HHS, APIC, and
SHEA honor 2014 Partnership in Prevention Award recipient for
healthcare-associated infection prevention
The U.S. Department of Health and Human Services (HHS), the Association for
Professionals in Infection Control and Epidemiology (APIC), and the Society
for Healthcare Epidemiology of America (SHEA) recognized the
University of Vermont Medical Center with the 2014
Partnership in Prevention Award for achieving sustainable improvements
toward eliminating healthcare-associated infections (HAIs).
Co-sponsored by HHS, APIC, and SHEA, this annual award is based on the
concepts of the âNational
Action Plan to Prevent Health Care-Associated Infections: Roadmap to
About 1 in every 25 inpatients has an infection related to hospital care,
and nearly 75,000 people die from an HAI each year. These infections cost
the U.S. healthcare system billions of dollars each year and lead to the
loss of tens of thousands of lives.
The University of Vermont Medical Center (UVM Medical Center) has created a
culture of safety that encourages collaboration across ranks and
disciplines, involving C-suite leaders, healthcare providers, caregivers,
infection prevention experts, quality improvement experts, environmental
services staff, and a team of infection prevention advocates from across the
hospital, ambulatory clinics, and dialysis centers. Since 2008, with C-suite
support and leadership, they have engaged multidisciplinary teams that focus
on infection prevention and control initiatives, significantly reducing
central line-associated bloodstream infections (CLABSI), surgical site
infections (SSI), and other HAIs in multiple patient populations.
The 562-bed academic medical center in Burlington, Vermont has demonstrated
innovative and creative solutions to sustain prevention of HAIs in some of
its most vulnerable patient populations. By 2013, UVM Medical Center had
achieved a 77 percent reduction in CLABSI in their medical intensive care
unit (MICU). In the past 12 months, the MICU CLABSI rate continued to
declineâfrom an 18-month baseline (January 2009 to June 2010) value of 2.72
infections per 1000 central line days to 0.33 infections per 1000 central
line days (July 2013 to July 2014). When the neonatal ICU recently
experienced two infections following a period of 36 months without a CLABSI,
the existing interdisciplinary team quickly mobilized to perform an analysis
to understand what occurred so it could be prevented in the future.
Additionally, UVM Medical Centerâs culture of safety led to the development
of two surgeon-directed initiatives that standardized and reduced variation
in practice resulting in a sustained SSI rate reduction. Total knee and hip
joint replacement infection rates for the past 12 months are 81 percent
lower than the 2009-2010 baseline rate, and orthopedic spinal fusion SSI
rates have dropped by 62 percent. For total knee surgery, UVM Medical Center
has performed 1677 infection-free procedures since the last infection
occurred in November 2010. UVM Medical Center plans to expand this
initiative for colon surgical procedures.
In 2009, UVM Medical Center joined the Centers for Disease Control and
Dialysis Bloodstream Infection Prevention Collaborative
to reduce access-related bloodstream infections in six outpatient dialysis
centers. Using staff engagement and education to improve adherence to the
CDCâs evidence based recommendations the six centers reduced the rate of
central line access-related bloodstream infection by 83 percent. In addition
the centers have partnered with the CDC to trial and validate revised
recommendations for routine disinfection of the dialysis station.
Visit APIC for the release.
Laparoscopic Power Morcellation use due to increased risk in women with
FDA has updated the use of laparoscopic power morcellators in the removal of
the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of
women. In an Immediately in Effect (IIE)
the FDA is also recommending that manufacturers of laparoscopic power
morcellators include in their product labeling specific safety statements in
the form of a boxed warning and two contraindications.
The boxed warning informs healthcare providers and patients that: Uterine
tissue may contain unsuspected cancer. The use of laparoscopic power
morcellators during fibroid surgery may spread cancer and decrease the
long-term survival of patients. This information should be shared with
patients when considering surgery with the use of these devices.
