Controversial Conversations: Key Takeaways From The Jeffrey Fudin Debates on Pain and Palliative Care Practices

In an interview with the Pharmacy Times®, Lee Kral, PharmD, FASHP, NBC-HWC, CPMC, CPE, clinical pharmacy specialist of pain management at the University of Iowa Hospitals and Clinics, shares her insights into pain management in palliative care for patients with cancer-related chronic pain. She highlights the crucial role of pharmacists in managing patient treatment regimens, including administration of opioids, the role of off-label prescribing, and the potential of deprescribing to improve patients’ quality of life.

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Pharmacy Times: What are The Jeffrey Fudin Debates and what were the subjects covered in the debate?

Lee Kral: The Fudin Debates originated from debates done at other conferences throughout the last 10 or 20 years. Jeffrey Fudin [PharmD, FCCP, FASHP, FFSMB] was actively involved in therapeutic debates with me and with many others for a lot of years, and I was lucky enough to debate with him several times. He was kind of my work/debate husband as it were, and we had a great deal of fun. The debates usually cover controversial topics in practice. But we really wanted to do a light spin and have a little bit of fun with it as well because sometimes I think that controversial topics get really heated. And so, he and I had always had the spirit of “let's have a little fun with this.” We didn't have any blood thirsty debaters. So, after his cancer diagnosis, I chatted with him, and I told him that I really want to continue his debate legacy, and he gave his stamp of approval and named them the Bowtie Banter. So that's what we've been using, and we've had some pretty good responses to that.

So, last year was our inaugural year at the SPPCP virtual conference. And again, we had pretty positive feedback from that. So, this year, we expanded the number of speakers and broke the subject matter down into 3 main practice areas: pain management, palliative care, and hospice. The pain management debate was whether cancer patients with pain should be exempt from universal precautions for opioid use, the palliative care topic was whether mirtazapine should be used as an appetite stimulant, and the hospice debate was more complex with regard to not only when deprescribing prior to admission to hospice should happen, but also who should do that.

Pharmacy Times: What was the consensus during the debates regarding opioid prescribing regulations and considerations of patients with chronic cancer-related pain?

Kral: So, cancer patients with chronic pain were considered exempt from the CDC national guidelines on opioid use. However, cancer organizations like [the American Society of Clinical Oncology] and [the National Comprehensive Cancer Network] also published some guidelines in the oncology setting that the speakers discussed. They're remarkably similar to the CDC guidelines, and Diana Ardelean [PharmD, BCPS, opioid stewardship pharmacist at the Dana-Farber Cancer Institute] and Maureen Sapphire [PharmD, BCGP, opioid stewardship and palliative medicine pharmacist at The Ohio State University James Cancer Hospital] encapsulated the vast collection of data on this topic, and it's really getting very, very deep with regard to data that's coming out about this particular area, and interestingly, or maybe not, the survey after the debate was fairly equally split between “yes, cancer patient should be exempt,” that was 57% of respondents, or “no, they shouldn't be exempt,” and that was 43% of the respondents. So, this illustrates exactly how controversial this topic is, with data supporting both sides. Like I said, there's getting to be a lot of data, and on both sides. The point of the debate isn't necessarily to find one correct answer, but to get audience members to think about all the different variables and the data on both sides of the issue.

Pharmacy Times: Tell us about the discussion around the use of mirtazapine for off-label appetite stimulation. What were some of the points shared by panelists?

Kral: Appetite stimulation in critically ill patients has been a quality-of-life concern forever. I think none of the therapeutic options have historically been remarkably and consistently effective. Dr. Joshua Borris [PharmD, MS, BCGP, palliative care clinical pharmacy specialist at MedStar Harbor Hospital] worse pointed out that mirtazapine when used for depression also causes weight gain. And it's also been shown to have modest weight gain and nursing home patients and those with Alzheimer's disease, functional dyspepsia, cystic fibrosis and hospitalized patients. So, a wide variety of patients have benefited from this for weight gain, or maybe with those with chronic noncancer, non-critically illnesses, maybe it's considered a side effect. But a lot of times we do use a medication for its side effects, and not just alone for its efficacy.

Pharmacy Times: In palliative care, patients often have complex medical needs and limited treatment options. How do you approach the decision to use off-label treatments, considering factors such as patient comfort, quality of life, and potential risks?

Kral: Interesting question and one clinicians grapple with every day. Due to the complexity and sometimes the short lifespan of the patients in these settings, it's almost impossible to conduct good studies on any therapy. So, a lot of what we use isn't labeled for the particular indication. If we only used labeled indications, we have an extremely short list of options for the vast array of comfort and quality-of-life concerns that these patients bring us, from nausea to anorexia to dyspnea, and so on. In these cases, we have to think outside the box like using mirtazapine for appetite stimulation by again utilizing the side effect profile of the medication for possible therapeutic benefit. And the pharmacist can offer the team information about the pharmacology of some of those options that may offer benefit. Even if it is a little bit controversial. They're the perfect team member to balance the possible efficacy with the safety concerns.

Pharmacy Times: How do you balance the potential benefits of deprescribing with the risks of withdrawal effects or the return of symptoms in patients?

Kral: The speaker stressed that trials and adjustments should be made early and on the continuum. I think that providers and patients are more open to the word “trial,” in that if they experience withdrawal or return of symptoms after reducing the dose or stopping the medication, that this can be reinstated. We do this in both the inpatient acute care setting as well as the outpatient setting, if small changes can be made to test the benefits of the therapy, or evaluate the risks like is the medication, the one that's causing the side effects? This is much easier to balance. So, words like “optimization” and “trial” are the philosophy as well as the keywords.

Pharmacy Times: Can you share a specific case where deprescribing had a significant impact on a patient's quality of life, and how you approached the decision-making process?

Kral: So, my area of practice is pain management, but my example crosses all of our practice settings. A vast majority of medications used for pain management have their pharmacologic activity in the central nervous system. This inherently causes cognitive adverse effects. We found that reducing or tapering off medications like the gabapentinoids and muscle relaxants can significantly improve cognitive function, not only in the critically ill patients, but relatively healthy patients as well.

In one case, I have a 71-year-old patient that has some generalized arthritis. Over the past couple of decades, her morphine dose had escalated to 600 milligrams per day. And then she had to switch providers and the new provider was extremely uncomfortable ordering opioids at all—he happens to be a cardiologist—let alone 600 milligrams daily. So, I had conversations with the patient, 2 of her sisters, and the provider, and everyone agreed to try a small dose reduction. Her sisters are her support system since she's widowed and lives alone. They were very concerned about her and strongly supported trying a dose reduction. That went pretty well actually. And over the past 3 years, we've gradually tapered her dose down to about 120 milligrams per day. Now, I talked to her every month, and we've built a strong and trusting relationship. And both the patient and her family have noted that she used to be a zombie and had withdrawn from her life. She said she didn't realize how bad that her cognitive function had gotten, and she wasn't really thinking clearly. And she said she felt like she used to be in a haze compared to how she feels now, and she had accepted that that is normal. But as her dose has been reduced, she started perking up.