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FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply

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The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.

These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply. 

“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.” 

Under the new proposed guidance:

  • The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated. 
  • The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months. 
  • Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months. 
  • All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation. 
  • Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.    

Other considerations in the guidance include:

  • No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use. 
  • Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently. 
  • Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C. 

Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):

  • Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
  • Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection. 
  • Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections. 
  • The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results. 

The agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood. However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood. The FDA will continue to track the latest data relevant to PrEP and blood donation. 

“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.” 

To inform these draft recommendations, the FDA carefully reviewed numerous data sources, including data from the United Kingdom and Canada, countries with similar HIV epidemiology that have implemented this gender-inclusive, individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, and the performance characteristics of nucleic acid testing for HIV. Additionally, the agency funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCEExternal Link Disclaimer) study. This study examined several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants.

As part of the FDA’s established process, today’s proposal will be open for public comment for 60 days. The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.

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10 Simple Changes You Can Make Today for Improved Health and Wellness

Improve your health and wellness with these simple changes to your daily routine.

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Boost Your Wellbeing with These Easy Tips

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Living a healthy lifestyle is important for our physical and mental well-being, but sometimes it can be overwhelming to know where to start. However, there are simple changes that we can make to our daily routines that can have a big impact on our health and wellness. Here are 10 simple changes you can make today to improve your health and wellness.

  1. Drink more water: Staying hydrated is key for our body’s systems to function properly. Aim for at least 8 glasses of water a day.
  2. Add more fruits and vegetables to your diet: Fruits and vegetables are packed with nutrients and antioxidants that can help protect against diseases. Aim for at least 5 servings a day.
  3. Move more: Regular exercise is important for maintaining a healthy weight, reducing stress, and improving overall health. Find activities that you enjoy and aim for at least 30 minutes of physical activity a day.
  4. Get enough sleep: Sleep is essential for our body to heal and regenerate. Aim for 7-9 hours of sleep each night.
  5. Reduce stress: Chronic stress can have negative effects on our physical and mental health. Find activities that help you relax and reduce stress, like meditation or yoga.
  6. Practice good hygiene: Good hygiene practices like washing your hands regularly and showering daily can help prevent the spread of germs and illnesses.
  7. Limit alcohol intake: Drinking too much alcohol can have negative effects on our liver and overall health. Limit your intake to no more than 1-2 drinks per day.
  8. Quit smoking: Smoking is a major cause of many diseases and can have negative effects on our health. Quitting smoking is one of the best things you can do for your health.
  9. Wear sunscreen: Protect your skin from the harmful effects of the sun by wearing sunscreen with at least SPF 30, especially when spending time outdoors.
  10. Connect with others: Social connections are important for our mental health and well-being. Make an effort to spend time with friends and family, or find a community group that interests you.

Making these simple changes to your daily routines can have a big impact on your health and wellness. Remember that small steps can lead to big changes. Start with one or two changes and gradually add more as you feel comfortable. With time, these habits will become a natural part of your daily routine, helping you to live a healthier and happier life.

https://stmdailynews.com/category/lifestyle/

STM Daily News is a multifaceted podcast that explores a wide range of topics, from life and consumer issues to the latest in food and beverage trends. Our discussions dive into the realms of science, covering everything from space and Earth to nature, artificial intelligence, and astronomy. We also celebrate the amateur sports scene, highlighting local athletes and events, including our special segment on senior Pickleball, where we report on the latest happenings in this exciting community. With our diverse content, STM Daily News aims to inform, entertain, and engage listeners, providing a comprehensive look at the issues that matter most in our daily lives. https://stories-this-moment.castos.com/


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Learn CPR as a Life-Saving Skill

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CPR

(Family Features) While many Americans agree Conventional CPR (cardiopulmonary resuscitation) or Hands-Only CPR (HOCPR) significantly improve a person’s chance of survival from cardiac arrest, less than half are confident they can perform either Conventional CPR or HOCPR in an emergency.

Learning CPR

Black or Hispanic adults who experience cardiac arrest outside a hospital setting are substantially less likely to receive lifesaving care from a bystander. In spite of these survey results, the American Heart Association is working to change this by empowering members of these communities to learn lifesaving CPR, and a growing segment of respondents are willing to act in an emergency.
The American Heart Association’s 2023 survey also revealed that as a result of the organization’s efforts to change attitudes about performing CPR, which can lead to lifesaving results, more than half of African Americans said they would be willing to perform CPR in an emergency compared to 37% two years ago. Additionally, Hispanic and Latino respondents are more confident in their abilities to perform CPR.

Committed to turning a nation of bystanders into lifesavers, the American Heart Association’s multiyear initiative, Nation of Lifesavers, helps teens and adults learn how to perform CPR and use an automated external defibrillator (AED); share that knowledge with friends and family; and engage employers, policymakers, philanthropists and others to create support for a nation of lifesavers.

“Each of us has the power in our own hands to respond to a sudden cardiac arrest,” said Anezi Uzendu, M.D., American Heart Association expert volunteer. “We simply need to know what to do and have the confidence to act.”

