- Email: [email protected]
Prospective Evaluation of an Opioid Reduction Protocol in Hand Surgery
EDITOR’S CHOICE
Prospective Evaluation of an Opioid Reduction Protocol in Hand Surgery C. Liam Dwyer, MD,* Maximillian Soong, MD,* Alice Hunter, MD,* Jesse Dashe, MD,* Eric Tolo, MD,* N. George Kasparyan, MD, PhD*
Purpose We investigated whether written guidelines for surgeons and educational handouts for patients regarding safe and effective opioid use after hand surgery could reduce prescription sizes while achieving high patient satisfaction and a low refill rate. Methods All patients undergoing isolated carpal tunnel release or distal radius volar locked plating in a hand surgery group practice during a 6-month period were prospectively enrolled. Surgeons prescribed analgesics at their own discretion based on written guidelines. Patients received an educational handout regarding safe opioid use and disposal, a diary to record daily pain visual analog scale score and consumption of opioid and over-the-counter (OTC) analgesics, and a pain catastrophizing scale questionnaire. Collected data were compared with a retrospective cohort of the same surgeons, procedures, and period 1 year earlier. Results In the carpal tunnel release group (121 patients), average prescription size was 10 opioid pills, compared with 22 in the prior year. Average consumption was 3 opioid pills, supplemented with 11 OTC pills. In the volar locked plating group (24 patients), average prescription size was 25 opioid pills, compared with 39 in the prior year. Average consumption was 16 opioid pills, supplemented with 20 OTC pills. Patient satisfaction was comparably high in both groups. Eight patients required opioid refills overall. Patients with pain catastrophizing scale greater than 10 used more than twice as many opioid pills. Of 109 patients with leftover opioids, 10 reported proper disposal. Conclusions Written guidelines and educational handouts significantly reduced the number of prescribed opioid pills by 35% to 55% while achieving high patient satisfaction and a low refill rate. We recommend 5 to 10 opioid pills for carpal tunnel release and 20 to 30 for distal radius volar plating. Pain catastrophizing is associated with greater opioid consumption and may help target patients for additional support. Potential for opioid abuse and diversion may persist despite these interventions. (J Hand Surg Am. 2018;-(-):-e-. Copyright Ó 2018 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic II. Key words Carpal tunnel, distal radius, opioids, prescriptions.
From the *Department of Orthopaedic Surgery, Lahey Hospital and Medical Center, Burlington, MA.
Corresponding author: Maximillian Soong, MD, Lahey Hospital and Medical Center, 41 Mall Road, Burlington, MA 01805; e-mail: [email protected].
Received for publication June 11, 2017; accepted in revised form January 22, 2018.
0363-5023/18/---0001$36.00/0 https://doi.org/10.1016/j.jhsa.2018.01.021
No benefits in any form have been received or will be received related directly or indirectly to the subject of this article.
Ó 2018 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1
2
P
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
national epidemic. From 1999 to 2015, the number of deaths involving overdoses of prescription opioids quadrupled to over 15,000 in 2015, reaching a total of over 183,000 during that period.1 Surgeons may contribute to this problem when managing postoperative pain, sometimes overprescribing opioids with the intention of minimizing patient phone calls, refills, and even potential disciplinary action or litigation for inadequate pain control.2,3 In recent years this problem has worsened, with pain being declared the “fifth vital sign” by the Joint Commission in 2000,2 and with an increasing focus on patient satisfaction.4 Overprescription of opioids by surgeons has been reported in diverse fields including hand surgery.5e8 Two recent studies demonstrated that two-thirds of the prescribed number of pain pills were left unconsumed by hand surgery patients.7,8 Fortunately, another study showed that hand surgeon prescribing behavior could be significantly improved by using written guidelines.9 However, of those 3 hand surgery studies, all had a variety of procedures, 2 had small numbers, and none tracked daily pain scores or daily consumption of opioids or over-the-counter (OTC) analgesics. We hoped to build on those studies by focusing on our most common soft tissue procedure (carpal tunnel release [CTR]) and bony procedure (distal radius volar locked plating [VLP]) and by collecting patient diaries for daily pain scores and pill consumption. In addition, pain catastrophizing has been associated with decreased satisfaction and greater patient-reported disability after CTR,10 as well as with increased pain and prolonged opioid use after orthopedic trauma surgery.11 We therefore sought to include this factor in our assessments, considering its potential to affect opioid use. Our hypothesis was that written guidelines for surgeons and educational handouts for patients regarding safe and effective opioid use after hand surgery could reduce prescription sizes while achieving high patient satisfaction with pain control and a low refill rate. We also hypothesized that patients with higher pain catastrophizing scores would consume more opioids.
