- Email: [email protected]
Opioid Prescribing Practices After Isolated Pilon Fractures
The Journal of Foot & Ankle Surgery 57 (2018) 11671171
Contents lists available at ScienceDirect
The Journal of Foot & Ankle Surgery journal homepage: www.jfas.org
Opioid Prescribing Practices After Isolated Pilon Fractures D1X XAndres Rodriguez-Buitrago, D2X XMD1, D3X XBasem Attum, D4X XMD, MS2, D5X XNichelle Enata, D6X XMS, ATC3, D7X XAdam EvansD8X3X , D9X XWilliam T. Obremskey, D10X XMD, MPH, MMHC4, D1X XManish Sethi, D12X XMD5, D13X XAlex Jahangir, D14X XMD, MMHC6 1
Research Coordinator, Orthopaedic Trauma, Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN Research Assistanat, Orthopaedic Trauma, Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN 3 Student, Meharry Medical College, Nashville, TN 4 Professor and Director, Division of Orthopaedic Trauma Research , Vanderbilt University Medical Center, Nashville, TN 5 Associate Professor, Orthopedic Trauma Service, Department of Orthopedics, Vanderbilt University Medical Center, Nashville, TN 6 Associate Professor and Division Director, Orthopaedic Trauma, Vanderbilt University Medical Center, Nashville, TN 2
A R T I C L E
I N F O
Level of Clinical Evidence: 3 Keywords: orthopedic trauma opiates pain management pilon fracture
A B S T R A C T
The purpose of our study was to identify the opioid-prescribing practices after operative treatment of isolated pilon fractures at a level 1 trauma center. Patients 18 years of age with an operatively treated isolated pilon fracture between 2005 and 2015 were identified. Total morphine milligram equivalents (MMEs) were then calculated. Mean and standard deviations were calculated for patients without a history of opiate use and for patients with a history of opiate use within 1 year prior to injury. Data were obtained from the State Controlled Substance Monitoring Database. Seventy-two patients met our inclusion criteria; of these, 54% (39/72) were opiate exposed at the time of injury. Median MMEs prescribed were 2738 (range 375 to 12,360). Orthopedic providers prescribed 61% of all the MMEs (median 2010; range 113 to 6825), while nonorthopedic providers prescribed a median of 338 MMEs (range 0 to 10,080) (p < .05). Combined, patients with exposure 1 year before the injury received more MMEs (median 3600; range 840 to 12,360) than opiate-naive patients (median 2520; range 375 to 10,610) (p < .05). Twenty-eight (38.9%) patients continued using opiates for more than 6 months after their injury; 25% (7/28) were not previously exposed. There is great variability regarding the quantity of opiates being prescribed after isolated pilon fractures, and 39% of opiate prescriptions are coming from nonorthopedic prescribers. Opiate-exposed patients are more likely to be prescribed more opiates by orthopedists and outside physicians and for a longer duration. We believe that adequate pain control can be obtained by prescribing 40 pills of oxycodone 10 mg with a maximum of 1 additional refill. In cases in which a staged procedure is planned, an additional refill is expected (total of 3 refills). © 2018 by the American College of Foot and Ankle Surgeons. All rights reserved.
The prescription of opiates is a common practice after orthopedic injuries, and a potential unintended consequence of this is substance abuse. In 2014, 1.9 million Americans over the age of 12 had a substance abuse disorder because of prescription narcotics, with 586,000 of them secondary to heroin (1). Drug overdose has been the leading cause of accidental death in the United States, with 18,893 deaths related to prescription pain relievers and another 10,574 related to heroin annually (1). In 2015, fatal drug overdoses surpassed deaths from suicides, car accidents, and firearms. In fact, the rate of fatal drug overdose has more than doubled since 1999.
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Alex Jahangir, MD, MMHC, Orthopedic Trauma Service, Department of Orthopedics, Vanderbilt University Medical Center, 1215 21st Avenue South, Suite 4200 MCE-South Tower, Nashville, TN 37232. E-mail address: [email protected] (A. Jahangir).
Interestingly, people between the ages of 55 and 64 were the most affected (2). This has raised the concern of opiate misuse in the older population, when traditionally younger people were the ones at most risk of opiate misuse. This rise in overdose deaths directly parallels the dramatic increase in the sale of opioids by pharmaceutical companies between 1999 and 2012, a period in which the sales of prescription pain relievers increased 400% from 1999 to 2010 (3). In 2012, 259,000,000 prescriptions were written for opioids in the United States alone—enough medication to give every adult American a bottle of opioids (1). This rise in opioid abuse has led to an increase in admissions to the emergency room for opioid abuse, with 709,000 admissions in 2012. Additionally, 90% of heroin users reported that their addiction started with prescription opiates (4). Opiates may be overprescribed in the United States, as evidenced by the fact that 99% of the world’s hydrocodone supply and 80% of the world’s oxycodone supply are used in the United States (5,6).