The long-term goal: to ensure that in the face of a cardiac emergency, anyone, anywhere is prepared and empowered to perform CPR and become a vital link in the chain of survival, aiming to double the survival rate of cardiac arrest victims by 2030. It takes just 90 seconds to learn how to save a life using HOCPR, which can be equally as effective as traditional CPR in the first few minutes of cardiac arrest.

Nationally supported by the Elevance Health Foundation, the American Heart Association’s HOCPR campaign is focused on chest compression-only CPR. If a teen or adult suddenly collapses due to a cardiac event, you can take two steps to save a life: immediately call emergency services and use these tips to begin performing HOCPR.

  1. Position yourself directly over the victim.
  2. Put the heel of one hand in the center of the chest and put your other hand on top of the first.
  3. Push hard and fast in the center of the chest at a rate of 100-120 beats per minute, which is about the same tempo as the song “Stayin’ Alive” by the Bee Gees, and at a depth of approximately 2 inches.
  4. Continue compressions and use an AED, if available, until emergency help arrives.

To learn more about how you could be the difference between life and death for someone experiencing a cardiac event, visit Heart.org/nation.

Photo courtesy of Shutterstock

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SOURCE:
American Heart Association

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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STM Daily News is a multifaceted podcast that explores a wide range of topics, from life and consumer issues to the latest in food and beverage trends. Our discussions dive into the realms of science, covering everything from space and Earth to nature, artificial intelligence, and astronomy. We also celebrate the amateur sports scene, highlighting local athletes and events, including our special segment on senior Pickleball, where we report on the latest happenings in this exciting community. With our diverse content, STM Daily News aims to inform, entertain, and engage listeners, providing a comprehensive look at the issues that matter most in our daily lives. https://stories-this-moment.castos.com/


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A Genetic Connection to Kidney Disease

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How APOL1-mediated kidney disease can impact you, your kidneys and your family

(Family Features) A genetic condition that can cause kidney failure, APOL1-mediated kidney disease (AMKD) represents a group of kidney diseases associated with mutations (changes or variants) in the apolipoprotein L1 (APOL1) genes.

Typically, the APOL1 genes – of which every person has two, one from each parent – create proteins that play a role in immunity. However, some people are born with mutations in one or both genes, and having mutations in both can increase the risk of developing kidney disease and even kidney failure.

In honor of National AMKD Awareness Day on April 30, consider this information from the experts at the American Kidney Fund to better understand the disease and become APOL1 aware.

Understanding Risk Factors
Research shows Black people with kidney disease are more likely to develop kidney failure than any other racial or ethnic group. The reasons for these health disparities include social determinants of health, a higher burden of diabetes and high blood pressure in the Black community, barriers to health care access and genetics.

The APOL1 gene mutations evolved over the past 3,000-10,000 years in people who lived in western and central Africa and are associated with increased protection from a parasite carried by the tse tse fly that causes African sleeping sickness. While protecting from one disease, the mutation – if inherited in both APOL1 genes – is more likely to lead to kidney disease in those of certain African descent, including people who identify as Black, African American, Afro-Caribbean or Latina or Latino.

In fact, an estimated 13% of Black Americans have two APOL1 gene mutations, according to the American Kidney Fund. While not everyone who has two APOL1 mutations will get kidney disease, there is a 1 in 5 chance they will go on to develop AMKD.

Identifying Symptoms
If you have kidney damage, symptoms may not occur until your kidneys are close to failing. As kidney damage worsens, one or more of these symptoms may occur:

  • Protein in urine
  • Swelling in legs or weight gain
  • Feeling weak or tired
  • High blood pressure

Should these symptoms occur and you have a family history of kidney disease, talk to a doctor about getting tested for kidney disease, as testing is the only way to determine kidney function. AMKD can cause damage to parts of the kidney that filter blood or, in some cases, cause cells in the kidneys to die, which can lead to damage and scarring that may eventually lead to kidney failure.

Getting a Diagnosis
The only way to know if you have APOL1 gene mutations is to do genetic testing via a blood or saliva sample. Genetic testing may be considered if you have kidney disease and don’t know the cause or if you’re considering donating a kidney. Testing may also be considered if a family member is a carrier for the mutation. If you have questions about genetic testing, discuss your options with a doctor or ask for a referral to a genetic counselor.

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Taking Steps to Prevent Kidney Disease
There are currently no treatments available for AMKD. However, there are steps you can take to protect your kidneys and promote general health. Work with your doctor to create a plan to prevent or delay the progression of kidney disease, which may include:

  • Doctor visits to check how your kidneys are working through urine and blood tests
  • Checking for and managing diabetes and high blood pressure
  • A healthy eating plan, which may involve limiting things like sodium (salt)
  • Taking prescription medications as directed
  • Being active at least 30 minutes each day of the week
  • Quitting smoking or using tobacco

If you have the APOL1 gene mutations, you may be able to take part in clinical trials. Trials could provide an opportunity for researchers to develop and test safe treatments for AMKD. Also speak with family members about having genetic testing done if you have the mutation as they may also have it.

Learn more and find additional resources at kidneyfund.org/APOL1aware.

Photo courtesy of Shutterstock

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SOURCE:
American Kidney Fund

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

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