Tag Archives for U.S. Food and Drug Administration

AARP Town Hall Gives Its Best to Educate Seniors on COVID-19

Published in the Woonsocket Call on April 5, 2020

With more than 278 Americans now infected with the Coronavirus virus (COVID-19) and at least 7,159 people dying from the deadly virus, according to an April 3 blog article the New York Times, “about 311 million people in at least 41 states, three counties, eight cities, the District of Columbia and Puerto Rico are being urged to stay home.” The Washington, DC-based AARP continues to intensify its efforts to educate seniors about COVID-19 by hosting weekly Coronavirus Information Tele-Town Hall events.

At AARP’s second Coronavirus Information Tele-Town Hall event, held Thursday, March 19, during the 90 minute live event, federal health experts gathered to answer questions about the latest changes to address the health impacts of COVID-19, family caregiving needs, and to give tips on how seniors can stay safe from scams and frauds. AARP’s Vice President Bill Walsh served a host and the panel of experts featured Dr. Jay Butler, M.D., the deputy director for infectious diseases at the Centers for Disease Control and Prevention, (CDC), Lance Robertson, the assistant secretary for aging and administrator of the Administration for Community Living (ACL) and Daniel Kaufman, the deputy director for the Federal Trade Commission’s Bureau of Consumer Protection. AARP’s Jean Setzfand. AARP’s senior vice president served as moderator.

CDC’s Butler called for the public to stay informed and take the coronavirus virus seriously. “As we’ve learned more about COVID-19, it’s very clear that most people who become infected do recover and do very well. But unfortunately, some get very sick. And some even die. And the risk of more severe illness is greatest for those who are older and for persons with underlying health conditions, especially chronic heart, lung or kidney disease, and those with diabetes,” he says.

Juggling Costs and Benefits While Promoting Social Distancing

According to Butler, grocery stores are juggling costs and benefits with promoting social distancing by designating special hours for seniors to shop if they don’t have someone who can make “that run to the grocery store or have delivery services available.”

“We’re at the end of flu season so if you develop symptoms (cough, muscle aches, headache, and temperature) it doesn’t mean that you have COVID-19, says Butler. For those concern, it is important to talk with your health care provider who will determine whether or not you should be evaluated and whether or not a test may be necessary, he adds, noting that COVID-19 testing is now covered by Medicare Part B when it’s ordered by a health care provider.

“Of course, if you suddenly become very ill—and that would be things like shortness of breath, chest pain, difficulty in getting your breath at all or noticing that your face or your lips are turning blue—that’s when you call 911, and get in as quickly as possible,” says Butler.

Butler notes that the primary transmission of the COVID-19 virus (as well as the six other coronaviruses that were previously known to cause disease in humans), is respiratory droplets.

By coughing or sneezing you produce droplets that contain the virus that can spread as far as five or six feet away from you, he says stressing that this is why social-distancing can protect you from catching the virus.

Many express concerns that COVID-19 can be picked up by handling letters and packages. But, says that the likelihood of transmission of is extremely low. So, consider sending a package a loved one in an assisted living facility or nursing home because it can be meaningful, says Butler.

For those over age 75 to age 80, Butler recommends that these individuals practice social distancing by connecting with their children or grandchildren by phone video chat to being exposed to COVID-19.

Butler gave simple tips for residents of senior living complexes to protect themselves from COVID-19. When you come back into your apartment after taking out trash to the chute or dumpster, “wash your hands,” he says. “And that means about 20 seconds with soap and water.

It seems like a long time but it’s the same amount of time it usually takes getting through the alphabet or to sing Happy Birthday twice,” adds Butler. Or just use a hand sanitizer with at least 60 percent alcohol as an alternative to hand washing.

ACL Administrator Robertson provided tips to unpaid caregivers who cannot visit their loved ones in nursing homes due to the necessary visiting restrictions. He says, get the facility’s up-to-date contact information along with details as to ways as how to make virtual visits, video chats and regular phone calls. He says, don’t forget to send cards and notes, not only to your loved one, but to other residents even to staff to say thank you.

Communicating with Your Loved Ones

Enhance your verbal communication by asking the facility staff to schedule the time for your call. “If your mom is most alert in the morning, pick a morning time, think about what music they might like and play that in the background or sing along or sing directly to your loved one,” recommends Robertson.

