A step towards better health care

 

step towardsToday, we live in an era of customization. Increasingly, customers can modify a product’s appearance, features, or content according to their unique needs or desires. Often, even the news we see in our newsfeeds is customized based off our preferences.

Why, then, are so many aspects of the health care industry still one-size-fits-all?

As doctors, we’ve seen firsthand how this can negatively impact patients who require more individualized care. One particular example is a practice known as “step therapy” or “fail first.”

Now, when patients visit their doctors for a prescription, the treatments they are prescribed are typically based on a variety of personal factors. These factors include their health history, underlying symptoms, and their doctor’s long-term understanding of their condition, such as whether they have already tried certain drugs under a different health insurance plan, if they have other medical conditions that might interfere with the drug’s effect, whether certain drug’s side effects will affect the patient’s ability to perform their job, or if the patient would prefer a drug that has a different ingestion method or dosage form. Treatment plans need to be based on the individual’s needs, and their doctors’ medical expertise and first-hand knowledge of their patients’ overall health.

 However, far too often, what happens next is the problem. When a patient goes to the pharmacy to fill their prescription, they may be informed that their physician-prescribed medicine will not be covered unless the patient first proves that another medication-one of the insurer’s choosing, not their doctor-will not work for them.

In such a case as this, failure is not only an option, it is the only option before getting appropriate treatment.

Under the current system, patients are left with a limited set of options: either try a medication that is not what their doctor recommended for their condition, or pay out of pocket for the treatment they need. For many people, that’s not a choice at all. They are simply forced to fail on a medication other than what their doctor prescribed.

Read More: http://snip.ly/3h8ax#http://thehill.com/blogs/congress-blog/healthcare/356083-a-step-towards-better-health-care

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

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The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging population
  • The huge spending power of one of the world’s largest economies
  • The infusion of new technologies into the field of medical devices, which pushes up costs initially
  • The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan1

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan3

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for the various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

Flu vaccine: NHS patients wanted to test ‘universal’ jab

Flu vaccine NHS pa

Researchers are seeking about 500 NHS patients to try out a new “universal” vaccine against seasonal flu.

The experimental vaccine works differently from the one currently available, which has to be remade each year based on a “best guess” of what type of flu is likely to be about.

The new jab targets part of the virus that does not change each year.

This means the vaccine should work against human, bird and swine flu, say the team at University of Oxford.

It will offer people better protection, they believe.

Extra protection

Immunisation is the best defence we have against flu but it is not always effective.

Last winter’s vaccine cut the risk of flu in adults under the age of 65 by about 40%, but barely worked in people over 65, despite being a good match for the type of flu in circulation.

As people age, their immune systems are often weaker and their bodies may not respond as well to a vaccine as younger people’s bodies.

Prof Sarah Gilbert and colleagues believe that using their vaccine alongside the current one could help.

It is the world’s first widespread human testing of such a vaccine, according to the National Institute for Health Research, which is supporting the project.

 

Flu vaccine.jpg

Patients aged 65 or older and living in Berkshire and Oxfordshire will be invited to take part in the trial.

Half of the 500 volunteers will receive the usual seasonal flu jab and a placebo or dummy jab, while the other half with get the regular vaccine plus the new experimental one.

Read More: http://snip.ly/dqyht#http://www.bbc.com/news/health-41467097

Program for parents improves ADHD behaviors in young children

Program for parents improves ADHD beha

A program that focuses on strengthening parenting skills also improves symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in 3-8 year-olds, according to researchers at the at the University of North Carolina at Chapel Hill. FPG scientists completed a rigorous review of evidence that demonstrated the effectiveness of the “Incredible Years Basic Parent Program.”

“Prior research already has shown that this program improves behavior difficulties in young ,” said Desiree W. Murray, FPG’s associate director of research. “This review provides new evidence specifically about its effectiveness for ADHD symptoms.”

Murray explained that not only reported sustained improvements for their children’s ADHD behaviors, but also for their social skills and interactions with peers.

She said effective early intervention is crucial for young children with ADHD, due to the unfavorable short-term and long-term outcomes associated with the disorder.

“ADHD in preschoolers can bring conflict with family members, and it carries elevated risk of physical injuries and suspension or expulsion from child care settings,” Murray said. “Negative trajectories over time can include the development of other psychiatric disorders and difficulties with social adjustment.”

Previous studies have also shown that children with ADHD struggle academically, with lower test scores and higher risk of dropping out of high school.

“We can help to prevent the wide array of negative outcomes that are associated with ADHD,” Murray said. “We believe the most effective intervention approaches may be those that target preschoolers with symptoms of ADHD but who have not yet met the full criteria for diagnosis with ADHD.”

Murray and her team, which included FPG research scientist Doré R. LaForett and UNC doctoral student Jacqueline R. Lawrence, screened 258 studies and narrowed their list to 11 studies that met stringent criteria for rigor and methodology. The evidence—primarily parent reports—showed the effectiveness of the Incredible Years Basic Parent Program for ADHD behaviors in young children. The Journal of Emotional and Behavioral Disorders recently published the results of the team’s review.

