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A New RSV Shot Could Help Protect Babies This Winter — If They Can Get It in Time

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Amelia Templeton, Oregon Public Broadcasting
Thu, 09 Nov 2023 10:00:00 +0000

Emily Bendt was in her third trimester of pregnancy when she first heard the Centers for Disease Control and Prevention had approved a new shot for infants to protect them from the respiratory syncytial virus, or RSV.

By Oct. 5, Bendt was cuddling with her new baby, Willow, on the couch at home in Vancouver, Washington. She was excited to get Willow the new therapy for infants, called nirsevimab, which had started shipping in September — but Bendt, a pediatric home nurse, couldn't find it anywhere.

That very morning, at Willow's two-week checkup, Bendt had asked the pediatrician when Willow could get it. “She literally just shrugged and was like, ‘Well, it's coming, but we don't know when,'” Bendt said. “I don't know why I feel like I'm to chase people down and still not get answers.”

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Bendt searched online, too, for clinics or pharmacies or government websites offering nirsevimab — and found nothing.

By mid-October, demand for nirsevimab, sold under the brand name Beyfortus, had already outstripped supply, according to the pharmaceutical company Sanofi, which developed the drug with AstraZeneca.

In response, the CDC issued interim guidance Oct. 23 to help pediatricians allocate the limited supply of doses, advising them to focus on the infants at highest risk of RSV complications: those under 6 months old, and those with underlying medical conditions.

RSV is the leading reason babies under 12 months old end up in the hospital, and an estimated 100-300 kids under age 5 die from it in the U.S. every year.

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Nirsevimab, a monoclonal antibody, is one of two new therapies available this fall that could dramatically reduce the risk of lung infections in infants.

The other option is an RSV vaccine from Pfizer called Abrysvo. It was first recommended for adults 60 and older, and then Sept. 22 the CDC approved its use in pregnant people, too, to confer some immunity on their infants.

But this adult vaccine is recommended only within a relatively short window in pregnancy, weeks 32 through 36, because of a potential but unproven concern it may increase preterm births. That might limit uptake during pregnancy.

By the time the vaccine was approved for pregnant people Sept. 22, Emily Bendt had given birth. So for Willow and other babies like her, nirsevimab will be the only option for protection from RSV this respiratory virus season.

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Nirsevimab is approved for all infants up to 8 months old, and for some older babies and toddlers considered at higher risk of severe illness from RSV. The American Academy of Pediatrics recommends that every baby whose mother did not get the RSV vaccine while pregnant receive nirsevimab in the first week of life.

The CDC is now asking prenatal care providers to warn their patients about potential nirsevimab supply shortages, with the hope that driving up the maternal vaccination rate could help ease the demand for nirsevimab.

Nirsevimab's Powerful but Pricey Potential

Pediatricians say the high cost of nirsevimab and bureaucratic obstacles in 's vaccine allocation system for children are slowing down nirsevimab's distribution. They fear these problems infants at risk — unnecessarily — of hospitalization this winter.

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In clinical trials, nirsevimab reduced RSV hospitalizations and visits in infants by almost 80%.

“This is groundbreaking, honestly,” said Katie Sharff, chief of infectious disease for Kaiser Permanente Northwest.

Nirsevimab is a monoclonal antibody treatment, not a traditional vaccine. The passive immunity it confers lasts about five months. That's long enough to get babies through their first RSV season, when they're at highest risk for complications.

After an infant's first winter, “their airways develop and their lungs develop,” Sharff said. “So getting RSV later, as a child instead of as an infant, [means the child is] probably less likely to have severe complications of difficulty breathing, needing to be on a ventilator.”

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Sharff's own daughter had an RSV infection as an infant, needed care in the emergency department, and went on to develop asthma, a condition more common in children who had severe RSV infections.

For health worn down by the “tripledemic” of respiratory viruses — covid-19, flu, and RSV — keeping infants out of the hospital this winter could be a game-changer.

Last year was a historically bad season for RSV. Earlier in the pandemic, measures that states took to slow the spread of covid, such as masking, depressed RSV infections for a while, too. But as infection-control measures were rolled back, more babies and toddlers were exposed to RSV for the first time, at the same time.

In Oregon, the surge prompted then-Gov. Kate Brown, a Democrat, to declare a public health emergency and forced hospitals to add capacity to their pediatric intensive care units. Some hospitals even sent patients out of state.

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“The promise of nirsevimab is that should never, never happen again,” said Ben Hoffman, a professor of pediatrics at Oregon Health & Science University's Doernbecher Children's Hospital in Portland and the president-elect of the American Academy of Pediatrics.

But that depends on the therapy's availability, and whether providers can get it to newborns efficiently.

The Most Expensive Childhood Vaccine

For babies born without the protection of the maternal RSV vaccine, the American Academy of Pediatrics says the best time to get nirsevimab is at birth, before an infant is exposed to RSV at all.

