Archive for the ‘Industry News’ Category

Custom-made meds may pose deadly threat

Wednesday, March 11th, 2009

While going through menopause, Marcia Sticka developed miserable hot flashes and night sweats, dry skin, a short temper, and an uncharacteristic lack of energy. No more: Every day for the past three years, she’s rubbed a low, precisely measured dose of the hormone testosterone onto her inner thighs, and she feels great.

“It really helped the hot flashes and night sweats, I’m not cranky all the time, and I wake up raring to go,” says Sticka, 57, of Hillsboro, Ore.

Sticka is one of millions of people benefiting from compounding — when pharmacists prepare drugs in doses, forms, and combinations not available from manufacturers. In this case, the standard prescription testosterone gel (Androgel) is suitable only for men, delivering several times the daily dose Sticka’s doctor prescribed.

More than 30 million prescription drugs are compounded each year, and they’re a godsend for people with needs that off-the-shelf pharmaceuticals can’t meet. But these drugs have recently come under attack. Critics are concerned that some compounders are acting like drug manufacturers, doctors, or both — but without the same safeguards. There’s good reason to be worried: Compounded drugs are blamed for a host of serious side effects, including three recent deaths. Even if this is the first you’ve heard of compounding, you shouldn’t feel immune to its potentially negative consequences. As the practice becomes more widespread (over the past decade, it’s burgeoned into at least a $5 billion business), it has the potential to affect millions.

Lifesaver or risky business?
All of the nearly 200,000 pharmacists in this country are licensed to compound, and about 5,000 make it a specialty. At their best, compounding pharmacists occupy a respected, time-honored position in the medical system. From modifying the strength of a medication to altering the form or flavor so it’s easier to swallow, they fill a vital need if you can’t take commercial, one-size-fits-all prescription drugs.

The problem is the changing nature of compounding. Traditionally, it involves a sacrosanct “triad relationship” between a patient with a special need (such as Sticka), a physician who writes her a prescription, and a pharmacist who tailors the drugs.

But lately some shady prescription drug manufacturers are calling themselves compounders to get around the FDA’s stringent oversight of pharmaceuticals. Even some corner drugstore types — in an effort to drum up new business and boost profits — seem to be overstepping their bounds in a way that puts consumers at risk.

Compounding goes awry
Though compounders aren’t supposed to make anything unless they receive a specific prescription, many are producing, stockpiling, and marketing large quantities of Rx drugs — creating what’s being dubbed a “shadow drug industry.” However, unlike drugs made by the pharmaceutical industry, compounded medicines aren’t regulated by the FDA. This lack of oversight is accepted when pharmacists make drugs for a single patient. But these large-scale compounders often employ poor manufacturing processes that can result in products without the required strength, quality, or purity — meaning an error could endanger many.

This worst-case scenario happened to Margrit Long of Portland, Ore., who sought relief from chronic back pain. Her doctor suggested injections of colchicine, a drug used in pill form to treat gout, and prescribed off-label in injection form for back pain. The doctor got the medication from ApothéCure, a Dallas pharmacy that promotes its compounded injectables. The strong anti-inflammatory action of the shots seemed to help with Long’s pain for several years — until March 2007, when an injection killed her. The problem: a measurement error by the person mixing the prescription, which meant that Long and at least two others were fatally injected with eight times the intended amount of colchicine. ApothéCure ultimately recalled more than 3,500 vials of the drug distributed nationwide.

Errors don’t have to be reported
Precisely how many other compounding errors there are isn’t known. That’s because — unlike commercial drug manufacturers — pharmacies in most states aren’t required to report adverse events associated with compounded drugs to the FDA or state pharmacy boards. But the one state that tests random samples of drugs has uncovered problems. When Missouri’s board of pharmacy spot-checked compounded prescriptions in 2007, 51 of 213 prescriptions tested were more than 10 percent off in the dose of active ingredients, one had only one-fifth of the amount needed, and another had 4 1/2 times the prescribed dose.

Horror stories like Long’s aren’t the exclusive domain of large-scale compounders: Local compounding pharmacists can be overconfident in their ability to make what patients and physicians need. In 2001, Doc’s Pharmacy in Walnut Creek, Calif., began compounding a steroid that the manufacturer had temporarily stopped making. But the reputable pharmacy was unable to create a sterile compound, and within a few months, three people treated with the contaminated injections died of meningitis. This outcome shouldn’t be that surprising, considering that just 1 in 5 schools of pharmacy offers a special course on compounding sterile medications. Only 13 percent of pharmacy school deans felt that their students graduated with adequate training in compounding sterile preparations, according to a 2005 survey. Yet all pharmacists are licensed to compound.

