Paul Davis Subject:
December 31, 2012 Texas Hospital Pharmacy News
Having trouble viewing this email? Click here
In This Issue December 31, 2012 Vo. 41, No. 49
Note: The TSHP Office will be closed until Wednesday, January 2, 2013.
The officers and staff wish you and your family, friends and colleagues a Happy New
On This Date On December 31, 1695, a window tax was imposed in England, causing many householders to brick up windows to avoid the tax. In 1943, John Denver was born in Roswell NM. In 1972, Roberto Clemente was killed along with 4 others when the cargo plane in which he was traveling crashed off the coast of Puerto Rico. In 1985, singer Rick Nelson died in a plane crash in De Kalb, TX. Today's trivia: 1. Why was Roberto Clemente in a cargo plane on December 31, 1972? 2. How did John Denver die? Quick Links Practice & Profession Questionable Botox on the Market. FDA has alerted 350 medical practices that they
may have purchased unapproved and potentially counterfeit versions of Botox from a
network of wholesalers controlled by Canada Drugs. Earlier in the year, the agency warned about purchases of fake Avastin from the same company. The company is a 10- year old Internet pharmacy that FDA has sought to close down. Administrators at two
medical practices identified by the FDA as buyers of the suspect Botox said sales
representatives from Quality Specialty Products, Bridgewater Medical, and other Canada Drugs-owned companies pitched doctors' offices discounted vials of the medicine.
Stressed Seniors Susceptible to Stroke. Depression, stress and a negative outlook among older individuals appear to predict their risk of dying from a stroke, according to a longitudinal study. Distress was strongly related to hemorrhagic strokes but not ischemic strokes. Stress and negative emotions often increase with age. In the study, the most distressed seniors were less educated, less physically active and had more chronic health conditions and antidepressant use. The study was reported online in Stroke by Susan Everson-Rose, PhD, MPH, of the University of Minnesota in Minneapolis and colleagues. Surgeons Choose Hospital Employment. A study in the December 17 issue of Archives of Surgery indicates that general surgeons and surgical subspecialists are opting for hospital employment over private practice. The trend is particularly strong among younger and female surgeons. According to the American Hospital Association, the number of U.S. physicians employed by a hospital has increased by 32% since 2000. According to authors of the surgeon study by the American Medical Association, factors driving this trend include the complex corporate environment, high costs of malpractice insurance, difficulties in obtaining reimbursement, administrative duties, and general risks and burden of solo or small group private practices. $100M Medical Mall Breaks Ground. Health insurer Highmark has announced plans for a "medical mall," which it hopes will become a one-stop healthcare shop of doctors' offices and medical services in the Western Pennsylvania area. The development is designed to compete with the University of Pittsburgh Medical Center, which has the region's largest networks of hospitals. The mall is the first in what the company anticipates may be 3 malls in the Western Pennsylvania area. The 174,000 square-foot medical mall in Wexford, PA, will include diagnostic imaging labs, oncology services, physical therapy rooms, primary care physicians, a cafe and a full-service pharmacy. It also will focus heavily on women's healthcare with pediatrics, a women's care center and a child care center for patients to drop off their children. Leadership Tips for First-Time Bosses. Many first-time bosses have delusions of "managerial grandeur," write Amanda Pouchot. Rather than trying to become a superhero, it's better to lower your expectations a little and focus on self- improvement and leadership development. Take time to develop new skills and learn from experience, Pouchot writes in Lessons from a Reluctant Manager. New Drugs & Devices FDA Approves Drug for Rare Lipid Disorder. FDA has approved lomitapide (Juxtapid) as add-on therapy for patients with homozygous familial hypdercholesterolemia (HoFH). It is designed to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high density lipoprotein cholesterol. The drug should be used with a low-fat diet and other lipid-lowering medications. HoFH is a rare genetic condition that can cause extremely high cholesterol levels, typically between 400 mg/dL and 1,000 mg/dL. It affects approximately 1 in 1 million people, or about 3,000 patients in the U.S. The drug carries a boxed warning for a serious risk of liver toxicity due to liver enzyme abnormalities and accumulation of fat in the liver. Other adverse events include diarrhea, vomiting, indigestion and abdominal pain. The drug will be marketed by Aegerion Pharmaceuticals. The annual cost of therapy is expected to be between $200,000 and $300,000. The company will be
required to train and certify physicians, patients and pharmacies, and insurers must pre- authorize reimbursement before the drug can be dispensed. The enrollment process will take between 3 and 4 months. FDA OKs Agitation Drug. FDA has approved Adasuve (loxapine) Inhalation Powder, 10 mg by Alexza Pharmaceuticals, Inc. for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Adasuve carries a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease patients. The drug will be available only through a restricted program under a REMS program. Adasuve should only be administered in a healthcare facility enrolled in the Adasuve REMS program. The drug will be available early in the 3rd quarter of 2013. FDA Approves Short-bowel Syndrome Drug. FDA has cleared Gattex (teduglutide) by NPS Pharmaceuticals, Inc. for treatment of patients with short-bowel syndrome to help them absorb nutrients. The approval carries with it a requirement for at least 10 years of post-marketing study for potential side effects. Short-bowel syndrome is the result of conditions such as Crohn's disease or trauma that requires much of the small intestine to be removed, causing a reduced ability to absorb water and nutrients. The drug will be available in March. Drug to Reduce Chickenpox Symptoms Approved. FDA has approved Varizig (varicella zoster immune