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Archive for the ‘Preventative Medicine’ Category

King Institute of Preventive Medicine and Research to test samples for monkeypox – The Hindu

Wednesday, August 3rd, 2022

All samples will be referred through the Directorate of Public Health and Preventive Medicine and the Regional Integrated Disease Surveillance Programme network

All samples will be referred through the Directorate of Public Health and Preventive Medicine and the Regional Integrated Disease Surveillance Programme network

After being the first laboratory in Tamil Nadu to initiate COVID-19 testing and having tested about 31 lakh samples so far, the Department of Virology, King Institute of Preventive Medicine and Research (KIPMR), will now test samples for monkeypox.

Health Minister Ma. Subramanian, who inspected the facilities at the laboratory on Thursday, told reporters that clinical specimens collected from the skin, lesions, urine, serum/plasma would be tested for monkeypox at the 123-year-old KIPMR.

According to a release, the Indian Council of Medical Research (ICMR)/National Institute of Virology (NIV), Pune, trained the laboratory, along with 15 facilities in the country, to initiate monkeypox testing. All samples would be referred through the Directorate of Public Health and Preventive Medicine/the Regional Integrated Disease Surveillance Programme network to KIPMR and tested by real-time PCR. The sample should be accompanied with the clinical history.

There would be parallel testing at NIV, Pune, and the results would be released after confirmation by NIV, Pune, initially, the release said.

Monkeypox has been reported in 77 countries. In India, four cases have been reported so far and there has been no case in Tamil Nadu, he said.

Samples of two persons who had returned from Canada and the U.S. were sent for testing to NIV, Pune, after they developed lesions on the face last month. Both samples were negative for monkeypox. There has been no case of monkeypox in Tamil Nadu so far, he said.

He added that there was mass fever screening at the international airports. An advisory was issued to screen passengers travelling from the 77 countries or on transit. They were screened for symptoms, including for lesions, he said.

The Department of Virology of KIPMR is a World Health Organization (WHO)-National Polio Laboratory, a WHO reference laboratory for measles and rubella and an ICMR/DHR regional influenza referral laboratory as well. It also serves as the State-level Virus Research and Diagnostic Laboratory under ICMR/DHR, the release said.

Health Secretary P. Senthilkumar, Director of Medical Education R. Narayana Babu, Director of Public Health and Preventive Medicine T.S. Selvavinayagam and Director of KIPMR Kaveri were present.

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Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations – World – ReliefWeb

Wednesday, August 3rd, 2022

Key populations provide valued contribution to development of new WHO guidelines

In 2020 the global key population networks including the International Network of People Who Use Drugs (INPUD), the Global Action for Trans Equality (GATE), the Network of Sex Worker Projects (NSWP) and the Global Action for Gay Mens Health Rights (MPACT) were commissioned by WHO to conduct values and preferences research within their communities in relation to HIV, viral hepatitis and STI services. This research has been used to inform the development of the new WHO Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations, launched on 29 July 2022 at AIDS2022 in Montreal, Canada.

To celebrate the launch of these important guidelines for improving the health and rights of the key populations in relation to HIV, viral hepatitis and STIs, INPUD reached out to several study participants from the community of people who use drugs and asked them to briefly reflect on why the key populations values and preferences research is important and what the new guidelines mean in the context of their lives. Here are extracts of their responses:

Why is it important to include the values and preferences of key populations living with and affected by HIV, viral hepatitis and STIs in the development of the WHO Key Populations Guidelines?

For people from marginalized and criminalized communities it often feels like no ones really listening to the knowledge we have to offer. Involving key populations in the development of the guidelines was critical to ensuring that lived and living experience was embedded within the guidelines not just being asked to make some comments after the guidelines are already developed. That happens way too often and it is tokenistic.

Involving the community is important for lots of reasons, including that peers are best placed to detect and identify stigma and discrimination. By making sure that the language of the guidelines is stigma-free and non-discriminatory, it establishes the standard we expect from health professionals using the guidelines and providing services. It is a practical way to show why our community must be at the heart of these kinds of processes.

Peers are clued into the real world settings of living with or being at risk of HIV, viral hep and STIs, where the clinical meets the real world. We will not achieve the elimination of HIV and viral hepatitis without the valuable perspective, insights, and expertise of peers.

Do WHO Key Population Guidelines such as these make a tangible difference in the lives of people living with and affected by HIV, viral hepatitis and STIs, including people who inject drugs?

As a trans person who injects drugs and is living with HIV, I feel empowered through the consultation process to inform the guidelines. I was able to contribute to the global response to HIV, viral hep, and STIs with something much bigger than myself and my work at the community level.

We are always talking about ways we can use policies and guidelines like these for our advocacy on behalf of people who use drugs. For example, we can use them to demand better services or human rights, but we can also use them to check against current guidelines, services and programmes and advocate for improvements.

Sometimes documents like these can seem far from our everyday lives as people who inject drugs, but if those providing harm reduction and other health services to people who inject drugs are aware of the guidelines and use them, it can really change the way we experience those services by removing some of the barriers.

The 2016 WHO Consolidated Guidelines focused on HIV, the revised Guidelines will focus on HIV, viral hepatitis and STIs among key populations. Was this shift important in your view?

The shift beyond HIV to include viral hepatitis and STIs brings a more holistic perspective of the interactions between belonging to priority populations and various risk factors HIV doesn't operate in a vacuum.

A lot can be shared and learnt by collaborating across infectious diseases at government, community, research, and clinical levels. Issues of human rights, criminalization, stigma, and discrimination all impact HIV, viral hepatitis and STIs. The experience of stigma is a shared experience across the priority communities.

Many of us are affected by multiple conditions and experiences and there are so many intersectionalities, as a queer woman of colour who injects drugs, it just makes sense to bring a wider lens to these issues rather than trying to put people into narrow boxes.

What can be done to make people who inject drugs globally more aware of the new Key Population Guidelines?

Well, community conversations are always a good place to start.

People who inject drugs are highly networked. It's important to consistently and constantly remind people who inject drugs about their inherent worth; we are beautiful human beings that deserve to be loved, have our human rights upheld, and be treated with respect, understanding, and compassion. The guidelines support these key messages.

Acknowledgement: we thank INPUD for conducting the interviews and writing this article and to the INPUD study participants who generously gave their time and offered their views.

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Consolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations - World - ReliefWeb

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SCYNEXIS Announces U.S. Food and Drug Administration – GlobeNewswire

Wednesday, August 3rd, 2022

JERSEY CITY, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Companys submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.

If approved for this second indication, BREXAFEMME, an oral non-azole therapy, would be the first and only product approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of RVVC, defined as three or more infections in a 12-month period.

The FDAs acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in womens health, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community.

SCYNEXIS will present CANDLE study results this week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston August 4-6, 2022.

Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-month priority review.

About BREXAFEMME(ibrexafungerp tablets)

BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal againstCandidaspecies, meaning it kills fungal cells.BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The approval was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.

INDICATION

BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

DOSAGE AND ADMINISTRATION

The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.

IMPORTANT SAFETY INFORMATION

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

For more information, visitwww.brexafemme.com. Please clickherefor Prescribing Information.

About SCYNEXIS

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the companys lead asset, ibrexafungerp, as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS launched its first commercial product in the U.S., BREXAFEMME(ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, clinical investigation and development of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visitwww.scynexis.com.

Forward-Looking Statements

Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: progressing filing of an sNDA for RVVC, of ibrexafungerp, its potential use by physicians and patients in multiple healthcare settings. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications, including the IV formulation of ibrexafungerp; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS need for additional capital resources; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT:

Investors:Irina KofflerLifeSci Advisorsikoffler@lifesciadvisors.com

Media:Debbie EtchisonSCYNEXISDebbie.Etchison@scynexis.com

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Dr. Sanjay Gupta: While monkeypox cases rise, why are we waiting for the cavalry to rescue us? – CNN

Wednesday, August 3rd, 2022

The pandemic, which has held the United States and almost every other country in its grip, should have taught us valuable lessons about how to manage a public health emergency, but it seems we are making some of the same mistakes we made not even three years ago, when the SARS-CoV-2 virus started to spread.

It is now clear: Preparedness alone does not guarantee a rapid response. With Covid-19, and now monkeypox, we were too slow to respond. It was as if we are sitting in a turbo-charged Ferrari, capable of massive acceleration, but instead only idling in the driveway.

Cavalry culture

Over the past three years, we have witnessed something counterintuitive. It was predominantly wealthy countries that were hit hardest during the Covid-19 pandemic. They had some of the highest death rates, despite their enormous resources.

While there are many reasons for this, including misinformation, lack of public trust, and the entangling of public health and politics, I think there is something else, as well: We have adopted what I call a "cavalry culture." We wait for the cavalry to ride in and rescue us, instead of taking smaller preventive steps -- such as establishing modern and reliable data systems, mastering our supply chain along the way, and acting early to head off the outbreak in the first place.

There are a couple of important axioms in public health. One is, by the time you think you must act to contain an outbreak, it is already too late. And, if you think you are overreacting, you are probably reacting just the right amount. In the case of Covid, and now monkeypox, we seem to have forgotten those basic public health principles. And, the real question now seems to be: When will the government finally hit the gas pedal on our highly tuned Ferrari?

I don't want to suggest any of this is easy. There are significant issues of uncertainty and unpredictability. Much like a hurricane forming at sea, we often don't know exactly where or how hard it will hit. We want to be measured, calm in our response and to cause as little disruption as possible. We want to be thoughtful and gather as much information as is available.

And therein lies one of our biggest problems: basic data. I have often wondered, how is it that a numbers-driven, high-tech country like the United States can't get basic data right?

Data disaster

As long as I've been reporting on the Covid pandemic, I have always had to offer the caveat that case numbers are probably off, sometimes wildly so. We have probably never had a clear vision on just how widely the virus was spreading at any given time in the United States, and going into the fall 2022, the situation isn't really any better.

"First, there's a lack of data access needed to understand where disease outbreaks are spreading. This is due to data collection limitations that Congress needs to fix," said Dr. Tom Frieden, president and CEO of Resolve to Save Lives and a former director of the US Centers for Disease Control and Prevention.

He said there is also a need to update analog systems and connect them to each other -- getting them to speak the same language. Right now, it's the Tower of Babel.

"Second, we lack sufficient numbers and, in some cases, skills of people and systems at the federal, state and local levels that can deliver services and communicate effectively with communities. Finally, we are in perpetual panic and neglect funding cycles," he said.

As a result of all of the things Frieden is describing, our current data collection and reporting system leaves important information fractured into dozens of states and territories, and thousands of county pieces for the CDC to puzzle together.

"I have been struck as we at CDC are now conquering another public health challenge -- monkeypox -- as to how little authority we at CDC have to receive the data," CDC Director Dr. Rochelle Walensky told the Washington Post.

Walensky is talking about basic data, like where the vaccine has gone, who has been vaccinated, whether the vaccine is working, and even monkeypox case data like who is getting infected, their age and race/ethnicity. Why might this be so?

"States don't routinely share vaccine doses administered data with the federal government -- Covid was really the first time that we were able to successfully put data use agreements in place," Claire Hannan, the executive director of the Association of Immunization Managers, told CNN. Part of the reason is because "states have laws in place to protect identifiable information."

Some information has been getting to the CDC, but it is challenging to get and incomplete. The CDC director told the Washington Post, "We have been speaking to our state and local partners probably at least three times a week, all of them. ... That is not how you synthesize data. We need ... standardization of those data, and we need to have those data come to us in a standardized fashion so that they can be connected, we can compile them and rapidly report them out. We cannot at CDC collect the data and make informed decisions by calling 64 jurisdictions, and honestly, 3,000 counties."