isolated CTR or VLP for acute fracture from April, 2016 through September, 2016 were prospectively enrolled. Exclusion criteria included open fracture, chronic opioid use (defined as an active prescription on a patient medication list), or history of opioid abuse or pain syndrome. Surgeons prescribed analgesics at their own discretion based on written guidelines as follows: For CTR: aged 65 years or younger: 15 pills, 1 to 2 tablets by mouth every 4 to 6 hours as needed for pain; aged greater than 65 years: 10 pills, one tablet by mouth every 4 to 6 hours as needed for pain. For VLP: aged 65 years or younger: 30 pills, 1 to 2 tablets by mouth every 4 to 6 hours as needed for pain; aged greater than 65 years: 20 pills, one tablet by mouth every 4 to 6 hours as needed for pain. All patients received an educational handout regarding recommendations for safe opioid use, prohibiting concurrent driving or alcohol intake, and encouraging OTC analgesic use when possible, as well as recommendations for disposal of unused opioids, including nearby drop box locations (Appendix A, available on the Journal’s Web site at www.jhandsurg.org). Specific OTC recommendations included acetaminophen and ibuprofen, although patients were advised to respect contraindications from their primary care providers, such as against ibuprofen in the presence of renal impairment, gastrointestinal bleeding, cardiovascular disease, or anticoagulant therapy. In addition, patients in the distal radius fracture group were advised to minimize use of ibuprofen. We did not prescribe a bowel regimen or monitor for abdominal symptoms. All patients also received a diary with instructions to record maximum daily pain on a visual analog scale, with 0 representing none and 10 worst possible, and daily consumption of opioid and OTC analgesics, as well as a pain catastrophizing scale (PCS) questionnaire. The CTR was performed with mini-open technique under local anesthesia, with or without sedation. The VLP was performed with a flexor carpi radialis approach without supplemental incisions, under regional block, along with sedation or general anesthesia. Patients with CTR were allowed to replace the dressing with an adhesive bandage as needed, and patients with VLP were advised to keep the plaster splint and dressing intact. Patients in both groups were encouraged to elevate and exercise the fingers on the affected extremity. At the first postoperative visit, scheduled 7 to 14 days after surgery, the diary and PCS questionnaire were collected. Patients were asked whether they were satisfied with the pain control. This was
RESCRIPTION OPIOID ABUSE IS A
MATERIALS AND METHODS The study was conducted among our group of 4 Certificate of Added Qualificationsecertified orthopedic hand surgeons in a hospital-based practice. All patients aged 18 years or older who were undergoing J Hand Surg Am.
r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
3
FIGURE 1: Daily pain visual analog scale (VAS) and consumption of opioid and OTC pills after CTR.
RESULTS A total of 145 patients were enrolled. All returned for follow-up at a minimum of 7 days after surgery (range, 7e14 days). Of these, 122 (84%) completed and returned their diary and PCS questionnaire. Although by protocol the diaries were given back to patients for further recording if needed, few of these extended diaries were returned to the office. Thus, for consistency, diary data for all patients (consisting of pain visual analog scale and opioid and OTC pill consumption) were truncated 7 days after surgery. Patients were not excluded for failure to return the diary. The most commonly prescribed opioid was hydrocodoneeacetaminophen 5/325 mg (51%), followed by oxycodone 5 mg or oxycodoneeacetaminophen 5/325 mg (22%), acetaminophenecodeine 300/30 mg (22%), and tramadol 50 mg (5%). Higher-strength opioids were not prescribed (ie, 10 mg oxycodone or 7.5 mg hydrocodone formulations). The most commonly consumed OTC analgesics were acetaminophen and ibuprofen, although pill strengths (milligrams) were not recorded. In the CTR group (n ¼ 121), average age was 63 years (range, 28e92 years). There were 72 women and 49 men. Average prescription size was 10 opioid pills (range, 0e20 pills), a significant reduction from 22 in the prior year (P < .05). Average consumption
recorded as yes (for responses of always or usually) or no (for responses of sometimes or never). Patients were also queried regarding the method of medication disposal, if any. For patients who were still taking analgesics at the first postoperative visit, the diary was returned to the patient for collection at a subsequent visit. Prescription refills were monitored within our electronic medical record (Hyperspace, Epic, Verona, WI, 2016), from which all prescriptions in our practice are generated, until discharge from follow-up. To estimate the required sample size, a retrospective review was performed using the same surgeons, procedures, and 6-month period 1 year prior, with the same inclusion and exclusion criteria. We found a preintervention average of 22 pills prescribed for CTR (n ¼ 204; SD, 14.9) and 39 pills for VLP (n ¼ 32; SD, 15.6). Based on these data, a sample size estimate was performed. For CTR, we calculated that 118 CTR procedures would be required to demonstrate a 25% reduction in the number of pills prescribed. For VLP, we calculated that 24 procedures would be required to demonstrate a 33% reduction in the number of pills prescribed. Means of opioid pill numbers were compared with t test. Our hospital institutional review board approved the study. All patients gave informed consent to participate. No funding was received in support of this investigation. J Hand Surg Am.
r
Vol. -, - 2018
4
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
FIGURE 2: Daily pain visual analog scale (VAS) and consumption of opioid and OTC pills after VLP.
was 3 opioid pills (range, 0e20 pills), supplemented with 11 OTC pills (range, 0e56 pills). Figure 1 shows average daily pain and pill consumption after CTR. For the 121 patients, 2 opioid refills were prescribed, including one at the first postoperative visit and one prior. In the prior year, for 204 patients, 4 opioid refills were prescribed, including 3 at the first postoperative visit and one before the first postoperative visit. This represents an equivalent refill rate of 2% in both periods. In the VLP group (n ¼ 24), average age was 66 years (range, 51e90 years). There were 21 women and 3 men. Average prescription size was 25 opioid pills (range, 20e40 pills), a significant reduction from 39 in the prior year (P < .05). Average consumption was 16 opioid pills (range, 0e30 pills), supplemented with 20 OTC pills (range, 0e65 pills). Figure 2 shows average daily pain and pill consumption after VLP. For the 24 patients, 6 opioid refills were prescribed, including 2 at the first postoperative visit and 4 before the first postoperative visit. In the prior year; for 32 patients, 3 opioid refills were prescribed, including 2 at the first postoperative visit and one prior. Although this suggests a higher refill rate (25% vs 9%), we found no significant difference (c2, P ¼ .15) with the numbers available. Patient satisfaction was comparably high in both groups (CTR, 96%; VLP, 88%). Patients with PCS J Hand Surg Am.
