Written by Marty Stempniak

Months have passed since Hurricane Maria slammed the shores of Puerto Rico. Yet, hospitals still are feeling the pinch thousands of miles away in Texas.

That’s because most manufacturers for crucial IV saline solutions — used to treat dehydration and dilute medications for injection — are located on the tiny island. Texas hospitals, already dealing with other ongoing drug shortages, are being forced to cope without one of the most crucial items in the supply cabinet.

KROLL
KROLL

“There is definitely serious concern right now,” said Carrie Kroll, vice president of advocacy, quality and public health at the Texas Hospital Association. “THA is aware of the issue; we are monitoring it daily, and we ask hospitals that are feeling an acute strain to contact us so that we can better understand the issue on the ground.”

It’s not just Texas hospitals that are feeling the pinch. In an informal survey of more than 320 of its members, the American Society of Health-System Pharmacists found that more than 99 percent of respondents have been impacted by this shortage. About 61 percent said the dearth of small-volume, shorter-duration IV solutions — 100 milliliters or less, with an infusion time of no longer than eight hours — is “severe,” meaning that it “has impacted daily operations and patient care.”

PASKO
PASKO

Some of the most common ways in which hospitals are responding to this shortage, ASHP found, include using alternate methods to administer drugs, such as “IV push” (about 85 percent); utilizing drugs that aren’t on insurance companies’ preferred lists (64 percent); and implementing protocols to restrict clinicians’ use of certain products (60 percent). Deborah Pasko, director of medication safety and quality at ASHP, believes this issue needs to receive more attention.

“I don’t think this is rising to the level of importance that it should be,” Pasko said. “The U.S. is focused right now on the opioid crisis, but we’ve never needed an opioid to save someone’s life. We do need IV solutions to save people’s lives, and this definitely is a crisis shortage right now.”

The Response in Texas

Baptist Hospitals of Southeast Texas, in Beaumont, has been grappling with drug shortages for years, said Aily Liem Powell, administrative director of pharmacy. But those issues have been exacerbated by both Hurricane Harvey here in Texas, and Puerto Rico’s Maria.

The system also has struggled with a shortage of injectable opioids — morphine, Dilaudid and fentanyl — caused by high demand for the drugs, along with production caps put in place by the U.S. Drug Enforcement Administration to combat the opioid epidemic, Powell said.

POWELL
POWELL

Last August, the DEA proposed cutting U.S. manufacturing of controlled substances by 20 percent this year, compared to 2017 output, responding to what it said was decreasing demand. In the wake of that announcement, the 350-bed Baptist has urged doctors, where prudent, to push patients toward oral painkillers or alternatives, such as Tylenol.

Powell said her organization is trying to view the concurrent shortages of opioids and IV fluids in a positive light, as doctors and nurses figure out how best to treat patients in this new reality.

“Everyone’s conserving what they’ve got. Having this crisis is kind of a double-edged sword,” Powell said. “Yes, we don’t have fluids like we should… but I’ve had a lot of physicians say ‘we over hydrate’ or give too much fluid to patients. So, it’s helping us be more conscientious of how we use our resources—IV fluids, opioids, all of the above.”

To help clinicians be more conscientious, Baptist has instituted a weekly drug shortage meeting — including a physician champion, nursing and pharmacy staff member— to discuss major topics that might affect all three staff segments, and what changes need to be instituted. Typically, those practice modifications are implemented within 24 hours, she said. Meanwhile, the pharmacy team meets twice a week on its own to go over inventory and strategize how to address shortages.

If Baptist gets down to a week’s supply of a particular drug, that’s when alarms start sounding, and pharmacy staff huddles with doctors and nurses, checking in again at the five-day mark. In one recent instance, when the system was running low on Ringer’s lactate, a type of IV saline solution, it instituted a “therapeutic interchange,” Powell explained, where doctors’ medication orders were swapped to more plentiful alternatives. Patients who needed the drug most, such as pregnant women in the operating room, were prioritized.

The system also has started drawing IV fluids and opioids into syringes, giving patients the lowest volume possible to help ration drugs. However, doing so is less than ideal, as such rationing must be performed in a sterile environment, can delay getting drugs to patients in need, and can shorten the shelf life of medications.

