As a result of the Danish Medicines Agency’s campaign “React when serious and unexpected side effects occur”, hospital doctors have more than ever contributed with information and thus given us a better basis to regularly assess the safety of the medicine on the market: Hospital doctors have put more focus on identifying and reporting side effects, and the number of reports submitted by hospitals across Denmark has increased on average.
During the six-month campaign, the number of side effect reports has increased from a monthly average of 55 reports to 90 reports. It shows that hospital doctors have taken steps towards changing their working culture and addressing the existing underreporting in the pharmacovigilance area.
During the past six months, all public hospitals and psychiatric units in Denmark have participated in the Danish Medicines Agency’s nationwide campaign “React when serious and unexpected side effects occur". The goal was to give doctors more insight into the side effects that they are required to report and to change their attitude to side effect reporting to highlight its significance. And the campaign has been successful.
Training has raised doctors’ awareness
During the campaign period, consultant doctors responsible for training in the hospitals have taught their colleagues which side effects they must report and how it is done. And doctors have changed their attitude. 68 % state that the campaign has increased their focus on reporting side effects. 80 % of them state they now know the rules of when a side effect must be reported. In 2009, only 35 % of doctors stated they knew the rules well.
"We are extremely pleased with these figures. The fact that the doctors know the rules and have more focus on reporting side effects is crucial to our activities of monitoring medicines", says Doris Stenver, Chief Medical Officer in the Consumer Safety Division of the Danish Medicines Agency.
The enthusiasm is shared by the Danish Medical Association.
"Training the doctors has proven to be the right method in this campaign. If you want to change a working culture, it should be done in unison – at a morning meeting, for example. I believe quite many doctors and departments have realised that this is a task that we must and will spend time on – for the sake of the patients", says Mads Koch Hansen, Chairman of the Danish Medical Association.
Still some way to go
Even though we have achieved good results, we still have some way to go before the number of reports reaches a level that the Danish Medicines Agency is content with. A detailed analysis of the figures from 2010 shows that differentiated efforts are needed both at regional and hospital level. "During the next year, we will therefore take initiative to open dialogue with both the Danish regions and the regional medicinal products committees", says Henrik G. Jensen, Director of Division in the Consumer Safety Division of the Danish Medicines Agency. "And we will continue cooperating with the Danish Medical Association and the Council for Adverse Drug Reactions to make doctors report more side effects from medicines.
Updated 17 May 2011