Pharmacists as physicians?
Some compounders veer toward practicing medicine themselves, dispensing advice directly to customers on the best drug for their ills. This is especially true when it comes to “bioidenticals.” These prescription hormones, frequently used to treat perimenopausal discomfort, are synthesized to be molecularly identical to specific human hormones. It’s okay for compounders to make up prescriptions for various combinations of hormones, but compounders frequently promote bioidenticals as natural, risk free, and able to prevent or cure a host of medical conditions. The truth: Bioidenticals are created in a laboratory, often by manipulating plant hormones, and there’s no proof they have fewer or different risks than other hormones or offer any specific health benefits.

But that’s not what many hear. At some pharmacies, you can go to a lecture on the benefits of bioidenticals, schedule an individual consultation to review your symptoms, take hormone tests that the pharmacist analyzes, and have a customized bioidentical hormone prescription recommended and sent to your physician’s office for a signature. If your doctor’s not amenable, the pharmacy helps you find a physician who is.

Read the entire article at http://www.msnbc.msn.com/id/29532018/

New Calcium Study

Monday, February 23rd, 2009

CHICAGO - A study in nearly half a million older men and women bolsters evidence that diets rich in calcium may help protect against some cancers.

The benefits were mostly associated with foods high in calcium, rather than calcium tablets.

Previous studies have produced conflicting results. The new research involved food questionnaires from participants and a follow-up check of records for cancer cases during the subsequent seven years. This research method is less rigorous than some previous but smaller studies.

But because of its huge size — 492,810 people and more than 50,000 cancers — the new study presents powerful evidence favoring the idea that calcium may somehow keep cells from becoming cancerous, said University of North Carolina nutrition expert John Anderson, who was not involved in the study.

The study was run jointly by the National Institutes of Health and AARP. The results appear in Monday’s Archives of Internal Medicine.

National Cancer Institute researcher Yikyung Park, the study’s lead author, called the results strong but said more studies are needed to confirm the findings.

Duke University nutrition researcher Denise Snyder said the results support the idea that food rather than supplements is the best source for nutrients.

Participants were AARP members aged 50 to 71 who began the study in the mid-1990s. A total of 36,965 men and 16,605 women were later diagnosed with cancer. There were more than 10 different kinds of cancer, the most common being prostate, breast, lung and colorectal.

Compared with people who got little calcium, those who consumed the most had the lowest chances of getting colon cancer. Those in that highest category got on average 1,530 milligrams a day among men and 1,881 milligrams daily among women. The recommended amount for older people is 1,200 milligrams, and getting much more than that didn’t result in any greater protection. Adults can get that amount from four cups of milk or calcium-fortified orange juice.

Men who got the most calcium from food were about 30 percent less likely to get cancer of the esophagus, about 20 percent less likely to get head and neck cancer and 16 percent less likely to get colon cancer, when compared to men who got low amounts of calcium.

Among women, those who got the most food-based calcium were 28 percent less likely to get colon cancer than low-calcium women.

In men, calcium supplements only seemed to help protect against colon cancer; for women, supplements meant a lower risk for liver cancer, which is rare.

Some previous studies have linked diets high in calcium with prostate cancer but the current study found no such risk.

Adults who ate the most calcium also tended to be healthier overall than the others.

Northwestern University preventive medicine instructor Patricia Sheean called the results impressive. But she noted that all those in the study, AARP members, may have been healthier and wealthier than the general U.S. population so it’s not clear if the results would apply to the wider population.

I found this article at http://www.msnbc.msn.com/id/29353337/

This week’s Healthcare News

Monday, February 23rd, 2009

Listen up Germophobes!

Thursday, February 19th, 2009

At least once a day, Lisa Pisano feels the itch. The 30-year-old fashion publicist goes to the reception desk of her New York City office to accept a delivery of clothing samples from a designer. The courier hands over the garments, swings his messenger bag forward on his hip, fishes inside for a clipboard and hands her a pen. And then she feels it: a tickle at the back of her mind. A little rush of disquiet. Oh, my God, she thinks. Where has that pen been?

She imagines the possibilities: tucked behind the courier’s ear. Clutched by a stranger’s hand, which that day had probably touched a bathroom door or a subway handrail. She thinks about the millions of people in New York, eating, scratching, rubbing their noses, picking up bacteria and then leaving it on that handrail, and then on the person’s hands, and then on the courier’s pen, and then on her hand, her face, her lungs, her… Ick.

Pisano has always been germ-conscious — she wipes off her purse if it’s been resting on the floor and swabs her keyboard, phone and mouse with disinfecting wipes — but the pen problem pushes her over the edge every time.