The two contraindications advise of the following: Laparoscopic power
morcellators are contraindicated (should not be used) for removal of uterine
tissue containing suspected fibroids in patients who are: peri- or
post-menopausal, or candidates for en bloc tissue removal (removing tissue
intact) through the vagina or mini-laparotomy incision. (These groups of
women represent the majority of women with fibroids who undergo hysterectomy
Laparoscopic power morcellators are contraindicated (should not be used) in
gynecologic surgery in which the tissue to be morcellated is known or
suspected to be cancerous.
Read the UPDATED MedWatch safety alert
FDA influence on design of pivotal drug studies
An examination of the potential interaction between pharmaceutical companies
and the U.S. Food and Drug Administration (FDA) to discuss future studies
finds that one-quarter of recent new drug approvals occurred without any
meeting, and when such meetings occurred, pharmaceutical companies did not
comply with one-quarter of the recommendations made by the FDA regarding
study design or primary outcome, according to a study in the November 26
issue of JAMA.
To enhance protocol quality, federal regulations encourage but do not
require meetings between pharmaceutical companies and the FDA during the
design phase of pivotal studies assessing drug efficacy and safety for the
proposed indication. These meetings often generate FDA recommendations for
improving research, although companies are not bound to follow them,
according to background information in the article.
Steven Woloshin, M.D., M.S., of the Dartmouth Institute for Health Policy
and Clinical Practice, Lebanon, N.H., and colleagues reviewed and analyzed
approximated 200 FDA documents (memos; meeting minutes; filing checklists;
and medical, statistical, and summary reviews) for 35 new drugs approved
between February 1, 2011, and February 29, 2012. The researchers identified
all FDA comments and analyzed recommendations about pivotal study design or
primary outcomes and characterized the effect of recommendations on study
Of 35 new drug approvals, companies met with the FDA to discuss pivotal
studies for 28. The FDA made 53 recommendations about design (e.g.,
controls, doses, study length) or primary outcome for 21 approvals.
Fifty-one recommendations were judged as increasing study quality (e.g.,
adding controls, blinding, or specific measures and frequency for toxicity
assessments, lengthening studies to assess outcome durability) and two as
having an uncertain effect.
Companies complied with 40 of the 53 recommendations. Examples of
non-compliance include a request for randomized trials of brentuximab and
crizotinib, but the companies conducted uncontrolled studies. Other cases
included primary outcome choice (e.g., progressionÂfree instead of overall
survival) and drug (active comparator) doses tested.
Companies can also request FDA review of pivotal trial protocols. If FDA
endorses the protocol it agrees not to object to any study design issues
when reviewing the drug for approval. Companies requested protocol review
for only 21 of the 35 new drug approvals â and FDA endorsed the protocol for
The authors write that instituting mandatory FDA review of pivotal trial
protocols with the power to issue binding recommendations could be an
effective way to optimize study quality. They believe that such review may
be even more important with increasingly flexible approval pathways. âAn
independent FDA-commissioned report suggested that stronger early FDA
involvement could avoid deficiencies that delay approval of effective drugs
and more clearly identify ineffective or harmful ones.â
Visit JAMA for the study.
Worldâs drug bill
will reach $1.3 trillion in 2018
Worldwide spending on medicines will reach almost $1.3 trillion by 2018, as
new treatments for hepatitis C and cancer come to market and as people
around the globe use rising incomes to buy pharmaceuticals.
The new drugs, such as
Sciences Inc.âs $1,000-per-pill hepatitis C treatment, will help drive the
increase in spending up 30 percent from 2013 levels, according to a report
published by the IMS Institute for Healthcare Informatics, the research arm
of IMS Health Holdings Inc., which tracks drug prescriptions and sells the
As drug spending rises, health systems and nations will have to make
decisions on how they allocate budgets, said Murray Aitken, IMS Instituteâs
executive director, in a telephone interview. âThe focus now is, how do we
get value from the trillion dollars weâre spending?â
The U.S. will remain the top spender per capita in 2018, and drug prices
there are under increasing scrutiny by health insurers and lawmakers. IMS
forecasts Americans will pay an average of $1,409 a person in 2018, up from
$1,075 last year, a faster rate of growth than the expansion of the
China, the worldâs second-biggest
pharmaceutical market, is forecast to spend $124 per capita in 2018, an
increase from $72.
