Opioid Drug Shortages Affect Patients, Health Systems

In an interview with Pharmacy Times, Alfred L’Altrelli, PharmD, CFMC, MBA, senior director of pharmacy at UPMC Presbyterian-Shadyside, discussed opioid shortages and how they are impacting patients and health systems. Pharmacists are experts at juggling shortages of all kinds, however, and L’Altrelli said they are crucial team members regarding opioid access challenges.

Q: What are some key causes of the recent drug shortages?

Alfred L’Altrelli, PharmD, CFMC, MBA: Yeah, that's a great question. These severe and prolonged shortages, particularly critical drug shortages, have been consistently growing both in number and intensity over the past decade or so. This results in added time, expense, supply management challenges, and the need to explore therapeutic alternatives. It can even potentially delay patient care and increase the possibility of resorting to less effective medications or more costly alternatives. All of these factors are precisely what we're juggling. There's an increased risk of adverse events, potential harm to patients, and unnecessary healthcare costs, all contributing to some sources suggesting over half a billion in yearly increases to the healthcare system.

So, the scope you're alluding to is something that's been escalating, and we're nearly there. There are approximately 309,010 active ongoing shortages on the ASHP drug shortage site, which is the highest number we've had in quite some time, approaching the all-time high. One of today's most pressing shortages includes medications that could be generic, such as chemotherapy agents and opioids. When specifically looking at opioids, it's been a persistent challenge, and there's a lot of buzz about it now due to the ongoing opioid crisis. The FDA site currently lists fentanyl injections, hydromorphone injections, morphine injections, and Remifentanil as the opioids in short supply. So there's a lot happening in this space, making shortages a hot topic at the moment.

I believe you also asked about the underlying causes of these shortages. There's a lot to consider. ASHP has identified issues with fentanyl patches, hydrocodone tablets, and oxycodone immediate release, among other medications. When we examine these various types of medications, including injections and oral drugs, there's really no single cause that applies universally across all these different forms and classes of drugs. Consequently, there's no single solution.

Many point to a lack of ingredients, particularly the active pharmaceutical ingredients (APIs), as a significant factor. Over 80% of APIs and raw materials come from overseas, which presents challenges. We rely on imported materials subject to regulations and logistics beyond our control to manufacture drugs in America.

Furthermore, we often hear claims that increased demand is a driving factor. People wonder why there's such a surge in usage. While demand spikes are indeed real, they tend to have short-term effects. The more severe and persistent shortages are predominantly driven by economic factors, which people often overlook. Various economic forces contribute to the complexity of the drug shortage issue.

One notable aspect is the extreme price competition among generic manufacturers. When a low-cost competitor enters the market for a generic drug, it can create a ripple effect that disrupts the market and the supply chain. New companies may offer lower prices, attempting to undercut existing manufacturers, which can force those manufacturers to exit the market or shift to different medications. This, in turn, results in drug shortages because the new entrants may not be able to support the entire market on their own.

Q: What opioid shortages or challenges are you seeing at your facility?

Alfred L’Altrelli, PharmD, CFMC, MBA: Yes, we've been fortunate here. There have been a few instances where shipments were delayed, but we managed to secure supplies at the last minute. We benefit from a robust integrated network encompassing numerous hospitals. I believe our situation is more favorable than that of many of my colleagues. We've been diligent in implementing evidence-based practices and optimizing opioid stewardship to ensure the most effective treatment for our patients. Often, this involves initiating treatment with an intravenous (IV) drip and transitioning patients to intermittent IV use before switching to oral medications, such as NSAIDs, as they progress.

This period has allowed us to reevaluate our approach and streamline the process of guiding patients in this direction as efficiently as possible. On several occasions, we've encountered situations where our outpatient services required escalated efforts to connect patients with the medications they need. However, we've successfully located these medications, albeit with additional work required. I think one of the big things we’re seeing is just the amount of effort our pharmacists and our physician colleagues, nurses, etc., have to put into making sure that we’re connecting patients with medication sources.

Q: Is this affecting all opioid medications, or are there alternatives that patients can turn to?

Alfred L’Altrelli, PharmD, CFMC, MBA: Indeed, it's primarily impacting the opioids I mentioned earlier. However, we do have alternatives to consider. When it comes to pain management, we often think about multimodal pain control, a practice recommended in virtually every acute pain management guideline. In this approach, we explore non-opioid options to reduce dependency on opioids.

One common strategy involves scheduled administration of Tylenol (acetaminophen) every 4 to 6 hours, up to a maximum of 4 grams. As pharmacists, our priority is patient safety, unless there's a contraindication. Scheduled Tylenol use contributes to pain relief and helps decrease the reliance on opioids.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen can also be considered for around-the-clock pain management unless specific concerns or contraindications exist, such as renal or gastrointestinal issues. Celecoxib, a selective COX-2 inhibitor, might be a suitable option when COX-2 selectivity is warranted due to gastrointestinal concerns.

In some cases, topical agents like lidocaine and diclofenac offer relatively safe local anesthetic options with minimal systemic absorption, reducing the risk of interactions with other medications due to their topical application. This approach can be especially valuable when there's an indication for it, although it's sometimes overlooked in favor of oral agents like OxyContin.

For perioperative patients, nerve blocks and regional anesthesia techniques like lidocaine infusions are routinely employed in hospitals to manage pain effectively.

