Paul Davis
From:
Sent:
To:
Subject:
Texas Society of Health-System Pharmacists <[email protected]>
Monday, July 29, 2013 4:00 AM
[email protected]
Texas Health-System Pharmacy News, July 29, 2013
In This Issue
July 29, 2013
On This Date
Vol. 42, No. 29
Practice & Profession
Annual Seminar
New Drugs & Devices
Recalls & Warnings
Legislative & Regulatory
Update
State, National &
International
On This Date
On July 29, 1958, Congress passed legislation establishing the National Aeronautics and
Space Administration (NASA). In 1967, "The Doors" scored their first #1 hit on the
popular music charts. In 1981, Prince Charles, heir to the British throne, married Lady
Diana Spencer. In 2000, Brad Pitt and Jennifer Aniston were married. Today's Birthdays:
Benito Mussolini (1883-1945, Italian dictator); Melvin Belli (1907-1996, American lawyer);
Peter Jennings (1938-2005, Canadian/American journalist); Ryan Braun (1980, baseball
player). Today's Trivia: 1. Melvin Belli had a well-earned nickname. What was it? What
was his most famous case? 2. Ryan Braun - where have you heard his name? 3. What
was "The Doors" first hit song?
Practice & Profession
1
People & Places
Answer to Today's Trivia
Cyclosporiasis Sickens 285. An outbreak of a rare stomach bug has sickened at least
285 people in 11 states, including 10 who have been hospitalized, according to
CDC. Cyclosporiasis, an intestinal illness caused by a parasite that is commonly linked to
fresh produce, has been widening its path since 2 Iowa residents got sick in June. While
previous outbreaks were traced to fresh raspberries, basil, snow peas and lettuce, no
specific foods have been pinpointed in the current outbreak. The disease causes
vomiting, diarrhea and weight loss, and is usually spread through infected food and
water, not person-to-person. So far, 66 people have been infected in Texas.
Go Figure . . . 15 Years after Autism Panic, a Measles Plague Erupts. A measles
outbreak in southwest Wales, U.K erupted between November 2012 and early July
2013, with an estimated 1,219 people infected, compared with 105 cases in all of Wales
in 2011. The region was a hotbed of resistance to the MMR vaccine in the late 1990s,
with many refusing the vaccine for their children after British physician Andrew Wakefield
suggested it might cause autism. While the U.S. had effectively eliminated new outbreaks
of measles by 2000, small outbreaks persist as travelers bring the virus back into the
country. New York City officials this spring traced a Brooklyn outbreak to someone they
believe was infected in London. So far this year, U.S. cases have amounted to 117, up
from 54 in all of 2012, and it could indicate that infections are on track to reach levels not
seen since 1996. England reported 1,168 cases in 2013, up 64% from the year-earlier
period and the highest recorded level since 1994. Wakefield's theory became publicized
in 1997-98, and in the U.K. MMR vaccination rates among 2-year-olds fell to 80% in
the 2004 fiscal year from about 92% in 1997.
Pharmacist Sues CVS. Joseph Zorek of Harrisburg, PA has filed a lawsuit in U.S.
District Court against CVS Caremark Corp, alleging he was wrongfully
discharged. Zorek claims he was fired in part because he complained to management
that staff cutbacks were contributing to increased pressure on pharmacists, causing
dispensing errors. It is his second suit against the second largest national chain. In
another pending lawsuit he alleges that CVS harassed him and tried relocating him after
he raised the staffing concerns.
Networking for Introverts. Most people consider themselves bad at networking - so if
you are struggling, know that you are not alone. You can get good at networking, but you
have to do it by doing it, not just reading about it. It gets easier with practice. You can
build a network without going to uncomfortable networking events. You can do it by
meeting a few people you genuinely like each year and then staying in touch with
them. You can build your network by giving genuine value and kindness to others. Be the
one to make the effort to stay in touch says Patty Azzarello on her blog. See her
suggestions.
Annual Seminar
Save the Date. April 11-13, 2014 are the dates of the next
TSHP Annual Seminar. The Alcálde Residency Conference
will be held April 9-10. Headquarters hotel for the events is
the Westin Galleria in Houston. Make your plans today to be
a part of the next Seminar - the leading gathering of hospital
and health-system pharmacy professionals in the Southwest.