greater than 10 consumed significantly more opioid pills for both procedures (CTR: 7.2 vs 2.6 [P < .05]; VLP: 26 vs 11 [P < .05]). Of the 1,795 total opioid pills prescribed, 795 were consumed, leaving 1,000 pills (55%) unconsumed. Of 109 patients with leftover opioids at the time of the first postoperative visit, 10 (9%) reported proper disposal, whereas the remainder reported an intention to save or dispose. DISCUSSION Our national opioid epidemic warrants action to minimize the potential for abuse and diversion of prescription opioids. Legislation enacted in Massachusetts in March, 2016 requires the use of an online opioid prescription monitoring system, a 7-day limit on firsttime outpatient opioid prescriptions, the option of partial filling at the pharmacy, as well as training and benchmarking programs for prescribers. For surgeons, the primary opportunity for opioid reduction exists with patient interaction around the time of surgery. Our study demonstrates that written guidelines for surgeons and educational handouts for patients significantly reduced opioid prescription sizes by 35% to 55% while achieving high patient satisfaction with pain control and a low refill rate. Furthermore, because the leftover pill rate of 55% was not dramatically different from that of prior studies reporting 66%,7,8 there may be an opportunity to r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
decrease prescription sizes even further (ie, leaving fewer leftover pills). If these interventions are widely adopted, the number of opioids available for abuse and diversion, from either initial prescriptions or leftover quantities, might be substantially reduced. For CTR, based on the average consumption of 3 opioid pills in the current cohort, we recommend prescribing 5 to 10 opioid pills. A recent study similarly recommended up to 10 pills for soft tissue hand and wrist procedures,8 and the same authors later published a subset of CTRs revealing an average consumption of 4 pills, comparable to ours.12 For VLP, based on the average consumption of 16 opioid pills in the current cohort, we recommend prescribing 20 to 30 opioid pills. Although the previously cited authors later published a subset of VLP cases demonstrating an average consumption of 15 pills, which was again comparable to ours, they recommended prescribing only 15 to 20 pills, while acknowledging that over 30% of their cohort consumed more than that amount and therefore would require refills.13 We favor a greater margin for pain control. For both procedures, older patients should generally be prescribed opioids at the lower end of each given range, as we did in our protocol, and as recommended in other studies.8,12,13 We also found that pain catastrophizing is associated with greater opioid consumption, and thus may help target patients for additional support, such as counseling or behavioral therapy.10,11 Awareness of this factor might help toward limiting consumption in such patients, or at least identifying potential outliers for individualized larger prescriptions (particularly in trauma situations in which counseling may not be feasible), thereby minimizing prescription sizes overall. Although there is no consensus threshold value for pain catastrophizing as measured by the PCS, a prior study of pain control after total knee arthroplasty used the value of greater than 15.14 We used a value of greater than 10, which appeared to be a distinct break point in our data for both groups, and which included the highest quintile within the current cohort. Safe disposal of unused opioids is another component of preventing abuse and diversion. A prior study found that only 5% of patients received disposal information.8 The patient education handout provided to every patient in our study ensured that 100% of patients were provided information regarding proper disposal procedures. This process should become universal, and has since been adopted in our practice. Only 9% of patients in our study reported safe disposal by the first J Hand Surg Am.
5
postoperative visit, and although many others expressed the intention to do so later, this equates to 91% of patients for whom opioids were unaccounted. Regardless, potential for opioid abuse and diversion may persist despite these interventions, and methods beyond handouts should be considered, such as an on-site medication depository (which our hospital has installed). Our study had limitations. Because the data were truncated 7 days after surgery, there may be underreporting of pill consumption. However, it appears that this would not likely change the numbers substantially, because opioid consumption at 7 days was already minimal (average of 0 to one pill for either group). As a practical matter, if further opioids are needed, a postoperative visit at 7 days provides the opportunity to evaluate the patient and consider whether opioid refills are appropriate, and it is consistent with the 7-day limitation on prescription sizes in Massachusetts. It is also possible that opioid use may increase at a later date, such as when therapy begins weeks after distal radius fixation. However, in our experience, OTCs vastly dominate during the therapy period. Another limitation is that the study was not powered to detect differences in refill rate from the prior year, nor were patient satisfaction data available from the prior year for comparison. A larger study would be needed to detect significant differences in the small number of refills or dissatisfied patients. For example, our higher rate of refills for VLP might be found to be statistically significant in a future study, thus warranting a higher margin for prescription size or targeted intervention for particular patients or procedures. We also did not exclude or identify patients with contraindications or intolerance to nonsteroidal anti-inflammatory drugs, who therefore might consume more opioids, although we suggested acetaminophen as another OTC option. The surgeons who participated in the study were aware of the nationwide concern regarding opioids, and may have been biased to write smaller prescriptions. Finally, although our study included daily patient diaries, recording of pain, pill consumption, and disposal may be subject to reporting bias, and prescriptions outside our hospital system, if any, were not tracked. We chose to use pill counts rather than calculate equianalgesic doses of the various opioids and OTCs, because such conversions are approximate and controversial, and vary among studies and patients (ie, differences in age, body mass, absorption, and liver metabolism).15 Combination drugs such as oxycodoneeacetaminophen and r
Vol. -, - 2018
6
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
REFERENCES
hydrocodoneeacetaminophen introduce further uncertainty, as do the variable strengths and consumption amounts of OTC medications, whether at baseline (such as often seen for arthritis or other pain) or after surgery. Four of the 5 previously cited studies in hand surgery7e9,12 similarly used pill counts, which are practical, easily defined, and clinically applicable. One study used proportions of hydrocodone and oxycodone nearly identical to those in our study,7 and another specifically showed no significant differences in consumption among oxycodoneeacetaminophen, hydrocodoneeacetaminophen, and acetaminophene codeine after CTR.12 We also understand that whereas achieving patient satisfaction is an important goal, it may be difficult to define and measure, and even counterproductive at times.4,16 We used a relevant and previously implemented method of specifically ascertaining satisfaction with pain control,17 but we acknowledge that other factors may influence responses (eg, expectation, occupation, recreation). Therefore, it should be noted that we calculated our sample size based on the more defined quantity of prescription size rather than patient satisfaction. Future investigation may seek to trace the final destination of unused opioids, because many of our patients still had them in the home, whether they intended to save or dispose of them. Interventions such as ours should be studied in other hand procedures, particularly those considered more or less painful than CTR and VLP, as well as in other surgical specialties and populations, which may also contribute to the opioid epidemic. Additional studies may examine whether simply using the informational handout or diary alone has an effect on opioid consumption, perhaps because of improved patient self-awareness and self-monitoring. Furthermore, it would be reasonable to investigate opioid-free postoperative regimens, possibly eliminating the potential for opioid abuse or diversion, particularly for carpal tunnel release and other soft tissue hand procedures.