Most physicians are on board with the special measures, and Powell believes that’s because of their transparent culture. “The biggest thing is making sure that you are collaborating with leadership, and keeping an open line of communication to everybody.” It also helps to have a backup plan, and a backup plan to the backup plan.

“It’s one thing to have a Plan A and a Plan B, but the way things have been going with this shortage, I also have a Plan C and Plan D,” Powell said. “Have several strategies, on the off chance that, when you run out of one product, you have another one ready.”

Powell also urged hospital leaders to reach out to others in the field to see how they’re coping with shortages. She’s been in touch regularly with peers at institutions such as the larger seven-hospital Houston Methodist, which is also grappling with supply scarcities.

VARKEY
VARKEY

Alex Varkey, director of pharmacy services at its flagship, 900-bed Houston Methodist Hospital, says the system started really feeling the strain of the shortage in October. Since then, its IT department has been working diligently to make sure that clinicians have the most up-to-date information on what medications are available and alternatives to those that are running short. Additionally, prescribers constantly are comparing notes with one another, he said.

Houston Methodist clinicians also regularly use the practice of “IV push,” where a drug is administered slowly to a patient using a syringe, without IV bags, which he said also are in short supply. That’s one of the practices changes recommended by ASHP, which recently sent out a list to members with a few dozen best practice to respond to IV shortages.

Both Varkey and Powell emphasized that, despite any modifications, patients still are receiving the same high-quality care as before, and that they have yet to run out of a drug, despite some close calls.

Varkey hopes that drug manufacturers take this shortage to heart and prepare to better serve hospital needs when the next disaster strikes. “This is something we’ve never seen before, and I think it points to a very important question, which is: Should there be alternative sites that are developed for the manufacturing of these products?”

What’s Next

Moving forward, the U.S. Food and Drug Administration announced in early January that Baxter, one of the leading producers of IV saline solutions, had returned to the commercial power grid in Puerto Rico and looks to ramp up production. That’s in addition to making more products available from its facilities in Ireland.

The FDA also encourages hospitals to follow the clinical recommendations released by AHSP. Plus, the federal officials have begun to explore further means to bump up the supply of IV fluids, granting approval for the use of products produced by companies such as Fresenius Kabi and Laboratorios Grifols, according to the Jan. 4 announcement.

“Given the improvements we’ve seen over the last few weeks, I’m optimistic that supplies of IV saline and amino acids will increase over the next few weeks and the stress of the shortage will begin to abate, even if the shortages will not be fully resolved immediately,” FDA Commissioner Scott Gottlieb, M.D., said in the release.

WOODWARD
WOODWARD

Even if the situation in Puerto Rico resolves, hospitals should still expect further supply chain disruptions to pop up down the line, cautioned Bill Woodward, vice president of contract and program services in pharmacy sourcing operations at Vizient. “This is an issue that has been ongoing for more than 10 years,” he said. “Unfortunately, it’s kind of a revolving door, where you resolve a couple of shortages and then, two more appear. We still have about 150 ongoing shortages in the marketplace today, and still there are new shortages popping up this year.”

That’s why hospital leaders, such as Varkey, stress that adaptability is the most crucial measure to prepare for what’s next.

“For hospital and pharmacy leadership teams, it’s really important to maintain a positive focus, and at the same time, be ready and willing to adapt,” Varkey said. “Because your best plans today might not be effective tomorrow, just based on the availability of product. It’s going to take a lot of patience and positivity, but eventually, we will get past this.”

ALEX VARKEY
ALEX VARKEY
DIRECTOR OF PHARMACY SERVICES
HOUSTON METHODIST

"For hospital and pharmacy leadership teams, it’s really important to maintain a positive focus, and at the same time, be ready and willing to adapt,” Varkey said. “Because, your best plans today might not be effective tomorrow, just based on the availability of product. It’s going to take a lot of patience and positivity, but eventually, we will get past this."


DEBORAH PASKO
DEBORAH PASKO
DIRECTOR OF MEDICATION SAFETY AND QUALITY
AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS

"I don’t think this is rising to the level of importance that it should be,” Pasko said. “The U.S. is focused right now on the opioid crisis, but we’ve never needed an opioid to save someone’s life. We do need IV solutions to save people’s lives, and this definitely is a crisis shortage right now."