New Drugs & Devices
2
Kidney Rejection Drug Approved. FDA has approved an extended-release formulation
of tacrolimus (Astagraf XL) for preventing kidney transplant rejection. The new version
can be taken daily, making it the first such product available in the U.S. Specific
indications for the extended-release form are for prophylaxis of graft rejection in kidney
transplant patients also receiving mycophenolate mofetil and corticosteroids, with or
without basiliximab (Simulect) induction. The U.S. is one of the last developed
countries to approve the product. It was cleared in Europe in 2007 and Japan the
following year. Common side effects include diarrhea, constipation, nausea, peripheral
edema, tremors, anemia, new-onset diabetes, hyperkalemia, hypertension, QT
prolongation, reversible posterior encephalophy and kidney toxicity.
Recalls & Warnings
MedStream Infusion Pump - Class I Recall. The Fill Level Sensor (FLS), a component
of the MedStream Programmable Infusion Pump, may malfunction. The malfunction may
cause the pump's low reservoir alarm, normally set at 3 mL, to sound too early or too
late. Affected products were distributed from July, 2009 through June, 2013 and
include Models 91-4200US 20 mL pump, 91-4201US 40 mL pump, 91-4200 20 mL pump,
91-4201 40 mL pump. On June 7, 2013, Codman issued a Medical Device Corrections
Notice to consignees to inform them of a potential problem with the pump. The notice
directed clinicians to evaluate the accuracy of the Fill Level Sensor, during each patient's
next scheduled refill session, or sooner if the patient is symptomatic. The firm provided a
worksheet (step-by-step instructions) to identify pumps with a miscalibrated Fill Level
Sensor and management recommendations for patients with affected devices. No action
for physicians is required beyond the recommendations provided in the Medical Device
Corrections Notification letter.
FDA Action on Diabetes Treatments. FDA is removing from the market illegal products,
including some labeled as dietary supplements that claim to mitigate, treat, cure or
prevent diabetes and related complications. To date, the FDA is not aware of any reports
of injury or illness associated with the illegally sold products, but is taking action to protect
the public health from potential harm related to the products.
The products include:




Products sold as "natural" treatments for diabetes, but containing undeclared
active pharmaceutical ingredients in unknown quantities that could cause harm or
complicate medical conditions;
Dietary supplements and ayurvedic products with claims to treat, cure, and/or
prevent diabetes;
Unapproved drugs sold over-the-counter, including some homeopathic products,
intended to treat complications associated with diabetes, which include relieving
symptoms caused by peripheral neuropathy; and
Prescription drugs for diabetes sold by online pharmacies without a prescription.
The agency is advising consumers not to use these or similar products because they may
contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed
as over-the-counter products when they should be marketed as prescription products.
Ketoconazole Warning - Fatal Liver Injury/Drug Interactions and Adrenal Gland Problems.
FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including
limiting the drug's use, warning that it can cause severe liver injuries and adrenal gland
problems, and advising that it can lead to harmful drug interactions with other
medications. FDA has approved label changes and added a new Medication Guide to
address these safety issues. As a result, Nizoral oral tablets should not be a first-line
3
treatment for any fungal infection. Nizoral should be used for the treatment of certain
fungal infections (endemic mycoses) only when alternative antifungal therapies are not
available or tolerated.
Hepatotoxicity- Nizoral tablets can cause liver injury, which may potentially result in liver
transplantation or death. FDA has revised the Boxed Warning, added a strong
recommendation against its use (contraindication) in patients with liver disease, and
included new recommendations for assessing and monitoring patients for liver toxicity.
Adrenal Insufficiency - Nizoral tablets may cause adrenal insufficiency by decreasing the
body's production of corticosteroids.
Drug Interactions - Nizoral tablets may interact with other drugs a patient is taking and
can result in serious and potentially life-threatening outcomes, such as heart rhythm
problems.
Nizoral tablets should be used only for the treatment of certain life-threatening mycoses
when the potential benefits outweigh the risks and alternative therapeutic options are not
available or tolerated. Healthcare professionals should assess the liver status of the
patient before starting oral ketoconazole, and monitor serum ALT levels during treatment.
Adrenal function should be monitored in patients with adrenal insufficiency or with
borderline adrenal function and in patients under prolonged periods of stress (major
surgery, intensive care, etc.). Review all concomitant medications for the potential for
drug interactions with Nizoral tablets.
Legislative & Regulatory Update
Federal Compounding Legislation Legislative Alert - S. 959. ASHP has asked for
members' assistance in talking to Texas Senators Cruz and Cornyn to encourage them to
vote in favor of S. 959-- the Pharmaceutical Quality, Security, and Accountability
Act. The Senate will vote on the bill very soon. The legislation is designed to help
ensure that tragedies like the meningitis outbreak caused by products prepared by NECC
will not happen again.