The CDC is currently working on agreements that would broaden the agency's access to states' data, as they successfully did with Covid. Hannan explained, "The need to quickly get the [monkeypox] vaccine out left no time to get data sharing agreements in place."

But even if those agreements were in place, it still doesn't mean the states' ability to actually obtain vaccine doses would be made any easier. That's because the states wouldn't be using the same data system for ordering and tracking doses they generally use. Because the US Department of Health and Human Services and the Administration for Strategic Preparedness and Response are in charge of monkeypox vaccine distribution, there would be yet another data system involved.

"They were asking states to request the vaccine using paper forms and email," said Hannan. "They were asking states to complete forms [with fillable fields] on those who were receiving the vaccine and return these forms to the federal government."

The problem was there weren't even the right fields for the specific questions being asked, such as reason for vaccination or type of exposure or risk, Hannan said. It wasn't that the necessary forms weren't being filled out, it was that they couldn't be filled out because of disparate data platforms.

It is a baffling level of bureaucracy in the middle of an unfolding outbreak.

Testing, vaccines, therapeutics

As things stand now, the issues with data collection, testing, vaccines, treatments and communication are sounding a lot like the ones we experienced with Covid-19.

The monkeypox outbreak is also different for another fundamental reason. Unlike with Covid, which was caused by a novel virus, the basic tools already exist either for monkeypox or its close relative, smallpox. We didn't have to build them from scratch. That means we could have had them or put them to better use by now.

Another tool that could be tremendously helpful is testing of wastewater. As we have seen with Covid, it can better define the scope of the outbreak and where it will emerge next. Two months into the outbreak, we still aren't doing this widely for monkeypox.

It also means that the vaccine, which can be given within 14 days of exposure (but preferably within four) to prevent or reduce the severity of disease, is currently being used more as a treatment -- a post-exposure prophylaxis -- rather than as a real preventive measure.

As National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said on CNN, that focus will have to shift.

"It's very clear with the spread of this that there now has to be a balance between vaccines available for those who clearly have been exposed, as well as those at risk," Fauci said. "What you want to do is a balance between vaccinating those who clearly have had an exposure but go well beyond that."

Finally, there is the issue of treatment. The CDC has made the antiviral smallpox treatment tecovirimat, called TPOXX, available to monkeypox patients who have or are at high risk of severe disease under an "alternate regulatory mechanism."

There are 1.7 million courses of TPOXX stockpiled. But once again, getting the medication to patients who could immediately benefit has proven to be bureaucratically burdensome for both patients and providers.

"You're talking about a five, six-day time lag to get that medication to you at a local doctor's office, no matter where you are. And the paperwork, and all of the bureaucracy to make that happen is very cumbersome, takes a few hours of your time. And that's the barrier," Dr. Stacy Lane, founder of the LGBTQ-centered Central Outreach Wellness Center in Pittsburgh, told me recently.

In the meantime, though, patients are suffering. Even though most cases are "mild," they are still uncomfortable, or downright painful, depending on where sores appear. Plus, there is a risk of long-term complications if the pox lesions develop in areas around the eye or GI tract.

All of these gaps have the hardest hit community on edge.

"Largely public health officials know how this has spread. They know how to vaccinate people ... we know how to treat it, and we know how to prevent it," says Samuel Garrett-Pate, managing director of external affairs of Equality California, the largest statewide LBGTQ+ civil rights organization.

"It unfortunately seems that despite two years of building up our public health infrastructure to prevent what happened with Covid-19 from ever happening again, despite the fact that we are better prepared in terms of already having a vaccine available, the CDC and FDA seem to be caught flat-footed once again. And I think as a result, you're seeing very real and understandable fear anxiety among the LGBTQ community."

Is it too late?

Dr. Scott Gottlieb, a former FDA commissioner and current board member of Pfizer, has been pessimistic about the trajectory of monkeypox in the United States.

"We're now at the cusp of this becoming an endemic virus, where this now becomes something that's persistent that we need to continue to deal with. I think the window for getting control of this and containing it probably has closed and if it hasn't closed, it's certainly starting to close," he said on Face the Nation on July 17.

CDC's Walensky pushed back on Gottlieb's assessment calling it "misinformed and off base," saying that while it's true there is much work to do, the US has made dramatic progress on priorities like testing, vaccines and education.

There has been measurable progress in these areas, no doubt. But, I do worry that we once again waited too long. We sat idling in our Ferrari, perhaps not wanting to believe that somehow we had suddenly found ourselves in the middle of yet another outbreak.

The world, however, is changing, as we have been reminded of twice in the last few years. There are new pathogens emerging, and existing pathogens are more easily traveling the world.

We have learned painful lessons in the last few years, and we are now in the midst of our first significant test since the Covid pandemic began, to see if we do any better this time around.

There is no doubt we are capable, and we are prepared. The question is will we use all those remarkable resources and respond, or we will wait and suffer until the cavalry has to rescue us once again?

CNN Health's Andrea Kane contributed to this report.

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Dr. Sanjay Gupta: While monkeypox cases rise, why are we waiting for the cavalry to rescue us? - CNN

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Governor Whitmer declares August 2022 as Breastfeeding Month, highlights additional breastfeeding observances – Michigan (.gov)

Wednesday, August 3rd, 2022

Indigenous Milk Medicine Week Aug. 8-14; Asian American, Native Hawaiian and Pacific Islander Breastfeeding Week Aug. 15-21; Black Breastfeeding Week Aug. 25-31

LANSING, Mich. Michigan is committed to encouraging a strong foundation for life in all infants by supporting breastfeeding parents for the first year of their childs life and beyond. As part of this effort, Gov. Gretchen Whitmer has issued a proclamation declaring August 2022 as Breastfeeding Month.

During National Breastfeeding Month we recommit ourselves to supporting infants and new parents and ensure that every Michigander has equitable access to the resources and support they need to give their child a great start, said Governor Whitmer. We will work with Michigans health care providers and local organizations to broaden public understanding about the impact breastfeeding has on improving infant health and reducing infant mortality rates within communities of color across the state. I will work with anyone to ensure every baby in Michigan has what they need to grow up and pursue their potential.

Breastfeeding is a public health imperative central to successful health equity strategies that confront racism, classism and sexism which are the root causes of inequities and combatting these are a key strategy in reducing maternal and infant mortality. Disparities in breastfeeding rates and other maternal and infant health outcomes are most evident among Black and Indigenous families in Michigan. Increased efforts highlighting increased support to breastfeeding are part of Governor Whitmers Healthy Moms Healthy Babies initiative.

Proper nutrition for infants is critical for their growth and development, and it is important for hospitals, business, communities and coalitions to work together to provide consistent support for breastfeeding parents in Michigan, said Dr. Natasha Bagdasarian, MDHHS chief medical executive.

The American Academy of Pediatrics has updated its recommendation to breastfeed up to 2 years of age because of the benefits to the infant and the parent. Breastfeeding provides countless benefits to the nursing infant including easy digestion, production of antibodies and reduced risk of infections and childhood obesity. It also offers faster recovery from birth and reduced risk for postpartum hemorrhage and uterine cancer for the breastfeeding parent.

Ways to support breastfeeding include advocating for paid maternity leave and adequate pumping time while at work and school, and by bolstering Baby Friendly hospitals. National Breastfeeding Month is also a time to highlight under-resourced communities where families do not have equal access to support, care and education. The national formula shortage amplified how food disparities impact our most vulnerable populations, black and brown families. It has shown us the areas where improvement is needed to protect babies and ensure that parents are provided adequate prenatal breastfeeding education to make an informed decision.

Although 86.9% of Michigan families initiate breastfeeding, only 58% are still breastfeeding at three months (PRAMS 2020), and there are barriers such as lack of access to supportive health care and childcare providers and lack of paid work leave that leads to early weaning. Additionally, there are fewer lactation professionals from communities of color.

According to the Centers for Disease Control and Prevention, Black infants are 20% less likely to have ever received breast milk than any other race. In Michigan, seven of every 1,000 babies born die by age one, and among Black babies, the number is more than double. Between 80 and 90 maternal deaths occur each year with Black women dying 2.4% more often.

The states Women, Infants and Children (WIC) program is celebrating National Breastfeeding Month with the theme In Every Drop. Michigan is committed to encouraging to improving outcomes for breastfeeding parents and helping community health workers such as community-based doulas and the WIC Peer Counseling support program to help diversify lactation support and increase breastfeeding rates in local communities across the state.

WIC supports breastfeeding in the following ways:

For more information, visit Michigan WIC.

# # #

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New student education program supports drug and alcohol abuse prevention – The Ohio State University News

Monday, July 25th, 2022

The Ohio State University is instituting a new educational requirement for all first-year and transfer undergraduate students targeting drug, tobacco and alcohol misuse.

The new online educational modules will cover alcohol and other drug misuse prevention, mental wellness and prescription drug abuse. The program will be used on all Ohio State campuses and begin this fall.

This initiative centers the health, safety and wellbeing of every Buckeye, said Senior Vice President for Student Life Melissa Shivers. We have historically communicated and provided a wide variety of education and prevention information and we continue to identify ways to improve programming to best reach all of our students. Education is critical to creating a community of informed, responsible Buckeyes.

Students will access the modules through BuckeyeLearn. Incoming students must complete the educational modules to register for classes next spring or fall semester.

Local and national data demonstrate the growing need for education around alcohol, tobacco and other drug misuse, especially in light of increasing overdose deaths due to alcohol and other drugs, said Shawnt Elbert, associate vice president for health and well-being, Office of Student Life. These educational modules are a best-in-class opportunity to help prepare our students for a safe and healthy Buckeye experience.

Vector Solutions, the provider of the modules, works with 2,200 colleges and universities. The company provides evidence-based education used by millions of students at institutions across the U.S.

The new modules help educate students about a growing problem facing campuses across the country: Nationally, from 2019 to 2021, deaths from synthetic opioids, such as fentanyl, doubled. In Ohio, as of January 2021, incidents of opioid overdose were at the highest rate in 10 years.

According to the 2022 National College Health Assessment:

These modules will be an additional requirement to those related to sexual misconduct and hazing, and part of a strong portfolio that builds on Ohio States commitment to the health, wellness and safety of the campus community, Shivers said.

While the modules are required for first-year and transfer undergraduate students, Ohio State is making the program available to and will actively encourage completion by any student who wants to take part by summer 2023.

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Suicide prevention training for health care providers a first step in longer-term efficacy – University of Washington

Monday, July 25th, 2022

Public Health | Social science | UW News blog

July 19, 2022

Most health care providers who took a suicide prevention training program developed by the University of Washington said they were better able to identify and respond to patients at risk of suicide.

Most people who die by suicide had contact with the health care system in the year before their deaths but only about one-third have received mental health services. This means that primary care and emergency room doctors, nurses and other specialists may be more often positioned to evaluate a person in crisis.

After Washington in 2012 became the first state to require suicide prevention training for health care professionals, the University of Washington developed a program, All Patients Safe, to help providers identify people at risk of suicide.

A new study, published online June 23 in the journal Psychiatric Services, finds large-scale training in this critical work is possible. The first wave of health care professionals to try All Patients Safe also report improved understanding of suicide and how to respond to people at risk.

The new Suicide & Crisis Lifeline is available by texting or calling 988.

The results suggest that it is possible to provide high-quality training to health care professionals about suicide, which is an important but not sufficient step in the prevention of suicide, said Jenn Stuber, associate professor of social work at the UW and the studys lead author. Its also essential to look at systems and policies to ensure there is maximum support for health care professionals to implement the clinical skills they were taught in the training.

