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IV drug shortages present challenges, opportunities

Hospitals contend with shortages of IV opioids and parenteral solutions, but find silver lining of improved opioid prescribing practices.

If you're a hospitalist in the U.S., you've probably gotten the memo: There's a chronic shortage of IV drugs, including the three most commonly used parenteral opioids.

Nationwide, nearly all hospitals appear to be affected by the shortage of injectable opioids that can be given subcutaneously, intramuscularly, or intravenously. In an April 2018 survey of about 350 American Society of Health-System Pharmacists (ASHP) members representing hospitals of various sizes, 98.4% of respondents reported experiencing moderate or severe shortages of morphine, hydromorphone, and fentanyl. While 28.4% reported moderate shortages that had not yet impacted patient care, 67.8% said the shortages were severe, affecting patient care as well as daily operations.

The manufacturing-related shortage, which has ramped up since the beginning of the year, began in 2017 with production delays at a Pfizer facility in Kansas due to various changes and upgrades, the FDA reported in a June 2018 statement. Pfizer, a major manufacturer of injectable opioids, expects that delays will continue until 2019 and continues to work with the FDA to mitigate the impact, the agency said.

Meanwhile, hospitals are contending with a separate shortage of small-volume parenteral solutions intended for IV administration, which resulted from the 2017 hurricane season. Most drug shortages tend to affect one clinical discipline or another, but this one is different, said Michael Ganio, PharmD, MS, director of pharmacy practice and quality for ASHP.

“From antibiotics to chemotherapy to electrolyte replacement, so much goes into these bags that every discipline has been affected, so it's a very broad-impact shortage as opposed to some of the other shortages,” he said.

The shortage has become less severe in recent months, Dr. Ganio noted, with the affected plant in Puerto Rico operating at capacity once again and the FDA allowing importation of a product to help alleviate the shortage. In a November 2017 ASHP survey, 99.1% of respondents indicated they were affected by the shortage of small-volume solutions, compared to 86.4% of those surveyed in April 2018. “Instead, most institutions have been focused on the injectable opioid shortage,” he said.

While the opioid shortage has strained virtually all hospitals, it has also presented an opportunity for hospitalists to do what's right during an epidemic of opioid misuse, said Aziz Ansari, DO, FACP, a hospitalist, palliative medicine specialist, and associate professor of medicine at Loyola University Medical Center in Maywood, Ill.

“Before, it was easy to give IV pain medications, and now it's forcing us to really think twice before we administer opioids and actually have those conversations with patients and families that opioids may not be necessary,” he said. “It's actually a blessing in disguise, in a sense.”

How hospitals are adapting

Oftentimes, pharmacy departments and hospital pharmacists manage to mitigate the impact of shortages to the point where many physicians are not aware of the problem, Dr. Ganio said. “But some of these [shortages] have gotten severe to the point that frontline practitioners have to make decisions, and then of course patient care can be impacted,” he said.

For the small-volume parenteral solutions, many institutions are switching administration of products to IV push when possible, Dr. Ganio said. But this is easier for some drugs than others. “Most antibiotics, for example, would run in over 30 minutes,” he said. “It's not ideal to have a nurse stand there to push a syringe of the medication, but it's safe to do so.”

For the injectable opioid shortage, the most common hospital responses in ASHP's April survey regarding methods of management were 1) converting patients to oral opioid medications (74.4%), 2) implementing restriction protocols on injectable opioids (55.7%), 3) prioritizing patients based on clinical need (51.9%), and 4) converting patients to nonopioid injectable medications (48.1%).

In March, Dr. Ansari, who is also the associate chief medical officer for clinical optimization and revenue integrity at Loyola, coauthored a hospital-wide memo about the shortage with Elizabeth Greenhalgh, PharmD, manager of pharmacy services, and Kevin Smith, MD, FACP, Loyola's associate chief medical officer for quality and safety. The memo specified three groups of patients who could receive IV hydromorphone and morphine during the shortage: comfort care patients, sickle cell patients with acute pain crises, and patients on strict NPO status, he explained.

The exceptions came with caveats. The default duration was 24 hours, after which clinicians had to have a discussion with a pharmacist to continue the medication, Dr. Ansari said. Second, if the reason for continuing intravenous pain medications was comfort care, a palliative care consultant would have to be called to assess whether the same care could be provided in a nonintravenous way. Finally, the hospital encouraged the use of scheduled oral acetaminophen, scheduled oral NSAIDs if appropriate, and oral short-acting oxycodone as needed, said Dr. Ansari.

“Even from a palliative care perspective, [the shortage] forced us to think how we can use oral or transdermal alternatives and achieve the same level of comfort as parenteral routes,” he said, adding that nursing staff also gave patients educational brochures.

At Cedars-Sinai Medical Center in Los Angeles, the pharmacy department worked with the pharmacy and therapeutics committee to develop protocols to automatically convert some IV opioid orders to bioequivalent oral regimens, said Jae H. Lee, MD, ACP Member, assistant medical director of the Inpatient Specialty Program, the hospital's largest private hospitalist group.

