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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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Community Fundraiser Hosted by CFC in Support of Infertility Awareness Week

Canadian Fertility Consulting and Fertility Matters Canada Unite for Virtual Paint Night Fundraiser

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TORONTO (Newswire.com) – Canadian Fertility Consulting is proud to announce a Virtual Paint Night Fundraiser in support of Infertility Awareness Week, scheduled for April 28, 2024. This event aims to raise awareness about infertility issues while supporting Fertility Matters Canada, a national charity dedicated to assisting those struggling with fertility challenges.

The virtual paint night will be led by the talented Jenny Hughes of Oceanside Art Studios, offering participants the opportunity to unleash their creativity while supporting a meaningful cause. Taking part is simple – join from the comfort of your home via Microsoft Teams, and we will provide all the necessary paint materials, conveniently shipped directly to your door.

“We are thrilled to host this virtual paint night fundraiser to support Infertility Awareness Week and Fertility Matters Canada,” said Janet Harbick, Administrative Specialist at Canadian Fertility Consulting. “It’s an opportunity for our community to come together, express themselves artistically, and raise vital funds for a cause that impacts so many lives.”

Participants are encouraged to register by April 12, 2024, to ensure timely delivery of the paint supplies. Registration and payment are required to secure your spot in this event.

The theme for the evening is to paint a beautiful hatching embryo, with each participant adding their own unique interpretation. No prior painting experience is necessary, as guidance will be provided throughout the virtual session.

Infertility affects one in six Canadians, leading many to explore alternative paths to parenthood. Statistics show that 40% of infertility cases are attributed to female factors, 30% to male factors, and 30% to joint infertility or remain unexplained. Additionally, various factors such as sexual orientation, genetic diseases, gynecological issues, and career considerations contribute to the complexity of infertility challenges faced by individuals and couples across every demographic and economic group.

Canadian Fertility Consulting is Canada’s largest surrogacy and egg donation agency, committed to assisting couples and individuals in their journey to parenthood. With a mission to build families with love, we provide guidance and support throughout the process of exploring alternative methods of family building.

Join us for a night of creativity and compassion as we come together to support Infertility Awareness Week and Fertility Matters Canada. Together, we can make a difference in the lives of those affected by infertility.

For more information and to register for the Virtual Paint Night Fundraiser, visit Paint Night Event Registration.

About Canadian Fertility Consulting:

Canadian Fertility Consulting is Canada’s largest surrogacy and egg donation agency, dedicated to helping couples and individuals navigate the challenges of infertility. With a focus on compassion and support, we assist in building families through surrogacy and egg donation arrangements.

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World Health Day 2020: Celebrating Nurses and Midwives in Healthcare

World Health Day: Celebrating nurses and midwives, the backbone of healthcare. #HealthcareHeroes #WorldHealthDay2020

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Today isWorld Health Day, an annual event that takes place on April 7th, organized by the World Health Organization (WHO). This day serves as a platform to highlight various health issues and set the tone for future developments in the global wellness and medical world. From mental health to insurance and everything in between, World Health Day tackles it all.

Let’s delve into the history of this significant day. The creation of the World Health Organization marked a turning point in international health efforts. In December 1945, officials from Brazil and China proposed the establishment of a comprehensive and independent international health organization. Half a year later, in July 1946, the WHO Constitution was approved in New York. On April 7, 1948, this constitution entered into force with 61 countries signing an agreement to inaugurate the NGO.

World Health Day: Celebrating nurses and midwives, the backbone of healthcare. #HealthcareHeroes #WorldHealthDay2020

Among the early initiatives of WHO was the introduction of World Health Day. Originally observed on July 22, 1949, the date was later changed to April 7, coinciding with the establishment of WHO, in order to encourage student participation. Since 1950, each World Health Day has been assigned a different theme, chosen by the WHO Director-General in consultation with member governments and staff.

World Health Day offers a globally significant opportunity to draw attention to crucial public health issues that impact communities worldwide. On this day, various promotional programs are launched that extend far beyond April 7th, raising awareness and fostering positive change.

This year, World Health Day shines a spotlight on the exceptional contributions made by nurses and midwives to the healthcare industry. Nurses and midwives are the devoted and restless workforce that has transformed healthcare as we know it. Their tireless efforts, compassion, and expertise make them the backbone of the healthcare system, providing invaluable care and support to individuals and communities across the globe.

