EXECUTIVE SUMMARY

There may be fewer drug shortages than in other recent years, but some shortages are more severe, according to experts. Emergency providers report these shortages are affecting patient care. In particular, emergency providers are struggling to deal with a shortage of IV opioid analgesic drugs that has been in effect since the end of 2017. They are working with hospital pharmacists to conserve such drugs for patients most in need and to find alternative therapies.

  • In a recent poll conducted by the American College of Emergency Physicians, 91% of emergency providers reported experiencing shortages of critical medications in the previous month. More than half of respondents reported concerns about the readiness of their EDs to respond to a potential disaster.
  • Emergency providers report there have been recent shortages of morphine, IV hydromorphone, and IV fentanyl, the top three injectable opioid pain relievers. Providers also have seen shortages of injectable anti-nausea medications.
  • Using substitute medications heightens the potential for errors. Experts urge clinicians to prioritize patient safety when opting for alternative therapies to which they may not be accustomed.
  • Experts advise hospitals and pharmacists to establish an ethical framework for distributing medications that are in short supply.

Drug shortages have become a fact of life for emergency physicians in recent years, but the problem has reached a point where many are saying that it is jeopardizing their ability to provide care.

In a poll conducted by the American College of Emergency Physicians (ACEP) between April 25 and May 6, 91% of emergency physicians reported experiencing shortages of a critical medication in the previous month, and 36% said drug shortages had negatively affected patient outcomes.

Further, 27% of survey respondents indicated that their EDs were not “completely ready” to respond to disaster-related surges, and 17% said their facilities were “not at all” ready.1

Other healthcare stakeholders are similarly concerned. The American Medical Association has declared the ongoing drug shortages an urgent health crisis, and the American Society of Health-System Pharmacists (ASHP) is calling on policymakers to address what they call the persistent shortages of critical medicines.

The news on this front isn’t all dire. Experts note that there are fewer drug shortages today than there have been in other years.

However, they also acknowledge that some shortages, especially regarding commonly used injectable opioid drugs, are longer-lasting and more significant than other drug shortages providers have faced over the last decade.

Emergency providers echoed these sentiments to ED Management. They noted their frustration with a problem that should be eminently solvable. Nonetheless, clinicians are working with hospital pharmacists to conserve critical drugs for those patients most in need, and to find alternative therapies for drugs they have long relied on in their practice.

Establish Workarounds

Maryann Mazer-Amirshahi, PharmD, MD, MPH, is an emergency medicine physician at MedStar Washington Hospital Center who has worked as a registered pharmacist in both inpatient and outpatient settings for a decade.

She notes that while there may be fewer drugs on shortage than in other years, the current shortages she is experiencing in her emergency medicine practice are more severe, affecting patient care. For example, Mazer-Amirshahi notes that supplies of several IV opioid analgesic drugs have been running low, making it difficult for providers to access even second-line options for the treatment of pain. “There have been shortages recently of IV morphine, IV hydromorphone, and IV fentanyl, so basically the top three injectable opioid pain relievers that we are using are out on shortage,” Mazer-Amirshahi explains. “Before, when you would reach for an alternative, you actually had an alternative to reach for.”

Susan Derry, MD, an emergency physician at Providence St. Peter Hospital in Olympia, WA, is experiencing similar challenges.

“The biggest shortages at my current facility are Dilaudid and morphine. Before I can give someone pain medication, I have to ask what do we have, and then I need to be more cognizant of side effects for medications because we are rationing Dilaudid for people only with renal failure,” Derry explains. “We were supposed to use morphine [as an alternative], but then we ran out.”

Derry observes that there is not much of a problem with drug-seeking behavior in her community ED. Washington has established a strong policy against treating chronic pain in the emergency setting.

“I don’t think [drug seeking] is as bad here as in some other places I have worked, but when you are needing to treat someone’s pain and you can’t, that is problematic,” she stresses.

Mazer-Amirshahi says that emergency providers have run into similar problems with shortages of injectable anti-nausea drugs.

“When you have drugs that you use for anti-nausea and vomiting, and both of the IV formulations of the most common medicines being used are out of stock, then you have to go to oral nausea medicines, which may not work as well, particularly if the patient is vomiting,” she says.

Another problematic shortage involves the small-volume saline bags used so commonly in healthcare settings, explains Michael Ganio, PharmD, MS, BCPS, FASHP, director of pharmacy practice and quality at the ASHP.

“That was due to the hurricanes that hit Puerto Rico and knocked out some of the manufacturing ability for Baxter,” he says. “That is where they made all of their products that were shipped to the United States. That left a lot of pharmacy departments and hospitals trying to find alternative ways of administering medicines that are typically in one of those small, piggyback bags.”

Sterile water also has been in short supply lately, Ganio observes.

“This is used to reconstitute a lot of medicines like antibiotics,” he says. “That may not have been a shortage that a lot of physicians or providers may have known about. A lot of times, pharmacies have a way to make those drugs without those products, but it was significant enough that it was having a national impact.”

