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

Abstract

BackgroundRELIS 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.ObjectiveTo describe the potential of RELIS’s dual service to improve detection and communication of drug-safety problems.Materials and methodsWe 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.ResultsA 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.ConclusionRELIS 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.

Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database

“…Finally, an online survey in a sample of 1500 individuals in the UK, found a lifetime prevalence of pregabalin misuse of 0.5 % [11]. In addition, a Norwegian study found 11 and 13 cases of pregabalin abuse, respectively, in a question-answer pair database and the Norwegian Adverse Drug Reactions Database [12].…”

Adverse Drug Reactions in Norway: A Systematic Review

“…Of the selected studies, one was conducted in the Netherlands with the inclusion of data from Norway [33] and the remainder were undertaken in Norway [34,35,36,37,38]. Three articles [34,36,37] were in the Norwegian language and the rest [33,35,38] were published in English. They all used a cross-sectional descriptive design for data collection and analysis.…”

“…They all used a cross-sectional descriptive design for data collection and analysis. The findings of the selected studies on ADR reporting and handling in the Norwegian healthcare context were presented under three central aspects of ‘patient reporting schema’ [33,36], ‘healthcare provider reporting schema’ [33,34,36,37], and ‘current pharmacovigilance system’ [33,35,36,37,38]. The characteristics of the studies’ findings were summarized in Table 3.…”

Drug information centres and their provision of decision support: The Scandinavian experience

“…Reviews of these databases can be used to identify recurring problems in pharmacotherapy including drug safety questions. [9][10][11] R eviews can also be used to address poor and inconsistent drug i nformation in prescribing and dispensing software systems, and to evaluate the impact of DICs advice among clinicians. A relevant e xample is the perception of risks associated with use of drugs in pregnancy and breast-feeding.…”