Liang F Z, Greenberg R B, Hogan G F
Legislative and Regulatory Division, American Society of Hospital Pharmacists, Bethesda, MD 20814.
Am J Hosp Pharm. 1988 Nov;45(11):2372-5.
The legal issues associated with selecting drug products under the formulary system when there are two or more recognized drug therapies are discussed. The primary legal issue involved is whether a decision by a health-care provider to use a particular drug product can be viewed as "reasonable" under the circumstances when there are two or more recognized drug therapies for treating a patient. In the institutional setting, the physician diagnoses and prescribes drug products but authorizes, under the formulary system, the selection of alternative agents. Imposition of civil liability on health-care providers for a patient's drug-related injury based on a formulary decision has not yet occurred. Liability would most likely be based on negligence in such a case. The standard of care a medical provider will be measured against is what a "reasonable provider" would do under like circumstances. An institution's decision whether or not to routinely have available a particular drug product that is among several accepted therapies would probably not be viewed as negligent, so long as that decision was based on the objective clinical judgment of the medical staff operating under the formulary system. It is unlikely that a decision to use one of two (or more) drug products would be "negligent" if that decision was based on a current and objective evaluation of the medical literature and supported by a recognized segment of medical opinion.
本文讨论了在有两种或更多公认药物治疗方法的情况下，根据处方集系统选择药品所涉及的法律问题。所涉及的主要法律问题是，当有两种或更多公认的药物疗法用于治疗患者时，医疗保健提供者选择使用特定药品的决定在这种情况下是否可被视为“合理”。在机构环境中，医生诊断并开出处方药品，但在处方集系统下授权选择替代药物。基于处方集决定而对医疗保健提供者因患者药物相关伤害施加民事责任的情况尚未发生。在这种情况下，责任很可能基于过失。衡量医疗提供者的护理标准是“合理提供者”在类似情况下会做的事情。只要机构的决定是基于在处方集系统下运作的医务人员的客观临床判断，那么机构决定是否常规备有几种可接受疗法之一的特定药品，可能不会被视为疏忽。如果对两种（或更多）药品之一的使用决定是基于对医学文献的当前客观评估并得到医学意见的认可部分的支持，那么该决定不太可能是“疏忽的”。
