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Research
Advancements in opioids research, transformations in postsurgical prescribing
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In an effort to address the prescription opioid epidemic by reducing unnecessary or excess opioid prescriptions, the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery has been leading Mayo's research on prescribing practices. Much of this work has been directed by Elizabeth B. Habermann, Ph.D., Deputy Director of Research, in close coordination with Mayo Clinic's Opioid Stewardship Program — led by Halena Gazelka, M.D., and in collaboration with the House of Surgery.
"We first began investigating Mayo Clinic opioid prescribing because it was the right thing to do," says Dr. Habermann. "Mayo Clinic needed to ensure that we were doing all we could to address the prescription opioid epidemic while appropriately managing patients’ pain at the same time. Internal examination has helped us provide better, more individualized pain management solutions for our patients."
"Mayo Clinic's groundbreaking opioid research led to the development and implementation of novel postoperative prescribing guidelines that improved patient care locally, nationally, and internationally," says Tad Mabry, M.D., an orthopedic surgeon who was a member of the Midwest Surgical Quality Subcommittee at Mayo Clinic when this work first started.
"We are fortunate to have the data analytics capabilities and research expertise of the Kern Center linked directly to Quality and embedded in the Practice," he says. "All across Mayo we are tapping into the growing body of evidence and shared expertise to further refine the lessons we learned in the early days of our opioids research." Today, Dr. Mabry is chair of the Midwest Quality Subcommittee, which includes Mayo Clinic in Rochester, Minnesota, and the entire Mayo Clinic Health System.
Center-based work has helped determine Mayo's baseline prescribing habits across practices and specific surgeries. Center colleagues (center co-authors identified with bold type) led efforts to implement and validate evidence-based prescribing guidelines throughout the surgical practice.
"Mayo's opioid stewardship efforts and related research have not only been transformative for our practice," says Dr. Habermann, "They have also allowed us to contribute to more far reaching efforts through state and national health policy forums and public health initiatives."
And in turn, legislation and the national conversation bolstered Mayo's decision to implement, analyze and refine prescribing guidelines.
One late 2019 publication describes a correlation from state legislation to changes in Mayo's prescribing practices: Association of Florida House Bill 21 With Postoperative Opioid Prescribing for Acute Pain at a Single Institution. Porter SB, Glasgow AE, Yao X, Habermann EB. JAMA Surg. 2020;155(3):263–264.
Another more recent publication looks at this as well at both Mayo Clinic in Arizona and Florida: Impact of Legislation on Opioid Prescribing following Hysterectomy and Hysteroscopy in Arizona and Florida. Carrubba AR, Glasgow AE, Habermann EB, Stanton AP, Wasson MN, DeStephano CC. Gynecol Obstet Invest. 2021 Oct 12;1-9.
Mayo's opioid research started long before the COVID-19 pandemic grabbed attention in the public health arena, and, like the opioid epidemic itself, has continued throughout. In 2020, the center team co-authored approximately 27 opioid-related publications, and in 2021 there have been more than a dozen thus far. Many showcase the leadership of the Kern Center's Surgical Outcomes Research team. Following are some recent publications:
Wyles CC, Thiels CA, Hevesi M, Ubl DS, Gazelka HM, Turner NS 3rd, Trousdale RT, Pagnano MW, Mabry TM, Habermann EB. J Am Acad Orthop Surg. 2021 Apr 1;29(7):e345-e353.
"Our earlier work led to the development of prescribing guidelines for surgical practices across Mayo Clinic. However, we thought further refinement was possible," says Dr. Habermann.
In a study designed to learn how many opioids different patients actually consume for pain management, this team of investigators conducted a prospective, multicenter survey study over 10 months, with this specific investigation focusing on patients receiving one of seven common elective orthopaedic surgical procedures — total knee arthroplasty, total hip arthroplasty, lumbar fusion, lumbar laminectomy, rotator cuff repair, arthroscopic meniscectomy, and carpal tunnel release.
Phone surveys were conducted between 21 and 35 days postoperatively. The team wanted to document both the amount and length of time patients consumed opioid medications.
Among the 919 survey respondents, 94.3% received opioids at discharge, with a median prescription of 388 morphine milligram equivalents (MMEs). Of these, 60% of the opioids went unused, with 34.7% of patients using only a fraction of their prescription, or less than 50 MMEs.
The authors report, "These data have informed further improvement of our opioid prescription guidelines to more precisely align with anticipated procedure- and patient-specific requirements."
This paper is a continuation of findings originally described in 2018’s Results of a Prospective, Multicenter Initiative Aimed at Developing Opioid-prescribing Guidelines After Surgery led by then Surgical Outcomes fellow Cornelius Thiels, D.O., who has recently joined the staff at Mayo Clinic in Rochester.
In this study, led by investigators at Mayo Clinic in Arizona, the researchers examined prescribing practices during 2014–2017 for 3,702 patients receiving kidney, liver or simultaneous kidney and liver transplants across the three geographically disperse transplant centers within Mayo Clinic.
At the time of this work, acute pain, including post-surgical pain, was treated by opioid prescriptions up to a maximum post-surgery or acute injury prescription of seven days, or 200 morphine milligram equivalents (MMEs). The team found that more than 80% of patients received more than 200 MME at discharge, and that prescriptions in general varied widely between sites and between types of transplant surgery.