One day, on the way to work, she spotted her salvation in an office-supply store window: a pen made of antibacterial plastic. She bought a handful and now, whenever the messengers buzz for her, she carries one to the door. Her co-workers tease her. She ignores them. “I’m known in the office for being a little nutty about my pens,” she says, laughing but not apologizing. “If you take my pen, I’m coming after you.”

Admit it: You’ve got something in your own life that makes you go ick. Ask any group of women what they do to protect themselves from germs, and the stories will pour out: We open the bathroom door with elbows, punch the elevator buttons with knuckles, carry wet wipes to disinfect the ATM — and we wonder whether we’re going a little too far. Even the doctors we turn to for reassurance aren’t immune. “I’m extremely aware of the potential for being ‘contaminated,’ in and out of my office,” says Susan Biali, M.D., a 37-year-old physician in Vancouver, British Columbia. “I wouldn’t touch the magazines in the waiting room if you paid me!”

When Self.com polled readers about their germophobia, more than three quarters said they flush public toilets with their foot, and 63 percent avoid handrails on subways, buses and escalators — all unnecessary precautions, experts say. Almost 1 in 10 say they avoid shaking hands, behavior that may flirt with full-fledged obsession, when your efforts to sanitize your life begin to stymie your day-to-day functioning.

Germophobia, of course, is not listed in the Diagnostic and Statistical Manual of Mental Disorders. But mental-health professionals agree that, in vulnerable people, extreme germ awareness can be both a symptom of and a catalyst for a variety of anxiety ailments for which women are already more prone — including obsessive-compulsive disorder, which often features repetitive hand washing and fear of contamination. Ironically, hands that are dry and cracked from overwashing are more likely to pick up an infection through openings in the skin, says Joshua Fox, M.D., a spokesman in New York City for the American Academy of Dermatology.

Read the entire article at http://www.msnbc.msn.com/id/29166897/

This Week in Healthcare

Monday, February 16th, 2009

Cure for the common cold??

Friday, February 13th, 2009

Snifflers of the world rejoice: Scientists are one step closer to finding effective treatments for the common cold now that researchers have deciphered the genetic code of the ubiquitous virus.

While a full-blown cure for the common cold is not expected anytime soon, the mapping of the human rhinovirus’s genetic blueprint will help scientists better understand and combat this highly contagious pathogen. In the meantime, there are always ways to help keep yourself from succumbing to the coughs and congestion.

Researchers from the University of Maryland School of Medicine in Baltimore and the University of Wisconsin-Madison cracked the cold’s code by sequencing the genomes of all 99 known strains of rhinovirus. This allowed the team to determine how all the strains were related to one another, creating a viral family tree of sorts.

The work, detailed in the Feb. 13 issue of the journal Science, confirmed some ideas about the nature of the human rhinovirus while providing a few surprises.

“We know a lot about the common cold virus,” said study co-author Ann Palmenberg of the University of Wisconsin-Madison, “but we didn’t know how their genomes encoded all that information. Now we do, and all kinds of new things are falling out.”

Read the entire article at http://www.msnbc.msn.com/id/29165133/

Hallway Medicine

Monday, October 27th, 2008

There’s no phone and no television. Only a screen offers privacy. But heart patient Edward Gray understands why the hospital put him in a cardiac unit hallway.

“They sent me up here to make room for other emergency patients,” Gray, 78, said last week from his bed in the hall of a New York area hospital. “This is the way things are in hospitals.”

It may not sound like ideal health care, but hospital officials nationwide are being urged to consider hallway medicine as a way to ease emergency department crowding, and some are trying it.
Leading the way is Stony Brook University Medical Center at Stony Brook, N.Y., where a study found that no harm was caused by moving emergency room patients to upper-floor hallways when they were ready for admission.

The study’s lead author says all hospitals should look at the program’s success.

“This is yet another battle cry for hospitals to get off their duffs and stop stacking people knee deep in the emergency department,” said Dr. Peter Viccellio, who is clinical director of the hospital’s emergency department.

He is to present the study’s findings Tuesday at a meeting of the American College of Emergency Physicians in Chicago.

Hospital-wide problem
Crowding is a hospital-wide problem that has been handed off to emergency departments, Viccellio said. His idea hands the problem back to the entire hospital.

Before the change, when his hospital filled up, patients were admitted but held in the ER in a common practice called boarding. On busy days, “things would grind to a halt and people would wait to be seen,” Viccellio said. Infectious patients would wait in the ER’s hallway for isolation rooms to open up elsewhere in the hospital.