Nearly 46,000 people died by suicide in 2020, according to the Centers for Disease Control and Prevention. It is among the leading causes of death for teens.

Stuber, who co-founded Forefront Suicide Prevention at the UW, helped push for the Washington state legislation to train health care providers, following the death of her husband by suicide. The law is named for him. A few years after passage, the law was amended to include all licensed health care providers not just behavioral health specialists in the requirement for training. Behavioral health specialists must participate in training every six years, whereas other health professionals must take a course only once.

In addition to Washington, 17 other states encourage or require such training for health care providers.

All Patients Safe was developed in collaboration with a variety of experts and heath care organizations, including the UW AIMS Center, and is one of a few dozen suicide prevention trainings that have been approved by the Washington State Department of Health.

Administered online in three- and six-hour versions, All Patients Safe is structured in modules and uses case-based materials and videos that model provider-patient interactions. The aim is to educate and empower providers to identify at-risk behaviors and to discuss with their patients, among other things, limiting access to lethal means.

Between November 2018 and December 2020, more than 1,500 providers completed the six-hour course and a pre-training survey. Just over half filled out a post-training survey and were included in the new study. Participants were asked about their understanding of and confidence in addressing a number of topics with a patient, including storage of medication and firearms, and thoughts of suicide.

Results from that survey showed improved levels of confidence and understanding in all areas. For example, the number of respondents who believed they could identify warning signs of suicide increased by 60%, while confidence in asking about medication and firearms also rose.

Researchers say the results indicate at least a short-term knowledge gain, as well as the potential for delivering the training to large numbers of providers. They say more study is warranted on the longer-term efficacy of the training in specific health care settings.

Co-authors were Sarah Porter of the UW School of Social Work; Anne Massey of the UW School of Public Health; and Betsy Payn and Anna Ratzliff of the UW Department of Psychiatry and Behavioral Sciences.

For more information, contact Stuber at jstuber@uw.edu.

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Pharmalittle: Congress may miss deadline to pass FDA user-fee bill; ViiV is urged to lower price for its HIV prevention drug – STAT

Monday, July 25th, 2022

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still getting sorted out, but we hope to catch up on our reading and hang with our oh-so-busy short person. And what about you? Normally, we would suggest you enjoy the great outdoors, but given the heat, we hesitate to do so, unless you have a Jetsons-like portable air conditioner you can strap on your back. With that in mind, this may be an opportunity to enjoy a flick or two on the telly, meet a fun friend at a whiskey bar, or simply take a few naps. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

The European Medicines Agency has recommended a vaccine made by Bavarian Nordic for protection against monkeypox, Reuters writes. The vaccine, which is the only one to have won approval for preventing monkeypox disease in the U.S. and Canada, has in the European Union so far only been approved to treat smallpox. But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for off-label use. The recommendation from the EMA is expected to be referred to the European Commission for final approval shortly.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

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Prevention of Bipolar Disorder Episodes: Is It Possible? – PsychCentral.com

Monday, July 25th, 2022

If you live with bipolar disorder, you may have wondered if you can prevent manic or depressive episodes. While everyone is different, there may be some options that can help you.

Bipolar disorder is a complex condition.

Some people may find that they are able to prevent some manic and depressive episodes.

Others may find that, while they are not able to prevent episodes completely, they can lessen or manage the symptoms. We asked two experts for tips on how to cope.

You may find that some depressive and manic episodes are preventable to some extent, though this may not be with 100% accuracy.

Thats because bipolar disorder is caused by a combination of factors that are unique to you some factors that are in your control and some that are not.

These include:

With that said, there are some preventive measures that can be put in place in order to decrease the frequency, intensity, or duration of manic and depressive episodes, says Chanel Johnson, a licensed professional counselor in Detroit, Michigan, who lives with bipolar disorder.

The most recent research supports this view. The goal of long-time management is to help prevent episodes with a combination of medication, psychotherapy, and psychoeducation.

A 2020 study noted that the earlier there is support and intervention, the better the treatment outcomes will be.

You may find it helpful to try a combination of approaches to see what works best for you.

A number of self-care strategies can help prevent bipolar disorder episodes, but first, its important to accept your symptoms and seek professional support, says Dr. Lee Phillps, a psychotherapist and certified sex and couples therapist in Virginia and New York.

Once you accept your diagnosis, you can work with a therapist on a treatment plan, he says. The most effective treatment for bipolar [disorder] is a combination of psychotherapy and medication management.

While in therapy, says Phillips, you can build your coping skills to help prevent or lessen future episodes. These coping skills can include joining a bipolar disorder support group, so you can be around others for support, he adds.

Research from 2018 shows that those living with bipolar disorder experience sleep disturbances and differences in their circadian rhythm, which is the bodys sleep-wake schedule.

If possible, try to wake up and go to sleep at the same time every night. Having a routine allows you to go on auto pilot and trains your body physiologically, says Johnson.

If your body knows that you go to bed at 10 p.m., it knows to release some extra melatonin around that time, which certainly helps if youre having racing thoughts (a symptom of mania) and having a hard time shutting things down, she says.

Research from 2020 notes that regular movement can be helpful in managing symptoms, thanks to the release of neurotransmitters in your brain, says Phillips.

Staying active can be helpful because it can help prevent a depressive episode. If youre [experiencing mania], exercise can help calm the nervous system, he says.

Research suggests that substance use may heighten some symptoms of bipolar disorder.

For example, a 2019 study noted that smoking tobacco (alone or while using other substances), was a risk factor for suicide attempts during depressive episodes.

You may find it helpful to reduce or limit substances, including:

Stress can be a trigger for bipolar episodes.

Some studies suggest that regular mindfulness practice may help bring you into the present moment and feel more balanced, says Johnson.

Adding meditation, yoga, and exercise to your daily routine is a great way to manage stress and help stabilize your mood. Activities that invoke mindfulness, focus, awareness, and physical activity help to soothe the nervous system, she says.

Research shows that weather can be a trigger for bipolar disorder, like temperature and sunlight, says Phillips.

During the winter months, you may feel more depressed. In the spring, you may become manic. Therefore, a therapist can help you prepare for these seasons with an action plan on how you are going to cope, he says.

A growing body of evidence suggests that a healthy diet of whole foods plays an important role in preventive maintenance, says Johnson.

Processed foods wreak havoc on our gut microbiome, affecting the neurotransmitters and hormones that regulate and stabilize our mood, she says.

Processed foods often come in the form of simple sugars that cause insulin levels to spike and drop drastically. Unstable insulin levels lead to an unstable mood, Johnson explains.

You may find it helpful to ask your doctor for a referral to a dietitian or nutritionist.

There may be times when you feel like you dont need your medication anymore.

You may stop taking medication because you feel great while experiencing mania. But this may only cause your symptoms to become worse, explains Phillips.

Instead, work with a doctor or therapist before making any adjustments to your medication. If necessary, ask a loved one to help keep you accountable.

You dont have to do this on your own. In most cases, the prevention and treatment of bipolar disorder include a multi-pronged approach.

Therapy can help you identify your thoughts, feelings, and situations that may be triggering symptoms of depression and mania, and then challenge your thinking by introducing cognitive restructuring, says Phillips.

Somatic therapy is great in helping you identify what is happening in your body first before naming your emotions. Mindfulness-based interventions are great because they can bring awareness of what is happening in the moment, he says.

You may find it helpful to find a therapist who specializes in bipolar disorder.

A medication regime may be effective in preventing some bipolar symptoms.

Current research shows that combining certain types of medications can help prevent the onset of more severe symptoms, like hospitalizations during mania, or suicidal thoughts during a depression episode.

Medications for bipolar disorder may include:

For some, antidepressants alone can actually lead to a manic episode, says Johnson. The ideal combination is going to be different for everyone. It may take some time to figure out how you respond to certain medications.

I was switched from an antidepressant and anxiety medication regimen to a mood stabilizer. I couldnt believe it after 2 weeks. I felt like myself again. If you have bipolar disorder, you know what a huge deal that is, says Johnson.

Bipolar disorder is a complex condition.

While there may be no way to prevent manic or depressive episodes 100% of the time, there are some supportive practices that may help, like keeping a regular routine, getting enough sleep, and balancing your nutrition, among other strategies.

Bipolar disorder, in general, is highly treatable and there is hope. A typical treatment plan includes a combination of therapy, medication, and lifestyle adjustments. Be sure to work with a professional to find the right treatment approach for you.

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Florida man in apparent medical distress crashes car through beach crowd before hitting the water – CNN

Monday, July 25th, 2022

CNN

A driver who apparently suffered a medical emergency crashed into beachgoers at Daytona Beach on Sunday afternoon, a beach safety official told CNN.

A little before 5 p.m., we had a driver go down the beach ramp at the International Speedway Boulevard and crash into the water, said Tamra Malphurs, deputy chief of Volusia County Beach Safety Ocean Rescue. He hit a toll booth and he entered the water, she added.

The driver appeared to have suffered from a medical condition, Malphurs said without elaborating.

At least five people were taken to local hospitals for precautionary reasons, including the four occupants of the vehicle and a young boy who was in the water at the time, Malphurs added. The boy was in stable condition late Sunday afternoon, Malphurs told CNN.

Video obtained by CNN affiliate WKMG shows a sedan partially in the water off Daytona Beach with visible damage to the front bumper and back doors.

People who saw the car drive through the toll booth and onto the sand said a group of at least 15 people jumped out of the way before the car hit the water.

One witness whose son was in the water said she took off trying to find him when she saw where the vehicle was headed. Another witness said people on the beach rushed to help and that adults with children were in the car.

Officials have not released information about the driver and say the investigation into the incident is ongoing.

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GAO Found Gap in Dirty Bomb Prevention – Government Technology

Monday, July 25th, 2022

The only place people expect and accept radiation is in a medical setting. Outside of thatit is bad, really bad!

What this means is that if you take medical radioactive waste or other radioactive material and combine it with conventional explosives, detonate it, and if it is detectedno one is going to enter that city again for a long, long time.

It is not so much the actual destructive aspect of the explosion, but the spreading of radiation in an area that people fear. The resulting socioeconomic impact is what does the damages.

The above is a low tech way to have maximum impact.

See this NBC News item: How easy is it to get the material to make a dirty bomb? Very, report says

Eric Holdeman is a contributing writer for Emergency Management magazine and is the former director of the King County, Wash., Office of Emergency Management.

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Study: Preventive care scarce in LGBTQ+ community – – Medical Marketing and Media

Monday, July 25th, 2022

Patients who identify as members of the LGBTQ+ community said they receive less information and use fewer preventive care services compared to the overall population, according to a recent study.

A joint report from Phreesia Life Sciences and Klick Health found that gender and sexual identity affects the care received by LGBTQ+ patients.

Nearly half of LGBTQ+ patients over 45 years old said their doctors havent brought up cancer screenings during the last two years. A similar percentage of respondents said that they have received preventive health reminder messages from their doctors offices, which is less than the overall population.

Furthermore, more than 40% said they feel not at all confident that they know which cancer screenings to schedule. Less than 30% reported that preventive care is completely covered by their insurance.

Phreesia associate director of strategy Thea Briggs said the study shows that medical marketers have an opportunity to help close the gap between LGBTQ+ patients knowledge and their use of these services. She added that the pandemic underscored the importance of receiving timely preventive care services and the risks associated with delaying regular visits.

A study conducted by the National Institutes of Health in 2021 found that the pandemic decreased the delivery of preventive care services and contributed to delayed diagnoses, increased mortality and increased health care costs. This phenomenon is especially concerning within marginalized communities and vulnerable patient populations, Briggs noted.

