Pharmacies were once routinely bequeathed from one generation to the next, but, in interviews with more than a dozen pharmacists, many said the pressure of running an independent drugstore have them pushing their offspring toward other careers.

This article was published December 17, 2021, by Kaiser Health News.

By Markian Hawryluk

Ted Billinger Jr. liked to joke that he would work until he died. That turned out to be prophetic.

When Billinger died of a heart attack in 2019 at age 71, he was still running Teddy B’s, the pharmacy his father had started more than 65 years earlier in Cheyenne Wells, Colorado. With no other pharmacist to work at the store, prescriptions already counted out and sealed in bottles were suddenly locked away in a pharmacy that no one could enter. And Cheyenne Wells’ fewer than 800 residents were abruptly left without a drugstore.

Pharmacies were once routinely bequeathed from one generation to the next, but, in interviews with more than a dozen pharmacists, many said the pressure of running an independent drugstore have them pushing their offspring toward other careers. And when they search for a buyer, they often find that attracting new pharmacists, especially to rural settings, is difficult. With a large group of pharmacists nearing retirement age, more communities may lose their only drugstore.

“It’s going to be harder to attract people and to pay them,” said David Kreling, a professor emeritus at the University of Wisconsin-Madison School of Pharmacy. “If there’s not a generational thing where someone can sit down with their son or daughter and say that they could take the store over, there’s a good chance that pharmacy will evaporate.”

Tom Davis, Billinger’s friend and co-owner of Kiowa Drug in Eads, Colorado, stepped in to sort out the mess in Cheyenne Wells. With permission from the State Board of Pharmacy, the county sheriff let Davis into Teddy B’s in the eastern Colorado town to take an inventory of the remaining drugs. Customers who had dropped off their prescriptions before Billinger died were able to pick up their medications.

Davis then bought the pharmacy from Billinger’s estate. He runs it as a convenience store and six days a week delivers prescriptions to it from Eads, 44 miles away.

“By the time you paid a pharmacist, the location there was borderline unprofitable,” Davis said.

He has received numerous requests to open pharmacies in other eastern Colorado towns, but making that work financially would be difficult. Reimbursements from insurance plans have dwindled, and customer bases have eroded as health insurers push patients toward mail-order deliveries.

“I fill prescriptions every day where my reimbursement is less than the cost of the drug,” Davis said. “In other settings, you might tell a patient, ‘We don’t have that in stock,’ or ‘Why don’t you go down the street to the chain?’ But down here, we just take care of our patients, and we just eat it.”

He can survive, he said, because, after 48 years, he no longer has any business debt.

“I look at my bottom line,” Davis said. “With the amount of profit that I had at the end of the year, that would not have been enough if I was having to pay a mortgage.”

Studies have found the number of pharmacists nationally to be sufficient, even more than enough, to meet current needs, although supply and demand don’t always line up. Finding pharmacists is more difficult in rural areas.

“Once they get a taste of the big city,” Kreling said, “it’s hard to get them back to the farm.”

Workforce data also shows worrisome trends. Concerns about a shortage of pharmacists led the federal government to pour money into pharmacy schools in the 1970s, creating a temporary bump in the number of graduates. The people in that bulge in the pharmacist pipeline have hit retirement age.

“Many of them owned independent pharmacies, and they were working in rural communities,” said University of Minnesota pharmacy professor Jon Schommer, who studies workforce issues.

Now, as the demand for pharmacists to provide testing and vaccinations during the covid-19 pandemic increases, drugstore chains are offering incentives — such as large salaries, signing bonuses and help paying off school loans — that are often more enticing than anything a rural pharmacy could muster.

How pharmacy graduates envision their careers has also shifted. Many no longer want to own a pharmacy and are content to work at pharmacy chains or other health care organizations, according to several pharmacy school professors. As of 2018, only about half of pharmacists worked in traditional retail drugstores.

That makes rural recruitment more difficult.

Denise Robins had worked at R&R Family Pharmacy in Springfield, Colorado, for 18 years when the owner retired. She and three family members bought the drugstore in a last-ditch effort to keep it open.

“None of us are pharmacists, so that made it a little tougher,” Robins said. “We just knew it was really going to make it hard for people here if they had to travel an hour to get to a pharmacy.”

But finding a pharmacist to work in the southeastern Colorado town of fewer than 1,400 people was a challenge. The first pharmacist Robins found commuted 48 miles one way from Lamar. But after a year and a half, the trip became too much.

