Background: Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. Methods:We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use.Results: In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (PϽ.05), few other drug characteristics predicted off-label prescription.Conclusions: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.
ObjectiveMedication errors in hospitals are common, expensive, and sometimes harmful to patients. This study's objective was to derive a nationally representative estimate of medication error reduction in hospitals attributable to electronic prescribing through computerized provider order entry (CPOE) systems.Materials and methodsWe conducted a systematic literature review and applied random-effects meta-analytic techniques to derive a summary estimate of the effect of CPOE on medication errors. This pooled estimate was combined with data from the 2006 American Society of Health-System Pharmacists Annual Survey, the 2007 American Hospital Association Annual Survey, and the latter's 2008 Electronic Health Record Adoption Database supplement to estimate the percentage and absolute reduction in medication errors attributable to CPOE.ResultsProcessing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% (95% CI 41% to 55%). Given this effect size, and the degree of CPOE adoption and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ∼17.4 million medication errors averted in the USA in 1 year.DiscussionOur findings suggest that CPOE can substantially reduce the frequency of medication errors in inpatient acute-care settings; however, it is unclear whether this translates into reduced harm for patients.ConclusionsDespite CPOE systems’ effectiveness at preventing medication errors, adoption and use in US hospitals remain modest. Current policies to increase CPOE adoption and use will likely prevent millions of additional medication errors each year. Further research is needed to better characterize links to patient harm.
Introduction-The long-term excess mortality associated with hip fracture remains controversial.
Use of antiobesity medications increased rapidly with public and professional interest in fenfluramine-phentermine (fen-phen) combination therapy. Despite reports of adverse outcomes associated with fenfluramine agents (fen-phen and dexfenfluramine), the use of these medication therapies did not diminish until soon before their removal from the market in 1997.
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