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What Happens to Unused Opioids After Total Joint Arthroplasty? An Evaluation of Unused Postoperative Opioid Disposal Practices
The Journal of Arthroplasty xxx (2019) 1e5
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What Happens to Unused Opioids After Total Joint Arthroplasty? An Evaluation of Unused Postoperative Opioid Disposal Practices Samuel T. Kunkel, MD, MS *, Matthew J. Sabatino, MD, MS, Daniel A. Pierce, MD, MS, Yale A. Fillingham, MD, David S. Jevsevar, MD, MBA, Wayne E. Moschetti, MD, MS Dartmouth-Hitchcock Medical Center, Department of Orthopaedic Surgery, One Medical Center Drive, Lebanon, NH
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Article history: Received 3 September 2019 Received in revised form 22 October 2019 Accepted 7 November 2019 Available online xxx
Background: This study evaluates the fate of unused opioids after total hip arthroplasty (THA) and total knee arthroplasty (TKA) at our facility. Methods: Medication disposal after primary elective THA and TKA was classified as appropriate (in accordance with United States Food and Drug Administration guidelines) or inappropriate for all patients undergoing these procedures during the second half of the fiscal year 2015. Results: In total, 199 THAs and 144 TKAs met inclusion criteria. Total pills prescribed were 55,635. Approximately 8925 (16%) of pills were unused. About 39.9% of patients disposed of unused opioids appropriately, while 60.1% of patients reported still having (18.5%), not knowing where they were (8.2%), or other (33.4%). There was no significant association with the type of opioid prescribed. Conclusion: A large volume of unused opioids were improperly disposed of after total joint arthroplasty. © 2019 Elsevier Inc. All rights reserved.
Keywords: total hip arthroplasty total knee arthroplasty opioids opioid disposal unused opioids
Elective primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) are 2 of the most common orthopedic procedures performed in the United States, with approximately 300,000 and 700,000 performed each year [1,2]. Expected growth in annual demand is likely to exceed 570,000 for THA and 3.48 million for TKA by 2030 [1,2]. Adequacy of pain management after these procedures can affect recovery of functional mobility, utilization of health resources, and patient satisfaction [3e5]. Because opioids are widely viewed as efficacious when compared with nonopioid modalities, they remain a cornerstone of postoperative pain management protocols [5e7]. However, their use carries substantial risks such as accidental overdose, illicit diversion, and addiction [8e10]. Currently, the United States represents <5% of the world’s population, yet consumes approximately 80% of the global opioid supply [11]. An increase in opioid prescriptions began in the 1990s and early 2000s, driven in part by administrative efforts of
One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to https://doi.org/10.1016/j.arth.2019.11.013. * Reprint requests: Samuel T. Kunkel, MD, MS, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH, 03756. https://doi.org/10.1016/j.arth.2019.11.013 0883-5403/© 2019 Elsevier Inc. All rights reserved.
organizations, like the Joint Commission on Accreditation of Healthcare Organizations, to redefine the way pain management was conceptualized by patients and providers [12e14]. The increased utilization of opioids has led to substantial consequences for individual patients and for society [11,13]. A staggering increase in nontherapeutic opioid use has been accompanied by a surge in addiction and unintentional overdose deaths [13]. Each day in the United States, 46 people die from prescription opioid overdose, and prescription opioids now contribute to more deaths per year than suicide or motor vehicle accidents [15]. In addition to the appalling human toll, this has imposed a substantial economic burden with an estimated cost of >$50 billion annually, mostly attributable to criminal justice costs and lost productivity [13,16]. Currently, orthopedic surgeons are the third highest prescribers of opioids among physicians, responsible for an estimated 7.7% of opioid prescriptions in the United States in 2009 [11]. Because of their associated risks it is imperative that surgeons understand patient opioid utilization practices after total joint arthroplasty, and take proactive steps to limit patient opioid requirements and opioid over-prescription after surgery [17]. Another important consideration is what patients do with excess unused opioids. Unfortunately, improperly disposed of unused opioid medications are a major source for illicit diversion [10,18]. This study evaluates the fate of unused opioids after THA and TKA at our facility.
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Table 1 US Food and Drug Administration Recommended Excess Opioid Disposal Techniques [23]. Disposal Method
Comments
US Drug Enforcement Agency Sponsored Drug Take Back Programs
DEA Prescription Drug Take Back Days DEA authorized collectors. These can be found by asking local law enforcement officials or via the DEA website: https://apps2.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution¼e1s1
Home disposal Flush down toilet Dispose in household trash
The FDA has studied the environmental effect of flushing commonly prescribed opioid pain medications and found this to be negligible [31] When disposing of drugs in household trash, the FDA recommends these steps: (1) Remove drugs from original container (2) Place medication in undesirable mixture such as used coffee grounds, dirt, cat litter, and so on (3) Place mixture in a bag (4) Scratch out personal information from medication container label and place medication container in garbage
DEA, US Drug Enforcement Agency; FDA, US Food and Drug Administration.
