Using Drugs Outside Their Licensed Indication

As can be seen in the preceding chapter, useful guidance on the management of a wide variety of pain conditions is provided by published guidelines. These guidelines represent the considered views of consensus panels and are based on the available published evidence. Although there is much merit in their use, significant and important aspects of pain control are not contained within them.

The medications recommended are often, but not always, licensed by the regulatory authorities for their use in these conditions. When "conventional" therapies fail to provide relief, less conventional treatments can be recommended, and it is much more common in these circumstances for the suggested drugs not to have a specific licence for use in that condition. When these options are suggested, it is not unusual for other practitioners to express concern about their unlicensed, off-label use. In reality, even these practitioners often prescribe medication off-label. For example, the use of a tricyclic antidepressant (TCA) for its sleep-enhancing and analgesic effect is usual in patients who receive a diagnosis of fibromyalgia, and yet no TCA has a licence for use in patients with fibromyalgia.

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