She then hired someone who wanted to work for only a year, to make enough money to travel. Then Robins interviewed two University of Colorado pharmacy school graduates. She hired one, but that didn’t work out. So she called back the second candidate, who still had not found a permanent job. He had two young kids, and he and his wife were working opposite schedules. He took the job two years ago and has remained there since.

In Berryville, Virginia, pharmacist Patricia White opened Battletown Pharmacy in 2011 because she wanted to carry on the family business. Her father had owned a local pharmacy and had recently died. But when turning a profit with Battletown proved a struggle, White decided to retire.

She lined up two potential buyers, but neither went through with the sale. She then hoped to transfer the pharmacy to a recent graduate but didn’t want to saddle him with a failing business.

“I told him he couldn’t make any money, and he said, ‘Thanks for being honest,’” White recalled.

Closing seemed like the only palatable option. Battletown shut down at the end of August. “I did not want to sell out to a chain,” she said. “That’s always been my mentality.”

When a chain buys a pharmacy, it doesn’t always decide to run it. Instead, it might close the pharmacy and transfer the pharmacy’s prescription files to one of its outlets. Retiring pharmacists who spent decades serving a community generally don’t want to see that happen, said David Zgarrick, a Northeastern University pharmacy professor.

“They’d like to sell their pharmacy to another pharmacist who would continue to run it very much in the same manner,” he said.

Some plan ahead, hiring another pharmacist and offering that person an equity stake in the business. Over time, the new pharmacist can buy out the owner. Many independent pharmacist-owners plan to live off the profits from selling their pharmacy, its inventory and its prescription records.

“Their pharmacy is their retirement savings,” Zgarrick said.

But, Zgarrick said, the added pressure from the pandemic may be pushing more pharmacists into retirement. And a long-running bull stock market may mean some pharmacists have enough in their retirement portfolios to call it quits without a sale.

In Eads, Davis, 70, still loves being a pharmacist. He and his brother co-own seven pharmacies and have started to plan for retirement by hiring five young pharmacists and allowing them to buy ownership stakes in those pharmacies over time.

He had wondered how long he could keep the Kiowa pharmacy running, though. With fewer than 700 residents, Eads may be the smallest town in Colorado with a pharmacy. Combining Davis’ customer base with Cheyenne Wells’ may have saved pharmacy access for both communities.

“So maybe where we could have lost two pharmacies in the area, we’ve been able to exist. We’re stronger now than we had ever been,” Davis said. “That wasn’t the original plan. We cared about those people and just wanted to take care of them.”

As deadly coronavirus cases spiked this year, daily pressures intensified on hospital floors. Some nurses retired; some became travel nurses, hired by agencies that advertised more than double, even triple, the day rates for intensive care unit, telemetry and emergency room nurses. Others gave up their jobs to avoid possibly carrying the covid virus home to their families.

This article was published December 16, 2021, by Kaiser Health News.

By Christine Spolar and Mark Kreidler and Rae Ellen Bichell

Nurses and health care workers across the country are finding strength in numbers and with labor actions not seen in years.

In California, which has a strong union tradition, Kaiser Permanente management misjudged workplace tensions during the covid-19 crisis and risked a walkout of thousands when union nurses balked at signing a four-year contract that would have slashed pay for new hires. In Colorado, Pennsylvania, North Carolina and Massachusetts, nurses have been embroiled in union battles over staffing and work conditions.

As deadly coronavirus cases spiked this year, daily pressures intensified on hospital floors. Some nurses retired; some became travel nurses, hired by agencies that advertised more than double, even triple, the day rates for intensive care unit, telemetry and emergency room nurses. Others gave up their jobs to avoid possibly carrying the covid virus home to their families.

“Things had gotten particularly stark for nurses,” said Rebecca Kolins Givan, an associate professor of labor studies at Rutgers University.

‘They Can Make More at McDonald’s’

It was so grim in Pittsburgh that registered nurses at West Penn Hospital, part of the Allegheny Health Network, voted this year to authorize a strike — less than a year after they unionized with SEIU Healthcare Pennsylvania. Chief among their complaints: The hospital system had balked at improving staff ratios even as it offered bonuses, up to $15,000 for some, to hire registered nurses to fill vacancies.

