Publications

20 March 2013 /Side effects and trials

Adverse drug reaction reports (ADRs) from consumers may improve patient safety

In a report, the DHMA has reviewed the ADR reports received during the years 2003–2011 to clarify how consumer reports differ from reports from healthcare professionals.

01 August 2012 /Side effects and trials

Danish Medicines Agency's annual pharmacovigilance report 2011

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

31 January 2012 /Side effects and trials

Long-term treatment of osteoporosis patients with bisphosphonates

At present, there is very limited knowledge about long-term treatment with bisphosphonates for osteoporosis patients. But over the past years, reports suggestive of long-term adverse reactions have been submitted, e.g. osteonecrosis of the jaw and atypical fractures.

12 October 2011 /Side effects and trials

Publication on medicines most frequently involved in serious adverse drug events

A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.

20 June 2011 /Side effects and trials

Danish Medicines Agency’s annual pharmacovigilance report 2010

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.

29 October 2010 /Side effects and trials

Assessment of safety of methylphenidate in ADHD treatment

The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.

29 March 2010 /Side effects and trials

Danish Medicines Agency’s annual pharmacovigilance report 2009

The annual report offers an insight into the pharmacovigilance work performed by the Danish Medicines Agency in 2009.

21 March 2006 /Side effects and trials

Report assessing the EU system monitoring medicinal product safety

In 2004, the EU Commission decided to launch an assessment of the existing system for monitoring of medicinal products, primarily to enable an assessment of the need for potential and possible improvements.