Materials and Methods This investigation was performed as part of an ongoing initiative to evaluate opioid prescription practices and utilization at our institution [19]. Internal Review Board approval was obtained prior to the performance of this study. All elective primary THAs and TKAs performed at our institution during the second half of the fiscal year 2015 were identified based on billing information. Included in the study were all English speaking patients 18 years old who underwent THA or TKA during the specified time period. Excluded were patients who underwent surgery in the setting of acute trauma, patients undergoing revision procedures, and patients who experienced postoperative complications necessitating revision surgery within the first postoperative year. For all patients included in the study, we evaluated electronic medical record data pertaining to preoperative opioid use (defined for the purposes of this study as having used opioids in the 30 days prior to surgery) and postoperative opioid prescriptions. Included patients were also contacted by telephone for participation in a survey to obtain information on opioid utilization, excess opioids, and pain control satisfaction. The telephone questionnaire was administered between December 2016 and March
2017. The questionnaire asked patients to report the number of pills utilized after surgery, the requirement of a refill prescription, and perception of adequacy of pain management (on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied”). Similar to the previously published method of Hill et al [20], number of pills utilized was determined by percentage of pills the patient reported remaining after they had stopped taking medications, subtracted from 100%. For patients who took no opioids a value of 0% taken was assigned, for those who took less than half of their prescriptions 25% taken was assigned, for those who took more than half of their prescription a value of 75% taken was assigned, and for those who took all of their prescription a value of 100% was assigned. The percentage of pills taken was then multiplied by the number of pills prescribed to determine how many total pills were taken. If refills were required, the percentage reported was multiplied by the amount of the last refill prescription required, and added to 100% of the number of pills in the original prescription and any prior refill prescriptions. All opioids were converted to oxycodone equivalents (1 pill ¼ 5 mg oxycodone) using an opioid analgesic equivalence chart [21,22]. With regard to opioid disposal patients were asked, “if you had any remaining opioid/narcotic pain medication, what did you do
Table 2 Description of Initial Study Sample Including Total Hip Arthroplasty and Total Knee Arthroplasty Patients. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Preoperative opioid use within the 30 d prior to surgery Operative time (min), mean (SD) Pain control satisfactionb 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Total Hip Arthroplasty (n ¼ 199) 66.5 (10.2) 102 (51.3%)
Total Knee Arthroplasty (n ¼ 144) 66.9 (10.0) 93 (64.6%)
194 1 1 2 1 43 143.8
(97.9%) (0.2%) (0.2%) (0.5%) (0.5%) (21.6%) (28.8)
144 0 0 0 2 22 137.1
(100%) (0) (0) (0) (1.4%) (15.3%) (24.2)
165 15 3 5 11
(82.9%) (7.5%) (1.5%) (2.5%) (5.5%)
104 19 13 4 4
(72.2%) (13.2%) (9.0%) (2.8%) (2.8%)
124 52 6 13 2 2
(62.3%) (26.1%) (3.0%) (6.5%) (1.0%) (1.0%)
72 58 3 9 2 0
(50%) (40.3%) (2.0%) (6.3%) (1.4%) (0%)
P Value .757 .014a .400
.383 .140 .023a .004a
.099
SD, standard deviation. a Statistically significant. b Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
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Table 3 Comparison of THA Patients Who Appropriately Disposed of Unused Opioid Medications and Patients Who Did Not Appropriately Dispose of Unused Opioid Medications. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Operative time (min), mean (SD) Pain control satisfactiona 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Appropriately Disposed of Unused Opioids (n ¼ 76) 67.6 (9.7) 45 (59.2%)
Did Not Appropriately Dispose of Unused Opioids (n ¼ 123) 65.9 (10.4) 57 (46.3%)
74 0 1 0 0 146.8
(98.7%) (0) (1.3%) (0) (0) (30.1)
120 1 0 2 1 141.9
(97.6%) (0.8%) (0) (1.6%) (0.8%) (27.9)
65 5 3 1 2
(85.5%) (6.6%) (3.9%) (1.3%) (2.6%)
100 10 0 4 9
(81.3%) (8.1%) (0) (3.3%) (7.3%)
44 25 1 5 1 0
(57.9%) (32.9%) (1.3%) (6.6%) (1.3%) (0)
80 27 5 8 1 2
(65.0%) (21.9%) (4.1) (6.5) (0.8) (1.6)
P Value .236 .078 .324
.434 .249 .104
.407
SD, standard deviation; THA, total hip arthroplasty. a Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
with the remaining medication?” Responses to this question were then coded by surveyors and disposal of medications was classified as either appropriate (in accordance with United States Food and Drug Administration [FDA] guidelines) (Table 1) or inappropriate (patient still had the pills, patient was unsure what happened to the pills, other) [23]. At our institution, opioids are usually prescribed upon discharge as part of a multimodal pain management strategy after total joint arthroplasty, which includes acetaminophen, gabapentin, and nonsteroidal anti-inflammatory drugs. During the study period we did not routinely provide written instruction pertaining to appropriate disposal of excess postoperative opioids. Chi-squared test was used to compare results among THA and TKA patients, and whether disposal varied with type of opioid
