Philadelphia woman tries passing fake scripts at Palmer pharmacy

PALMER TWP., Pa. – A Philadelphia woman is facing fraud charges after she allegedly arrived at a Northampton County pharmacy Wednesday night with fake prescriptions for more than 200 pills.
Police arrested Samantha M. Brown at a Palmer Township Rite Aid with fraudulent prescriptions for Oxycodone, Alprazolam and Flexiril. The 25-year-old now faces three felony counts of trying to acquire a controlled substance. District Judge James Narlesky arraigned Brown late Wednesday night, setting bail at $7,500.
Palmer Township police were dispatched to the Rite Aid at 601 S. 25^th St. about 8:30 p.m. The pharmacist told officers that a woman later identified as Brown was sitting in the waiting area, according to court records.
The pharmacist said she tried filling prescriptions for 120 30 mg tablets of Oxycodone, 60 1 mg tablets of Alprazolam and 30 10 mg tablets of Flexiril. Alprazolam is an anxiety medication, and Flexiril is a muscle relaxant.
The prescription was in another person’s name, and the pharmacist told police that she confirmed with the doctor listed on the script that it was a fake. A search of the doctor’s name listed in the criminal complaint shows a physician in Williamsport, Lycoming County.
The doctor notified the pharmacist that the prescription was not filled out in the manner he usually writes scripts and that the person listed on the prescription was not a patient.

Read More: http://snip.ly/q0s14#http://www.wfmz.com/news/lehigh-valley/philadelphia-woman-tries-passing-fake-scripts-at-palmer-pharmacy/654023244

Study finds link between increased brain glucose levels and Alzheimer’s

A new study published yesterday in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, found a link for the first time between abnormalities in the mechanism of glucose breakdown in the brain and the severity of tangles and amyloid plaques in the brain, as well as the commencement of visible symptoms of Alzheimer’s disease.

Credit: Juan Gaertner / Shutterstock.com
This National Institute on Aging-supported study analyzed the brain tissue samples at autopsy from participants involved in the Baltimore Longitudinal Study of Aging (BLSA). BLSA, which is one of the world’s longest-running scientific studies on human aging, records neurological, psychological as well as physical data of participants over many decades.
In the study, glucose levels in various areas of the brain, such as the temporal and frontal cortex that are prone to Alzheimer’s disease pathology as well as some resistant areas like the cerebellum, were evaluated.
The researchers investigated three different categories of BLSA participants during the study — (a) participants with Alzheimer’s symptoms throughout life and with confirmed pathology of Alzheimer’s disease, including neurofibrillary tangles and beta-amyloid protein plaques in the brain at the time of death; (b) those who lacked symptoms throughout life, yet had notable levels of Alzheimer’s pathology identified during the brain post-mortem; and (c) healthy controls.
The findings indicated discrete abnormalities in glycolysis, which is the major process involved in the breaking down of glucose in the brain, and provided evidence associating the severity of the abnormalities with the severity of the disease pathology.
Poorer glycolysis rates and increased levels of brain glucose were linked with more severe tangles and plaques in the brains of people affected with Alzheimer’s. Also, the more serious declines in brain glycolysis were associated with the manifestation of disease symptoms like memory issues during life.
Richard J. Hodes, M.D, the NIA Director, commented that this kind of research initiates novel ideas on how to investigate the connections between glycolysis, symptoms, and the disease pathology in escalating the search for better and more effective treatment and prevention methods for Alzheimer’s disease.
Even though the likenesses between Alzheimer’s and diabetes had been suspected for a long time, an evaluation of the link has remained difficult, as insulin is not required for the entry of glucose to the brain or to the neurons.
Glucose used by the brain was tracked by calculating ratios of the amino acids serine, alanine and glycine to glucose, which allowed the assessment of rates of the vital steps involved in glycolysis.
The researchers identified that in comparison with samples of normal brain tissue, the enzyme activities that controlled those vital glycolysis steps were lesser in Alzheimer’s cases.
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Putting an effective complaint and recall management system in place

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of their users.
In the context of medical devices; complaints are any communication made in writing, electronically or in verbal form about any of these aspects of a medical device after its release for the purpose of distribution: identity, quality, durability, reliability, safety, effectiveness, or performance
FDA and ISO standards

