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Article: Adverse drug reactions – examples of detection of rare events using databases

TitleAdverse drug reactions – examples of detection of rare events using databases
Authors
KeywordsAdverse drug reactions
Attention deficit hyperactivity disorder
Database
Retinal detachment
Sudden death
Toxic epidermal necrolysis (TEN)
Issue Date2015
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2125
Citation
British Journal of Clinical Pharmacology, 2015, v. 80 n. 4, p. 855-861 How to Cite?
AbstractIt is recognised that randomised controlled trials are not feasible for capturing rare adverse events. There is an increasing trend towards observational research methodologies using large population‐based health databases. These databases offer more scope for adequate sample sizes, allowing for comprehensive patient characterisation and assessment of the associated factors. While direct causality cannot be established and confounders cannot be ignored, databases present an opportunity to explore and quantify rare events. The use of databases for the detection of rare adverse events in the following conditions, sudden death associated with attention deficit hyperactivity disorder (ADHD) treatment, retinal detachment associated with the use of fluoroquinolones and toxic epidermal necrolysis associated with drug exposure, are discussed as examples. In general, rare adverse events tend to have immediate and important clinical implications and may be life‐threatening. An understanding of the causative factors is therefore important, in addition to the research methodologies and database platforms that enable the undertaking of the research.
Persistent Identifierhttp://hdl.handle.net/10722/200778
ISSN
2017 Impact Factor: 3.838
2015 SCImago Journal Rankings: 1.486
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChan, EW-
dc.contributor.authorLiu, Q-
dc.contributor.authorChui, SLC-
dc.contributor.authorSing, CW-
dc.contributor.authorWong, LYL-
dc.contributor.authorWong, ICK-
dc.date.accessioned2014-08-21T07:01:02Z-
dc.date.available2014-08-21T07:01:02Z-
dc.date.issued2015-
dc.identifier.citationBritish Journal of Clinical Pharmacology, 2015, v. 80 n. 4, p. 855-861-
dc.identifier.issn0306-5251-
dc.identifier.urihttp://hdl.handle.net/10722/200778-
dc.description.abstractIt is recognised that randomised controlled trials are not feasible for capturing rare adverse events. There is an increasing trend towards observational research methodologies using large population‐based health databases. These databases offer more scope for adequate sample sizes, allowing for comprehensive patient characterisation and assessment of the associated factors. While direct causality cannot be established and confounders cannot be ignored, databases present an opportunity to explore and quantify rare events. The use of databases for the detection of rare adverse events in the following conditions, sudden death associated with attention deficit hyperactivity disorder (ADHD) treatment, retinal detachment associated with the use of fluoroquinolones and toxic epidermal necrolysis associated with drug exposure, are discussed as examples. In general, rare adverse events tend to have immediate and important clinical implications and may be life‐threatening. An understanding of the causative factors is therefore important, in addition to the research methodologies and database platforms that enable the undertaking of the research.-
dc.languageeng-
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1365-2125-
dc.relation.ispartofBritish Journal of Clinical Pharmacology-
dc.rightsThe definitive version is available at www.blackwell-synergy.com-
dc.subjectAdverse drug reactions-
dc.subjectAttention deficit hyperactivity disorder-
dc.subjectDatabase-
dc.subjectRetinal detachment-
dc.subjectSudden death-
dc.subjectToxic epidermal necrolysis (TEN)-
dc.titleAdverse drug reactions – examples of detection of rare events using databases-
dc.typeArticle-
dc.identifier.emailChan, EW: ewchan@hku.hk-
dc.identifier.emailChui, SLC: cslchui@hku.hk-
dc.identifier.emailWong, ICK: wongick@hku.hk-
dc.identifier.authorityChan, EW=rp01587-
dc.identifier.authorityChui, SLC=rp02527-
dc.identifier.authorityWong, ICK=rp01480-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1111/bcp.12474-
dc.identifier.pmid25060360-
dc.identifier.pmcidPMC4594728-
dc.identifier.scopuseid_2-s2.0-84942552796-
dc.identifier.hkuros233004-
dc.identifier.volume80-
dc.identifier.issue4-
dc.identifier.spage855-
dc.identifier.epage861-
dc.identifier.isiWOS:000362084200033-
dc.publisher.placeUnited Kingdom-

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