prescribed. Statistical significance was set at P < .05. Statistical analysis was performed using Stata Version 14 (StataCorp, College Station, TX: StatCorp LP, 2016). Results A total of 415 patients met inclusion criteria (240 THAs and 175 TKAs). Among these patients, 82.9% (199/240) of THA and 82.3% (144/175) of TKA were able to be contacted and agreed to participate. Among our sample, THA and TKA patients were similar with regard to age, race, ethnicity, preoperative opioid use, and type of opioid prescribed after surgery (Table 2). There was a higher percentage of females in the TKA group (64.6%) compared to the THA
Table 4 Comparison of TKA Patients Who Appropriately Disposed of Unused Opioid Medications and Patients Who Did Not Appropriately Dispose of Unused Opioid Medications. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Operative time (min), mean (SD) Pain control satisfactiona 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Appropriately Disposed of Unused Opioids (n ¼ 60) 67.9 (9.3) 38 (63.3%)
Did Not Appropriately Dispose of Unused Opioids (n ¼ 84) 66.1 (10.0) 55 (65.5%)
60 0 0 0 2 137.6
(100%) (0) (0) (0) (3.3) (22.1)
84 0 0 0 0 136.7
(100%) (0) (0) (0) (0) (25.7)
47 8 3 1 1
(78.3%) (13.3%) (5.0%) (1.7%) (1.7%)
57 11 10 3 3
(67.9%) (13.1%) (11.9%) (3.6%) (3.6%)
29 25 0 6 0 0
(48.3%) (41.7%) (0) (10.0%) (0) (0)
43 33 3 3 2 0
(51.2%) (32.3%) (3.6) (3.6) (2.4) (0)
P Value .274 .791 NA
.094 .828 .510
.200
NA, not applicable; SD, standard deviation; TKA, total knee arthroplasty. a Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
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group (51.3%) (P ¼ .014), and operative time was on average approximately 7 minutes longer among THA patients (P ¼ .023). There was also significant variation in pain control satisfaction between THA and TKA groups, with a higher percentage of THA patients reporting that they were “very satisfied” with their pain control (P ¼ .004). Within both THA (Table 3) and TKA (Table 4) groups, patients who did and patients who did not properly dispose of opioid medications were similar in terms of age, race, ethnicity, preoperative opioid use, postoperative pain control satisfaction, and type of opioid prescribed after surgery. Total pills prescribed were 55,635. Approximately 8925 (16%) of pills were unused. Mean unused pills per patient were 29 (95% confidence interval [CI] 26-33). Among our sample, 39.9% of patients disposed of unused opioids correctly, while 60.1% of patients reported still having (18.5%), not knowing where they were (8.2%), or other (33.4%). Separating these by procedure, the total number of pills prescribed after THA was 26,615, and the total pills prescribed after TKA was 29,020. Mean number of pills prescribed after THA was 134 (95% CI 116-152), and after TKA was 201 (95% CI 175-228). The number of unused opioids after THA was 5,418, and after TKA was 3507. This amounted to approximately 20% of total pills being unused after THA, and approximately 12% after TKA. Mean unused pills per patient were 31 (95% CI 26-35) for THA and 27 (95% CI 2233) for TKA. Survey results demonstrated that for THAs 38.4% of patients disposed of their opioids correctly, while 61.6% of patients reported still having (19.2%), not knowing where they were (9.6%), or other (33.8%). Similarly, for TKAs 41.9% of patients disposed of opioids correctly, while 58.0% of patients reported still having (17.5%), not knowing where they were (6.3%), or other (34.2%). Chisquared test demonstrated no significant differences in excess pill disposal practices between THA and TKA patients. Similarly, there was no significant association between excess pill disposal practices and type of opioid prescribed. With regard to the actual numbers of pills, approximately 37% (3314/8925) of unused pills were not appropriately disposed of. This corresponds to approximately 6% (3314/55,635) of total pills prescribed being unused and improperly disposed of. To generate an accurate annual estimate this number was multiplied by 2 to account for the other half of the fiscal year, and divided by 0.826 to account for patients who were unable to be contacted or refused to complete the survey. This produced an estimate of 8024 unused pills (95% CI 6346-9705) that were improperly disposed of over a 1year period, for approximately 830 primary total joint replacements. Discussion The findings of this study provide important information regarding opioid prescription and utilization after THA and TKA. We found that a large volume of unused opioids were improperly disposed of after total joint arthroplasty, and were potentially available for illicit diversion. Our results highlight the importance of limiting postoperative prescriptions, and educating patients on proper disposal of unused opioid medications, in accordance with recommended FDA guidelines. These guidelines are readily available on the FDA website and can be incorporated into medication discharge information provided to patients [23]. From a societal prospective, these considerations are of paramount importance. A large volume of excess, improperly disposed of pills in a small community such as the one served by our hospital could have a substantial negative impact. A 2015 survey of US adults demonstrated that approximately 60% of individuals who reported opioid misuse during the preceding year obtained opioids from a source other than a physician’s prescription, and nearly 41% obtained prescription opioids from friends or relatives [18].
Projected Unused Opioid Disposal Over One Year
Total Pills Used
Properly Disposed of Unused Pills
Improperly Disposed of Unused Pills
Fig. 1. Graph of projected unused opioid disposal practices over 1 year. Graph demonstrating projected annual unused opioid disposal practices. Total pills prescribed divided into total pills used and unused pills, and the percentage of unused opioid pills divided into properly disposed of unused pills (ie, in accordance with FDA recommendations) and improperly disposed of unused pills.
