Off-label use in Palliative Care – more common than expected. A retrospective chart review

Abstract Objective Off-label drug use seems to be integral to 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 a palliative care unit. Methods Retrospective chart review of all adult patients treated on a palliative care unit in 10/2017. All data on drug use e.g. 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 2,352 drug application days (d) 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 This single-unit data confirms the high prevalence of off-label use in palliative medicine and demonstrates that off-label use in palliative care is very multifaceted. The data presented allows for a more precise characterization of various aspects of off-label use in order to derive concrete further measures for research and clinical practice. What is already known on this subject Off-label drug use is likely to be common in palliative care, but detailed data is very limited Off-label drug use is a potential threat for patient safety Physicians state to make therapeutic decisions based on their own experience, due to a lack of available evidence and lack of support in assessment What this study adds off-label use in palliative care is multifaceted the mode of administration (e.g. combination with other drugs in a syringe driver) is beside indication a common reasons for off label use the proportion of off-label use without sound evidence is high.