June 2, 2017
A breakdown in the supply chain of sodium bicarbonate—the same basic compound as household baking soda—for use in medical procedures is likely to limit access to certain treatments in hospitals through the end of the year.
A shortage of the antacid is prompting health care providers to carefully prioritize procedures, delay some operations or choose alternative treatments.
The crisis is directly connected to troubles at a supplier of pharmaceuticals giant Pfizer, but it has rippled through the medical sector, which relies on the compound to treat various conditions, including drug overdoses and acidosis. The shortages could affect patients facing severe renal disease, diabetes, severe dehydration and cardiac arrest.
“Drug shortages have this potential to compromise” the need for immediate care, said Sandra Kane-Gill, chair of the medication use safety committee at the Society of Critical Care Medicine. “It does have potential patient safety implications.”
Documents filed with the U.S. Food and Drug Administration (FDA) show that dozens of treatments won’t be back to full availability until the fourth quarter, including several that may take until December.
The shortage, which started in September, is rooted in delays at Pfizer’s Hospira manufacturing plant in North Carolina. That production jam caused greater demand and delays at competitor Amphastar Pharmaceuticals, which has since increased its production capacity.
A third pharmaceuticals manufacturer, Athenex, reported Wednesday it is coordinating a plan with the FDA to temporarily import an Australian-made injection of sodium bicarbonate for emergency sales in the United States.
Pfizer spokesman Thomas Biegi said the company expects to restore all of its sodium bicarbonate products by the fourth quarter. The company this week shipped “a limited supply” to major wholesalers and will deliver one syringe-based product in June, he said in an email.
But different products with varying concentrations of sodium bicarbonate, including certain emergency syringes, won’t be available until much later, according to FDA files.
“Pfizer is working hard to restore supply of sodium bicarbonate,” Biegi said in an email. “We understand and regret the challenges the shortage poses to clinicians and patients. We have prioritized the manufacture of this medicine, and given the complexity of the production process we will continue to work diligently to alleviate shortages while ensuring the highest quality and safety standards for all of our products.”
Biegi blamed the shortage on a critical supplier to its North Carolina facility. Citing confidentiality agreements, he declined to identify the supplier or reveal the exact problem—whether it’s a manufacturing breakdown, financial matter or internal issue—except to say it’s not a crisis connected to raw materials.
Drug shortages are a fairly regular occurrence in the pharmaceuticals business, particularly following a prolonged period of consolidation that has left only a few drug makers for certain products. Much like a recall of a single engine part can affect millions of cars at multiple automakers, the pharmaceutical business is susceptible to a breakdown when one supplier faces a crisis.
“The FDA recognizes this is an important drug and is working with the drug manufacturer so that the drug may return to the market as quickly as possible, while ensuring safety for patients,” FDA spokeswoman Andrea Fischer said.
The FDA is currently tracking about 55 treatments with shortages. Because it’s not unusual to have occasional shortages, health care providers “have gotten used to managing these scenarios,” Kane-Gill said. They can typically choose certain critical procedures over less important treatments to ensure patient health.
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