ACEP News - June 2008 - (Page 14)

ACEP NEWS • J U N E 2 0 0 8 NEWS FROM THE COLLEGE “We’re hoping these data will be one more piece of the argument that there needs to be greater funding directed toward emergency medicine to allow us to continue to provide the outstanding care that we do on a daily basis,” he said. This year’s national study is being conducted with financial support from ACEP, the Emergency Medicine Residents’ Association, the Emergency Nurses Association, the Society for Academic Emergency Medicine, the Emergency Medicine Foundation, GE Healthcare, and the Council of Residency Directors in Emergency Medicine. One of the key features added to this year’s workforce study is a separate and complementary survey for emergency department nurse managers. “In the past studies, we looked at some nursing issues, but this year we are going to have a survey that is specifically devoted to ED nursing,” Dr. Counselman said. “I think it is a great and needed addition.” Also new this year is an updated and improved study instrument. And the previously paper-generated survey will now be online. “The survey is not something you could easily sit down and knock out in one sitting. You are going to have to gather some information,” Dr. Counselman pointed out. “But what we’re hoping is that ED directors and nurse managers will recognize how critically important this information is for work force planning in our specialty,” he added. “We hope they will make that extra effort to complete the survey.” There are some incentives to participate in the study. Physicians can receive a 15 percent discount on ACEP Bookstore purchases. Nurses can win one of two dozen $50 gift certificates. All participants are also entered into a raffle for one of five airline tickets. Postcards are being sent to emergency department directors and nurse managers, each with a unique ID and a Web address to complete the survey online. The survey will run from June 16 through Aug. 8. “If you receive a postcard, whether you are an ACEP member or not, please complete the survey,” Dr. Counselman said. “We want information from everyone. We want to get the whole landscape.” ■ ACEP Workforce Study Needs Your Input T he 2008 ACEP Workforce Study is underway, with more than 2,000 randomly selected emergency departments asked to participate. Like the previous two workforce studies in 1997 and 1999, this study will describe the current state of emergency department staffing nationwide. The results can then be used, in part, to strengthen our arguments with legislators and regulatory agency officials when developing solutions to daily challenges encountered by emergency physicians. “Emergency medicine faces some difficult issues, and it’s clear from many different sources, including the Institute of Medicine reports, that emergency medicine needs more support than it has received from the state and federal level,” said Dr. Frank Counselman, Chair of ACEP’s Workforce Technical Advisory Group. Valproate KEPPRA (1500 mg twice daily) did not alter the pharmacokinetics of valproate in healthy volunteers. Valproate 500 mg twice daily did not modify the rate or extent of levetiracetam absorption or its plasma clearance or urinary excretion. There also was no effect on exposure to and the excretion of the primary metabolite, ucb L057. Other Antiepileptic Drugs Potential drug interactions between KEPPRA and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. These data indicate that levetiracetam does not inﬂuence the plasma concentration of other AEDs and that these AEDs do not inﬂuence the pharmacokinetics of levetiracetam. Oral Contraceptives KEPPRA (500 mg twice daily) did not inﬂuence the pharmacokinetics of an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel, or of the luteinizing hormone and progesterone levels, indicating that impairment of contraceptive efﬁcacy is unlikely. Coadministration of this oral contraceptive did not inﬂuence the pharmacokinetics of levetiracetam. Digoxin KEPPRA (1000 mg twice daily) did not inﬂuence the pharmacokinetics and pharmacodynamics (ECG) of digoxin given as a 0.25 mg dose every day. Coadministration of digoxin did not inﬂuence the pharmacokinetics of levetiracetam. Warfarin KEPPRA (1000 mg twice daily) did not inﬂuence the pharmacokinetics of R and S warfarin. Prothrombin time was not affected by levetiracetam. Coadministration of warfarin did not affect the pharmacokinetics of levetiracetam. Probenecid Probenecid, a renal tubular secretion blocking agent, administered at a dose of 500 mg four times a day, did not change the pharmacokinetics of levetiracetam 1000 mg twice daily. Cssmax of the metabolite, ucb L057, was approximately doubled in the presence of probenecid while the fraction of drug excreted unchanged in the urine remained the same. Renal clearance of ucb L057 in the presence of probenecid decreased 60%, probably related to competitive inhibition of tubular secretion of ucb L057. The effect of KEPPRA on probenecid was not studied. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C : There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. KEPPRA should be used during pregnancy only if the potential beneﬁt justiﬁes the potential risk to the fetus. Administration to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [MRHD] on a mg/m2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the MRHD on a mg/m2 basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m2 basis). There was no overt maternal toxicity at the doses used in this study. Treatment of pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (approximately 4 times MRHD on a mg/m2 basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1800 mg/kg/day (12 times the MRHD on a mg/m2 basis). The developmental no effect dose was 200 mg/kg/day (1.3 times the MRHD on a mg/m2 basis). Maternal toxicity was also observed at 1800 mg/kg/day. When pregnant rats were treated during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a dose of 3600 mg/kg/day (12 times the MRHD). 1200 mg/kg/day (4 times the MRHD) was a developmental no effect dose. There was no evidence of maternal toxicity in this study. Treatment of rats during the last third of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m2 basis). KEPPRA Pregnancy Registry UCB, Inc. has established the KEPPRA Pregnancy Registry to advance scientiﬁc knowledge about safety and outcomes in pregnant women being treated with KEPPRA. To ensure broad program access and reach, either a healthcare provider or the patient can initiate enrollment in the KEPPRA Pregnancy Registry by calling (888) 537-7734 (toll free). Patients may also enroll in the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free). KEPPRA is a registered trademark of UCB S.A. © 2008, UCB, Inc., Smyrna, GA 30080 Labor and Delivery The effect of KEPPRA on labor and delivery in humans is unknown. Nursing Mothers Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from KEPPRA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of KEPPRA injection in patients below the age of 16 years have not been established. Geriatric Use Of the total number of subjects in clinical studies of levetiracetam, 347 were 65 and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufﬁcient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of KEPPRA in these patients. A study in 16 elderly subjects (age 61-88 years) with oral administration of single dose and multiple twice-daily doses for 10 days showed no pharmacokinetic differences related to age alone. Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Use in Patients with Impaired Renal Function Clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance. Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing hemodialysis. The dosage should be reduced in patients with impaired renal function receiving KEPPRA and supplemental doses should be given to patients after dialysis [see Clinical Pharmacology, Pharmacokinetics, and Dosage and Administration, Adult Patients With Impaired Renal Function in the full prescribing information]. All rights reserved. Printed in the U.S.A. Rev. 4E 02/2008 K1915-0208 4E

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ACEP News - June 2008 Contents News - Time to Move Tricks of the Trade - Revealing Tips Focus On - Dengue Fever Practice Trends - EMTALA Results

ACEP News - June 2008

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