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Friday, November 27, 2020

What to know before visiting a nursing home this holiday season

 The first publicized U.S. outbreak of coronavirus took place in a nursing home in King County, Washington, in late February. A reported 81 nursing home residents were infected, as were 34 staff members and 14 visitors. As a result of the facility's transmission control efforts, residents were confined to their rooms and visitors were prohibited, raising concerns from patients' rights advocates and the residents' families.

But as the United States faces its third wave of the  pandemic and an average of more than 160,000 new cases of COVID-19 a day and climbing, restrictions on nursing home visitations are on the rise. The U.S. Centers for Medicare and Medicaid Services, which oversees thousands of nursing homes across the United States, issued guidance recently urging nursing home directors to discourage residents from leaving facilities for  with their families during the holidays. Maryland Gov. Larry Hogan announced last week that indoor visits to state nursing homes would be limited to compassionate care visits—a distinction that is not specifically defined in the order but typically includes end-of-life visits and situations in which the visit is materially beneficial to the residents' health, as in cases where visitors are needed to encourage eating or to relieve a resident's emotional distress.

For help understanding the nuances of nursing home visitations during the coronavirus pandemic and what families should keep in mind when planning a holiday visit if permitted by their state, the Hub spoke with geriatric nurse practitioner Valerie Cotter, associate professor at the Johns Hopkins University School of Nursing. An expert in aging, dementia, gerontology, and , Cotter is a principal faculty member of the Center for Innovative Care in Aging and a nurse practitioner in the Memory and Alzheimer's Treatment Center.

In the very first wave of the coronavirus pandemic, we saw nursing homes lock down visitations to prevent the spread of illness in their facilities. Why is it a last-resort option for governments to restrict nursing home visitation when it's such a vulnerable population in the first place?

There are two reasons. The first is that not all nursing homes are the same, and there are different levels of care in nursing homes. There's skilled care, there's hospice care. And so their needs are different. The other reason is that nursing homes are part of a community, and across the United States, each community is affected in a different way in terms of case rates and death rates. And so blanket policies prohibiting visitation to any nursing home in the U.S. just don't make a lot of sense.

Older adults are at high risk for severe COVID-19—they're frail, they have medical comorbidities, or they have functional impairments that prevent them from taking care of themselves—and it's of course important that we keep them as safe as possible. But we also don't want to restrict their autonomy in such a severe way. And so the idea of restricting access to nursing homes across the country needs to be balanced with the rights and well-being of those individuals that reside in nursing homes and the health care workers that care for them.

It's hard because especially very frail, cognitively impaired people really need that socialization. I'm a  at the Memory and Alzheimer's Treatment Center, and I know how this coronavirus has affected people living at home, in terms of not having access to adult day care or other routines and social activities that they're used to. It can really create more behavioral disturbances, depression, or social isolation. Social interaction, activity, and being with people that care about them is really important for nursing ' quality of life.

I imagine that family visits help provide necessary structure and routine for nursing home residents.

It does. But remember, too, that when a person is living in a nursing home, they have care staff, nursing assistants, and nurses that are there with them. They become their second family, if you will. They don't replace their primary family, but they get used to those people taking care of them and being with them, establishing relationships with them. It's not like your own family, but I think that nursing home staff really do to try to provide the kind of care that their family member would like them to receive.

Do you expect there to be a rise in nursing home COVID cases as a result of the holidays?

Yes. I'm sure that each nursing nurse has their own policies around if residents can leave or receive visitors and what that involves. But that's also only half of the equation, because the people that provide care in  are also going to be with family members for the holidays before coming back to work to care for the nursing home residents. If they're not being cautious with their own holiday activities, they're going to be bringing the illness back to the nursing home. So, yes, there's a lot at stake here.

What are some of the precautions someone should take if they're visiting a loved one in a nursing home or planning to bring a loved one home for a visit?

They should call ahead and talk with the nursing home staff about what their policies and procedures are. That way it's not a surprise for the family or facility staff and everyone knows what to expect. The State of Maryland doesn't define compassionate care in its order, so I would advise Maryland families to talk with the nursing facility about the visit.

In some parts of the country, the residents might be able to visit with family members outside, which is nice and cuts down on risk. But that of course is weather-permitting.

Is there anything else that you wish more people understood about the nuances of the situation for nursing home residents and their families?

It's a hard position to be put in. A person who's living in a nursing home is there because they have such health care needs or functional needs that they can no longer be alone or their family can't take care of them. But they live in a community now where they need to respect and adhere to policies that, were they living on their own, they wouldn't need to be thinking about. But nevertheless, they and their families need to consider how their behaviors can affect other people in the nursing —the residents and the care staff. I think that that could be really challenging, because it's not just about what they and their  want—they have to consider the community where they live and abide by those policies.

https://medicalxpress.com/news/2020-11-nursing-home-holiday-season.html

Indivior trades in red after Reckitt files GBP1.07B suit over demerger

 

Oral insulin, by Israeli mom-son team, starts final trials to become world’s 1st

 An Israeli company has started final-stage tests of its oral insulin, bidding to become the first to make the product available on the international market.

The product started phase three trials under the US Food and Drug Administration in California on Monday, after 14 years of development.  If all goes well, Oramed Pharmaceuticals says it expects type 2 diabetics to start taking its pills in just over three years, followed by type 1 diabetics after further testing.

“This has the potential to improve lives of hundreds of millions of diabetics worldwide,” Oramed CEO Nadav Kidron told The Times of Israel. “And by improving treatment it can reduce complications and, in turn, reduce the cost of treating diabetics.”

He said that the dosing tech that is being used for insulin has “very significant” potential for the creation of oral versions of other medical injections.

An Indian company, Biocon, is also working on oral insulin, but unlike Oramed it has not started advanced trials with the FDA, which is seen as the main path to the international market.

