a b s t r a c t

Background: Emergency department (ED) visits associated with Prescription opioids have increased in the last ten years. This study describes the Opioid utilization of patients discharged from the ED with an opioid prescrip- tion for pain, 14 to 21 days post discharge.

Methods: This is a prospective, single-centered, survey-based observational descriptive study conducted from De- cember 2017 to February 2018 in the ED at a tertiary level 1 trauma center. The primary outcomes were the per- centage of patients with unused opioids and the quantity of opioids remaining 14 to 21 days post ED discharge. A sample of ED patients who received an oral Opioid prescription were approached for informed consent and re- ceived a telephone survey 14 to 21 days post discharge.

Results: Of 178 patients approached for consent, 122 were enrolled. Among them, 98 were successfully surveyed (80.3%). The median number of pills prescribed was 8 (IQR:8-12). Nearly half (49%) of patients had unused opi- oids 14 to 21 days post ED discharge, not including 9.2% of patients who never filled their prescriptions. Of the total 980 pills prescribed, 327 pills remained unused (33.4%). Only 55.1% of patients reported receiving counsel- ing on side effect of opioids and 21.4% of patients reported they received counseling on storage and disposal. Conclusion: The majority of patients in this study had unused or unfilled opioids 14 to 21 days post ED discharge, and approximately one third of the opioids prescribed remained unused. Most patients did not recall receiving opioid related education including proper disposal of medication.

(C) 2019

Introduction

The opioid overdose epidemic is a growing Public health concern in the United States and is associated with high mortality rates and sub- stantial health care costs [1,2]. Between 1991 and 2016, the rate of opi- oid related overdose deaths increased dramatically [3-6]. In 2008, deaths attributed to prescription opioid overdose surpassed deaths due to motor vehicle crashes as the leading cause of Accidental death, and 2014 marked the all-time high for number of opioid-related deaths at 28,647 [7-9]. This astonishing increase in opioid mortality was

* Corresponding author at: 1614 Calvary Circle, Apt 406. Charlottesville, VA 22911, USA.

E-mail address: [email protected] (R. Shi).

correlated to a 700% increase in opioid prescribing over the same time period [9]. Opioid abuse and overdose-related deaths represent a signif- icant cost to the United States economy, with an estimated $78.5 billion spent annually [3]. Excess Medical costs related to the opioid epidemic were estimated at $23.7 billion [10].

The emergency department (ED) has historically been cited as one of the central contributors to the opioid epidemic. ED visits associated with prescription opioids increased 174% from 2004 to 2010. In 2009, emergency physicians ranked 3rd among specialists prescribing opioids to patients aged 20 to 39 years [1,10,11]. Some emergency providers re- ported that their pay and performance review were partly influenced by metrics that determine timely control of pain and patient satisfactions [12-14]. Emergency physicians are frequently prescribers of opioids

https://doi.org/10.1016/j.ajem.2019.158421

0735-6757/(C) 2019

R. Shi et al. / American Journal of Emergency Medicine 38 (2020) 1568-1571 1569

because pain is one of the most common reasons patients seek care in the ED. An estimated 10-17% of all patients discharged from the ED re- ceive a prescription for opioid analgesic [6,15]. Despite recent efforts to bring awareness to providers, the prescribing pattern remains highly variable [6,8,16-18]. This is partly due to a lack of robust formal policies or best practice guidelines for opioid prescribing in the ED.

Studies in post-surgical patient populations show that 42-71% of pa- tients had unused opioids from discharge prescriptions [19,20]. It is cur- rently unclear if patients discharged from the ED with Opioid prescriptions for the treatment of acute pain have unused opioids. The purpose of this study is to evaluate the percentage of patients with un- used opioids and the quantity of unused prescription opioid pills for pa- tients discharged from the ED with an opioid prescription.