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With the rise of the opioid epidemic and the increase in diversion of controlled substances, many efforts have been made to reduce access to opiates. Since leftover medications are one of the main sources of diversion, a standard prescribing practice of opiates for isolated orthopedic injuries is needed to adequately treat pain while decreasing diversion potential (7). Data on the number of pills prescribed for many isolated orthopedic injuries have not been reported in the literature. The primary purpose of this study was to identify opioid-prescribing practices, determine the amount of morphine milligram equivalents (MMEs) prescribed by orthopedic/nonorthopedic team members, and provide prescribing recommendations for patients with isolated lower-extremity injuries. Patients and Methods Patients over 18 years of age with an operatively treated isolated pilon fracture between 2005 and 2015 at a level 1 academic trauma center were identified using Current Procedural Terminology codes 27,824; 27,825; 27,826; 27,827; and 27,828. State laws limited access to the state’s Controlled Substance Monitoring Database (CSMD) before January 2013; thus, patients treated before 2013 were excluded. Electronic medical records were used to verify inclusion criteria and collect demographic data. CSMD data were used to identify the type(s) and strength(s) of opiate(s) prescribed 12 months before the study injury and up to 6 months after definite fixation. To identify patients at risk, payer practice information was collected (cash pay when the patient had insurance) and the use of 5 different prescribers and/or the use of 5 different pharmacies within a 90-day period. Total number of MMEs was calculated for every opiate used, using the following equation: Number of pills prescribed x Strength of opiate prescribed ¼ Total MMEs 10 pills of Oxycodone x 1:5 ¼ 45 MMEs To aid in clinical relevance, number of MMEs was converted to number of pills of oxycodone 10 mg (OC10mg) Total MMEs Pills of Oxycodone 10 mg ¼
1:5
10
1 Pill of Oxycodone 10 mg ¼
15 MMEs 1:5
10
To prevent skewness of the data, top outliers for each injury were excluded. Descriptive statistics were performed, and data for every patient were plotted as a standard distribution curve for MME use. MME prescribing practices were reported using the means and medians. Wilcoxon signed-rank tests and Mann-Whitney U tests were performed to evaluate differences. For analysis, statistical significance was defined at the 5% (p .05) level and performed using SAS version 9.1 software (SAS Institute, Cary, NC).
Results Initially, 828 patients were identified. Of these, 608 were excluded due to state laws limiting access prior to January 2013; 142 were excluded due to multiple injuries, lack of opiate prescriptions by orthopedic surgeons, or lack of CSMD data; and 6 outliers were excluded to prevent skewness of the data. Seventy-two patients met our inclusion criteria. The mean age was 44 § 15 y; 39/72 (54%) were male; 70/72 (97.2%) had insurance; and 60/70 (85%) had private insurance. Thirtythree (46%) patients were prescribed opiates 1 year prior to the study injury. Median opiate prescriptions among those with a prior history was 2, and the mean was 7 § 10 (range 1 to 49). Complete demographic information is presented in Table 1. Orthopedic and nonorthopedic prescriptions for every patient were plotted for MME use and are shown in Figure 1. In total, patients were prescribed 291,429 (19,429 pills of OC10mg) MMEs A statistically significant difference was observed between orthopedic and nonorthopedic prescriptions. Orthopedic providers prescribed a median of 2010 (mean 2487 § 1628, range 113 to 6,825) MMEs, whereas nonorthopedic providers prescribed a median of 338 (mean 1566 § 2338, range 0 to 10,080) MMEs (p < .05) (Table 2). Opiate-naive patients (defined as not being exposed to opiates the year prior to the study injury) were prescribed a median of 1845 (mean 2432 § 1669,
Table 1 Patient Demographics (N = 72)
Age Mean § standard deviation Range Gender Male Female Type of insurance Private State provided Military No insurance History of opiate consumption Yes No Number of prescriptions before injury Median Mean § standard deviation Range Opioids for more than 6 months No Yes Prior exposure
44 § 15 (18 to 91) 39 (54%) 33 (46%) 61 (85%) 9 (13%) 0 (0%) 2 (3%) 33 (46%) 39 (54%) 2 7 § 10 (1 to 49) 44 (61%) 28 (39%) 21/28 (75%)
range 375 to 6825) MMEs by orthopedic prescribers and a median of 0 (mean 864 § 1702, range 0 to 7935) MMEs by nonorthopedic prescribers (p < .05). Conversely, patients with exposure 1 year before the study injury were prescribed a median of 2035 (mean 2553 § 1600, range 113 to 6410) MMEs by orthopedic prescribers and a median of 2100 (mean 2395 § 2716, range 0 to 10,080) MMEs by nonorthopedic prescribers (p = .25). A significant difference was also found between prescriptions made by orthopedic and nonorthopedics to patients with a history of consumption 1 year before the injury and to opiate-naive patients (p < .05) (Table 3). Twenty-eight (39%) patients continued using opiates for more than 6 months after their injury; of those, 7 (25%) were opiate naive. Outliers (n = 6) were excluded from the study; they were prescribed 25% (i.e., 72,324 MMEs or 4822 pills of OC10mg) of what was prescribed for the rest of the study population (Fig. 2). Final recommendations were based on current orthopedic prescriptions (i.e., 40 pills of oxycodone 10 mg). This recommendation can be adapted to prescribe pills of oxycodone 5 mg. Discussion We found a significant difference in the consumption of opiates between opiate-naive and opiate-exposed patients. Opiate-exposed patients are expected to require more pain medications and have a higher likelihood of consuming opiates for more than 6 months after injury. We thought that dividing our study population into these subgroups was necessary because pre-injury opioid use has been shown to be higher in the orthopedic trauma population. (8) A recent study by Ruder et al (9) retrospectively examined 110 patients who had 135 prescriptions written during their review period. All patients received opioids at the time of discharge, with the average mean MMEs being 114 mg/day for an average of 7.21 days. In this study, patients with preinjury risk factors were prescribed opioids for similar duration compared to those without any risk factors, but they were prescribed significantly more MMEs (130 MMEs versus 108; p < .05) than patients without risk factors. A query by Holman et al (10) found that 15.5% of orthopedic trauma patients filled prescriptions within 3 months prior to injury, compared to 9.2% in the general population. Within 3 months pre-injury, 12.2% of orthopedic trauma patients filled more than 1 prescription, compared
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Fig. 1. Total morphine milligram equivalents prescribed for patients with isolated pilon fractures (N = 72). Morphine milligram equivalents (MMEs) prescribed by orthopedic and nonorthopedic providers. Each bar represents 1 unique patient.