“The pharmacists are looking at each patient and seeing if they're taking any oral food or medications and, if they have IV narcotic orders, then making switches to the pain regimen accordingly,” he said. “It's been helpful that individual physicians haven't been left to just figure out for themselves how to deal with the shortage.”

Patient care challenges

The solution of converting patients to nonopioid injectable medications, such as IV acetaminophen, IV ibuprofen, and IV ketamine, is a more expensive strategy and is potentially less effective, said Dr. Ganio.

Hospitals have responded by using whatever suitable medication they have in stock, he noted. “The opioid shortage has been an interesting one because it has affected different products at different times. One week, an institution may have more hydromorphone, and then the following week, they may have more morphine,” Dr. Ganio said.

In the April ASHP survey, respondents indicated that the hydromorphone shortage was the most severe, with 19.6% indicating they were completely out of stock and 38.9% indicating that they had seven or fewer days' supply. Fentanyl was least impacted, with only 1.9% of those surveyed reporting they were out of stock and 44.8% reporting that they had more than 14 days' supply.

At Johns Hopkins Medicine in Baltimore, the hydromorphone shortage has been the biggest issue and has required relying on fentanyl and other medications to manage patients' pain, said ACP Member Rab Razzak, MD, who directs outpatient palliative medicine and moonlights as a hospitalist. “There are select patients that are suffering because of side effects and intolerances to multiple agents,” he said.

For example, a patient with cancer-related pain who is unable to take oral medications may have severe itching from hydromorphone, but he or she may also have liver or kidney disease and so should avoid morphine if possible. “In these cases, rotating to an opioid like fentanyl may be more beneficial, and the itching may resolve,” Dr. Razzak said.

In select patients, IV ketamine presents a viable option for pain control during this shortage, often requiring less dosage of opioids as a result, Dr. Razzak added. “I think it can be a great tool to be used. That's something that I've seen our chronic pain service using more and more when appropriate,” he said, adding that nonpharmacological treatment modalities like mindfulness can also be useful. “It will also be important to consider using adjuvant agents like NSAIDs, gabapentin, and/or nortriptyline to better manage their pain, when appropriate.”

While the current situation is difficult, Dr. Razzak said the shortage also presents an opportunity to be agile and creative in patient care. “It's sort of what hospitalists are known for, right? We find challenges within the health care system and we find ways to address them,” he said. “This is another test for us to make sure we are able to provide the care that people need.”

Despite the impact of the opioid shortages on patient care, Dr. Ganio said he is not aware of any substantial adverse patient safety events. “There's always a risk for harm,” he said. “However, a similar shortage of morphine in 2010 resulted in two patient deaths from incorrect conversion between opioids.”

Communicating with patients

In addition to communicating with pharmacy and care management to stay abreast of the shortages, hospitalists also need to have clear communication with patients, said Dr. Razzak. “This is another challenge for us to step into and show the versatility of hospitalists,” he said.

Some discussions with patients are more difficult than others. At practically any hospital, there is a very small subset of patients with chronic pain who come in with acute pain and are accustomed to receiving IV opioids, said Dr. Lee. “There have been some instances with some of my colleagues where patients have been very unhappy about it, and they've strongly voiced their concerns,” he said. “But it does allow for us to kind of gently push back and re-educate patients.”

Dr. Lee, who hasn't gotten much pushback himself, said being honest about appropriate use of opioids and calling attention to the opioid epidemic, which most patients are aware of, can make these discussions less challenging. “[Patients] typically do seem to understand it and see it more as I am expressing some concern for them personally,” he said. “I think they appreciate that.”

Using appropriate communication skills softens the delivery of what can be a harsh message. Dr. Ansari recommended sitting down with patients, and having empathy, acknowledging and respecting their pain while explaining the shortage and that they do not meet the criteria to make an exception. “A lot of times, what you uncover is a lot of emotional angst. Some will understand and some won't, but you just have to stay firm, empathic, and respectful and follow evidence-based medicine,” he said.

One silver lining of the shortage is that it has pushed hospitalists to more often discuss appropriate and safe use of opioids, “which I think is a discussion that has unfortunately been a long time coming for all of our patients, particularly the patients who have pain issues,” said Dr. Lee.

Even after the shortage is resolved, Dr. Ansari said he believes the hospital's current policy should continue because opioid use often begins with a health care event and spirals outside the walls of the hospital. “We don't want to go back to the ways we were practicing before because that has contributed to the opioid crisis,” he said.

Both the injectable opioids shortage and the shortage of IV fluids seem worse than past shortages because they affect so many patients, Dr. Ganio said. “But hopefully these specific shortages are getting better and we have the capacity to start dealing with whatever might come next,” he said. “It is hurricane season again. We have all been dreading that.”