By Alex Kacik | May
26, 2017
The country's only two
suppliers of a widely used drug have nearly run out of their stock that most
homes have in their kitchen cabinet—baking soda.
Hospitals use the sterile form of baking soda—a sodium bicarbonate solution, which has baking soda as its base ingredient—in vital situations including heart surgery and other emergency events when a patient's blood is too acidic, which can lead to coma and death if left unchecked. The supplier shortage has forced providers to delay surgeries and shift operations as they search for new manufacturers and treatment alternatives, healthcare experts said.
"I can't imagine, being a former pharmacy director, not having access to sodium bicarbonate," said Chris Jones, director of pharmacy automation and technology for the group purchasing organization Premier. "There is no other substitute that can work as well and quickly as that can. It truly is a life-and-death kind of drug."
Providers often stock the drug on emergency crash carts for critical-care settings during advanced cardiac life support and as an antidote to some poisons. It is also used in some types of chemotherapy.
The biggest U.S.-based drugmaker, Pfizer, which is the main manufacturer of sodium bicarbonate, said in a May 16 letter that a manufacturing issue sparked the shortage. Pfizer and the other sodium bicarbonate manufacturer, Amphastar Pharmaceuticals, expect to restock the syringes and vials by mid-August, according to the American Society of Health-System Pharmacists. That's probably the best-case scenario, healthcare officials said.
The Food and Drug Administration allowed the vetted Australian drugmaker Phebra to export vials of sodium bicarbonate to the U.S. to help alleviate the shortage, but that relief won't come for a few weeks, officials estimate.
"Pfizer apparently has an issue with their supplier of glass syringes," said Erin Fox, director of drug information at the University of Utah Health Care's drug information service. "We don't know why they only have one supplier and they don't have a backup plan. We also don't know why Pfizer didn't ramp up production of these drugs in vials if they knew they had issues with syringes."
The sodium bicarbonate shortage is one of many shortages of generic sterile injectible drugs that have plagued providers over the years, including a dwindling supply of norepinephrine. Healthcare experts say the main problem is a lack of competition, but there is no quick solution. In the meantime, regulators have asked manufacturers to give the industry more lead time to mitigate shortages through an early alert system.
"Drug shortages have been around forever, but they are getting worse and worse for generic items," Jones said.
Cleveland Clinic is in a unique position to create its own sodium bicarbonate compounds, which is a multimillion-dollar luxury most systems cannot afford, said Dr. Scott Knoer, chief pharmacy officer. The Cleveland Clinic is currently using its compounding facility, at significant time and expense, to manufacture its own sodium bicarbonate. But the clinic is not able to sell the drug to other providers due to regulatory constraints, he said.
"It's not uncommon for intensive-care patients to need sodium bicarb," Knoer said. "It's used a lot in hospitals across the country. It's a huge deal."
Premier is encouraging alternative suppliers to file abbreviated new drug applications and has group purchasing organization contracts ready to sign upon approval, the company said. It is also working with the FDA on an importation strategy and is suggesting licensed compounders to the agency to see if they can help fill the gaps.
Compounders are held to a different set of regulations than traditional pharmaceutical manufacturers, but they have received much more scrutiny since the contaminated New England Compounding Center led to a meningitis outbreak in 2012, healthcare executives said.
"We have to have more competition in the marketplace and more manufacturers making these products," said Wayne Russell, vice president of pharmacy at Premier. "This is what happens when you have one main supplier. We are lucky to have compounders that are ready to step up."
FDA Commissioner Scott Gottlieb said Thursday that he wants to accelerate the review of the agency's backlog of some 2,640 applications of generic drugs to inject competition into the marketplace and curb drug price hikes. Stock traders responded early Friday by buying stock in generic drug firms.
That policy shift could lead to more competition for sodium bicarbonate and other drugs coming through the pipeline, Russell said.
Generic drug manufacturers typically limit production to an often outdated single facility given the significant expense, which can essentially halt production in the event of equipment failure or quality control problem. Single-source drugs, or ones without generic alternatives, are largely to blame for a steady increase in annual pharmaceutical spending, research shows.
There are several measures moving through Congress that aim to reduce drug costs. Two bills, with the shorthand names CREATES Act and FAST Generics Act, target alleged anticompetitive behavior that stifles generic-drug development. The bills could curb behaviors such as preventing generic developers from accessing samples of branded products to demonstrate that a generic is equivalent and blocking access to safety protocols needed to gain federal approval. It is estimated the bipartisan FAST Generics Act would reduce drug costs by $5.4 billion a year.
"Anytime there is not enough competition, all it takes is one or two suppliers to go down, and suddenly you are in big trouble," Jones said.
