Tag Archives: Pharmacy

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Controlling hypertension: Do electronic pill bottles and text messaging work?

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Only half of the 77.9 million adults in the United States with high blood pressure have their condition under control. By 2030, it is estimated that the prevalence of hypertension will increase 7.2% from 2013 estimates. High blood pressure was listed as a primary or contributing cause of death in about 348,102 of the more than 2.4 million U.S. deaths in 2009.

The risks increase as blood pressure rises, whether you have high blood pressure or a normal blood pressure. Between the age of 40 and 70, for every rise of 20 mmHg systolic or every 10 mmHg diastolic, the risk of heart disease and stroke doubles.

As shown in the Framingham Heart Study, high blood pressure is more common with age. In that study, 5,300 participants were divided into three age groups: younger than 60, 60-79, and 80 or older. The blood pressure percentages for each age group were 27% in the younger than 60 group, 63% in the 50-79 group, and 74% in the 80 and older group.

A major factor in uncontrolled hypertension is patients’ failure to consistently take their medications.

Researchers from Penn Medicine tested new tactics, including text messaging and remote monitoring via an electronic pill bottle to test adherence. They found that although each method appeared to keep medication adherence high, neither method seemed to drive down blood pressure levels.

About 150 patients who took medication for their high blood pressure across four Philadelphia primary care practices participated in the study and were split into three groups: group 1 received standard of care; group 2 received electronic pill bottles that monitored their medication adherence, and group 3 received automated text messages asking about medication adherence. Groups 2 and 3 also received daily text messaging prompting them to take their medications.

The electronic pill bottles recorded every time they were opened and transmitted that data to the researchers using Penn Medicine’s Way to Health automated technology platform. Each day, participants received one of two text messages either congratulating them for taking their medication the previous day or acknowledging that they hadn’t taken their medication the previous day. Both messages featured a reminder to take the medication that day.

Participants using two-way text messaging were asked to respond “yes” or “no” to whether they had taken their medications. Automated messages also either congratulated them for taking their medication the day before or acknowledged that they hadn’t.

Adherence to medication was found to be high among participants, both near 80%. Despite the extra methods employed, the researchers found that both blood pressure levels and rates of adherence to blood pressure medications remained similar to patients in the control group.

Participants’ blood pressure levels might not have improved because of non-adherence, but it is also possible that the participants may have needed higher doses of their medications or new medications.

Shivan Mehta, MD, MBA, associate chief innovation officer at Penn Medicine, an assistant professor of medicine, and lead author of the study, is now testing the social support factor in a new trial that also offered blood pressure cuffs and remote monitoring to patients. This new study also nudges clinicians to consider dose escalation or additional medications.

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Collaboration in healthcare: Beyond the silo

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Silos are a common sight in the farmlands of the world, but what about the silos we inhabit as healthcare clinicians, researchers, academicians, and administrators?

Individually and collectively, why do we wall ourselves off at the expense of advancement and discovery? What would happen if the silos disappeared? What kind of collaborations might result and how would the face of medicine and healthcare change?

APRNs and MDs

Historically, nurses have been at the beck and call of physicians, relegated to tasks previously identified as “non-professional.” Recently, the separate silos of nurses and doctors have become less pronounced, allowing for increased trust, collaboration, and shared practice.

The rise of advanced practice nurse (APRN) autonomy, especially here in the United States, has put nurse practitioners more on par with physicians. And as the Doctor of Nursing Practice (DNP) terminal degree becomes de rigueur and an increasing number of APRNs earn their DNP, parity of training and education with doctors becomes more robustly realized.

Moving APRNs from working under the direct supervision of physicians to a place of autonomous practice allows these nurses with highly advanced training to come out of the old-school nursing silo into the realm of being highly valued providers in their own right.

In this respect, a bridge has been built for APRNs who can now coexist in a much broader field of knowledge that links them on many levels to their physician colleagues. Additionally, the advent of nursing research and science has allowed RNs more autonomy, with an increase in respect for the knowledge and skill they bring to the table.

Healthcare Innovation

Tech-oriented innovation in healthcare is a bellwether of the changes afoot in the 21st century. While 20th-century tech appeared to be siloed away in its own universe, various factors have led to healthcare providers themselves having more of a hand in the rise of new technologies.

