Annual pharmacovigilance report 2012

07 August 2013

In the Danish Health Authority's (DHMA's) annual pharmacovigilance report, you can read about some of the pharmacovigilance work performed by the DHMA in 2012.

The overall aim of the pharmacovigilance work is continued improvement of the safety of medicinal products. In 2012, the DHMA worked for improvements in a number of fields including communication and openness, analyses of adverse reaction data and the international collaboration, among other things.

You can read the entire annual pharmacovigilance report 2012 by clicking the link in the box to the right.

New EU legislation concerning monitoring safety of medicinal products

In July 2012, new EU pharmacovigilance legislation entered into force. The DHMA was, among other things due to the Danish EU Presidency, closely involved in the implementation of the new legislation.

The new legislation aims to strengthen patient safety by improving the present system used for monitoring safety of medicinal products in Europe (see pages 20-21).

As a direct consequence of the amended legislation, the DHMA has noticed that more companies reported consumer adverse reactions in 2012 compared to the previous years (see pages 5-6 and 20-21).

Publication of adverse reaction data from the Danish adverse drug reaction database

As part of the action plan for a strengthened pharmacovigilance 2011-2013, the DHMA will process adverse reaction data reported in order to publish general overviews of adverse reaction data (Drug Analysis Prints, DAPs) in anonymised form.

These DAPs were published on the DHMA's website in June and July 2012, which has contributed to increased openness with respect to adverse reactions reported (see pages 25-26).

Continued focus on making more people report adverse reactions

To call attention to the importance of reporting adverse reactions to the DHMA, we launched an adverse reaction campaign in 2012 targeted at healthcare professionals in the care sector.

The DHMA also launched a campaign targeted at medicine users, including follow-up targeted at nursing staff. Furthermore, a pre-analysis was initiated to prepare for a campaign in the field of psychiatric adverse reactions.

You can read more about the development in the number of adverse reaction reports from 2009-2012 (see page 5) and about the campaigns in the annual report (see pages 28-29).