Hospitals use the sterile form of baking soda—a sodium bicarbonate solution, which has baking soda as its base ingredient—in vital situations including heart surgery and other emergency events when a patient's blood is too acidic, which can lead to coma and death if left unchecked. The supplier shortage has forced providers to delay surgeries and shift operations as they search for new manufacturers and treatment alternatives, healthcare experts said.
"I can't imagine, being a former pharmacy director, not having access to sodium bicarbonate," said Chris Jones, director of pharmacy automation and technology for the group purchasing organization Premier. "There is no other substitute that can work as well and quickly as that can. It truly is a life-and-death kind of drug."
Providers often stock the drug on emergency crash carts for critical-care settings during advanced cardiac life support and as an antidote to some poisons. It is also used in some types of chemotherapy.
The biggest U.S.-based drugmaker, Pfizer, which is the main manufacturer of sodium bicarbonate, said in a May 16 letter that a manufacturing issue sparked the shortage. Pfizer and the other sodium bicarbonate manufacturer, Amphastar Pharmaceuticals, expect to restock the syringes and vials by mid-August, according to the American Society of Health-System Pharmacists. That's probably the best-case scenario, healthcare officials said.
The Food and Drug Administration allowed the vetted Australian drugmaker Phebra to export vials of sodium bicarbonate to the U.S. to help alleviate the shortage, but that relief won't come for a few weeks, officials estimate.
"Pfizer apparently has an issue with their supplier of glass syringes," said Erin Fox, director of drug information at the University of Utah Health Care's drug information service. "We don't know why they only have one supplier and they don't have a backup plan. We also don't know why Pfizer didn't ramp up production of these drugs in vials if they knew they had issues with syringes."
The sodium bicarbonate shortage is one of many shortages of generic sterile injectible drugs that have plagued providers over the years, including a dwindling supply of norepinephrine. Healthcare experts say the main problem is a lack of competition, but there is no quick solution. In the meantime, regulators have asked manufacturers to give the industry more lead time to mitigate shortages through an early alert system.
"Drug shortages have been around forever, but they are getting worse and worse for generic items," Jones said.
Cleveland Clinic is in a unique position to create its own sodium bicarbonate compounds, which is a multimillion-dollar luxury most systems cannot afford, said Dr. Scott Knoer, chief pharmacy officer. The Cleveland Clinic is currently using its compounding facility, at significant time and expense, to manufacture its own sodium bicarbonate. But the clinic is not able to sell the drug to other providers due to regulatory constraints, he said.
"It's not uncommon for intensive-care patients to need sodium bicarb," Knoer said. "It's used a lot in hospitals across the country. It's a huge deal."
Premier is encouraging alternative suppliers to file abbreviated new drug applications and has group purchasing organization contracts ready to sign upon approval, the company said. It is also working with the FDA on an importation strategy and is suggesting licensed compounders to the agency to see if they can help fill the gaps.
Compounders are held to a different set of regulations than traditional pharmaceutical manufacturers, but they have received much more scrutiny since the contaminated New England Compounding Center led to a meningitis outbreak in 2012, healthcare executives said.
"We have to have more competition in the marketplace and more manufacturers making these products," said Wayne Russell, vice president of pharmacy at Premier. "This is what happens when you have one main supplier. We are lucky to have compounders that are ready to step up."
FDA Commissioner Scott Gottlieb said Thursday that he wants to accelerate the review of the agency's backlog of some 2,640 applications of generic drugs to inject competition into the marketplace and curb drug price hikes. Stock traders responded early Friday by buying stock in generic drug firms.
That policy shift could lead to more competition for sodium bicarbonate and other drugs coming through the pipeline, Russell said.
Generic drug manufacturers typically limit production to an often outdated single facility given the significant expense, which can essentially halt production in the event of equipment failure or quality control problem. Single-source drugs, or ones without generic alternatives, are largely to blame for a steady increase in annual pharmaceutical spending, research shows.
There are several measures moving through Congress that aim to reduce drug costs. Two bills, with the shorthand names CREATES Act and FAST Generics Act, target alleged anticompetitive behavior that stifles generic-drug development. The bills could curb behaviors such as preventing generic developers from accessing samples of branded products to demonstrate that a generic is equivalent and blocking access to safety protocols needed to gain federal approval. It is estimated the bipartisan FAST Generics Act would reduce drug costs by $5.4 billion a year.
"Anytime there is not enough competition, all it takes is one or two suppliers to go down, and suddenly you are in big trouble," Jones said.
Alex Kacik is the hospital operations reporter for Modern
Healthcare in Chicago. Aside from hospital operations, he covers supply chain,
legal and finance. Before joining Modern Healthcare in 2017, Kacik covered
various business beats for seven years in the Santa Barbara, California region.
He received a bachelor's degree in journalism from Cal Poly San Luis Obispo in
Central California.
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