Tag: pharmacies and pharmacists

Chronic pain patients struggle to get opioid prescriptions filled, even as CDC eases guidelines | CNN

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KHN
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Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,” said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

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For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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Naloxone nasal spray may soon be in your pharmacy. Our medical analyst explains what it is and who can use it | CNN

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CNN
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Two advisory committees to the US Food and Drug Administration have voted unanimously to recommend that a nasal spray version of the opioid overdose antidote, naloxone (also called Narcan), be made available over the counter.

If the FDA agrees with this recommendation, naloxone may soon be sold without a prescription in pharmacies and made available in grocery stores, big-box stores, gas stations, and corner stores around the country.

This development comes at a time when opioid overdoses are at a record high, rising more than 15% in one year. Deaths attributed to opioids rose from around 70,000 in 2020 to 80,800 in 2021, according to the US Centers for Disease Control and Prevention. The highly potent and lethal opioid, fentanyl, is implicated in the majority of these deaths.

What is naloxone, and how does it work to save lives from opioid overdose? How do you know if someone is overdosing, and how can bystanders administer the antidote? How can people get access to it now, and what will it mean if the FDA approves it for over-the-counter use? What more needs to be done to reduce overdose deaths?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she was Baltimore’s health commissioner, where she led the city’s overdose prevention strategy.

CNN: How does naloxone work to save people overdosing on opioids?

Dr. Leana Wen: Naloxone is a medicine that rapidly reverses the effect of an opioid overdose. It is an antagonist to opioids, meaning that it attaches to the opioid receptors in the brain, and in doing so, reverses and blocks the effects of opioids.

Someone who has taken too large of a quantity of opioids can become unconscious and stop breathing. This is deadly — a person can die within minutes after they stop breathing. Naloxone reverses the effect of the opioid overdose and can restore normal breathing within a couple of minutes.

CNN: What are the different versions of naloxone? Does it work against illicit drugs like heroin and fentanyl as well as prescription drugs?

Wen: Naloxone comes in two main forms. There is the nasal spray version, with one manufacturer calling its product Narcan Nasal Spray. This version is sprayed into the nostril, similar to some allergy medications.

Naloxone also comes as a liquid. This form can be injected either intravenously through an IV, if a patient already has an IV inserted, or intramuscularly, usually as a shot through the quadriceps muscle in the leg.

Several years ago, there was another version of naloxone that was in an autoinjector, similar to an EpiPen that’s given to people with life-threatening allergic reactions. In 2019, the manufacturer made a business decision to stop making that version available to the public. (An autoinjector is still approved for use by the military and for chemical incident responders.)

The nasal spray, intravenous and intramuscular versions all work very well, and they all work against various versions of opioids. That includes not only heroin and fentanyl but also common opioid medications like oxycodone, hydrocodone, codeine and morphine. It’s important to note that one dose may not be enough, depending on how potent and how much opioid was taken. Often, several doses are needed to revive someone.

CNN: How do you know if someone is overdosing, and how can bystanders administer the antidote?

Wen: Signs of overdose include being unable to be awakened, breathing slowly or not breathing at all, and fingernails and lips taking on a blue or purple color while the skin becomes pale and clammy to the touch. Their pupils are often described as “pinpoint,” or very small.

Someone can overdose from taking too much of an opioid by accident. This often happens when fentanyl, an extremely potent opioid, is mixed with whatever the person is taking without their knowledge. Also, if an opioid is mixed with alcohol or benzodiazepines or other opioids, they can also become unresponsive. And there are instances when someone may not realize they are taking opioids, but the pill they obtained is contaminated with fentanyl.

If someone is overdosing, you or someone who is with you must call 911 immediately. In the meantime, administer naloxone. Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important for the person to receive medical attention after receiving the drug. Depending on the opioid the person took, they may need to be monitored in the hospital for hours after in case naloxone wears off while the opioid continues to have an effect.

