Complete listings of suspected adverse drug reactions (ADRs) reported by healthcare professionals, patients and relatives are made available for download by the Danish Health and Medicines Authority.
The listings are called Drug Analysis Prints (DAPs)
The DAPs, or simply the prints, contain all the suspected adverse drug reactions that have been reported in Denmark.
DAPs based on active substance
The DAPs reported adverse drug reactions by active substance, but the brand name of the medicine is included if the submitted report has specifically stated it.
DAPs outline number of adverse drug reaction, reports and deaths
Page 1 of the DAP gives information about:
- the total number of reactions (each submitted report relates to a single patient and may contain multiple reactions)
- the total number of ADR reports (Adverse Drug Reactions)
- the total number of fatal ADR reports (total number of deaths)
Groupings in System Organ Classes
Page 2 of the DAP displays how the adverse drug reactions and number of reports break down on the so-called System Organ Classes, e.g. cardiac disorders, metabolism and psychiatric disorders.
Detailed overview of the individual System Organ Classes
Page 3 and the following pages give a more detailed breakdown of the adverse drug reactions on individual System Organ Classes.
What can the DAPs be used for?
The DAPs show all suspected adverse reactions experienced and reported by patients and doctors. The prints may be helpful in monitoring how the number of reports develops and can be useful in helping to identify possible safety issues with medicines.
Reported reactions are not necessarily caused by the medicine
The information in the DAPs cannot be used alone to make conclusions on the safety and risks of medicines.
The fact that an adverse drug reaction has been reported does not necessarily mean that a connection between the medicine and the reaction has been proven. This is important to note since we ask doctors, patients and relatives, etc., to report an adverse drug reactions even if they only have a suspicion that the medicine may have caused it.
DAPs do not inform of the likelihood of having an adverse drug reaction
The information in the DAPs cannot be used to assess how great the risk is of having an adverse drug reaction from a particular medicine as there is limited information about how many people have taken the medicine without experiencing a reaction.
Likewise, the prints cannot be used to measure the frequency of an adverse reaction from a particular medicine as not all reactions are reported to the Danish Health and Medicines Authority.
The risks of different medicines cannot be compared
It is not possible to compare the risks of different medicines by comparing the numbers presented in a DAP.
Vaccines
Due to technical constraints, reports on adverse reactions from vaccines are not available online.
But you are welcome to request an individually generated report on adverse reactions from vaccines by sending an email to dap-box@dkma.dk. We will process your request within 15 days.
Cases are not to be reported to the Danish Health and Medicines Authority
All data contained in the DAPs come from the Danish Health and Medicines Authority's database of adverse reactions. The cases have been sent out to all relevant pharmaceutical companies and to the larger EudraVigilance database under the London-based European Medicines Agency (EMA).
Therefore, the pharmaceutical companies are not to report these cases to the Danish Health and Medicines Authority.
The Danish Health and Medicines Authority does not disclose the identification numbers of the adverse reaction reports that form the basis of the figures in the DAPs.
