Danish Medicines Agency’s annual pharmacovigilance report 2010

20 June 2011

In 2010, primarily the Danish Minister for the Interior and Health’s action plan to improve monitoring of side effects marked the work in the pharmacovigilance area. The action plan was launched in 2009 in cooperation with the Council for Adverse Drug Reactions and was fully implemented in 2010. The annual report offers an insight into much of the pharmacovigilance work performed by the Danish Medicines Agency in 2010.

You can read the full annual pharmacovigilance report 2010 by clicking the link in the right-hand box.

Continued increase in the number of side effect reports

The number of side effect reports has increased significantly over the past couple of years, and much suggests that it is a continuing trend. In particular the number of reports from patients and their relatives has increased. In 2010, there were twice as many reports from patients and their relatives compared to 2008. The number of reports from physicians has also increased over the past two years. A side effect campaign launched to enhance reporting from hospital physicians played a part in increasing the number of reports from physicians in the hospital sector.

In the annual report to the right, you can read more about the number of side effect reports from 2008 to 2010 (see page 5) and about the campaign "Respond to serious and unexpected side effects" aimed at hospital physicians (see pp. 15 and 17). 

Focus on encouraging more people to report side effects

In 2010, we had particular focus on side effect reporting. Besides our campaign aimed at hospital physicians, we launched a campaign aimed at medicine users and their relatives. Both campaigns focused particularly on the importance of reporting serious and unexpected side effects.

Read more about our campaigns in 2010 on pp. 17-19 in the annual report.

Risk-based pharmacovigilance

In 2010, we therefore started focusing much more than usual on risk-based monitoring of side effects. This meant that we began putting special focus on identified issues within medicine safety which, for some reason or other, call for particular attention. For example, we made a thorough assessment of the safety of methylphenidate in ADHD treatment, which resulted in a focus report, which we published in October 2010.

Read more about our focus report about methylphenidate and about risk-based side effect monitoring on pp. 20-22 in the annual report.

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