Beyond pharmacological approaches, there are non-pharmacological interventions to consider, such as physical therapy and cognitive therapy.

I think shortages really forced us to look at the bigger picture of how we manage patients and what [the] options are. And a lot of times what is truly interesting is, you know, you think kind of outside of your norm and you can connect patients with something that they’re much more satisfied with, in terms of the patch, physical therapy, cognitive therapy, things that they typically wouldn’t think of. I actually had a patient just yesterday that pointed out that he’s been in pain, hasn’t really been taking anything. He got acupuncture and was shocked that it actually worked. So, who knows, it’s worth considering all of these other things as alternatives to opioid medications.

Q: How are these shortages intersecting with the ongoing opioid crisis, if at all?

Alfred L’Altrelli, PharmD, CFMC, MBA: Certainly, individuals who are in recovery from an opioid use disorder may still rely on opioids to help stabilize their condition during the transition period as they titrate off them. A concern in this scenario is the potential risk of relapse and a return to opioid use if the necessary medications are unavailable.

When managing patients moving away from an abusive situation, there is often a pharmacological approach involving opioids to facilitate this transition. It's important to ensure the availability of these medications to support individuals in their recovery journey.

Moreover, if prescription opioids become scarce, individuals who are dependent on them, whether through legal or illegal means, can face dangerous situations. They may turn to illicit alternatives to manage their pain or dependency. This is worrisome because these illicit sources might contain contaminants and impurities that are unpredictable and far from pure when compared to prescription medications.

When individuals resort to these illicit means, which can involve unapproved, non-FDA-approved drugs or the misuse of FDA-approved drugs not prescribed to them, there's a significantly higher risk of overdose and even potential fatalities. This presents a substantial public health concern, and it is closely linked to the factors that precipitated the opioid crisis in the first place. It underscores the importance of ensuring access to safe and regulated medications for individuals in recovery.

Q: There are many questions around delineating which patients do need opioids versus who might be better served with an alternative, and of course managing addiction concerns. How do you think about these issues when evaluating a patient?

Alfred L’Altrelli, PharmD, CFMC, MBA: Indeed, that's an excellent question. It's crucial to approach patient care holistically and consider an individualized perspective. To do so effectively, we must take into account several key factors. First and foremost, the patient's medical history plays a vital role. Understanding their past medical experiences, conditions, and treatments is essential.

Additionally, we need to assess the nature and duration of the patient's pain, any underlying medical conditions, and their history of previous pain management strategies. Equally important is evaluating whether there's a history of substance use disorder.

Beyond medical aspects, we should consider the patient's mental state, social support systems, and socio or psychosocial factors that might influence their pain experience or response to therapy. As pharmacists, we have valuable tools at our disposal, such as validated screening tools, to assess potential risk factors for addiction.

Regular monitoring of a patient's opioid use is also critical. By doing so, we can serve as early identifiers of any signs of misuse or diversion.

In essence, our approach needs to encompass the patient's journey from their medical history to the current pain management strategies. When considering alternative therapies or transitions, we must evaluate risks from multiple angles, including pain management and addiction. Our role extends to supporting patients throughout these transitions and their use of medications. If issues arise, such as inadequate pain control or the potential development of addiction, our intervention can make a significant difference in their care.

Q: How can pharmacists help patients navigate these shortages?

Alfred L’Altrelli, PharmD, CFMC, MBA: Pharmacists undoubtedly play a pivotal role in addressing the challenges posed by opioid shortages. Our expertise is invaluable in navigating various drug shortages, and opioid shortages are no exception. Our primary objective is to ensure that patients have uninterrupted access to essential medications while simultaneously advocating for their safe and responsible use, a mission of utmost importance when it comes to opioids.

Collaboration with other healthcare providers is a cornerstone of our approach. Together, we explore alternative strategies for pain management. Pharmacists excel in tasks such as dose conversions, meticulous calculations, and dose adjustments tailored to a patient's specific needs. We consider various treatment options to provide the best possible care.

In the hospital setting, we are well-versed in providing guidance on transitioning between opioids safely. This involves ensuring that when switching from one opioid to another, the conversion is equitable and potent, mitigating the risk of adverse effects. This expertise becomes even more crucial during shortages when alternative selections are necessary.

Another area where pharmacists shine is in assessing and managing pain flare-ups. We can devise effective dosing strategies for opioids or other therapies that patients or providers might not be as familiar with due to limited prior use.

In the community, pharmacists are vigilant about early refills and monitoring multiple opioid prescriptions from different providers. While patients may, with good intentions, seek different providers and prescriptions to manage their pain, we understand the potential dangers associated with such practices.

It's important to underscore that pharmacists don't merely act as a link between patients and therapy outcomes. We also serve a critical role in the realm of safety and regulation, particularly concerning opioids. Our expertise and vigilance contribute significantly to ensuring the safe and responsible use of these medications.

Q: Is there anything you'd like to add?

Alfred L’Altrelli, PharmD, CFMC, MBA: No, I think I pretty much got it all out there. I would just encourage pharmacists to really think about the bigger picture. Whenever we experience shortages, what are all of the alternatives? How do you get in front of patients or connect with patients to pick strategies that are right for them? It might not be what we typically do, but it is something that can be, you know, a good outcome and something that can be a pleasant experience for our patients.