First, professional healthcare providers now have the means to harness computing power in the development of innovative ideas. Using 3-D printers, user-friendly design software, and other new technologies, there are healthcare providers who can themselves choose to launch collaborative efforts for a plethora of relavant applications.

Around the world, healthcare entrepreneurs — including nurses — are creating startups where the fabrication of prototypes and the bringing of new hardware and software to the market is increasingly feasible for those with bold ideas.

Whereas new bedside tech was previously generally developed in research labs by non-clinicians and then beta-tested with actual nurses, we now see more nurses involved long before the prototypes are created; this saves resources and brings nurses’ knowledge to bear from the start, rather than once the design decisions have been made by someone unfamiliar with what nurses actually do.

Medical innovation is now being fueled by both academics and non-academics, who bring more parties to the table, avoiding the silo mentality that keeps us separated and mistrustful of our multidisciplinary colleagues.

Creativity and Multidisciplinary Innovation

When we bring academics, clinicians, researchers, and others to the table for conversations that have the potential of leading to new collaborative efforts, much creativity can result. When a nurse has an MBA, for instance, they can speak knowledgeably about healthcare economics and have the opportunity to truly collaborate with those on the financial end of healthcare delivery.

If nursing and medical students are trained in tandem during portions of their studies, it can bring about increased trust, the willingness to listen, and open-mindedness. For nurses and physicians, a mutual valuing of each profession’s contributions, skills, and knowledge can lead to powerful outcomes that benefit everyone, including patients, the true end users within the healthcare milieu.

Silos keep us separate, but breaking down the walls brings us together and opens the door to new ideas and solutions to problems. If we continually challenge ourselves to “reach across the aisle” (to borrow an overused political term) towards those with differing viewpoints and backgrounds, we create an environment where listening, respect, and true partnership result.

The increased understanding and acceptance of homosexuality, new forms of gender identity, and the expanded roles of women are examples of the deconstruction of silos that have long thwarted the attainment of a more just human society, even as discrimination, racial supremacy, homophobia, and other human ills are still alive and well.

We may have a long way to go, but we can draw interesting parallels between such aforementioned close-mindedness and how pushing back against it can benefit the collective good.

When physicians stop judging nurses and allow them to practice to the fullest extent of their license, everyone wins. When clinicians are brought to the design table for new software or hardware, that collaborative effort subverts the old silos that long kept us apart.

At this point in history, we can clearly see that silos do little or nothing for the innovative spirit of healthcare.

Thus, the more we emerge from our silos and see others for who they truly are and what they might contribute to the conversation, countless unforeseen benefits will emerge. So, exit your silo and see what the future can bring.

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Study provides new insight into the decline of older brains

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Although there have been many reports over the last 100 years of age-related differences in cognitive functioning, there is still considerable controversy about the age at which cognitive decline begins.

Many interventions currently target adults 60 years of age and older. However, if people start to decline when they are in their 20s and 30s, a large amount of change will likely have already occurred by the time they are in their 60s and 70s.

More than 16 million people in the United States are living with cognitive impairment. Of adults with perceived cognitive impairment in five states, 49-66% were aged 50 years or older. The number of Americans over the age of 65 is projected to more than double in the next 40 years, increasing from 40.2 million in 2010 to 88.5 million in 2050.

Although age is the primary risk factor for cognitive impairment, other risk factors include family history, education level, brain injury, exposure to pesticides or toxins, physical inactivity, and chronic conditions such as Parkinson’s disease, heart disease and stroke, and diabetes.

As people age, their ability to perform tasks may be impaired not just because they can’t remember but because they are unable to suppress other memories that are irrelevant. A recent study showed that some older adults who had no noticeable cognitive problems had a more difficult time separating irrelevant information from what they needed to do than younger people.

According to Susan Courtney, a cognitive neuroscientist at Johns Hopkins, some memory problems are more a matter of retrieving the correct information at the right time to solve the problem at hand rather than a matter of specific memory.

The researchers gave a mental arithmetic task to 34 young adults (18 to 30 years of age) and 34 older adults (65 to 85 years). Brain activity was measured through magnetic resonance imaging (MRI). The task compared the participants’ ability to inhibit irrelevant information automatically retrieved from long-term memory.

They were asked to indicate whether a proposed solution to an addition or multiplication problem was correct. The math examples would create interference as participants considered the right answer because although they should answer “incorrect,” the proposed solution seems correct at first glance, based on long-term memories of basic math (ie.8×4=12 or 8+4=32).