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But babies like Willow who were born before nirsevimab became available will need to get it from an outpatient clinic.

Except for the first dose of the hepatitis B vaccine, administration of childhood vaccines start one month after birth, in a pediatrician's office, but the cost of nirsevimab might make that hard.

At $495 per dose, it's the most expensive standard childhood shot, and insurers may not reimburse providers for it this year. That's a particular problem for small pediatric practices, which can't afford to lose that much money on a standard childhood vaccine.

“When all of a sudden you have a new product that you're supposed to give to your entire birth cohort, and you've got to pay $500 that may or may not get paid back, that's just not financially viable,” said Sean O'Leary, a pediatric infectious-disease specialist at the University of Colorado School of Medicine.

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Some insurers, but not all, have announced they will cover nirsevimab right away. Because of a quirk in the Affordable Care Act, commercial insurance plans can wait up to a year after a new therapy is approved before they are required to cover it.

Sanofi has announced an “order now, pay later” option for doctors, which would give them more time to work out reimbursement deals.

Could Hospitals Help?

A government program that supplies free shots to about half the children in the United States is structured in a way that makes it hard to get nirsevimab to babies right after birth.

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Vaccines for Children is a safety-net program that provides vaccines to kids on Medicaid, uninsured children, and Alaska Native and American Indian children.

Health care providers can't bill Medicaid for shots like nirsevimab. Instead, they must register and enroll in the VFC program. Through it, the federal government purchases shots from companies like Sanofi at a discount, and then arranges for them to be shipped free to VFC-enrolled providers, which tend to be pediatric practices or safety-net clinics.

But most hospitals aren't part of VFC, which presents a problem.

“Many of our newborns go home to caring, affectionate, loving siblings who are actively dripping snot at the time that the child is born,” said Eddie Frothingham, a pediatrician with Mid-Valley Children's Clinic in Albany, Oregon. “The sooner we can protect them, the better.”

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Right now, only about 10% of birthing hospitals nationwide are enrolled in VFC and can get nirsevimab free.

Until nirsevimab's debut a few months ago, most hospitals didn't have a strong incentive to participate in Vaccines for Children because childhood vaccines outside of hepatitis B are typically given to kids by pediatricians, in outpatient clinics.

VFC can be burdensome and bureaucratic, according to interviews with several Oregon hospitals and immunization experts. The program's stringent anti-fraud measures discourage health care providers from enrolling, they say.

Once enrolled, providers must track and store VFC-provided vaccines separately, apart from other vaccine supplies. The person giving a pediatric shot has to know what insurance the child has, and account for each dose in a state- electronic record system.

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Mimi Luther, immunization program manager for Oregon, said the rules are nearly impossible for most hospitals to follow.

“I look forward to the day when the feds have the opportunity to modernize that system to make it easier for providers to enroll and stay enrolled,” she said.

The CDC has relaxed some program rules in light of the shortage of nirsevimab, allowing providers to “borrow” up to five VFC doses for infants covered by private insurance — as long as those doses are paid back within a month.

This has forced some health systems to make difficult choices. Many are allowing infants to leave the hospital without the shot, assuming they will get it at the first pediatric outpatient visit.

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Frothingham said that also creates an equity problem. Newborns whose parents don't have transportation, or financial resources, are more likely to miss those first pediatric appointments after birth.

Samaritan Health Services, the health system Frothingham works for, has decided to privately purchase a small number of doses to offer in its hospitals, for newborns whom doctors as high risk because of breathing problems or family poverty.

“It's important to us that infants be able to access this regardless of their financial or social circumstances,” Frothingham said.

Nationwide, many birthing hospitals are to enroll in the VFC program for next year. But this fall, most won't have free nirsevimab on hand.

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Most babies who get RSV ultimately recover, including those who require hospitalization to help with their breathing. But it's challenging to treat, and each year some babies die.

In his decades in medicine, OHSU's Hoffman has lost infant patients to RSV.

“Knowing that some kids may potentially suffer because of delayed access or absence of access to a product that could potentially save their lives is awful,” Hoffman said. “No pediatrician in the country is happy right now.”

This article is from a partnership that includes OPB, NPR, and KFF Health .

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——————————
By: Amelia Templeton, Oregon Public Broadcasting
Title: A New RSV Shot Could Help Protect Babies This Winter — If They Can Get It in Time
Sourced From: kffhealthnews.org/news/article/a-new-rsv-shot-could-help-protect-babies-this-winter-if-they-can-get-it-in-time/
Published Date: Thu, 09 Nov 2023 10:00:00 +0000

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Kaiser Health News

The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care

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Michelle Andrews
Fri, 17 May 2024 09:00:00 +0000

For many , seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on doctors for.

