Effect of deferasirox on iron absorption in a randomized, placebo-controlled, crossover study in a human model of acute supratherapeutic iron ingestion.

STUDY OBJECTIVE: In 2005, the Food and Drug Administration approved deferasirox as an oral iron chelating agent for chronic iron overload. To determine usefulness in management of acute iron ingestion, we study the effect of orally administered deferasirox in healthy human adults. METHODS: A double-blinded, placebo-controlled, randomized, crossover study of 8 healthy human volunteers was conducted. Subjects ingested 5 mg/kg of elemental iron in the form of ferrous sulfate. One hour after iron ingestion, subjects were randomized to receive 20 mg/kg of deferasirox or placebo. Serial iron levels were then obtained. A 2-week washout was used between study arms. The paired t test was used to compare area under time-concentration curves from baseline to both 12- and 24-hour iron levels between groups. RESULTS: Baseline serum iron levels were similar in the 2 groups. Deferasirox significantly reduced serum iron area under concentration-time curves compared with placebo during both 1 to 12 hours and 1 to 24 hours (12 hour=577 µmol-hour/L and 392 µmol-hour/L, 95% confidence interval for the difference 15.8 to 353.0 µmol-hour/L; 24 hour=808 µmol-hour/L and 598 µmol-hour/L, 95% confidence interval for difference 54.4 to 366.7 µmol-hour/L). CONCLUSION: Orally administered deferasirox significantly reduced serum iron levels when administered 1 hour after iron ingestion during the 12- and 24-hour periods after acute ingestion of 5 mg/kg of elemental iron in healthy human volunteers. Further study is required to determine optimal dosing, but deferasirox may be an important addition to current therapy for acute iron poisoning.

Duty hours in emergency medicine: balancing patient safety, resident wellness, and the resident training experience: a consensus response to the 2008 Institute of Medicine resident duty hours recommendations.

BACKGROUND: Representatives of emergency medicine (EM) were asked to develop a consensus report that provided a review of the past and potential future effects of duty hour requirements for EM residency training. In addition to the restrictions made in 2003 by the Accreditation Council for Graduate Medical Education, the potential effects of the 2008 Institute of Medicine (IOM) report on resident duty hours were postulated. DISCUSSION: The elements highlighted include patient safety, resident wellness, and the resident training experience. Many of the changes and recommendations did not affect EM as significantly as other specialties. Current training standards in EM have already emphasized patient safety by requiring continuous onsite supervision of residents. Resident fatigue has been addressed with restrictions of shift lengths and limitation of consecutive days worked. CONCLUSION: One recommendation from the IOM was a required 5-h rest period for residents on call. Emergency department (ED) patient safety becomes an important concern with the decrease in the availability and in the patient load of a resident consultant that may result from this recommendation. Of greater concern is the already observed slower throughput time for admitted patients waiting for resident care, which will increase ED crowding and decrease patient safety in academic institutions. A balance between being overly prescriptive with duty hour restrictions and trying to improve resident wellness was recommended. Discussion is included regarding the appropriate length of EM training programs if clinical experiences were limited by new duty hour regulations. Finally, this report presents a review of the financing issues associated with any changes.

Duty hours in emergency medicine: balancing patient safety, resident wellness, and the resident training experience: a consensus response to the 2008 institute of medicine resident duty hours recommendations.

Representatives of emergency medicine (EM) were asked to develop a consensus report that provided a review of the past and potential future effects of duty hour requirements for EM residency training. In addition to the restrictions made in 2003 by the Accreditation Council for Graduate Medical Education (ACGME), the potential effects of the 2008 Institute of Medicine (IOM) report on resident duty hours were postulated. The elements highlighted include patient safety, resident wellness, and the resident training experience. Many of the changes and recommendations did not affect EM as significantly as other specialties. Current training standards in EM have already emphasized patient safety by requiring continuous on-site supervision of residents. Resident fatigue has been addressed with restrictions of shift lengths and limitation of consecutive days worked. One recommendation from the IOM was a required 5-hour rest period for residents on call. Emergency department (ED) patient safety becomes an important concern with the decrease in the availability and in the patient load of a resident consultant that may result from this recommendation. Of greater concern is the already observed slower throughput time for admitted patients waiting for resident care, which will increase ED crowding and decrease patient safety in academic institutions. A balance between being overly prescriptive with duty hour restrictions and trying to improve resident wellness was recommended. Discussion is included regarding the appropriate length of EM training programs if clinical experiences were limited by new duty hour regulations. Finally, this report presents a review of the financing issues associated with any changes.