However, Ganio agrees that the most pressing current shortage for emergency providers involves injectable opioids. “Hydromorphone and fentanyl have all been on backorder and in short supply since the end of last year,” he says. “We know that providers and pharmacists working together are developing recommendations to use non-opioid injectable alternatives, to use oral opioid alternatives, to use non-pharmacologic pain treatments when possible, and to really look at the entire patient to try to treat pain without primarily using hydromorphone or morphine.”

In many cases, hospitals or health systems are putting restrictions on who can use these medications, Ganio notes. For example, hospitals might restrict the medications for use with patients suffering from burns or traumatic injuries. “They might have this type of restriction in place to conserve as much as they can for when they are really going to need the injectable opioids,” Ganio offers.

Prioritize Safety

Pharmacy departments also will search a wholesaler’s inventory to see if different strengths of a needed drug are available. These departments will stock that strength or dosage until they can obtain the dosage or strength that they normally use.

“They may be buying in larger sizes or multi-dose vials and then repackaging the dosages into syringes that are more appropriate for patient administration,” says Ganio. “There is some compounding involved.”

However, such strategies can heighten the potential for adverse consequences.

“Any time you deviate from your normal practice, you have a risk of a medication error,” Ganio says. “We know that conversion among opioids can be dangerous. If a prescriber is used to ordering morphine, and the hospital is out of morphine, and they have to order hydromorphone, the physician and the pharmacist should make sure that the dose is converted correctly.”

Ganio notes that back in 2010, there were two deaths associated with incorrect conversions between morphine and hydromorphone that were reported to the Institute for Safe Medication Practices.

“Communication among all the disciplines is very important. The electronic medical record [EMR] over the last 10 years has become a really helpful tool in making sure that we can alert providers [to errors], even at the point of dispensing from an automated dispensing cabinet,” Ganio says. “The technology has the ability to bring up an alert on the screen to remind the nurse or whatever provider is accessing the medicine that the medicine is a different strength than what he or she is used to administering.”

Derry acknowledges that recalculating dosages and resorting to alternative therapies may offer the side benefit of strengthening a clinician’s skills, but such tactics definitely elevate risks.

“We ran out of D50 [a formulation of dextrose], and we were trying to treat diabetic insulin overdoses or hypoglycemic episodes,” she says. “When you don’t have any D50, you are doing complex math to figure out how much D10 you need to give to an adult because you have D10.”

Further, Derry notes that when clinicians cannot access the therapies they are accustomed to using and must go to an alternative, clinicians may be unfamiliar with the side effects or contraindications of the substitute.

“You are doing just so much more thinking. It removes you from what your standard practice was, and opens you up for making errors with patients,” Derry says. “That is our biggest concern.”

Anticipate Shortages

At MedStar Washington Hospital Center, Mazer-Amirshahi notes that pharmacists try to be proactive when they get word of potential shortages.

“The hospital pharmacists monitor the FDA’s website and the other website provided through the ASHP that posts information about upcoming shortages,” she says.2,3 “One of the things they will do is send out information [to clinicians] that a drug is going to be on shortage in the near future and offer things we can do to conserve it.”

For instance, in anticipation of IV pain medication shortages, clinicians will be advised to use oral medications when possible. Also, instead of keeping certain medications in the automatic dispensing machines, the hospital pharmacy might keep those drugs in a central location and distribute them more on an as-needed basis, Mazer-Amirshahi shares.

When the shortages are in effect, the pharmacists will send information to providers, letting them know what substitutes they have available and how the alternative medications should be used. This information includes detailed instructions regarding dosage adjustments and intervals, potential side effects, contraindications, and recommendations for patient monitoring.

“We make sure that everybody is on the same page about how to use the alternative drugs, which some [clinicians] may not have used in a while,” Mazer-Amirshahi says.

For example, during a recent shortage of IV Pepcid, the hospital pharmacists alerted clinicians that they were able to obtain an alternative medicine in the same class.

“The pharmacists did education about it so that all the nurses and physicians knew this was what we were going to be using so that we could use it safely,” Mazer-Amirshahi says.

Use ED-based Pharmacists

Hospital pharmacists are engaged in similar activities at Providence St. Peter Hospital, Derry reports.

“I work for a pretty large hospital system. Pharmacists are working across hospitals to try and smooth the impact of shortages across facilities, and provide early warning of upcoming shortages so that we can ... try to modify what we are doing ahead of time,” she says. “They will put hard stops [in the EMR] so we don’t order and deliver a drug that we are trying to reserve for critically in-need patients.”

The collaboration between hospital pharmacists and emergency physicians has been a huge asset, Derry asserts.

“We have a very strong ED-based pharmacist staff, along with the central pharmacy staff, largely because we have such huge advocacy for emergency medicine,” she says. “We are at the forefront of the central pharmacy’s mind because we have someone in our department with their finger on the problem.”

