Sodium bicarbonate solution is a simple drug—its base ingredient, baking soda, is a kitchen pantry staple—but U.S. hospitals are scrambling to stockpile the drug amid a nationwide shortage, Katie Thomas reports for the New York Times.
According to Thomas, sodium bicarbonate solution is a "vitally important" drug that's crucial for patients whose blood has become too acidic. The drug is used during open-heart surgery, as an antidote to certain poisons, when a patient's organs are failing, in some types of chemotherapy, and to reduce pain when removing stitches.
Why the shortage
Health care providers are short on the drug right now because the only two suppliers in the country—Pfizer and Amphastar—"have run out," Thomas reports.
According to Erin Fox, a drug shortage specialist at the University of Utah, the problem appears to have begun in February, when Pfizer—the main supplier—announced a shortage, which a spokesperson attributed to a manufacturing delay with an unnamed third-party supplier. A subsequent "spike in demand then led Amphastar to run low," Thomas reports, and now, "even less-than-ideal alternatives to sodium bicarbonate, such as sodium acetate, are difficult to obtain."
Neither Pfizer nor Amphastar has confirmed when they'll be restocked. The drugmakers said it will take until at least June to resolve the issues with certain formulations of the drug and until at least August to address issues with other forms. Thomas Biegi, a spokesperson for Pfizer, said the company "has a dedicated team focused on working with suppliers to address this and have already taken several steps to expedite supply recovery of this drug."
Andrea Fischer, a spokesperson for FDA, said the agency has spoken with the drugmakers and that FDA is "exploring all possible solutions to this critical shortage, including temporary importation, to help with this shortage until it's resolved."
How health systems are responding
The shortage has forced some hospitals to delay elective procedures or make "difficult decisions about which patients merit the drug," Thomas reports.
For instance, in a recent meeting about how to respond to the shortage, leadership at Providence Hospital in Mobile, Alabama, determined that seven scheduled open-heart operations would need to be postponed. According to head pharmacist Gino Agnelly, one of those patients had to be transferred to another hospital because the patient's procedure couldn't wait.
Pfizer sent an emergency shipment a few days after the meeting, though Agnelly has still had "to make hard choices," Thomas reports. "Does the immediate need of a patient outweigh the expected need of a patient?" Agnelly asked. "It's a medical and ethical question that goes beyond anything I've had to experience before."
Meanwhile, some large hospitals, such as Duke University Hospital, have compounding pharmacies that allow them to produce drugs such as sodium bicarbonate solution when faced with a shortage. However, Kuldip Patel, the associate chief pharmacy officer at Duke, said the process is time-consuming. He added that drug companies should develop better contingency plans for keeping vital drugs in supply.
A familiar problem
Thomas writes that the sodium bicarbonate solution "is only the latest example of an inexpensive hospital staple's supply dwindling to a critical level." According to Fox, unexpected shortages have become routine in the health care sector. In fact, another sodium bicarbonate solution shortage occurred as recently as 2012, and hospitals in 2014 grappled with a saline solution shortage.
<p><a href="https://www.advisory.com/daily-briefing/2016/03/15/to-bypass-drug-shortages-these-hospitals-are-going-straight-to-the-source"><strong>To bypass drug shortages, these hospitals are going straight to the source </strong> <span class="ico ico-arrow-red-right-med"></span></a></p>
Mark Sullivan, the head of pharmacy operations at Vanderbilt University Hospital and Clinics, questioned whether manufacturers are investing enough in the production process of cheaper, staple hospital drugs. "The specialty, high-dollar medicines—I don't ever seem to see them experiencing shortages with those products," he said.
But Fischer contended that FDA in recent years has made progress in preventing supply issues. Thomas reports that there were 23 new drug shortages in 2016, down from 251 new shortages in 2011—a record high. FDA's website currently lists more than 50 drugs as being in shortage (Thomas, New York Times, 5/21).
What you need to know about health system specialty pharmacies
Health systems must develop a strategy for managing both specialty drug spending and patients on specialty medications to realize the benefits of these therapies.
However, as health systems increasingly assume responsibility for the total costs of patient care, the key to financial sustainability will rely on managing both specialty drug spending and patients on specialty medications.