1. health and fitness
2. disease
3. cancer

Paul Davis
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Monday, May 28, 2012 4:00 AM
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TSHP E-News, May 28, 2012
May 28, 2012
Vol. 41, No. 19
NEWS HIGHLIGHTS
The TSHP Office will be closed on Monday, May 28 for the Memorial Day
holiday. Please drop us a note or contact us on or after Tuesday. We hope
that you and your family have a peaceful holiday weekend.
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ON THIS DATE
On May 28, 1830 President Andrew Jackson signed the Indian Removal Act,
which began relocation of Native Americans to federal land west of the
Mississippi River. In 1937, the National Socialist Party of Germany formed a
new state-owned automobile company, Geselischaft zur Vorbereitung des
Deutschen Volkswagens mbH, later renamed to simply Volkswagenverk or
“The People’s Car Company.” In 1957, National League Baseball owners
voted unanimously to allow the New York Giants and Brooklyn Dodgers to
move to San Francisco and Los Angeles, respectively. In 1965, methane gas
caused a mine explosion near Dharbad, India that killed 375 people and
injured hundreds more. In 1983, Irene Cara hit #1 for the 2nd time on the pop
charts. Today’s Birthdays: Ia n Fleming (1908-1964, English author); Hunter
“Patch” Adams (1945, American physician and social activist); John Fogerty
(1945, Singer/songwriter). Today’s Trivia: 1. What was the hit Irene Cara had
on May 28, 1983? 2. What group is John Fogerty associated with?
PRACTICE & PROFESSION
Nix the PSA Testing. According to a final recommendation from the United
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States Preventive Services Task Force (USPSTF), healthy men should no
longer have PSA measurements as a screening test for prostate cancer. The
recommendation applies to men of all ages, but does not apply to the use of
PSA testing for monitoring patients after a prostate cancer diagnosis or
treatment. The task force cited a lack of evidence that PSA testing has an
impact on reducing prostate cancer deaths. According to an article published in
the Annals of Internal Medicine, “there is adequate evidence that the benefit of
PSA screening and early treatment ranges from 0 to 1 prostate cancer deaths
avoided per 1,000 men screened.” Psychological harm from false-positive tests
and additional testing, including one or more biopsies, more than outweigh the
likelihood of finding a case of prostate cancer, and increased adverse events
possibly resulting in hospitalization. Critics of the report noted that the
USPSTF included no urologists or cancer specialists. The American Cancer
Society weighed in on the issue, and generally supported the recommendation.
Test All Baby Boomers for Hep C. The CDC estimates that about 2 million
Americans born from 1945 to 1965 are infected with Hepatitis Virus C
(Hepatitis C) and consequently recommends that everyone ages 47 to 67 be
tested for the infection. The recommendation is made mainly because it may
be years before noticeable symptoms develop, and due to the potential
exposure of that generation to causative factors for the disease such as illegal
injected drugs, blood products or organ transplants before HVC testing and
patients with HIV. The recommendation is open for public comment until June
8 after which CDC will release a final version.
Want to be Healthier? Get more Education and Money! Health, United
States, 2011 is the 35th annual report prepared by the National Center for
Health Statistics. It includes a compilation of health data through 2010 from a
number of sources within the federal government and in the private sector. The
report indicates that people with higher levels of education and higher
income have lower rates of many chronic diseases, compared to those with
less education and lower income levels. Obesity was tied to households with
less than a high school education, and in women over 25 with less than a
bachelor’s degree. Life expectancy at age 25 was lower for men and women
without a high school diploma then those with a bachelor’s degree or higher.
Beyond these conclusions, the report contains a wealth of data on other health
conditions of the American public.
