Roswell Park’s opioid-restricting postoperative protocol reduces use safely, substantially
For patients who have undergone surgery as part of their cancer treatment, the need to manage postoperative pain often must be weighed against the need to avoid conversion to chronic opioid use.
For this reason, researchers at Roswell Park Comprehensive Cancer Center developed an opioid-restricting postoperative pain medication prescribing protocol. They tested the protocol in a prospective case-control study of 2,051 patients at the cancer center who underwent surgery for which postoperative opioids are routinely prescribed. Under this protocol, implemented between February 2019 and July 2019, patients who underwent maximally invasive surgery were discharged with a 3-day supply of opioids, whereas patients who underwent laparoscopic or other minimally invasive surgery did not routinely receive opioids at discharge. The researchers compared results of this group with those of 2,015 patients who underwent similar surgeries between August 2018 and January 2019.
Results, presented during the virtual ASCO Annual Meeting, showed use of the protocol resulted in a 45% decrease in the amount of postoperative opioids prescribed for all participating patients, from 323,674 morphine milligram equivalents to 179,458 morphine milligram equivalents (P < .001). In addition, the new protocol did not appear to compromise patient recovery or satisfaction.
“We tracked how our patients were recovering and also all opioid refill requests in New York state for 30 days after the surgery,” Emese Zsiros, MD, PhD, FACOG, gynecologic oncologist and senior author of the study, said in an interview with Healio. “We were shocked to find that we had significantly fewer opioid refill requests when we provided less opioid pain medication at the time of discharge, and our patients came back feeling happy and satisfied with their postsurgical pain management.”
Zsiros spoke with Healio about the protocol, which has been implemented in all surgical departments at Roswell Park, and its potential value to institutions across the country.
Healio: How did you formulate this protocol?
Zsiros: I trained in Europe and stayed there for medical school. Throughout my European training, I saw that patients can recover very well after a surgical procedure using minimal to no opioids. When the opioid epidemic became very evident in the United States, we started brainstorming as surgeons how we could better minimize the risk for conversion and harm of the opioids we were prescribing to our patients.
So, in 2017, the five surgeons in our gynecologic oncology department decided to implement this protocol. We split our patients into two categories. Patients who underwent major surgery with a large incision would go home with a 3-day opioid supply, only 12 tablets. Patients who underwent robotic or laparoscopic surgery or any small, outpatient procedure would be discharged with no opioids, but would receive ibuprofen and Tylenol scheduled around the clock. We told our patients that if they were uncomfortable and needed additional pain medications, we were happy to prescribe them.
Our gynecologic oncology department initially piloted this approach for about a month, and during that time we radically changed our opioid-prescribing practices and then extended these protocols a year later to the entire cancer center, including all surgical services.
Healio: What have previous data indicated about the rate of conversion to chronic opioid use after surgery in the U.S.?
Zsiros: A study from Michigan looking mostly at refill requests from insurance claims showed that about 6% to 6.5% of patients become chronic opioid users after a single surgical procedure. This truly should be considered a postsurgical complication, but we don’t track it. I’m a surgeon, and if someone told me they had a 6% rate of any other complication, such as a deep vein thrombosis, infection or pneumonia, we would all find that unacceptable.
Healio: How did you come to implement this protocol for all surgical departments at your institution?
Zsiros: We implemented this in our department for about a year and published our data in JAMA Network Open in 2018. Then, we decided to extend the protocol to the entire cancer center. I was appointed as a quality officer and worked with all surgical departments to implement the protocol. All the chairs agreed to proceed. We asked them to put their surgical patients into three categories. Patients who underwent minor or minimally invasive procedures would go home without opioids. The middle group would get a 1-day supply, only four tablets. That was requested mostly by our breast surgeons, who reasoned that because mastectomy patients have a bigger incision, they should get a few tablets. The third group would get the 3-day supply of 12 tablets.
We allowed the surgeons to prescribe up to 24 tablets, which is still a 3-day supply, but with two tablets every 6 hours. Our preference was to give only 12 tablets. Still, we chose a 3-day supply because data suggest that the highest risk for conversion to chronic opioid use comes after the third day of use. So, our question was, is 3 days’ additional supply sufficient to manage outpatient pain? Most guidelines allow us to provide up to 7 days, but many states do not have a cap on that.
For the first 6 months, we watched everything very closely. I had a dedicated pharmacy team who went through the list of surgical patients, who were getting discharged that day and made sure that the surgeons were following the restrictive opioid-prescribing protocols. If someone was not familiar with the protocol or violated it, we would call them and ask if there was a medical reason to prescribe opioids at higher quantities. We didn’t restrict providers; they could prescribe whatever they ultimately felt was necessary for their patients. However, sometimes residents or visiting physicians would forget about it and overprescribe out of habit.
After those first 6 months, I could tell our pharmacists really didn’t need to remind people. They learned and were following the protocol.
Two years later, we have implemented this protocol without deviation across the entire cancer center and our compliance is 95%.
We acknowledge that not every patient can be strictly fit into one of the three categories, but most of the patients did quite well with the 3-day opioid supply at the time of discharge. There was no increase in refill requests and no decrease in patient satisfaction.
We know that many physicians are afraid to make such a radical change because they are concerned that their patients will be upset, and satisfaction scores will go down. We clearly showed this did not happen. Surveys before and after protocol implementation showed our patients were equally functional and satisfied. If anything, we had fewer complications because they weren’t suffering from side effects from the opioids.
Healio: Should this guideline be applied at all institutions across the country?
Zsiros: Yes, for sure. We speak to roughly one or two institutions per week about this. New York state is very curious about our data. I think it’s going to drive some of the decisions about opioid-prescribing practices and how, from the regulatory or the legislative standpoint, the state is allowing physicians to prescribe opioids. Our data clearly show that 3 days’ supply is sufficient. We demonstrated in the ASCO abstract that by doing this, our rate of conversion to chronic opioid use went down from 6.5% to less than 3%.
We’re finalizing our figures and manuscript for the cancer center data, so that should be out soon. ASCO was the first forum where we presented our data, because we wanted to get long-term compliance, as well.
Healio: Is there anything else that is important to mention about this?
Zsiros: This is feasible in an institution with multiple specialties, and it’s feasible to be compliant with the protocol. It’s one thing to implement something, but if people are not compliant, it’s a big problem. We were able to harmonize and synchronize practice patterns among all surgical services in a large tertiary center, and our patients were equally satisfied with their postsurgical pain management.
References:
Brummett CM, et al. JAMA Surg. 2017;doi:10.1001/jamasurg.2017.0504.
Mark J, et al. JAMA Netw Open. 2018;doi:10.1001/jamanetworkopen.2018.5452.
Ricciuti J, et al. Abstract 103. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.
For more information:
Emese Zsiros, MD, PhD, FACOG, can be reached at Roswell Park Comprehensive Cancer Center, Elm and Carlton streets, Buffalo, NY 14263; email: emese.zsiros@roswellpark.org.
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Ricciuti J, et al. Abstract 103. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.