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• W2011609924 abstract "In September, 2013, the Portal for Patient Safety/Central Medication incidents Registration (CMR) in the Netherlands issued an alert concerning eight reconstitution errors with cabazitaxel (licensed as Jevtana, Sanofi-Aventis, Paris) that had resulted in doses that were more than 15% higher than intended.1Medicatieveiligheid.infoFout in VTGM-voorschrift leidt tot te hoge dosering cabazitaxel (Jevtana®). (in Dutch).http://www.medicatieveiligheid.info/websites/nvza_remedie/docs/CMR_Alertmelding_VTGM-fout_cabazitaxel_DEF2.pdfGoogle Scholar The underlying problem was insufficient clarity in the summary of product characteristics about the appropriate reconstitution of a solution for infusion from two different vials. When the CMR approached the Dutch Medicines Evaluation Board and the national representative of the manufacturer, it turned out that the same problem had been observed in Spain and that ISMP (Instituto para el Uso Seguro de los Medicamentos)-Spain had already sent out an alert in July, 2012.2Instituto para el Uso Seguro de los MedicamentosRiesgo de errores en la preparación de cabazitaxel (Jevtana®). (in Spanish).http://www.ismp-espana.org/ficheros/Nota%2520de%2520advertencia%2520sobre%2520cabazitaxel.pdfGoogle Scholar In the UK, four patients were also reported to have received overdoses of cabazitaxel. In October, 2013, the UK branch of the manufacturer (in association with the European Medicines Agency and the UK regulatory agency) sent out a warning, which identified adverse drug reactions, such as bone marrow suppression and gastrointestinal disorders, as potential complications of the overdose.3Hussein J Jevtana (cabazitaxel): risk of medication error.http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con333636.pdfGoogle ScholarThis sequence of events shows that national centres for medication errors can learn valuable lessons not only from the data that they collect themselves, but also from alerts issued by sister organisations. At first sight, the International Medication Safety Network might seem to be an obvious candidate to act as a coordinator.4Institute for Safe Medication PracticesAbout ISMP.http://www.ismp.org/about/default.aspGoogle Scholar However, this organisation does not have the time or funding required to set up and maintain a system for the international monitoring, evaluation, and exchange of medication errors alerts. We propose that the European Medicines Agency would be a much better candidate for this role.The European Medicines Agency can provide European coordination and also has the authority to impose binding decisions. Furthermore, recent European legislation requires that all adverse drug reactions (including harm from medication errors) should be reported to the EudraVigilance database.5European Medicines AgencyMedication errors.http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000570.jsp&mid=WC0b01ac0580659655Google Scholar The European Medicines Agency should now show further leadership by bringing all parties involved in medication errors together. Besides national pharmacovigilance centres, centres for medication errors (such as the CMR) should also participate, because they also cover medication errors without actual harm (an area still outside the scope of EudraVigilance), and because they disseminate medication error alerts in which they focus on the drug treatment process rather than on pharmacological properties. A global perspective could be added by WHO Uppsala Monitoring Centre, which collects adverse drug reactions (including harm from medication errors) in its worldwide VigiBase.View Large Image Copyright © 2014 Wladimir Bulgar/Science Photo LibraryWe declare that we have no competing interests. In September, 2013, the Portal for Patient Safety/Central Medication incidents Registration (CMR) in the Netherlands issued an alert concerning eight reconstitution errors with cabazitaxel (licensed as Jevtana, Sanofi-Aventis, Paris) that had resulted in doses that were more than 15% higher than intended.1Medicatieveiligheid.infoFout in VTGM-voorschrift leidt tot te hoge dosering cabazitaxel (Jevtana®). (in Dutch).http://www.medicatieveiligheid.info/websites/nvza_remedie/docs/CMR_Alertmelding_VTGM-fout_cabazitaxel_DEF2.pdfGoogle Scholar The underlying problem was insufficient clarity in the summary of product characteristics about the appropriate reconstitution of a solution for infusion from two different vials. When the CMR approached the Dutch Medicines Evaluation Board and the national representative of the manufacturer, it turned out that the same problem had been observed in Spain and that ISMP (Instituto para el Uso Seguro de los Medicamentos)-Spain had already sent out an alert in July, 2012.2Instituto para el Uso Seguro de los MedicamentosRiesgo de errores en la preparación de cabazitaxel (Jevtana®). (in Spanish).http://www.ismp-espana.org/ficheros/Nota%2520de%2520advertencia%2520sobre%2520cabazitaxel.pdfGoogle Scholar In the UK, four patients were also reported to have received overdoses of cabazitaxel. In October, 2013, the UK branch of the manufacturer (in association with the European Medicines Agency and the UK regulatory agency) sent out a warning, which identified adverse drug reactions, such as bone marrow suppression and gastrointestinal disorders, as potential complications of the overdose.3Hussein J Jevtana (cabazitaxel): risk of medication error.http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con333636.pdfGoogle Scholar This sequence of events shows that national centres for medication errors can learn valuable lessons not only from the data that they collect themselves, but also from alerts issued by sister organisations. At first sight, the International Medication Safety Network might seem to be an obvious candidate to act as a coordinator.4Institute for Safe Medication PracticesAbout ISMP.http://www.ismp.org/about/default.aspGoogle Scholar However, this organisation does not have the time or funding required to set up and maintain a system for the international monitoring, evaluation, and exchange of medication errors alerts. We propose that the European Medicines Agency would be a much better candidate for this role. The European Medicines Agency can provide European coordination and also has the authority to impose binding decisions. Furthermore, recent European legislation requires that all adverse drug reactions (including harm from medication errors) should be reported to the EudraVigilance database.5European Medicines AgencyMedication errors.http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000570.jsp&mid=WC0b01ac0580659655Google Scholar The European Medicines Agency should now show further leadership by bringing all parties involved in medication errors together. Besides national pharmacovigilance centres, centres for medication errors (such as the CMR) should also participate, because they also cover medication errors without actual harm (an area still outside the scope of EudraVigilance), and because they disseminate medication error alerts in which they focus on the drug treatment process rather than on pharmacological properties. A global perspective could be added by WHO Uppsala Monitoring Centre, which collects adverse drug reactions (including harm from medication errors) in its worldwide VigiBase. We declare that we have no competing interests." @default.
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• W2011609924 title "Improving European cooperation on medication errors" @default.
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