Tag Archives for U.S. Food and Drug Administration

AARP: Making Seniors a Priority in Getting COVID-19 Vaccines

Published in Pawtucket Times on January 11, 2021

Last month, a statement the Rhode Island Department of Health (RIDOH) announced recommendations from the Rhode Island COVID-19 Vaccine Subcommittee for hospitals that vaccinations would begin for frontline hospital workers against COVID-19. This recommendation was made at an emergency meeting of the Subcommittee. RIDOH has accepted this recommendation and has communicated to hospitals that they may begin vaccinating these workers, as soon as vaccine arrives.

Two doses will be needed for someone to be fully immunized. Second doses will start arriving in Rhode Island in roughly three weeks. Rhode Island expects to receive approximately 10,000 doses of Pfizer vaccine the first week it is available, and approximately 19,000 doses of Moderna vaccine the first week it is available. Vaccine will come to Rhode Island in weekly allotments over the coming months, says RIDOH.

Epidemiologists, primary care providers, pharmacists, pediatricians, long-term care advocates, ethicists, nonprofit leaders, school leaders, faith leaders serve on Rhode Island’s COVID-19 Vaccine Subcommittee.  This group is responsible for performing an independent review of the process for evaluating the safety and efficacy of the vaccine. The Subcommittee is advising RIDOH on how to prioritize distribution of the vaccine to ensure that it is done equitably, and in a way that best protects the State as a whole.

At press time, the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization for a COVID-19 vaccine developed by Pfizer, and a vaccine made Moderna.

Making COVID-19 Vaccine Available Throughout the Ocean State

“After a rigorous scientific review, we know that COVID-19 vaccine is safe. We also know that it is one of the most effective vaccines ever developed,” announced Director of Health Nicole Alexander-Scott, MD, MPH in the Dec. 14 statement. “In the coming weeks and months, as vaccine becomes more available, getting vaccinated will be one of the most powerful things you can do to keep yourself and the people you love safe from COVID-19. We are going to work to ensure that every person in every community in Rhode Island has access to the vaccine, especially those communities hardest hit by this virus,” she said.

Added, Philip Chan, MD, MS, Consultant Medical Director for RIDOH’s Division of Preparedness, Response, Infectious Disease, and Emergency Medical Services, “We have never had a vaccine that has been – or will be – more closely monitored than the COVID-19 vaccine.”

“Teams of scientists at the national level have been scrutinizing thousands of pages of technical data for weeks, focusing on vaccine effectiveness, safety, and the manufacturing process, and our own local review has happened here in Rhode Island. I absolutely plan on getting vaccinated when it is my turn.,” said Chan.

According to RIDOH, the national vaccine trials for the COVID-19 vaccine involved tens of thousands of people to make sure they meet safety standards and people of different ages, races, and ethnicities. There were no serious safety concerns. (When vaccinated against COVID-19, people do sometimes develop post-vaccination symptoms such as soreness at the spot of the shot and headaches. This is normal, healthy, and expected. It means your immune system is working to develop protection.) Several systems are in place to do ongoing safety monitoring of the vaccine.

As of January 8, the last update on RIDOH’s COVID-19 Data Tracker, out of the 31,541 does administered, 29,743 have been vaccinated with their first of two doses, only 1,798 people were fully vaccinated with two doses.

Don’t look for the roll out of COVID-19 to take days or weeks, it will take months to complete, warns RIDOH officials. Phase 1 of the vaccination program is expected to run through late March.  At press time, the state is currently working its way through the top three tiers of this phase, including hospital staff, healthcare workers, EMS personnel, home health and hospice workers, nursing home staff and residents, high-risk incarcerated persons, first responders, school nurses, and even hard-hit communities.

Finally, those in the final two tiers of Phase 1 to be vaccinated include outpatient providers (Dentists, primary care), Dialysis Center workers and death care professionals, expected to begin Jan. 25, and adults over 75 years of age, expected to start by February.

Phase 2 is expected to kick-in by late March.  A number of factors are being considered to target the distribution of COVID-19 vaccinations a person’s age, high-risk conditions, occupation and geography.  

Make Older Rhode Islanders a Priority in Receiving Vaccines

AARP Rhode Island, representing 132,000 older Rhode Islanders, calls for Governor Gina Raimondo to make the state’s seniors a priority in its time-line for on distributing COVID-19 vaccines.  The Jan. 8 correspondence, cosigned by Kathleen Connell, State Director of AARP Rhode Island and Phil Zarlengo, the group’s State President, called on Raimondo “to increase COVID vaccination transparency,” as it relates to older Rhode Islanders.

AARP Rhode Island asked the Governor to include the numbers of Rhode Islanders vaccinated by age and other criteria on a daily/weekly basis on RIDOH’s COVID-19 Data Tracker.  Specially, the largest state-wide advocacy group called for the state’s website to include:

·         the numbers and percentages of older Rhode Islanders by race and ethnicity, that have been vaccinated:

·         the number of Rhode Islanders vaccinated and their age demographics on a daily/weekly basis;

·         a clear and easy-to-understand schedule of vaccine administration for all populations; and the process by which individuals may seek and obtain a vaccine;

·          the numbers and percentages of long-term care residents, by facility, that have received their first and second doses of vaccines;

·         the numbers and percentages of long-term care staff, by facility, that have received their first and second doses of vaccines.

While acknowledging the many challenges the state officials must tackle in determining how to equitably, safely and effectively distribute COVID-19 vaccines, Connell and Zarlengo call for Rhode Islanders age 50 and older to be made a priority in receiving a vaccine.

“The data clearly show that the older people are, the higher risk they face if they contract COVID-19.  Given that older individuals are at a greater risk of death from COVID-19, we strongly urge you to ensure that Rhode Islanders age 50 and older are prioritized to receive a vaccine.  These individuals must be given priority access to vaccines, in addition to those individuals receiving care in nursing homes and other long-term care facilities,” say Connell and  Zarlengo.

“For years, the long-term care system has been shifting away from institutional care in nursing homes to home and community-based settings (HCBS). Here in Rhode Island, a significant percentage of long-term services and supports are provided in the home or settings such as assisted living facilities, residential care facilities, veterans homes, and in individuals’ own homes,” says Connell and Zarlengo, stressing that this why the state should prioritize seniors, especially those with underlying conditions, receiving care in these additional settings and the staff providing care, to receive a COVID-19 vaccine.

Finally, AARP Rhode Island’s correspondence urges the Governor to ensure that all providers are fully complying with established state procedures for vaccine distribution and prioritization. “We urge you to investigate and take swift action against anyone who attempts to commit fraud, including by inappropriately selling the vaccine or intentionally providing vaccines to those who do not meet qualifying criteria in an attempt to circumvent the distribution process.”

From AARP’s National

 “We urge public health officials at the state and local level, as they decide on vaccine allocations, to rely on the evidence and make plans backed by science.  As production is ramping up, AARP is advocating hard to ensure every older American who wants to get the vaccine can get it.  It’s also vital that distribution plans for authorized vaccines are smoothly implemented.  There’s no time to waste: it’s time for full-scale mobilization, and any delays or early bottlenecks in distribution systems need to be addressed urgently,” says AARP Executive Vice President and Chief Advocacy & Engagement Officer Nancy A. LeaMond in a Dec. 28 statement.  

 

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/.