Such interference did not occur if participants were asked to answer false equations like 8×4=22. To make the task even more difficult, researchers asked the participants to switch to multiplication after they saw the addition symbol and vice versa.

Also, older adults were a little slower at answering the questions than younger participants, especially when there was interference. However, in the brain scans of older adults, those who had more difficulty with interference also had more frontal brain activation than young adults.

Brain imaging of some of the older participants revealed that fibers connecting the front and back of the brain had been damaged, likely by time. On the other hand, some of the older adults had fibers like the young adults. The greater the integrity of the fibers, the better participants’ task performance.

Despite functioning memories, researchers saw other differences. During the complicated and tricky parts of the task, those with the strongest brain fiber connections counterintuitively performed even better as if challenging the mind made the most agile minds even more so. According to Courtney, without good connections between brain networks, there will be interference.

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Safety issues and trackability in personal care product packaging

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There are already certain concerns we have about quality when purchasing personal care products, but there are also several safety concerns pertaining to the manufacturing and packaging of these products.

Personal care products may be referred to as “cosmetics” by law, but they consist of much more than fragrance and makeup products. Cosmetics can refer to everything from body wash and shampoo to toothpaste and skin lotions. While millions of consumers use personal care products on a daily basis, there are certain safety measures that they often lack that put consumers at risk.

Less Tracking Regulation

Unlike personal hygiene products, the FDA doesn’t have any safety testing requirements for the ingredients used to make personal care products. In fact, the federal law in place to keep these products safe has remained relatively unchanged since its implementation in 1938.

Cosmetic companies don’t even need to register with the FDA, implement good manufacturing practices, submit any ingredient statements, make safety records accessible, or report any adverse events such as instances of hospitalization. The FDA is also unable to quickly suspend all production or initiate a mandatory recall of contaminated products if a company doesn’t engage in a voluntary recall.

Conversely, manufacturers of prescription drugs, over-the-counter drugs, medical devices, and food must adhere to FDA regulations and requirements.

Packaging That Isn’t Tamper-Proof

Another problem with personal care products is that there aren’t any sufficient tamper-resistance measures in packaging. This could leave products vulnerable to contamination and present a hazard for consumers.

Most other consumer products are required to have tamper-proof packaging to prevent product theft or contamination, including childproof caps, proper sealing, and other measures.

The Personal Care Products Safety Act

In an effort to make personal care products safer for the general public and modernize FDA regulations, legislators have introduced a bipartisan bill, the Personal Care Products Safety Act. This act would require companies to make sure all their products are safe prior to marketing them. It would also supply the FDA with the tools needed to keep the public safe.

Introduced by Sens. Susan Collins, R-Maine; Dianne Feinstein, D-Calif; and Rep. Frank Pallone, D-N.J., the bill proposes certain changes to give the FDA authority to oversee various aspects of personal care product safety, which include:

  • On an annual basis, the FDA would perform a safety review for five different contaminants and ingredients, including chemicals that release formaldehyde, along with long-chained paraben, diazolidinyl urea, diethyl phthalate, and quaternium-15.
  • Companies will need to register their facilities.
  • Companies will need to disclose all ingredients they use to the FDA.
  • The FDA could inspect records and factories.
  • Companies will be required to report any serious adverse events to the agency within 15 days, including hospitalization, disfigurement, or death. Health effects that may result in hospitalization without early intervention would also need to be reported.
  • The FDA may initiate mandatory recalls of products presenting a danger to the public.
  • The FDA may force companies to implement specific warnings and labels for products containing ingredients that are unsuitable for certain individuals.

With these changes made to FDA authority, cosmetics manufacturers would need to comply with FDA regulations like many other industries. To further prevent contamination or improper use and make sure that products meet FDA standards, tamper-proof packaging would also be more crucial.

Improving Safety for Personal Care Products

With the help of the new act, the FDA would be able to ensure that companies adhere to safety standards that are already in place for myriad products. As a result, consumers would also be more comfortable in knowing that their products are consistently safe for consumption, while companies will be encouraged to develop solutions that maintain quality and minimize the potential for faulty or dangerous products.

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Study: Fluoride may decrease liver, kidney function in adolescents

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No one debates the many dental benefits of fluoride. They are widely established and scientifically backed. But in recent years, concerns have been raised regarding the appropriateness of the widespread addition of fluoride to drinking water and salt in North America.