The FDA has a very clear and well-defined set of regulatory guidelines on complaint handling in the field of medical devices. These are set out in FDA 21 CFR 820.198. The FDA requires medical device companies to also comply with ISO 13485:2016 Section 8.2.2., which suggests what document procedures to put in place to ensure timely handling of complaints in a compliant manner. Just how seriously the FDA takes complaint handling can be gauged from the fact that deficiency in complaint handling is one of the top reasons quoted for issuance of 483’s by the FDA.
Although complying with these regulations is a part of regulatory requirements; these regulations only mention what needs to be done in order to maintain a complaint and recall management system; how to do it is left to the individual medical device company. These regulations specify the exact elements of a complaint handling system, such as maintaining complaint files, proceeding about the complaints in a timely manner, documenting verbal complaints, and so on. However, it is up to the medical device manufacturer to implement the complaint handling and recall system in such a manner that it is perfectly streamlined and organized to the point where the complaint is handled exactly in the manner prescribed.
Full learning on how to implement an effective and compliant complaint and recall management system
The ways by which medical device companies can do this to optimize their complaint handling mechanism will be the teaching from a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, who brings more than three decades of experience in Quality and Regulatory management, during which he has implemented and overseen quality system operations and assured compliance, at all companies of all sizes, from start-up to more than $100 million in revenue; will be the Director.

Please visit Putting an effective complaint and recall management system in place to enroll for this seminar and gain thorough understanding of how to put an effective complaint and recall management system in place. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An activity that cuts across many cross functions
Jeff will emphasize the point that complaint handling is a highly coordinated, cross functional area for a medical device company’s Quality System. Almost all niche areas of the medical device company, such as customer service, sales and marketing, Regulatory Affairs, QA, R and D, and Quality Engineering, are involved in complaint handling. This makes the need for orchestrated coordination and synchrony between these departments a must, for if the complaint handling mechanism is not well lubricated; it is bound to make the complaint handling act a failure, inviting all the undesirable penal actions from the regulatory and enforcement agencies.
John will highlight the role and importance of each of these functions in complaint handling. In these, activities relating to defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications, will be discussed in detail.
Distinguishing between complaints and “non-complaints”
He will also explain what constitutes a complaint, and will suggest recommended practice on the ways of handling “non-complaint” feedback. He will also show how to apply risk management to a complaint handling system, and explain a specific risk management system to drive home this point.
A substantial part of this seminar will be spent on making a streamlined review of the regulations, at which the critical process requirements for compliance with the regulations will be examined in detail. Jeff will offer straightforward and compliant recommendations for the methods of documentation relating to complaint records, root cause investigations, and corrective actions, and show how to apply risk management principles to complaint investigation.
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The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.
In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

Nobel prizes 2017: everything you need to know about circadian rhythms

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder
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Second Death From Flesh-Eating-Bacteria Infection After Hurricane Harvey Is Reported

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.
He is the second person to die from flesh-eating bacteria since Hurricane Harvey struck the Gulf Coast. Two weeks ago, a 77 year old woman died after a fall inside her flooded home in which she cut her arm and subsequently contracted the flesh-eating bacteria.
When the man initially presented to the hospital on October 10th, officials described an infected wound affecting the upper portion of his left arm.

The aggressive and deadly soft tissue infection is formally referred to as necrotizing fasciitis . It’s a rare infection under normal circumstances, but if promptly recognized, diagnosed and treated with the appropriate antibiotics and surgery to remove dead or dying tissue, the majority of patients recover without any serious consequences.

Necrotizing fasciitis, or “nec fasc”, is most commonly caused by Group A Strep , but a mixed infection with anaerobic bacteria including Clostridium may also develop, leading to what is commonly known as gas gangrene. Necrotizing fasciitis causes pain out of proportion in the affected area, relative to the degree of injury.