If you have the nasal spray version, insert the tip of the device into the nostril and squeeze. Another spray may be given in the other nostril in two to three minutes if the patient remains unresponsive, and another one in another two to three minutes until either the patient responds or emergency help arrives. If you are trained to perform CPR, and the person isn’t breathing, you should administer CPR as well, in between giving naloxone.

CNN: Is naloxone safe to use? What if you’re not sure if someone is overdosing from opioids?

Wen: Yes, naloxone is extremely safe. If someone is not on opioids and is unresponsive, say, because they drank too much alcohol or has had a stroke, naloxone will have no adverse effect for them. That’s why emergency medical personnel routinely administer naloxone to patients who are found to be unresponsive; there is no harm to people who are unresponsive from non-opioid-related reasons.

If someone overdosed on opioids, naloxone reversal will send them into withdrawal. This could be unpleasant for the individual and could lead to vomiting, agitation, shivering, tearing up and having a runny nose. These aren’t desirable side effects, of course, but in cases when naloxone must be given, the alternative is death.

CNN: How can people get access to naloxone now? What will it mean if the FDA approves it for over-the-counter use?

Wen: As an emergency physician, I’ve given naloxone many times. First responders like paramedics and emergency medical technicians also routinely administer naloxone. When I served as Baltimore’s health commissioner, I felt strongly that everyone should be able to save someone else’s life.

Nonmedical personnel may already obtain and carry naloxone with them, but specific requirements and regulations vary by the state. Health departments and some community nonprofit groups have low-priced or free naloxone that they distribute to community members. Often, the naloxone is distributed to individuals who use drugs, because they are most likely to be around others who are overdosing. Also, their family members can use naloxone to revive them.

If the FDA approves the nasal spray naloxone for over-the-counter use, that means it will be more accessible. People should be able to purchase the spray from pharmacies, grocery stores, gas stations and perhaps even vending machines.

The problem is cost. We don’t yet know how the over-the-counter naloxone spray will be priced, and whether and how much insurance companies cover it will probably vary.

CNN: What more needs to be done to reduce overdose deaths?

Wen: Naloxone access is an important step. Someone who is overdosing has no chance for a better tomorrow if they are dead today. I would encourage everyone with a family member who is on opioids for chronic pain or has an opioid addiction to carry naloxone with them, so that they could save their loved one’s life.

Longer-term, a person who has an opioid use disorder needs treatment with a combination of medications and psychosocial supports. Much more needs to be done to expand treatment access, as well as to reduce the supply of illicitly manufactured drugs like fentanyl that are worsening the overdose crisis.

Finally, I want to remind everyone of 988, a new 24/7 phone and chat hotline that provides suicide counseling, crisis supports and referral for people in need of mental health and addiction support.

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A shortage of albuterol is about to get worse, especially in hospitals | CNN

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CNN
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An ongoing shortage of a medicine commonly used to treat people with breathing problems is expected to get worse after a major supplier to US hospitals shut down last week.

Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. It has been on the US Food and Drug Administration’s shortages list since October. The news of the plant shutdown worries some doctors who work with patients with breathing problems such as asthma.

“This is definitely concerning, especially as we are coming out of the respiratory season where we had a big demand with RSV, Covid-19 and flu, and are now heading into spring allergy season when a lot of kids and adults experience asthma symptoms,” said Dr. Juanita Mora, a national volunteer medical spokesperson for the American Lung Association and an allergist/immunologist based in Chicago. “This is a life-saving drug and being able to breathe is vital for everyone.”

The manufacturer that recently shut down, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.

It was the only company to make certain albuterol products used for continuous nebulizer treatment. It’s a staple in children’s hospitals, but had been out of stock since last fall. Without that particular form of the product, hospitals have had to scramble to find alternatives.

“Members are either forced to compound it themselves to make the product or go to an outside third party source who is compounding the product,” said Paula Gurz, senior director of pharmacy contracting with Premier Inc., a major group purchasing company for hospitals.

With the Akorn shutdown, Gurz said products from the one remaining major domestic source of liquid albuterol, Nephron Pharmacuticals, have been on back order. Nephron just started shipping albuterol last Friday, Gurz said, but to get back on track, “it’s going to be an uphill climb.”

