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Home/Legal & Regulatory and Reimbursement/Procedure-Specific Opioid Prescribing Guidelines
Legal & Regulatory and Reimbursement

Procedure-Specific Opioid Prescribing Guidelines

November 21, 2018 3 min read Premium comments

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Procedure-Specific Opioid Prescribing Guidelines
Courtesy of Johns Hopkins Medicine
#opioidSecondary#johnshopkinsschoolofmedicine#opioidguidelines

In a breakthrough which literally shows government how to govern, Johns Hopkins Medicine (JHM, which includes Johns Hopkins University, Johns Hopkins Hospital, and Johns Hopkins Health System) created what are apparently the first-in-the-nation, procedure-specific guidelines which set precise dose ranges for prescribing opioids for 20 procedures.

Four of the guidelines are for orthopedic procedures: arthroscopic partial meniscectomy, arthroscopic ACL/PCL [anterior cruciate ligament/posterior cruciate ligament] repair, arthroscopic rotator cuff repair, and open reduction and internal fixation (ORIF) of the ankle.

The JHM team got this job done after the Centers for Disease Control (CDC), which has been criticized for two years in many quarters for its one-size-fits-all 2016 opioid guideline (updated in 2017).

Meanwhile, the Food and Drug Administration (FDA) announced in August that it was stepping into the procedure-specific and situation-specific opioid-guideline business by contracting with another federal agency, the National Academies of Sciences, Engineering, and Medicine (NASEM) to some day develop opioid guidelines for “specific conditions or procedures” (see “FDA’s Draconian Opioid Plan Rebukes CDC,” Orthopedics This Week, September 19, 2018).

At the pace these and other federal agencies are going, the opioid crisis might well be over by the time they produce anything useful.

Meanwhile, JHM went ahead and created these procedure-specific, scientifically defensible guidelines.

The only down side: as of August 2018, these guidelines covered only 20 procedures. However, the method used was fast (compared to the glacial pace of government action), efficient, and could be easily replicated for other procedures and situations.

The article on how JHM developed its guidelines, “Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert Panel Consensus,” was first published online in August and is now in the October 2018 issue of the Journal of the American College of Surgeons. The study authors: Heidi N. Overton, M.D., Marie N. Hanna, M.D., M.E.H.P., William E. Bruhn, B.S., Susan Hutfless, Ph.D., M.S., Mark C. Bicket, M.D., and its senior author, Martin A. Makary, M.D., M.P.H., FACS, a professor of surgery and health policy expert at the Johns Hopkins University School of Medicine.

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“The ranges offered for each of 20 common operations generally call for reductions from the current rates of opioid prescription, and the researchers say that patients themselves favor using less of the drugs than physicians often prescribe,” a JHM announcement said.

How did JHM do this while the feds continue to write planning documents on how to create roadmaps?

“We used a 3-step modified Delphi method*involving a multidisciplinary expert panel of 6 relevant stakeholder groups (surgeons, pain specialists, outpatient surgical nurse practitioners, surgical residents, patients, and pharmacists) to develop consensus ranges for outpatient opioid prescribing at the time of discharge after 20 common procedures in 8 surgical specialties. Prescribing guidelines were developed for opioid-naïve adult patients without chronic pain undergoing uncomplicated procedures. The number of opioid tablets was defined using oxycodone 5 mg oral equivalents,” the full JHM study says.

*The Delphi method involves sending several rounds of questionnaires to panels of experts, with each subsequent round taking into consideration the answers to the earlier rounds. It’s noteworthy that patients were among the experts consulted.

The Surprising Results

“For all 20 surgical procedures reviewed, the minimum number of opioid tablets recommended by the panel was 0. Ibuprofen was recommended for all patients unless medically contraindicated. The maximum number of opioid tablets varied by procedure (median 12.5 tablets), with panel recommendations of 0 opioid tablets for 3 of 20 (15%) procedures, 1 to 15 opioid tablets for 11 of 20 (55%) procedures, and 16 to 20 tablets for 6 of 20 (30%) procedures. Overall, patients who had the procedures voted for lower opioid amounts than surgeons who performed them.”

The fact that patients voted for lower opioid amounts might be less significant than it appears at first glance. The article says they “were patients who volunteered because of a desire to contribute to addressing the opioid crisis and therefore were well informed individuals with a high level of health literacy on postoperative pain management before serving on the panel.”

In other words, they were selected for already having strong views that opioid prescriptions are a contributing problem. Given the fact that the chief author of the study, Dr. Makary, had already expressed strong views in a British Journal of Medicine editorial saying opioids were prescribed too much, that “desire to contribute” might reasonably be interpreted as agreeing with his views.  Patients with enduring post-operative pain might have voted very differently.

The JHM study also said that default opioid-prescription settings in its electronic medical record system were too high. See that separate story.

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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