![]() ![]() Off-label prescribing, while an accepted practice, adds risk management considerations and additional requirements for clinical decision making and documentation of rationale and consent. However, it has also been associated with increased risk of harm to patients and liability for providers, particularly if poor outcomes arise from an off-label use and evidence for safety and efficacy is lacking. Food and Drug Administration (FDA) as "safe and effective." It is common, frequently beneficial to patients, and may represent the standard of care for a given condition. ![]() "Off-label" use of medical products (i.e., drugs, devices, and biologics) is the practice of prescribing drugs and biologics, and using medical devices, in a manner different from that approved by the U.S.
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