She added that where there have been investments in outreach and communication about health risks to the LGBTQ+ community, like HIV, there are higher levels of understanding and awareness.

Still, there needs to be more focus on encouraging other health protocols, such as routine cancer screenings, Briggs stressed.

One of the important things is to make sure that marketers, for example, when theyre developing information about preventive care, are actively considering these populations and making sure that what theyre developing doesnt exclude people, she explained. They need to make sure that they arent approaching how they disseminate this information in a way that tends towards either the middle of the bell curve or ignores specific communities.

Incorporating more LGBTQ+ voices in the development of educational materials should go a long way toward ensuring that accidental mistakes or unconscious biases dont dissuade patients from receiving timely, necessary care, Briggs said. In addition to imagery in pamphlets or commercials, this could also include listing gender identity on office check-in forms.

These small steps toward a more inclusive patient experience could ultimately reset the baseline for the number of diverse viewpoints involved in such discussions.

Theres a lot that the industry could be doing to better equip both patients and healthcare providers to have these conversations, Briggs continued. At the end of the day, it comes down to two people talking in a room about the most sensitive things in the world. Health is critical and how people identify is a huge part of that.

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The rise of preventive insurance purchases in India – ETHealthWorld

Monday, July 25th, 2022

By Sylvester Carvalho

Lifestyle-related health issues are at their all-time high leading to the early onset of health issues. This, coupled with todays inflated medical prices, makes well-designed, comprehensive health insurance an essential in todays time. The world saw a new wave of disease with the emergence of COVID-19, and it is hence safe to say that the future will see more such illnesses. Adding to this, energy transition, urbanisation, and climate change have bought massive changes in the human health condition.

What is Preventive Health Insurance? As opposed to health insurance that provides financial aid in the event of hospitalisation or treating an illness, preventive health insurance covers the costs of any care received towards preventing the onset of an ailment. While regular general health check-up was standard only for the elderly, the fast-paced way of life is leading to the emergence of health conditions in the late 30s or early 40s among many, leading to the rise in the need for preventive health measures. Some of the most commonly covered preventive health insurance packages include annual check-ups, immunisations, flu shots, fertility tests, screenings, etc.

Lack of awareness and access to preemptive healthcare facilities are the main reasons preventive health care is not prominent in India. As several major health care and insurance agencies invest in preventive health care, the masses will gain access to affordable preventive health insurance.

Many workplaces have also begun considering preventive health insurance as part of their employee health care plan since the rise in the prevalence of chronic and non-communicable diseases. As customer demands and expectations continue to change, insurers are changing ways to adapt their business models to meet new needs and provide relevant products and services. Hence, the insurers are now moving to the approach of Innovate or perish. During the pandemic, the changing consumer behaviour spurred companies to reimagine and build new product strategies to offer relevant preventive insurance products that sustain customer interest, raising the need for preventive insurance.

By Sylvester Carvalho, Lead - Product, Riskcovry

(DISCLAIMER: The views expressed are solely of the author and ETHealthworld does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person / organisation directly or indirectly.)

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Why Are My Feet Always Cold? Cold Feet Causes and Treatment – Prevention Magazine

Monday, July 25th, 2022

If youve tried all of the cozy socks and slid on the best slippers to try and keep your toes warm, but you still experience cold feet on the regular, it may be time to talk to your doctor. Cold feet can sometimes be totally harmless, but they can also be a symptom of more serious conditions.

Anyone can experience cold feet, but its most common in people with high cholesterol, who carry too much weight, are sedentary, smoke, dont follow a well-balanced diet, or have other circulation or inflammation issues, says Brad Schaeffer, D.P.M., board-certified podiatrist and foot surgeon at SOLE Podiatry NYC and star of TLCs My Feet Are Killing Me.

Cold feet are often related to your arteries, which are the blood vessels that blood flows through, says Barbara Bawer, M.D., a family physician at The Ohio State University Wexner Medical Center. When these vessels narrow, they lead to less blood flow to your extremities, including your feet, she says.

Here, we chat with experts to determine why your feet are always cold and how to treat them.

The most common cause of cold feet is a vascular issue or poor circulation where blood is not circulating efficiently to your legs and feet, Dr. Schaeffer says. Its especially important to make note if youre experiencing cold sensations in just one foot, as this may be a sign of peripheral vascular disease which should be treated ASAP, says Dr. Bawer.

Note: If you smoke, have high blood pressure, or have high cholesterol, these can put you at risk for vascular disease or other issues with your blood vessels, which can cause cold hands and feet, says Meghann Kirk, M.D., board-certified internal medicine doctor and pediatrician with MedStar Health.

Think back and consider how often you experience cold feet. For some people, cold hands and feet are simply a result of how their body metabolism works. Unless you also have lost a considerable amount of weight recently, this may just be how your body operates, Dr. Kirk says.

While cold feet can sometimes be normal, you should never ignore a recurring physiological symptom that bothers you, Dr. Schaeffer notes. But it is completely possible its simply an inherited trait that does no harm.

Peripheral neuropathy is a nerve problem that occurs in your extremities, like your hands and feet, explains Dr. Kirk. Symptoms tend to begin at the furthest part away, so nerve issues are often noticed in the legs and feet. Dr. Schaeffer adds if youre experiencing coldness, but your skin itself is not cold, this could be a symptom of a neurological condition.

Dr. Kirk says if youve lost a lot of weight recently, this can change your circulation and cause cold hands and feet. Weight loss can also change metabolism by slowing it down to preserve calories, leaving you feeling chilly. If youre experiencing unexplained weight loss, be sure to let your doctor know as this can be a symptom of a more serious issue.

Some medications have a common side effect of cold extremities. For example, Dr. Kirk says some blood pressure medications may slow down the circulation which could cause your feet to feel colder than usual. Some migraine medications, stimulants or amphetamines, or cancer drugs can also cause cold feet, Dr. Bawer says.

Additionally, some over-the-counter medications, like decongestants, may constrict or tighten blood vessels, Dr. Kirk adds. Always tell your physician about all medications youre taking, because some over-the-counter drugs can interact with prescription medications, she warns.

Peter Deane, M.D., F.A.C.P., medical director at MVP Health Care explains that diabetes can sometimes cause cold feet because the condition is associated with poor circulation. According to the American Diabetes Association, the condition can lead to nerve damage, called neuropathy, which in turn can cause poor blood flow to the feet. Additionally, this can make the blood vessels in your feet and legs narrow and harden, so its recommended to take precautions to keep blood pressure and cholesterol under control.

Though its not super common, Dr. Kirk says an iron deficiency in the diet may make red blood cell counts low, which means your feet will get little oxygen.

This syndrome typically starts in your teenage years or early 20s when fingers and toes turn colors when exposed to a temperature change, Dr. Kirk explains. It can occur on its own suddenly, or happen along with other autoimmune or connective tissue diseases like lupus, rheumatoid arthritis, or thyroid disorders, according to Hopkins Medicine. Be sure to let your doctor know if you notice color changes in addition to temperature changes in your feet.

Low vitamin B12 levels can lead to nerve damage, Dr. Kirk says. Some people dont have the ability to absorb vitamin B12 properly and may have a B12 deficiency, while others (especially those who follow a plant-based diet) may not have enough B12 in their diet. Foods that are high in vitamin B12 include seafood like salmon, clams, and trout, beef liver, milk, and fortified cereal. If you suspect this may be an issue, speak to your doctor ASAP. This can cause cold hands and feet when sick with an infection, UTI, fever, or other illness.

If you havent changed climate and have a sudden onset change in cold feet, this is likely when there is an underlying issue, Dr. Kirk says. And if your feet hurt, or you experience numbness, tingling, or burning associated with the cold feeling, its something to mention to your healthcare provider.

Additionally, any color changes on the skin or around the feet that pop up along with the temperature change should also send a red flag to go see your doc, she adds. This can look like a darkening, purple color, or even a rash. If you cant stand on your tippy toes or high heels (which requires stretching the muscles and nerves in the foot), she also recommends checking in with your doctor.

Talk with your healthcare provider about cold feet. Dr. Schaeffer says your doctor will likely take a complete medical history because there are many reasons you may be experiencing cold feet. For feet and toes, in particular, podiatrists and foot and ankle surgeons are very familiar with how extremities look and react to touch if blood flow is compromised, he adds.

Your doctor will then determine the best treatment for you based on what the cold feet appear to be related to. If its a circulation issue, for example, your doctor may suggest getting up and moving more often to get the blood flowing, reducing your intake of fatty and sugary foods, drinking more water, elevating your feet, or wearing compression socks.

Additionally, Dr. Deane says cardiovascular exercise can help increase blood flow, medications to treat the underlying problem can offer relief, and in extreme cases, bypass surgery in the legs may be necessary if the arteries are blocked.

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Agency looking to open overdose prevention site in Saint John amid ‘poisoned’ drug supply – CBC.ca

Monday, July 25th, 2022

A harm reduction organization in Saint John is preparing to apply to Health Canada for a licence to operate an overdose prevention site, as they grapple with a "poisoned" drug supply on the street.

Julie Dingwell says three clients of Avenue B died last week, and a couple more in the week before that.

Some were experienced drug users, but Dingwell said the addition of fentanyl in street drugs means people no longer know what they're taking.

"We're just in constant grief here with losing people," said Dingwell, who is Avenue B's executive director. "We lost a couple people that we've worked with for 20 years."

Avenue B is planning to build a new facility on Waterloo Street in Saint John's uptown, but in the meantime, Dingwell is looking for another spot to open the overdose preventionsite.

For her, the need is urgent, a matter of life and death.

"We just want to keep people alive," she said.

It would be the second overdose prevention site in the province, after Ensemble Greater Moncton opened a site late last year. The clinic offers people a safe place to test and use their substances, where staff can intervene if they have a negative reaction.

In March, after a spate of opioid overdoses in the community, at least two people were revivedat the Moncton site.

"Their site has gone very well," Dingwell said.

"I'm hoping the province looks at that and says, 'Oh look, it's been so successful in Moncton, we're ready.'"

Saint John Police Chief Robert Bruce said officers used to see a call for an overdose once every three or four days. Now, Bruce said it's not uncommon to see one or two calls per shift.

Overdose calls were up 30 per cent between January and April of this year compared to 2021, which was already up significantly over the same stretch in 2020, according to Bruce.

In some of those cases, people have died and Bruce said testing from the coroner has found "much higher levels of fentanyl."

"Some of the people know what they can handle and what they can'tbecause they've been addicted for some time," he said.

"When they overdose, then you know something isn't right."

All of the police force's supervisors carry Narcan, which can be used to revive someone after an opioid overdose. Sometimes it can take two or three doses, Bruce said, because of the "increasing toxicity" of the drugs.

"We're just about to go to Narcan in every car for our members, just because of the amount of people that we're running into," Bruce said.

"Before it was alright to have a patrol supervisor that had it and could bring it to you fairly quickly, but now we're finding that our officers are going to more of these, so they require it in the vehicle."

Like Dingwell, he too feels there's a sense of urgency when it comes to Avenue B's plan to open an overdose prevention site.

"Avenue B, they're on the ground, they're there every day, they're looking into the eyes of people," Bruce said.

"They know what the issues are. So if they're looking at trying something new, then I'm totally interested in finding out what we can do, how we contribute, how we can work together to try to at least minimize the overdoses that we're seeing."

Bruce has created acommunity action group with "on-the-ground practitioners" ranging from Dingwell with Avenue B, to other social agencies, youth services and provincial correctional staff. It's all part of a belief Bruce hasthat police can't arrest their way out of the problem, that it requires solving deeper social issues.

One committee within that group focuses specifically on substance use, in addition to committees on connected issues like homelessness.