Table 2 Opioid prescribing practices by orthopedic and nonorthopedic team members (N = 72) Orthopedic Prescribers
Median Mean § standard deviation Range
Nonorthopedic Prescribers
Total
MMEs
Pills*
MMEs
Pills*
MMEs
Pills*
p Value
2010 2487 § 1 628 (113 to 6825)
134 166 § 109 (8 to 455)
338 1566 § 2338 (0 to 10,080)
23 23 § 156 (0 to 672)
2738 4053 § 3 118 (375 to 12,360)
183 270 § 208 (25 to 824)
p < .05
Abbreviation: MMEs, morphine milligram equivalents. * Number of pills of oxycodone 10 mg.
to 6.4% in the general population. They also found that patients who filled more than 1 opiate prescription within 3 months pre-injury were 6 times more likely to use opiates for more than 12 weeks and 3.5 times more likely to obtain opiates from another prescriber . A recent study by Rosenbloom et al (11) of 122 patients found that pain severity and self-efficacy were significant factors in using opioids longer than 4 months after musculoskeletal injury. There is a clear concern currently that opioids are being overprescribed, leading to potential abuse. A study recently evaluated overprescribing of opiates upon hospital discharge of 18,343 patients who
underwent 21,452 procedures. In this study, 6548 patients (35.7%) used no opioids in the 24 hours prior to hospital discharge, but of these same patients, 2988 (45.6%) were prescribed opioids at hospital discharge. Services with the highest rate of overprescribing were obstetrics and gynecology, orthopedics, and plastic surgery. Of all surgical subspecialties, pediatric surgery was the only service with no potential cases of over-prescription (12). By determining the current prescribing practices after isolated pilon fractures, orthopedic surgeons can begin to standardize pain prescribing practices after injury. The hope is that after standardizing the
Table 3 Opiates prescribed to patients with a prior history of consumption versus patients who were opiate naive (N = 72)
Prior history (n = 33)
Naive (n = 39)
Median Mean § standard deviation Range Median Mean § standard deviation Range
Abbreviation: MMEs, morphine milligram equivalents. * Number of pills of oxycodone 10 mg.
Orthopedic Prescribers
Nonorthopedic Prescribers
Total
MMEs
Pills*
MMEs
Pills*
MMEs
Pills*
p Value
2035 2553 § 1600 (113 to 6410) 1845 2432 § 1,669 (375 to 6825) p < .05
136 170 § 107 (8 to 427) 123 162 § 111 (25 to 455)
2100 2395 § 2716 (0 to 10,080) 0 864 § 1702 (0 to 7395) p < .05
140 160 § 181 (0 to 672) 0 58 § 113 (0 to 529)
3600 4947 § 3431 (840 to 12,360) 2,520 3296 § 2640 (375 to 10,610) p < .05
240 330 § 229 (56 to 824) 168 220 § 176 (25 to 707)
.25
< .05
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Fig. 2. Total morphine milligram equivalents prescribed before outliers were excluded (N = 78). Morphine milligram equivalent (MMEs) prescriptions before removal of the outliers. Six patients were prescribed 25% of what was prescribed for the rest of the study population. Each bar represents 1 unique patient.
prescribing practices, the number of pain pills prescribed can be reduced while still providing adequate pain relief. Hill et al (13) looked at 5 general surgery procedures (partial mastectomy [PM], PM with sentinel lymph node biopsy [SLNB], laparoscopic cholecystectomy [LC], laparoscopic inguinal hernia [LIH] repair, and open inguinal hernia [IH] repair) and found that opioids were being overprescribed. In this study, guidelines were implemented to decrease the number of opiates prescribed by 50% and satisfy 80% of patient requirements. In that study, the mean number of opioid pills prescribed for each operation markedly decreased: PM 19.8 versus 5.1; PM SLNB 23.7 versus 9.6; LC 35.2 versus 19.4; LIH 33.8 versus 19.3, and IH 33.2 versus 18.3; all p < .0003. Overall, the number of pills prescribed decreased by 53% when compared with the number that would have been prescribed before educational intervention. Stanek et al (14) found that after surgeons were given a pink card with historical prescribing patterns for select procedures, the average postoperative prescription size decreased for all types of cases by 15% to 48%. Several studies have demonstrated that current prescribing practices may be a contributor to the opioid overuse epidemic. A study of patients who had dermatologic surgery found that 86% of patients had leftover pills, and 53% of these patients planned on keeping the unused pills (15). A urologic surgery study found that 67% of patients had leftover narcotics, and 91% intended on keeping them. A recent prospective evaluation of opioid use after upper-extremity surgery found that 28% of patients did not take any of the prescribed medication, 56.1% discontinued use voluntarily before finishing the medication, and only 0.6% of patients were still taking medication at the time of the first postoperative visit (16). Another study on outpatient upper-extremity surgery found that, in 250 patients, a total of 4639 tablets were left unused, leading to a potential source of diversion. This study found that lowering the number of narcotics prescribed initially to 15 pills with 1 refill led to a 79% reduction in leftover medication (8). Limiting the number of narcotics prescribed, even in the acute setting, can make an impact on the opioid epidemic, since it has been shown that 71% of young adults who abused opiates stated that they were obtained by stealing or were given to them by a friend or relative. Of these diverted opiates, 90% came from legitimate physician prescriptions (5). Brat et al (17) studied over 1,000,000 patients and showed that eventual misuse of opioids was best predicted by the number of post-discharge prescriptions and duration. In patients with 1 refill, the rate of misuse increased by 44% compared to patients with no refills. With each week of additional use, the rate of misuse increased 32%. Opiate prescribing even in low-risk surgery contributes to the problem. In
