AP (2/5, Johnson) reports that the Food and Drug Administration approved a “new inhaled steroid treatment for preventing asthma attacks in young children” — Asmanex Twisthaler. The inhaler, which is manufactured by drugmaker Schering-Plough Corp., “is the first once-a-day, inhaled corticosteroid medicine for asthma,” and “can be taken by children as young as 4.” According to a “small study in children 4 to 11,” the inhaler was shown to reduce “day and nighttime symptoms, plus ‘interruptions’ of daily life such as emergency medical visits.” But “Asmanex has some significant side effects, like other inhaled corticosteroids: It can slow growth rate in kids, cause fungal infections of the mouth, and increase risk of glaucoma or cataracts.” Still, “[i]nhaled corticosteroids are now the cornerstone of asthma care, the first treatment given newly diagnosed patients because they go straight to the lungs rather than through the bloodstream like the ingredients in pills,” according to the Asthma and Allergy Foundation of America.

MedScape (2/5, Cassels) notes that “nonfatal falls account for 500,000 hospitalizations among seniors and an estimated 1.8 million” ED visits each year.

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MedPage Today (2/5, Phend) reports that according to research presented at the Society of Critical Care Medicine meeting in Honolulu, Hawaii, “[e]xtracorporeal membrane oxygenation (ECMO) was associated with a lower incidence of death or disability in cases of severe but potentially reversible respiratory failure in adults.”

Giles Peek, M.D., of Glenfield Hospital in Leicester, England, and colleagues said that “[o]ne life would be saved for every six adults treated with ECMO rather than with conventional mechanical ventilation.” Furthermore, “the survival benefit did not come at the expense of severe disability, they reported in the final results of the randomized controlled CESAR (Conventional Ventilatory Support versus Extracorporeal Membrane Oxygenation for Severe Adult Respiratory Failure) trial.” Heidi J. Dalton, M.D., of Children’s National Medical Center in Washington, D.C., “who chaired the late-breaking trials session where the findings were presented,” said that U.S. physicians “have been reluctant to use ECMO in adult patients since the trials in the ’70s,” but added that much of “the old data that people base [ECMO decisions] on in the adult world are based on information that has no applicability today.”

Bloomberg (2/5, Randall) reports that Clostridium difficile “costs more than $1.3 billion a year to treat in the U.S.,” according to a study published in the Feb. 4 issue of the journal Clinical Infectious Diseases.

Researchers estimate that the cost of each infection of the bacteria, which is “acquired in hospitals and causes severe diarrhea,” is “more than $7,000.” In the study, “[r]esearchers analyzed the records of more than 24,000 patients admitted to a hospital in St. Louis, Missouri, in 2003. Of those, 439 developed” C. difficile. Treatment “cost from $2,454 to $3,240, and follow-up treatments cost $5,042 to $7,179, the study found.” The researchers multiplied “the cost per treatment at the St. Louis hospital” by “the number of estimated hospital cases in the U.S.” to come up with their estimate.

USA Today (2/5, Rubin) reports that, as “[s]leep deprivation can result in a decreased production of growth hormone needed for healing, impaired resistance to infection, and increased oxygen use,” some “critical-care doctors and nurses have begun paying more attention to the problem” of “beeping monitors, bright lights and frequent interruptions” in ICUs. In one study published last month in The Journal of Trauma: Injury, Infection and Critical Care, researchers at the University of Texas Southwestern Medical Center in Dallas found that for 16 ICU patients, “sleep was fragmented and significantly abnormal,” and almost “all of their sleep was in a superficial stage, which represents only about half of a normal night’s sleep.” In a 2005 review article in Critical Care Nursing Clinics of North America, Judith Reishtein, an assistant professor of nursing at Philadelphia’s Drexel University, wrote, “Among ICU patients on ventilators, only half of sleep occurs during the normal sleep hours of 10 p.m. to 6 p.m., and, sometimes, they get no REM sleep at all.”

These are case reports of people subjected to the extravasating effects of IV phenergan: 

In 2005, a 19-year-old woman went to the emergency department with flu-like symptoms and received the branded drug Phenergan IV (Friederich S. Malpractice allegations spotlight anti-nausea medication. The Daily World, Aberdeen, WA; December 7, 2005. Accessed at: www.thedailyworld.com/articles/2005/12/07/local_news/02news.txt). During the injection, she yelled out in pain and was tempted to pull out her IV line. After the injection, she told the nurse that her arm was still in significant pain and that she felt “something was wrong.” The nurse reassured the patient and left the room. The patient’s arm and fingers became purple and blotchy. The patient remained in the hospital for 30 days, during which she watched her previously healthy fingers turn black and shrivel (see photo in the PDF version of the newsletter). Her thumb, index finger, and top of her middle finger had to be amputated. 

In 2005, a patient received 12.5 mg of promethazine IV into an IV site in the hand. During the injection, the patient complained of extreme burning, but the nurse continued administering the medication. The patient developed an area of necrosis on his hand, eventually requiring skin grafting and physical rehabilitation.