Now, a study published by Mount Sinai researchers in Environment International asserts that fluoride exposure may lead to a reduction in kidney and liver function among adolescents.

The study examined the relationship between fluoride levels in drinking water and blood with kidney and liver health among adolescents. The group of young people was participating in the National Health and Nutrition Examination Survey, a group of studies that assess health and nutritional well-being in the United States.

The findings showed that exposure to fluoride might contribute to changes in kidney and liver function among youth in the United States, where 74% of public water systems add fluoride for dental health benefits. Fluoridated water is the primary source of fluoride exposure in the U.S. The findings also suggest that young people who have poor kidney or liver function may absorb more fluoride in their bodies than their healthy peers.

This subject is important to study because a child’s body excretes only 45% of fluoride in urine via the kidneys, while an adult’s body clears it at a rate of 60%, and the kidneys accumulate more fluoride than any other organ in the body. These facts are courtesy of the study’s first author Ashley J. Malin, Ph.D., postdoctoral fellow in the Department of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai.

“This study’s findings suggest that there may be potential kidney and liver health concerns to consider when evaluating fluoride use and appropriate levels in public health interventions,” said Dr. Malin. “Prospective studies are needed to examine the impact of chronic low-level fluoride exposure on kidney and liver function in the U.S. population.”

This study’s findings, combined with other previous studies of childhood exposure to higher fluoride levels, show there is a dose-dependent relationship between fluoride and kidney and liver function. The findings, if confirmed in other studies, suggest it may be important to consider children’s kidney and liver health in drafting public health guidelines in the future.

Potential health side effects include renal system damage, liver damage, thyroid dysfunction, bone and tooth disease and impaired ability to metabolize protein.

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Viral infections among organ transplant recipients may be influenced by gut microbiome

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A study recently presented at the American Transplant College shows that the gut’s microbiome plays a significant role in whether a transplant recipient will develop a viral infection of not.

“Our results confirm and extend the novel association between the gut microbiome and the development of viral infections from stem cell transplant recipients to solid organ graft recipients,” Dr. John Lee and colleagues wrote in the abstract. “Altogether, these findings support targeting the gut microbiota as a strategy to prevent and/or treat viral infections.”

Dr. Lee works in the division of nephrology and hypertension at Weill Cornell Medicine in New York. His collaborators were infectious disease specialists from the Sloan-Kettering Cancer Center.

“Recent studies suggest that the gut microbiome plays a critical role in protecting its host from infections beyond Clostridium difficile,” Dr. Lee wrote. “Notably, butyrate-producing bacteria may be beneficial to gut health and have recently been associated with lower rates of respiratory tract infections in bone marrow transplant recipients.”

In the study, researchers looked at the relationship between butyrate-producing gut bacteria and the future development of viral infections in kidney recipients. Samples were collected from 115 kidney recipients two weeks following transplantation surgery.

Researchers said they profiled the gut microbiome using 16S rRNA gene-deep sequencing of the V4-V5 hypervariable region. The next step was determining the likelihood of patients with less than 1% relative abundance of butyrate-producers developing one of three very common viral infections within two years of transplantation. The viruses were BK viremia, cytomegalovirus viremia and respiratory tract (RV) infections.

The patients who had a low abundance of butyrate-producers were at significantly increased risk for developing RV infections than those who had a high abundance of butyrate-producers. Of the 115 individuals studied, 23 patients developed RV infections while 22 developed BK viremia and 15 developed CMV viremia; Fifty developed at least one out of the three.

The study results indicate the need to monitor the risk of infection closely in both solid organ transplant recipients and stem cell recipients, researchers say.

Along with viruses, solid organ recipients are also at greater risk of contracting a Clostridioides difficile infection. The illness is caused bybacteria that causes bloody diarrhea and other intestinal complications. It poses greater risks for solid organ recipients.

A team of researchers from Columbia University Irving Medical Center in New York discussed the prevalence of CDI in solid organ transplant patients during the American Transplant College. Of 2.622 recipients, 8.5% experienced CDI within a year of transplant.

Of those cases, 64% were considered severe. Pancreas recipients had the highest rate of CDI at 12.5%. Lung, liver, heart and kidney followed in that order. The media time of transplant to CDI was 56 days, and nearly 30% of patients had recurrent CDIs.