Robertson notes, “If you find the conversation struggling a bit, maybe play a game of trivia, reminisce, work on a crossword puzzle together, sing songs, read poetry or other materials.

Watch a TV show at the same time and just discuss. Again, throw in some creativity and you can help prevent both boredom and isolation.”

For those more technically savvy, face-to-face interaction through FaceTime, Messenger, Facebook, Zoom, can enhance your contact, says, Robertson.

Adds Robertson, make sure you ask the facility staff to keep the scheduled time of the care conference, holding it over the phone. “We know they’re busy, but it’s imperative that you remain linked as a caregiver,” he says.

For those caregivers seeking resources to take care of their loved one at home, call ACL’s Eldercare Locator, recommends Robertson. It’s toll-free 1-800-677-1116.

During this COVID-19 emergency FTC’s Daniel Kaufman warned that you will see “unscrupulous marketers” trying to take advantage of senior’s fears by selling them bogus treatments. In early March, he told the listeners that the FTC and the U.S. Food and Drug Administration (FDA) sent out warning letters to seven companies that were claiming products (such as cheese, essential oils and colloidal silver) could treat or prevent the coronavirus. He quipped, these companies are not making these claims anymore and urged seniors to report any scams they come across by going to ftc.gov/complaint.

Kaufman says that seniors can also go to ftc.gov/coronavirus or just go to ftc.gov to see a very prominent link for coronavirus scams. If you want to receive consumer alerts directly from the FTC, you can go to ftc.gov/subscribe.

Skyrocketing of COVID-19 Related Scams

According to Kaufman, FTC is seeing an increase in scams, from phishing emails, charity and stock scams, to robocalls selling cleaning supplies and masks.

“We are seeing a lot of bogus emails that are going out to consumers, that use headers about coronavirus to get people to open them. You know, these are fake emails that are purporting to come from legitimate and important organizations like the World Health Organization or the CDC,” says Kaufman. “Don’t click on links when you get those emails. Don’t open those emails. They will download viruses or be harmful to software onto your computer, or they will try to get your private information or credit card information,” he adds.

Watch out for charity scams, too, warns Kaufman. “You know, this is a difficult time and we all want to help. But we want to make sure we’re helping charities and not scammers who are pretending to be charities, he says, suggesting that you do your homework to protect your pocketbooks.

With COVID-19 spreading across the nation you are now seeing more robocalls touting products and services to protect you from being exposed to virus. “Just hang up. Keep in mind that anyone who’s robocalling you, if they’re trying to sell you a product, they’re already doing something that’s unlawful,” he says.

Kaufman also recommends that seniors use a credit card when purchasing products, whether it’s cleaning supplies or masks, on websites. “It’s pretty easy to set up a website that’s purporting to provide, to sell these kinds of products. And they’re taking consumers’ payment information but not delivering, he notes.

Finally, Kaufman urges seniors to watch out for watch out for fraudsters who are touting that a certain company’s stock that is certainly going to explode because they have products that can treat coronavirus. Don’t fall for this stock scam and buy this stock.

For the latest coronavirus news and advice, go to http://www.AARP.org/coronavirus.

To see transcript, go to http://www.aarp.org/health/conditions-treatments/info-2020/tele-town-hall-coronavirus-03-19.html.

AARP Takes a Look at the Prescribing of Dementia Drugs

Published in the Woonsocket Call on September 15, 2018

Last month, the AARP Public Policy Institute released a report, Insight on Issues, 137, that just might be a good read for physicians, medical societies, insurers, even the Center for Medicare and Medicaid (CMS), and Congressional lawmakers. According to the report’s findings, dementia drugs are often prescribed long-term despite lack of clinical evidence. Of interest to payers, reducing overuse of dementia drugs could result in substantial savings for patients and payers.

The AARP report findings indicate that a majority (70 percent) of elderly dementia patients prescribed dementia drugs are on them long-term despite the lack of evidence that they provide any benefit beyond one year. The study found that some patients took dementia drugs for as long as a decade, costing as much as $20,000 per patient.

“Our research shows some health care providers continue prescribing dementia drugs to patients for much longer than is supported by the clinical evidence,” said Elizabeth Carter, Senior Health Services Research Advisor, AARP Public Policy Institute, and co-author of the study. “Not only do these drugs carry potential side effects, they are costing both patients and the health care system a lot of money,” she says.

