Abstract
Background: Off-label-use is an indispensable element of palliative medicine. Up to one third of all drugs are prescribed beyond their licence. It is challenging to find the right balance between potential risks and benefits in the context of limited therapeutic options. To date, little is known how physicians deal with this challenge in daily practice.Objectives: To evaluate (1) the awareness of German palliative medicine physicians of off-label-use, (2) the basis for decision-making for off-label-use, (3) the existence of guidelines for off-label prescribing and (4) practical problems arising in clinical practice.Methods: Anonymous online survey among German palliative medicine physicians. Medical directors and consultants/other doctors were surveyed independently with two different questionnaires. The questionnaires included questions regarding documentation, legal and practical aspects of off-label drug use.Results: In total, 578/605 emails sent were delivered. One hundred and forty-one questionnaires were fully completed, 8 partially. Response rate 23%. The majority of participants worked in specialist palliative home care and palliative care units (n = 134). One hundred and two (68%) participants were aged >50 years and 103 (69%) practised medicine >20 years. One hundred and twelve medical directors participated, 95 (85%) reported that no guidance on documentation of off-label-use was available. In total, 30/37 consultants and other doctors indicated experience as basis for their decision making on off-label-use. Twenty-four (75%) of the consultants and other doctors regularly used off-label-therapies with little or no evidence base. Uncertainties exist regarding drug safety, legal issues and the cost coverage.Conclusions: More recommendations on the management of off-label drug use are necessary. Participants demand greater legal security including unbureaucratic prescribing.
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