BACKGROUNDThe gabapentinoid drugs gabapentin and pregabalin were originally developed as antiseizure drugs but now are prescribed mainly for treatment of pain. For gabapentin, the only pain-related indication approved by the US Food and Drug Administration (FDA) is postherpetic neuralgia. For pregabalin, FDA-approved indications related to pain are limited to postherpetic neuralgia, neuropathic pain associated with diabetic neuropathy or spinal cord injury, and fibromyalgia. Despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. Such use is growing, possibly because clinicians are searching increasingly for alternatives to opioids.OBSERVATIONS This report summarizes the limited published evidence to support off-label gabapentinoid uses, describes clinical cases in which off-label use is problematic, and notes how review articles and guidelines tend to overstate gabapentinoid effectiveness.CONCLUSIONS Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses.
The use of race in clinical decision-making is coming under increasing scrutiny, in part because of growing recognition that race-based diagnosis and treatment reflect flawed social, biological, and genetic assumptions. Despite this concern, guidelines, algorithms, and advisory and regulatory bodies (including the US Food and Drug Administration [FDA]) regularly use race in ways that influence clinical decisions. For example, race-based "corrections" have been deemed problematic in algorithms, risk scores, and physiologic calculations used in cardiology, nephrology, urology, and obstetrics. 1,2 Pharmacogenomics is a field that explores relationships between genes and drug effects, with potential to "personalize" medical therapy. For clinical scenarios in which a genotype is clearly linked to important outcomes, direct genetic testing would appear to obviate the need to use race as a surrogate for genetic predisposition in decision-making. However, pharmacogenomics research often invokes race to stratify genetic risk: The assumption is that racial categories can sufficiently distinguish populations with high or low prevalences of certain genes, allowing clinicians to identify
This Invited Commentary is written by coauthors working to implement and study new models of interprofessional practice and education in clinical learning environments. There are many definitions and models of collaborative care, but the essential element is a spirit of collaboration and shared learning among health professionals, patients, and family members. This work is challenging, yet the benefits are striking. Patients and family members feel seen, heard, and understood. Health care professionals are able to contribute and feel appreciated in satisfying ways. Learners feel included. Care interactions are richer and less hierarchical, and human dimensions are more central. A crucial insight is that collaborative care requires psychological safety, so that people feel safe to speak up, ask questions, and make suggestions. The most important transformation is actively engaging patients and families as true partners in care creation. A leveling occurs between patients, family members, and health professionals, resulting from closer connections, deeper understandings, and greater mutual appreciation. Leadership happens at all levels in collaborative care, requiring team-level capabilities that can be learned and modeled, including patience, curiosity, and sharing power. These abilities grow as teams work and learn together, and can be intentionally advanced by reconfiguring organizational structures and care routines to support collective team reflection. Collaborative care requires awareness and deliberate practice both individually and as a team together. Respectful work is required, and setbacks should be considered normal at first. Once people have experienced the benefits of collaborative care, most "never want to go back."
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