The Norwegian Adverse Drug Reaction Registry
The Norwegian Adverse Drug Reaction Registry (the NorADR registry) contains reports of suspected adverse reactions to medicines submitted by health professionals and patients and their next of kin in Norway.
The NorADR registry aims to contribute to the safe and effective use of medicines through the ongoing and systematic collection, assessment and analysis of information in reports on suspected adverse drug reactions.
The purpose of the NorADR registry is to safeguard patient safety by:
- Identifying suspected cases of unexpected, new or serious adverse reactions as rapidly as possible
- Contributing to the establishment of causal links between medicines and possible adverse reactions.
- Identifying patient groups at risk for adverse reactions
Healthcare professionals can report adverse reactions without the consent of the patient. The regional medicines information and pharmacovigilance centres (RELIS) and the Norwegian Institute of Public Health (for vaccines) assess reports from health professionals and give feedback to the reporter. The Norwegian Medicines Agency handles reports from the public (patients and next of kin) and has overall responsibility for the NorADR registry.
What is an adverse reaction?
An adverse reaction is a harmful and unintended effect of a medicine. This applies regardless of whether or not the medicine has been used as described in the product information.
The definition also includes harmful and unintended effects linked to:
- misuse (incorrect use)
- medication errors
- dosing errors
- off-label use (treatment not covered by the approved indication for use)
- occupational exposure
How are adverse reactions reported to the NorADR registry?
Reports on suspected adverse drug reactions can be submitted by healthcare professionals, patients, next of kin and pharmaceutical companies. National health registries, such as the NorADR registry, are statutory and nationwide registers, and healthcare professionals have a duty to report relevant information to the various registries. Adverse reactions are reported on the basis of a suspected link, i.e. the person who submits the report believes there may be a link between the use of one or more medicines and an event that has occurred (presumed adverse reaction). There is no requirement for the link to have been proven before reporting.
What does the Norwegian Medicines Agency do with the adverse reaction reports?
The information from the NorADR registry is used in the ongoing benefit-risk assessment that is carried out for all medicines. The Norwegian Medicines Agency is responsible for the data and uses it in its continuous monitoring of all medicines approved for use in Norway.
The reports received are assessed in a two-stage process. The data is first assessed at individual level, and then in wider analyses at population level.
Reports on suspected adverse drug reactions are processed by RELIS, the Norwegian Institute of Public Health or the Norwegian Medicines Agency. This means that the content of the report is coded according to an international coding system, so that symptoms, medical conditions and drugs are given an internationally standardised format. Coding is important in order to search for new signals of adverse drug reactions across national borders. In addition, the event is described in free text.
In the case of reports on suspected adverse drug reactions submitted by healthcare professionals, RELIS or The Norwegian Institute of Public Health (vaccines) will assess how likely the link between the medicine and the suspected adverse drug reaction is. This assessment is based on a scale developed by the World Health Organization (WHO), and information concerning the medicine, such as product information and scientific studies. The assessment is also based on the information on the patient and suspected adverse reaction given in the report. Assessments of possible links between medicines and suspected adverse reactions may change over time as more becomes known about the medicine concerned.
Healthcare professionals who have reported are given feedback once the causal relationship has been assessed. No individual feedback is given to patients or next of kin who report suspected adverse reactions for themselves.
The Norwegian Medicines Agency continuously forward reports on suspected adverse drug reactions, without any identity information, to the European Medicines Agency (EMA). EMA ensures that the information is forwarded to the WHO's global database (Vigibase). Pharmaceutical companies are given access to reports on suspected adverse drug reactions concerning their own drugs from EMA's database.
The Norwegian Medicines Agency, EMA, WHO and the pharmaceutical companies continually analyse the data (reports on suspected adverse drug reactions). This is known as ‘signal detection’ and involves both statistical calculations and a data review in order to identify unknown adverse drug reactions. When a signal is identified, a more thorough analysis is carried out to assess whether it could be a new adverse reaction to the medicine, or whether any other factors could explain the signal. Based on these analyses, it may be decided to update the product information with new safety information or introduce various risk minimization measures. In the most serious cases, it may be necessary to withdraw the medicine from the market.
In addition to signals of possible new adverse drug reactions, the information in the database provides information on the types of adverse reactions that may arise from use of medicines, as well as other information such as how suspected adverse drug reactions are distributed by gender and age.
Why is it necessary to state the patient’s national ID number?
National ID numbers (fødselsnummer) are used to link information from different sources or aspects of the development of an event to a single person (compilation of different data sources). This makes reports on suspected adverse drug reactions more useful, because they can be shared and enriched with data from other registries. Such compilations are of great value to more detailed studies of adverse reactions and help to improve patient safety.
National ID numbers are separated from other information and encrypted before processing. They are not accessible during the ordinary use of the registry information or after linking with data from other health registries. In the NorADR registry, the data subject's name, address and national ID number are not stored together with the information about the use of medicines and the suspected adverse reaction. National ID numbers were not recorded in adverse reaction reports submitted before the Adverse Drug Reaction Registry Regulation came into force on 1 January 2020.
National ID numbers will, for various reasons, be missing in some of the reports in the NorADR registry. It will then not be possible to collate these reports with other registries.
The pharmaceutical companies report adverse reactions to the Norwegian Medicines Agency without any reference to national ID numbers.
Reports submitted directly by patients and next of kin during the first part of 2020, as this functionality is not yet in place in the report form.
Electronic reports submitted by healthcare professionals between 1 January 2020 and 30 April 2020, when it was not possible to submit reports with a national ID number.
The Norwegian Medicines Agency also accept reports on suspected adverse drug reactions which for various reasons does not contain national ID number.
How is privacy and information security safeguarded?
There are strict requirements regarding privacy and information security regarding the NorADR registry.
In order to protect the patient's privacy, public access to reports on suspected adverse drug reactions is limited to aggregated level in the form of statistics.
What rights do you have if you have been registered in the NorADR registry?
Anyone who is registered in the NorADR registry is entitled to certain information and access to their own data. Data subjects also have the right to be told who has accessed or received health information linked to their name or national ID number. Data subjects in the NorADR registry may also object to health data being made available for uses other than the main purpose.
How long is data concerning suspected adverse reactions stored for?
Data may be stored indefinitely (see Section 4-7 of the Adverse Drug Reaction Registry Regulation). The reason for this is that such data must be available for as long as the active ingredient is on the market. Active ingredients that have previously been on the market may also come to be used for clinical purposes again in the future.