globulin) to minimize chickenpox symptoms when administered within 4 days of exposure to the virus that causes the disease. It was approved for high-risk people, including those with compromised immune systems, newborns, pregnant women, premature infants, children less than a year old and people with no immunity to the virus. Varizig is produced from the blood plasma of healthy donors with high levels of antibodies to the chicken-pox-causing virus, the FDA said. The donated plasma comes from collection facilities licensed by the FDA. The drug is meant to be administered in one or more doses, depending on the recipient's weight, within 96 hours of exposure. The most common side effects noted in clinical testing were injection- site pain and headache. FDA Panel Denys Chronic Fatigue Drug. An FDA Advisory Panel declined to recommend Ampligen (HEB-25.00%) by Hemispherx Biopharma, Inc. The drug was proposed to treat chronic fatigue syndrome. The agency said there was missing data in clinical studies that made it hard to tell whether the drug is safe. Potential safety concerns include infections and liver problems. FDA medical reviewers questioned whether the data meet drug-approval requirements demonstrating "substantial evidence" of safety and efficacy, or effectiveness. Recalls & Warnings
Carboplatin Injection Recall. Hospira, Inc. has issued further information about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a routine sample inspection. Findings have identified the particles as Carboplatin crystals. If particulate matter from crystallization is injected into a patient, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle to arrange for the return of the product. Xyrem Drug safety Communication. FDA has reminded healthcare professionals that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to
respiratory depression. The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided. The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death. Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/500 mg Recall. Mylan has announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone & Acetaminophen USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573).The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in unit dose. Qualitest also issued a nationwide recall for 101 lots of tablets. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen. Medtronic Drug Infusion Pump Recall. FDA and Medtronic have notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump's performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps contain and administer prescribed drugs or fluids to a specific site inside the patient's body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump. Do not use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump. Legislative & Regulatory Update FDA Plans Hearing on Rx Pain Drugs. A 2-day public hearing is being planned by FDA for early February to find a balance between patient needs for prescription pain killers and professional concerns over addiction and abuse. The agency expects to introduce a guideline on developing tamper resistant opioid analgesics. An FDA panel is also set to discuss the benefits and risks of using hydrocodone combinations as cough suppressants or pain relievers. The actions follow a probe begun last Spring by the U.S. Senate Finance Committee into companies that sell prescription painkillers as well as several patient advocacy groups and various physicians due to "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers." Notification of the hearing and background information appear in the Federal Register. TSHP/ASHP/Local Chapters TSHP Seeking Program Review Volunteers. As part of the ACPE requirements for accredited providers, TSHP is occasionally required to review speakers' presentations for any evidence of bias. When a speaker indicates that she or he has a financial relationship with a drug manufacturer, such reviews are required. By policy, TSHP uses 3 individuals to review a program, and the process is completed electronically. There are usually fewer than 10 programs during a year - most around the Annual Seminar - and the time requirement is minimal - consisting of just the time it takes to review the slides
and write comments. If you would be interested in serving as a reviewer, contact the TSHP office (firstname.lastname@example.org) and we can send you additional information. Best Practices Column. We're resurrecting the TSHP Best Practices column in the TSHP Journal and need your help! This is a contributor-driven forum to share best practices or management tips with your colleagues. We'd like to include this as a recurring column, but it's only successful if people submit their ideas. That's where you come in! Do you have a procedure, policy or practice that might prevent someone else from re-inventing the wheel? Has something worked for you that might work at another facility? Share it with us. It doesn't have to be a lengthy tome; in fact a short, to-the-point paragraph works just great. If you have an idea to improve pharmacy services - no matter how small or how large, write to email@example.com and we'll get you published! Answer to Today's Trivia 1. Roberto Clemente, a Hall of Fame baseball player for the Pittsburgh Pirates, was on his way to deliver relief supplies to Nicaragua following a devastating earthquake there on December 23. 2. Singer/songwriter/actor John Denver died at age 53 when he lost control of the experimental aircraft he was flying over Monterey bay in October, 1997.
This email was sent to firstname.lastname@example.org by email@example.com |
Hormones and Behavior 31, 145 – 158 (1997) Article No. HB971376 Hormonal and Experiential Correlates of Maternal Responsiveness during Pregnancy and the Puerperium in Human Mothers Alison S. Fleming Department of Psychology, University of Toronto, Erindale Campus,Mississauga, Ontario L5L 1C6, Canada Diane Ruble Department of Psychology, New York University, New York, New York 10012 H
Első hazai tapasztalatok vareniklinnel a dohányzás abbahagyásának támogatásában Vadász Imre dr. Országos Egészségfejlesztési Intézet, „Dohányzás vagy Egészség” Központ, Budapest Összefoglalás A feldolgozás célja, jellege . A vareniklin hatásosságának és alkalmazhatóságának meghatározás a dohányzás abbahagyásának elősegítésében a napi rutin bet