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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.
The proportion of patients harmed by medication errors is small but when harm does occur it can be catastrophic, including death. The primary physical harm is only the tip of the iceberg as long-term psychological, emotional, and financial impacts are added to physical injury. These secondary effects are aggravated by failures to respond to adverse events in a caring, compassionate and transparent manner, fulfilling what we have called “the next promise”. The approach of the clinicians and institution involved in a harmful medication error is critical to recovery, and requires 1) full and transparent disclosure of all known causes for the error; 2) an apology that includes empathy and emotional support, a listening at length to the patients and their families without any attempt to deflect blame or downplay the impact; 3) appropriate and rapid compensation; 4) accountability; and 5) regular feedback to all regarding ongoing investigations into the event, and interventions that have been made to prevent this event happening to another patient. There is an excellent body of knowledge to guide institutions and their inter-professional clinical teams about how to design and implement a communication and resolution program that is ethical, patient centered and provides emotional support not only to patients and their families, but also to staff involved in the error.
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