American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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Am J Health Syst Pharm · Nov 2013
Impact of implementing smart infusion pumps in a pediatric intensive care unit.
The impact of smart infusion pumps on the interception of errors in the programming of i.v. drug administrations on a pediatric intensive care unit (PICU) is investigated. ⋯ The use of smart pumps in a PICU improved patient safety by enabling the interception of infusion programming errors that posed the potential for severe injury to pediatric patients.
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In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. ⋯ Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.