Off-label medicine use/prescribing controversies through patients’ eyes/“rights”: the example of povidone-iodine enemas/suppositories for “terminal” pouchitis

Abstract

There is an abundance of literature addressing the everlasting legal/ethical/moral controversies about the off-label use/prescribing of medicines and the need to streamline the practice [1,2]. The issue is visited herein from the patient's viewpoint, via a particular example and a suggestion is put forth. Pouchitis is the most frequent long-term complication for inflammatory bowel disease (IBD) patients who have undergone ileal pouch-anal anastomosis [3]. While antibiotics are routinely effective against the inflammation of the constructed pouch ("pouchitis" classified as IBD), indicating that a pathogen might be involved, there is a significant proportion of patients who end up having chronic antibiotic refractory pouchitis, for whom the future is bleak (if they are to avoid pouch excision and permanent ileostomy): mesalazine and immunosuppressants are prescribed, without a firm basis of clinical trials, at severe infection risks (for the latter) and frequently at very high costs (i.e. for tumor necrosis factor alpha antagonists), with dubious outcomes. Thus, a patient facing unremitting disease/pouchitis, with major complications and medication side-effects, is often willing to risk off-label medicines never used before for pouchitis, provided he/she can find a physician willing to prescribe ("quasi-experimentally") and accept the legitimacy of his/her choice.