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November 26, 2014 Download print version

HHS, APIC, and SHEA honor 2014 Partnership in Prevention Award recipient for healthcare-associated infection prevention

FDA discourages Laparoscopic Power Morcellation use due to increased risk in women with uterine fibroids

Study examines FDA influence on design of pivotal drug studies

World’s drug bill will reach $1.3 trillion in 2018

‘Text neck’ is becoming an ‘epidemic’ and could wreck your spine

Pharmacist testifies: generic drug price spikes wreaking havoc on patients, pharmacists and healthcare payers

Giving oxygen to people having a heart attack can cause more damage to the heart 

Why do so many people die shoveling snow?

ECRI Institute creates Ebola price index for personal protective equipment

Happy Thanksgiving from Healthcare Purchasing News


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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 “National Action Plan to Prevent Health Care-Associated Infections: Roadmap to Elimination.”

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 decline—from 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 Center’s 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 Prevention’s (CDC) 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 CDC’s 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.



FDA discourages Laparoscopic Power Morcellation use due to increased risk in women with uterine fibroids

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) guidance, 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 and myomectomy.)

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 here.



Study examines 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 quality.

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., progression­free 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 – and FDA endorsed the protocol for 12. 

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. “An 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.”

Visit JAMA for the study.



World’s 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 Gilead Sciences Inc.’s $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 data.

As drug spending rises, health systems and nations will have to make decisions on how they allocate budgets, said Murray Aitken, IMS Institute’s executive director, in a telephone interview. “The focus now is, how do we get value from the trillion dollars we’re spending?”

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 population. China, the world’s 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, IMS found.

Other types of health spending, such as on hospitals and doctor visits, won’t necessarily rise in proportion, said Aitken. In some cases, drugs can lower total spending by keeping patients out of the hospital or doctor’s 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 medicines. About 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.



‘Text neck’ is becoming an ‘epidemic’ 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 cervical spine begins to increase. At a 15-degree angle, this weight is about 27 pounds, at 30 degrees it’s 40 pounds, at 45 degrees it’s 49 pounds, and at 60 degrees it’s 60 pounds.

That’s the burden that comes with staring at a smartphone — 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 “text neck,” can lead to early wear-and-tear on the spine, degeneration and even surgery.

“It is an epidemic or, at least, it’s very common,” Hansraj, chief of spine surgery at New York Spine Surgery and Rehabilitation Medicine, told The Washington Post. “Just look around you, everyone has their heads down.”

Can’t grasp the significance of 60 pounds? Imagine carrying an 8-year-old around 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. That’s 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.

“The problem is really profound in young people,” he said. “With 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.”

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 Association‘s 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.

“As you stretch the tissue for a long period of time, it gets sore, it gets inflamed,” he said. It can also cause muscle strain, pinched nerves, herniated disks and, over time, it can even remove the neck’s natural curve. It’s a risk for some 58 percent 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.

Speaking to TODAY, 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 “the muscles of good posture,” Hansraj said.

Visit the Washington Post for the article.



Pharmacist 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 “wreaking havoc” on the healthcare system while jeopardizing the viability of community pharmacies.

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. He described to senators the sudden nature of the price spikes and their impact on patients, payers and community pharmacists.

“Historically, 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,” Frankil testified. “Therefore it was extremely concerning when, about a year ago, pharmacies began noticing a rash of dramatic price increases for many common, previously low-cost generic drugs.”

The cost increases, he warned, have a “profound effect on patients.” Patients who are uninsured or on Medicare drug plans or high-deductible plans are most directly affected.

The cost of Digoxin at Frankil’s pharmacy jumped from about $15 to $120 for a 90-day supply – an 800 percent increase. That astounded one of his patients in the Medicare coverage gap (or “donut hole”) who thought Frankil was overpricing the medication. Phone calls to a few competing pharmacies confirmed the new reality.

“Ultimately, everyone pays for these cost increases, now or later,” said Frankil. “Insurance plans aren’t likely to simply just absorb these higher costs, so even those with generous insurance plans will pay the price in higher future premiums.”

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 responsibility.

“In 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 – without reimbursing pharmacies retroactively,” Frankil said. He questioned whether the PBMs were profiteering from the situation by “spread pricing” – paying pharmacies low, while 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.

“The current situation in which unprecedented spikes in previously inexpensive generic medications are becoming commonplace is one that cannot be allowed to continue,” Frankil concluded. “These 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.”

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.

“For 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,” said the principal investigators, Dr Karen Smith from Ambulance Victoria and Professor Stephen Bernard from The Alfred.

“More recently there have been questions about whether oxygen really helps, and uncertainty about what is the best treatment for patients.”

“Our data suggests that routine oxygen supplementation could cause greater harm for patients having a heart attack,” they said. “The study found increased heart damage on MRI scans at six months.”

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 world’s 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. 

“High-flow oxygen has been shown to narrow coronary arteries and reduce the heart’s blood flow, as well as accelerate the production of harmful reactive oxygen molecules which increase heart inflammation and stress,” 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 winter.

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, Franklin says.

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 heart attacks.

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.



ECRI Institute creates Ebola price index for personal protective equipment

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.

“The 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,” 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 Center—an 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.



Happy 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. We’ll be back with more news on Monday, December 1.