Methods

Design, setting and population

This prospective, single-centered, survey-based observational study was conducted from December 1, 2017 through February 28, 2018 at the Intermountain Medical Center emergency department, a tertiary Level 1 trauma center in Murray, Utah. The hospital serves the popula- tion of the Salt Lake valley and the surrounding areas, and the ED has over 87,000 annual visits. This study utilized the electronic health re- cord (EHR), chart review, and telephone survey of a convenience sam- ple of patients discharged home from the ED who received an oral opioid prescription. Patient identification and study enrollment were based on the availability of the research investigators in the ED. Patients were approached for informed consent if they were flagged for dis- charge on the EHR tracking board with an oral prescription medication that included pill forms of any of the following: hydrocodone, oxyco- done, codeine, hydromorphone, tramadol, morphine, or any of the com- bination products containing the aforementioned opioids. Patients were excluded from the study if they were under the age of 18, pregnant, ad- mitted to the hospital or hospital observational unit, discharged to hos- pice care, discharged to a skilled nursing facility or long-term care facility, incarcerated, diagnosed with active cancer, diagnosed with his- tory of drug overdose, using methadone or buprenorphine/naloxone for the purpose of Substance use disorders, or were incapable of giving in- formed consent.

Following informed consent, patients received a standardized tele- phone survey 14 to 21 days post ED discharge (Appendix A). The time frame of 14 to 21 days was chosen based on a similar study conducted at Intermountain Medical Center in urological surgery patients in which patients were asked about unused opioids 14 to 28 days post- surgery [21]. Patient’s contact information and best time-to-contact were gathered at the time of informed consent. Patients were consid- ered lost-to-follow-up if we failed to conduct the survey after five calls on consecutive days or after day 21. Successful filling of medication was verified through Utah Division of Occupational and Professional Li- censing Controlled Substance Database (DOPL-CSD) as it is an accurate way to assess if opioid prescriptions are filled. All other information was gathered from survey responses. The survey assessed whether the patients felt adequate pain control from the quantity of opioid pills pre- scribed and if there were still unused pills from the initial prescription. The survey also asked if patients developed side effects related to the opioid and whether they received discharge counseling from ED per- sonnel regarding side effects, storage, and disposal. Patients with un- used opioids were asked if they planned to finish prescription or keep the pills for future use.

The primary outcomes were the percentage of patients with unused opioids 14 to 21 days post ED discharge and quantity of pills left unused. To assess prescribing of excess opioids, patients who never filled their prescription are included as having the full amount unused. To assess the excess of opioid pills in our community, patients who never filled their prescriptions are excluded, thus analyzing only the pills that

made into the community. Secondary outcomes included a subgroup descriptive analysis of the primary endpoint in five different pain cate- gories based on discharge diagnosis: renal colic pain, extremity pain, ab- dominal pain, chest/back pain, and facial/head pain. The survey results were presented as descriptive statistics. This study was approved by the Institutional Review Board at Intermountain Medical Center (#1050621).

Statistical analysis

Descriptive statistics were used to characterize the study population and the telephone survey results. Continuous data were assessed using Students-t-test or ANOVA and nominal variables with Fisher’s exact test; descriptive variables were presented as percentages or medians with interquartile ranges (IQR), as appropriate. All calculations were completed using R version 3.4.3 (2017-11-30).

Results

During the study period, we approached 178 patients who were discharged from the ED with one or more oral opioid prescriptions for informed consent. Of this group, 13 patients left the ED prior to our in- vestigator arriving to the patient room, 23 patients declined informed consent, and 20 patients were excluded based on our enrollment criteria. The overall telephone survey response rate was 98 of 122 (80.3%) (see Fig. 1). The median days after ED discharge of Successful contact was 15 (IQR: 14-16) and the median number of contact at- tempts was 1 (IQR: 1-2.8). From the successfully surveyed group, 47% were male and mean age was 51. Our sample patients included 95% Caucasian, which matches the demographics of Utah, which is 92% Cau- casian [22]. Additionally, 53% of patients had Commercial insurances. The median initial pain score reported was 8 (IQR: 6-10). The median number of pills prescribed was 8 (IQR: 8-12) and median morphine milligram equivalents (MME) prescribed was 60 (IQR: 40-75) (see Table 1).

