Knowledge of adverse drug reaction reporting and the pharmacovigilance of biological medicines: A survey of healthcare professionals in Ireland.

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dc.contributor.authorO'Callaghan, Joan
dc.contributor.authorGriffin, Brendan T.
dc.contributor.authorMorris, J. Michael
dc.contributor.authorBermingham, Margaret
dc.contributor.funderHealth Products Regulatory Authority (HPRA), Irelanden
dc.contributor.funderRegulatory Science Irelanden
dc.contributor.funderUniversity College Corken
dc.contributor.funderIrish Pharmaceutical Healthcare Association (IPHA)en
dc.date.accessioned2018-05-17T14:19:37Z
dc.date.available2018-05-17T14:19:37Z
dc.date.issued2018-05-02
dc.date.updated2018-05-17T14:02:37Z
dc.description.abstractBackground: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. Objective: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Methods: Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. Results: There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. Conclusion: This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.en
dc.description.sponsorshipIrish Pharmaceutical Healthcare Association (IPHA research grant to support regulatory science research)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationO’Callaghan, J., Griffin, B. T., Morris, J. M. and Bermingham, M. (2018) 'Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland', BioDrugs (14pp). doi: 10.1007/s40259-018-0281-6en
dc.identifier.doi10.1007/s40259-018-0281-6
dc.identifier.endpage11en
dc.identifier.issn1179-190X
dc.identifier.journaltitleBioDrugsen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/6142
dc.language.isoenen
dc.publisherAdis/Springer International Publishingen
dc.rights© The Author(s) 2018. Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.en
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectAdverse drug reaction (ADR)en
dc.subjectPharmacovigilanceen
dc.subjectBatch traceabilityen
dc.subjectLegislationen
dc.subjectBiosimilar medicineen
dc.subjectBiological medicinesen
dc.subjectADR reportingen
dc.titleKnowledge of adverse drug reaction reporting and the pharmacovigilance of biological medicines: A survey of healthcare professionals in Ireland.en
dc.typeArticle (peer-reviewed)en
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