Moreover, unused medications are the major source for illicit opioid diversion among youths [10,24]. If the findings at our institution are broadly generalizable to across the United States, then for the approximately 1,000,000 THAs and TKAs currently performed annually, there would be over 9 million improperly disposed unused opioid pills. This is the first study to our knowledge to quantify the amount of excess opioid pills that are improperly disposed of after total joint arthroplasty. We found only one other study evaluating opioid disposal practices in this setting [25]. In that study of 112 TKA patients, only 25.7% disposed of opioids properly. That study did not evaluate THA patients, and in their study the amount of patients who correctly disposed of unused medications was lower than the 41.9% of TKA and 38.4% of THA patients who correctly disposed of excess opioids in our study. The reason for this difference is unclear, but may be related to patient-specific factors such as education level, postoperative instructions, or local availability of opioid disposal centers. However, we reviewed multiple demographic factors including age, gender, race, ethnicity, length of surgery, and type of opioid used, and did not find any association of these demographic factors with opioid disposal patterns. Another consideration is that, among our patients, while the majority of patients with excess opioids did not dispose of them correctly, only 37% of actual excess opioid pills were incorrectly disposed of (Fig. 1). This difference may be explained by some patients with larger amounts of excess opioid medications engaging in appropriate disposal practices. Another possible explanation is that some patients maintained a small percentage of their excess pills with the intention of having some medication “on-hand” if they needed it in the future. This practice has been described by Buffington et al [26], in their evaluation of factors that contribute to different unused opioid disposal practices among chronic pain patients. That study also demonstrated that a significantly greater proportion of patients who receive education about proper disposal of unused opioids will dispose of them correctly [26]. There are several limitations to the current study. The retrospective nature of our study design precluded controlling for patient factors that might affect opioid utilization and disposal practices. However, attempt was made to contact all patients who
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underwent these procedures during the study period, and our participation rate was high at approximately 82% for both THA and TKA. Moreover, among our sample, none of the demographic factors evaluated appeared to influence postoperative disposal practices. We believe that our included sample of patients is therefore broadly representative of our patient population. Another limitation is that the method by which total pills utilized by patients was ascertained in this study relies on patient recall and self-reporting, both of which may be subject to inherent bias. However, this method has been utilized successfully in prior studies, and we believe that the data we collected are likely a close approximation of the true number of pills utilized [19,20]. Furthermore, our categorization of opioid disposal practices as appropriate or inappropriate included a large percentage of “other.” Because all FDA approved disposal methods were captured by our coding of responses, as well as if the patient still had the pills or if the patient was unsure where the pills were, this “other” category comprised inappropriate disposal scenarios where pills could still be accessible. This likely includes simply throwing the pills away in household trash without attempting to disguise or make them less appealing, or transferring the pills to other individuals. Although more granular information could be helpful with regard to focusing efforts on limiting postoperative opioid diversion, the focus of our study was to evaluate appropriate vs inappropriate disposal. Also, our approximation of annual excess and improperly disposed of pill numbers is predicated on an assumption that the other half of the fiscal year evaluated was similar, and that disposal practices of the approximately 18% of patients who were unable to be reached or refused to participate in the survey were similar to those who participated. This may be biased by such factors as seasonal variation in arthroplasty volumes. A further limitation is that the population we serve in northern New England is largely homogenous in terms of race and ethnicity, which limits our ability to assess the influence of these factors on opioid utilization. Despite the stated limitations, we believe the findings from this study are an important contribution to the growing body of evidence related to the risks of opioids after total joint arthroplasty [27e30]. The majority of patients with excess opioids after hip and knee arthroplasty do not dispose of them appropriately. This results in a large volume of opioids potentially available for illicit diversion in the community. Excess opioid disposal is a potential area of risk modification that surgeons should attempt to manage through patient education and utilization of FDA approved unused medication guidelines. References [1] Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007;89:780e5. https://doi.org/10.2106/JBJS.F.00222. [2] Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am 2014;96:624e30. https://doi.org/10.2106/jbjs.m.00285. [3] Cheville A, Chen A, Oster G, McGarry L, Narcessian E. A randomized trial of controlled-release oxycodone during inpatient rehabilitation following unilateral total knee arthroplasty. J Bone Joint Surg Am 2001;83:572e6. [4] Illgen RL, Pellino TA, Gordon DB, Butts S, Heiner JP. Prospective analysis of a novel long-acting oral opioid analgesic regimen for pain control after total hip and knee arthroplasty. J Arthroplasty 2006;21:814e20. https://doi.org/ 10.1016/j.arth.2005.10.011. [5] Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg 2002;10:117e29. [6] de Beer Jde V, Winemaker MJ, Donnelly GA, Miceli PC, Reiz JL, Harsanyi Z, et al. Efficacy and safety of controlled-release oxycodone and standard therapies for postoperative pain after knee or hip replacement. Can J Surg 2005;48:277e83.