Of the 98 patients evaluated, 48 patients (49%) had some unused opioid pills and an additional 9 patients (9.2%) never filled their pre- scription 14 to 21 days post ED discharge. Patients who never filled their prescription were verified through cross-reference of EHR and DOPL-CSD. The median number of excess pills prescribed was 2 (IQR: 0-6) and the median excess MME prescribed was 15 (IQR: 0-30). Of the total pills prescribed, 327 of 980 pills (33.3%) remained unused. Similarly, when converted to MME prescribed, 2246.25 of 6657.5 MME (33.7%) were unused. Excluding the patients who never filled their prescriptions, the median number of unused pills is 2 (IQR: 0-5) and median MME of unused pills is 10 (IQR: 0-25).

For the secondary outcome, patients were stratified based on pain diagnosis categories. Among the successfully surveyed group, there were 20 patients with renal colic pain, 32 patients with extremity pain, 18 patients with abdominal pain, 21 patients with chest or back pain, and 7 patients with facial or head pain. See Tables 2 and 3 for the descriptive statistics regarding each pain condition.

Fig. 1. Patient enrollment.

1570 R. Shi et al. / American Journal of Emergency Medicine 38 (2020) 1568-1571

Table 1

Baseline characteristics.

Characteristics n = 98

Age (years), mean +- SD 51 +- 18

Male sex, no. (%) 46 (47)

Race, no. (%)

White 93 (95)

Other 5 (5)

Insurance type, no. (%)

Commercial 52 (53)

Medicaid 5 (5)

Medicare 24 (24)

None 17 (17)

Initial pain score, median (IQR) 8 (6-10)

Number of pills prescribed, median (IQR) 8 (8-12)

MME prescribed, median (IQR) 60 (40-75)

Of the 98 patients evaluated, medication distribution was hydrocodone-acetaminophen (56.1%), oxycodone-acetaminophen (29.6%), oxycodone (8.2%), tramadol (5.1%), and morphine immediate release (1%). The median pain score at the time of survey was 2 (IQR: 0-4.4), which represents a median decrease of 5 (IQR: 3-8) from initial pain score at ED presentation. Adequate pain control with an opioid pre- scription was achieved in 74.2% of patients. Only 15.7% of patients expe- rienced side effects related to the opioid and 69.4% of patients reported taking additional over-the-counter pain medications. Regarding patient discharge education, 55.1% of patients reported that they received counseling from ED personnel on how to take the medication and the side effects associated with opioids, and only 21.4% of patients reported receiving counseling on storage and disposal of opioid medications. Of the 48 patients with unused opioid pills, 40 patients (83.3%) reported not expecting to finish the prescription, and 28 of 40 (70%) patients expressed plans to keep the remaining opioids for future use. Among the 12 patients with plans to dispose of medication, 7 patients had plans to dispose of opioids at the police or sheriff’s department while 5 patients reported plans to dispose of opioids in toilet or sink.

Discussion

In this single-centered prospective survey-based observational study at a level 1 trauma center ED, we found that a majority of patients had unused or unfilled opioid medication at 14 to 21 days post ED dis- charge. This is consistent with previous study by Bates, et al. with uro- logical surgical patients in that majority of patients had surplus of opioid postoperatively [21]. While this study was a convenience sample of patients seen in our ED, if extrapolated to the entire ED patient pop- ulation it suggests there are a substantial number of unused opioids in our communities. It is important to note that prior to the conception and implementation of this study, the ED physician group at Inter- mountain Medical Center independently created and utilized internal guidance that strongly encouraged a maximum prescription of eight opioid pills. This was a part of a larger health-system-wide and state- wide effort to reduce the number of opioids prescribed in our EDs due to the high historical rate of opioid deaths in the state of Utah [20]. The median number of pills prescribed in our survey sample was 8 and the MME prescribed was 60, reflecting the implementation of this policy. Despite having a low number of pills prescribed, this study shows a median over-prescribing of 2 pills or 15 MME post ED

Table 2

Percentage of patients with unused opioids.