J Hand Surg Am.
1. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Prescription opioid overdose data. https://www.cdc.gov/ drugoverdose/data/overdose.html. Accessed June 12, 2017. 2. Lucas CE, Vlahos AL, Ledgerwood AM. Kindness kills: the negative impact of pain as the fifth vital sign. J Am Coll Surg. 2007;205(1): 101e107. 3. Manchikanti L, Fellows B, Ailinani H, et al. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010;13(5):401e435. 4. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405e411. 5. Harris KL, Curtis J, Larsen B, et al. Opioid pain medication use after dermatologic surgery. JAMA Dermatol. 2013;149(3):317e321. 6. Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011;185(2):551e555. 7. Rodgers J, Cunningham K, Fitzgerald K, et al. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012;37(4):645e650. 8. 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(20):e89. 9. 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 Am. 2015;40(2):341e346. 10. Lozano Calderón SA, Paiva A, Ring D. Patient satisfaction after open carpal tunnel release correlates with depression. J Hand Surg Am. 2008;33(3):303e307. 11. Helmerhorst GT, Vranceanu AM, Vrahas M, Smith M, Ring D. Risk factors for continued opioid use one to two months after surgery for musculoskeletal trauma. J Bone Joint Surg Am. 2014;96(6): 495e499. 12. Chapman T, Kim N, Maltenfort M, Ilyas AM. Prospective evaluation of opioid consumption following carpal tunnel release surgery. Hand. 2017;12(1):39e42. 13. O’Neil JT, Wang ML, Kim N, Maltenfort M, Ilyas AM. Prospective evaluation of opioid consumption after distal radius fracture repair surgery. Am J Orthop. 2017;46(1):E35eE40. 14. Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 2010;468:798e806. 15. Rennick A, Atkinson T, Cimino NM, Strassels SA, McPherson ML, Fudin J. Variability in opioid equivalence calculations. Pain Med. 2016;17(5):892e898. 16. Graham B. Defining and measuring patient satisfaction. J Hand Surg Am. 2016;41(9):929e931. 17. Bot AG, Bekkers S, Arnstein PM, Smith RM, Ring D. Opioid use after fracture surgery correlates with pain intensity and satisfaction with pain relief. Clin Orthop Relat Res. 2014;472(8):2542e2549.
r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
APPENDIX A. Pain Control Information Handout
safely and securely disposed of in 24-hour drop-boxes in the Main Lobby of the Burlington Police Department, Peabody Police Department, Winchester Police Department, and most other local police departments.
Dosing Recommendations
Prescribed pain medications are to be taken “as needed.” This means that these medications should only be taken while the patient feels pain or discomfort in order to assist in controlling the post-operative pain. If you do not require prescription medications to control pain, you may take over-the-counter Tylenol or Ibuprofen unless told otherwise by your physician. For certain procedures in which an anesthetic block was provided, we encourage starting the use of prescription pain medication prior to feeling pain symptoms to avoid having severe pain after the block wears off.
Burlington Police 45 Center Street Burlington, MA 01803 781-272-1212 Peabody Police 6 Allens Lane Peabody, MA 01960 978-531-1212
Safety Recommendations
Winchester Police 30 Mount Vernon Street Winchester, MA 01890 781-729-1802
You should avoid driving, operating heavy machinery, or drinking alcohol while taking prescribed pain medications as these medications may cause drowsiness, dizziness, lightheadedness, and other impairment of physical and mental abilities.
If you are unable to bring unused prescription pain medications to your local police department, you may flush them down the toilet, as recommended by the U.S Food & Drug Administration (FDA). For further information on the FDA recommendations, go to: http://www.fda.gov/Drugs/ResourcesForYou/ Consumers/BuyingUsingMedicineSafely/Ensuring SafeUseofMedicine/SafeDisposalofMedicines/ucm 186187.htm#Flush_List
Disposal Recommendations
We recommend that you remove expired, unwanted, or unused medicines from your home as quickly as possible to help reduce the chance that others may accidentally take or intentionally misuse them. Prescription pain medications (including hydrocodone, Vicodin, Norco, oxycodone, Percocet, codeine, Tylenol #3, hydromorphone, Dilaudid) can be
J Hand Surg Am.
