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Off-label use in adult palliative care – more common than expected. A retrospective chart review
  1. Vera Hagemann1,
  2. Claudia Bausewein1,
  3. Constanze Remi1,2
  1. 1Department of Palliative Medicine, University Hospital, LMU Munich, Munich, Germany
  2. 2Hospital Pharmacy, Ludwig Maximilians University Munich Faculty of Medicine, Munich, Germany
  1. Correspondence to Dr Constanze Remi, Department of Palliative Medicine, Ludwig Maximilians University Munich Faculty of Medicine, Munich, Germany; constanze.remi{at}med.uni-muenchen.de

Abstract

Objective Off-label drug use seems to be integral to adult palliative care pharmacotherapy. Balancing potential risks and benefits in the context of limited therapeutic options is challenging. To provide specific support for clinicians in dealing with off-label use, it is essential to understand off-label use in everyday clinical practice. The aim of this pilot study was to quantify and describe off-label use in an adult palliative care unit.

Methods Retrospective chart review of all adult patients treated on a palliative care unit in October 2017. All data on drug use (eg, indication, dose, route of administration) were extracted and matched with the prescribing information. Identified off-label use was subsequently compared with recommendations in the relevant literature. The main outcome measure was frequency and type of off-label drug use.

Results Some 2352 drug application days and 93 drugs were identified for 28 patients. Of all drugs, 47 (51%) were used off-label at least once. Most off-label uses concerned indication (57%) followed by mode of administration. In drugs highly relevant to palliative care the rate of off-label use was as high as 67%. The extent to which off-label therapy was supported by literature was very variable and ranged from 0% to 88%.

Conclusions These data from a single unit confirm the high prevalence of off-label use in palliative medicine and demonstrate that off-label use in adult palliative care is multifaceted. The data presented allow for a more precise characterisation of various aspects of off-label use in order to derive concrete further measures for research and clinical practice.

  • palliative care
  • safety
  • quality of health care
  • drug-related side effects and adverse reactions
  • evidence-based medicINE

Data availability statement

Data are available upon reasonable request. Deidentified prescribing data are available from the corresponding author upon reasonable request.

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Data availability statement

Data are available upon reasonable request. Deidentified prescribing data are available from the corresponding author upon reasonable request.

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