ACPE Moves to Paperless MyCPE Monitor Requirement. Effective
January 1, 2013, all pharmacists and technicians seeking continuing
education credit from any ACPE-approved provider will be required to
provide their NABP e-Profile ID # and date of birth for issuance of CPE
Statements of Credit through the “My CPE Monitor” web site. Providers will
be required to provide ACPE credit for participants through the online service,
and will be unable to send statements to individuals that do not provide this
information. For full details visit: http://www.nabp.net/programs/cpemonitor/cpe-monitor-service/index.php
Are You Losing your Integrity to a Silent Killer? According to Mary Jo
Asmus, unethical behavior is a slippery slope. A small transgression, which
appears harmless, can soon snowball into major ethical tangles that make it
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harder to do your job effectively. “(L)oss of integrity is a silent leadership
killer.. . The erosion of this value may happen very slowly over time without
much notice of integrity violations on the part of those who participate in
questionable practices,” she writes in SmartBrief/SmartBlog on Leadership.
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NEW DRUGS & DEVICES
FDA Panel Nixes Xarelto. An FDA advisory panel voted 6-4 against
expanding the use of Xarelto® (rivaroxaban) to reduce the risk of potentially
lethal clots in people with acute coronary syndrome. The decision was
somewhat of a surprise, due to a lack of data on potential side effects and some
trial data showing there was an increased risk of potentially fatal bleeding. A
final decision from FDA is expected June 29.
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RECALLS, WARNINGS & SHORTAGES
Safety Communication: Dialysate Concentrates Used in Hemodialysis.
FDA has issued a safety communication for healthcare providers to consider
the presence and quantity of acetate, citrate, and/or acetic acid in dialysate
concentrates when determining the patients’ dialysate prescription. The FDA
received a complaint describing alkali dosing errors that occurred during
hemodialysis using dialysate concentrates containing acetic acid and acetate.
When metabolized, these potential sources of alkali can contribute to elevated
bicarbonate levels in patients undergoing hemodialysis. This can contribute to
metabolic alkalosis, which is a significant risk factor associated with
cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia,
hypercapnia, and cardiac arrhythmia. Dialysate acid concentrate can contain
acetic acid, acetate or citrate, and these substances can be converted in the
body to bicarbonate, potentially contributing to metabolic alkalosis. These
substances typically are found in acid concentrate in amounts ranging from 1.5
to 8 mEq/L. This potential exists for all currently marketed dialysate
concentrate products containing acetate, acetic acid, or citrate. It is
recommended that health care providers review the dialysate acid concentrate
labeling for the specific concentrate that they prescribe to determine the
components that can contribute to the patient’s overall bicarbonate levels. The
levels of acetate, citrate and/or acetic acid vary by formulation and by
manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum
bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk
of death in hemodialysis patients. For more details, see the FDA MedWatch
safety alert.
Hospira Carpuject Recall Update. FDA is alerting healthcare providers of a
potential safety risk in some Carpuject pre-filled cartridges manufactured
by Hospira, Inc. The pre-filled cartridges containing the products listed in the
Drug Alert may be overfilled by at least twice the expected amount, resulting
in potential overdose. Because pharmacists and other healthcare providers can
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visually identify the presence of an overfilled Carpuject pre-filled cartridge,
FDA is recommending that these steps be taken at this time rather than a
product recall, because a recall of the affected products would result in an
immediate shortage. Subsequent inspection of retained product by Hospira
found additional overfilled Carpuject pre-filled cartridges. The manufacturing
problem thought to be responsible for this overfilling has resulted in the risk
for overfilled Carpuject pre-filled cartridges for as many as 280 lots of 15
different Carpuject pre-filled cartridge products. FDA is advising healthcare
providers to follow the instructions provided with the medication and visually
inspect and confirm that the Carpuject pre-filled cartridge contains the labeled
fill volume before dispensing and again before administering to patients.
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LEGISLATIVE & REGULATORY UPDATE
Senate Passes PDUFA. The Senate voted 96-1 last week to pass the bill
reauthorizing the FDA user fee program (PDUFA). The legislation also
creates new user fees for generic and biologic drugs. The House must now pass
its version, which could occur as early as May 30. The bill also contains a
provision that would require drug manufacturers to give FDA early
warning if they foresee a potential for drug shortages, one portion of
legislation that was being sought by pharmacy groups to deal with the drug
shortage situation. The one vote of dissent on the bill was Sen. Bernie Sanders
(I-VT). In adopting the bill, the Senate rejected several amendments including
one from Sen. John McCain (R-AZ) that would have allowed Americans to
buy cheaper drugs from Canada; and one from Sen. Dick Durbin (D-IL) that
would have required manufacturers of dietary supplements, including energy
drinks, to register their products with FDA.