A cut, scrape, puncture or any break in the skin may serve as a portal of entry for the dangerous bacteria, which then leads to destruction of blood vessels, fat, nerves and a white fibrous covering of the muscle known as the fascia. The infection then proceeds to enter the muscle, compromising blood flow and leading to death of the tissue.
Its important to realize that bacteria don’t actually digest the tissue, but instead produce a deadly toxin that is responsible for the extensive tissue damage.
As the bacteria enter the bloodstream, fever, chills and vomiting may rapidly develop, leading to a dangerous condition known as sepsis which is characterized by low blood pressure, rapid and difficult breathing and confusion.

Early warning signs include severe pain and tenderness in the infected area, spreading redness and warmth and blue to purple skin discoloration, with darkened tissue in the later stages. The presence of gas or air in the soft tissue known as “crepitus” produces a crackling sound or crunching sensation if the area of skin is palpated. An abscess containing pus may also form as the infection becomes more organized.

Necrotizing fasciitis is a surgical emergency. Aggressive fluid resuscitation along with broad spectrum antibiotics must be started promptly with emergent preparation for surgery to remove or debride the affected area in order to contain the infection.
Persons with diabetes, chronic kidney disease and cancer who are receiving chemotherapy are most at risk for complications, due to poor blood supply to skin, muscle and soft tissue from having such chronic conditions.
Flood waters harboring bacteria (from sewage), along with dirty surfaces or debris contacting the victim’s initial cut or injury, likely led to the onset of this aggressive and deadly infection. As a general rule, it’s best to keep all cuts or blisters covered with a dry gauze and waterproof type dressing if there is any potential to come in contact with floodwater or dirty surfaces or debris.
The CDC describes about 700-1,110 cases annually in the U.S., the result of an active surveillance and reporting network that is set up to monitor such aggressive infections.
Cases of typhoid and cholera, invasive and aggressive diarrheal illnesses typically associated with floods in developing countries, never materialized after the hurricane, according to data from the CDC. In addition, cases of tetanus, which can develop from heavily contaminated wounds after soil exposure, have generally not been a concern with such flooding in the U.S., as supported by data from the CDC.
“Necrotizing fasciitis is caused by strep group A (flesh-eating bacteria) or anaerobic bacteria which thrive in areas without oxygen,” said Debra Spicehandler, MD, Co-Chief of Infectious Diseases, Northern Westchester Hospital.  ”Antibiotics are important but swift surgical debridement is necessary. The cases caused by strep release a toxin which can also cause systemic effects and organ failure leading to mortality.”
Read More: http://snip.ly/rjcse#https://www.forbes.com/forbes/welcome/?toURL=https://www.forbes.com/sites/robertglatter/2017/10/25/second-victim-of-flesh-eating-bacteria-after-hurricane-harvey-dies/&refURL=&referrer=

Heart surgery survival chances ‘better in the afternoon’

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.
The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.
And it says the difference is not down to surgeons being tired in the morning.
Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.
The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

• 54 out of 298 morning patients had adverse events
• 28 out of 298 afternoon patients had adverse events
• Afternoon patients had around half the risk of complications
• One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”
He also said it would be impossible for hospitals to conduct surgery only after lunch.
But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”
Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.
Heart health is already known to fluctuate over the course of a day.
The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.
“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

• BBC Body Clock: What makes you tick?
• Body clock scientists win Nobel Prize
• Weekend camping resets body clock

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.
Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard.
“It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion.
June was referring to a revolutionary cancer therapy that he helped bring from lab bench to market. Co-developed with the drug giant Novartis, the therapy, CAR-T, genetically alters a patient’s own immune cells to target and destroy cancer cells.
Recently, in a historic decision, the FDA threw their support behind Kymriah (tisagenlecleucel), a “living drug” that is designed to treat blood and bone marrow cancer in children that, even with aggressive chemotherapy, is often lethal.
An entire process rather than a packaged pill, the therapy harvests a patient’s own immune cells—T cells that patrol and destroy abnormal cells—retrains them with extra bits of genetic code, and turns them into torpedoes aimed at cancerous cells once reintroduced into patients’ bodies.
“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Dr. Scott Gottlieb in a statement, adding that the therapy is “the first gene therapy available in the United States.”
Read More: http://snip.ly/bunjk#http://www.philly.com/philly/business/fda-advisors-give-a-thumbs-up-to-glaxosmithklines-shingles-vaccine-20170913.html

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