"We're a relatively small city comparatively in this country, but we certainly have big city problems here," the police chief said.

"They're related to mental health, substance use and homelessness."

At Avenue B, Dingwell is assembling a team to "get everything in order" ahead of applying for a licence to operate the overdose prevention site. Once they get a green light, Dingwell believes they'll be ready to move quickly to open.

But first, the non-profit agency needs support from the provincial government to hire staff and outfit the site.

"Implementing overdose prevention sites" is listed as a priority in the province's 2021-25 mental health and addiction plan, but the government hasn't provided a timeline for when it might fund additional overdose prevention sites.

No one from the Department of Health was made available for an interview.

"Overdose Prevention Sites (OPS) provide a much-needed service to people who use various substances, especially for those who are precariously housed or homeless," Department of Health spokesperson Coreen Enos wrote in an emailed statement.

Enos said the department is continuing "to work with community partners to understand the needs and support the community-led plans for more Overdose Prevention Sites across New Brunswick."

"When those details are finalized, the provincial government will have more to share with the public," Enos wrote.

Beyond an overdose prevention site, Dingwellwould like to see a safe supply of opioids. A clinic in the city offers a safe, prescribed supply, but Dingwell said it's not enough for the "hundreds" of clients at Avenue B. She would also like to see the government decriminalize possession of some substances for personal use.

"We just have to be thinking much harder about what we can do to keep people alive," she said.

"It's terrible the amount of ongoing grief that we have to work with."

When asked about the idea of decriminalization, Bruce said nothing should be off the table. He said the New Brunswick Chiefs of Police are studying the effect of decriminalization in British Columbia.

"What we're doing now isn't working that well," he said. "So there must be other ways to do it. We have to do a better job."

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UVA Expert Offers Insight on the Use of Dietary Supplements for Cancer Prevention – UVA Today

Monday, July 25th, 2022

The Conversation asked Katherine Basbaum, a clinical dietitian at UVA Health who specializes in cardiovascular disease, to explain what this recommendation means for the general public, particularly those who are currently or considering taking dietary supplements in hopes of preventing cancer and cardiovascular disease. In this Q&A with Basbaum, she interprets the data behind the task forces conclusion.

Q. What was the basis of the task forces recommendation?

A. The U.S. Preventive Services Task Force evaluated and averaged the results of multiple studies looking at health outcomes associated with beta carotene and vitamin E supplements. Beta carotene is a phytonutrient or plant chemical with a red-orange pigment; both beta carotene and vitamin E are found in many fruits and vegetables such as carrots, sweet potatoes, kale, spinach, Swiss chard and avocados, to name a few.

The panel of experts concluded that with regard to the prevention of cardiovascular disease or cancer, the harms of beta carotene supplementation outweigh the benefits and that there is no net benefit of supplementation with vitamin E for those purposes. Their recommendation applies to adults who are not pregnant and excludes those who are chronically ill, are hospitalized or have a known nutritional deficiency.

Beta carotene and vitamin E are powerfulantioxidants, substances that may prevent or delay cell damage. They are commonly taken as dietary supplements for their potential health and anti-aging benefits, such as to combat age-related vision loss and the inflammation associated with chronic disease. Vitamin E has also been shown tohelp support the immune system.

Our bodies do requirebeta carotene and various nutrients for a variety of processes, such as cell growth, vision, immune function, reproduction and the normal formation and maintenance of organs. But it is important to point out that more than 95% of the U.S. population receivesadequate levels of vitamin A, vitamin E and beta carotenethrough the foods they consume. Therefore, the average healthy adult likely does not need additional supplementation to support the processes mentioned above.

The task force did not focus on other potential benefits of vitamin supplementation. It noted that there may be other benefits of some supplements that were not covered in this review owing to its focus on cardiovascular disease and cancer prevention.

Q. What risks did the task force point to?

A. Based on its review of the evidence, the expert panel concluded that beta carotene supplementation likely increasesthe risk of lung cancer incidence, particularly in those at high risk for lung cancer, such as people who smoke or who have occupational exposure to asbestos. It also found a statistically significantincreased risk of death from cardiovascular diseaseassociated with beta carotene supplementation.

In one of the clinical trials reviewed by the task force for their recommendation statement, people who smoked or had workplace asbestos exposure were atincreased risk of lung cancer or death from heart diseaseat doses of 20 and 30 milligrams per day of beta carotene. This dosage is higher than the standard recommendation for beta carotene supplementation,which ranges from 6 to 15 milligrams per day.

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Alzheimer’s: Targeting key protein in blood may slow progression – Medical News Today

Monday, July 25th, 2022

A new study published in Molecular Psychiatry demonstrated that replacing the blood of an Alzheimers disease (AD) mouse model with the blood of a wild-type mouse reduced the levels of AD brain markers and improved spatial memory in the mouse model.

Although the mechanisms underlying these findings remain unclear, the results suggest that manipulating certain components in the blood could help treat AD.

Targeting components in the blood for the treatment of AD can help bypass the challenges associated with developing drugs that can cross the blood-brain barrier.

AD is the most common form of dementia, accounting for 60-80% of all dementia cases. More than 6 million individuals in the United States currently have AD and projections indicate that this number is may reach 13 million by 2050. Thus, there is an urgent need for effective treatments for this condition.

A central characteristic of AD is the abnormal accumulation of the beta-amyloid protein into deposits, known as plaques, in the brain.

Single units, or monomers, of the beta-amyloid protein tend to aggregate together to form short chains called oligomers. These soluble oligomers aggregate to form fibrils, which later form insoluble plaques. Experts consider these beta-amyloid aggregates to be responsible for the damage to brain cells in AD.

Beta-amyloidmonomers are produced in the brain and also in other organs. Beta-amyloid monomers and oligomers can cross the blood-brain barrier, passing from the brain to the blood and from the blood to the brain. The beta-amyloid protein is broken down in peripheral organs, including the kidneys and the liver, which explains its presence in blood.

Moreover, research suggests that there is a close association between beta-amyloid levels in the brain and the bloodstream.

In a study conducted using a genetically engineered or transgenic AD mouse model, receiving blood from older, transgenic mice with beta-amyloid deposits accelerated the formation of beta-amyloid deposits in younger transgenic animals.

In contrast, isolating the beta-amyloid protein in the blood using antibodies that cannot cross the blood-brain barrier can reduce the levels of beta-amyloid deposits in the brain.

Similarly, surgically connecting the blood circulation of a wild-type mouse with that of a transgenic AD mouse model can reduce the levels of beta-amyloid deposits in the brain of the rodent.

These data suggest that beta-amyloid protein levels in the blood could impact the levels of beta-amyloid deposits in the brain. Thus, treatments that lower beta-amyloid levels in the blood circulation could be used to slow down the progression of AD.

In the present study, the researchers examined whether the partial replacement of the blood of a transgenic mouse model of AD with the blood of wild-type mice could reduce the levels of beta-amyloid in the brain of the mouse model.

During the blood exchange treatment, the researchers withdrew 40-60% of the blood from the transgenic mice and replaced the withdrawn blood with blood from healthy wild-type mice.

They started this blood exchange treatment when the transgenic mice were 3 months old which means they were mature adults and before the onset of the formation of beta-amyloid plaques.

This blood exchange procedure was performed once a month for the next 10 months until the mice were 13 months old, or middle-aged.

Unlike the untreated transgenic mice that showed beta-amyloid plaques at 13, the transgenic mice receiving the blood exchange treatment showed fewer plaques and a lower plaque burden, which is a measure of the area of the brain covered by plaques.

The researchers also assessed the impact of the blood transfusions from wild-type mice on the memory of the transgenic AD mouse models at 12.5 months of age.

The transgenic mice from the blood exchange group performed better in short-term and long-term spatial memory tests than untreated transgenic mice. Furthermore, the performance of the mice in the blood exchange group was similar to wild-type mice.

In a similar experiment, the researchers continued the monthly blood exchange procedure until 17 months of age. They used the data from the mice sacrificed at 13 and 17 months of age to assess the rate of plaque growth during this period.

The researchers thus found that the blood exchange treatment slowed down the rate of plaque growth.

In the first set of experiments, the researchers started the blood exchange procedure in 3-month-old mice before the development of beta-amyloid plaques.

To examine the potential of this procedure for the treatment of AD, the researchers started the monthly blood exchange treatment at 13 months when transgenic mice tend to show beta-amyloid deposits in the brain and memory deficits.

The researchers found that transgenic mice receiving blood exchange treatment showed fewer beta-amyloid plaques and lower plaque burden at 17 months of age than age-matched untreated transgenic mice.

Moreover, the plaque burden in the 17-month-old transgenic mice receiving the blood exchange treatment was similar to untreated transgenic mice at 13 months. These results suggest that the blood exchange treatment prevented further accumulation of beta-amyloid plaques.

Notably, the performance of the transgenic mice in the blood exchange treatment group in the spatial memory tests was similar to age-matched wild-type mice and better than age-matched untreated transgenic mice.

These experiments show that blood exchange could serve as a disease-modifying treatment, which delays or halts the progression of AD.

The researchers found that beta-amyloid levels in the blood of the transgenic mice increased soon after the blood transfusion from wild-type mice.

Thus, it is possible that the lowering of blood beta-amyloid levels upon the introduction of blood from wild-type mice could enhance the transfer of beta-amyloid from the brain to the bloodstream. This might be a mechanism for the decline in brain beta-amyloid levels due to the blood exchange procedure.

However, the researchers did not directly remove beta-amyloid from the blood of the transgenic AD mouse model and other proteins or factors in the blood could also explain these results.

Thus, more research is needed to characterize the blood components and pinpoint the mechanisms underlying the impact of the blood exchange treatment on memory and beta-amyloid plaques.

The characterization of the blood components underlying these effects of the blood exchange treatment could facilitate the development of treatments for AD patients.

The studys lead author, Dr. Claudio Soto, a neurology professor with McGovern Medical School at UTHealth Houston, told Medical News Today that procedures such as plasmapheresis and blood dialysis could be adapted to remove the beta-amyloid protein from the blood or other blood components and treat individuals with AD.

Dr. Soto noted that [s]tudies in mouse models are necessary as a first step to analyze the efficacy of a therapeutic strategy. Of course, he added, mice are not humans, so we would need to show that our approach works in real life with real patients.'

Whole blood exchange as we did in this study is not feasible in humans [as such], but there are two technologies currently in common medical practice that may work: plasmapheresis and blood dialysis. We are currently adapting these techniques for mice studies and if we obtain positive results, the next step will be to start some clinical trials in humans affected by AD.

Dr. Claudio Soto

We also spoke with Dr. Erik S. Musiek, a professor of neurology at Washington University School of Medicine in St. Louis, who was not involved in this study.

Commenting on the study, Dr. Musiek noted: The authors focus on the idea that there is a pool of beta-amyloid in the periphery that is in equilibrium with that in the brain, and that adding blood with minimal beta-amyloid creates a sink by which beta-amyloid transfers from the brain to the blood, limiting plaque formation. This peripheral sink hypothesis has been around for a long time and has been demonstrated in mice after [the] administration of Abeta antibodies.

However, there are likely many other possible mechanisms at play here, he cautioned. Moreover, according to Dr Musiek, [t]he fact that the blood donors are young, while the AD model mice receiving the blood get quite old (13 months), suggests that there may be factors in the young blood which directly limit beta-amyloid pathology and promote cognition.

It is also possible that the fresh, young blood alters the immune response in the brain of the recipients, facilitating beta-amyloid metabolism Dr. Musiek hypothesized. Finally, it remains unclear if blood exchange in mice that already have [a] significant plaque burden can enhance [the] removal of plaques, as opposed to [preventing] their initial accumulation.