Federal Bill Calls for Elimination of Drug Patents. Almost as if to prove
that things can always get weirder, Sen. Bernie Sanders (I-VT) has introduced
S 1138, the “Prize Fund for HIV/AIDS Act,” which would de-link R&D
incentives from drug prices, specifically for new HIV/AIDS medicines, and
create a $3 billion annual prize fund to reward the discover of new treatments.
Calling the current system of awarding patents to drug companies
“monopolies,” Sanders called for elimination of that system which he believes
would be replaced by the power of the competitive marketplace, making more
products available at lower cost. Sanders believes the patent system drives up
the cost of new drugs, and the hearing he called of a subcommittee of the
Senate Health Education, Labor and Pensions Committee last week to hear th e
bill, is “the first Congressional hearing ever held to discuss the possibility of
ending monopolies for medicines and offering a serious proposal to replace our
broken system with one that would accelerate innovation while providing
virtually universal access to life-saving medicines.” He primarily focused his
attention on Atripla® from Gilead which costs more than $25,000 per person
per year, but which generically (unavailable in the U.S.) costs less than $200
per patient per year. The generic version is being purchased from a competitive
supplier by the Presidents’ Emergency Plan for AIDS Relief for distribution in
developing countries. Sanders acknowledge that the legislation isn’t going
anywhere anytime soon – he is the sole sponsor – and a number of opposing
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forces are lined up against the legislation.
Federal/State Law Info Online. George Washington University has
initiated a new website to help providers understand federal and state health
information laws. HealthInfoLaw.org contains information on current health
information laws, offering insights in to legislation including HIPAA, the
HITECH Act and the Affordable Care Act. For details, see the announcement
online.
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STATE, NATIONAL AND INTERNATIONAL
There’s Gotta be a Health Story in Here Somewhere!? New Delhi, capital
of India, is increasingly home to more than its notorious bands of monkeys, as
urbanization and wildlife collide. Wild boar, mongoose, snakes and cattle are
also competing for space with the monkeys, which are seen as living
representatives of the Hindu god Hanuman, and fed Tuesdays and Saturdays in
accordance with Hindu tradition. “They bring whole cars full of food and feed
the monkeys. They do not give a care about the hungry children on the street,
but will feed the monkeys,” said the city’s wildlife warden, D.M Shukla. “They
get what even human beings in India don’t get,” according to the article in the
New York Times.
Docs’ Average Pay Exceeds $100K. The national average salary for family
and general practitioners is $177,330, according to a new report from the
U.S. Bureau of Labor Statistics. The agency has also found that the salaries
average above $100,000 in 256 metropolitan areas within the U.S. except for 2.
The highest incomes are in Waterloo, Iowa ($249,950) and Ogden, Utah
($243,150). The lowest average occurred in Columbia, MO ($73,150). The
average in Texas for family docs and GPs was $182,270. Click here for
information about the pay scales for a wide range of health-care jobs in 2009
and 2010.
International Pact Inked. The U.S. and Mexico have adopted a set of
technical guidelines that will outline how information will be shared during
public health events and “emergencies of mutual interest,” the U.S.
Department of Health & Human Services announced last week. HHS also
announced that Mexico joined the Centers for Disease Control and
Prevention’s Laboratory Response Network, which links national and
international labs to enhance responses to public emergencies.
Texas Medicaid Rx Transfer Issue. CMS has recently observed an increase
in beneficiary complaints related to the transfer of prescriptions from retail
pharmacies to either mail-order or specialty pharmacy without their explicit
consent. The agency issued a memorandum to review the requirements related
to the transfer of prescriptions. Specifically: Any prescription transfer from one
pharmacy to another, initiated by the Part D Plan, would require release of the
model notice and permission by the beneficiary. The model notice should only
be used when the transfer of the prescription is not initiated by the beneficiary
(or someone on their behalf). The beneficiary can initiate the request by
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contacting the plan or pharmacy or can mail/fax the permission form to the
plan. Unsolicited phone calls made by the Part D Plan or pharmacy seeking
permission from beneficiaries to transfer a prescription are not permitted. The
2012 Model Prescription Transfer Letter can be found at:
www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Part-D-Marketing-ModelMaterials.html. The use of other mechanisms, such as Prior Authorization
forms, to steer a beneficiary into a mail-order pharmacy is against CMS
requirements and should be discontinued immediately. The choice of which
network pharmacy to use is at the sole discretion and convenience of the
beneficiary.