	Renal colic	Extremity	Abdominal	Chest/Back	Facial/Head
Some leftover	13 (65%)	12 (37.5%)	10 (55.6%)	11 (52.4%)	2 (28.6%)
None leftover	5 (25%)	17 (53.1%)	6 (33.3%)	9 (42.9%)	4 (57.1%)
Never filled	2 (10%)	3 (9.4%)	2 (11.1%)	1 (4.8%)	1 (14.3%)
Total	20 (20.4%)	32 (32.7%)	18 (18.4%)	21 (21.4%)	7 (7.1%)

Table 3

Percent of opioid prescription left unused.

Pain category	Mean % of opioid unused (95% CI)	n
Renal colic	37.6 (15.7, 59.6)	20
Extremity	23.8 (6.5, 41.0)	32
Abdominal	47.3 (24.0, 70.6)	18
Chest/Back	24.1 (3.3, 45.0)	21
Facial/Head	23.6 (0, 61.6)	7

discharge. Based on our results, it appears that further reduction to 6 pills or 45 MME may be a better estimate of opioids prescriptions for ED prescribers. This dose reduction falls in line with evidence showing the risk of opioid-related overdoses are dose-dependent and that MME greater or equal to 50 per day doubles the risk of opioid-related over- doses, per the Centers for Disease Control and Prevention (CDC) guide- lines for opioid prescribing [23-25]. Similarly, when excluding individuals who never filled their prescription patients have a median of 2 unused pills or 10 MME left.

We did not find a meaningful difference in the subgroup-analysis among the five pain diagnosis categories, although abdominal pain group had most patients with unused opioids and most percent of un- used opioids. According to the survey data, there was a decrease in pain scores in patients 14 to 21 days post-discharge compared to initial ED presentation. A large majority of patients surveyed achieved ade- quate pain control with the opioid prescription provided by the ED, but a majority also used over-the-counter non-Opioid pain medications to achieve sufficient analgesia. Data on number and type of over-the- counter pain medications was not collected as part of this survey but may be useful data to collect in future studies to help guide prescribing patterns.

The survey data showed inconsistency in patient education on opi- oid prescriptions by ED personnel. Only 55.1% of patients we surveyed recalled receiving counseling regarding the opioid prescriptions and the side-effects associated with taking them. In our ED, physicians, nurses, and pharmacists are able to provide counseling regarding dis- charge opioid medications, but there is not required standardized edu- cation or training regarding the specific content of the counseling. Therefore, while the percentage of patients who were actually received counseling may be higher than 55.1%, patients may not have recalled the information 14 to 21 days later. Similarly, only 21.4% of patients sur- veyed recalled receiving information on how to store and dispose of the opioid medications. The lack of information on storage and dispels likely contributed to the finding that 58.3% with unused opioids decided to keep the prescription for future use since many patients surveyed iden- tified that the lack of instruction for disposal was a contributing factor for the decision. This represents 145 prescription opioid pills or 1133.8 MME available at risk for misuse, potentially contributing to the opioid epidemic. For the patients with plans to dispose of their opioid medica- tions, 9 of the 12 patients described proper disposal techniques per U.S. Food & Drug Administration (FDA) guideline for disposal of controlled substances. Three patients planned to dispose of their hydrocodone- acetaminophen in the toilet or sink, which is against FDA recommenda- tions since hydrocodone-acetaminophen should only be flushed if take- back options are not available [26]. Our findings are similar to previous study in post-surgical patients in our institution in the overall lack of pa- tient education regarding opioid disposal, as well as the percentage of improper disposal of leftover opioid medications [21].

The importance of proper and consistent patient education on pre-

scription opioids, especially regarding storage and disposal information and resources is highlighted by this study. Patients may gain some of the information from prescription handouts or package inserts, but ma- jority are likely unaware of the specifics. This study identified potential future Quality improvement projects in standardizing training for pa- tient discharge counseling among the ED nurses, physicians, and pharmacists.

