For a condition such as AZOOR in which there is no well-established standard of care, off-label use of medications is often initiated. It’s important to keep in mind that the greatest risk for harm arises when “an off-label use lacks a solid evidentiary basis.”2 With the substantial risks involved in using off-label medications, how do we appropriately define the roles of the rheumatologist and ophthalmologist in making these difficult decisions?
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Explore This IssueMay 2014
According to the American College of Physicians (ACP) Ethics Manual, 6th edition:
In almost all circumstances, patients should be encouraged to initially seek care from their principal physician. Physicians should in turn obtain competent consultation whenever they and their patients feel the need for assistance with care. The purpose, nature and expectation of the consult should be clear to all.
The major dilemma in this case is that the principal physician has not been established. Patients with “autoimmune retinopathy” do not fall exclusively under either subspecialty. The ACP Ethics Manual addresses complex clinical situations where multiple subspecialists are involved in a patient’s care. However, these guidelines again reference the principal physician as the provider who should “assure a coordinated effort that is in the best interest of the patient …” and that “unless authority has been formally transferred elsewhere, the responsibility of the patient’s care lies with the principal physician.”3
Unfortunately, these guidelines do not outline a course of action when roles are not established. Similarly, the American College of Rheumatology’s Code of Ethics does not address this issue.4 Keeping in mind that the “physician’s primary commitment must always be to the patient’s welfare and interest,”3 one would hope that after an open discussion between the involved clinicians, a reasonable plan could be established. In reality however, once physicians start to consider the liability of prescribing off-label medications for rare diseases that fall outside the normal scope of their subspecialty, everyone gets nervous. The issue becomes more complex when the clinicians involved do not agree on what agent or agents should be used or how they should be used.
When providers do not agree on treatment and high-quality studies are not available, a few strategies may be considered. With regard to off-label steroid-sparing agents, providers should follow responsible off-label prescribing practices. These include:
- Evaluating whether there is sufficient evidence to justify an off-label use;
- Pressing for additional information from experienced experts or institutions when adequate published evidence is lacking; and
- Informing patients about the uncertainties, risks and potential costs of medications under consideration.2
Although the patient should not be put in a position of arbiter of any disagreement, all recommendations should be thoroughly reviewed with the patient. Good documentation, including details of obtaining the patient’s informed consent, is essential.