Off-label drug use in palliative medicine: Delphi study for the consensus of evidence-based treatment recommendations

Background: Off-label use of drugs is an integral part of everyday clinical practice in palliative medicine. However, it is associated with many uncertainties, that is, drug therapy safety or legal issues including cost coverage. Healthcare professionals often lack time and resources for comprehensive literature search and patient-specific risk-benefit analyses. Aim: The aim of this project is to develop, evaluate and rate agreement/disagreement on treatment recommendations for off-label use in adult palliative medicine. Design: Online Delphi study with two rounds each to rate agreement/disagreement with treatment recommendations for off-label use in adult palliative medicine. An international expert panel consisting of physicians, pharmacists and nurses working in palliative care evaluated previously developed recommendations based on the best available evidence. Setting:/participants: Professionals (physicians, pharmacists, nursing staff) working in inpatient and home palliative care involved in the medication process were recruited as experts to participate. Between 64 and 75 experts participated in the first two Delphi studies. Results: A total of 64/68 recommendations on 21 drugs and 14 applications were agreed upon. Topics related to routes of administration as well as indications for sialorrhea, bronchorrhea, xerostomia, pruritus, singultus, fistula, gastroparesis and hot flashes. Recommendations that reached consensus are available to health care professionals via a free of charge database. Conclusion: For many off-label use applications, it is likely that there will be no registration studies and therefore no drug approvals in the future. The consensus-based recommendations are intended to facilitate individual treatment planning for prescribers and to enable a more reflected handling of off-label use.