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What Happens to Unused Opioids After Total Joint Arthroplasty? An Evaluation of Unused Postoperative Opioid Disposal Practices Samuel T. Kunkel, MD, MS *, Matthew J. Sabatino, MD, MS, Daniel A. Pierce, MD, MS, Yale A. Fillingham, MD, David S. Jevsevar, MD, MBA, Wayne E. Moschetti, MD, MS Dartmouth-Hitchcock Medical Center, Department of Orthopaedic Surgery, One Medical Center Drive, Lebanon, NH
a r t i c l e i n f o
a b s t r a c t
Article history: Received 3 September 2019 Received in revised form 22 October 2019 Accepted 7 November 2019 Available online xxx
Background: This study evaluates the fate of unused opioids after total hip arthroplasty (THA) and total knee arthroplasty (TKA) at our facility. Methods: Medication disposal after primary elective THA and TKA was classified as appropriate (in accordance with United States Food and Drug Administration guidelines) or inappropriate for all patients undergoing these procedures during the second half of the fiscal year 2015. Results: In total, 199 THAs and 144 TKAs met inclusion criteria. Total pills prescribed were 55,635. Approximately 8925 (16%) of pills were unused. About 39.9% of patients disposed of unused opioids appropriately, while 60.1% of patients reported still having (18.5%), not knowing where they were (8.2%), or other (33.4%). There was no significant association with the type of opioid prescribed. Conclusion: A large volume of unused opioids were improperly disposed of after total joint arthroplasty. © 2019 Elsevier Inc. All rights reserved.
Keywords: total hip arthroplasty total knee arthroplasty opioids opioid disposal unused opioids
Elective primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) are 2 of the most common orthopedic procedures performed in the United States, with approximately 300,000 and 700,000 performed each year [1,2]. Expected growth in annual demand is likely to exceed 570,000 for THA and 3.48 million for TKA by 2030 [1,2]. Adequacy of pain management after these procedures can affect recovery of functional mobility, utilization of health resources, and patient satisfaction [3e5]. Because opioids are widely viewed as efficacious when compared with nonopioid modalities, they remain a cornerstone of postoperative pain management protocols [5e7]. However, their use carries substantial risks such as accidental overdose, illicit diversion, and addiction [8e10]. Currently, the United States represents <5% of the world’s population, yet consumes approximately 80% of the global opioid supply [11]. An increase in opioid prescriptions began in the 1990s and early 2000s, driven in part by administrative efforts of
One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to https://doi.org/10.1016/j.arth.2019.11.013. * Reprint requests: Samuel T. Kunkel, MD, MS, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH, 03756. https://doi.org/10.1016/j.arth.2019.11.013 0883-5403/© 2019 Elsevier Inc. All rights reserved.
organizations, like the Joint Commission on Accreditation of Healthcare Organizations, to redefine the way pain management was conceptualized by patients and providers [12e14]. The increased utilization of opioids has led to substantial consequences for individual patients and for society [11,13]. A staggering increase in nontherapeutic opioid use has been accompanied by a surge in addiction and unintentional overdose deaths [13]. Each day in the United States, 46 people die from prescription opioid overdose, and prescription opioids now contribute to more deaths per year than suicide or motor vehicle accidents [15]. In addition to the appalling human toll, this has imposed a substantial economic burden with an estimated cost of >$50 billion annually, mostly attributable to criminal justice costs and lost productivity [13,16]. Currently, orthopedic surgeons are the third highest prescribers of opioids among physicians, responsible for an estimated 7.7% of opioid prescriptions in the United States in 2009 [11]. Because of their associated risks it is imperative that surgeons understand patient opioid utilization practices after total joint arthroplasty, and take proactive steps to limit patient opioid requirements and opioid over-prescription after surgery [17]. Another important consideration is what patients do with excess unused opioids. Unfortunately, improperly disposed of unused opioid medications are a major source for illicit diversion [10,18]. This study evaluates the fate of unused opioids after THA and TKA at our facility.
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Table 1 US Food and Drug Administration Recommended Excess Opioid Disposal Techniques [23]. Disposal Method
Comments
US Drug Enforcement Agency Sponsored Drug Take Back Programs
DEA Prescription Drug Take Back Days DEA authorized collectors. These can be found by asking local law enforcement officials or via the DEA website: https://apps2.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution¼e1s1
Home disposal Flush down toilet Dispose in household trash
The FDA has studied the environmental effect of flushing commonly prescribed opioid pain medications and found this to be negligible [31] When disposing of drugs in household trash, the FDA recommends these steps: (1) Remove drugs from original container (2) Place medication in undesirable mixture such as used coffee grounds, dirt, cat litter, and so on (3) Place mixture in a bag (4) Scratch out personal information from medication container label and place medication container in garbage
DEA, US Drug Enforcement Agency; FDA, US Food and Drug Administration.