Kathleen Jae, a member of the bargaining team that reached a pact without a work stoppage, said nurses wanted management to work harder to retain veteran staff members: “We had to face the fact that nurses are retiring, nurses are leaving the bedside out of frustration, and, in certain instances this year, nurses had more patients than they felt comfortable taking care of.”

Allegheny Health Network said the first-ever pact with RNs at West Penn provides “competitive wages and benefits” to help it “recruit and retain talented, experienced nurses.”

Liz Soriano-Clark, a teacher-turned-nurse on the bargaining team, said the pandemic had made workers across the health sector more careful and choosier about what jobs they’ll take.

“There’s a nursing shortage and a shortage of nursing instructors, nationwide. They’ve seen aides leave. They’ve seen cleaners leave,” Soriano-Clark said. “Why is that? Because they can make more at McDonald’s and not have to clean up vomit.”

In September, the American Nurses Association alerted the Biden administration to an “unsustainable nurse staffing shortage facing our country” in a letter to the Department of Health and Human Services. The ANA said a “crisis-level human resource shortage” was evident: Mississippi had 2,000 fewer nurses than it did at the beginning of 2021. Tennessee called on its National Guard to reinforce hospital staffs. Texas was recruiting 2,500 nurses from outside the state.

Union membership among U.S. nurses has inched up over the past 15 years and held steady, at about 17%, for five years, according to unionstats.com, an academic website. But 2021, a year of union organizing and holdouts in such disparate workplaces as Starbucks cafes and John Deere tractor plants, might well be a turning point for essential workers in health care.

“If you ask nurses what they want,” said Givan, who interviewed dozens of nurses for a 2016 book on health care workers, “they want working conditions where they can provide a high level of care. They don’t want appreciation that is lip service. They don’t want marketing campaigns. They don’t want shiny new buildings.”

Still, Givan noted, the health care sector has spent handsomely to fight unions.

After years of staff retention issues at Longmont United Hospital in Colorado, nurses are awaiting the results of a vote on whether to join National Nurses United, the largest union of registered nurses in the U.S.

Stephanie Chrisley, a registered nurse in the hospital’s ICU, said nurses are regularly caring for double the number of patients considered appropriate — often three to four “ventilated, sedated, critically ill patients.”

She and others protested outside the hospital in early December. They said the company that runs the hospital, Centura Health, this year had employed aggressive union-busting tactics, including disputing a handful of votes, which dragged out the union election for about five months. In another instance, her colleague Kris Kloster said, Centura, founded by Catholic nuns, issued company-wide emails announcing raises and retention bonuses for everyone except nurses at her hospital.

“Where there should have been newly hired nurses, there were anti-union consultants roaming around the hospital,” Chrisley said. Since July, she added, the hospital has lost nearly 80 RNs, “nearly a third of our nursing staff.” Longmont United Hospital Interim CEO Kristi Olson said in a statement that the hospital “will remain open and fully operational” and that “we are committed to making sure that all voices were heard” in the union election.

Organizing can take a long time, Givan said, pointing to tense labor negotiations in Massachusetts, North Carolina and Pennsylvania. “But when there is a crisis — what we call a hot shop — you can get workers to organize quite quickly.” Nurses represented by the Massachusetts Nurses Association walked off the job March 8 in Worcester. A chance to break the bitter impasse collapsed when management, Tenet Healthcare, refused to allow some nurses to return to their original jobs. In North Carolina, registered nurses at Mission Hospital in Asheville ratified a contract with the HCA management that locked in 17% raises over three years and set up a committee to review patient care conditions.

A recent poll by Gallup, the global analytics firm, found that the share of Americans who say they approved of unions was at 68%, its highest point since 1965.

Sal Rosselli, president of the National Union of Healthcare Workers, said that in the past year “there has just been an explosion of leads,” queries from health workers exploring how to unionize.

Rosselli, whose organization represents about 15,000 health workers, said the pandemic exposed practices that had long antagonized employees. Too many hospitals scrambled for masks, gloves and gowns, he said, and front-line workers were on round-the-clock schedules and facing ghastly daily deaths. “They weren’t keeping their employees and their patients safe,” Rosselli said, “and all because these systems were focused on profit over anything else. That has been coming on for a long, long time.”

Registered nursing is among the U.S. occupations expected to experience the greatest levels of job growth in the next decade, according to the Bureau of Labor Statistics’ Employment Projections 2020-2030. Also among the fastest-growing occupations are nurse practitioners, home health care aides and assistants. Shortages of RNs and other health care workers are expected to be the most intense in the South and West.

