title: A plea for rational mitigation of poor outcomes in the 'off-label use' of medications for the management of pain.
abstract: Neuropathic pain is a common and difficult to manage public health problem characterized by frequent treatment failure and high management costs. The variable presentation and response to treatment among patients make it difficult for physicians to apply a single, standardized approach for management. The physician's role in treating neuropathic pain is complex. Clinical decisions must be drawn from personal and shared experience, case reports, and evidence-based, controlled trials performed on selected populations of patients with common, narrowly-defined conditions. Recent advances in our understanding of the mechanisms that underlie the processing of nociceptive stimuli and the perception of pain have led to the increased 'off-label use' of adjuvant medications in an attempt to provide relief for many patients who heretofore have suffered unnecessarily with intractable neuropathic pain. Unfortunately, as with any treatment, sound clinical decisions can occasionally result in an untoward adverse response. It is therefore imperative that potential adverse effects inherent to all medications be considered and weighed against the untoward consequences of withholding treatment prior to incorporating their use in any course of management. This commentary presents a case report that illustrates a particularly devastating consequence that was encountered when a medication was selected for 'off-label use' in the treatment of intractable pain and presents an opinion for consideration in developing guidelines for determining acceptable risk and standard of care based upon rational adherence or deviation from the approved indications offered for the use of a medication at the time of its introduction into practice is granted.
authors.affiliation: Department of Neurology, Louisiana State University Health Sciences Center, New Orleans, LA, United States.
authors.forename: Faraz
authors.initials: F
authors.lastname: Khursheed
authors.affiliation: Department of Internal Medicine, Section of Physical Medicine and Rehabilitation, United States.
authors.forename: Julia
authors.initials: J
authors.lastname: Ioffe
authors.affiliation: Department of Neurology, Louisiana State University Health Sciences Center, New Orleans, LA, United States; Department of Internal Medicine, Section of Physical Medicine and Rehabilitation, United States; Department of Anesthesiology, Louisiana State University Health Sciences Center, New Orleans, LA, United States; Department of Neuroscience Center of Excellence, Louisiana State University Health Sciences Center, New Orleans, LA, United States; Center of Excellence for Oral and Craniofacial Biology, Louisiana State University Health Sciences Center, New Orleans, LA, United States; Pain Mastery Center of Louisiana, Louisiana State University Health Sciences Center, New Orleans, LA, United States. Electronic address: hgould@lsuhsc.edu.
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Gould
mesh_terms: D000328:Adult; D019468:Disease Management; D005260:Female; D006801:Humans; D055118:Medication Adherence; D009437:Neuralgia / Q000188:drug therapy*; D056687:Off-Label Use; D010818:Practice Patterns, Physicians'; D012307:Risk Factors; D016896:Treatment Outcome
keywords: Adjuvant medications; Malpractice; Neuropathic pain; Off-label prescribing; Physicians' Desk Reference; Shared responsibility