This is very important, as we generally identify people with preclinical AD based on the fact that they already have plaques, and primary prevention therapies to prevent that gradual plaque accumulation are very difficult to implement in humans. However, this study certainly reveals a very interesting phenomenon and should inspire future research, said Dr. Musiek.

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NPPC, FAS focused on ASF prevention in the Philippines – MEAT+POULTRY

Monday, July 25th, 2022

WASHINGTON Following the notice ofa trade missionto the Philippines, The National Pork Producers Council (NPPC) announced it would work with the Foreign Agricultural Service (FAS) on a project to help the fight against African swine fever (ASF).

Leaders from the Philippine Department of Agriculture and the Minnesota Department of Agriculture will start the project focusing on risk assessment to support safe trade of US pork products in the Philippines.

NPPC is proud to have worked with the Philippine government, US government, and the University of Minnesota to see this grant proposal to the finish line, said Terry Wolters, president of NPPC. Creating international partnerships provides further safeguards to keep American agriculture safe from foreign animal disease so US pork producers can continue to provide consumers in both countries with safe and affordable pork products.

In recent years, the Philippines dealt with ongoing ASF outbreaks and continues to seek better ways to control the virus which ties into food price inflation.

NPPC said it worked with the Philippine embassy to determine the needs of the government and producers ASF outbreak management.

The associations international affairs team partnered with the University of Minnesota to develop a proposal for government assistance which FAS agreed to for both the Philippines and Vietnam.

The knowledge to be gained from the program is a win-win for both countries as it will help us better understand how to prepare, prevent and mitigate a potential ASF outbreak, said Andres M. Perez, DVM, PhD, professor, Department of Veterinary Population Medicine at the University of Minnesota. Assisting other countries to implement control measures that reduce the spread of the disease simultaneously limits the risk to the US pork industry.

Perez also directs the universitys Center for Animal Health and Food Safety (CAHFS).

The new program will also include workshops for provincial officers and intense in-person training of fellows identified by the Philippine Department of Agriculture. Asynchronous training will also be available for participants on material developed and delivered in advance of the workshops.

NPPC wants to thank USDA for funding this program and their broader commitment to prevention and preparedness against ASF and other foreign animal diseases, Wolters added. This program ties in well with the $500 million committed by USDA for ASF preparedness and prevention and the recently launched USDA Borlaug Fellowship Program aimed at developing quick and affordable testing kits for African swine fever and other transboundary animal diseases.

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NPPC, FAS focused on ASF prevention in the Philippines - MEAT+POULTRY

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Implementation of IPT in people living with HIV | RMHP – Dove Medical Press

Monday, July 25th, 2022

Introduction

Successful implementation of healthcare innovations is not an easy-going process. It was shown that only a small fraction of such innovations are ever put into practice.1 Innovation can be an idea, a health intervention, technology, or practice that is perceived as new to an existing system.2 The diffusion or implementation process of an innovation encompasses a complex chain of processes that require non-stop advocacy programs, sensitization workshops, trainings and other systematic approaches to persuade users and facilitators to ensure their acceptability.2,3 Once the innovation is accepted by the implementors and users, it is then easier to ensure its successful implementation. Acceptability is an important outcome measure used to assess implementation success of an innovation.4,5 Healthcare providers acceptability of healthcare interventions is known to be key to success.6 Acceptability is defined as a perception among implementation shareholders that a given treatment, service, practice or innovation is agreeable, palatable, or satisfactory.7

Isoniazid Preventive Therapy (IPT) is one of the healthcare innovations recommended by the World Health Organization (WHO) to reduce the development of active tuberculosis (TB) in people living with HIV (PLHIV).8 As per the recommendation, eligible countries are expected to achieve at least 90% IPT coverage to ensure successful protection. Despite efforts made by member states, the global uptake of IPT in newly enrolled patients at HIV clinics was reported to be very low, ie 46%.9 Different studies conducted in different parts of the world reflect that roll out of IPT have been affected by multifaceted problems such as health system-related factors (inadequate political support, increased workload, stock-outs of IPT, inaccuracy of TB screening tools to exclude active TB, and shortage of isoniazid and tuberculin skin tests); HIV control programs-related factors (limited engagement of healthcare providers during introduction of IPT, poor integration of IPT-related services including TB/HIV collaborative activities, unclear IPT guidelines and standard operating procedures, lack of national consensus on IPT-related services, limited training, and weak monitoring and supervision); provider-related factors (perceived fear of isoniazid resistance, peer influence, negative perception on the benefits/risks of IPT, rumors and misconception about IPT); product-related factors (long duration of IPT, adverse effects); and patient-related factors (non-adherence, pill burden).1015

Eritrea has a TB incidence rate of 67 cases per 100,000 people16 and HIV prevalence of 0.93% in the general population17 and 0.65% of pregnant women attending antenatal care services.18 When the Ministry of Health decided to programmatically introduce IPT, guidelines on its roll out was incorporated in the national Comprehensive HIV/AIDS Care Manual.19 Despite efforts made by the communicable disease control (CDC) program to maximize IPT uptake, the overall average implementation coverage was insufficient, 75% (range: 1285%)20even though it was better than the global average.9 Anecdotal reports show that there was resistance from healthcare professionals on the implementation of IPT which might be among the barriers to implementation. However, no documented information is available on the healthcare providers perception, acceptability and the possible influencing factors on IPT implementation. This qualitative study was, thus, conducted to explore the perspectives of healthcare providers and professionals working in the CDC program on the factors that caused limited implementation of IPT in Eritrea.

This was an exploratory qualitative study that used a framework content analysis to explore the factors limiting the implementation of IPT in Eritrea. An in-depth interview with senior HIV care clinic prescribers were carried out between October 13, 2020 and February 22, 2021. Key informants interview (KII) with senior staff of the CDC division was also conducted on November 1011, 2021.

This study was conducted in HIV care clinics in all Eritreas regional referral hospitals, namely: Hazhaz, Keren, Barentu, Assab, and Mendeferra, and Massawa hospitals and one national referral hospital, ie, Halibet national referral hospital. These clinics serve for about 65% of all PLHIV in Eritrea. All interviews were conducted in a quiet place, and there were no other participants present during the interview.

Purposively selected senior physicians and nurse practitioners working in the HIV care clinics at national and regional referral hospitals were enrolled for in-depth interviews. HIV care clinic prescribers (physicians and registered degree nurses) who had the longest years of working experience were included in the study. Though these were the pre-set criteria for selection, all prescribers working in the HIV care clinics of the regional referral hospitals were included as they were few in number. From Halibet National Referral Hospital, one of the two prescribers was purposively selected and interviewed. Eritrea has two national referral hospitals that have HIV care clinics, Hablibet and Orotta. Prescribers at Orotta National Referral Hospital, which had good uptake of IPT and served both adults and pediatrics, were not interviewed as we had already reached a theoretical data saturation point. Nurse practitioners and counselors who were involved only in counseling and refill of medicines were excluded from the study as they had no decision-making power in prescribing medicines. Anecdotal reports showed that implementation of IPT was poor in the majority of regional referral hospitals and that was later confirmed by a recent study.20 For this reason, priority was given to the prescribers from the regional referral hospitals. The large number of PLHIV served by regional referral hospitals and their prescribers potential influence on other prescribers working in the lower-level health facilities were also additional reasons. The sample size was determined by a theoretical data saturation at which no new information was gathered by additional interviews. Senior staff of the CDC of whom it was expected that they could provide adequate information on the planning and implementation efforts of IPT were also purposively selected as key informants.

MR is a pharmacist, pharmacoepidemiologist and pharmacovigilance specialist and was a PhD student during the data collection period. He works for the National Medicines and Food Administration (NMFA) of Eritrea and is a trained and experienced professional in designing, conducting and reporting qualitative studies. Though the interviewer had no affiliation with the study sites, he had a work-related relationship with some of the participants. The participants were well aware that the researcher and his colleagues were conducting the study to explore how people feel about the value of IPT in Eritrea, and to identify factors limiting implementation of IPT and possible solutions. The other authors had no direct role in the data collection process or interviews. DYBJ is an epidemiologist with experience in mixed-method research, and he is a PhD student at the Erasmus Medical Centre, the Netherlands. ST, a pharmacist working for the NMFA, is an experienced researcher in qualitative studies. BHS and KV, who supervised the research project, are pharmacoepidemiologists working for the Erasmus Medical Centre as professor and associate professor, respectively.

A semi-structured interview guide (S1) adapted to the local context from a similar study conducted previously10 was used for the in-depth interviews. The interview guide aimed to explore the overall impression of prescribers towards the implementation of IPT, multi-level factors that could affect successful implementation of IPT, and areas of improvements.

All interviews were done by one of the researchers (MR), and all except two in-depth interviews were conducted face-to-face by following COVID-19 prevention protocols. Data from the two respondents who were not interviewed face-to-face was collected using telephone interviews as one respondent was not available during the data collection visit and the other was working about 800 kilometers away from the interviewers address. Prior to each interview, the interviewer introduced himself and the objectives of the study, and provided information with regard to a consent. Consent for all the interviewees was taken verbally and was audio-taped for audit trail. Appointments were made in advance with every interviewee at his/her convenience and the timing of the interview was recorded. All interviews were audio-tapped, upon consent, for full documentation and to allow quote verbatim statements or phrases. Probing questions were included in the interviewers guide, but additional follow-up questions were asked as appropriate. Based on the objective of the study, the questions including probes were focused on exploring the factors limiting the IPT implementation. Facial expressions, sense of confusion and reluctance of interviewees, if any, were documented by the interviewer. All interviews were successful at the first attempt and thus, there was no need for repeated interviews. Data coding was performed in parallel to the interviews. All interviews were conducted within the study sites in a local language, Tigrigna. The average time taken for each interview was about 19 minutes long (range: 1026 minutes).

A semi-structured KII guide was self-developed based on the preliminary findings of the in-depth interviews of the prescribers. Key informants were senior professionals working at the CDC division, including HIV and TB control programs. The KII guide was mainly designed in a way to confirm claims made by the prescribers, understand the key informants assumption on possible causes of the problem, assess the extent of planning and efforts made in implementing IPT as well as what they would do differently to avoid problems in the future (S2). Interviews were carried out in their workplace with no other participants. All interviews were successful at the first attempt. Other procedures of data collection such as audio-taping, consent, record of the interview duration, medium of interview [language], and use of probes and follow-up questions were the same as what was followed for the in-depth interview of the prescribers.

All audio records were transcribed verbatim and translated into English by nine research assistants, all pharmacists. Each transcribed and translated interview was again validated by another research assistant. Finally, each transcription and translation was approved by the lead investigator (MR). After repeated reads of the verbatim translation, data was coded and charted by MR and DBYJ. During data familiarization, important phrases or words that were related to the topic of interest were identified and coded by selecting a significant word or phrase from the interviewees statement. No software was used to code or manage the data. Codes were revisited several times, merged, split and modified as appropriate. Codes along with their summary notes were then charted in an Excel spreadsheet to look at patterns and ensure consistencies of data coding. Similar codes were aggregated and classified into meaningful categories. The major categories were labelled as themes and named as appropriate. Sub-categories of every theme were considered as sub-themes. To illustrate the themes and sub-themes, selected quotations are presented and each quotation is accompanied by a coded participant number. Prescribers are coded as HP1, HP2, etc., while key informants are coded as KI1, KI2, and KI3.