With experts predicting a looming Alzheimer’s epidemic, AARP Public Policy researchers saw the need to gather data on the prescription of dementia medications, and the costs associated with the disease currently total more than $270 billion annually and could reach $1.1 trillion by 2050, says Carter. “The efficacy of drug treatment for dementia, however, remains limited and there is little information about how or when to de-prescribe these products. Given the potential for unnecessary costs and potential side effects, we thought that current prescribing patterns warranted a closer look,” adds Carter.

“While there’s a lot of research from clinical trials on the efficacy of dementia drugs, I could find no other study showing the real-world prescribing patterns of these drugs among older adults, notes Carter.

Taking a Closer Look at Prescribing Dementia Drugs

The AARP report takes a look at two types of drugs are approved by the U.S. Food and Drug Administration for the treatment of dementia symptoms: cholinesterase inhibitors (ChEl) (Aricept®, Razadyne®, Exelon®) and memantine (Namenda®, Namenda XR®). Both types may help with symptoms like memory loss and confusion for approximately three to twelve months, but some patients see no improvement.

The AARP report asserts that the benefits of currently-approved dementia drugs are modest and do not affect the underlying cause of the disease or slow the rate of cognitive decline. They also do not delay institutionalization, improve quality of life, or lessen the burden on caregivers. Potential side effects of dementia drugs include low blood pressure and loss of consciousness, abnormally slow heart rate, and hip fracture.

The AARP report noted that claims data from 36,000 Medicare Advantage enrollees who started dementia drug treatment between 2006 and 2015 showed that 58 percent of patients were prescribed a ChEl, 33 percent were prescribed both ChEl and memantine together, and 8 percent were prescribed memantine. The majority (70 percent) of all patients taking dementia drugs were on them for 13 months or longer.

“Older adults typically take multiple medications, often on a long-term basis, and see multiple health care providers without any meaningful oversight of their overall prescription drug regimens,” said Leigh Purvis, Director of Health Services Research, AARP Public Policy Institute, and co-author of the report. “These findings really highlight the importance of ensuring that health care providers have access to reliable information to help them reassess medications that may no longer be of benefit, or even cause harm.”

Nursing Home Industry Weighs In

The AARP Study did not differentiate among patients who live in a nursing facility and those who live elsewhere, says Virginia Burke, President of the Rhode Island Health Care Association, representing the state’s nursing and assisted living facilities. She noted that the AARP study used billing records from a single Medicare Advantage plan, to see how frequently and for how long the drugs were purchased for Medicare beneficiaries.

Burke estimates that the percentage of billing records of nursing facility residents to be analyzed by the AARP researchers to be small because about three percent of those age 65 and older are in a facility at any given time – most of these individuals are age 80 and older.

“Keep in mind that nursing facilities don’t prescribe our patient’s medicines, rather we are required by regulation to administer the drugs prescribed by the patient’s physician. Nurses do have the ability to influence prescribing physicians, however, as evidenced by the reductions in use of anti-psychotics and antibiotics over the past few years,” says Burke. .

Changes in prescribing patterns of dementia drugs patterns starts must start with physicians, says Burke. “I expect that physicians might want to see more data, and perhaps a peer-reviewed replicated study, before it has an effect on their prescribing patterns [of dementia drugs],” she adds.

While Carter recognizes the efforts nursing facilities have made to reduce the unnecessary use of antipsychotic drugs on residents with dementia, there is still more work to do. “I’ve also heard anecdotal reports that some nursing homes are finding ways to skirt the problem by either replacing antipsychotics with other mood-altering drugs or diagnosing residents with conditions, such as bipolar or schizophrenia, that would justify the use of antipsychotics,” she says.

Carter says that AARP is planning to get the word out about their dementia drug prescription study through a partnership with OptumLabs to disseminate the findings to larger audiences, including physicians. “This type of potential overutilization is hardly unique to dementia drugs so we may look at the use of other prescription drugs in a follow-up study,” she says.

Physicians have other options to treat residents with dementia in nursing facilities, adds Carter. “There’s evidence supporting the use of non-pharmacological treatments such as environmental modification and cognitive behavioral therapy,” she says.