one study, opiate-naive patients who received an opioid prescription within 7 days after short-stay surgery were 44% more likely to become long-term opioid users within 1 year compared to patients who did not receive opiates (18). The importance of prescribing as little narcotic as possible, while providing adequate pain care, cannot be overemphasized. In a study of Veterans Administration patients, Bohnert et al (19) found that a higher dose of opiates correlated with increased risk of overdose. Additionally, the morphine-equivalent dose (MED)/Day of long-acting opioids decreased by 27%; the proportion of patients on doses 120 mg/day of MED and the number of opioid-related deaths decreased by 50% (20). We reported on the amount of medication prescribed. We did not know the amount of medication consumed or left over and the fate of that medication. The potential is most likely similar to other orthopedic injuries previously reported. Physicians can use these data to adjust prescribing habits. There have been attempts reported in the literature to create a weaning protocol for opiates. Morris et al described an opiate protocol that starts the weaning process from the initial prescription. Oxycodone is initially prescribed at 10 mg, then every 2 weeks is weaned down to tramadol as needed by week 6. Although this protocol is effective and has reduced opiate prescriptions, this is a general protocol and is not specific to injuries (6). We think that the prescribing practice of opioids, like other medications in medicine, needs to be standardized. Other studies reported in the nonorthopedic literature have shown that there is substantial variability in prescribing practices for the same diagnosis. Webster et al (21) found that of 8262 claimants, 21.3% received at least 1 early opioid prescription refill. Significant between-state variation was also found, from 5.7% (Massachusetts) to 52.9% (South Carolina). Although some variability is expected, standardizing prescribing practices may help decrease such extremes, as 51.4 million inpatient procedures and 53.3 million outpatient procedures are performed annually, with approximately 98.6% of these patients receiving opioids (22,23). By identifying current prescribing practices after operatively treated isolated pilon fractures, surgeons can identify “at-risk” patients who are being prescribed more than 1 to 2 standard deviations from the norm. This is the first step in standardizing opiate prescribing practices for pilon fractures. As a final recommendation, we think that adequate pain control can be obtained by prescribing 40 pills of oxycodone 10 mg with a maximum of 1 refill (or its equivalent in pills of oxycodone 5 mg). In cases in
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which a staged procedure is planned, 1 additional refill might be necessary (for a total of 3 prescriptions). This study had several limitations. Its retrospective nature was an inherent limitation. Also, inpatient prescribing practices were not recorded, and patients with conditions requiring chronic opiate use were not excluded. We did not specify the admitting service (i.e., general surgery trauma service or orthopedic trauma service), which could alter prescribing practices. CSMD data did not allow us to reliably determine if more opiates were used due to postoperative complications, additional surgeries, patient factors affecting opioid use, nonopioid medications prescribed, new injuries, or the number of refills. We think that the percentage of complications in these types of fractures does not alter our data. An uncontrollable limitation of this study was that some patients may have been supplementing opioids through diverted pills that were not considered with our data, or they did not consume a prescription that was provided. Even though CMSD information is available since 2010, state laws limit data access before January 2013, which affected our sample size. To our knowledge, this is the first study to rely on CSMD data to describe prescribing practices of isolated pilon fractures. In conclusion, there is wide variability in what is being prescribed after isolated pilon fractures, and 39% of all prescriptions are coming from outside prescribers. Additionally, a large subset of our population had a history of opiate exposure within 1 year of the pilon fracture. Patients with a history of narcotic use prior to their injury obtained far more narcotics from outside physicians and for a longer duration than opiate-naive patients. Patients with pilon fractures should be expected to require more opiates due to the inherent characteristics of the injury. These data can help orthopedic surgeons set expectations and educate their team members and, most importantly, their patients, especially when they are falling out of the norm. References 1. CDC. Division of Vital Statistics, Mortality Data. Available at: https://www.cdc.gov/ nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_20002014.pdf. Accessed December 20, 2017. 2. CDC. Drug Overdose Deaths in the United States, 1999-2016. NCHS Data Brief No. 294. Available at: https://www.cdc.gov/nchs/products/databriefs/db294.htm. Accessed December 20, 2017. 3. Paulozzi LJ, Weisler RH, Patkar AA. A national epidemic of unintentional prescription opioid overdose deaths: how physicians can help control it. J Clin Psychiatry 2011;72:589. 4. Kuehn BM. SAMHSA: pain medication abuse a common path to heroin: experts say this pattern likely driving heroin resurgence. JAMA 2013;310:1433–1434.