Some of the most powerful nursing unions in the nation operate out of California, representing employees in Western states. “The nurses in California have the hours they have, the care they have, the protections they have because of the union,” said Soriano-Clark, who has worked at hospitals in California and Pennsylvania.

Ready to Picket in a Pandemic

Douglas Wong, a physician assistant, never imagined hoisting a “strike” sign outside Riverside Medical Center. But that nearly happened after a sobering breakdown in talks between Kaiser Permanente and a top nurses union at the facility, part of the KP system. Nurses, pharmacists and operations staffers are among the insurers’ 160,000-plus unionized employees, according to KP spokesperson Marc Brown.

The California-based health system giant tried to force a two-tier pay schedule that would have cut wages for new nurses by 26%. Wong and thousands of allies — many who dryly noted they had been heralded as “heroes” in the covid crisis — prepared to picket in the middle of a pandemic. Kaiser Permanente’s demands crumbled when dozens of affiliated unions threatened one-day sympathy strikes.

The tiered-pay demand and an attempt to lower wages in some markets were dropped. Staffing ratios were adjusted to ease safety concerns. Wong said that, despite the pact, the bruising negotiations “felt like a betrayal.”

“Make no mistake: This was an enormous win for labor, especially pushing back on the two-tier. At the end of the day, they pulled back. And we made huge strides toward improvement in our staffing,” said Wong, a six-year KP employee and an official with the United Nurses Associations of California/Union of Health Care Professionals.

The negotiations were a marked shift for Kaiser Permanente, which for most of three decades has relied on a labor-management partnership with its unions, emphasizing cooperative decision-making and robust discussions. Talks were held with teams, set around circular tables, hashing out concerns. KP was known for much of the past decade as a market leader in wages and quality of care, and the labor-management partnership was received by academics and labor experts as an innovative, successful approach to managing a workforce.

The health system recently hired new top executives, and, to the surprise of the unions, Kaiser Permanente used negotiations this year to offer the two-tier pay regimen, a tactic used by auto- and steel-makers during economic downturns in the 1980s. The union negotiators noted this: The health care giant’s management wanted to scale back wages after notching $6.8 billion in net revenue from 2018 to 2020.

On Thursday, workers voted to ratify a four-year contract with KP. The company declined to comment for this article. In a news release, Christian Meisner, KP’s chief human resources officer, said: “This contract reflects our deep appreciation for the extraordinary commitment and dedication of our employees” during the pandemic. “We look forward to working together with our labor partners,” he said, to “further our mission of providing high-quality, affordable care.”

The Wall Street Journal recently reported that nurses’ pay was sweetened in 2021 by thousands of dollars in raises — handed out without union wrangling — as hospitals competed for workers. Premier, a health care consultancy hired by the Journal, analyzed 60,000 registered nurses’ salaries and found that average annual pay, not including overtime or bonuses, grew about 4% in the first nine months of the year, to more than $81,000. That compares with a 2.6% rise in 2019, according to federal data.

Raises don’t necessarily mean retention.

“There always seems to be a shortage of nurses,” said professor Paul Clark, who is a former director of Penn State University’s School of Labor and Employment Relations and has studied nursing and labor organizing. “But it’s important to realize there’s not a shortage of RNs. There’s a shortage of RNs willing to work under the conditions they’ve been asked to work.”

Aya Healthcare, a national travel nurse provider, has found that the pandemic aggravated historical understaffing at hospitals, spokesperson Lisa Park said in an email. “There were over 100,000 vacancies at the start of the pandemic. And now, that number has increased to over 195,000,” Park said. Travel nurses account for fewer than 2% of the nursing workforce, she added, but “with the increase in permanent vacancies due to burnout/resignations, the demand for temporary healthcare workers has increased.”

David Zonderman, a professor of labor history at North Carolina State University, noted that nurses unions have grown more political and more outspoken — in Washington, D.C., and their home states. Nurses on the hospital floor lived through a crisis — fearing for their lives amid shortages of protective equipment — much like the trials of American workers in the mining and manufacturing industries in decades past.

“This may sound weird,” Zonderman said, “but nurses are a little like coal miners. They tend to help each other. They are watching each other’s back. They have solidarity.”

“And,” he said, “if you treat people badly long enough, they finally say, ‘I’m done.’”

Patients with other ailments are frustrated, and nurses and doctors are stressed and burned out, as unvaccinated covid-19 patients fill ICU and acute care beds.

