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Article: Defining off-label and unlicensed use of medicines for children: Results of a Delphi survey

TitleDefining off-label and unlicensed use of medicines for children: Results of a Delphi survey
Authors
KeywordsDefinition
Off-label
Paediatric medicine
Survey
Unlicensed
Issue Date2008
PublisherAcademic Press. The Journal's web site is located at http://www.elsevier.com/locate/issn/10436618
Citation
Pharmacological Research, 2008, v. 58 n. 5-6, p. 316-322 How to Cite?
AbstractThe aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities. © 2008 Elsevier Ltd. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/132858
ISSN
2015 Impact Factor: 4.816
2015 SCImago Journal Rankings: 2.108
ISI Accession Number ID
Funding AgencyGrant Number
European Community's 6th framework programmeLSHB-CT-2005-005216
Funding Information:

This study was funded under the European Community's 6th framework programme project number LSHB-CT-2005-005216: Task force in Europe for Drug Development for the Young (TEDDY).

References

 

DC FieldValueLanguage
dc.contributor.authorNeubert, Aen_HK
dc.contributor.authorWong, ICKen_HK
dc.contributor.authorBonifazi, Aen_HK
dc.contributor.authorCatapano, Men_HK
dc.contributor.authorFelisi, Men_HK
dc.contributor.authorBaiardi, Pen_HK
dc.contributor.authorGiaquinto, Cen_HK
dc.contributor.authorKnibbe, CAJen_HK
dc.contributor.authorSturkenboom, MCJMen_HK
dc.contributor.authorGhaleb, MAen_HK
dc.contributor.authorCeci, Aen_HK
dc.date.accessioned2011-04-04T07:57:37Z-
dc.date.available2011-04-04T07:57:37Z-
dc.date.issued2008en_HK
dc.identifier.citationPharmacological Research, 2008, v. 58 n. 5-6, p. 316-322en_HK
dc.identifier.issn1043-6618en_HK
dc.identifier.urihttp://hdl.handle.net/10722/132858-
dc.description.abstractThe aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities. © 2008 Elsevier Ltd. All rights reserved.en_HK
dc.languageengen_US
dc.publisherAcademic Press. The Journal's web site is located at http://www.elsevier.com/locate/issn/10436618en_HK
dc.relation.ispartofPharmacological Researchen_HK
dc.subjectDefinitionen_HK
dc.subjectOff-labelen_HK
dc.subjectPaediatric medicineen_HK
dc.subjectSurveyen_HK
dc.subjectUnlicenseden_HK
dc.titleDefining off-label and unlicensed use of medicines for children: Results of a Delphi surveyen_HK
dc.typeArticleen_HK
dc.identifier.emailWong, ICK: wongick@hku.hken_HK
dc.identifier.authorityWong, ICK=rp01480en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/j.phrs.2008.09.007en_HK
dc.identifier.pmid18852048-
dc.identifier.scopuseid_2-s2.0-56949107492en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-56949107492&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume58en_HK
dc.identifier.issue5-6en_HK
dc.identifier.spage316en_HK
dc.identifier.epage322en_HK
dc.identifier.eissn1096-1186-
dc.identifier.isiWOS:000261855500009-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridNeubert, A=7003774960en_HK
dc.identifier.scopusauthoridWong, ICK=7102513915en_HK
dc.identifier.scopusauthoridBonifazi, A=25635549900en_HK
dc.identifier.scopusauthoridCatapano, M=6603663401en_HK
dc.identifier.scopusauthoridFelisi, M=6507112638en_HK
dc.identifier.scopusauthoridBaiardi, P=6603678168en_HK
dc.identifier.scopusauthoridGiaquinto, C=7006585659en_HK
dc.identifier.scopusauthoridKnibbe, CAJ=6603354434en_HK
dc.identifier.scopusauthoridSturkenboom, MCJM=21743803900en_HK
dc.identifier.scopusauthoridGhaleb, MA=8903103000en_HK
dc.identifier.scopusauthoridCeci, A=7006836326en_HK

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