All patients had a twofold increase in the chance of death. Since CDI is especially dangerous for solid organ recipients, researchers indicated “Novel strategies to prevent and effectively treat CDI in SOT are urgently needed,” in the abstract.

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Preventing chronic pain in lab mice

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According to data from the 2012 National Health Interview Survey, within a previous three-month period, 25 million adults in the U.S. had daily chronic pain, and 23 million more reported severe pain. Of those in pain, 27% suffer from lower back pain, 15% from severe headache or migraine pain, and 15% from neck pain.

In the U.S., chronic pain affects more people than cardiovascular disease, cancer, and diabetes combined.

Neuropathic pain persists after the initial injury has healed. The condition is notoriously resistant to treatment, with a prevalence of 7 to 10% in the general population.

When pain is chronic, signaling persists over time and can lead to biochemical changes in the nervous system. Options for treating chronic pain include oral (nonsteroidal anti-inflammatory drugs, acetaminophen, opioids) and topical therapies (ointment, cream, or patch applied to skin).

Other options include physical therapy, exercise, acupuncture, relaxation techniques, and psychological counseling. In a 2006 survey, more than half of chronic pain sufferers felt they had little or no control over their pain.

Effective drugs against chronic pain are not necessarily forthcoming. However, researchers have recently identified a protein as a future potential target for medicinal drugs.

Assistant professor Mette Richner is employed at the Department of Biomedicine and the DANDRITE research center of Aarhus University in Denmark. Richner, who began on the project as a Ph.D. student in professor Anders Nykjaer’s group, subsequently completed the project as a postdoc in associate professor’s Christian B. Vaegter’s research group.

According to Richner, once nerve damage has occurred, and the nerve cells go into overdrive, molecules are released, which start a domino effect that ultimately triggers pain. The domino effect can be inhibited by a molecule in the spinal cord called neurotensin, and her studies show that the neurotensin is captured by sortilin, so that the brake is itself inhibited. The protein sortilin is expressed on the surface of nerve cells and plays a role in pain development in laboratory mice.

Studying the pain-related puzzle in relation to the spinal cord arose from decades of research in both pain and sortilin. The initial studies involved mice that lacked the ability to form sortilin and were pain free despite nerve damage.

The researchers determined that normal mice also did not develop pain after nerve damage when the researchers blocked sortilin, ultimately explained by the regulation of the pain-inhibiting molecule neurotensin.They hope that investigations will continue to investigate whether it is possible to block sortilin locally in the spinal cord, so that the neurotensin can move freely and get the brake to function, thereby inhibiting the pain.

Vaegter speculates that although the research has been carried out on mice, some of the fundamental mechanisms are similar in humans and mice, providing an explanation of what is happening in people suffering from chronic pain.

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Noise: An invisible danger in sports and recreation

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While most people wouldn’t think twice about wearing hearing protection at a noisy workplace, it’s easy to forget that noise can be equally damaging when we’re at play.

As we leap into summer, let’s take a quick look at the sound level of our recreational activities.

Recreational activities with dangerous noise levels

Many things we do for leisure can put us at risk for noise-induced hearing loss. Dangerously high noise levels are inherent in sports involving ATVs, motorcycles and snowmobiles.

Interestingly, excessive noise isn’t always just produced by the machinery being used. For example, in motorcycle riding, the sound generated by the wind against the helmet can reach dangerous levels. When traveling between 75 and 80 miles per hour, wind noise is around 105 dB, reports hearing expert Brande Plotnick. This level is sustainable for only around four minutes without affecting hearing.

To know how much noise certain devices and equipment generally produce, there are online resources like this comprehensive decibel chart. With apps that can be downloaded to your smartphone, it’s easy to see the decibel level of your recreational activities.

One single explosive sound can damage the delicate hairlike structures of the cochlea in the inner ear, resulting in permanent hearing loss. This is why hearing protection is a must for anyone who fires guns for sport.

The best type of protection will depend on the type of shooting you do, note Michigan-based hearing professionals in their blog. Options include muff headphones, which keep sound from reaching the cochlea; in-the-ear foam plugs with a Noise Reduction Rating (NRR) of 30 or more; combining the aforementioned for double protection; and, finally, electronic noise-cancelling headphones that allow a conversation to be heard but cancel the transient sounds of gunfire.

