E-DRUG: Post-Marketing Surveillance and ADR Monitoring in Denmark
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Dear E-druggers,
I have with great interest read the correspondences related to the theme" Post-Marketing Surveillance and ADR Monitoring in India"
Recently I started a PhD project on critically analysing the spontaneous reporting system of adverse drug reactions and exploring possible signals that are embedded in the systems, but not detected today.
The project has been established as a collaborative effort between the Danish Medicines Agency where I am employed, and The Danish University of Pharmaceutical Sciences.
I would like to comment on the questions related to registration of adverse drug reactions in Denmark:
Voluntary reporting of adverse drug reactions has occurred since May 1st 1968 with the establishment of the Danish National Health Service's Board on Adverse Reactions to drugs.
From the beginning doctors were obliged by law to report suspected adverse drug reaction to the national board. In 1972 dentists were also obliged to report adverse drug reactions by law, and in 2003 it became possible for consumers to report adverse drug reactions directly to the responsible authority, the Danish Medicines Agency. Consumers are not obliged by law to report adverse drug reactions.
The numbers of inhabitants in Denmark are around 5 million. In the period 1968-2005 nearly 52000 reports of adverse drug reactions have been submitted to the system by the reporters. Doctors and patients way of reporting to the system are mainly through paper forms or electronic forms. Market authorisation holders are obliged to report electronically.
Denmark is exchanging information of adverse drug reactions with the WHO database and the European database, the EudraVigilance system.
Further information's about the Danish pharmacovigilance system and the Danish Medicines Agency is available at the web-site: www.dkma.dk
Yours sincerely,
Lise Aagaard
Pharmacist
The consumer safety division
The Danish Medicines Agency
E-mail: lia@dkma.dk