Read News Broadcasts of the day From All News Channels in USA , national news, sports, entertainment, finance, technology, and more from USA Today Broadcast

Saturday, 3 June 2017

How a baking soda shortage became a health-care crisis

File photo taken in 2016 shows Pfizer's company logo outside the pharmaceutical giant's New York headquarters.
A breakdown in the supply chain of sodium bicarbonate — the same basic compound as household baking soda — for use in medical procedures is expected 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 and choose alternative treatments in some instances.

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 it to treat various conditions including drug overdoses and acidosis. The shortages also 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 show that dozens of treatments won't be back to full availability until sometime in 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 has caused greater demand and delays at competitor Amphastar Pharmaceuticals, which has since increased its production capacity.

A third pharmaceuticals manufacturer, Athenex, reported Wednesday that it is coordinating a plan with the FDA to temporarily import an Australian-made injection of sodium bicarbonate for emergency sales in the U.S.

Pfizer spokesman Thomas Biegi said the company expects to restore all of its sodium bicarbonate products, including injectable treatments, 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 drugmakers 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.

But health care providers can find themselves in desperate need of supplies, leading to difficult decisions with patients.

The American Society of Health-System Pharmacists advised clinicians to conserve supplies of sodium bicarbonate wherever possible. They can use sodium acetate as an alternative in some instances.

Pfizer competitor Amphastar is aiming to make up for the shortfall. The company is "regularly shipping this product but we are currently in back order," Amphastar President Jason Shandell said in an email. "We have invested significant money in our facility to expand the capacity to meet the demand."

If the shortage of baking soda is having an effect on consumer products sold in grocery stores, it was not immediately evident.

A spokesperson for Church & Dwight, which owns the Arm & Hammer brand, did not respond to a request seeking comment. But Arm & Hammer baking soda sales contributed to increased first-quarter, the company said on May 4.

Source USA Today
Share:

Search This Blog

Blog Archive

Pages