Maybe you don’t fire guns or always use protection at the firing range, but what about exposure to firecrackers and fireworks, which can exceed 150 dB?

Who goes to see the Fourth of July fireworks with hearing protection? Well, taking into account these helpful tips for enjoying your Independence Day fireworks without damaging your (or your child’s) hearing — we all should.

As stadiums compete to be the loudest, spectators need to beware

Even when we’re not participating at sport, we need to exercise care with our hearing.

The loudest spectator sport on the chart is stock car races, which sustain levels of 130 decibels near the track and 100 in the stands. While a great part of the excitement of auto racing is hearing the roar of the engines, Indianapolis Motor Speedway President Doug Boles has become an advocate for protecting the hearing of fans. With his own hearing in jeopardy, he urges people in this newscast before this year’s Indy 500 to bring hearing protection or purchase it at the race.

Yet spectators of other less noisy sports also need to exercise caution as the stadiums compete to be the loudest — at times exceeding 130 decibels.

“We’re really up against it with these sports stadiums pushing the crowd to be louder and louder, trying to be the loudest stadium,” confesses audiologist Tracy Winn. “Unfortunately, people like it! There’s truly a physical reaction to dangerous levels of noise, it stimulates vestibular system and people like it.”

In a fun blog listing the loudest events ever recorded on a decibel meter, we learn that Seattle Seahawks fans broke the Guinness Book record for world’s loudest stadium in 2013 when they reached an astounding 137.6 dB. In college sports, Kansas Jayhawks basketball fans generated 130.4 dB of crowd noise and hold the official record for indoor crowd noise.

Winn notes that such decibel levels or those posted on stadium boards to encourage fans are peak levels when everyone’s cheering, so they aren’t sustained very long. But here’s the catch — when you are up over 100 decibels, you can be exposed to it a very short time without causing permanent damage.

Exposure time and volume: the magic equation

So, what’s a dangerous noise level? As Winn suggests, there’s a clear equation for how long the ear can endure loud noises before permanent damage can occur.

Damage is linked to exposure to loud noise over time. There’s a magic number between duration and level — 85 decibels is the limit for eight hours of exposure in each 24-hour period per standards set by National Institute for Occupational Safety and Health (NIOSH). Beyond that level, if you’re an employee, you need hearing protection.

The problem is the decibel scale isn’t linear — for every three-decibel increase, the time you can be exposed without protection is cut in half. For example, as you get up to 88, exposure time is cut to four hours. At 91 decibels you are only good for two hours.

Checking this noise dose chart, you can see that the maximum exposure time for the 130 to 140 dB level, like that reached at the record-making stadiums, is less than one second per 24-hour period. What’s more, for children, the World Health Organization (WHO) recommends no exposure above 120 dB. You can bet there were a few children attending those events.

“We know that excessive noise exposure over time will cause hearing loss, yet since there is a genetic component there’s no standard rate at which noise-induced hearing loss develops,” explains Audiologist Jennifer Phelan. “Additionally, the effects are cumulative.”

Protect your hearing from permanent damage

It’s never too late to begin to protect your hearing, assures Phelan. Saving your hearing boils down to three basic actions: use protection, distance yourself from the sound and reduce the sound level.

When possible, move away from the sound source. By doubling your distance, you reduce the decibel level by 6 dB, given that there’s no echo, according to the Dangerous Decibels site. If you experience 90 dB at 10 feet, the decibel reading will go down to 84 when you’re 20 feet from the sound source.

Phelan believes that not enough is being done to encourage adults to wear hearing protection. As you can imagine, there are many products available — some geared towards work environments while others are clearly targeting young concert- and party-goers.

If you’re at home and can turn down the sound on whatever device you’re using for entertainment, great. But if you’re going out to be entertained, best carry hearing protection with you — and use it.

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Court’s blockage of liver-sharing policy sparks conflict

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A plan intended to correct regional inequities among liver transplant recipients is on hold after a lawsuit to block its implementation was filed by transplant centers in the South and Midwest.

The United Network for Organ Sharing (UNOS) has worked to create a new way of distributing organs since 2012. The plan calls for the most critically ill patients within a set geographic parameter to receive organs first. For example, if a liver became available in Nashville, the sickest patient within a 500 nautical-mile radius would receive it.

