Annual Report on Spontaneous Reporting of Adverse Drug Reactions

Summary

Stable and harmonized data source.

Type of data

Data Source
Registry

Type of Study
Other: Longitudinal survey. Data colleceted from different sources (health staff, marketing authorisation holders, patients, side effects in clinical trials, etc.)

Data gathering method
Registries

Access to data

Conditions of access

Type of available data (e.g. anonymised microdata, aggregated tables, etc.)
Aggregated tables

Formats available
Excel

Coverage

Coverage Years of collection, reference years, and sample sizes
Data has been collected from 2004 until 2012.

First year of collection
2005

Stratification if applicable
Stratification by county, adverse drug reactions, side effects

Base used for sampling

Geographical coverage and breakdowns
NUTS-1, NUTS-3

Age range
All ages

Statistical representativeness
Special group, please specify

Coverage of main and cross-cutting topics
The data cover all spontaneous reporting of adverse drug reactions. The data source allows for a detailed study.

Linkage

Standardisation
The European Medicines Agency (EMA) and The Heads of Medicines Agencies

Possibility of linkage among databases
A common variable is patient ID.

Data quality

Entry errors if applicable
NA

Breaks
NA

Consistency of terminology or coding used during collection
NA

Governance

Contact information
Dr. Viola Macolic-Šarinic / Pharmacovigilance Department
Agency for Medicinal Products and Medical Devices (HALMED)
Ksaverska cesta 4
10000 Zagreb Croatia Phone: +38514884100
Email: halmed(at)halmed.hr
Url: http://www.almp.hr/pdf/publikacije/Izvjesce_o_nuspojavama_u_2012.pdf

Timeliness, transparency
Data is available within one year of collection.