Oramed has big money behind its innovation: In 2015 it signed a $50 million licensing and investment deal with China’s Hefei Life Science & Technology Park Investments and Development Co. (HLST), a subsidiary of Chinese pharma giant Sinopharm, for the rights to its oral insulin capsule in China.

Kidron said his product transports insulin to where the body can make the best use of it — the liver, rather than the bloodstream, where it is currently delivered.

“One benefit of oral insulin is that we overcome the fear of the needle, but, more importantly, the insulin is being delivered directly to the liver.

“By taking it to the liver we are stopping the excessive production of glucose in the place where the production actually happens. Usually, injections go into the bloodstream and deal with glucose there instead of stopping production in the liver, its source.”

Pills will become a major source of insulin, he predicted, but they won’t replace injections entirely, as type 1 diabetics will still need to inject some of their doses.

He said that as well as helping insulin-dependent diabetics, it will allow doctors who are hesitant to start injections to prescribe occasional insulin via pills.

The direct delivery minimizes side effects, especially weight gain which is the bane of many diabetics’ lives, Kidron said.

“So far in the phases of trials conducted to date, we [have] not seen the weight gain that is associated with injected insulin,” he commented.

In Phase 2b trials, the oral insulin showed a statistically significant lowering of hemoglobin A1c levels, a key marker of diabetes, without serious adverse events or weight gain.

The initial technology was developed at Hadassah Medical Center in Jerusalem — by Kidron’s mother, biochemist Miriam Kidron, today Oramed’s chief scientific officer. The Nobel laureate and Israel Prize-winning biochemist Avram Hershko is one of the company’s scientific advisers.

The big obstacle to oral insulin has been that the gut would harm it before it reaches the liver. Oramed’s tech overcomes this with a specially-coated pill that stays whole and releases the insulin as it gets to the liver.

“The fact we’re able to get the pill to the liver, which is exactly where the insulin is needed, is a major achievement,” said Kidron. “For nearly 100 years the world has looked for ways to be able to give insulin orally. This technology could be a real game-changer in how we treat diabetes.”

https://www.timesofisrael.com/oral-insulin-by-israeli-mom-son-team-starts-final-trials-to-become-worlds-1st/

Carlyle Group nears acquisition of India pharma firm for $1B

 

As COVID-19 cases swell, US extends telehealth to acute care

 The US government has introduced a scheme to allow hospitals to reduce the number of inpatients they see through a telehealth platform that would helps deliver acute care at home.

The move comes as the number of new cases of COVID-19 have been climbing to around 180,000 a day, with deaths since the start of the pandemic now rising above 260,000, and concerns that some hospitals could become overwhelmed over the winter months.

The Centers for Medicare & Medicaid Services (CMS) announced the plans as part of  broad plan to free up hospital capacity amid the COVID-19 surge, although it stressed patients won’t have to use the service unless they want to, and the first assessment by a physician must take place in person.

It said that treatment for more than 60 different acute conditions, including asthma, heart failure, pneumonia and chronic obstructive pulmonary disease (COPD), can be carried out “appropriately and safely in home settings with proper monitoring and treatment protocols.”

The new telehealth scheme applies to patients with conditions that require at least daily visits by a physician and ongoing medical team monitoring.

Six health systems across the country have already been approved to participate in the program, getting the necessary Medicare waivers to allow them to treat patients at home.

They are Brigham and Women’s Hospital in Massachusetts, Massachusetts General Hospital, Huntsman Cancer Institute in Utah, Mount Sinai Health System in New York City, Presbyterian Healthcare Services in New Mexico, and Iowa’s UnityPoint Health.

Participating hospitals must have screening protocols in place before care at home begins, to assess that patients have access to working utilities, ensure there are no other physical barriers to care, and rule out welfare concerns such as a risk of domestic violence.

The US healthcare system has rapidly adopted telehealth and remote patient monitoring during the response to the coronavirus pandemic, with some suggesting it will transform the future of health care delivery, although there are dissenting voices.

On March 13, President Trump made an emergency declaration that empowered the CMS to issue waivers to Medicare program requirements to support healthcare providers and patients during the crisis.

Since then, the CMS has added dozens of services to the list of telehealth services it will reimburse during the public health emergency, including emergency department visits, initial nursing facility and discharge consultations, home visits, and physical, occupational and speech therapy services.

Some of the changes have found their way into the proposed 2021 Physician Fee Schedule, which will make reimbursement for some telehealth and digital services permanent.

“We’re at a new level of crisis response with COVID-19 and CMS is leveraging the latest innovations and technology to help healthcare systems that are facing significant challenges to increase their capacity to make sure patients get the care they need,” said CMS Administrator Seema Verma.

“With new areas across the country experiencing significant challenges to the capacity of their health care systems, our job is to make sure that CMS regulations are not standing in the way of patient care for COVID-19 and beyond,” she added.

https://pharmaphorum.com/news/as-covid-19-cases-swell-us-extends-telehealth-to-acute-care/

Cassava up as lead drug candidate's chemical name modified to simufilam for Alzheimer’s

 

FDA OKs Rhythm Pharma's Imcivree for weight management in obesity

 

  • The FDA has approved Rhythm Pharmaceuticals' (NASDAQ:RYTM) Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.
  • With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.
  • The company expects to make Imcivree commercially available in U.S. in Q1 2021.
  • With this approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher to Rhythm. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
  • Rhythm’s marketing application for setmelanotide to treat people living with obesity is currently under EMA review.
  • The company hosted conference call today at 9:30 a.m. ET to discuss the FDA approval of Imcivree.
  • https://seekingalpha.com/news/3639653-fda-oks-rhythm-pharmas-imcivree-for-weight-management-in-obese-patients