In 2005, a physician intern posted the following request on the ISMP message board: “I am hoping by posting this message I might get some immediate feedback…I am currently doing a rheumatology consult and saw a patient who presented with a history of an intra-arterial injection of Phenergan at another hospital, likely causing her extreme pain throughout the arm and gangrenous first two digits, which will most likely be amputated. I am hoping anyone who reads this with experience handling this problem or knows of a possible reversal please contact me ASAP. From what I have been able to gather, there is no current published treatment protocol. The patient will likely have her two fingers amputated soon, and in my opinion, could require more and suffer from lifelong chronic pain. This is a relatively young individual which makes everything more tragic.”

In 2004, a professional guitar player was awarded $2.4 million for her past and future medical expenses and $5 million for her pain and suffering after she endured two amputation surgeries following accidental arterial administration of the branded drug Phenergan (Patrick J. Marshfield woman wins 7.4 million jury award after she loses arm. The Barre Montpelier Times Argus; Barre, VT; March 19, 2004). Suffering from a migraine, the woman had gone to the emergency department, where she received the Phenergan, intended for IV administration. She developed circulatory problems and then progressive gangrene which led to amputation of her arm in stages.

The following comes from The Institute for Safe Medication Practices:

Safe Practice Recommendations: Along with the manufacturer recommendations, the following strategies should be considered to prevent or minimize tissue damage when giving IV promethazine. 

Limit concentration. Since 25 mg/mL is the highest concentration of promethazine that can be given IV, stock only this concentration (not the 50 mg/mL concentration).

Limit the dose. Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients. Hospitals have reported that these smaller doses have proven quite effective.

Dilute the drug. Require further dilution of the 25 mg/mL strength to reduce vesicant effects and enable slow administration. For example, dilute the drug in 10 to 20 mL of normal saline if it will be administered via a running IV, or prepare the medication in minibags containing normal saline if there is time for pharmacy to dispense them as needed for individual patients. (Trissel confirms that promethazine is physically compatible when diluted in normal saline, with little or no drug loss in 24 hours at 21 degrees C in the dark, when prepared in glass, PVC, and polyethylene-lined laminated containers [Handbook on Injectable Drugs, 13th edition. ASHP, Bethesda, MD; 2005:1266].) Extravasation can also be recognized more quickly when promethazine is diluted than if the drug is given in a smaller volume.

Use large patent veins. Give the medication only through a large-bore vein (preferably via a central venous access site, but absolutely no hand or wrist veins). Check patency of the access site before administration. Note: according to the package insert, aspiration of dark blood does not preclude intra-arterial placement of the needle because blood can become discolored upon contact with promethazine. Use of syringes with rigid plungers or small bore needles might obscure typical arterial backflow if this is relied upon alone.

Inject into the furthest port. Administer IV promethazine through a running IV line at the port furthest from the patient’s vein. 

Administer slowly.  Consider administering IV promethazine over 10-15 minutes.

Revise orders. Revise preprinted order forms to ensure orders for promethazine reflect the safety measures listed above.

Educate patients. Before administration of the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.

Create alerts. Build an alert to appear on computer-generated medication administration records (MARs), electronic MARs, and on automated dispensing cabinet screens for nurses to view each time they access and administer a dose of promethazine, reminding them that the drug is a vesicant and should be diluted and administered slowly through a running IV. 

Treat. The manufacturer notes there is no proven successful management of unintentional intra-arterial injection or perivascular extravasation. However, sympathetic block and heparinization have been employed during acute management of promethazine extravasations. 

Use alternatives. Consider safer alternatives that can be used for the various conditions treated with IV promethazine. For example, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists may be used for both prophylaxis and as a rescue antiemetic. The package insert for ZOFRAN (ondansetron), for instance, states: “For patients who do not receive prophylactic Zofran injection and experience nausea and/or vomiting postoperatively, Zofran injection may be given to prevent further episodes. (Zofran goes off patent in late 2006, so generic alternatives should be available by 2007.) Also ensure that appropriate surgical patients are receiving a 5-HT3 for prophylaxis and are well hydrated to reduce the risk of post-operative nausea and vomiting and, thus, the need for a rescue antiemetic.  

Remove from formulary. Some hospitals that have continued to experience adverse outcomes despite safety measures have removed promethazine from their formulary or banned its IV use.

FDA, 2007:  FDA has reviewed reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone.  These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes).  Physicians prescribing methadone should be familiar with methadone’s toxicities and unique pharmacologic properties.  Methadone’s elimination half-life (8-59 hours) is longer than its duration of analgesic action (4-8 hours).  Methadone doses for pain should be carefully selected and slowly titrated to analgesic effect even in patients who are opioid-tolerant.  Physicians should closely monitor patients when converting them from other opioids and changing the methadone dose, and thoroughly instruct patients how to take methadone.   Healthcare professionals should tell patients to take no more methadone than has been prescribed without first talking to their physician. 

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