Materials and Methods This investigation was performed as part of an ongoing initiative to evaluate opioid prescription practices and utilization at our institution [19]. Internal Review Board approval was obtained prior to the performance of this study. All elective primary THAs and TKAs performed at our institution during the second half of the fiscal year 2015 were identified based on billing information. Included in the study were all English speaking patients 18 years old who underwent THA or TKA during the specified time period. Excluded were patients who underwent surgery in the setting of acute trauma, patients undergoing revision procedures, and patients who experienced postoperative complications necessitating revision surgery within the first postoperative year. For all patients included in the study, we evaluated electronic medical record data pertaining to preoperative opioid use (defined for the purposes of this study as having used opioids in the 30 days prior to surgery) and postoperative opioid prescriptions. Included patients were also contacted by telephone for participation in a survey to obtain information on opioid utilization, excess opioids, and pain control satisfaction. The telephone questionnaire was administered between December 2016 and March
2017. The questionnaire asked patients to report the number of pills utilized after surgery, the requirement of a refill prescription, and perception of adequacy of pain management (on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied”). Similar to the previously published method of Hill et al [20], number of pills utilized was determined by percentage of pills the patient reported remaining after they had stopped taking medications, subtracted from 100%. For patients who took no opioids a value of 0% taken was assigned, for those who took less than half of their prescriptions 25% taken was assigned, for those who took more than half of their prescription a value of 75% taken was assigned, and for those who took all of their prescription a value of 100% was assigned. The percentage of pills taken was then multiplied by the number of pills prescribed to determine how many total pills were taken. If refills were required, the percentage reported was multiplied by the amount of the last refill prescription required, and added to 100% of the number of pills in the original prescription and any prior refill prescriptions. All opioids were converted to oxycodone equivalents (1 pill ¼ 5 mg oxycodone) using an opioid analgesic equivalence chart [21,22]. With regard to opioid disposal patients were asked, “if you had any remaining opioid/narcotic pain medication, what did you do
Table 2 Description of Initial Study Sample Including Total Hip Arthroplasty and Total Knee Arthroplasty Patients. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Preoperative opioid use within the 30 d prior to surgery Operative time (min), mean (SD) Pain control satisfactionb 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Total Hip Arthroplasty (n ¼ 199) 66.5 (10.2) 102 (51.3%)
Total Knee Arthroplasty (n ¼ 144) 66.9 (10.0) 93 (64.6%)
194 1 1 2 1 43 143.8
(97.9%) (0.2%) (0.2%) (0.5%) (0.5%) (21.6%) (28.8)
144 0 0 0 2 22 137.1
(100%) (0) (0) (0) (1.4%) (15.3%) (24.2)
165 15 3 5 11
(82.9%) (7.5%) (1.5%) (2.5%) (5.5%)
104 19 13 4 4
(72.2%) (13.2%) (9.0%) (2.8%) (2.8%)
124 52 6 13 2 2
(62.3%) (26.1%) (3.0%) (6.5%) (1.0%) (1.0%)
72 58 3 9 2 0
(50%) (40.3%) (2.0%) (6.3%) (1.4%) (0%)
P Value .757 .014a .400
.383 .140 .023a .004a
.099
SD, standard deviation. a Statistically significant. b Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
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Table 3 Comparison of THA Patients Who Appropriately Disposed of Unused Opioid Medications and Patients Who Did Not Appropriately Dispose of Unused Opioid Medications. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Operative time (min), mean (SD) Pain control satisfactiona 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Appropriately Disposed of Unused Opioids (n ¼ 76) 67.6 (9.7) 45 (59.2%)
Did Not Appropriately Dispose of Unused Opioids (n ¼ 123) 65.9 (10.4) 57 (46.3%)
74 0 1 0 0 146.8
(98.7%) (0) (1.3%) (0) (0) (30.1)
120 1 0 2 1 141.9
(97.6%) (0.8%) (0) (1.6%) (0.8%) (27.9)
65 5 3 1 2
(85.5%) (6.6%) (3.9%) (1.3%) (2.6%)
100 10 0 4 9
(81.3%) (8.1%) (0) (3.3%) (7.3%)
44 25 1 5 1 0
(57.9%) (32.9%) (1.3%) (6.6%) (1.3%) (0)
80 27 5 8 1 2
(65.0%) (21.9%) (4.1) (6.5) (0.8) (1.6)
P Value .236 .078 .324
.434 .249 .104
.407
SD, standard deviation; THA, total hip arthroplasty. a Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
with the remaining medication?” Responses to this question were then coded by surveyors and disposal of medications was classified as either appropriate (in accordance with United States Food and Drug Administration [FDA] guidelines) (Table 1) or inappropriate (patient still had the pills, patient was unsure what happened to the pills, other) [23]. At our institution, opioids are usually prescribed upon discharge as part of a multimodal pain management strategy after total joint arthroplasty, which includes acetaminophen, gabapentin, and nonsteroidal anti-inflammatory drugs. During the study period we did not routinely provide written instruction pertaining to appropriate disposal of excess postoperative opioids. Chi-squared test was used to compare results among THA and TKA patients, and whether disposal varied with type of opioid