S. 959 creates a new category--"compounding manufacturer"-- which will be regulated
by the Food and Drug Administration (FDA). Hospitals and health systems are
considered traditional compounders in the Senate legislation and will remain under the
purview of state boards of pharmacy.
ASHP is asking for the support of Senators with a "yes" vote for the bill.
Here is a link to ASHP that further describes what you can
do: http://www.ashp.org/takeaction
Feel free to contact ASHP's Government Affairs Division at [email protected] if you have
questions, as well.
Also, please pass this on to your hospital's government affairs folks and your colleagues.
You can write Sen. Cornyn electronically here.
And you can contact Sen. Ted Cruz here.
If you have a better or personal link with either Senator, please use this opportunity to
4
exercise that option.
Federal Compounding Legislation - House Actions. Meanwhile on the House of
Representatives side of Congress, pharmacy organizations appeared before the
House Energy & Commerce Subcommittee on Health to comment on various bills and
bill drafts under consideration. The Committee heard comments on S. 959, HR 2186 and
a discussion draft filed by Rep. Morgan Griffith (R-VA). Griffith's proposal contained no
new authorities for FDA unlike the 2 bills filed by Democrats. The pharmacy groups and
others appearing before the committee included the National Community Pharmacists
Association (NCPA), ASHP, PhRMA, the Generic Pharmaceutical Association, Pew
Charitable Trust, the International Academy of Compounding Pharmacists (IACP)
and NABP. While some groups supported Griffith's vision that focused on the
requirements for a specific prescription or purchase order and require a system for
improved communication between FDA and state boards of pharmacy, other groups
expressed concern that state boards could effectively regulate pharmacy compounding
and urged additional powers for FDA. FDA Commissioner Janet Woodcock supported
the Senate bill.
State, National & International
Appeals Court Slaps FDA for Importing Execution Drugs. A three-judge panel of a
federal appeals court affirmed a lower court ruling that bars the FDA from allowing the
importation of sodium thiopental, rejecting the agency's argument that it had discretion to
allow unapproved drugs into the U.S. The FDA policy "was not in accordance with law,"
said the panel of the U.S. Court of Appeals for the District of Columbia Circuit Court. FDA
is reviewing the decision.
TSHP/ASHP/Locals
ASHP Responds to AMA Resolution. In June the AMA House of Delegates passed a
resolution that said pharmacists were making inappropriate inquires on the rationale
when calling physicians' offices to question diagnosis for and use of opiate
drugs. (See July 15 TSHP E-News.) Some pharmacies have policies that seem to direct
calling and faxing to verify the legitimacy of all controlled substance prescriptions before
dispensing. ASHP EVP Paul. W. Abramowitz has written a letter to the AMA CEO saying
that the pharmacy group would be glad to work with AMA and other stakeholders to find
solutions to the broader and underlying problem of drug abuse.
People & Places
A new $135 million hospital is being constructed near State Highway 45 and LaFrontera
Blvd. in Williamson County (Austin area). Forest Park Medical Center Austin is an
offshoot of the Forest Park Medical Center system, which was created by physicians in
Dallas in 2006 and 2007. About 60 Austin-area physicians will own the hospital,
which will be completed in December, 2014.
The University of Texas at Tyler is scheduled to announce that Dr. Lane Brunner will
be named founding dean of the new College of Pharmacy in Tyler. Brunner is
currently Professor and Chair of Pharmaceutical and Biomedical Sciences at California
Northstate College of Pharmacy. He was previously Founding Dean of the School of
Pharmacy at Regis University. He also previously served on the faculty of The University
of Texas at Austin College of Pharmacy from 1996 to 2004.
5
Answer to Today's Trivia
1. Melvin Belli earned his nickname "King of Torts," from a number of personal injury
cases he was involved with early in his career. Possibly his best-known case was his
representation of Jack Ruby for free after Ruby shot and killed Lee Harvey Oswald. His
defense was an attempt to prove that Ruby was legally insane and had a history of
mental illness in his family. 2. You probably recognize the name of Ryan Braun in one
of two ways: He was the National League "Rookie of the Year" in 2007, playing for the
Milwaukee Brewers, and was named to 5 MLB All Star teams following that honor. In
2011 he was named National League MVP. However, he was recently the first major
leaguer to be suspended by MLB for his connection to the Biogenesis of America clinic
for use of performance enhancing drugs on July 23 for the remainder of the season. 3.
"The Doors" first hit was "Light my Fire."
This email was sent to [email protected] by [email protected] |
Update Profile/Email Address | Instant removal with SafeUnsubscribe™ | Privacy Policy.
Texas Society of Health-System Pharmacists | 3000 Joe DiMaggio #30A | Round Rock | TX | 78665
6