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Off Label Drug Use in Paediatric Patients : An Evidence Based Literature Study analysing Liposomal Amphotericin B, Micafungin, Ciprofloxacin, Ganciclovir, Tropisetron, Palonosetron and Diphenhydramine
AuthorPichler, Anna-Theresia
CensorStriessnig, Jörg
Thesis advisorStriessnig, Jörg ; Jeske, Martina
Institutional NoteInnsbruck, Univ., Diplomarb., 2017
Arbeit an der Bibliothek noch nicht eingelangt - Daten nicht geprüft
Date of SubmissionFebruary 2017
Document typeThesis (Diplom)
Keywords (DE)Liposomal amphotericin B / AmBisome / micafungin / Mycamine / ciprofloxacin / ganciclovir / tropisetron / palonosetron / Aloxi / dimenhydrinate / Vomex / Kind / Kinder / Pädiatrie / Dosierung / Sicherheit / Verträglichkeit / Effizienz / Nebenwirkungen / Off-label
Keywords (EN)Liposomal amphotericin B / AmBisome / micafungin / Mycamine / ciprofloxacin / ganciclovir / tropisetron / palonosetron / Aloxi / dimenhydrinate / Vomex / children / paediatric / dosage / safety / tolerability / efficacy / adverse events / off-label
URNurn:nbn:at:at-ubi:1-6438 Persistent Identifier (URN)
 The work is publicly available
Off Label Drug Use in Paediatric Patients [2.94 mb]
Abstract (English)

Background: Clinical departments of oncology and paediatrics are the main affected by off-label drug use in children with medicines only approved for adults. Paediatric cancer patients treated with off-label drugs are at risk of unexpected drug-related adverse events, as no clear declarations for dosage, age and indication exist. By law, the prescribing physician is fully responsible for these effects. Consequently, there is a strong need for adequate, if possible evidence-based, recommendations.

Methods: A literature-based data collection dealing with antiemetic and antimicrobial therapy in paediatric cancer patients was conducted. Information in terms of dosage, safety and efficacy was considered for the following drugs suggested by the paediatric division of the department of Haematology and Oncology of the University Hospital Innsbruck: liposomal amphotericin B, micafungin, ciprofloxacin, ganciclovir, tropisetron, palonosetron and dimenhydrinate. Relevant studies were identified according to a defined search strategy using literature databases like PubMed, Cochrane Library and ClinicalTrials.com. Evidence was rated for all selected publications on the basis of Jadad-Score and a classification of evidence of the different study types. The relevance of the obtained studies was measured by means of specified PICO criteria. Additionally, the bibliography of existing reviews was screened. Furthermore, study results were compared with dosage and application recommendations of the paediatric databases Kinderdosierungen.ch® and DrugDoses®. The aim was to elaborate a systematic survey including recent recommendations and experiences with respect to safety, dosage, tolerability and adverse events to facilitate the treatment of (oncologic) paediatric patients.

Results: The number of adequate studies was drug dependent, but in general very low for tropisetron and dimenhydrinate. As expected for off-label use in paediatric cancer patients, the amount of studies assessed with high evidence was low. Evaluation by Jadad-Score was scarcely possible. The database DrugDoses® offered clear dosage recommendations for every single drug reviewed in this work, whereas Kinderdosierungen.ch® supplied dosage recommendations for ciprofloxacin and liposomal amphotericin B, only.

Conclusion: Due to a well-functioning search strategy, adequate publications were successfully selected by online databases. The wide-ranging database DrugDoses® turned out to be useful for dosage comparison, whereas dosage-information on the platform Kinderdosierungen.ch® is much more limited, as it is specified on certain drugs. Outcomes of this review aim to support dose-selection by prescribing physicians of the Department of Haematology and Oncology of the University Hospital Innsbruck and to provide information on safety and efficacy.