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5. Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of opioids. Pain physician 2008;11(2 suppl):S63–S88. 6. Morris BJ, Mir HR. The opioid epidemic: impact on orthopedic surgery. J Am Acad Orthop Surg 2015;23:267–271. 7. Volkow ND, McLellan TA. Curtailing diversion and abuse of opioid analgesics without jeopardizing pain treatment. JAMA 2011;305:1346–1347. 8. Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg 2012;37:645–650. 9. Ruder J, Wally M, Oliverio M, Seymour R, Hsu J. PRIMUM Group. Patterns of opioid prescribing for an orthopedic population. J Orthop Trauma 2017;31: e179–e185. 10. Holman JE, Stoddard GJ, Higgins TF. Rates of prescription opiate use before and after injury in patients with orthopedic trauma and the risk factors for prolonged opiate use. J Bone Joint Surg Am 2013;95:1075–1080. 11. Rosenbloom B, McCartney C, Canzian S, Kreder H, Katz J. Predictors of prescription opioid use 4 months after traumatic musculoskeletal injury and corrective surgery: a prospective study. J Pain 2017;18:956–963. 12. Chen EY, Marcantonio A, Tornetta P. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg 2017;153. e174859e174859. 13. Hill MV, Ryland S, McMahon ML, Beeman JL, Barth Jr RJ. An educational intervention decreases opioid prescribing after general surgical operations. Ann Surg 2017;263:468–472. 14. Stanek JJ, Renslow MA, Kalliainen LK. The effect of an educational program on opioid prescription patterns in hand surgery: a quality improvement program. J Hand Surg 2015;40:341–346. 15. Harris K, Curtis J, Larsen B, et al. Opioid pain medication use after dermatologic surgery: a prospective observational study of 212 dermatologic surgery patients. JAMA Dermatol 2013;149:317–321. 16. Kim N, Matzon JL, Abboudi J, et al. A prospective evaluation of opioid utilization after upper-extremity surgical procedures: identifying consumption patterns and determining prescribing guidelines. J Bone Joint Surg Am 2016;98:e89. 17. Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ 2018;360:j5790. 18. Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med 2012;172:425–430. 19. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011;305:1315–1321. 20. Franklin GM, Mai J, Turner J, Sullivan M, Wickizer T, FultonKehoe D. Bending the prescription opioid dosing and mortality curves: impact of the Washington State opioid dosing guideline. Am J Ind Med 2012;55:325–331. 21. Webster BS, Cifuentes M, Verma S, Pransky G. Geographic variation in opioid prescribing for acute, workrelated, low back pain and associated factors: a multilevel analysis. Am J Ind Med 2009;52:162–171. 22. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory Surgery in the United States, 2006. Washington, DC: US Department of Health and Human Services, Centers for Disease Control and Prevention; 20092009. 23. Kessler ER, Shah M, K Gruschkus S, Raju A. Cost and quality implications of opioidbased postsurgical pain control using administrative claims data from a large health system: opioidrelated adverse events and their impact on clinical and economic outcomes. Pharmacotherapy 2013;33:383–391.
Contents lists available at ScienceDirect
The Journal of Foot & Ankle Surgery journal homepage: www.jfas.org
Opioid Prescribing Practices After Isolated Pilon Fractures D1X XAndres Rodriguez-Buitrago, D2X XMD1, D3X XBasem Attum, D4X XMD, MS2, D5X XNichelle Enata, D6X XMS, ATC3, D7X XAdam EvansD8X3X , D9X XWilliam T. Obremskey, D10X XMD, MPH, MMHC4, D1X XManish Sethi, D12X XMD5, D13X XAlex Jahangir, D14X XMD, MMHC6 1
Research Coordinator, Orthopaedic Trauma, Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN Research Assistanat, Orthopaedic Trauma, Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN 3 Student, Meharry Medical College, Nashville, TN 4 Professor and Director, Division of Orthopaedic Trauma Research , Vanderbilt University Medical Center, Nashville, TN 5 Associate Professor, Orthopedic Trauma Service, Department of Orthopedics, Vanderbilt University Medical Center, Nashville, TN 6 Associate Professor and Division Director, Orthopaedic Trauma, Vanderbilt University Medical Center, Nashville, TN 2
A R T I C L E
I N F O
Level of Clinical Evidence: 3 Keywords: orthopedic trauma opiates pain management pilon fracture
A B S T R A C T
The purpose of our study was to identify the opioid-prescribing practices after operative treatment of isolated pilon fractures at a level 1 trauma center. Patients 18 years of age with an operatively treated isolated pilon fracture between 2005 and 2015 were identified. Total morphine milligram equivalents (MMEs) were then calculated. Mean and standard deviations were calculated for patients without a history of opiate use and for patients with a history of opiate use within 1 year prior to injury. Data were obtained from the State Controlled Substance Monitoring Database. Seventy-two patients met our inclusion criteria; of these, 54% (39/72) were opiate exposed at the time of injury. Median MMEs prescribed were 2738 (range 375 to 12,360). Orthopedic providers prescribed 61% of all the MMEs (median 2010; range 113 to 6825), while nonorthopedic providers prescribed a median of 338 MMEs (range 0 to 10,080) (p < .05). Combined, patients with exposure 1 year before the injury received more MMEs (median 3600; range 840 to 12,360) than opiate-naive patients (median 2520; range 375 to 10,610) (p < .05). Twenty-eight (38.9%) patients continued using opiates for more than 6 months after their injury; 25% (7/28) were not previously exposed. There is great variability regarding the quantity of opiates being prescribed after isolated pilon fractures, and 39% of opiate prescriptions are coming from nonorthopedic prescribers. Opiate-exposed patients are more likely to be prescribed more opiates by orthopedists and outside physicians and for a longer duration. We believe that adequate pain control can be obtained by prescribing 40 pills of oxycodone 10 mg with a maximum of 1 additional refill. In cases in which a staged procedure is planned, an additional refill is expected (total of 3 refills). © 2018 by the American College of Foot and Ankle Surgeons. All rights reserved.
The prescription of opiates is a common practice after orthopedic injuries, and a potential unintended consequence of this is substance abuse. In 2014, 1.9 million Americans over the age of 12 had a substance abuse disorder because of prescription narcotics, with 586,000 of them secondary to heroin (1). Drug overdose has been the leading cause of accidental death in the United States, with 18,893 deaths related to prescription pain relievers and another 10,574 related to heroin annually (1). In 2015, fatal drug overdoses surpassed deaths from suicides, car accidents, and firearms. In fact, the rate of fatal drug overdose has more than doubled since 1999.
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Alex Jahangir, MD, MMHC, Orthopedic Trauma Service, Department of Orthopedics, Vanderbilt University Medical Center, 1215 21st Avenue South, Suite 4200 MCE-South Tower, Nashville, TN 37232. E-mail address: [email protected] (A. Jahangir).