Holding patients in ERs can cause deaths, doctors say. In a 2007 survey of nearly 1,500 emergency doctors, 13 percent said they personally experienced a patient dying as a result of boarding in the emergency department. The survey was conducted by the American College of Emergency Physicians.

The new study found slightly fewer deaths and intensive care unit admissions in the hallway patients compared to the standard bed patients. That was no surprise, Viccellio said, because the protocol calls for giving the first available rooms to the sickest patients. Intensive care patients never go to hallways.

The study is based on four years of Stony Brook’s experience with more than 2,000 patients admitted to hallways from the ER.

Other hospitals resist the idea, doctors say. Dr. Michael Carius, who heads the emergency department at Norwalk Hospital in Norwalk, Conn., would like it adopted at his hospital. But nurses and government regulators have resisted, citing safety issues, “as though the emergency department hallway is a safer environment,” he said in frustration.

“When you’re full of admitted patients, you’re no longer an emergency department, you’re just a holding area,” Carius said.

‘They could see the problem’
In Texas, all it took to convince nurses at Harris Methodist Fort Worth Hospital was a tour of the ER, said Barbara VanWart, emergency nurse manager.

“They could see the problem and help us make things happen because now it’s before their eyes,” VanWart said. The hospital started its hallway protocol in 2005.

Dr. Kirk Jensen of the nonprofit Institute for Healthcare Improvement in Cambridge, Mass., said the best reason to adopt the concept is the way it gets the whole hospital involved in finding rooms more quickly for admitted patients.

“It’s out of sight, out of mind, even if they know that patients are there in the emergency department,” Jensen said. With patients in their own hallways, “they get a lot more creative and aggressive with workflow practices.”

When Stony Brook began the hallway practice, the staff noticed “the miracle of the elevator,” said Carolyn Santora, who heads the hospital’s patient safety efforts. Somehow, rooms became available by the time hallway-bound emergency patients made it upstairs, she said.

Nurses hate seeing patients in their hallways, Santora said, and that’s fine with her.

“I want them to hate it. I want them to do everything to expedite flow to get the patient out of hallway.”

Gray, the hallway patient at Stony Brook, came to the ER with chest pains and was stabilized before being sent upstairs. He is a retired nurse and said hospital crowding deserves attention from lawmakers.

“I wish the $700 billion went for hospitals, roads and bridges and not to bail out those folks on Wall Street,” he said.

Read entire article at http://www.msnbc.msn.com/id/27389321/

Hospital Nuclear Waste

Friday, September 26th, 2008

Tubes, capsules and pellets of used radioactive material are piling up in the basements and locked closets of hospitals and research installations around the country, stoking fears they could get lost or, worse, stolen by terrorists and turned into dirty bombs.

For years, truckloads of low-level nuclear waste from most of the U.S. were taken to a rural South Carolina landfill. There, items such as the rice-size radioactive seeds for treating cancer and pencil-thin nuclear tubes used in industrial gauges were sealed in concrete and buried.

“Instead of safely secured in one place, it’s stored in thousands of places in urban locations all over the United States,” said Rick Jacobi, a nuclear waste consultant and former head of a Texas agency that unsuccessfully tried to create a disposal site for that state.

State and federal authorities say the waste is being monitored, but they acknowledge that it is difficult to track and inspected as little as once every five years. Government documents and dozens of Associated Press interviews with nuclear waste generators, experts, watchdogs and officials show that thousands of these small radioactive items have already been lost, and that worries are growing.

Flea markets and eBay; landfills and recycling plants
“They’ll end up offered up on eBay and flea markets and sent to landfills, or metal recycling plants — places where you don’t want them to be,” said Stephen Browne, radiation control officer at Troxler Electronic Laboratories, one of the world’s largest manufacturers of industrial gauges that use radioactive material.

There are millions of radioactive devices in use for which there is no long-term disposal plan. These include tiny capsules of radioactive cesium isotopes implanted to kill cancerous cells; cobalt-60 pellets that power helmet-like machines used to focus radioactive beams on diseased brain tissue; and cobalt and powdered cesium inside irradiation machines that sterilize medical equipment and blood.

Most medical waste can simply be stored until its radioactivity subsides within a few years, then safely thrown out with the regular trash. Some institutions store their radioactive material in lead-lined safes, behind doors fitted with alarms and covered with yellow-and-black radiation warning signs.

Over the past decade, however, 4,363 radioactive sources have been lost, stolen or abandoned, according to a Nuclear Regulatory Commission report released in February. Though none of the material lost was rated “extremely dangerous” — meaning unshielded, up-close exposure can cause permanent injury within a few minutes and death within an hour — more than half the radioactive items were never recovered, the NRC said.

