Should hospitals be #compounding #IVfluids? Logistics and safety concerns could make it prohibitive.

Commonhealth, WBUR’s health blog, reports on a potential shortage of IV fluids at MGH. One approach to deal with it: compounding.  But, a 2014 story in Health Leaders Media quoted pharmacists who believe “Logistics and safety concerns would make it prohibitive.”

Saline Compounding a Poor Option for Hospitals

Nov. 12 2014

By Tinker Ready

For Health Leaders Media

mclean-jpg

Hospitals are learning how to stretch their limited supplies of IV fluids and are unlikely to resort to compounding saline for routine use, pharmacists say.

Three times in the past year, the Food and Drug Administration responded to the ongoing shortage by allowing three top US suppliers—BBraunFresenius Kabi USA and Baxterto distribute supplies from European plants. While there is some hope that the shortage may clear up in 2015, the once plentiful and much-in-demand product remains in short supply.

Bona E. Benjamin, director of medication use quality improvement with the American Society of Health-System Pharmacists (ASHP), says she is unaware of any hospitals that are routinely compounding their own solutions. Logistics and safety concerns would make it prohibitive, says Benjamin, who spent roughly 30 years working in hospital compounding services.

Because hospitals use saline for both rehydration and drug delivery, any in-house compounding effort would “approach the scope of manufacturing,” she says. And the volume of saline solution needed by a hospital would overwhelm a hospital- based compounding service.

“As an IV person , I would not want to be tasked with doing that,” she said. “You would need a lot of space, a lot of people, and a lot of equipment, and you would have to run it 24/7.”

State Regulation
A survey by the AHSP earlier this year found that 6% of the responding hospitals reported a shortage of IV saline. “While conservation strategies are working for 53% of respondents experiencing this shortage, 29% of respondents reporting a shortage have a supply inadequate to meet all patient needs,” the group reported.

Compounding of saline would fall under the same regulatory rules as other compounding activities. While the FDA regulates commercial compounding companies, state pharmacy boards oversee hospital pharmacy operations. In-house compounding efforts must comply with the rules set by the United States Pharmacopeia (USP), a federally recognized standards-setting organization. Compliance is also reviewed as part of Joint Commission accreditation process.

David Jaspan, director of pharmacy and materials management at Union Hospital of Cecil County in Elkton, MD says he’s beginning to see “some loosening up ” of the supply, but noted that it’s still a problem. Hospitals are getting limited allocations based on their past routine use.

“If we routinely use 100 bags a week, and I’m given 60, after a period of time it is gong to be a problem,” he says.

He sees compounding as a last report that his staff members use on occasion to produce half-normal saline, which Jaspan says is also currently unavailable. Both Jaspan and Benjamin cited another downside of using concentrated sodium chloride for compounding – it too is in short supply too and there is no substitute. 

Hospital Compounding Discouraged
The non-profit Association for Safe Medication Practices also defines compounding as a last resort. A January “safety alert”issued by the group’s website notes that: “We can’t stress enough the importance of exhausting all other alternatives before compounding IV sodium chloride solutions.”

One major safety concern is labeling, Benjamin says. Bags of saline come from the manufacturers with labels. If the hospitals were to reuse bags, they would have to be re-labled, which raises the risk of medication errors.

So, hospitals are finding ways to conserve. But, the shortage can have an impact on patient services and budgets. With scarcity, comes price increases.

At Union Hospital, that means a greater awareness of a product that many once took for granted.

“For every patient who comes into the emergency department, they used to hang a liter of normal [saline] and now maybe they hang a 500cc bag because if they don’t use it all, they throw it away after the patient is evaluated,” Jaspan said.

Benjamin says that efforts like these have kept the shortage from having a visible impact on care. She encourages hospital administrators to be sure they are monitoring the shortages and giving staff the resources they need to cope.  

“It’s only by of a lot of dancing behind the scenes and just-in-time management that patients are not feeling this worse than they already are,” she says.

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MGH surgeon, who treated #bombing victims in Afghanistan and #Boston, brings #tourniquet campaign to area schools

How sad is it that teachers are learning how to use tourniquets?  Dr. David King, a Mass General surgeon tells the Globe that he thinks some of the students at Newtown might have survived if teachers had those skills.