The Incredible Years Basic Parent Program is designed for parents of high-risk children and those who display behavioral problems. It focuses on helping parents strengthen relationships with their children, providing praise and incentives, setting limits, establishing ground rules, and effectively addressing misbehavior.

Read More: http://snip.ly/kj65u#https://medicalxpress.com/news/2017-10-parents-adhd-behaviors-young-children.html

 

Man (35) in vegetative state for 15 years ‘showing signs of consciousness’

Man (35) in vegetative

A 35-year-old man who had been in a vegetative state for 15 years is showing signs of consciousness after receiving a pioneering treatment based on nerve stimulation.

In the month since a vagus nerve stimulator was put into his chest, the man, who was injured in a car accident, has begun responding to simple orders that had been impossible before.

The findings reported in Current Biology may help to show that by stimulating the vagus nerve “it is possible to improve a patient’s presence in the world”, according to lead researcher Angela Sirigu of Institut des Sciences Cognitives Marc Jeannerod in Lyon, France.

The researchers say it may challenge the view that a vegetative state which lasts for more than 12 months is irreversible.

“Other scientists have hailed it as “a potentially very exciting finding” but have also urged caution.

After treatment, it was reported the patient could follow an object with his eyes, turn his head on request and his mother said there was an improved ability to stay awake when listening to his therapist reading a book.

The vagus nerve connects the brain to many other parts of the body, including the gut.

It is known to be important in waking, alertness, and many other essential functions.

The patient, who was picked because he had been lying in a vegetative state for more than a decade with no sign of improvement, also appeared to react to a “threat”.

Researchers spotted that he reacted with surprise by opening his eyes wide when the examiner’s head suddenly approached his face.

 

Read More: http://snip.ly/sfxny#http://www.independent.ie/life/health-wellbeing/health-features/man-35-in-vegetative-state-for-15-years-showing-signs-of-consciousness-36173341.html

FDA approves first commercial product for peanut allergy prevention

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The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children.

The Hello, Peanut! introduction kit offers convenience in the form of packets of peanut powder blended with oat given in increasing quantities for seven days, as long as children tolerate it well. After which maintenance packets are recommended for use up to three times a week. The introduction kit is $25, and the maintenance kit sells for $20 for eight packets.

The FDA decision was informed by the landmark Learning Early About Peanut Allergy study published in 2015. It showed that high-risk children who regularly consumed peanut in infancy had far fewer peanut allergies by age 5 than their counterparts who avoided peanut over the same span of time. This understanding led to new guidelines published in 2017 by National Institutes of Health about giving peanut to babies to protect against peanut allergy.

Infants who have severe eczema or egg allergy are considered at high-risk of developing a peanut allergy. By offering peanut early in life – between 4-6 months of age – and continuing with regular consumption, we can prevent the onset of peanut allergy in many of these children. High-risk children should see their doctor before parents introduce peanut protein in any form. The physician may decide to do skin or blood testing.  If the test is negative, age-appropriate peanut products can be given at home. However, if a child tests positive, introduction to peanut is done under clinical supervision. If the child is deemed already allergic to peanuts, the guidelines recommend strict avoidance of peanut and ready access to epinephrine auto-injectors.

Read More: http://snip.ly/ktety#http://www.philly.com/philly/health/kids-families/fda-approves-first-commercial-product-for-peanut-allergy-prevention-20170926.html

6 Ways To Start Improving Your Gut Health Today

Brooke Lark / Unsplash

Considering the rapid rise in kombucha, sauerkraut and probiotic products, it’s pretty clear gut health is on everyone’s minds. And with good reason — more and more research is emerging showing just how important good gut health is for overall wellbeing.

“Having a healthy gut is so important,” accredited practising dietitian and sports dietitian Chloe McLeod told HuffPost Australia.

“It’s linked to a number of different medical conditions. When your gut isn’t healthy it can have an impact on mental health, weight, mood and a number of other digestive disorders. Keeping your gut nice and healthy can help keep the rest of your body healthy.”

Brooke Lark / Unsplash

How do you know if you have good gut health?

“Signs of good gut health include not getting bloating, gas, diarrhoea and constipation,” McLeod said.

“You find you feel better in general — better mood, more energy, a healthy weight and not feeling fatigued. These are all more pronounced when your gut is healthier.”

How do you know if you have bad gut health?

“If you have poor gut health you may have loose, unformed stools, or you’re really constipated, maybe your faeces are foul smelling, you feel gassy, feel foggy headed or have poor mood. These are some of the most common signs,” McLeod explained.

What can negatively affect gut health?

There are a number of diet and lifestyle-related factors which can impact the health of your gut.

“From a nutrition perspective, factors that negatively impact gut health include poor diet, alcohol and having a high fat intake,” McLeod said.

“Also, if you are someone with food intolerances, any large quantity of those trigger foods can have a negative effect on your gut health.

“Being highly stressed all the time impacts cortisol levels, and stress can be a factor for some people. Some medications can also affect gut health.”

 

Read More: http://snip.ly/r70uc#http://www.huffingtonpost.com.au/2017/09/24/6-ways-to-start-improving-your-gut-health-today_a_23218661/