Since the Sept. 11 attacks, owners of dangerous amounts of radioactivity have been told by the government to take greater precautions, such as having 24-hour surveillance, erecting barriers and fingerprinting employees, regardless of whether the devices are in use or stored as waste.

Close to a crisis?
Yet in 2003, the federal Government Accountability Office reported there wasn’t even a record of how many radioactive sources existed nationwide. In June, the GAO concluded that while there has been progress, more must be done to track radioactive material to prevent it from falling into terrorists’ hands and ending up in a dirty bomb, or one that uses conventional explosives to scatter radiation.

“I don’t think we’re yet in crisis, but certainly there’s information out there to suggest we may be closer to that than is comfortable for me,” said Gregory Jaczko, a commissioner with the NRC, one of the agencies charged with tracking the material.

In 1987, four people died and hundreds fell ill after looters in Brazil found a cancer-therapy machine in an abandoned medical clinic and sold it as scrap metal. More recently, 19 small vials of cesium-137, implanted for cervical cancer treatments, disappeared in 1998 from a locked safe at Moses Cone Memorial Hospital in Greensboro, N.C. The tubes were never found and were believed stolen.

A terrorist would need to gather far more of those vitamin-sized capsules to create a dirty bomb capable of killing anyone within one city block, said Kelly Classic, a health physicist at Mayo Clinic in Minnesota.

For decades, the government urged states to build low-level nuclear waste landfills, either on their own or in cooperation with nearby states. But those efforts have run into strong not-in-my-backyard resistance of the sort that led South Carolina lawmakers to close the Barnwell County landfill to all but three states. Only one low-level landfill, in Utah, has opened in the past 30 years. One more could open in Texas by the end of next year, but it would accept trash from only Vermont and the Lone Star State.

 

The government never set up penalties for states that failed to build landfills.

“Congress should have gotten involved a long time ago,” said Richard Gallego, vice president of Thomas Gray and Associates Inc., a California company that prepares low-level waste for disposal.

Rich Janati, chief of nuclear safety for Pennsylvania’s Department of Environmental Protection, said: “It’s a national issue, and we should look at it as a national problem and come up with a solution.”

The government this week did move to shore up security by requiring hospitals and labs to better secure machines used to irradiate blood. Also, dirty-bomb fears have prompted the National Research Council to urge replacing the roughly 1,300 such machines in the U.S. with less hazardous but more expensive equipment.

Article found at http://www.msnbc.msn.com/id/26891309/

Almost There!!!

Tuesday, September 23rd, 2008

To all the second year nursing students nearing graduation-hang in there To the first year students finishing your first semester or quarter…..enjoy your free time now!

This time of the year is particularly difficult for nursing students. Not only is there the demanding schedule of clinical rotations and work associated with finals and nursing exams, but you also have the upcoming holidays, sporting events, and work! Balancing these responsibilities can often be difficult-so remember……you are almost done with school! It might seem like school will never end but it will. And once you are done you can enjoy the holidays like never before. Imaging just how thankful you will be next Thanksgiving when you are working amongst the world’s kindest and brightest, earning a generous wage, and helping people in distress. Imagine Christmas with extra money for the holidays. Sounds good right! So keep your focus and keep your eyes on the prize.

Many of you may in fact have secured jobs and positions with your current employer or at a facility in which you are performing clinical. But many of you are also still feeling out the job market and interested in exploring some of the many exciting opportunities soon to be available to you. For the latter, look for a Medical Staffers booth at a college job fair or university career fair near you! Please take the time to stop by and visit, ask questions, and enjoy some of our free merchandise and snacks while you visit. We look forward to seeing you there!

Change of Season

Thursday, September 11th, 2008

Autumn and Winter are special times for many traveling medical professionals. While many travelers in the industry scamper South to obtain assignments in warmer climates, a few brave souls embrace the opportunity and adventure that can only be found spending the Holidays and New Year in the great northern parts of the United States.

If like the many before you, you have ever dreamed of walking through the Autumn leaves of the gorgeous New England States, skiing or snowboarding Vail and Aspen, relaxing with a good book and cup of hot cocoa in Montana, or going to Soldier Field to catch a Bears game, then now is the time to take the challenge of bundling up for great assignment with Travel Nurse Career and go north for the fall and winter season!

TNC offers a vast array of fall and winter positions in the Northern US. And what’s better than a real white Christmas-a white Christmas with GREAT PAY and bonus*!

*Any candidates who sing up by Nov 1 will receive a real Christmas courtesy of medical staffers.