World Health Day 2020 celebrates nurses and midwives by organizing advocacy events worldwide. One of the highlights is the launch of the first-ever State of the World’s Nursing Report. This groundbreaking report will provide critical insights and recommendations to optimize the contributions of the nursing workforce. In 2021, a similar report focusing on the midwifery workforce will follow.

On this World Health Day, let us all join hands in acknowledging and appreciating the vital role played by nurses and midwives in providing healthcare. We owe them our gratitude and support. Take a moment to thank a nurse or midwife who has made a difference in your life or participate in events and discussions that promote their recognition.

Remember, every day is an opportunity to prioritize our health and well-being. Let World Health Day serve as a reminder to embrace healthy living, support those who care for us, and work towards a healthier future.

Stay joyful, stay healthy, and happy World Health Day!

https://nationaltoday.com/world-health-day/

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

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Walk Your Way to Better Health

A walk is not just good for your body, it’s also good for your soul. Physical activity, like walking, is one of the best ways to reduce stress and boost your mood for better health.

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(Family Features) A walk is not just good for your body, it’s also good for your soul. Physical activity, like walking, is one of the best ways to reduce stress and boost your mood. However, reports show walking rates are declining steadily in the United States.

On average, 1 out of every 4 U.S. adults sits for longer than eight hours each day, per research from the Centers of Disease Control and Prevention, which can have negative consequences on physical and mental health. Regular exercise improves mood, boosts energy and can even help you sleep better. Staying active is one of the best ways to keep your mind and body healthy.

Consider this advice from the American Heart Association, which has worked for decades to promote policies and strategies that make it easier for communities to get and stay active. One example is National Walking Day on April 3, established by the organization to encourage people to move more throughout the day so they can feel, think, sleep and live better.

Indeed, adding more movement can benefit your body and mind in numerous ways, such as:

Lowering disease risk. Getting the recommended amount of physical activity (at least 150 minutes of moderate, 75 minutes of vigorous or a combination of those activities per week) is linked to lower risk of diseases, stronger bones and muscles, improved mental health and cognitive function and lower risk of depression, according to the U.S Department of Health and Human Services.

Increasing sunlight exposure. Outdoor exercise is an easy way to get moving and take in the sunlight, which can improve mood, boost immunity and help you get some vitamin D. Spending time outdoors is a no-cost option and has been shown to reduce stress, promote a sense of belonging and improve mood.

Improving cognitive and mental function. Physical activity keeps your mind sharp now and later. Studies show higher fitness levels are linked to better attention, learning, working memory and problem solving. What’s more, a study published in the “British Journal of Sports Medicine” shows people who get the recommended amount of physical activity are less likely to develop depression.

Living longer. Healthy life expectancy can be positively impacted by increasing activity. According to research published in the “American Journal of Epidemiology,” swapping just 30 minutes of sitting with low-intensity physical activity reduced risk of death by 17%.

Get moving to reduce your stress and step into better health. Learn more at heart.org/movemore.

Get Inspired to Get Moving

A little creativity can go a long way to make your walk more fun. You might think of walking as a solo activity, but a companion makes it even more enjoyable. Ask colleagues, friends or family to join you.

A walk is a perfect excuse to take a break from a long day at your desk. If you work remotely, take a conference call on the go or plan your walk as a reward for completing a project.

Use your walk as a guilt-free opportunity to listen to a new audiobook or create a walking soundtrack of your favorite upbeat music.

Mix up your scenery. Taking new routes keeps your walks interesting and helps prevent boredom from traveling the same predictable path.

If you need an extra nudge to get moving, a pet may help you get fit. Dog parents are more likely to reach their fitness goals than those without canine companions. In fact, according to the “Journal of Physical Activity & Health,” dog parents are 34% more likely to fit in 150 minutes of walking a week than non-dog owners. Pets can also help lower stress, blood pressure, cholesterol and blood sugar and boost your overall happiness and well-being.

Photos courtesy of Shutterstock


SOURCE:
American Heart Association

https://stmdailynews.com/category/lifestyle/health-and-wellness/health/

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