But NPs in specialty care? That's not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This worries some people who track the workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

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“They're succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Physicians' Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers grew rapidly. The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, , and certification steps. NPs can practice without a doctor's supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

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About 88% of nurse practitioners are certified in an area of primary care, according to the American Association of Nurse Practitioners. But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they're generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research published in 2018.

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the most recent projections by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

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When it to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington University.

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners' salaries vary widely by location, type of facility, and experience. Still, according to data from recruiter AMN Healthcare Physician Solutions, formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal Bureau of Labor Statistics, nurse practitioner jobs will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

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To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can receive “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don't “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

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There are a number of training programs for family nurse practitioners who want to develop skills in other .

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master's endocrinology training program at Mount Marty University. She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich's new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

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“There aren't a lot of options,” she said.

——————————
By: Michelle Andrews
Title: The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care
Sourced From: kffhealthnews.org//article/nurse-practitioners-trend-primary-care-specialties/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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Clean Needles Save Lives. In Some States, They Might Not Be Legal.

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Ed Mahon, Spotlight PA and Sarah Boden, WESA
Fri, 17 May 2024 09:00:00 +0000

Kim Botteicher hardly thinks of herself as a criminal.

On the main floor of a former Catholic church in Bolivar, Pennsylvania, Botteicher runs a flower shop and cafe.

In the former church's basement, she also operates a nonprofit organization focused on helping people caught up in the drug epidemic get back on their feet.

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The nonprofit, FAVOR ~ Western PA, sits in a rural pocket of the Allegheny Mountains east of Pittsburgh. Her organization's home county of Westmoreland has seen roughly 100 or more drug overdose deaths each year for the past several years, the majority involving fentanyl.

Thousands more residents in the region have been touched by the scourge of addiction, which is where Botteicher comes in.

She helps people find housing, , and care, and works with families by running support groups and explaining that substance use disorder is a disease, not a moral failing.

But she has also talked publicly about how she has made sterile syringes available to people who use drugs.

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“When that person comes in the door,” she said, “if they are covered with abscesses because they have been using needles that are dirty, or they've been sharing needles — maybe they've got hep C — we see that as, ‘OK, this is our first step.'”

Studies have identified public health benefits associated with syringe exchange services. The Centers for Disease Control and Prevention says these programs reduce HIV and hepatitis C infections, and that new users of the programs are more likely to enter drug treatment and more likely to stop using drugs than nonparticipants.

This harm-reduction strategy is supported by leading health groups, such as the American Medical Association, the World Health Organization, and the International AIDS Society.

But providing clean syringes could put Botteicher in legal danger. Under Pennsylvania , it's a misdemeanor to distribute drug paraphernalia. The state's definition includes hypodermic syringes, needles, and other objects used for injecting banned drugs. Pennsylvania is one of 12 states that do not implicitly or explicitly authorize syringe services programs through statute or regulation, according to a 2023 analysis. A few of those states, but not Pennsylvania, either don't have a drug paraphernalia law or don't include syringes in it.

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Those working on the front lines of the opioid epidemic, like Botteicher, say a reexamination of Pennsylvania's law is long overdue.

There's an urgency to the issue as well: Billions of dollars have begun flowing into Pennsylvania and other states from legal settlements with companies over their role in the opioid epidemic, and syringe services are among the eligible interventions that could be supported by that money.

The opioid settlements reached between drug companies and distributors and a coalition of state attorneys general included a list of recommendations for spending the money. Expanding syringe services is listed as one of the core strategies.

But in Pennsylvania, where 5,158 people died from a drug overdose in 2022, the state's drug paraphernalia law stands in the way.

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Concerns over Botteicher's work with syringe services recently led Westmoreland County officials to cancel an allocation of $150,000 in opioid settlement funds they had previously approved for her organization. County Commissioner Douglas Chew defended the by saying the county “is very risk averse.”

Botteicher said her organization had planned to use the money to hire additional recovery specialists, not on syringes. Supporters of syringe services point to the cancellation of funding as evidence of the need to change state law, especially given the recommendations of settlement documents.

“It's just a huge inconsistency,” said Zoe Soslow, who leads overdose prevention work in Pennsylvania for the public health organization Vital Strategies. “It's causing a lot of confusion.”

Though sterile syringes can be purchased from pharmacies without a prescription, handing out free ones to make drug use safer is generally considered illegal — or at least in a legal gray area — in most of the state. In Pennsylvania's two largest , Philadelphia and Pittsburgh, officials have used local health powers to provide legal protection to people who operate syringe services programs.

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Even so, in Philadelphia, Mayor Cherelle Parker, who took office in January, has made it clear she opposes using opioid settlement money, or any funds, to pay for the distribution of clean needles, The Philadelphia Inquirer has reported. Parker's position signals a major shift in that city's approach to the opioid epidemic.