6.e1
r
Vol. -, - 2018
Prospective Evaluation of an Opioid Reduction Protocol in Hand Surgery C. Liam Dwyer, MD,* Maximillian Soong, MD,* Alice Hunter, MD,* Jesse Dashe, MD,* Eric Tolo, MD,* N. George Kasparyan, MD, PhD*
Purpose We investigated whether written guidelines for surgeons and educational handouts for patients regarding safe and effective opioid use after hand surgery could reduce prescription sizes while achieving high patient satisfaction and a low refill rate. Methods All patients undergoing isolated carpal tunnel release or distal radius volar locked plating in a hand surgery group practice during a 6-month period were prospectively enrolled. Surgeons prescribed analgesics at their own discretion based on written guidelines. Patients received an educational handout regarding safe opioid use and disposal, a diary to record daily pain visual analog scale score and consumption of opioid and over-the-counter (OTC) analgesics, and a pain catastrophizing scale questionnaire. Collected data were compared with a retrospective cohort of the same surgeons, procedures, and period 1 year earlier. Results In the carpal tunnel release group (121 patients), average prescription size was 10 opioid pills, compared with 22 in the prior year. Average consumption was 3 opioid pills, supplemented with 11 OTC pills. In the volar locked plating group (24 patients), average prescription size was 25 opioid pills, compared with 39 in the prior year. Average consumption was 16 opioid pills, supplemented with 20 OTC pills. Patient satisfaction was comparably high in both groups. Eight patients required opioid refills overall. Patients with pain catastrophizing scale greater than 10 used more than twice as many opioid pills. Of 109 patients with leftover opioids, 10 reported proper disposal. Conclusions Written guidelines and educational handouts significantly reduced the number of prescribed opioid pills by 35% to 55% while achieving high patient satisfaction and a low refill rate. We recommend 5 to 10 opioid pills for carpal tunnel release and 20 to 30 for distal radius volar plating. Pain catastrophizing is associated with greater opioid consumption and may help target patients for additional support. Potential for opioid abuse and diversion may persist despite these interventions. (J Hand Surg Am. 2018;-(-):-e-. Copyright Ó 2018 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic II. Key words Carpal tunnel, distal radius, opioids, prescriptions.
From the *Department of Orthopaedic Surgery, Lahey Hospital and Medical Center, Burlington, MA.
Corresponding author: Maximillian Soong, MD, Lahey Hospital and Medical Center, 41 Mall Road, Burlington, MA 01805; e-mail: [email protected].
Received for publication June 11, 2017; accepted in revised form January 22, 2018.
0363-5023/18/---0001$36.00/0 https://doi.org/10.1016/j.jhsa.2018.01.021
No benefits in any form have been received or will be received related directly or indirectly to the subject of this article.
Ó 2018 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1
2
P
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
national epidemic. From 1999 to 2015, the number of deaths involving overdoses of prescription opioids quadrupled to over 15,000 in 2015, reaching a total of over 183,000 during that period.1 Surgeons may contribute to this problem when managing postoperative pain, sometimes overprescribing opioids with the intention of minimizing patient phone calls, refills, and even potential disciplinary action or litigation for inadequate pain control.2,3 In recent years this problem has worsened, with pain being declared the “fifth vital sign” by the Joint Commission in 2000,2 and with an increasing focus on patient satisfaction.4 Overprescription of opioids by surgeons has been reported in diverse fields including hand surgery.5e8 Two recent studies demonstrated that two-thirds of the prescribed number of pain pills were left unconsumed by hand surgery patients.7,8 Fortunately, another study showed that hand surgeon prescribing behavior could be significantly improved by using written guidelines.9 However, of those 3 hand surgery studies, all had a variety of procedures, 2 had small numbers, and none tracked daily pain scores or daily consumption of opioids or over-the-counter (OTC) analgesics. We hoped to build on those studies by focusing on our most common soft tissue procedure (carpal tunnel release [CTR]) and bony procedure (distal radius volar locked plating [VLP]) and by collecting patient diaries for daily pain scores and pill consumption. In addition, pain catastrophizing has been associated with decreased satisfaction and greater patient-reported disability after CTR,10 as well as with increased pain and prolonged opioid use after orthopedic trauma surgery.11 We therefore sought to include this factor in our assessments, considering its potential to affect opioid use. Our hypothesis was that written guidelines for surgeons and educational handouts for patients regarding safe and effective opioid use after hand surgery could reduce prescription sizes while achieving high patient satisfaction with pain control and a low refill rate. We also hypothesized that patients with higher pain catastrophizing scores would consume more opioids.