R. Shi et al. / American Journal of Emergency Medicine 38 (2020) 1568-1571 1571

Limitations

There are several limitations to this study. This was a single-centered study with a fairly homogenous patient population. It may not translate to patient populations of other areas of the country where there is more social-economic diversity. This study utilized a convenience sample which could have introduced selection bias. Additionally, we were unable to collect the baseline information of patients who did not give informed consent or reasons for declining consent, and therefore could further in- crease the risk of selection bias. Survey-based studies inherently include a risk for recall bias. This is especially pertinent for patients recollecting if they received counseling by the ED personnel. Fourteen to 21 days post-ED discharge may not have been enough time for some patients to adequately treat their pain; however, only 8% of patients surveyed expressed a desire to continue the opioid. Behavioral changes with opioid utilization may have also occurred since patients were approached in the ED for informed consent. Patients willing to enroll in the study may be more likely to be judicious with opiate use, however, the exact content of the survey questions were not given to the patient prior to the tele- phone interview, including questions pertaining to our primary outcomes of unused opioids. Additionally, physician prescribing and counseling be- havior may have also been affected since the ED physicians were aware of the study and changes had recently been made to ED opioid prescribing protocols in the institution. Finally, we were unable to verify if the patient had chronic pain, acute on chronic pain, or actual acute pain conditions, which may have skewed the results of the study.

Conclusions

The majority of patients in this study had unused or unfilled pre- scription opioids 14 to 21 days post ED discharge. We also identified that most patients did not recall receiving opioid related education. Fur- ther prospective studies are warranted to identify the appropriate num- ber of opioids prescribed and the effects of standardized opioid education for patients discharged from the emergency department.

Financial disclosure

This research did not receive any specific grant from funding agen- cies in the public, commercial, or not-for-profit sectors.

Acknowledgements

Harland Hayes, MD.

Appendix A

Survey.

Telephone survey questions

Q1. Please rate your current pain on a scale of 0 to 10 0 to 10

References

1. Lyapustina T, Castillo R, Omaki E, Shields W, McDonald E, Rothman R, et al. The contribution of the emergency department to opioid pain reliever misuse and diversion: a critical review. Pain Pract. 2017; 17(8): 1097-1104. [PubMed: 28226416].
2. Zacny J, Bigelow G, Compton P, Foley K, Iguchi M, Sannerud C. College on prob- lems of Drug dependence taskforce on prescription opioid non-medical use and abuse: position statement. Drug Alcohol Depend. 2003; 69: 215-232. [PubMed: 12633908].
3. Schuchat A, Houry D, Guy GP Jr. New data on opioid use and prescribing in the United States. JAMA. 2017; 318(5): 425-26. [PubMed: 28687823].
4. Guy Jr GP, Zhang K, Bohm MK, Losby J, Lewis B, Young R, et al. Vital signs: changes in opioid prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017;66(26):697-704 [PubMed: 28683056].
5. Centers for Disease C, Prevention. Vital signs: overdoses of prescription opioid pain relievers-United States, 1999-2008. MMWR Morb Mortal Wkly Rep. 2011;60 (43):1487-92 [PubMed: 22048730].
6. Smulowitz PB, Cary C, Boyle KL, Novack V, Jaminas L. Variation in opioid prescribing patterns between ED providers. Intern Emerg Med. 2016;11:1121-4 [PubMed: 27424280].
7. Stempniak M. The opioid epidemic. Hosp Health Netw. 2016;90(3):22-9 [PubMed: 27180399].
8. Burton JH, Hoppe JA, Echternach JM, Rodger JM, Donato M. Quality improvement ini- tiative to decrease variability of emergency physician opioid analgesics prescribing. West J Emerg Med. 2016;17(3):258-63 [PubMed: 27330656].
9. Strayer RJ, Motov SM, Nelson LS. Something for pain: responsible opioid use in emergency medicine. Am J Emerg Med. 2016; 35(2): 337-341. [PubMed: 27802876].
10. Substance Abuse and Mental Health Services Administration, Drug Abuse Warning Network, 2010: National Estimates of drug-related emergency department visits. HHS publication no. (SMA) 12-4733, DAWN series D-38. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012. . http://www.samhsa.gov. Accessed July 21, 2017.
11. Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011;1299-1301:305 [PubMed:

    21467282].

