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

Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance C...

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Main Authors: Schjøtt J, Bergman J
Format: Article
Language:English
Published: Dove Medical Press 2014-07-01
Series:Drug, Healthcare and Patient Safety
Online Access:http://www.dovepress.com/joint-medicine-information-and-pharmacovigilance-services-could-improv-a17428
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spelling doaj-9219cfba4cc94a7e908cf141572633c92020-11-24T23:25:31ZengDove Medical PressDrug, Healthcare and Patient Safety1179-13652014-07-012014default899217428Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problemsSchjøtt JBergman J Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest), Haukeland University Hospital, Bergen, Norway 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, pregabalinhttp://www.dovepress.com/joint-medicine-information-and-pharmacovigilance-services-could-improv-a17428
collection DOAJ
language English
format Article
sources DOAJ
author Schjøtt J
Bergman J
spellingShingle Schjøtt J
Bergman J
Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
Drug, Healthcare and Patient Safety
author_facet Schjøtt J
Bergman J
author_sort Schjøtt J
title Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
title_short Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
title_full Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
title_fullStr Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
title_full_unstemmed Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
title_sort joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems
publisher Dove Medical Press
series Drug, Healthcare and Patient Safety
issn 1179-1365
publishDate 2014-07-01
description Jan Schjøtt,1–3 Jenny Bergman3 1Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, 2Institute of Clinical Science, Faculty of Medicine and Dentistry, University of Bergen, 3Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest), Haukeland University Hospital, Bergen, Norway 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
url http://www.dovepress.com/joint-medicine-information-and-pharmacovigilance-services-could-improv-a17428
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