isolated CTR or VLP for acute fracture from April, 2016 through September, 2016 were prospectively enrolled. Exclusion criteria included open fracture, chronic opioid use (defined as an active prescription on a patient medication list), or history of opioid abuse or pain syndrome. Surgeons prescribed analgesics at their own discretion based on written guidelines as follows: For CTR: aged 65 years or younger: 15 pills, 1 to 2 tablets by mouth every 4 to 6 hours as needed for pain; aged greater than 65 years: 10 pills, one tablet by mouth every 4 to 6 hours as needed for pain. For VLP: aged 65 years or younger: 30 pills, 1 to 2 tablets by mouth every 4 to 6 hours as needed for pain; aged greater than 65 years: 20 pills, one tablet by mouth every 4 to 6 hours as needed for pain. All patients received an educational handout regarding recommendations for safe opioid use, prohibiting concurrent driving or alcohol intake, and encouraging OTC analgesic use when possible, as well as recommendations for disposal of unused opioids, including nearby drop box locations (Appendix A, available on the Journal’s Web site at www.jhandsurg.org). Specific OTC recommendations included acetaminophen and ibuprofen, although patients were advised to respect contraindications from their primary care providers, such as against ibuprofen in the presence of renal impairment, gastrointestinal bleeding, cardiovascular disease, or anticoagulant therapy. In addition, patients in the distal radius fracture group were advised to minimize use of ibuprofen. We did not prescribe a bowel regimen or monitor for abdominal symptoms. All patients also received a diary with instructions to record maximum daily pain on a visual analog scale, with 0 representing none and 10 worst possible, and daily consumption of opioid and OTC analgesics, as well as a pain catastrophizing scale (PCS) questionnaire. The CTR was performed with mini-open technique under local anesthesia, with or without sedation. The VLP was performed with a flexor carpi radialis approach without supplemental incisions, under regional block, along with sedation or general anesthesia. Patients with CTR were allowed to replace the dressing with an adhesive bandage as needed, and patients with VLP were advised to keep the plaster splint and dressing intact. Patients in both groups were encouraged to elevate and exercise the fingers on the affected extremity. At the first postoperative visit, scheduled 7 to 14 days after surgery, the diary and PCS questionnaire were collected. Patients were asked whether they were satisfied with the pain control. This was
RESCRIPTION OPIOID ABUSE IS A
MATERIALS AND METHODS The study was conducted among our group of 4 Certificate of Added Qualificationsecertified orthopedic hand surgeons in a hospital-based practice. All patients aged 18 years or older who were undergoing J Hand Surg Am.
r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
3
FIGURE 1: Daily pain visual analog scale (VAS) and consumption of opioid and OTC pills after CTR.
RESULTS A total of 145 patients were enrolled. All returned for follow-up at a minimum of 7 days after surgery (range, 7e14 days). Of these, 122 (84%) completed and returned their diary and PCS questionnaire. Although by protocol the diaries were given back to patients for further recording if needed, few of these extended diaries were returned to the office. Thus, for consistency, diary data for all patients (consisting of pain visual analog scale and opioid and OTC pill consumption) were truncated 7 days after surgery. Patients were not excluded for failure to return the diary. The most commonly prescribed opioid was hydrocodoneeacetaminophen 5/325 mg (51%), followed by oxycodone 5 mg or oxycodoneeacetaminophen 5/325 mg (22%), acetaminophenecodeine 300/30 mg (22%), and tramadol 50 mg (5%). Higher-strength opioids were not prescribed (ie, 10 mg oxycodone or 7.5 mg hydrocodone formulations). The most commonly consumed OTC analgesics were acetaminophen and ibuprofen, although pill strengths (milligrams) were not recorded. In the CTR group (n ¼ 121), average age was 63 years (range, 28e92 years). There were 72 women and 49 men. Average prescription size was 10 opioid pills (range, 0e20 pills), a significant reduction from 22 in the prior year (P < .05). Average consumption
recorded as yes (for responses of always or usually) or no (for responses of sometimes or never). Patients were also queried regarding the method of medication disposal, if any. For patients who were still taking analgesics at the first postoperative visit, the diary was returned to the patient for collection at a subsequent visit. Prescription refills were monitored within our electronic medical record (Hyperspace, Epic, Verona, WI, 2016), from which all prescriptions in our practice are generated, until discharge from follow-up. To estimate the required sample size, a retrospective review was performed using the same surgeons, procedures, and 6-month period 1 year prior, with the same inclusion and exclusion criteria. We found a preintervention average of 22 pills prescribed for CTR (n ¼ 204; SD, 14.9) and 39 pills for VLP (n ¼ 32; SD, 15.6). Based on these data, a sample size estimate was performed. For CTR, we calculated that 118 CTR procedures would be required to demonstrate a 25% reduction in the number of pills prescribed. For VLP, we calculated that 24 procedures would be required to demonstrate a 33% reduction in the number of pills prescribed. Means of opioid pill numbers were compared with t test. Our hospital institutional review board approved the study. All patients gave informed consent to participate. No funding was received in support of this investigation. J Hand Surg Am.
r
Vol. -, - 2018
4
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
FIGURE 2: Daily pain visual analog scale (VAS) and consumption of opioid and OTC pills after VLP.
was 3 opioid pills (range, 0e20 pills), supplemented with 11 OTC pills (range, 0e56 pills). Figure 1 shows average daily pain and pill consumption after CTR. For the 121 patients, 2 opioid refills were prescribed, including one at the first postoperative visit and one prior. In the prior year, for 204 patients, 4 opioid refills were prescribed, including 3 at the first postoperative visit and one before the first postoperative visit. This represents an equivalent refill rate of 2% in both periods. In the VLP group (n ¼ 24), average age was 66 years (range, 51e90 years). There were 21 women and 3 men. Average prescription size was 25 opioid pills (range, 20e40 pills), a significant reduction from 39 in the prior year (P < .05). Average consumption was 16 opioid pills (range, 0e30 pills), supplemented with 20 OTC pills (range, 0e65 pills). Figure 2 shows average daily pain and pill consumption after VLP. For the 24 patients, 6 opioid refills were prescribed, including 2 at the first postoperative visit and 4 before the first postoperative visit. In the prior year; for 32 patients, 3 opioid refills were prescribed, including 2 at the first postoperative visit and one prior. Although this suggests a higher refill rate (25% vs 9%), we found no significant difference (c2, P ¼ .15) with the numbers available. Patient satisfaction was comparably high in both groups (CTR, 96%; VLP, 88%). Patients with PCS J Hand Surg Am.