    Poon SJ, Greenwood-Ericksen MB. The opioid prescription epidemic and the role of emergency medicine. Ann Emerg Med. 2014;64(5):490-5 [PubMed: 25017821].

12. Lembke A. Why doctors prescribe opioids to known opioid abusers. N Engl J Med. 2012;367:1580-1 [PubMed: 23094719].
13. Bhakta HC, Marco CA. Pain management: association with patient satisfaction among emergency department patients. J Emerg Med. 2014; 46: 456-464. [PubMed: 23849365].
14. Hoppe JA, Nelson LS, Perrone J, Weiner SG, POSED study investigators. Opioid pre- scribing in a cross section of US emergency departments. Ann Emerg Med. 2015; 66(3):253-259.e1 [PubMed: 25952503].
15. Osborn SR, Yu J, Williams B, Vasilyadis M, Blackmore CC. Changes in provider pre- scribing patterns after implementation of an emergency department prescription opioid policy. J Emerg Med. 2017; 52(4): 538-46. [PubMed: 28111065].
16. Tamayo-Sarver JH, Dawson NV, Cydulka RK, Wigton RS, Backer DW. Variability in emergency physician decision making about prescribing opioid analgesics. Ann Emerg Med. 2004;43(4):483-93 [PubMed: 15039692].
17. a Barnett ML, Ar Olenski, Jena AB. Opioid-prescribing patterns of emergency physi- cians and risk of long-term use. N Engl J Med. 2017;376(7):663-73 [PubMed: 28199807].

    b Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2017;10:399 [PubMed: 17525776].

    Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription opioid analgesics commonly unused after surgery: a systematic review. JAMA Surg. 2017; 152(11): 1066-1071. [PubMed: 28768328].

18. Johnson E. HB 137 final report. . http://health.utah.gov/prescription/pdf/2009final_ programreport.pdf; 2009. Accessed date: 27 June 2018.
19. Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in uro-

    Q2. Do you feel like your pain was adequately controlled with the opioid Medication prescription?

    Q3. You were given a prescription opioid medication when you discharged from the ED. Do you have any pills left? If so, how many?

    Q4. Did you experience any side effects that made you stop taking the opioid medication?

    Q5. Since you have been discharged from the ED, have you taken any over-the-counter pain medications?

    Q6. Did you receive information from doctor, nurse, or pharmacist on how to correctly take the medication and potential side effects?

    Q7. Did you receive information from doctor, nurse, or pharmacist regarding how to store or dispose of the opioid medication?

    Yes/No

    Yes/No

    # Quantity Yes/No Yes/No Yes/No

    Yes/No

    logical practice. J Urol. 2011; 185(2): 551-555. [PubMed: 21168869].

    Utah Department of Health Center for Multicultural Health. Health status report by race and ethnicity. . http://health.utah.gov/disparities/data/race-ethnicity-report/ healthstatus.pdf; 2010. Accessed date: 19 August 2019.

20. Zedler B, Xie L, Wang L, Joyce A, Vick C, Kariburyo F, et al. Risk factors for serious pre- scription opioid-related toxicity or overdose among Veterans Health Administration patients. Pain Med. 2014; 15(11): 1911-29. [PubMed: 24931395].
21. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Associa- tion between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305(13):1315-21 [PubMed: 21467284].
22. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. JAMA. 2016;315(15):1624-45 [PubMed: 26977696].
23. FDA. Disposal of unused medicines: what you should know. . https://www.fda.gov/ Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/

    Q8. Do you expect you will finish all of the pills in this prescription? Yes/No/NA

    EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm; 2018.

    Accessed date: 27 June 2018.