(CNN) — A shortage of a drug commonly used to treat respiratory problems is about to get worse in the United States, as a major supplier to hospitals shut down last week.
Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. Since October it has been on the shortage list of the US Food and Drug Administration (FDA). News of the plant closure worries some doctors who work with patients with respiratory problems such as asthma.
“This is worrying, especially since we are coming out of the respiratory season, in which there was a great demand due to the virus syncytial respiratory disease, COVID-19 and influenza, and now we’re heading into spring allergy season, when many children and adults experience asthma symptoms,” said Dr. Juanita Mora, National Volunteer Medical Spokesperson for the American Association of Pulmonary Medicine and Chicago-based allergist and immunologist.”This is a life-saving drug and being able to breathe is vital for everyone.”
The recently closed manufacturer, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.
It was the only company that made certain albuterol products used for continuous nebulizer therapy. It’s a staple at children’s hospitals, but it’s been out of stock since last fall. Without that specific form of the product, hospitals have had to look for alternatives.
“Members are forced to either make the product themselves or have a third party make it,” explains Paula Gurz, director of pharmacy recruiting for Premier Inc, a major group purchasing company for hospitals.
With Akorn’s closure, Gurz said products from the only remaining major national source of liquid albuterol, Nephron Pharmacuticals, have been on backorders. Nephron started sending albuterol last Friday, Gurz said, but getting back on track “is going to be an uphill climb.”
Hospitals cope with shortages
Hospitals across the country said they are closely monitoring the supply chain and their current stocks.
They worry that they will have to delay the discharge of patients because they do not have enough medicines, or that there will be more visits to the emergency room by people with respiratory problems who do not have access to them.
Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital hasn’t been largely affected so far, but for months she has heard of retail pharmacies and other health systems having problems with the albuterol shortage.
“The big problem we’ve heard about is inhalation solutions, not really inhalers, but rather solutions that go into nebulizer machines and are inhaled by patients,” Piper explained.
Without the larger Akorn product, staff at Chicago’s Lurie Children’s Hospital had to squeeze the albuterol contents out of smaller containers.
“It takes a long time and is laborious, since 40 containers have to be opened to obtain 20 ml (each patient receiving continuous albuterol needs between 3 and 5 syringes a day)”, explains Julianne Bardele, a spokeswoman for the hospital, in an email. electronic.
When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different strength and use an alternative liquid bronchodilator, levalbuterol.
Most hospital pharmacies are aware of supply issues for many drugs, especially pediatric ones, said TJ Grimm, director of retail and outpatient services at Cleveland University Hospitals Medical Center, and are trying to keep more stocks high, especially for less expensive drugs such as albuterol.
“Just so we can cover situations like this,” Grimm said.
Grimm said his system has a couple of months’ supply of albuterol yet, but he is frustrated and worried about the supply chain.
When supply chains are “just in time”, problems can arise when something goes wrong,” added Grimm.
“There’s the short-term crisis that we all have to get through and then there’s the long-term. We have to think about these things a little more strategically, especially with our minors.”
Dr. Jerrod Milton, chief clinical officer at Children’s Hospital Colorado, said they have been paying close attention to the albuterol shortage for many months. The hospital has experienced shortages in the past, and has continued to apply protocols to conserve doses.
“The challenges are what we face when it comes to pediatric medicine. We view most of the children we serve as therapeutic orphans,” says Milton. “It’s just another one of the countless shortages we have to deal with, I guess.”
Concern for the supply chain
Jessica Daley, vice president of Premier’s strategic sourcing group, said she doesn’t expect albuterol shortages to be an ongoing problem for years, but when the market has only a handful of suppliers, “it becomes a very tight market, a very tight market. very worrying right now.”
Daley said there are things hospitals can do to help, such as protocol changes, manufacturing products on-site and finding different suppliers.
The Children’s Hospital Association stepped in when it heard from members who were having difficulty finding enough supplies. The association collaborated with STAQ Pharma, a facility that supplies pediatric compounded medicines, to initiate batch production of albuterol for children’s hospitals in the sizes they needed.
“We’ve been creative and tried to work proactively. So when we think there’s going to be a problem, we try to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.
STAQ Pharma should go into full production in May, so that hospitals will have a constant and stable supply before the next season, in which respiratory viruses will circulate widely, according to the association.
Premier’s Daley said that in an ideal world there would be more suppliers of these products, especially generic drugs, so that when there was a problem with one, the market could fix it.
When there is a concentration of manufacturing with a small number of suppliers, it is very difficult to recover, he said.
“We really advocate for diversity and supply to avoid these types of issues,” Daley said. “That is, at least three global and geographically diverse suppliers that supply enough products to the market.”
Guidance for patients
Piper of Children’s Hospital of New Orleans said they are encouraging patients with respiratory problems to take precautions and avoid asthma triggers if possible. She said that if you can’t find the drug at your regular pharmacy, it’s also good to check with a doctor to see if another drug is available.
Inhalers don’t appear to be affected by the shortage so far, but Daley said if people panic about a lack of albuterol for hospitals, that could change.
“Albuterol is one of those things that if there’s a patient that needs it, you want to have it all the time. So there’s always the possibility that the market will respond and react in a way that there’s a shortage of other sizes or presentations of a product,” explains Daley.
To avoid that problem, Milton, of Children’s Hospital of Colorado, said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”