Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

Abstract

Background

RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR) reports published in a question–answer pair (QAP) database (the RELIS database) and the Norwegian ADR database, respectively.

Objective

To describe the potential of RELIS’s dual service to improve detection and communication of drug-safety problems.

Materials and methods

We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS’s potential to detect new drug-safety information through a limited number of QAPs and ADR reports.

Results

A total of 5,427 (26%) of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4%) of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7%) of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin) and different aspects of abuse.

Conclusion

RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the potential to detect new drug-safety problems with a limited number of questions and ADR reports.

Keywords:

• pharmacovigilance
• drug safety
• database
• pregabalin

Author contributions

Jenny Bergman performed acquisition and analysis of cases concerning pregabalin. Jan Schjøtt and Jenny Bergman collected data from the RELIS database and the Norwegian ADR database. Jan Schjøtt wrote the manuscript. Both authors contributed to the conception, design, analysis, and interpretation of data. Both authors have been involved in drafting the manuscript and revising it critically for important intellectual content, and have given final approval of the version to be published.

Disclosure

The authors report no conflicts of interest in this work.