greater than 10 consumed significantly more opioid pills for both procedures (CTR: 7.2 vs 2.6 [P < .05]; VLP: 26 vs 11 [P < .05]). Of the 1,795 total opioid pills prescribed, 795 were consumed, leaving 1,000 pills (55%) unconsumed. Of 109 patients with leftover opioids at the time of the first postoperative visit, 10 (9%) reported proper disposal, whereas the remainder reported an intention to save or dispose. DISCUSSION Our national opioid epidemic warrants action to minimize the potential for abuse and diversion of prescription opioids. Legislation enacted in Massachusetts in March, 2016 requires the use of an online opioid prescription monitoring system, a 7-day limit on firsttime outpatient opioid prescriptions, the option of partial filling at the pharmacy, as well as training and benchmarking programs for prescribers. For surgeons, the primary opportunity for opioid reduction exists with patient interaction around the time of surgery. Our study demonstrates that written guidelines for surgeons and educational handouts for patients significantly reduced opioid prescription sizes by 35% to 55% while achieving high patient satisfaction with pain control and a low refill rate. Furthermore, because the leftover pill rate of 55% was not dramatically different from that of prior studies reporting 66%,7,8 there may be an opportunity to r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
decrease prescription sizes even further (ie, leaving fewer leftover pills). If these interventions are widely adopted, the number of opioids available for abuse and diversion, from either initial prescriptions or leftover quantities, might be substantially reduced. For CTR, based on the average consumption of 3 opioid pills in the current cohort, we recommend prescribing 5 to 10 opioid pills. A recent study similarly recommended up to 10 pills for soft tissue hand and wrist procedures,8 and the same authors later published a subset of CTRs revealing an average consumption of 4 pills, comparable to ours.12 For VLP, based on the average consumption of 16 opioid pills in the current cohort, we recommend prescribing 20 to 30 opioid pills. Although the previously cited authors later published a subset of VLP cases demonstrating an average consumption of 15 pills, which was again comparable to ours, they recommended prescribing only 15 to 20 pills, while acknowledging that over 30% of their cohort consumed more than that amount and therefore would require refills.13 We favor a greater margin for pain control. For both procedures, older patients should generally be prescribed opioids at the lower end of each given range, as we did in our protocol, and as recommended in other studies.8,12,13 We also found that pain catastrophizing is associated with greater opioid consumption, and thus may help target patients for additional support, such as counseling or behavioral therapy.10,11 Awareness of this factor might help toward limiting consumption in such patients, or at least identifying potential outliers for individualized larger prescriptions (particularly in trauma situations in which counseling may not be feasible), thereby minimizing prescription sizes overall. Although there is no consensus threshold value for pain catastrophizing as measured by the PCS, a prior study of pain control after total knee arthroplasty used the value of greater than 15.14 We used a value of greater than 10, which appeared to be a distinct break point in our data for both groups, and which included the highest quintile within the current cohort. Safe disposal of unused opioids is another component of preventing abuse and diversion. A prior study found that only 5% of patients received disposal information.8 The patient education handout provided to every patient in our study ensured that 100% of patients were provided information regarding proper disposal procedures. This process should become universal, and has since been adopted in our practice. Only 9% of patients in our study reported safe disposal by the first J Hand Surg Am.
5
postoperative visit, and although many others expressed the intention to do so later, this equates to 91% of patients for whom opioids were unaccounted. Regardless, potential for opioid abuse and diversion may persist despite these interventions, and methods beyond handouts should be considered, such as an on-site medication depository (which our hospital has installed). Our study had limitations. Because the data were truncated 7 days after surgery, there may be underreporting of pill consumption. However, it appears that this would not likely change the numbers substantially, because opioid consumption at 7 days was already minimal (average of 0 to one pill for either group). As a practical matter, if further opioids are needed, a postoperative visit at 7 days provides the opportunity to evaluate the patient and consider whether opioid refills are appropriate, and it is consistent with the 7-day limitation on prescription sizes in Massachusetts. It is also possible that opioid use may increase at a later date, such as when therapy begins weeks after distal radius fixation. However, in our experience, OTCs vastly dominate during the therapy period. Another limitation is that the study was not powered to detect differences in refill rate from the prior year, nor were patient satisfaction data available from the prior year for comparison. A larger study would be needed to detect significant differences in the small number of refills or dissatisfied patients. For example, our higher rate of refills for VLP might be found to be statistically significant in a future study, thus warranting a higher margin for prescription size or targeted intervention for particular patients or procedures. We also did not exclude or identify patients with contraindications or intolerance to nonsteroidal anti-inflammatory drugs, who therefore might consume more opioids, although we suggested acetaminophen as another OTC option. The surgeons who participated in the study were aware of the nationwide concern regarding opioids, and may have been biased to write smaller prescriptions. Finally, although our study included daily patient diaries, recording of pain, pill consumption, and disposal may be subject to reporting bias, and prescriptions outside our hospital system, if any, were not tracked. We chose to use pill counts rather than calculate equianalgesic doses of the various opioids and OTCs, because such conversions are approximate and controversial, and vary among studies and patients (ie, differences in age, body mass, absorption, and liver metabolism).15 Combination drugs such as oxycodoneeacetaminophen and r
Vol. -, - 2018
6
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
REFERENCES
hydrocodoneeacetaminophen introduce further uncertainty, as do the variable strengths and consumption amounts of OTC medications, whether at baseline (such as often seen for arthritis or other pain) or after surgery. Four of the 5 previously cited studies in hand surgery7e9,12 similarly used pill counts, which are practical, easily defined, and clinically applicable. One study used proportions of hydrocodone and oxycodone nearly identical to those in our study,7 and another specifically showed no significant differences in consumption among oxycodoneeacetaminophen, hydrocodoneeacetaminophen, and acetaminophene codeine after CTR.12 We also understand that whereas achieving patient satisfaction is an important goal, it may be difficult to define and measure, and even counterproductive at times.4,16 We used a relevant and previously implemented method of specifically ascertaining satisfaction with pain control,17 but we acknowledge that other factors may influence responses (eg, expectation, occupation, recreation). Therefore, it should be noted that we calculated our sample size based on the more defined quantity of prescription size rather than patient satisfaction. Future investigation may seek to trace the final destination of unused opioids, because many of our patients still had them in the home, whether they intended to save or dispose of them. Interventions such as ours should be studied in other hand procedures, particularly those considered more or less painful than CTR and VLP, as well as in other surgical specialties and populations, which may also contribute to the opioid epidemic. Additional studies may examine whether simply using the informational handout or diary alone has an effect on opioid consumption, perhaps because of improved patient self-awareness and self-monitoring. Furthermore, it would be reasonable to investigate opioid-free postoperative regimens, possibly eliminating the potential for opioid abuse or diversion, particularly for carpal tunnel release and other soft tissue hand procedures.
