) from the department of the Ministry of Health. The new name is Statens Serum Institut, National Institute for Health Data and Disease Control (SSI).

As this annual report covers the year 2011, the former names are used throughout this report.

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