Their findings led to individualized prescribing guidelines that have been implanted across Mayo Clinic's transplant practice. In the paper, the authors also call for creation of national opioid prescribing guidelines in transplantation. Additionally, they posit that transplant regulatory bodies could play a role in curtailing excess prescribing by mandating the creation of center-specific protocols around opioids.
Krauss WE, Habermann EB, Goyal A, Ubl DS, Alvi MA, Whipple DC, Glasgow AE, Gazelka HM, Bydon M. Neurosurgery. 2021 Aug 16;89(3):460-470.
This study sought to evaluate the impact of departmental postoperative prescribing guidelines on opioid prescriptions following elective spine surgery. Approximately half (47.7%) of the 1,193 patients in the study were treated before the guidelines were implemented.
After guideline implementation, fewer patients received a postoperative opioid prescription. In addition, among those who received opioids, median prescriptions decreased from 300 morphine milligram equivalents (MME) to 225 MME. The 30-day refill rate also dropped slightly, indicating the changes did not adversely affect pain control.
This is the first study to evaluate a practice and procedure-specific initiative to reduce opioid prescribing following neurosurgery. The authors cite Mayo's multidisciplinary approach as the reason for successful implementation of guidelines with positive outcomes. This allows inclusion of all possible unique perspectives and ensures buy-in from all members of the care team.
Warner NS, Finnie D, Warner DO, Hooten WM, Mauck KF, Cunningham JL, Gazelka H, Bydon M, Huddleston PM, Habermann EB. Mayo Clin Proc. 2020 Sep;95(9):1906-1915.
"We don't ever do our research in a vacuum," says Dr. Habermann. "It's not simply enough to collect numbers and report findings in peer-reviewed journals. We have a responsibility to disseminate practice transformative knowledge across Mayo Clinic and assist in implementation when appropriate."
Dissemination and implementation is not like flipping a switch. Even research conducted by expert multidisciplinary teams at Mayo Clinic doesn't automatically become part of the fabric of patient care. The Kern Center has an entire program dedicated to the science of dissemination and implementation.
In this study, led by Kern Health Care Delivery Scholar Nafisseh Warner, M.D., the researchers delved into some of the reasons that 'implementing' prescribing guidelines takes a much more circuitous path than flipping the proverbial switch.
Several unique themes emerged during the course of 20 one-on-one interviews with a range of primary care and surgical health care providers involved with care of patients who undergo major spinal surgery — after prescribing guidelines had been developed and 'implemented.'
Providers did not view opioid prescribing guidelines in the same way. Depending on their level of clinical experience, prescribing oversight and how many other demands on the provider's time existed, prescribing practices were likely to vary.
Universally, opioid tapering was viewed as an area in which more education and support was desired. The participants also agreed that expectation setting for both acute and chronic pain management was challenging. And finally, there was no hand-off process to transition opioid prescribing responsibilities between surgical and primary care teams.
"With Dr. Nafisseh Warner's championship, we continue to work on this problem," says Dr. Habermann. Find more publications from Dr. Warner on PubMed.
Goyal A, Payne S, Sangaralingham LR, Jeffery MM, Naessens JM, Gazelka HM, Habermann EB, Krauss W, Spinner RJ, Bydon M. J Neurosurg Spine. 2021 Aug 6:1-9.
This publication resulted from a multi-faceted study using the OptumLabs Data Warehouse, in which the researchers sought to find ways to address a growing concern in health care of sustained postoperative opioid use after elective surgery.
An earlier publication by the same team, Variations in Postoperative Opioid Prescription Practices and Impact on Refill Prescriptions Following Lumbar Spine Surgery, published online in June in World Neurosurgery, set the stage. In it, the authors examined the records of 43,572 adult patients undergoing anterior lumbar fusion, posterior lumbar fusion, circumferential lumbar fusion, or lumbar decompression and discectomy for degenerative spine disease. They found wide variance in prescriptions between types of surgeries, as well as between patients receiving the same surgery. They also found a preponderance of prescriptions for more than 200 morphine milligram equivalents — a commonly accepted limit of opioid prescriptions for acute pain management in the seven days following severe injury or surgery.
By further analyzing the pharmacy claims for 25,587 patients who received posterior lumbar fusion or lumbar decompression and discectomy, the authors identified incidence and predictors of long-term opioid use after these elective lumbar spine surgeries.
The following were identified to be significantly associated with higher risk of long-term opioid use following posterior lumbar fusion:
- Discharge opioid prescription of greater than or equal to 500 morphine milligram equivalents (MMEs).
- Prescription of a long-acting opioid.
- Female sex, multilevel surgery or comorbidities such as depression and drug abuse.
Conversely, older patients — age 65 years or older — or people who had not been taking opioids prior to surgery, i.e. "opioid naïve," were at lower risk of progressing to long-term use.
For patients undergoing lumbar decompression and discectomy, the authors had similar findings, but also noted additional risk factors:
- Discharge opioid prescription greater than or equal to 400 MMEs.
- Prescription of tramadol alone at discharge.
- Inpatient surgery.
The Mayo Clinic Kern Center for the Science of Health Care Delivery is fully embedded in Mayo Clinic's medical Practice. Its scientists collaborate across the Practice to identify and solve challenges for patients, providers and the health care system at large.
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