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Here we consider various examples of legal and regulatory responses to avoidable adverse medication events. There are a wide range of poorly interlinked regulatory processes, regardless of the country examined. Some approaches are proactive while others are reactive, serving mostly to provide compensation or to punish those felt responsible. Regulation can assist in promoting medication safety through influence and through compulsion, but what is really required is the whole-hearted engagement of everyone in the organization in the mission of achieving safe, high quality patient care. This goal will require both physician efforts, through professionalism and self regulation, and those of hospital boards of directors, through setting priorities and driving a just culture. While there is a role for the civil law (compensation for injured and in some degree of declarative retribution), litigation is likely to most effective when it is directed against institutions. The best approaches are based on “full disclosure and rapid compensation” practices. Criminal action in the regulation of safe medication practices in the perioperative period should be reserved for when recklessness is involved or where deliberate malfeasance is a factor.
Surgical patients undergo multiple transitions of care, from home to the operating room, to a recovery unit to a ward, and so on. Each transition poses a risk of medication error if the current medications are not reconciled or managed appropriately in the new phase of care. Home medications may be suspended, stopped, substituted for, or need to be continued, often in the face of changing preoperative guidelines. Admission and discharge medication reconciliations are at high risk for inaccuracies and for mis-information for the patient as well as the patient's primary provider. Intraoperative medication management is largely but not exclusively, under the control of the anesthesiologist, who serves as the sole agent for the prescription, dispensing, preparation, administration, documentation and monitoring of the anesthetic medications. Common errors include syringe or vial swaps, omissions (e.g., no redosing of antibiotics), wrong route, wrong dose, and even wrong choice of medication. Medication errors occur in approximately every 2 anesthetics, most are of little to no harm, but each has the potential for significant injury. Medication errors also can be made by a surgeon or OR nurse; communication failures between care team members often contribute.
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