liu.seSearch for publications in DiVA
Change search
ReferencesLink to record
Permanent link

Direct link
Key Elements in Adverse Drug Interaction Safety Signals An Assessment of Individual Case Safety Reports
Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences.
WHO Collaborating Centre Int Drug Monitoring, Sweden .
Linköping University, Department of Medical and Health Sciences, Clinical Pharmacology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre for Diagnostics, Department of Clinical Pharmacology.
2013 (English)In: Drug Safety, ISSN 0114-5916, Vol. 36, no 1, 63-70 p.Article in journal (Refereed) Published
Abstract [en]

Background A large proportion of potential drug interactions are known from pre-authorization studies, but adverse drug reactions (ADRs) due to interactions (adverse drug interactions) are often first detected through astute observation in clinical practice. Individual case safety reports (ICSRs) are collected from broad patient populations and allow for the identification of groups of similar reports. Systematic screening for adverse drug interactions in ICSRs will require an understanding of which information on these reports can be suggestive of adverse drug interactions. less thanbrgreater than less thanbrgreater thanObjective The aim of the study was to identify what reported information may support the identification of drug interaction safety signals in collections of ICSRs. less thanbrgreater than less thanbrgreater thanMethods Three previously published safety signals of suspected adverse drug interactions were re-evaluated. To this end, 137 reports related to these signals were retrieved from the WHO Global ICSR Database, VigiBase (TM), and corresponding original reports were obtained from national pharmacovigilance centres. Criteria from an operational score for causality analysis of drug interactions of clinical cases, the Drug Interaction Probability Scale (DIPS), were applied to each of these reports with the aim of identifying what supportive information tends to be available in ICSRs. For three DIPS elements (plausible time course, resolution of the ADR after terminating the drug inducing the interaction without changes in affected drug therapy (positive dechallenge) and alternative causes of the reaction) we also compared the amount of information in VigiBase (TM) and in original reports, and in free text and structured data. less thanbrgreater than less thanbrgreater thanResults Commonly fulfilled DIPS elements on reports supporting an adverse drug interaction signal were plausible time course (50 reports; 36 %) and positive dechallenge (8 reports; 6 %). Alternative causes for the observed adverse reaction were observed in 72 (53 %) reports. We found limited differences between VigiBase (TM) and original reports for the structured data, although a substantial amount of additional information was available in free text in original reports. less thanbrgreater than less thanbrgreater thanConclusions Information on plausible time courses and resolution of the adverse reaction upon withdrawal of the drug suspected to have induced the interaction may be a useful element in identifying suspected adverse drug interactions from ICSRs. Of these, plausible time course is by far the most commonly reported element in the three signals studied here. Our analysis also demonstrated the importance of sharing and analysing information available in free text where relevant clinical details are often available, such as those mentioned above, along with severity and dosage changes.

Place, publisher, year, edition, pages
Adis , 2013. Vol. 36, no 1, 63-70 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-91347DOI: 10.1007/s40264-012-0003-9ISI: 000316357700007OAI: diva2:617244
Available from: 2013-04-22 Created: 2013-04-22 Last updated: 2013-04-22

Open Access in DiVA

No full text

Other links

Publisher's full text

Search in DiVA

By author/editor
Strandell, JohannaHägg, Staffan
By organisation
Clinical PharmacologyFaculty of Health SciencesDepartment of Clinical Pharmacology
In the same journal
Drug Safety
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 31 hits
ReferencesLink to record
Permanent link

Direct link