J Hand Surg Am.
1. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. Prescription opioid overdose data. https://www.cdc.gov/ drugoverdose/data/overdose.html. Accessed June 12, 2017. 2. Lucas CE, Vlahos AL, Ledgerwood AM. Kindness kills: the negative impact of pain as the fifth vital sign. J Am Coll Surg. 2007;205(1): 101e107. 3. Manchikanti L, Fellows B, Ailinani H, et al. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010;13(5):401e435. 4. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med. 2012;172(5):405e411. 5. Harris KL, Curtis J, Larsen B, et al. Opioid pain medication use after dermatologic surgery. JAMA Dermatol. 2013;149(3):317e321. 6. Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011;185(2):551e555. 7. Rodgers J, Cunningham K, Fitzgerald K, et al. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012;37(4):645e650. 8. 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(20):e89. 9. 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 Am. 2015;40(2):341e346. 10. Lozano Calderón SA, Paiva A, Ring D. Patient satisfaction after open carpal tunnel release correlates with depression. J Hand Surg Am. 2008;33(3):303e307. 11. Helmerhorst GT, Vranceanu AM, Vrahas M, Smith M, Ring D. Risk factors for continued opioid use one to two months after surgery for musculoskeletal trauma. J Bone Joint Surg Am. 2014;96(6): 495e499. 12. Chapman T, Kim N, Maltenfort M, Ilyas AM. Prospective evaluation of opioid consumption following carpal tunnel release surgery. Hand. 2017;12(1):39e42. 13. O’Neil JT, Wang ML, Kim N, Maltenfort M, Ilyas AM. Prospective evaluation of opioid consumption after distal radius fracture repair surgery. Am J Orthop. 2017;46(1):E35eE40. 14. Riddle DL, Wade JB, Jiranek WA, Kong X. Preoperative pain catastrophizing predicts pain outcome after knee arthroplasty. Clin Orthop Relat Res. 2010;468:798e806. 15. Rennick A, Atkinson T, Cimino NM, Strassels SA, McPherson ML, Fudin J. Variability in opioid equivalence calculations. Pain Med. 2016;17(5):892e898. 16. Graham B. Defining and measuring patient satisfaction. J Hand Surg Am. 2016;41(9):929e931. 17. Bot AG, Bekkers S, Arnstein PM, Smith RM, Ring D. Opioid use after fracture surgery correlates with pain intensity and satisfaction with pain relief. Clin Orthop Relat Res. 2014;472(8):2542e2549.
r
Vol. -, - 2018
EVALUATION OF AN OPIOID REDUCTION PROTOCOL
APPENDIX A. Pain Control Information Handout
safely and securely disposed of in 24-hour drop-boxes in the Main Lobby of the Burlington Police Department, Peabody Police Department, Winchester Police Department, and most other local police departments.
Dosing Recommendations
Prescribed pain medications are to be taken “as needed.” This means that these medications should only be taken while the patient feels pain or discomfort in order to assist in controlling the post-operative pain. If you do not require prescription medications to control pain, you may take over-the-counter Tylenol or Ibuprofen unless told otherwise by your physician. For certain procedures in which an anesthetic block was provided, we encourage starting the use of prescription pain medication prior to feeling pain symptoms to avoid having severe pain after the block wears off.
Burlington Police 45 Center Street Burlington, MA 01803 781-272-1212 Peabody Police 6 Allens Lane Peabody, MA 01960 978-531-1212
Safety Recommendations
Winchester Police 30 Mount Vernon Street Winchester, MA 01890 781-729-1802
You should avoid driving, operating heavy machinery, or drinking alcohol while taking prescribed pain medications as these medications may cause drowsiness, dizziness, lightheadedness, and other impairment of physical and mental abilities.
If you are unable to bring unused prescription pain medications to your local police department, you may flush them down the toilet, as recommended by the U.S Food & Drug Administration (FDA). For further information on the FDA recommendations, go to: http://www.fda.gov/Drugs/ResourcesForYou/ Consumers/BuyingUsingMedicineSafely/Ensuring SafeUseofMedicine/SafeDisposalofMedicines/ucm 186187.htm#Flush_List
Disposal Recommendations
We recommend that you remove expired, unwanted, or unused medicines from your home as quickly as possible to help reduce the chance that others may accidentally take or intentionally misuse them. Prescription pain medications (including hydrocodone, Vicodin, Norco, oxycodone, Percocet, codeine, Tylenol #3, hydromorphone, Dilaudid) can be
J Hand Surg Am.
6.e1
r
Vol. -, - 2018