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TSHP/ASHP/LOCAL CHAPTERS
TSHP New Practitioner Section Recognized. Recently, the ASHP New
Practitioners Forum Membership and Outreach Advisory Group
coordinated a state affiliate outreach project to spotlight state affiliates that are
providing exceptional services or unique programming and membership events
to new practitioners. The following states have developed various types of
programs to encourage new practitioner involvement and interaction. The
states spotlighted on the ASHP website include: California, Illinois, Minnesota,
Missouri, North Carolina, Texas and Wisconsin. Information on each state
appears online.
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PEOPLE & PLACES
TSHP member Tammy S Cohen, Pharm.D., MS, FASHP has accepted the
position of System Director of Pharmacy for the Baylor Healthcare System
in Dallas Texas. She had been serving as Interim System Director and Clinical
Coordinator for Baylor. Tammy continues to serve TSHP as Chair of the
Council on Organizational Affairs.
TSHP Member Michael Piñón has accepted a position as a Medical Science
Liaison with the U.S. Medical Affairs division of Affymax, Inc. Piñón, a
member of the TSHP R&E Foundation Board of Directors, had been with
Novartis as Regional Scientific Associate Director in the Cardiovascular,
Metabolic and Inflammatory Disease division for several years.
TSHP member Monica Puebla, has completed requirements for her MBA and
MHA degrees from Texas Woman’s University. She will be serving as Chair
of the TSHP Council on Professional Affairs in 2012-13.
Jeanne D. Waggener, R.Ph., President of the Texas State Board of
Pharmacy, has been elected to a 3-year term as a member of the National
Association of Board of Pharmacy District 6 Executive Committee.
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Christus Santa Rosa Health System has announced that it will permanently
close Christus Santa Rosa Hospital-City Centre in downtown San Antonio
by August 13. In its notification of May 21, the system said that the closure
will result in the elimination of all departments and units at City Centre and a
”permanent employment loss for the majority of associates” who currently
work at the hospital, which includes approximately 400 individuals. Some City
Centre employees will have an opportunity to transfer to other hospitals within
the organization.
The Board of Regents of Texas Tech University System has accepted a gift
of $2.3 million designated for the exclusive use of establishing the
Department of Immunotherapeutics and Biotechnology as part of the
School of Pharmacy. The new department will be housed on the Abilene
campus. The new department is expected to become operational on September
1, 2012.
Four students from The University of Texas College of Pharmacy have been
awarded pre-doctoral fellowships by the American Foundation for
Pharmaceutical Education (AFPE). They include Kelly Daniels, Christine
Dao, Michael Sandoval and Neha Thakore. A total of 42 fellowships were
awarded nationally, chosen from among 119 applications.
The Board of Regents of The University of Texas have agreed to invest in a
new medical school that will be located in Austin. The Regents agreed to
allocate up to $30 million a year from the State’s Available University Fund to
establish a school. That, along with a pending $250 million commitment from
the Seton Healthcare Family for a new teaching hospital, brings the hospital
one step closer to reality.
Parkland Update. The Dallas Morning News reports that Parkland
Memorial Hospital’s governing board has agreed to extend the contract of
its interim chief executive office by 90 days. Dr. Thomas Royer will remain
on board for a while longer as the construction continues on a new facility and
CMS investigators and oversight teams remain in place monitoring the
hospital’s changes. The hospital has reorganized its nursing structure to
address problems found in the federal inspections.