CMS Must Take Notice

CMS, the federal agency that oversees the Medicare program and insurers might consider taking a closer look at studies that look at the appropriate use and cost of the long-term prescribing dementia drugs. France’s health system did, says Carter, noting that “They will no longer reimburse for dementia drugs we studied (donepezil, galantamine, rivastigmine and memantine) as of August 2018,” she adds.

But, taking a closer look at the appropriate use, effectiveness and cost of long-term prescribing of dementia, might be a good strategy for Congress to put the brakes on the skyrocketing cost of pharmaceutical drugs.

Carter and Purvis, coauthors of this AARP report, conclude their study by urging health care providers to “regularly assess patients and their drug regimens to ensure these regimens remain appropriate reflecting the changing health status and needs of the patient.” They suggest more research can provide “up-to-date information on a drug’s effectiveness and side-effects that essentially can help increase the practice of de-prescribing medications that may no longer be of benefit, or even cause harm.”

This is sound advice to consider.

For details about AARP’s dementia drug study, go to http://www.aarp.org/dementiadrugstudy/.

Inaction on RIPAE Proposals Would Be a State Tragedy

Published in the Pawtucket Times on May 20, 2002

Lawmakers are rushing to finalize the state’s business, hoping to adjourn as early as the end of May.

With thousands of proposals in the legislative hopper, each representative was directed by House leadership to choose three of their own sponsored bills to push for in the Senate.

All legislative proposals that do not make the “priority” lists are as good as dead for the year.

At press time, one proposal, Pharmaceutical Assistance for the Elderly Program (RIPAE) moves closely to passage.

The House Finance Committee has put the proposal (H 7291) into the state budget article. Susan Sweet, a consultant and aging advocate said she expects full House passage of the state budget article by the end of the week.

Once passed by the House, the state budget article goes to the Senate for their consideration and approval. Sweet told All About Seniors that she believes that the Senate will quickly pass the budget, too.

With passage, the final state budget will be  forwarded to Governor Lincoln Almond.

Under H 7291, the state Department of Human Services would seek a waiver from the federal government, allowing Rhode Island to use Medicaid funding to pay for prescription drugs for low-income seniors with incomes up to $ 17,720 and couples with incomes up to $ 23,880.

The legislative proposal, authored by Lt. Governor Charles Fogarty and sponsored by Rep. Constantino and House Finance Chairman Gordon Fox, would enroll about 90 percent of the 37,000 seniors now enrolled in RIPAE. Because seniors would now qualify for prescription drug coverage under Medicaid all U.S. Food and Drug Administration (FDA) drugs would be covered not just those currently covered by RIPAE.

Seniors would pay a small copayment rather than the 40 percent co-payment currently charged.

With the passage of the state budget article, then “cleanup” begins on all legislative proposals, Sweet noted, adding that the two other RIPAE proposals have not been acted upon yet.

These legislative proposals would make prescription drugs more affordable to seniors and persons with disabilities who are not covered by the Medicaid waiver.

One bill (H 7290) would allow seniors enrolled in the RIPAE program to buy prescription drugs not currently covered by RIPAE at the discounted state price.

The other (H 7524) would allow low-income disabled persons on Social Security Disability Income who are between ages of 55 and 65 to become members of RIPAE and purchase prescription medications at the state discounted rate. Under booth, the state would be able to obtain the manufacturer’s rebate available through RIPAE.

Sweet along with other aging advocate groups, has called on the Rhode Island General Assembly to pass the three RIPAE proposals, which don’t cost the state one penny.

Not acting on them will continue a tragic trend that is well-documented in Rhode Island and nationwide.

That is, the high cost of prescription drugs forces many seniors on fixed incomes into not taking their prescribed medications at all or using only partial doses.

Moreover, noncompliance can lead to unnecessary hospitalization, nursing home admission and premature death.

Even in the shadow of a huge state budget deficit, lawmakers have the opportunity to lower the spiraling out-of-pocket costs of costs of prescription drugs, at no cost to the state.

The Ocean State is now posed to enact sound public policy that will result in no fiscal impact to state coffers.

If Congress is not ready to tackle this aging policy issue through the creation of a Medicare pharmaceutical benefit, then the Rhode Island General Assembly must take the lead and pass the three RIPAE proposals.

Simply put, it is the right thing to do on behalf of older and disabled constituents.