Hospitals around the country said they’re watching the supply chain – and their current stock – closely. There’s concern they might have to delay discharging patients because they don’t have enough medicine, or that they may see more ER visits for people with breathing problems who don’t have access to medicine.

Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital has been largely unaffected so far, but for months she has heard about retail pharmacies and other health systems that have had issues with albuterol shortages.

“The big problem we’ve been hearing about is inhalation solutions, not really the inhalers, it’s more like the solutions that go into the nebulizer machines for inhalation that the patients breath in,” said Piper.

Without the larger Akorn product, staff at Lurie Children’s Hospital in Chicago had to squeeze out the albuterol contents from smaller packages.

It’s “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day),” said hospital spokesperson Julianne Bardele in an email.

When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different concentration and use an alternative liquid bronchodilator, levalbuterol.

Most hospital pharmacies are aware of supply issues for many medicines, particularly pediatric medicines, said T.J. Grimm, the director of retail and ambulatory services at University Hospitals Cleveland Medical Center, and they try to keep a higher stock – especially of the less expensive medicines like albuterol.

“Just so we can cover situations like this,” Grimm said.

Grimm said his system has albuterol supply for a couple of months still, but he’s frustrated and concerned about the supply chain.

“When you have supply chains that are just-in-time, it can create some issues with when something goes off,” Grimm added. “There’s the short-term crisis we all have to get through and then there’s a longer term. We need to think about these things a little more strategically, especially with our kids.”

Jerrod Milton, the chief clinical officer at Children’s Hospital Colorado, said they’ve been paying close attention to the albuterol shortages for many months. The hospital has experienced shortages in the past, and has continued to implement protocols to conserve doses.

“Challenges are what we deal with when it comes to pediatric medicine. We consider most of the kids that we take care of as somewhat therapeutic orphans,” Milton said. “It’s just another one of the myriad of shortages that we have to deal with, I guess.”

Jessica Daley, the group vice president of strategic sourcing for Premier, said that she doesn’t anticipate that the albuterol shortage will be an ongoing problem for years, but when the market has only a handful of suppliers, “it makes for a very tight market, a very concerning market right now.”

Daley said there are things hospitals can do to help, such as protocol changes, making products on site and finding different suppliers.

The Children’s Hospital Association stepped in to help when it heard from members having difficulty finding enough supply. The association worked with STAQ Pharma, a facility that provides compounded pediatric medication, to start production on batches of albuterol for children’s hospitals in the sizes they needed.

“We’ve been creative and trying to work proactively. So when we think there’s going to be a problem, we’re trying to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.

STAQ should be at full production by May, so hospitals will have a steady, stable supply ahead of the next season in which respiratory viruses are in wide circulation, the association says.

Daley at Premier said that in an ideal world, there would be more suppliers of these products, particularly with generic drugs, so that when there is a problem with one, the market could handle it. When there is a concentration of manufacturing with a small number of suppliers, it is very hard to recover, she said.

“We really advocate for diversity and supply to prevent types these types of issues,” Daley said. “Meaning at least three globally, geographically diverse suppliers that are supplying the market with sufficient products.”

For patients, Piper at Children’s Hospital of New Orleans said they are encouraging patients with breathing problems to take precautions and avoid asthma triggers if possible. She said if a patient’s usual pharmacy runs out, it’s also good to check with a doctor to see if there is another medication that’s available.

Inhalers don’t seem to be impacted by the shortage so far, but Daley said if people panic about the lack of albuterol for hospitals, that could change.

“Albuterol is one of those things that if there’s a patient who needs it, you want to have it all the time. So there’s always that potential for the market to respond and react in a way that that will then create downstream shortages of other sizes or presentations of a product,” Daley said.

To avoid that problem, Milton at Children’s Hospital Colorado said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”

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Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes | CNN

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CNN
 — 

Eli Lilly announced Wednesday a series of price cuts that would lower the price of the most commonly used forms of its insulin 70% and said it will automatically cap out-of-pocket insulin costs at $35 for people who have private insurance and use participating pharmacies.

