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Paul Davis
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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 (paul.davis@tshp.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 paul.davis@tshp.org 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 paul.davis@tshp.org by paul.davis@tshp.org | Update Profile/Email Address | Instant removal with SafeUnsubscribe™ | Privacy Policy. Texas Society of Health-System Pharmacists | 3000 Joe DiMaggio #30A | Round Rock | TX | 78665

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