This article was published December 15, 2021, by Kaiser Health News.

By John Daley, Colorado Public Radio

Harold Burch's home has a spectacular view in Paonia, a rural part of Colorado's Western Slope at the foot of Mount Lamborn. But the landscape has been little consolation to the 60-year-old as he has battled a cascade of health problems during the pandemic.

"It's been a real rodeo," Burch said. "It's been a lot of ups and downs and lately it's been mostly just downers."

Burch has battled chronic osteoarthritis and rheumatoid arthritis and has had two major intestinal surgeries. One specialist he was seeing left her practice last year. Another wouldn't accept his insurance. Then, Nov. 1, he started experiencing major stomach pain.

"When we talk terrible problems, I can't leave the house," he said. He hasn't eaten anything substantial in three weeks, he added.

Burch had to wait that long to be seen by a primary care doctor. He said the doctor told him, "‘If things were different, I would tell you to go to the hospital and be diagnosed, have some tests run and see what's going on with you.' But he says, ‘As of today, Delta County hospital is clear full. There are no beds available.'"

The covid variant delta has overwhelmed the Colorado county of the same name. Hospitals on the Western Slope have been slammed for weeks, and the statewide picture is similarly grim. As of Monday, the state's coronavirus website reported 1,294 patients hospitalized with covid-19. Half of the state's hospitals said they anticipated a staffing shortage in mid-December; more than a third of them anticipated bed shortages in their intensive care units at the same time.

And behind those numbers, patients are feeling the impact.

Burch's doctor told him he might have to wait hours in the emergency room, perhaps with people who have flu or covid symptoms. So Burch stayed home.

He's fully vaccinated. But just 57% of eligible people in Delta County have received at least one dose of a covid vaccine. And 84% of hospitalized covid patients in Colorado are not vaccinated.

"It's really frustrating because I did the right thing and like so many other people have, and we're being just kind of like told, ‘Unless you have a really serious problem, like a heart attack, a stroke, you're going to have a baby or something like that, we really don't have time to mess with you,'" Burch said. "I mean, it's just wrong."

Burch's situation is not uncommon this fall, as the state faces its second-worst covid surge for hospitalizations and deaths. Hospitals are under tremendous strain and that means delays and changes from normal care, as strapped providers do more with less.

"Hospitals across Colorado are in critical condition. We have been at 90%-plus capacity in our ICU and acute care beds for weeks now. And unfortunately, there doesn't appear to be an end to that situation in the near future," said Cara Welch, a spokesperson for the Colorado Hospital Association.

Diann Cullen, 72, a retiree in Broomfield, Colorado, was told by her doctor that her hernia surgery would have to be postponed for weeks. Her reaction: "Frustration, extreme frustration, actually anger, because I said a bad word. … He flat-out told me we can't even do it because of too many covid patients."

The combination of too many covid patients, the need to treat those who delayed care and staff shortages have pushed hospitals into crisis, said Robin Wittenstein, CEO of Denver Health, which runs one of the state's biggest hospital and clinic systems.

"They're coming into hospitals now sicker than ever before. And they're coming in larger numbers than we've ever seen before," Wittenstein said on the day when most metro-area counties announced they were enacting a new indoor, public mask mandate. "Our system is on the brink of collapse."

At the academic medical center UCHealth, Dr. Abbey Lara said the crush of unvaccinated patients in the ICU means patients face longer waits or they don't get much-needed diagnostic tests. In the worst-case scenario, "patients who could have survived something had their life cut short because they weren't able to access care," she said.

And when there are too many patients being treated by too few staffers, Lara said, that ratchets up the difficulty for providers.

"I just worry that there's going to be not only a lot of turnover in the near future," Lara said. "But I think that access to health care is just going to get even worse in the future."

Lara predicted the effects of the pandemic will be felt long after the emergency ends: "The sky isn't falling, but the sky is going to turn a very different color."

In Longmont, Colorado, about 50 miles north of Denver, nearly a third of Longmont United Hospital's registered nurses have left since the start of July and many have not been replaced, said Kris Kloster, who has been a nurse for 32 years. She is backing an effort by nurses to unionize there.

The stress nurses and doctors feel is compounded when they feel powerless to take what they regard as an ethically correct action in treating a patient.