After a stint in Afghanistan, where he responded to a truck bomb, and hours the Mass General OR working on the those injured in the marathon bombing,  King is familiar with lower limb injuries.

The lay people, the volunteers, the teachers: Those are the people who are truly the first who can respond to these kinds of incidents,” he said.

To prepare for such unforeseen events, King and other doctors are calling for greater access to commercially manufactured tourniquets and for training in their proper use.

In this story from Health Leaders Media, he explains why the marathon bombing made this clear.

His experiences here and overseas where 75 percent of all injuries were caused by explosions— have made King a huge promoter of the tourniquet. The bystanders at the finish line did their best with t-shirts, belts, and other makeshift tourniquets, he said. But, it takes a medical-quality device to stop arterial hemorrhaging and prevent blood loss that can make a leg wound fatal.

Here he talks about his own experience that day, when he was called in MGH after finishing the marathon himself.

Dr King’s Marathon from Tinker Ready on Vimeo.

Genetics and autism: One study, one story

Two Boston-linked stories today on the genetics of Autism.

ss sciFrom the Scientist Last year a team of Australian scientists claimed to have developed a genetic test that predicts risk for autism spectrum disorder (ASD) with “72 percent accuracy.”y night at a Boston fundraiser in support of his research into the functioning of brain synapses in autism

The Scientists reports that they said the test  “may provide a tool for screening at birth or during infancy to provide an index of at-risk status.”

But a new study, led by Benjamin Neale from Massachusetts General Hospital, suggests that those claims were overblown. Neale’s team replicated the Australian group’s research in a larger sample, and found that the proposed panel of markers did not accurately predict ASDs.

“The claims in the original manuscript were quite bold. If they were true, it really would have been quite a major advance for the field, with serious ramifications for patients and other risk populations,” said Neale. “I think it’s important to ensure that this kind of work is of the highest quality.”

More here from SciBlogger Emily Willingham. 

And, this from WBUR

BOSTON — For Timmy and Stuart Supple, a pool is one of the best places to be. That’s where their mother thought the boys, who are 8 and 10 years old and severely autistic, would be the most calm and least stressed for a very important introduction.

“We, we, we go see the doctor?” 10-year-old Stuart asked his mother.

His mother, Kate Supple, tells him the man standing in front of him by the pool is the doctor. Dr. Thomas Sudhof has never met the boys, but he wants to see their autism unchecked.

Sudhof isn’t a pediatrician or one of the myriad of therapists trying to get into their world and bring them out. The Stanford University neuroscientist — who this year shared the Nobel Prize in medicine for his decades of study into how brain cells communicate — has been studying Tommy and Stuart’s genes, specifically an alteration in one gene, for five years. The Supples hosted Sudhof Wednesda

From the Scientist Last year a team of Australian scientists claimed to have developed a genetic test that predicts risk for autism spectrum disorder (ASD) with “72 percent accuracy.”y night at a Boston fundraiser in support of his research into the functioning of brain synapses in autism

The Scientists reports that they said the test  “may provide a tool for screening at birth or during infancy to provide an index of at-risk status.”

But a new study, led by Benjamin Neale from Massachusetts General Hospital, suggests that those claims were overblown. Neale’s team replicated the Australian group’s research in a larger sample, and found that the proposed panel of markers did not accurately predict ASDs.

“The claims in the original manuscript were quite bold. If they were true, it really would have been quite a major advance for the field, with serious ramifications for patients and other risk populations,” said Neale. “I think it’s important to ensure that this kind of work is of the highest quality.”

Health reform and cancer: Mass can’t get either one right?

Fortune/CNN jumps all over Mass health reform

 …(T)he plans offer lavish subsidies that swell the demand for health care, they do nothing to increase the supply of medical services in a market suffering from shortages of everything from family doctors to nurses to hospital beds. Two years after enacting health-care reform to rein in costs, Massachusetts strengthened “certificate of need laws” that prevent hospitals and other providers from competing with high-cost, entrenched suppliers. The state now requires that ambulatory surgical centers and outpatient treatment facilities get permission from regulators before they can enter the market. Their rivals invariably lobby the regulators to block competition, and usually win.