Lilly says it will also expand its Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured.

President Joe Biden heralded the announcement as “a big deal.”

“For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It’s flat wrong,” Biden said in a statement on Wednesday.

The President also urged other pharmaceutical companies to cut insulin prices.

“Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that. It’s a big deal, and it’s time for other manufacturers to follow,” Biden said.

Eli Lilly says it will cut the list price of its nonbranded insulin to $25 a vial as of May 1, making it the lowest list-priced mealtime insulin available. Its current list price is $82.41 for a vial.

Lilly will also lower the list price of Humulin and its most commonly prescribed insulin, Humalog, in the fourth quarter of 2023. The current list price of a Humalog vial is $274.70, and the new list price will be $66.40. For people with commercial insurance who use participating pharmacies, the out-of-pocket costs will now be capped at $35.

Although insulin is relatively inexpensive to manufacture, the cost has been a problem for many Americans for years. At least 16.5% of people in the US who use it report rationing it because of cost.

The average price of insulin nearly tripled between 2002 and 2013, the American Diabetes Association says. GoodRx research shows that the trend has continued, with the average retail price of insulin rising 54% between 2014 and 2019.

Demand for insulin has grown significantly as diabetes has become the fastest-growing chronic disease in the world, a 2022 study found.

In the US alone, the number of adults with diabetes has doubled over the past 20 years, and more than 37.3 million people now have it, according to the US Centers for Disease Control and Prevention. Another 96 million Americans – 38% of the population – have prediabetes, a condition in which blood sugar levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. This can often lead to diabetes.

People with diabetes rely on insulin because their bodies have stopped producing enough of this hormone or aren’t using it efficiently to convert food into energy.

When a person eats, their body breaks down food, mostly into sugar. This sugar enters the bloodstream, and that signals the pancreas to release insulin, which works like a key that allows the sugar to energize cells. But if diabetes keeps sugar in the bloodstream for too long, it can lead to serious problems like kidney disease, heart problems and blindness. In 2019, diabetes was the seventh leading cause of death in the US, according to the American Diabetes Association.

This year’s Inflation Reduction Act capped insulin costs for seniors who get their health coverage through Medicare Part D at $35 a month. Congressional Democrats pushed to extend that price cap to people covered by private insurance, but Republicans stripped that measure from the bill.

The US Food and Drug Administration’s approvals of generic insulin and biosimilars – drugs similar to original versions that can be made differently or with slightly different substances – have driven down the price at least somewhat, according to GoodRx.

Some states have taken matters into their own hands. Twenty-two states and the District of Columbia have price caps ranging from $25 to $100 for insulin as well as diabetes supplies and devices – but that’s only for people covered by insurance plans regulated by those states.

“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap.”

Lilly has been one of the biggest players in the US insulin market since it became the first company to commercialize the lifesaving drug 100 years ago. The company said that its price changes should make a difference, but more is needed to help all Americans with diabetes – 7 out of 10 don’t use the company’s insulin.

The Medicare Part D cap “should be the new standard in America,” Ricks said on CNN This Morning on Wednesday.

He called on the insurance industry, policymakers and other manufacturers to join them in making insulin more affordable.

“We call on everyone to meet us at this point and take this issue away from a disease that’s stressful and difficult to manage already – to take away the affordability challenges,” Ricks told CNN’s Don Lemon.

Other companies have cut insulin costs over the years.

In 2019, Sanofi created the Insulin Valyou Savings Program, which charged patients $99 a month for insulin, regardless of income. In 2021, Novo Nordisk created a similar program called My$99Insulin.

Also that year, Novo Nordisk collaborated with Walmart to sell private-label analog insulin at a deep discount. Walmart said its ReliOn NovoLog vials and FlexPens save customers 58% to 75% off the cash price for branded insulin.

For Eli Lilly insulin, the new price cap will automatically apply at most pharmacies with no additional action from the patient. Otherwise, a coupon will be available for patients to use at the remaining 15% of pharmacies where the electronic system does not allow for the automatic price drop, Ricks said.

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