Texas Health has launched a new program to transform care within its
facilities. The program will dramatically change the way healthcare is accessed
and delivered to North Texas, according to Douglas D. Hawthorne, CEO of
Arlington-based Texas Health. The system has reached a 10-year agreement
with Franklin, TN-based Healthways which will offer weight-loss, smoking
cessation and other health programs as well as cell phone reminders to
people to eat better, exercise more and make other health changes. Texas
Health and Healthways will provide technology and management tools and
population health experts to assist physicians in tracking evolving patient
populations and guide their patients’ health.
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RESEARCH
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UTMB to Collaborate on New Drugs. The University of Texas Medical
Branch at Galveston and the University of Washington have received an
$8.1 million biodefense grant, along with Seattle-based Kineta, Inc. to
develop new drugs to treat some of the world’s most dangerous diseases. The
funding to advance next-general antiviral therapeutics comes from the National
Institute of Allergy and Infectious Diseases. The grant is designed to increase
the number of disease targets to include Ebola and Nipah viruses, along with
Yellow Fever, Marburg, plague and others for which there is a lack of effective
drug therapy.
Diabetes Drug Wins Orphan Status. Andromeda Biotech Ltd. has obtained
orphan drug status from FDA for its DiaPep277 drug for the treatment of
type 1 diabetes. The company is currently conducting a Phase III clinical trial
of the product, which reportedly can prevent the destruction of insulin
secreting beta cells. The drug is designed to treat type 1 patients with residual
insulin secreting cells in order to preserve their function.
Probiotics May Prevent Antibiotic Diarrhea. An article published in the
Journal of the American Medical Association (May 9) reports on a metaanalysis of 62 trials that concluded that probiotic administration
significantly reduced the incidence of diarrhea associated with
administration of antibiotics. Probiotic administration was associated with a
42% reduced relative risk of antibiotic-associated diarrhea. “Restoration of the
gut’s microbiology through receptor competition, competition for nutrients,
inhibition of epithelial and mucosal adherence of pathogens, introduction of
lower colonic pH favoring the growth of nonpathogenic species, stimulation of
immunity, or production of antimicrobial substances,” are all mechanisms
proposed for the beneficial role of probiotics. The study was reported by
MedPage Today.
Pfizer Drug Effective in Some Childhood Tumors. Reuters and Bloomberg
News report that Pfizer’s Xalkori® (crizotinib), has been found to be
successful in treating children with cancers similar to non-small-cell cancer
tumors with ALK gene abnormalities (for which Xalkori is currently
approved). The therapy was successful in 70 children with a variety of cancers,
but most dramatic with anaplastic large-cell lymphoma, a cancer known to
have ALK rearrangements in some patients. The Phase I trial was reported at
the American Society of Clinical Oncology annual meeting.
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EDUCATIONAL OPPORTUNITIES
The ASHP-Accredited Austin Community College (ACC) Pharmacy
Technician Program has announced that is has been approved as an ACPE
provider. ACC will be offering a wide range of Continuing Pharmacy
Education (CPE) activities including: Sterile Compounding and Aseptic
Technique; Extemporaneous Compounding; Pediatric Preparations; TPN
Compounding; and Chemotherapy Compounding. ACC is also excited to offer
the Instructor’s Course: Teaching Sterile Compounding and Aseptic Technique
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to Pharmacy Technicians, a course for pharmacists, pharmacy technicians, and
pharmacy technician educators who train, instruct, and/or supervise pharmacy
personnel who prepare compounded sterile preparations (CSPs). For more
information about ACC Pharmacy Technician Program ACPE continuing
pharmacy education activities, including date, cost, format, and location of
CPE activities; information on course prerequisites, course objectives, and
course instructors, contact ACC Pharmacy Technician Program CPE
Administrator – Lisa McCartney, BAAS, CPhT, PhTR at: 512-223-5949 or
at: [email protected]
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ANSWER TO TODAY'S TRIVIA
1. Irene Cara’s song “Flashdance (What a Feeling)” from the Flashdance
movie soundtrack was her #1 single 29 years ago. She had previously (1980)
recorded “Fame” and “Out Here on my Own” from the movie “Fame.” 2.
Although John Fogerty and his brother started the group “The Golliwogs,” the
band was largely ignored. After renaming themselves, the group ‘Creedence
Clearwater Revival” took off from 1967 to 1972 with a number of hits in their
“swamp rock” style.
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