While new, high-price medicines will drive spending in developed countries,
population growth and rising incomes, and more access to healthcare, will
raise spending in
Africa, Asia and elsewhere,
Other types of health spending, such as on hospitals and doctor visits,
wonât necessarily rise in proportion, said Aitken. In some cases, drugs can
lower total spending by keeping patients out of the hospital or doctorâs
office, he said.
New hepatitis C drugs are already pushing up spending this year, Aitken
said. From 2014 to 2018, the world will spend $100 billion on the new
3.2 million Americans have the
liver infection, and the new drugs do away with side-effect heavy injections
while vastly improving chances of a cure.
Cancer drugs will take an even bigger role in driving up spending in the
U.S. and worldwide in coming years. There are 120 oncology drugs in the
final stage of testing before approval by regulators, and another 374 in the
mid-stage trials. Global spend on cancer medicines will grow by 50 percent
to more than $100 billion in 2018, according to IMS.
Only France and Spain will see spending on drugs decrease in the next five
years, IMS found. This trend is due to strict cost controls implemented by
the two countries after the global financial recession, said Aitken.
Visit Bloomberg for the report.
âText neckâ is
becoming an âepidemicâ and could wreck your spine
The human head weighs about a dozen pounds. But as the neck bends forward
and down, the weight on the
begins to increase. At a 15-degree angle, this weight is about 27 pounds, at
30 degrees itâs 40 pounds, at 45 degrees itâs 49 pounds, and at 60 degrees
itâs 60 pounds.
Thatâs the burden that comes with staring at a smartphone â the way millions
do for hours every day, according to research
published by Kenneth Hansraj in the
National Library of Medicine.
The study will appear next month in
Surgical Technology International. Over time,
researchers say, this poor posture, sometimes called âtext
can lead to early wear-and-tear on the spine, degeneration and even surgery.
âIt is an epidemic or, at least, itâs very common,â Hansraj, chief of spine
surgery at New York Spine Surgery and Rehabilitation Medicine, told The
Washington Post. âJust look around you, everyone has their heads down.â
Canât grasp the significance of 60 pounds? Imagine carrying an
your neck several hours per day. Smartphone users spend an average of two to
four hours per day hunched over, reading e-mails, sending texts or checking
social media sites. Thatâs 700 to 1,400 hours per year people are putting
stress on their spines, according to the research. And high-schoolers might
be the worst. They could conceivably spend an additional 5,000 hours in this
position, Hansraj said.
âThe problem is really profound in young people,â he said. âWith this
excessive stress in the neck, we might start seeing young people needing
spine care. I would really like to see parents showing more guidance.â
Medical experts have been warning people for years. Some
say for every inch
the head tilts forward, the pressure on the spine doubles.
Tom DiAngelis, president of the
American Physical Therapy Associationâs
Private Practice Section, told
CNN last year the
effect is similar to bending a finger all the way back and holding it there
for about an hour.
âAs you stretch the tissue for a long period of time, it gets sore, it gets
inflamed,â he said. It can also cause muscle strain, pinched nerves,
herniated disks and, over time, it can even remove the neckâs natural curve.
Itâs a risk for some
of American adults who own smartphones.
Michelle Collie, a doctor who heads Performance Physical Therapy in Rhode
Island, told CNN last year she started seeing patients with mobile
technology-induced head, neck and back pain some six or seven years ago.
Poor posture can cause other problems as well. Experts say it can reduce
lung capacity by as much as 30 percent. It
has also been linked
to headaches and neurological issues, depression and heart disease.
Hansraj gave smartphone users tips to avoid pain: Look down at your device
with your eyes. No need to bend your neck.; Exercise: Move your head from
left to right several times. Use your hands to provide resistance and push
your head against them, first forward and then backward. Stand in a doorway
with your arms extended and push your chest forward to strengthen âthe
muscles of good posture,â Hansraj said.
