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Data access from health registries, health studies and biobanks

Access to data from the Norwegian Prescription Database

Guidelines for applying for data from the Norwegian Prescription Database and information about how data are released.

Illustrasjonsfoto: Colourbox.com
Illustrasjonsfoto: Colourbox.com

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 The Norwegian Prescription Database (NorPD) contains information about the use of prescription drugs dispensed in Norway. You can obtain information about the number of users of a particular drug or drug category.

The database only contains information about drugs dispensed by prescription. Drugs bought from a pharmacy or grocery store (over-the counter drugs) are not included.

Application for data

If an application is legitimate and justified, the NorPD may disclose more detailed information for research, management and planning, or other purposes that are consistent with the database regulations. It is important to describe what the data will be used for (purpose) in the application.  All applications are handled by the group appointed for delivery of data from NorPD, which consists of experts from several disciplines (drugs, statistics and law).

Types of data that may be disclosed on application

Statistiscal data (table data)

Application for access to statistical data (aggregated data) on drug consumption is relevant in cases where the desired information cannot be derived from http://www.norpd.no/. A precise description of the data needed must be included in the application, including metrics, time period, drugs (ATC code) etc. An empty table (shell table) showing the desired table layout (with only row and column names) should be attached. Statistical data from the NorPD are generally presented in excel format.

Research data (research files)

In a research file, each drug dispensed to each individual is presented by one row. A completed list of needed variables from the NorPD must be attached to the application (see below). It is important to only apply for variables that are necessary and justified by the research project's purpose. Data from the NorPD is generally delivered as a txt.file delimited by semicolon. For linkage of data from multiple health registries (including NorPD) or other data sources, the applicant should also choose the application form 'Application for access to data’.

Links to other data sources

NorPD can be coupled with all key health registers and other data sources with access to the full identity of the individuals in the study population, provided legal permission has been granted. 

Application

It is important that applicants only tick variables that are necessary and relevant to the project objectives. This includes variables from registers that will be connected with NorPD.

Legal requirements

Legal requirements for the delivery of data (only NorPD)

Various legal permissions can be required when applying for data from the NorPD. Disclosure of anonymous data does normally not require any special legal permission. When applying for disclosure of information about the birth month and/or municipality, NorPD will require that the applicant notifies the Data Protection Officer at the institution where the applicant is located, or the Norwegian Data Inspectorate.

Legal requirements for the delivery of linked data from NorPD with other data sources

Data from the NorPD can be linked with data from other statutory health registries defined by the Health Register Act § 11 ref. the NorPD regulation § 5-3 first paragraph. The linkage must be performed so that individuals can not be recognised based on the linked data. A licence from the Norwegian Data Inspectorate is required, unless anonymous data is requested.  Ensuring that data sets based on linked data from different statutory health registries are anonymous is highly challenging. An anonymous dataset will need to have few and roughly categorised variables, usually resulting in a dataset with limited value for research and health analyses. This implies that applicants should apply for a licence from the Data Inspectorate. It is also recommended to get an ethical evaluation of the project from the Regional Ethics Committee (REC).

Linkage of data from the NorPD and other data sources than the statutory health registries requires a licence from the Data Inspectorate, ref. the NorPD Regulation § 5-3 second paragraph. In the absence of consent from the study population, a confidentiality exemption from REC is also required. It is also recommended to get an ethical evaluation of the project by the Regional Ethics Committee (REC).

Please note that the NorPD will not disclose data that can lead to identification of individuals via the variables, ref. the NorPD Regulation § 5-3 first paragraph. If the applicant has requested many and detailed variables it can be problematic to link with other registries or other data sources that contain detailed information about individuals. It is therefore important that the applicant only requests variables that are relevant for the research project’s purpose. This applies both to variables from the NorPD and to variables requested from other data sources to be linked with NorPD.

Delivery deadlines

According to the regulations, the NorPD has a 30 day delivery deadline for uncoupled data and a 60 day delivery deadline for coupled data when data from all sources are available and legal permission is in place.

Price

The current cost of obtaining information from the Norwegian Prescription Database is NOK 875 per hour’s work, excluding VAT.

Appeals

According to Norwegian legislation, a decision about data delivery can be challenged. Any complaints should be sent to the Norwegian Institute of Public Health. If the institute does not respond satisfactorily, the appeal can be sent further to the Ministry of Health and Care Services for a final decision.

Acknowledgements

All publications and presentations that use data from the Norwegian Prescription Database must refer to it as the source.

If acronyms or abbreviations are required, please refer to NorPD (in both English and Norwegian).

All publications should include "The Norwegian Prescription Database" in the title or abstract text to highlight the register in PubMed searches.

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