Interestingly, people between the ages of 55 and 64 were the most affected (2). This has raised the concern of opiate misuse in the older population, when traditionally younger people were the ones at most risk of opiate misuse. This rise in overdose deaths directly parallels the dramatic increase in the sale of opioids by pharmaceutical companies between 1999 and 2012, a period in which the sales of prescription pain relievers increased 400% from 1999 to 2010 (3). In 2012, 259,000,000 prescriptions were written for opioids in the United States alone—enough medication to give every adult American a bottle of opioids (1). This rise in opioid abuse has led to an increase in admissions to the emergency room for opioid abuse, with 709,000 admissions in 2012. Additionally, 90% of heroin users reported that their addiction started with prescription opiates (4). Opiates may be overprescribed in the United States, as evidenced by the fact that 99% of the world’s hydrocodone supply and 80% of the world’s oxycodone supply are used in the United States (5,6).
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With the rise of the opioid epidemic and the increase in diversion of controlled substances, many efforts have been made to reduce access to opiates. Since leftover medications are one of the main sources of diversion, a standard prescribing practice of opiates for isolated orthopedic injuries is needed to adequately treat pain while decreasing diversion potential (7). Data on the number of pills prescribed for many isolated orthopedic injuries have not been reported in the literature. The primary purpose of this study was to identify opioid-prescribing practices, determine the amount of morphine milligram equivalents (MMEs) prescribed by orthopedic/nonorthopedic team members, and provide prescribing recommendations for patients with isolated lower-extremity injuries. Patients and Methods Patients over 18 years of age with an operatively treated isolated pilon fracture between 2005 and 2015 at a level 1 academic trauma center were identified using Current Procedural Terminology codes 27,824; 27,825; 27,826; 27,827; and 27,828. State laws limited access to the state’s Controlled Substance Monitoring Database (CSMD) before January 2013; thus, patients treated before 2013 were excluded. Electronic medical records were used to verify inclusion criteria and collect demographic data. CSMD data were used to identify the type(s) and strength(s) of opiate(s) prescribed 12 months before the study injury and up to 6 months after definite fixation. To identify patients at risk, payer practice information was collected (cash pay when the patient had insurance) and the use of 5 different prescribers and/or the use of 5 different pharmacies within a 90-day period. Total number of MMEs was calculated for every opiate used, using the following equation: Number of pills prescribed x Strength of opiate prescribed ¼ Total MMEs 10 pills of Oxycodone x 1:5 ¼ 45 MMEs To aid in clinical relevance, number of MMEs was converted to number of pills of oxycodone 10 mg (OC10mg) Total MMEs Pills of Oxycodone 10 mg ¼
1:5
10
1 Pill of Oxycodone 10 mg ¼
15 MMEs 1:5
10
To prevent skewness of the data, top outliers for each injury were excluded. Descriptive statistics were performed, and data for every patient were plotted as a standard distribution curve for MME use. MME prescribing practices were reported using the means and medians. Wilcoxon signed-rank tests and Mann-Whitney U tests were performed to evaluate differences. For analysis, statistical significance was defined at the 5% (p .05) level and performed using SAS version 9.1 software (SAS Institute, Cary, NC).
Results Initially, 828 patients were identified. Of these, 608 were excluded due to state laws limiting access prior to January 2013; 142 were excluded due to multiple injuries, lack of opiate prescriptions by orthopedic surgeons, or lack of CSMD data; and 6 outliers were excluded to prevent skewness of the data. Seventy-two patients met our inclusion criteria. The mean age was 44 § 15 y; 39/72 (54%) were male; 70/72 (97.2%) had insurance; and 60/70 (85%) had private insurance. Thirtythree (46%) patients were prescribed opiates 1 year prior to the study injury. Median opiate prescriptions among those with a prior history was 2, and the mean was 7 § 10 (range 1 to 49). Complete demographic information is presented in Table 1. Orthopedic and nonorthopedic prescriptions for every patient were plotted for MME use and are shown in Figure 1. In total, patients were prescribed 291,429 (19,429 pills of OC10mg) MMEs A statistically significant difference was observed between orthopedic and nonorthopedic prescriptions. Orthopedic providers prescribed a median of 2010 (mean 2487 § 1628, range 113 to 6,825) MMEs, whereas nonorthopedic providers prescribed a median of 338 (mean 1566 § 2338, range 0 to 10,080) MMEs (p < .05) (Table 2). Opiate-naive patients (defined as not being exposed to opiates the year prior to the study injury) were prescribed a median of 1845 (mean 2432 § 1669,
Table 1 Patient Demographics (N = 72)
Age Mean § standard deviation Range Gender Male Female Type of insurance Private State provided Military No insurance History of opiate consumption Yes No Number of prescriptions before injury Median Mean § standard deviation Range Opioids for more than 6 months No Yes Prior exposure
44 § 15 (18 to 91) 39 (54%) 33 (46%) 61 (85%) 9 (13%) 0 (0%) 2 (3%) 33 (46%) 39 (54%) 2 7 § 10 (1 to 49) 44 (61%) 28 (39%) 21/28 (75%)
range 375 to 6825) MMEs by orthopedic prescribers and a median of 0 (mean 864 § 1702, range 0 to 7935) MMEs by nonorthopedic prescribers (p < .05). Conversely, patients with exposure 1 year before the study injury were prescribed a median of 2035 (mean 2553 § 1600, range 113 to 6410) MMEs by orthopedic prescribers and a median of 2100 (mean 2395 § 2716, range 0 to 10,080) MMEs by nonorthopedic prescribers (p = .25). A significant difference was also found between prescriptions made by orthopedic and nonorthopedics to patients with a history of consumption 1 year before the injury and to opiate-naive patients (p < .05) (Table 3). Twenty-eight (39%) patients continued using opiates for more than 6 months after their injury; of those, 7 (25%) were opiate naive. Outliers (n = 6) were excluded from the study; they were prescribed 25% (i.e., 72,324 MMEs or 4822 pills of OC10mg) of what was prescribed for the rest of the study population (Fig. 2). Final recommendations were based on current orthopedic prescriptions (i.e., 40 pills of oxycodone 10 mg). This recommendation can be adapted to prescribe pills of oxycodone 5 mg. Discussion We found a significant difference in the consumption of opiates between opiate-naive and opiate-exposed patients. Opiate-exposed patients are expected to require more pain medications and have a higher likelihood of consuming opiates for more than 6 months after injury. We thought that dividing our study population into these subgroups was necessary because pre-injury opioid use has been shown to be higher in the orthopedic trauma population. (8) A recent study by Ruder et al (9) retrospectively examined 110 patients who had 135 prescriptions written during their review period. All patients received opioids at the time of discharge, with the average mean MMEs being 114 mg/day for an average of 7.21 days. In this study, patients with preinjury risk factors were prescribed opioids for similar duration compared to those without any risk factors, but they were prescribed significantly more MMEs (130 MMEs versus 108; p < .05) than patients without risk factors. A query by Holman et al (10) found that 15.5% of orthopedic trauma patients filled prescriptions within 3 months prior to injury, compared to 9.2% in the general population. Within 3 months pre-injury, 12.2% of orthopedic trauma patients filled more than 1 prescription, compared
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Fig. 1. Total morphine milligram equivalents prescribed for patients with isolated pilon fractures (N = 72). Morphine milligram equivalents (MMEs) prescribed by orthopedic and nonorthopedic providers. Each bar represents 1 unique patient.