prescribed. Statistical significance was set at P < .05. Statistical analysis was performed using Stata Version 14 (StataCorp, College Station, TX: StatCorp LP, 2016). Results A total of 415 patients met inclusion criteria (240 THAs and 175 TKAs). Among these patients, 82.9% (199/240) of THA and 82.3% (144/175) of TKA were able to be contacted and agreed to participate. Among our sample, THA and TKA patients were similar with regard to age, race, ethnicity, preoperative opioid use, and type of opioid prescribed after surgery (Table 2). There was a higher percentage of females in the TKA group (64.6%) compared to the THA
Table 4 Comparison of TKA Patients Who Appropriately Disposed of Unused Opioid Medications and Patients Who Did Not Appropriately Dispose of Unused Opioid Medications. Variable Age, mean (SD) Gender, percent female Race White Black Asian Native American Hispanic ethnicity Operative time (min), mean (SD) Pain control satisfactiona 5 (completely satisfied) 4 3 2 1 (not satisfied at all) Postoperative opioid analgesic prescribed Oxycodone Hydromorphone Hydrocodone Tramadol Morphine None
Appropriately Disposed of Unused Opioids (n ¼ 60) 67.9 (9.3) 38 (63.3%)
Did Not Appropriately Dispose of Unused Opioids (n ¼ 84) 66.1 (10.0) 55 (65.5%)
60 0 0 0 2 137.6
(100%) (0) (0) (0) (3.3) (22.1)
84 0 0 0 0 136.7
(100%) (0) (0) (0) (0) (25.7)
47 8 3 1 1
(78.3%) (13.3%) (5.0%) (1.7%) (1.7%)
57 11 10 3 3
(67.9%) (13.1%) (11.9%) (3.6%) (3.6%)
29 25 0 6 0 0
(48.3%) (41.7%) (0) (10.0%) (0) (0)
43 33 3 3 2 0
(51.2%) (32.3%) (3.6) (3.6) (2.4) (0)
P Value .274 .791 NA
.094 .828 .510
.200
NA, not applicable; SD, standard deviation; TKA, total knee arthroplasty. a Pain control satisfaction rated on a scale of 1-5, with 1 representing “not satisfied at all” and 5 representing “completely satisfied.”
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group (51.3%) (P ¼ .014), and operative time was on average approximately 7 minutes longer among THA patients (P ¼ .023). There was also significant variation in pain control satisfaction between THA and TKA groups, with a higher percentage of THA patients reporting that they were “very satisfied” with their pain control (P ¼ .004). Within both THA (Table 3) and TKA (Table 4) groups, patients who did and patients who did not properly dispose of opioid medications were similar in terms of age, race, ethnicity, preoperative opioid use, postoperative pain control satisfaction, and type of opioid prescribed after surgery. Total pills prescribed were 55,635. Approximately 8925 (16%) of pills were unused. Mean unused pills per patient were 29 (95% confidence interval [CI] 26-33). Among our sample, 39.9% of patients disposed of unused opioids correctly, while 60.1% of patients reported still having (18.5%), not knowing where they were (8.2%), or other (33.4%). Separating these by procedure, the total number of pills prescribed after THA was 26,615, and the total pills prescribed after TKA was 29,020. Mean number of pills prescribed after THA was 134 (95% CI 116-152), and after TKA was 201 (95% CI 175-228). The number of unused opioids after THA was 5,418, and after TKA was 3507. This amounted to approximately 20% of total pills being unused after THA, and approximately 12% after TKA. Mean unused pills per patient were 31 (95% CI 26-35) for THA and 27 (95% CI 2233) for TKA. Survey results demonstrated that for THAs 38.4% of patients disposed of their opioids correctly, while 61.6% of patients reported still having (19.2%), not knowing where they were (9.6%), or other (33.8%). Similarly, for TKAs 41.9% of patients disposed of opioids correctly, while 58.0% of patients reported still having (17.5%), not knowing where they were (6.3%), or other (34.2%). Chisquared test demonstrated no significant differences in excess pill disposal practices between THA and TKA patients. Similarly, there was no significant association between excess pill disposal practices and type of opioid prescribed. With regard to the actual numbers of pills, approximately 37% (3314/8925) of unused pills were not appropriately disposed of. This corresponds to approximately 6% (3314/55,635) of total pills prescribed being unused and improperly disposed of. To generate an accurate annual estimate this number was multiplied by 2 to account for the other half of the fiscal year, and divided by 0.826 to account for patients who were unable to be contacted or refused to complete the survey. This produced an estimate of 8024 unused pills (95% CI 6346-9705) that were improperly disposed of over a 1year period, for approximately 830 primary total joint replacements. Discussion The findings of this study provide important information regarding opioid prescription and utilization after THA and TKA. We found that a large volume of unused opioids were improperly disposed of after total joint arthroplasty, and were potentially available for illicit diversion. Our results highlight the importance of limiting postoperative prescriptions, and educating patients on proper disposal of unused opioid medications, in accordance with recommended FDA guidelines. These guidelines are readily available on the FDA website and can be incorporated into medication discharge information provided to patients [23]. From a societal prospective, these considerations are of paramount importance. A large volume of excess, improperly disposed of pills in a small community such as the one served by our hospital could have a substantial negative impact. A 2015 survey of US adults demonstrated that approximately 60% of individuals who reported opioid misuse during the preceding year obtained opioids from a source other than a physician’s prescription, and nearly 41% obtained prescription opioids from friends or relatives [18].
