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Administration of label and off-label drugs by the subcutaneous route in palliative care: an observational cohort study
  1. Jesper Jørgen Jensen1 and
  2. Per Sjøgren2
  1. 1Arresoedal Hospice, Frederiksvaerk, Copenhagen, Denmark
  2. 2Section of Palliative Medicine, Department of Oncology, Rigshospitalet, København, Denmark
  1. Correspondence to Dr Jesper Jørgen Jensen, Arresoedal Hospice, 3300 Frederiksvaerk, Copenhagen, Denmark; jej{at}arresoedal-hospice.dk

Abstract

Background The marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.

Aim To assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.

Material and methods Retrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.

Results Drugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.

Conclusion Subcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.

  • clinical assessment
  • drug administration
  • hospice care
  • pharmacology
  • quality of life
  • symptoms and symptom management
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Footnotes

  • Contributors JJJ conceptualised, designed the study and made the search. He screened, analysed the data and made the quality assessments, and drafted the original version of the manuscript. PS supervised the study and critically reviewed the original version of the manuscript. He critically reviewed the manuscript and shortened the original version of the manuscript. Both authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Since the study was a non-interventional observational cohort study of an established clinical practice, according to Danish law there was no need for ethical committee approval.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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