To better understand the problem, a conceptual framework model was developed using a problem tree analysis or root cause analysis.21 To do this, the existing problems were first identified from the generated themes and sub-themes. A core or central problem of the overall problem, which is expected to be the trunk of the problem tree, was identified. At the end, causes and effects (consequences) of the central problem were identified. The themes and sub-themes were identified to be the causes and/or effects of the central problem(s). Finally, a conceptual framework model was developed and designed as a problem tree diagram for better visualization (Figure 1).

Figure 1 Conceptual framework model describing the factors that affect or limit the implementation of isoniazid preventive therapy (IPT) in Eritrea, 2021.

Abbreviations: ADRs, Adverse drug reactions; DILI, Drug-induced liver injury; HCPs, Healthcare professionals; INH, Isoniazid; SOPs, Standard Operating Procedures.

The study was reported according to the Standards for Reporting Qualitative Research (SRQR) and Consolidated Criteria for Reporting Qualitative research (COREQ).22,23 The manuscript was shared with study participants to check its appropriateness.

Overall, in-depth interviews with 11 prescribers working in HIV care clinics and three senior key informants working in the CDC Division of the Department of Public Health of the Ministry of Health were conducted. None of the approached prescribers and key informants refused to take part in the study. The demographic details of the study participants are depicted in Table 1. Theoretical data saturation was reached at the 10th prescriber and confirmed after another prescriber was interviewed, and no new information was gathered.

Table 1 Demographic Characteristics of the Study Participants Involved in Interviews on Factors Limiting Implementation of Isoniazid Preventive Therapy in People Living with HIV in Eritrea

In an effort to identify the factors that limit implementation of IPT in PLHIV in Eritrea, five themes and 13 sub-themes emerged from the in-depth interviews and KIIs. The main themes and sub-themes are summarized in a thematic framework analysis (Figure 1). Based on the perspectives of the healthcare professionals and key informants, five multi-level factors that are related to (1) health systems, (2) the National HIV Control Program, (3) healthcare professionals, (4) the product itself, and (5) patients were reported.

This domain captures system-related elements that are mainly associated with the then existing laboratory setup and its challenges.

Unavailability of chemistry laboratory and shortage of laboratory supplies, especially, in the regional hospitals, were among some of the frequently reported challenges for implementation of IPT. Even though the national HIV guideline did not require routine liver function tests for initiating IPT in PLHIV, due to fear of drug-induced liver injury, some of the clinicians reported that unavailability/inadequacy of chemistry laboratory test was one of the major challenges for IPT implementation. Complete dependence on clinical monitoring was also reported to be impractical, as some patients without clinical signs were found to have markedly elevated liver enzymes. Initiating IPT without having baseline information was reported to be challenging. This was reported by one of the HIV care clinic prescribers as follows:

Here we have no chemistry lab and we usually do not dare to start IPT without baseline data. Incidence of hepatitis in our zone is high and thus, it is difficult to start IPT without having baseline data. [HP1]

Another respondent from another health facility also raised the laboratory-related issue as a central problem for the poor uptake of IPT in their setting and stated it as:

There is a need to take baseline [lab] tests. Hepatitis B & C testing and LFT are a must and you cannot put someone on IPT without those tests. But this has been a constant problem for us. I mean, hepatitis B & C testing has been unavailable for several months. The biggest issue therefore is the laboratory. Other constraints are subjective and are not as important. If lab tests were available, there wouldnt have been problems because we would be able to detect and explain scenarios. [HP3]

In situations where chemistry laboratory was available, intermittent stock-outs of laboratory supplies for testing hepatitis B and C, as well as liver function tests, were reported as a challenge. Accordingly, for patients that were suspected or at risk of developing isoniazid-induced liver injury, blood specimens were sent to the National Health Laboratory which was reported as discouraging due to delays in obtaining results.

Few prescribers reported that stock-outs of INH, though infrequent, as a setback in implementing IPT. Although this problem is categorized under the system-related factors, it can also be program-related as the procurement and supply chain management of the CDC have been playing a role in ensuring the availability of INH. One prescriber reported:

Our main reason for not starting IPT was mainly the unavailability of INH. Otherwise, we have no problem to start INH. [HP7]

Using inductive approach, several limiting factors, related to the National HIV Control Program, such as inadequacy of information, lack of collaboration and ownership, inadequate preparation, and lack of outcome evaluation, were identified and labeled as program-related factors.

Implementation of the IPT without adequate planning, advocacy, engagement of healthcare professionals (HCPs), working documents such as registers, guidelines and standard operating procedures (SOPs), awareness raising activities, regular follow-ups, and so on were reported as major challenges for successful implementation of IPT. Inadequate preparation was one of the most often reported problems by prescribers. From their perspectives, all the aforementioned issues should be addressed prior to the introduction of IPT. A key informant acknowledged this as follows:

We should have prepared a good guideline before starting to implement the IPT [six months isoniazid]. We should have collected cohort based-data until patients complete their six-month INH regimen and analyzed it as appropriate. Besides, continuous training should have been given to healthcare professionals and the consumers of IPT. Campaigns targeting consumers on the consequence/risks of TB on PLHIV and the benefits of the IPT should be have been carried out by their [PLHIVs] association. [KI1]

The key informants also disclosed that the program did not take adequate measures in planning and implementation of the intervention. The above KI also reported the inadequate preparation as follows:

I do not believe that adequate measures were taken [by the program]. Advocacy and sensitization were not as it should be. There was not even a register and also no SOPs. The guideline was not in-depth. The program was only following whether it [isoniazid] was started; monitoring tools that can measure final outcomes were not in place. Meaning, there was no follow-up approaches. [KI1]

Deployment of IPT without provision of adequate information to healthcare professionals on benefits/effectiveness of INH, its risks, how a six-month IPT intake could prevent TB for several years, risk of resistance, adverse drug reaction monitoring, etc., were reported among the major factors for hesitancy. The ART clinic physicians asserted that the intervention was introduced without adequate training/sensitization to healthcare professionals.

One of the prescribers disclosed that they had been administering INH to prevent incidents of TB in children having contact with TB patients with full confidence as they had enough information on it. As for the INH preventive therapy in PLHIV, due to limited information on its clinical benefits, potential risks and how the mechanism works, the importance of its implementation was reported as doubtful. The significance of inadequate information in limiting the implementation of IPT was explained by an ART clinic physician, who was not in favor of it, as:

If I could get someone who can tell me all the benefits and risks of implementing IPT in detail and found it convincing, I would definitely initiate it to my patients. [HP5]

The clinician also added:

This has always been in my agenda. We have pressure [from the program] to start implementing it [INH] but with the existing rumors and the limited knowledge we have, we could not dare to start IPT. If the study you have been conducting comes up with concrete answers/information that favors its implementation, we will use it. [HP5]

There were claims that there was lack of coordination, collaboration, and stakeholders engagement and that policy-making decisions related to the introduction of IPT were made behind closed doors. Some of the stakeholders were dissatisfied with communication gaps because they were unable to get involved and did not consider themselves as part of the process. The HIV/TB collaboration was reported to be very weak and the two programs had no sense of collaboration in implementing IPT. This was considered as one of the contributory factors. One prescriber said:

It has been forgotten by all parties. Currently, everyone does not know how to move forward as there is no unified approach. [HP6]

Some of the HIV care clinic prescribers claimed that they were not part of the planning process when IPT was introduced. It was reported that there was a rush from the program and HIV care clinics were simply instructed to implement IPT without clear guidelines and adequate orientation. One of the key informants acknowledged the prescribers claim as follows:

Most of them have no good impression on it [IPT]. Usually, as program managers, we insist on implementing IPT. We tell them that it is important for patients. When I see its acceptability even by the counselors, it seems low. They usually say, if we are instructed to do so we will do. Thus, instead of just ordering to implement the TB preventive therapy, it would be good to involve senior ART clinic physicians prior to introduction. It is not good to simply order or impose without providing adequate information and reaching to consensus. [KI2]

Unavailability of evidence to evaluate the impact of the intervention in Eritrea, despite its use for many years, was also reported as a limiting factor. Some prescribers reported that the unavailability of local data on the benefits and risks of the intervention was discouraging. They had the expectation that the program could regularly evaluate the impact of the intervention so that they could build confidence in it. One of the key informants reported the limitations as follows:

In the past, except the number of people who started isoniazid, we had no information on how many people have completed the preventive therapy, how many of them experienced ADRs, discontinued treatment, experienced hepatotoxicity, and died. The information we have so far is mainly from the studies conducted recently [by the authors]. [KI1]

Fear of ADRs, peer influence/rumors, doubts on duration of protection of IPT and effectiveness of IPT in settings with high latent TB infection, as well as fear of INH resistance and genetic polymorphism were some of the prescriber-related factors that were reported to affect the implementation of IPT.

Some healthcare professionals were not encouraged to administer INH due to fear of potential risks of ADRs. Though they personally had no patients with serious adverse effects, they had the understanding that INH could cause serious hepatic injury especially when there are no laboratory monitoring strategies. Accordingly, several prescribers disclosed that they were sometimes asking their patients if they would like to start IPT, but they had no courage to motivate them. One prescriber said:

We simply ask patients to take IPT, but we dont motivate them because of the risks of ADRs. [HP4]

The interviews indicate that a few fatal experiences of hepatic injury had tremendous impact in creating hesitancy in several prescribers. Two prescribers reported their source of hesitancy as follows:

At this time, we all [our staff] have fear of starting IPT. We had a patient who had good adherence to his medications. One day one of our staff, who had close contact with him, met him in town and she up-front informed him about the new TB preventive therapy being introduced [isoniazid] and encouraged him to come and start it. He completely agreed and came the next day. Within one month following initiation of isoniazid, he developed severe hepatotoxicity and died within a short period of time. As a consequence, the condition was traumatizing, though it was a single experience. [HP2]

One patient died with complications of hepatic injury, yet; other patients begun to question the drug and even healthcare professionals started to have some sort of fear on deciding to whether they should put their patients on INH. This was the biggest problem in patients as well as health workers. It even influenced me. This was a big set-back to be frank. [HP3]

On the other hand, a few prescribers mentioned that INH is tolerable and incidence of hepatic injury was minimal.

A fast-spreading rumor related to a few fatal hepatic injuries was reported to be influential in intensifying healthcare professionals and consumers hesitancy on the IPT. For this reason, some prescribers reported that they had no confidence to initiate IPT with their patients and were waiting for further evidence that would help them to take informed decision. Two prescribers stated the impact of the rumors as follows:

Even recently we have been instructed by the program to start IPT but we are not encouraged with the existing rumors. [HP5]

we heard from the HIV focal persons that there is a controversy surrounding it [INH] that put us in a limbo. So, we had to wait for further data and thus, we havent started with any new patients [HP6]

Another prescriber also reported that the rumor was spreading fast and reached out to patients and the Bdeho (HIV patients) association that triggered discussions with the program.

For some prescribers, it was not clear how a six-month IPT could prevent incident TB for several years. Based on the national guidelines, some prescribers had the assumption that a six-month IPT could protect all their patients from TB for about five years. In clinical practice, observing a short-lived protection of TB in some patients was reported as discouraging/conflicting. Moreover, the fact that different studies show inconsistent lengths of duration of protection of IPT in PLHIV was described as confusing.

Two prescribers argued that administering IPT in settings where latent TB infection is common could not be effective. They had the assumption that it might work in the developed world but not in their settings (Eritrea) as almost every HIV patient could have latent TB due to environmental contamination and poor standard of living. One prescriber stated this as follows:

There are arguments that latent TB is common in all our setting and thus, administering TPT will not be effective; maybe in developed countries. Hence, there are many healthcare professionals who do not accept it. [HP9]

While some of the key informants had the assumption that adverse effects of INH could be the main source of hesitancy, some prescribers voiced that the risk of antibiotic [INH] resistance was a concern. Unavailability of information on INH acetylation profile of the Eritrean population was also reported as a concern by one prescriber.