There's a term for that, "moral distress," said Dr. Barbara Statland, a hospitalist at Denver Health. The tension comes "because you can't do what you feel is ethically proper. And I'd say that health care workers have been riddled with this."

Despite the stress and distress, many front-line providers are hanging in there, continuing to care for patients every day. That made the difference for at least one covid patient who said he was appreciative he was able to get care — just in time.

"They saved my life. I do feel grateful for everything they did," said 58-year-old Rob Blessin, of Fort Collins.

He caught the virus this fall and spent 30 days in an ICU ward with pneumonia at North Colorado Medical Center in Greeley. He described the efforts of his doctors and nurses as heroic, some working nine or 10 days in a row, many taking overtime. And others, Blessin said, were filling in.

"So often you'd have people from different departments being trained on the fly," Blessin said. "So there's a lot of pressure on people. They're just trying to get warm bodies in there."

Respiratory therapists are in short supply in hospitals, and Blessin said as more coronavirus patients were admitted, the staff struggled to keep up.

Blessin said he landed in the hospital because he was swayed by internet misinformation and didn't get vaccinated. It's a decision he came to regret.

"I guess my recommendation would be to get vaxed, you know, even if you're totally against it; don't fall into the internet hype," Blessin said.

After his experience being hospitalized for a month due to the coronavirus, and having talked with his physicians there, he now plans to get vaccinated.

This story is from a reporting partnership that includes Colorado Public Radio, NPR and KHN

As overdose deaths nationwide reach all-time highs, the Biden administration has made increasing access to naloxone a key part of its overdose prevention strategy. But advopcates say the administration hasn't addresses the greatest barrier: naloxone's prescription-only status.

This article was published December 14, 2021, by Kaiser Health News.

By Aneri Pattani

Treatment for addiction is available. For help, call the free and confidential treatment referral hotline (1-800-662-HELP), or visit findtreatment.gov.

GREENSBORO, N.C. — Louise Vincent figures her group, the North Carolina Survivors Union, saves at least 1,690 lives a year.

The harm-reduction and syringe service program distributes the opioid overdose reversal medication naloxone to people who use drugs. Research suggests this approach is effective, since people who use drugs are most likely to witness an overdose and administer naloxone.

The 1,690 number refers to how many times participants in the Survivors Union reported using the medication between July 2020 and June 2021. But the true number of lives saved could be higher: The program distributed nearly 9,400 doses of naloxone during that time.

Now, as overdose deaths nationwide reach all-time highs, the Biden administration has made increasing access to naloxone a key part of its overdose prevention strategy. It has allotted an unprecedented $30 million in federal funds for harm-reduction groups and announced the creation of a model law that state legislatures can pass to improve access.

But Vincent and her peers say the administration has not addressed their greatest barrier to obtaining the lifesaving medication: naloxone’s prescription-only status.

“This designation is the root of all evil,” said Nabarun Dasgupta, a scientist at the University of North Carolina’s school of public health and co-founder of the Buyers Club, a collective of more than 100 harm-reduction programs in the U.S.

The Food and Drug Administration approved naloxone as a prescription drug to treat opioid overdose in 1971, when it was only an injectable drug. That remains the cheapest form and the one used most by harm-reduction groups, which have long relied on a deal with Pfizer to buy the medication for less than $5 a dose. However, newer, nasal spray versions of naloxone — including the brand-name drug Narcan, which has a discounted price of about $38 a dose — are available in many police stations, libraries and schools.

All 50 states allow individuals to buy naloxone at the pharmacy without a prescription. States don’t have the authority to designate it as an over-the-counter medication, but they’ve created workarounds — such as a state health official writing one prescription that can be used for every resident. But these workarounds don’t apply to organizations that purchase naloxone in bulk from drugmakers. When a hospital, harm-reduction group or any other organization orders naloxone from pharmaceutical companies, the companies are required to treat naloxone the way the federal government sees it: as a prescription medication, Dasgupta said. As a result, the companies impose a series of requirements on buyers.

For example, an organization that orders naloxone must have a doctor sign for the order, and that doctor must be someone who has not signed for another group. The organization must also have an address that is not a private home to receive shipments, a medical or pharmacy license and the ability to comply with regulations for storing and dispensing the drugs.

Hospitals and health departments can easily fulfill these requirements. But they can be onerous for smaller, grassroots groups, many of which are led by volunteers and operate out of makeshift home or car offices, said Eliza Wheeler and Maya Doe-Simkins, co-founders of the Buyers Club and co-authors of a paper with Dasgupta on this subject.

