In a reversal of a decades-long practice that many in the LGBTQ+ community consider discriminatory, Stanford Blood Center (SBC) will join others across the United States in implementing a new policy that helps gay men. men and bisexual men, as well as women, have an easier time having sex with men. bisexual men donate blood.
When AIDS emerged in the early 1980s, federal law banned gay and bisexual men from donating blood because of the risk of HIV, which can be transmitted through blood transfusions. Over the years, that restriction was gradually relaxed, taking into account the time of an individual’s last sexual intercourse.
Now, under new guidance issued by the U.S. Food and Drug Administration last May, blood transfusion centers nationwide must treat all potential blood donors equally, screening Filter them for HIV risk factors based on the same criteria. Stanford will implement this policy on October 19. “This policy eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with men.” men who have sex with men (MSM) and women who have sex with MSM,” the FDA announced in May.
These guidelines follow policies already in place in the UK and Canada (UK policy takes effect in 2021; Canada in 2022). The FDA asserts that the new policy will continue to ensure the safety of the nation’s blood supply while expanding potential funding sources.
This initiative comes at a time when there is an urgent need for blood in the wake of the COVID pandemic, when blood donations have dropped significantly. Expanding donations to as many people as possible – while ensuring the safety of the blood supply – will encourage a stronger donor base and help ensure there will be enough blood products for local patients. method when they need it.
Suchi Pandey, MD, medical director at Stanford Blood Center, has been closely monitoring the process. The SBC was part of a study that found that bulldozing the sponsor’s qualifying field would not jeopardize safety. When SBC implemented the new policy on October 19, Pandey discussed the importance of the policy change in terms of equity and how it would impact the local blood supply.
Why is this new policy important?
This is an important step forward in bringing comprehensiveness to our donor screening process. It is the basis of eligibility and donor deferral due to high-risk behavior based on individual assessment, regardless of the donor’s gender or sexual orientation. All donors will be asked the same set of questions about sexual behavior. It’s a more equitable approach, while also maintaining the safety of the blood supply.
Why now? What has changed?
Data from the ADVANCE (Assessing Sponsor Variation and Emerging Concepts of Eligibility) study completed in late 2022 was a key driver of this change. The ADVANCE study is designed to evaluate the feasibility of questions that could be added to the donor history questionnaire, which would allow the United States to move to an individual risk-based approach than. Furthermore, it is very important that this change is driven by the experience of countries such as the UK and Canada, which have adopted a similar approach.
Data from these countries shows that making this change does not pose a risk to blood safety. This change is also supported by extensive data collected by the FDA’s national surveillance system to assess the incidence of HIV and hepatitis in blood donors before and after the policy change. Finally, with this data and advances in blood donor testing, the FDA was able to move to a more fair and equitable blood donor selection process in the United States.
Does Stanford Blood Center engage in advocacy for policy change?
Stanford Blood Center and blood centers across the country have worked with the FDA on deferral policies and strongly supported research that could consider different ways to assess eligibility. Stanford has been engaged for years in asking the FDA to evaluate the effectiveness of the delay ban and see whether there is a more comprehensive yet safer strategy. SBC is one of four centers participating in the ADVANCE study, so we had a direct role in one of the groundbreaking studies that led to this change. We have also had representatives who have attended meetings on Capitol Hill to advocate for prioritizing this issue for several years.
The feedback has been very positive – that this is a step in the right direction. You are not questioned because of your gender or sexuality. I think the LGBTQ+ community supports that approach. It will allow certain individuals to donate without restrictions.
Understandably, there are concerns around the delayed requirement for PrEP (pre-exposure prophylaxis to prevent HIV transmission). People taking oral PrEP will have a deferral of three months from the last dose and two years for injectable PrEP.
It is important to understand why the FDA is delaying PrEP. PrEP is an excellent and important public health measure to reduce sexual transmission of HIV. The challenge with PrEP is that it does such a good job of keeping virus levels low that it can take longer for an HIV test to turn positive if someone is infected.
This means you could get a false negative result on a donor screening test. The FDA will continue to evaluate this issue and possible changes to PrEP deferrals may be made in the future. Blood centers and the FDA advise that individuals should not stop or delay taking prescribed medications in order to donate blood.
How will you monitor the impact of the new policy?
We’ll look at how many people are being deferred and how many more sponsors we’re seeing. We want to understand how this change impacts people. And of course, we always monitor our infectious disease rates.
Overall, I hope we see more sponsors. We are likely to see an increase in donor visits as more people donate who were previously unable to donate. And we always need blood.
I think the new strategy of screening all donors with these same questions is a very safe strategy. It’s important for people to realize that we have many layers of safety. For example, we still test every donor using highly advanced HIV and hepatitis testing platforms. When you combine all of these measures, you can be sure that your blood supply will continue to be safe.
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