Greenberg R B
Am J Hosp Pharm. 1980 Dec;37(12):1656-9.
The implications for institutional pharmacists of the recent Food and Drug Administration omnibus regulation that mandates patient package inserts (PPIs) are discussed. FDA issued a final rule on September 12, 1980, establishing a three-year trial period during which PPIs must be dispensed with each new prescription for 10 specific drugs or drug classes. Involved are the drugs cimetidine, clofibrate, propoxyphene, phenytoin, warfarin, digoxin, and methoxsalen, and the drug classes ampicillins, benzodiazepines, and thiazides. FDA will evaluate costs and benefits of this program during the three-year period and will issue a regulatory analysis before additional drugs are added to the rule. Institutions may adopt an alternate system to make PPIs available to inpatients. Specific recommendations for implementation of the PPI program in institutions are made.
讨论了美国食品药品监督管理局（FDA）近期强制要求提供患者用药指导（PPI）的综合法规对机构药剂师的影响。FDA于1980年9月12日发布了一项最终规定，设立了一个为期三年的试验期，在此期间，必须随10种特定药物或药物类别中的每种新处方配给PPI。涉及的药物有西咪替丁、氯贝丁酯、丙氧芬、苯妥英、华法林、地高辛和甲氧沙林，以及药物类别氨苄青霉素、苯二氮䓬类和噻嗪类。FDA将在三年期间评估该计划的成本和效益，并在该规定增加其他药物之前发布一份监管分析报告。机构可以采用替代系统，以便为住院患者提供PPI。文中还针对机构实施PPI计划提出了具体建议。