It was reported that following observation of serious hepatic injuries in some patients, with fast spreading rumors, others started to get concerned of the adverse effects of the intervention. Pill burden was also another issue mentioned as a barrier to implementing IPT. One prescriber mentioned this as follows:

In the beginning, patients had full acceptance over the TB preventive therapy. Later, when some patients start to experience ADRs, they communicated with each other and some of them started to reject it. [HP4]

Serious INH-induced liver injuries, although rarely encountered, were of concern to several prescribers and they were not confident to administer INH without baseline and follow-up liver function tests and tests for hepatitis B and C markers. Some prescribers were administering INH without baseline and follow-up liver function tests, but when they observed a few life-threatening hepatic injuries including death, they were forced to discontinue the treatment in several patients. One prescriber reported:

In the beginning, in the absence of laboratory tests we used to put patients on the regimen but with the occurrence of adverse drug reactions [drug-induced liver injury] we started to worry and we realized that we could not start it without having baseline and follow-up tests. [HP2]

One of the key informants also reported that many of the HIV care clinic physicians were against the tuberculosis preventive therapy as they started to observe many previously stable patients deteriorating following initiation of INH.

Several multi-level - immediate, intermediate, and root - causes/factors related to the healthcare system, HIV control program, healthcare professionals, patients and the product were identified as barriers to the successful implementation of IPT in Eritrea (Figure 1). Information gap on IPT and fear of drug-induced liver injury were found to be the central problems for the limited implementation of IPT in PLHIV. This study revealed that healthcare professionals had lots of information gaps that resulted in rumors and doubts on the benefits and risks of IPT which ultimately caused reluctance on its implementation.

Inadequate advocacy, unavailability of detailed working documents such as registers, guidelines and SOPs, inadequate sensitization and training, lack of regular outcome evaluation of the intervention were among the immediate/intermediate causes/factors for the information gap created which in turn limited the implementation of IPT. Failing to involve key stakeholders including prescribers in the planning and introduction of IPT could also be a source of hesitancies. The thematic analysis reflects that there were program-related problems in convincing the implementors and users to successfully implement the intervention. Taking the multi-level causes into consideration, successful implementation of IPT seems to be a complex process that requires a well-thought-out plan and operationalization. Provision of adequate knowledge on the intervention and persuasion of providers and users to help them decide on the implementation of IPT is important.2 Once an intervention is accepted by the providers and users, it is then easier to ensure its wider diffusion in the healthcare system. Identifying early adopters of the intervention such as senior clinicians/experts and working with them could also facilitate the implementation process. Overall, one of the root causes for the poor acceptability and limited implementation of IPT in Eritrea was found to be inadequate planning and preparation of the National HIV Control Program towards deployment of IPT [Figure 1]. As reported by one of the key informants, one reason for the inadequate planning/preparation was downplaying of the risks of hepatic injury related to IPT in the WHO information note on adverse events of IPT.24 The information note emphasized that INH is generally safe and routine baseline liver function tests are not recommended given the paucity of data on its role, rarity of adverse events and absence of evidence on any real predictor for future toxicity.

A considerably reported cause/factor that forced prescribers to be reluctant on the implementation of IPT was fear of INH-induced liver injuries. This was based on real (rarely encountered but fatal cases of hepatic injuries), perceived risks, and/or rumors. During the early days of introduction, some prescribers reported that they had some level of confidence to prescribe a six-month INH to PLHIV without taking baseline and follow-up laboratory tests. Later, when some clinicians started to experience life-threatening adverse effects that caused death in a few patients, the majority of them became reluctant to administer INH without close laboratory monitoring. Another root cause of hesitancy in administering INH was the inadequacy of laboratory setups, especially in the regional hospitals. This might be the probable reason why about 50% of PLHIV attending regional referral hospitals were not exposed to IPT as compared to the 14.3% in the Central region.20 Acknowledging the existing practicality challenges to carry out regular laboratory monitoring for every patient on IPT, strengthening laboratory setups would help clinicians to at least closely monitor at-risk patients as clinical monitoring only might not be adequate. This could ultimately build confidence on the prescribers to administer IPT and accordingly facilitate its implementation.

Studies, conducted elsewhere, that assessed the general barriers to IPT implementation reported that inaccuracy of TB screening tools to exclude active TB, shortage of isoniazid and tuberculin skin tests, lack of knowledge on the benefits of IPT, pill burden, perceived fear of isoniazid resistance due to poor adherence, poor monitoring and lack of high-level supervision of the IPT implementation, lack of coordination between TB and HIV activities, and heavy workload were among the factors that deter the roll out of IPT.1015 Although the methods of problem analysis differ among studies, the barriers to implementing IPT identified in this study are more or less similar to what has been reported elsewhere. One of the aforementioned factors, lack/inadequate collaboration between TB/HIV activities, needs to be highlighted as it is one of the bottlenecks. Coordinated inputs such as logistical, technical, and operational would create fertile grounds for a successful implementation of IPT in Eritrea as they were doing for forecasting, procurement, and supply chain management of INH.

The findings of the study have the following important programmatic/policy implications: In future, before the introduction of any form of TB preventive therapy, non-stop advocacies, provision of adequate information through regular trainings and campaigns, as well as preparation of adequate working documents should be considered. Also, the involvement of civil societies such as PLHIVs association and other professional societies, HIV care clinic prescribers, the national pharmacovigilance center and National TB Control Program in the planning and operationalization of the intervention would be required for a successful implementation and to ensure ownership of stakeholders. Jointly with stakeholders, setting national and regional indicators, coordination and implementation mechanisms, and a monitoring and evaluation framework are critical factors for success. Another implication is that, once a new intervention is introduced, there should be a requirement to collect cohort-based data for regular evaluation of the benefits and risks of the intervention and elucidate uncertainties by effectively disseminating findings among stakeholders. Moreover, the laboratory setups in HIV care clinics need to be capacitated in order to ensure improved uptake of TB preventive therapy. In Eritrea, the HIV control program is one of the strongest public health programs in the country that has achieved several success stories in planning, advocacy, public campaigns, implementation of new therapeutic agents, program evaluation, and fund acquisition/mobilization. Considering the programs capacity and capability, the afore-mentioned recommendations could be achievable.

Conducting in-depth interviews with programmers and prescribers working in all regional hospitals and a national referral hospital that serve for about 60% of the PLHIV in Eritrea helped us to critically analyze and comprehensively understand the perceived central problems and root causes for the limited implementation of IPT. The study, however, was not without limitations. It was only aimed to identify implementation problems of IPT from perspectives of HCPs as resistance to implementation the TB preventive therapy was mainly reported by prescribers. Considering the perspectives of consumers would, however, be important. Besides, thoughts of the HCPs were collected after things have happened, and we have seen that some people were enthusiastic with IPT before changing their minds and others were, however, already skeptical. Thus, we are not sure of the prescribers perspective on IPT during its first introduction. Another limitation was that the findings of this study would not necessarily represent the situation for other countries. Moreover, the fact that the interviews were conducted by staff of the Ministry of Health of Eritrea might have led to bias in responding to some questions. Further input that could analyze the challenges of the HIV control program in addressing the issue would be important.

The reasons for the limited implementation of IPT in Eritrea were complex multi-level factors/causes and the core problems were mainly related to the HIV control program and the healthcare system. The authors therefore recommend ensuring adequate planning and operationalization on provision of adequate working documents, organizing regular advocacies, strengthening TB/HIV collaborative activities, sensitization and educational programs prior to deployment of a new TB preventive therapy and evaluation of the impact of the intervention. Where it is practical, ensuring the availability of biochemical tests for close laboratory monitoring of at-risk patients would minimize the fear of ADRs that warrants capacitating the laboratory setups. The program is also recommended to take immediate actions to fully understand such problems and strategically restore any confidence gap that may arise during the implementation process as appropriate.

ADRs, adverse drug reactions; ART, antiretroviral therapy; CDC, Communicable Disease Control; HCPs, healthcare professionals; INH, isoniazid; IPT, isoniazid preventive therapy; KI, key informant; KII, key informant interview; LFT, Liver function tests; NMFA, National Medicines and Food Administration; PLHIV, people living with HIV; SOPs, standard operating procedures; TB, tuberculosis; WHO, World Health Organization.

All information gathered is included in the manuscript and the codebook can be requested from the corresponding author ([emailprotected] or [emailprotected]).

Ethical clearance to conduct the study was obtained from the Health Research Ethics and Protocol Review Committee of the Ministry of Health of the State of Eritrea (reference number: 7-18/2020). As obtaining written informed consent might create insecurities on some respondents and some interviews were carried out via telephone, the researchers opted to take verbal informed consent that was approved by the ethics committee. Thus, audiotaped verbal consent was taken, and all ethical and professional considerations were followed, particularly with confidentiality of the reports; only anonymized information is reported.

The authors sincerely thank the study participants for their time and willingness. The authors would also like to acknowledge the staff of the National Medicines and Food Administration of Eritrea, namely: Azania Werede, Feven Ghebreberhan, Liya Abraham, Merhawi Bahta, Merhawi Debesai, Meron Tesfagaber, Michael Habteslassie, Natnael Araya, and Yodit Fitsum who participated in the transcription and translation of the interviews and for their review comments. Finally, the authors sincerely thank the Communicable Disease Control (CDC) division of the Ministry of Health of the State of Eritrea for their immense cooperation, comments and partial funding of the study.

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

This work was funded, in part, by the CDC Division of the Ministry of Health of the State of Eritrea (Global Fund HIV Grant activity code: 9.8) and the funding agency had no role in the design, interpretation and write-up of the article.

Katia Verhamme reports grants from Chiesi, GSK, UCB, Amgen, Pfizer-Boehringer Ingelheim, and EMA, outside the submitted work. The authors report no other potential conflicts of interest in relation to this work.

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The rest is here:
Implementation of IPT in people living with HIV | RMHP - Dove Medical Press

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NL starts preventive vaccination against monkeypox in Amsterdam, The Hague – NL Times

Monday, July 25th, 2022

For the first time, the Netherlands is vaccinating people preventively against the monkeypox virus. The preventive shots start on Monday in the Amsterdam and The Hague regions because most infections have been detected there. The health authorities will expand it to the rest of the country later. The first group eligible for vaccination consists of approximately 32,000 people.

Over the past weeks, the Dutch health services GGD already vaccinated a small group of people against the monkeypox virus. They were at active risk of becoming infected, for example, because they had close skin-to-skin contact with an infected person.

As of Thursday, there were 712 cases of monkeypox in the Netherlands. The number of infections increased quickly in the past weeks. Most of the people who tested positive are men who have sex with men (MSM). Therefore, the GGDs first invited MSM and transgender people who are HIV positive or taking medicines to prevent them from contracting HIV for the vaccination. Here there is expected to be a large overlap with the highest risk group for monkeypox infection, according to the expert advice on which the health service based the vaccination strategy.

Each person requires two doses of vaccine four weeks apart.

The monkeypox virus spreads through skin-to-skin contact. While the Netherlands current outbreak primarily affects men who have sex with men, anyone can get the virus. At least three women and one child have been infected in the Netherlands.

People tend not to get very sick from the monkeypox virus. It causes symptoms like fever, headaches, muscle aches, and general malaise. A rash with blisters may appear a few days into the infection.

The preventive vaccination campaign is kicking off sooner than the GGDs expected. Last week, a spokesperson for GGD Amsterdam said it would take another few weeks to get ready.

Link:
NL starts preventive vaccination against monkeypox in Amsterdam, The Hague - NL Times

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