Prescribing in palliative medicine – Off-license, off-label or just confused.

Regulatory authorities register medications (formulation and strength) in specific doses (amount, frequency and duration) for specific indications (population and disease). The use of licensed medications for unlicensed indications, formulation or routes (off-label) is common practice, especially in palliative medicine. This has implications for poor prescribing practices, uncertain clinical efficacies, adverse events and medico-legal consequences. The aim of this national survey was to determine which off­ label medications were being prescribed most frequently by palliative medicine clinicians in Australia.

A cross-sectional online survey was sent out to Australian palliative medicine clinicians. Participants were asked "Please list the top three licensed drugs for un-licensed use I routes that you use, their indication, and routes of administration". Drugs and indications were categorised into unregistered, off-label, or on-label according to criteria set by the national regulatory body.

105 respondents proposed 236 off-label drug/indication dyads. 118/236 (50%) were off-label, 72/236 (31%) were on-label and 45/236 (19%) were unregistered. For the thirty-six drugs nominated, 26 were used off-label, 12 drugs on-label, and 2 unregistered (some drugs had more than one indication and thus contributed to the counts in more than one category).

Off-label prescribing was poorly recognised by palliative medicine clinicians in their area of specialty practice. There were inadequate service-level policies to guide off-label prescribing. Low level recognition of off-label prescribing may reflect poor understanding of medication registration and access, the evidence base for these medications, and potential medico-legal implications.