Table 2 Opioid prescribing practices by orthopedic and nonorthopedic team members (N = 72) Orthopedic Prescribers
Median Mean § standard deviation Range
Nonorthopedic Prescribers
Total
MMEs
Pills*
MMEs
Pills*
MMEs
Pills*
p Value
2010 2487 § 1 628 (113 to 6825)
134 166 § 109 (8 to 455)
338 1566 § 2338 (0 to 10,080)
23 23 § 156 (0 to 672)
2738 4053 § 3 118 (375 to 12,360)
183 270 § 208 (25 to 824)
p < .05
Abbreviation: MMEs, morphine milligram equivalents. * Number of pills of oxycodone 10 mg.
to 6.4% in the general population. They also found that patients who filled more than 1 opiate prescription within 3 months pre-injury were 6 times more likely to use opiates for more than 12 weeks and 3.5 times more likely to obtain opiates from another prescriber . A recent study by Rosenbloom et al (11) of 122 patients found that pain severity and self-efficacy were significant factors in using opioids longer than 4 months after musculoskeletal injury. There is a clear concern currently that opioids are being overprescribed, leading to potential abuse. A study recently evaluated overprescribing of opiates upon hospital discharge of 18,343 patients who
underwent 21,452 procedures. In this study, 6548 patients (35.7%) used no opioids in the 24 hours prior to hospital discharge, but of these same patients, 2988 (45.6%) were prescribed opioids at hospital discharge. Services with the highest rate of overprescribing were obstetrics and gynecology, orthopedics, and plastic surgery. Of all surgical subspecialties, pediatric surgery was the only service with no potential cases of over-prescription (12). By determining the current prescribing practices after isolated pilon fractures, orthopedic surgeons can begin to standardize pain prescribing practices after injury. The hope is that after standardizing the
Table 3 Opiates prescribed to patients with a prior history of consumption versus patients who were opiate naive (N = 72)
Prior history (n = 33)
Naive (n = 39)
Median Mean § standard deviation Range Median Mean § standard deviation Range
Abbreviation: MMEs, morphine milligram equivalents. * Number of pills of oxycodone 10 mg.
Orthopedic Prescribers
Nonorthopedic Prescribers
Total
MMEs
Pills*
MMEs
Pills*
MMEs
Pills*
p Value
2035 2553 § 1600 (113 to 6410) 1845 2432 § 1,669 (375 to 6825) p < .05
136 170 § 107 (8 to 427) 123 162 § 111 (25 to 455)
2100 2395 § 2716 (0 to 10,080) 0 864 § 1702 (0 to 7395) p < .05
140 160 § 181 (0 to 672) 0 58 § 113 (0 to 529)
3600 4947 § 3431 (840 to 12,360) 2,520 3296 § 2640 (375 to 10,610) p < .05
240 330 § 229 (56 to 824) 168 220 § 176 (25 to 707)
.25
< .05
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Fig. 2. Total morphine milligram equivalents prescribed before outliers were excluded (N = 78). Morphine milligram equivalent (MMEs) prescriptions before removal of the outliers. Six patients were prescribed 25% of what was prescribed for the rest of the study population. Each bar represents 1 unique patient.