 And, the NY Times holds up MGH research as an example of the limits of targeted cancer therapies.

 Enthusiasts for the targeted drug have been saying for years that tumors will eventually be characterized by their molecular profiles — which mutated genes they have — rather than where in the body they occur. Names like breast cancer and lung cancer will be supplanted by terms like B-RAF-positive or EGFR-positive tumors. And drugs will be chosen based on that profile, the way antibiotics are generally selected based on the pathogen that is causing the infection, not on where in the body the infection occurs.

 Massachusetts General Hospital, for instance, is running a clinical trial testing a drug from AstraZeneca on any type of cancer — providing it has a mutation in the gene B-RAF, the same gene that is the target of PLX4032.

 But the test of PLX4032 in colon cancer suggests that the location of the tumor still does matter, that it will not be just a case of looking at the target. There are other examples as well. Erbitux and Vectibix do not work in colon cancer patients with a mutation in a gene called K-RAS. But the relationship between the mutation and the effectiveness of Erbitux does not seem to hold in lung cancer.

 

Scott Brown joins Avatar in fight again health reform devil

A little game of connect the Globe dots.

1)     With Sen. Scott Brown at this side, Arizona Sen. John McCain sought to out-Bible his Tea Party challenger by defining himself as the Senate’s devil hunter. From the Globe:

“Scott and I just returned from trying to do the Lord’s work in the city of Satan,’’ McCain said. He called the health care plan “unsavory, Chicago-style sausage making,’’ and said, “We’re going to fight, and fight, and fight.’’

In the meantime, McCain’s opponent unleashed an ad in time for the Oscars that cast the former presidential candidate as a character from the movie Avatar. According to the ad, McCain is only acting like a conservative.

2)   In the meantime, back in town, about 20 Tea Party protested gathered outside the Liberty Hotel fundraiser featuring House Speaker Nancy Pelosi. They railed against the Democrats’ health reform plan with Mass General as a backdrop.

3)   Meanwhile, the storied hospital was coping with a letter from the Medicare program, which, during a recent inspection found problems with the quality of care, including one that “constitutes a serious and immediate threat to the health and safety of patients.”

4)     And, the state’s insurance companies want more money to pay for that care. From the Globe:

 Three weeks after Governor Deval Patrick warned that his administration might turn down health insurance premium increases it deemed excessive for individuals and small businesses, insurers have asked the state to approve rate hikes of 8 to 32 percent for April 1.

 

 

 

Evolutionary biology wins Nobel for Harvard’s Szostak, et al.

Mass Life Sciences Center photo
Mass Life Sciences Center photo
From the AP Wire

The trio (Szostak, Elizabeth Blackburn, Carol Greider) solved a big problem in biology: how chromosomes can be “copied in a complete way during cell divisions and how they are protected against degradation,” the citation said.

It said the laureates have shown that the solution is to be found in the ends of the chromosomes — the telomeres — and in an enzyme that forms them. Telomeres are often compared to the plastic tips at the end of shoe laces that keep those laces from unraveling.

“The discoveries by Blackburn, Greider and Szostak have added a new dimension to our understanding of the cell, shed light on disease mechanisms, and stimulated the development of potential new therapies,” the prize committee said in its citation.

This from Szostak’s 2008 podcast from Scientific American.

 Sci Am : What exactly does somebody who is studying origins of life do that a regular old evolutionary biologist does not do when they are doing their research?

Szostak: Well, what we’re really trying to understand his how molecules can get together and start to act in a Darwinian fashion, so we’re talking about the origin of cellular systems that can evolve, which is completely different from the way the chemicals interact with each other.

Steve: How is it different?

Szostak: Well, chemical reactions are, you know, controlled by the thermodynamics of chemistry by kinetic considerations, but Darwinian evolution is completely different because in our case we are talking about populations with variation and the selection of variants that are more fit, and it’s that[‘s] it’s repeated and repeated; then better variants come to dominate the population. We just don’t have that kind of cyclic feedback system in a simple chemical reaction.