Visit the Washington Post for the article.
testifies: generic drug price spikes wreaking havoc on patients, pharmacists
and healthcare payers
A pharmacist testified before a Senate subcommittee that unprecedented price
hikes for formerly inexpensive generic prescription drugs are âwreaking
havocâ on the healthcare system while jeopardizing the viability of
Rob Frankil of
Sellersville Pharmacy in Sellersville,
PA, appeared on behalf of the
National Community Pharmacists Association
(NCPA) at a hearing of the Senate Subcommittee on Primary Health and Aging.
described to senators
the sudden nature of the price spikes and their impact on patients, payers
and community pharmacists.
âHistorically, generic drugs have provided significant cost savings to
payers and consumers alike by providing safe and effective alternatives to
typically more costly brand name drugs,â Frankil testified. âTherefore it
was extremely concerning when, about a year ago, pharmacies began noticing a
rash of dramatic price increases for many common, previously low-cost
The cost increases, he warned, have a âprofound effect on patients.â
Patients who are uninsured or on Medicare drug plans or high-deductible
plans are most directly affected.
The cost of Digoxin at Frankilâs pharmacy jumped from about $15 to $120 for
a 90-day supply â an 800 percent increase. That astounded one of his
patients in the Medicare coverage gap (or âdonut holeâ) who thought Frankil
was overpricing the medication. Phone calls to a few competing pharmacies
confirmed the new reality.
âUltimately, everyone pays for these cost increases, now or later,â said
Frankil. âInsurance plans arenât likely to simply just absorb these higher
costs, so even those with generous insurance plans will pay the price in
higher future premiums.â
While the cost pharmacies must pay their wholesalers for drugs goes up,
Frankil explained, the reimbursement rates for those drugs does not keep up.
Insurance middlemen known as pharmacy benefit managers (PBMs) bear that
âIn this era of instant communication, it is indefensible for PBMs to wait
weeks or even months before updating their pharmacy payment benchmarks in
the wake of these price spikes â without reimbursing pharmacies
retroactively,â Frankil said. He questioned whether the PBMs were
profiteering from the situation by âspread pricingâ â paying pharmacies low,
charging insurance plans high.
The Centers for Medicare & Medicaid Services (CMS) finalized a regulation
earlier this year at the urging of NCPA to mitigate the problem. It would
require PBMs, starting in 2016, to update generic pricing benchmarks used in
Medicare drug plans every seven days. Bipartisan house legislation, H.R.
4437, has also been introduced and 16 states have enacted comparable laws.
âThe current situation in which unprecedented spikes in previously
inexpensive generic medications are becoming commonplace is one that cannot
be allowed to continue,â Frankil concluded. âThese prices are wreaking havoc
on patients, pharmacists and health care payers alike. In addition, the
associated payment lags on these medications are jeopardizing the ability of
small business pharmacies to remain viable and continue to provide critical
medications and related care to patients.â
Visit PR Newswire for the article.
Giving oxygen to
people having a heart attack can cause more damage to the heart
A new study conducted in Victoria could change the practices of ambulance
services across Australia and even across the world.
The incredible research has found that giving oxygen to a heart attack
patient could actually cause them harm and could entice more heart attacks.
The landmark study, which followed more than 400 patients treated by
Ambulance Victoria's Mobile Intensive care ambulance paramedics, said
providing oxygen offers no benefit at all and instead could cause further
damage to the heart muscle. The new study has found that giving oxygen to
heart attack patients could cause harm and entice more heart attacks.
The landmark study followed more than 400 patients treated by Ambulance
Victoria's who had chest pain and evidence that they had sudden blockage to
one of the heart arteries. Those who took part in the study had chest pain
and evidence that they had sudden blockage to one of the heart arteries,
with half treated with oxygen and the other without.