prescribing practices, the number of pain pills prescribed can be reduced while still providing adequate pain relief. Hill et al (13) looked at 5 general surgery procedures (partial mastectomy [PM], PM with sentinel lymph node biopsy [SLNB], laparoscopic cholecystectomy [LC], laparoscopic inguinal hernia [LIH] repair, and open inguinal hernia [IH] repair) and found that opioids were being overprescribed. In this study, guidelines were implemented to decrease the number of opiates prescribed by 50% and satisfy 80% of patient requirements. In that study, the mean number of opioid pills prescribed for each operation markedly decreased: PM 19.8 versus 5.1; PM SLNB 23.7 versus 9.6; LC 35.2 versus 19.4; LIH 33.8 versus 19.3, and IH 33.2 versus 18.3; all p < .0003. Overall, the number of pills prescribed decreased by 53% when compared with the number that would have been prescribed before educational intervention. Stanek et al (14) found that after surgeons were given a pink card with historical prescribing patterns for select procedures, the average postoperative prescription size decreased for all types of cases by 15% to 48%. Several studies have demonstrated that current prescribing practices may be a contributor to the opioid overuse epidemic. A study of patients who had dermatologic surgery found that 86% of patients had leftover pills, and 53% of these patients planned on keeping the unused pills (15). A urologic surgery study found that 67% of patients had leftover narcotics, and 91% intended on keeping them. A recent prospective evaluation of opioid use after upper-extremity surgery found that 28% of patients did not take any of the prescribed medication, 56.1% discontinued use voluntarily before finishing the medication, and only 0.6% of patients were still taking medication at the time of the first postoperative visit (16). Another study on outpatient upper-extremity surgery found that, in 250 patients, a total of 4639 tablets were left unused, leading to a potential source of diversion. This study found that lowering the number of narcotics prescribed initially to 15 pills with 1 refill led to a 79% reduction in leftover medication (8). Limiting the number of narcotics prescribed, even in the acute setting, can make an impact on the opioid epidemic, since it has been shown that 71% of young adults who abused opiates stated that they were obtained by stealing or were given to them by a friend or relative. Of these diverted opiates, 90% came from legitimate physician prescriptions (5). Brat et al (17) studied over 1,000,000 patients and showed that eventual misuse of opioids was best predicted by the number of post-discharge prescriptions and duration. In patients with 1 refill, the rate of misuse increased by 44% compared to patients with no refills. With each week of additional use, the rate of misuse increased 32%. Opiate prescribing even in low-risk surgery contributes to the problem. In
one study, opiate-naive patients who received an opioid prescription within 7 days after short-stay surgery were 44% more likely to become long-term opioid users within 1 year compared to patients who did not receive opiates (18). The importance of prescribing as little narcotic as possible, while providing adequate pain care, cannot be overemphasized. In a study of Veterans Administration patients, Bohnert et al (19) found that a higher dose of opiates correlated with increased risk of overdose. Additionally, the morphine-equivalent dose (MED)/Day of long-acting opioids decreased by 27%; the proportion of patients on doses 120 mg/day of MED and the number of opioid-related deaths decreased by 50% (20). We reported on the amount of medication prescribed. We did not know the amount of medication consumed or left over and the fate of that medication. The potential is most likely similar to other orthopedic injuries previously reported. Physicians can use these data to adjust prescribing habits. There have been attempts reported in the literature to create a weaning protocol for opiates. Morris et al described an opiate protocol that starts the weaning process from the initial prescription. Oxycodone is initially prescribed at 10 mg, then every 2 weeks is weaned down to tramadol as needed by week 6. Although this protocol is effective and has reduced opiate prescriptions, this is a general protocol and is not specific to injuries (6). We think that the prescribing practice of opioids, like other medications in medicine, needs to be standardized. Other studies reported in the nonorthopedic literature have shown that there is substantial variability in prescribing practices for the same diagnosis. Webster et al (21) found that of 8262 claimants, 21.3% received at least 1 early opioid prescription refill. Significant between-state variation was also found, from 5.7% (Massachusetts) to 52.9% (South Carolina). Although some variability is expected, standardizing prescribing practices may help decrease such extremes, as 51.4 million inpatient procedures and 53.3 million outpatient procedures are performed annually, with approximately 98.6% of these patients receiving opioids (22,23). By identifying current prescribing practices after operatively treated isolated pilon fractures, surgeons can identify “at-risk” patients who are being prescribed more than 1 to 2 standard deviations from the norm. This is the first step in standardizing opiate prescribing practices for pilon fractures. As a final recommendation, we think that adequate pain control can be obtained by prescribing 40 pills of oxycodone 10 mg with a maximum of 1 refill (or its equivalent in pills of oxycodone 5 mg). In cases in
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which a staged procedure is planned, 1 additional refill might be necessary (for a total of 3 prescriptions). This study had several limitations. Its retrospective nature was an inherent limitation. Also, inpatient prescribing practices were not recorded, and patients with conditions requiring chronic opiate use were not excluded. We did not specify the admitting service (i.e., general surgery trauma service or orthopedic trauma service), which could alter prescribing practices. CSMD data did not allow us to reliably determine if more opiates were used due to postoperative complications, additional surgeries, patient factors affecting opioid use, nonopioid medications prescribed, new injuries, or the number of refills. We think that the percentage of complications in these types of fractures does not alter our data. An uncontrollable limitation of this study was that some patients may have been supplementing opioids through diverted pills that were not considered with our data, or they did not consume a prescription that was provided. Even though CMSD information is available since 2010, state laws limit data access before January 2013, which affected our sample size. To our knowledge, this is the first study to rely on CSMD data to describe prescribing practices of isolated pilon fractures. In conclusion, there is wide variability in what is being prescribed after isolated pilon fractures, and 39% of all prescriptions are coming from outside prescribers. Additionally, a large subset of our population had a history of opiate exposure within 1 year of the pilon fracture. Patients with a history of narcotic use prior to their injury obtained far more narcotics from outside physicians and for a longer duration than opiate-naive patients. Patients with pilon fractures should be expected to require more opiates due to the inherent characteristics of the injury. These data can help orthopedic surgeons set expectations and educate their team members and, most importantly, their patients, especially when they are falling out of the norm. References 1. CDC. Division of Vital Statistics, Mortality Data. Available at: https://www.cdc.gov/ nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_20002014.pdf. Accessed December 20, 2017. 2. CDC. Drug Overdose Deaths in the United States, 1999-2016. NCHS Data Brief No. 294. Available at: https://www.cdc.gov/nchs/products/databriefs/db294.htm. Accessed December 20, 2017. 3. Paulozzi LJ, Weisler RH, Patkar AA. A national epidemic of unintentional prescription opioid overdose deaths: how physicians can help control it. J Clin Psychiatry 2011;72:589. 4. Kuehn BM. SAMHSA: pain medication abuse a common path to heroin: experts say this pattern likely driving heroin resurgence. JAMA 2013;310:1433–1434.
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