For years, organ distribution has been carried out within 11 geographic areas. Each area maintained its own waiting list and when a liver became available, the sickest patient within the region received it.

UNOS has worked for years to revise the organ distribution system. Waiting lists on the coasts and in urban centers have always been longer than those in rural areas. Consider that the waiting list at Vanderbilt Medical Center in Nashville has about 171 patients, while the one at the University of California’s San Francisco Medical Center has more than 750.

Yet each center performs roughly 140 transplants each year. Plus, organ donation rates in the South and Midwest tend to be higher than those in more populated areas. The system also allows patients with more resources to work the system. Steve Jobs once bought a house in Memphis so he could join Tennessee’s waiting list, which is much shorter than California’s where his primary residence was located.

Transplant centers in less populated areas fear the proposed change will allow big-city centers to poach from their supply of organs. That’s why the proposal has created something of a turf battle among urban and rural transplant centers.

It’s not just patient care that concerns rural transplant centers. Transplants are extremely lucrative for the hospitals that perform them. According to a consulting firm, a single liver transplant results in $800,000 in billed charges. Dr. Seth Karp, director of Vanderbilt Medical Center’s program says the change could force smaller programs to close or scale significantly back.

“If the program in Mississippi closes, if the program in Iowa closes because of this, that’s a real national public health problem,” he said.

To keep the distribution from going into effect, transplant centers in the South and Midwest filed suit in late April. A temporary restraining order was denied on May 13, but a U.S. district judge issued a cease and desist order upon appeal. That means organs continue to be distributed within the 11 geographic regions until the case is taken up in court again.

UNOS has always maintained the new distribution method will save lives.

“This is good news for the sickest candidates waiting for livers,” said Brian Shepard, CEO of UNOS, in an interview with NPR. He said 100 additional lives would be saved each year with a more efficient distribution method. “Targeting the livers towards those folks who are really the most critically ill will result in fewer people dying on the waiting list.”

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What’s next for association health plans after federal judge’s ruling?

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U.S. District Court Judge John D. Bates found that the Department of Labor’s issuance of a final rule last June 19 that lets groups of small businesses offer association health plans (AHPs), are “clearly an end-run” around the 2010 Affordable Care Act’s consumer protections that became law under President Obama. Kev Coleman, president and founder of AssociationHealthPlans.com, disputes Judge Bates’ ruling.

“The new study on chamber of commerce association health plans painfully illustrates the insurance gains that will be lost to small businesses if the recent court ruling is not overturned,” Coleman said in a prepared statement. “Should the ruling stand, we will return to the prior unfair system where large companies will pay less than small companies for the same health benefits.”

The study, “Chamber of Commerce Association Health Plans Building Political Bridges While Refuting Opposition,” finds, in part, that: “Through the new Department of Labor regulation, the same large company insurance model that already covers roughly 95 million Americans was made available to small businesses through associations. This change has been a matter of market access. The definition and rules related to large company health insurance have not changed. Instead, the playing field between small companies and large companies was leveled with respect to health insurance costs.”

An improved and more level field of play between large and small companies regarding the prices of health insurance is less than meets the eye, though, according to David I. Levine, a professor of law at University of California Hastings, where he teaches civil litigation and remedies.

“It looks as if the federal judge was on very solid legal ground in rejecting the labor department regulations,” he told MultiBriefs via email. “If the administration wants to make the necessary changes to allow these plans, the changes must be done through legislation approved by Congress.”

That branch of government, not the White House, must deliberate and legislate AHP changes.

Anthony Wright, head of Health Access California, a statewide healthcare consumer advocacy coalition, also agrees with Judge Bates’ action. “In California, we have already banned so-called short-term plans and have put strong standards for association health plans,” Wright told MultiBriefs in an email interview, “but it benefits our whole health system to prevent these junk plans at the federal level. These substandard plans not only trap people in junk insurance that may not cover them when they need it, but also destabilize the overall market and raise premiums for the rest of us.”

America’s Health Insurance Plans (AHIP), a political advocacy and national trade association, declined a MultiBriefs request to comment on Judge Bates’ recent ruling. However, after the DOL finalized its AHP rule in June 2018, the AHIP did comment on possible outcomes.

“We remain concerned that broadly expanding the use of AHPs may lead to higher premiums for consumers who depend on the individual or small group market for their coverage,” Kristine Grow, AHIP senior vice president of communications, said in a statement.

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