When these groups can’t order naloxone, the people they serve can die, Wheeler and Doe-Simkins said.

Those clients won’t necessarily turn to pharmacies. Indeed, as overdose deaths surged in 2020, pharmacy sales of naloxone decreased. The cost of the medication, requirements to show ID, a fear of discrimination from pharmacists and an inability to find a pharmacy that stocks naloxone are all barriers, said West Virginia University researcher Robin Pollini, who studies naloxone distribution.

So harm-reduction groups are calling on the FDA to allow naloxone to be sold over-the-counter so they can order it more easily and distribute it to the people at the greatest risk of overdosing.

The product has long been deemed safe and effective for community use, harm-reduction groups say, even by the FDA. Other advocates have suggested that the Department of Health and Human Services issue an order allowing manufacturers to sell naloxone to organizations buying in bulk without a prescriber’s signoff.

“Having more naloxone on the street can only do good. It can’t do harm,” said Thomas Stopka, an epidemiologist and substance use researcher at Tufts University School of Medicine. “We need to pull out all the stops and consider a bunch of different avenues to address this issue of supply.”

The concern was highlighted this year when a manufacturing problem depleted Pfizer’s stock of naloxone and the company couldn’t fill orders for harm-reduction groups. Hikma, another company that makes naloxone, offered to donate 50,000 injectable doses to the affected groups. But because of naloxone’s prescription status and Hikma’s associated paperwork requirements, only three harm-reduction programs qualified, Dasgupta said. (Pfizer said that the manufacturing issue has been resolved and that shipments resumed this fall.)

In Oklahoma, Stop Harm on Tulsa Streets (SHOTS) didn’t qualify for Hikma’s donation because the group didn’t have a doctor who could sign for its order, co-founder Hana Fields said. The doctor the group had previously worked with retired in January, and SHOTS had yet to find a replacement. Many doctors are worried about liability or simply don’t return her calls, she said. In the meantime, SHOTS relies on naloxone donations from other programs.

“The stakes are so high. My friends are dying,” said Fields, whose life has been saved by naloxone and who has been in recovery for seven years.

In a statement to KHN, the FDA laid responsibility on the companies making naloxone, saying it has encouraged pharmaceutical manufacturers to apply for over-the-counter designation for years, even doing the legwork to develop consumer-friendly labels that are typically the purview of companies.

“We continue to hope that one or more sponsors will submit an application, as this would be the most direct regulatory path for the FDA to be able to approve a non-prescription naloxone,” the agency said.

But when, or if, that’ll happen is unclear.

Pfizer and Hikma told KHN that they do not have current plans to pursue an over-the-counter designation. Emergent BioSolutions, which makes Narcan, said it is “evaluating the potential for OTC naloxone” but warned of “unintended consequences” from the switch, such as insurers no longer covering the cost and consumers having to pay out-of-pocket. (Experts say products typically are cheaper when sold over the counter.)

Harm Reduction Therapeutics, a nonprofit pharmaceutical company, said it plans to apply for an over-the-counter naloxone nasal spray next year, with the goal that it be on shelves in 2023. CEO Michael Hufford said the company will donate most of its product to harm-reduction groups and raise funds to offset the cost to consumers at retail pharmacies. Currently, the bulk of the company’s funding comes from Purdue Pharma, the maker of OxyContin.

But advocates say the FDA should make the switch itself.

“We have this lifesaving tool available throughout the whole time of this crisis, and the federal government has just been sitting on its hands,” said Leo Beletsky, a professor of law and health sciences at Northeastern University in Boston.

Some pharmaceutical companies in the past have argued that the government doesn’t have the authority to designate a prescription drug as over-the-counter, but others point to a statute that allows a drug’s prescription status to be removed “when such requirements are not necessary for the protection of the public health.” In 1982, the FDA designated an asthma inhaler as an over-the-counter drug without the company’s request, though it later rescinded that status because of widespread criticism that the inhalers would be overused.

Meanwhile, harm-reduction organizations, like the North Carolina Survivors Union in Greensboro, see the demand for naloxone daily. Vincent, who runs the program, said cost and regulatory burdens prevent her from ordering naloxone directly. Instead, she relies on donations from other groups. But she fears the day her group doesn’t have enough.

“I can’t look someone in the eye and tell them I can’t give them medicine that’s going to save their lives,” Vincent said.

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