A Vital Drug Runs Low, Though Its Base Ingredient can be in Many Kitchens

The shortage of sodium bicarbonate solution can be only the latest example of an inexpensive hospital staple’s supply dwindling to a critical level. In recent years, hundreds of generic injectable drugs have become scarce, vexing hospital administrators in addition to government officials, who have called on the manufacturers to give better notice when they are about to run short.

Without an abundant supply of sodium bicarbonate, some hospitals are postponing elective procedures or creating difficult decisions about which patients merit the drug. At Providence Hospital in Mobile, Ala., supplies ran so low a few weeks ago that will Gino Agnelly, the head pharmacist, embarked on a desperate scavenger hunt, culling vials by the 50 crash carts that will were stowed around the hospital.

Mr. Agnelly said he had been getting by having a supply of about 175 vials when a patient having a heart problem suddenly needed 35 of them.

He called a meeting of doctors in addition to administrators, in addition to they came to a difficult conclusion: They might need to postpone the seven open-heart operations that will were scheduled for the next week. One critically ill patient was sent to a hospital across town because his surgery could not be delayed, Mr. Agnelly said.

Pfizer sent an emergency shipment a few days later, however the continuing shortage has forced Mr. Agnelly to make hard choices.

“Does the immediate need of a patient outweigh the expected need of a patient?” he asked. “This kind of’s a medical in addition to ethical question that will goes beyond anything I’ve had to experience before.”

Erin Fox, a drug shortage expert at the University of Utah, said unexpected shortfalls of critical medicines had become routine. In 2014, a shortage of saline solution — salt water — sent hospitals into a similar panic. This kind of can be not even once that will the supply of sodium bicarbonate has run out. The last shortage occurred in 2012.

“This kind of can be unbelievably frustrating,” Ms. Fox said. “This kind of makes me so mad that will we are out of these truly basic lifesaving medications.”

Mr. Sullivan, of Vanderbilt, said the shortages typically occurred with cheaper, “bread-in addition to-butter” hospital drugs, leading him to question whether manufacturers were investing enough inside the production process needed to make a reliable supply.

“The specialty, high-dollar medicines — I don’t ever seem to see them experiencing shortages with those products,” he said.


Gino Agnelly, the head pharmacist at Providence Hospital in Mobile, Ala., has had to be careful with his supply of sodium bicarbonate injections.

Meggan Haller for The brand new York Times

The situation with sodium bicarbonate solution appears to have begun in February when Pfizer, the main supplier, announced This kind of was in short supply, Ms. Fox said. A spike in demand then led Amphastar to run low. at This kind of point, even less-than-ideal alternatives to sodium bicarbonate, such as sodium acetate, are difficult to obtain.

Kuldip Patel, the associate chief pharmacy officer at Duke University Hospital in North Carolina, said he had become accustomed to the juggling act required when an old standby was suddenly unavailable.

“This kind of’s not like we haven’t been here before,” he said.

Mr. Patel said the problem had worsened just after Pfizer went by shipping its generic injectable products by a few regional warehouses to one national distribution center, part of a reorganization after its acquisition of the drugmaker Hospira.

“that will’s when This kind of all derailed,” he said.

A spokesman for Pfizer said the shortage of sodium bicarbonate was not related to the change in distribution, however was due to a manufacturing delay caused by an outside supplier. The spokesman, Thomas Biegi, said the delay had not been caused by a problem with the supplier of the raw ingredient, sodium bicarbonate, however he added that will he could not divulge further details, citing confidentiality agreements.

Regardless of the reason, Mr. Patel said, drug companies should do a better job of creating contingency plans for keeping vital drugs in supply, especially during transitions.

“In situations like This kind of, where a major some sort of can be buying out another major some sort of of critically needed drugs, there has to be a detailed backup plan in case things don’t go smoothly,” Mr. Patel said.

Mr. Biegi said Pfizer was working hard to fix the problem. “Pfizer incorporates a dedicated team focused on working with suppliers to address This kind of in addition to have already taken several steps to expedite supply recovery of This kind of drug,” he said.

Andrea Fischer, a spokeswoman for the Food in addition to Drug Administration, said companies were asked to notify the agency of problems, however “there are no requirements that will firms keep emergency supplies or that will they stock up prior to any improvements they make.”

She said the agency was in close contact with the companies in addition to “exploring all possible solutions to This kind of critical shortage, including temporary importation, to help with This kind of shortage until This kind of’s resolved.”

Ms. Fischer said the agency had recently made progress in preventing supply problems. In 2011, This kind of tracked 251 brand new shortages, an all-time high. however by 2016, she said, there were only 23 brand new shortages. Currently, more than 50 drugs are classified as being in shortage on the F.D.A. website.

“Unfortunately,” she said, “not all shortages can be prevented.”

The shortage problem has been traced to a confluence of factors, ranging by problems with suppliers of the raw ingredients to trouble at the aging facilities where many of the most inexpensive generics are made. Consolidation inside the industry has also reduced the number of companies producing certain drugs, in order that will when one company incorporates a problem, the different quickly runs out as well.

Ms. Fischer said the F.D.A. gave the approval process a priority status when a company wanted to enter a market that will was in short supply.

Some large hospitals, such as Duke, house so-called compounding pharmacies, which can make custom batches of generics like sodium bicarbonate. Mr. Patel said that will Duke was inside the process of doing just that will, however that will setting up the process took time. The solution must be pure in addition to sterile because This kind of can be injected into the bloodstream.

At Providence Hospital in Mobile, Mr. Agnelly said he was so desperate that will he had done an internet search to investigate if he could safely mix his own batch with some baking soda in addition to water. The hospital does not have a compounding pharmacy.

He discovered just one research paper, dating to 1947, when doctors did exactly that will during World War II.

“This kind of can be not brand new technology. These are not expensive materials,” Mr. Agnelly said, adding that will he quickly abandoned the idea. “This kind of’s not what you might expect inside the First World.”

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A Vital Drug Runs Low, Though Its Base Ingredient can be in Many Kitchens

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