New campaign aimed at doctors: High-quality ADR reports make a difference

The monitoring of the safety of COVID-19 vaccines over the last months has shown us just how important the reports on suspected side effects from doctors are. A new campaign to promote the quality of ADR reports submitted by doctors sets out to improve the monitoring of medicine safety even further.

The Danish Medicines Agency has launched a new campaign aimed at doctors to highlight how important high-quality ADR reports are for fast and efficient monitoring of medicine safety, both at the national and European levels.

– While monitoring the COVID-19 vaccines, we have seen what a difference it makes when doctors report suspected adverse drug reactions and pay attention to submitting high-quality reports. It has enabled us to act very quickly, and that is for the benefit of the public, said Tanja Erichsen, acting Director of Pharmacovigilance at the Danish Medicines Agency.

Watch the Danish Medicines Agency’s campaign video at YouTube

Medicines prevent, relief and diagnose diseases for millions of people, but all of them may cause side effects. From what we have seen with the COVID-19 vaccines, it is still possible for rare and serious side effects to occur even though they were not recognised in even major clinical trials. That is why the safety of all medicines is monitored throughout the medicines’ marketed life, and the concerted efforts of the general public, doctors and authorities enable an effective monitoring. 

– We would very much like to maintain this good cooperation with doctors on ADR reporting and expand it to other medicines. Doctors can help us identify new or changed risks of a medicine, and it is essential that we get more high-quality ADR reports precisely from doctors. That’s the reason why we are launching this campaign aimed at doctors, said Tanja Erichsen.

Doctors play an important role in side effect monitoring

Doctors fulfil a crucial function when they report suspected side effects to the Danish Medicines Agency. They are often the first to observe possible side effects, and as medical experts they can contribute essential information to the monitoring of the safety of medicines for the benefit of patient safety.

The Danish Medicines Agency monitors the safety of medicines, and the reports on suspected side effects we receive are an essential part of our ongoing observations of any new signals of new or changed risks of a medicine. For this reason, it is important that doctors report suspected side effects to us and that they submit high-quality reports for inclusion of the information in the monitoring of the safety of medicines.

The information provided by doctors could be decisive in the authorities’ monitoring of the safety of medicines. This was illustrated by the discovery of the syndrome known as VITT/TTS following COVID-19 vaccination.

In early March 2021, the Danish Medicines Agency received a report from a doctor describing a fatal outcome that had occurred immediately following vaccination with the COVID-19 vaccine from AstraZeneca. The report described symptoms of blood clots accompanied by a low level of platelets and bleeding.

Thoroughly completed report led to the discovery of VITT/TTS

The thoroughly completed ADR report and the close collaboration with the Danish doctor to obtain new information about the case enabled the Danish Medicines Agency to act promptly. As a result, this report was included as an important element in the common European vaccine monitoring, and on 7 April 2021, the European Medicines Agency (EMA) concluded that a low level of platelets accompanied by blood clots was to be included in the product information as a possible side effect of the AstraZeneca vaccine.

The information about the Danish report also formed the basis of the Danish Health Authority’s decision of 11 March 2021 to pause the vaccine from AstraZeneca.