Projected Unused Opioid Disposal Over One Year
Total Pills Used
Properly Disposed of Unused Pills
Improperly Disposed of Unused Pills
Fig. 1. Graph of projected unused opioid disposal practices over 1 year. Graph demonstrating projected annual unused opioid disposal practices. Total pills prescribed divided into total pills used and unused pills, and the percentage of unused opioid pills divided into properly disposed of unused pills (ie, in accordance with FDA recommendations) and improperly disposed of unused pills.
Moreover, unused medications are the major source for illicit opioid diversion among youths [10,24]. If the findings at our institution are broadly generalizable to across the United States, then for the approximately 1,000,000 THAs and TKAs currently performed annually, there would be over 9 million improperly disposed unused opioid pills. This is the first study to our knowledge to quantify the amount of excess opioid pills that are improperly disposed of after total joint arthroplasty. We found only one other study evaluating opioid disposal practices in this setting [25]. In that study of 112 TKA patients, only 25.7% disposed of opioids properly. That study did not evaluate THA patients, and in their study the amount of patients who correctly disposed of unused medications was lower than the 41.9% of TKA and 38.4% of THA patients who correctly disposed of excess opioids in our study. The reason for this difference is unclear, but may be related to patient-specific factors such as education level, postoperative instructions, or local availability of opioid disposal centers. However, we reviewed multiple demographic factors including age, gender, race, ethnicity, length of surgery, and type of opioid used, and did not find any association of these demographic factors with opioid disposal patterns. Another consideration is that, among our patients, while the majority of patients with excess opioids did not dispose of them correctly, only 37% of actual excess opioid pills were incorrectly disposed of (Fig. 1). This difference may be explained by some patients with larger amounts of excess opioid medications engaging in appropriate disposal practices. Another possible explanation is that some patients maintained a small percentage of their excess pills with the intention of having some medication “on-hand” if they needed it in the future. This practice has been described by Buffington et al [26], in their evaluation of factors that contribute to different unused opioid disposal practices among chronic pain patients. That study also demonstrated that a significantly greater proportion of patients who receive education about proper disposal of unused opioids will dispose of them correctly [26]. There are several limitations to the current study. The retrospective nature of our study design precluded controlling for patient factors that might affect opioid utilization and disposal practices. However, attempt was made to contact all patients who
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underwent these procedures during the study period, and our participation rate was high at approximately 82% for both THA and TKA. Moreover, among our sample, none of the demographic factors evaluated appeared to influence postoperative disposal practices. We believe that our included sample of patients is therefore broadly representative of our patient population. Another limitation is that the method by which total pills utilized by patients was ascertained in this study relies on patient recall and self-reporting, both of which may be subject to inherent bias. However, this method has been utilized successfully in prior studies, and we believe that the data we collected are likely a close approximation of the true number of pills utilized [19,20]. Furthermore, our categorization of opioid disposal practices as appropriate or inappropriate included a large percentage of “other.” Because all FDA approved disposal methods were captured by our coding of responses, as well as if the patient still had the pills or if the patient was unsure where the pills were, this “other” category comprised inappropriate disposal scenarios where pills could still be accessible. This likely includes simply throwing the pills away in household trash without attempting to disguise or make them less appealing, or transferring the pills to other individuals. Although more granular information could be helpful with regard to focusing efforts on limiting postoperative opioid diversion, the focus of our study was to evaluate appropriate vs inappropriate disposal. Also, our approximation of annual excess and improperly disposed of pill numbers is predicated on an assumption that the other half of the fiscal year evaluated was similar, and that disposal practices of the approximately 18% of patients who were unable to be reached or refused to participate in the survey were similar to those who participated. This may be biased by such factors as seasonal variation in arthroplasty volumes. A further limitation is that the population we serve in northern New England is largely homogenous in terms of race and ethnicity, which limits our ability to assess the influence of these factors on opioid utilization. Despite the stated limitations, we believe the findings from this study are an important contribution to the growing body of evidence related to the risks of opioids after total joint arthroplasty [27e30]. The majority of patients with excess opioids after hip and knee arthroplasty do not dispose of them appropriately. This results in a large volume of opioids potentially available for illicit diversion in the community. Excess opioid disposal is a potential area of risk modification that surgeons should attempt to manage through patient education and utilization of FDA approved unused medication guidelines. References [1] Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 2007;89:780e5. https://doi.org/10.2106/JBJS.F.00222. [2] Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am 2014;96:624e30. https://doi.org/10.2106/jbjs.m.00285. [3] Cheville A, Chen A, Oster G, McGarry L, Narcessian E. A randomized trial of controlled-release oxycodone during inpatient rehabilitation following unilateral total knee arthroplasty. J Bone Joint Surg Am 2001;83:572e6. [4] Illgen RL, Pellino TA, Gordon DB, Butts S, Heiner JP. Prospective analysis of a novel long-acting oral opioid analgesic regimen for pain control after total hip and knee arthroplasty. J Arthroplasty 2006;21:814e20. https://doi.org/ 10.1016/j.arth.2005.10.011. [5] Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg 2002;10:117e29. [6] de Beer Jde V, Winemaker MJ, Donnelly GA, Miceli PC, Reiz JL, Harsanyi Z, et al. Efficacy and safety of controlled-release oxycodone and standard therapies for postoperative pain after knee or hip replacement. Can J Surg 2005;48:277e83.
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