Off‐label prescribing is the prescription of a registered medicine for a use that is not included in the product information. The practice is common, with rates up to 40% in adults and up to 90% in paediatric patients.
Off‐label prescribing is not illegal and may sometimes be clinically appropriate, but is associated with a number of clinical, safety and ethical issues. To date, no explicit guidance has been available to help clinicians assess appropriateness in off‐label prescribing.
We describe the development of a guide for clinicians, policymakers and funders of health care in evaluating the appropriateness of medicines proposed for off‐label use.
Three broad categories of appropriate off‐label use are identified:
➢off‐label use justified by high‐quality evidence;
➢use within the context of a formal research proposal; and
➢exceptional use, justified by individual clinical circumstances.
An appropriate process for informed consent is proposed for each category.
If there is no high‐quality evidence supporting off‐label use, and the medicine is not suitable for exceptional or research indications, its use is generally not recommended. This will reduce inappropriate use, enhance patient safety by reducing exposure to unnecessary risk, and may stimulate more clinically relevant medicines research.
The ethical arguments which underpin the call for interdisciplinary collaboration are analysed. In particular, the concept of 'teamwork' is considered as well as the organisational, professional, personal and cultural obstacles that constitute the barriers to the effective development of interdisciplinary relationships.
Advanced directives are infrequently used in residential care. Further qualitative and quantitative studies are warranted to explore current processes of decision making.
Objective
To determine attitudes among surgeons in Australia to assisted death, and the proportion of surgeons who have intentionally hastened death with or without an explicit request.
Design
Anonymous, cross‐sectional, mail‐out survey between August and November 1999
Participants
683 out of 992 eligible general surgeons (68.9% response rate).
Main outcome measures
Proportion of respondents answering affirmatively to questions about administering excessive doses of medication with an intention to hasten death.
Results
247 respondents (36.2%; 95% CI, 32.6%–39.9%) reported that, for the purpose of relieving a patient's suffering, they have given drugs in doses that they perceived to be greater than those required to relieve symptoms with the intention of hastening death. More than half of these (139 respondents; 20.4% of all respondents; 95% CI, 17.4%–23.6%) reported that they had never received an unambiguous request for a lethal dose of medication. Of all respondents, only 36 (5.3%; 95% CI, 2.9%–6.1%) reported that they had given a bolus lethal injection, or had provided the means to commit suicide, in response to an unambiguous request.
Conclusions
More than a third of surgeons surveyed reported giving drugs with an intention to hasten death, often in the absence of an explicit request. However, in many instances, this may involve the use of an infusion of analgesics or sedatives, and such actions may be difficult to distinguish from accepted palliative care, except on the basis of the doctor's self‐reported intention. Legal and moral distinctions based solely on a doctor's intention are problematic.
None of the arguments that patients have an obligation to participate in medical education are convincing. We believe that patients participate in training largely out of altruism rather than obligation. Where possible, sick patients should be substituted for by healthy patients or simulations.
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