On the other side of the state, opioid settlement funds have had a big effect for Prevention Point Pittsburgh, a harm reduction organization. Allegheny County reported spending or committing $325,000 in settlement money as of the end of last year to support the organization's work with sterile syringes and other supplies for safer drug use.

“It was absolutely incredible to not have to fundraise every single dollar for the supplies that go out,” said Prevention Point's executive director, Aaron Arnold. “It takes a lot of energy. It pulls away from actual delivery of services when you're constantly having to find out, ‘Do we have enough money to even purchase the supplies that we want to distribute?'”

In parts of Pennsylvania that lack these legal protections, people sometimes operate underground syringe programs.

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The Pennsylvania law banning drug paraphernalia was never intended to apply to syringe services, according to Scott Burris, director of the Center for Public Health Law Research at Temple University. But there have not been court cases in Pennsylvania to clarify the issue, and the failure of the legislature to act creates a chilling effect, he said.

Carla Sofronski, executive director of the Pennsylvania Harm Reduction Network, said she was not aware of anyone having faced criminal charges for operating syringe services in the state, but she noted the threat hangs over people who do and that they are taking a “great risk.”

In 2016, the CDC flagged three Pennsylvania counties — Cambria, Crawford, and Luzerne — among 220 counties nationwide in an assessment of communities potentially vulnerable to the rapid spread of HIV and to new or continuing high rates of hepatitis C infections among people who inject drugs.

Kate Favata, a resident of Luzerne County, said she started using heroin in her late and wouldn't be alive today if it weren't for the support and community she found at a syringe services program in Philadelphia.

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“It kind of just made me feel like I was in a safe . And I don't really know if there was like a come-to-God moment or come-to-Jesus moment,” she said. “I just wanted better.”

Favata is now in long-term recovery and works for a medication-assisted treatment program.

At clinics in Cambria and Somerset Counties, Highlands Health provides free or low-cost medical care. Despite the legal risk, the organization has operated a syringe program for several years, while also testing patients for infectious diseases, distributing overdose reversal medication, and offering recovery options.

Rosalie Danchanko, Highlands Health's executive director, said she hopes opioid settlement money can eventually support her organization.

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“Why shouldn't that wealth be spread around for all organizations that are working with people affected by the opioid problem?” she asked.

In February, legislation to legalize syringe services in Pennsylvania was approved by a committee and has moved forward. The administration of Gov. Josh Shapiro, a Democrat, supports the legislation. But it faces an uncertain future in the full legislature, in which Democrats have a narrow majority in the House and Republicans control the Senate.

One of the bill's lead sponsors, state Rep. Jim Struzzi, hasn't always supported syringe services. But the Republican from western Pennsylvania said that since his brother died from a drug overdose in 2014, he has come to better understand the nature of addiction.

In the committee vote, nearly all of Struzzi's Republican colleagues opposed the bill. State Rep. Paul Schemel said authorizing the “very instrumentality of abuse” crossed a line for him and “would be enabling an evil.”

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After the vote, Struzzi said he wanted to build more bipartisan support. He noted that some of his own skepticism about the programs eased only after he visited Prevention Point Pittsburgh and saw how workers do more than just hand out syringes. These types of programs connect people to resources — overdose reversal medication, wound care, substance use treatment — that can save lives and to recovery.

“A lot of these people are … desperate. They're alone. They're afraid. And these programs bring them into someone who cares,” Struzzi said. “And that, to me, is a step in the right direction.”

At her nonprofit in western Pennsylvania, Botteicher is hoping lawmakers take action.

“If it's something that's going to help someone, then why is it illegal?” she said. “It just doesn't make any sense to me.”

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This story was co-reported by WESA Public Radio and Spotlight PA, an independent, nonpartisan, and nonprofit newsroom producing investigative and public-service journalism that holds power to account and drives positive change in Pennsylvania.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

——————————
By: Ed Mahon, Spotlight PA and Sarah Boden, WESA
Title: Clean Needles Save Lives. In Some States, They Might Not Be Legal.
Sourced From: kffhealthnews.org/news/article/clean-needles-syringe-services-programs-legal-gray-area-risk-pennsylvania/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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Watch: John Oliver Dishes on KFF Health News’ Opioid Settlements Series

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Fri, 17 May 2024 09:00:00 +0000

Opioid manufacturers, distributors, and retailers are paying tens of billions of dollars in restitution to settle lawsuits related to their role in the nation's overdose epidemic. A recent of “Last Tonight With John Oliver” examined how that money is being spent by and local governments across the United States.

The segment from the KFF Health “Payback: Tracking the Opioid Settlement Cash.” You can learn more about the issue and read our collection of articles by Aneri Pattani here.

——————————
Title: Watch: John Oliver Dishes on KFF News' Opioid Settlements Series
Sourced From: kffhealthnews.org/news/article/watch-john-oliver-kff-health-news-payback-opioid-settlements-series/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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