For instance, when auto-injectors containing Narcan were recalled, the pharmacists prepared syringes of the drug so that clinicians would have a continuous supply ready to treat overdose patients.

“They helped with that problem so that we weren’t at the bedside trying to do math and remember how much Narcan to give,” Derry recalls. “The pharmacists did that for us.”

Derry adds that ED-based pharmacists can help emergency providers develop a deeper knowledge base on many therapies that can be used as alternatives when critical drugs are on shortage.

Boost Transparency

The FDA is working behind the scenes to prevent drug shortages from causing disasters, Ganio observes.

“The agency has a reporting process where manufactures can let the FDA know that they are anticipating a disruption in their supply,” he says. “The FDA has the ability to reach out to other manufacturers of that product and let them know to increase production, although it doesn’t have the ability to require anyone to make any product.”

Ganio concurs with other healthcare professionals that not all drug shortages are created equal. He would like to receive more information from manufacturers about potential supply disruptions and when those situations will be resolved..

“We would like to see a little bit more authority granted to the FDA to allow more requirements around reporting estimated timelines of how long the supply is going to be disrupted. A little bit more transparency from the manufacturers would be helpful,” Ganio offers. “We would also like to see manufacturers have emergency preparedness plans in place so if there is a national disaster or some other catastrophic event that shuts down their facility, there is a backup plan.”

No one solution is going to address the recurring drug shortage issue successfully, Mazer-Amirshahi advises.

“The problem is multifactorial. There is the economic climate, and there is also concern about the quality and safety of production facilities,” she says. “If a production facility gets cited for quality problems, I don’t think we should be advocating for less quality assurance and oversight. I do think we need to be advocating on a national level ... to make sure we have redundancy in our [drug] manufacturing system.”

Some drugs are only made at a single plant. If there is a problem at that one manufacturing facility, that is going to precipitate a tremendous shortage, Mazer-Amirshahi laments.

“We need to advocate for more redundancy so that we have more of a backup.”

Establish a Framework

On an institutional level, Mazer-Amirshahi suggests ED leadership ensure clinicians are informed about upcoming shortages. Further, she suggests leaders outline procedures for conserving valuable resources that will be in short supply. Also, clinical leaders need to work with hospital pharmacists to develop an ethical framework for distributing limited supplies of drugs and minimizing waste.

“Going back to pain medicines, if you have a patient who is able to take medicines by mouth, that is the type of patient who doesn’t necessarily need IV medications as much as someone who has just had intestinal surgery,” she says. “We try to have those protocols in place so that we are using the doses we have available in an efficient way and minimizing waste, but also prioritizing them for patients who need them the most.”

Certainly, it is frustrating to have to resort to such strategies, but permanent solutions to the shortage problem will take time.

“We did not get here in one step, and it is going to take multiple steps [to fix the problem],” Mazer-Amirshahi predicts. “The biggest thing is we have to ensure patient safety by being proactive and really developing a framework to use limited resources.”

Derry, who also serves as a co-chair of Physicians Against Drug Shortages, would like to see more emergency physicians educate themselves about safe harbor provisions. Enacted by Congress in 1987, these provisions exempt group purchasing organizations (GPOs) from criminal penalties for taking kickbacks from suppliers.

Derry believes these provisions are anti-competitive and a key contributing factor to the drug shortage problem.

Of course, GPOs were created to enable hospitals to save money by buying supplies, such as pharmaceuticals, in bulk. Yet some analysts believe the safe harbor provisions have led to a reduction in the number of drug manufacturers, thereby dampening free market competition.

It is a complex matter, but Derry believes emergency physicians should be wielding their influence to resolve the drug shortage problem.

“This is a national issue, but we are on the front lines of it. From a patient perspective, we are the face of it, so it is a little bit painful for us,” she says. “We need to join together [on this] for patient safety.”

REFERENCES

  1. American College of Emergency Physicians. Most emergency physicians report hospitals lack critical medicines; not “fully prepared” for disasters, mass casualty incidents. May 22, 2018. Available at: https://bit.ly/2xcdEtZ. Accessed June 26, 2018.
  2. U.S. Food and Drug Administration. FDA Drug Shortages. Available at: https://bit.ly/2xtyPG0. Accessed June 26, 2018.
  3. American Society of Health-System Pharmacists. Drug Shortages List. Available at: https://bit.ly/2L3zRNv. Accessed June 26, 2018.

SOURCES

  • Maryann Mazer-Amirshahi, PharmD, MD, MPH, Emergency Physician, MedStar Washington Hospital Center, Washington, DC. Email: maryannmazer@gmail.com.
  • Susan Derry, MD, Emergency Physician, Providence St. Peter Hospital, Olympia, WA.
  • Michael Ganio, PharmD, MS, BCPS, FASHP, Director, Pharmacy Practice and Quality, American Society of Health-System Pharmacists, Bethesda, MD. Phone: (301) 657-3000.