âFor more than 100 years, it has been routine practice across the world to
give oxygen to people having a heart attack because it was thought this
would be beneficial,â said the principal investigators, Dr Karen Smith from
Ambulance Victoria and Professor Stephen Bernard from The Alfred.
âMore recently there have been questions about whether oxygen really helps,
and uncertainty about what is the best treatment for patients.â
âOur data suggests that routine oxygen supplementation could cause greater
harm for patients having a heart attack,â they said. âThe study found
increased heart damage on MRI scans at six months.â
While some hospitals and ambulance services, including Ambulance Victoria,
have modified practices, it is still very common to give patients oxygen
both in Australia and across the globe. The landmark study also found that
those patients who were receiving oxygen could be more likely to have
further heart attacks.
The study findings are likely to change practices for ambulance services
across Australia and even across the world. The surprising results from the
study have just been released at one of the worldâs leading medical
conferences, the annual American Heart Association conference in Chicago.
Alarmingly it also showed those who were receiving oxygen could be more
likely to have further heart attacks.
Co-researcher and Ambulance Victoria Paramedic Ziad Nehme said there were
several reasons for oxygen causing additional damage.
âHigh-flow oxygen has been shown to narrow coronary arteries and reduce the
heartâs blood flow, as well as accelerate the production of harmful reactive
oxygen molecules which increase heart inflammation and stress,â he said.
Visit the Daily Mail for the study.
Why do so many
people die shoveling snow?
A number of people have died from heart attacks while shoveling snow in
Buffalo, NY. Every winter, about 100 people in the US die doing this. Why? A
study looking at data from 1990 to 2006 by researchers at the US Nationwide
Children's Hospital recorded 1,647 fatalities from cardiac-related injuries
associated with shoveling snow. In Canada, these deaths make the news every
Cardiologist Barry Franklin, an expert in the hazardous effects of snow
removal, believes the number of deaths could be double that. "I believe we
lose hundreds of people each year because of this activity," says Franklin,
director of preventative cardiology and cardiac rehabilitation at William
Beaumont Hospital, Michigan.
His team found that when healthy young men shoveled snow, their heart rate
and blood pressure increased more than when they exercised on a treadmill.
"Combine this with cold air, which causes arteries to constrict and decrease
blood supply, you have a perfect storm for a heart attack," he says.
Snow shoveling is particularly strenuous because it uses arm work, which is
more taxing than leg work. Straining to move wet and heavy snow is
particularly likely to cause a surge in heart rate and blood pressure,
Many people hold their breath during the hard work, which also puts a strain
on the body. In addition, the prime time for snow clearance is between 6am
and 10am which is when circadian fluctuations make us more vulnerable to
Franklin considers snow shoveling to be so dangerous that he advises anyone
over the age of 55 not to do it.
Visit the BBC for the article.
creates Ebola price index for personal protective
The recent Ebola crisis has challenged the healthcare community to step up
its preparedness for managing new cases of Ebola and other high-risk
infectious diseases. As a free public service, ECRI Institute, an
independent nonprofit that researches best approaches to improving patient
safety, has established and continues to develop an Ebola
Resource Center with
ECRI-authored guidance on risk and patient safety, technology management,
and important pricing data.
âThe Ebola PPE Price Index provides a free benchmarking service that
hospitals can use now, and importantly, it establishes a mechanism to create
a crowdsourced, ongoing resource for pricing,â says Jeffrey C. Lerner,
PhD, president and chief executive officer, ECRI Institute.
To help healthcare organizations step up preparedness and staff training in
the event of a potential Ebola outbreak in the U.S., ECRI Institute's
experts and engineering staff have compiled the Ebola Resource Centerâan
online resource of guidance, recommendations, and authoritative documents
that focus on PPE products and pricing, technology management, risk
management, and patient safety.
Visit ECRI for more information.
Thanksgiving from Healthcare Purchasing News
The staff at HPN wishes you and your families and friends a wonderful
and healthy Thanksgiving. We will be spending the next few days with our
loved ones as well. Weâll be back with more news on Monday, December 1.