The United States currently is undergoing an opioid crisis. Research has demonstrated that many postoperative pain prescription amounts are written to excess.1,2 The potential for addiction is increased with each pill, as excess pills lead to greater potential for abuse or diversion.3 Furthermore, in patients undergoing surgery including rotator cuff repair, a history of chronic opioid use preoperatively leads to worse patient-reported outcomes and greater opioid requirements postoperatively.4–6 To counteract this epidemic and the negative effects of chronic opioid use, physicians and politicians have focused on limiting the overprescription of narcotic pain medication. Because of the growing epidemic and deadly nature of opioid use, national and state legislators are passing laws regulating the prescription of opioid medications.
The state of New Jersey recently passed one of the most restrictive laws regarding the prescribing of opioids. With the passing of New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, on February 15, 2017, providers currently can prescribe no more than a 5-day supply of a Schedule II controlled substance for acute pain, including postoperative pain. A second prescription may be given but requires significant documentation and justification. The responsibility clearly is placed on providers to justify any narcotic prescription and to educate patients. Providers are required to document a thorough history, access and consider a relevant prescription monitoring program, develop a treatment plan, and discuss the reason for opioid treatment options and risks.7 Failure to adhere to regulations will provide a basis to suspend or limit the license of prescribing physicians.8
This study evaluated the effect of New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, on the prescription of postoperative opioids following arthroscopic rotator cuff repair (RCR). The authors hypothesized this legislation would lead to a decrease in the prescription of postoperative opioids.
Materials and Methods
This study was a single-center, retrospective chart review conducted at a large academically affiliated private institution. Institutional review board approval was obtained for this study. All 4 participating orthopedic surgeons were fellowship trained in either shoulder and elbow or sports medicine. Patients were included in the study if they were older than 18 years and underwent arthroscopic RCR; no patients were excluded.
Two cohorts were developed: a pre-law cohort and a post-law cohort. The prelaw cohort was developed with consecutive patients who underwent arthroscopic RCR during a 6-month period (June 2016 to December 2016) prior to the inception of the New Jersey opioid state law. The post-law cohort consisted of consecutive patients who underwent arthroscopic RCR at the same institution during a similar 6-month period (June 2017 to December 2017) after the law was passed. There was a minimum of 6 months of postoperative follow-up for both the pre- and post-law cohorts.
A 6-month window for implementation of the law was given between both cohorts. During that time, an opioid committee was developed at the authors' practice to ensure compliance with the law. The practice-wide protocol for law implementation and compliance was as follows: a maximum 5-day opioid prescription following surgery; appropriate documentation of a thorough history, physical examination, and treatment plan discussing the cause of pain; use of the Prescription Monitoring Program Database; and physician conversation with appropriate documentation and justification for a second prescription (shown to be necessary, did not present an undue risk of abuse or addiction, and discussed risks with the patient).
For each cohort, patient age, sex, body mass index (BMI), alcohol consumption, smoking status, and preoperative opioid consumption were recorded; a previous diagnosis of diabetes or chronic pain syndrome also was noted. These variables were compared between cohorts to ensure they were matched groups (Table 1). Alcohol consumption, smoking status, diabetes, and chronic pain syndromes were self-reported by patients on the patient in-take forms and were recorded in patients' electronic medical records. Body mass index also was taken from patients' electronic medical records.
Demographics for Patients Who Underwent Arthroscopic Rotator Cuff Repair Pre-Law and Post-Law
Preoperative opioid consumption was recorded using the New Jersey Prescription Monitoring Program Aware Drug Database, which is a centralized database that tracks all narcotics prescriptions filled by a patient in the state, regardless of the prescriber. This database allows practitioners to access patients' opioid use for the previous 2 years. Preoperative consumption was defined as any amount of opioid prescribed by any provider 3 months prior to surgery. Three months was chosen because the majority of opioid prescriptions were given for 1 month, and this allowed 2 months for drug clearance and for patients to achieve an opioid-free state.
The primary outcome measure was prescribed postoperative morphine milligram equivalents (MME), a value assigned to opioids to represent their relative potencies. Using the New Jersey Prescription Monitoring Program Aware Drug Database, the authors collected the number of postoperative opioid pills prescribed for each patient. For the purpose of this study, all narcotics were converted to MME to account for the different opiates prescribed (eg, oxycodone/acetaminophen, oxycodone, or tramadol).4 Pill count also was reported, which is the number of all narcotic pills each patient was prescribed, regardless of opiate and prescription strength. The MMEs and pill counts were compared between the preand post-law cohorts.
To compare differences in patient demographics between the pre- and post-law cohorts, t tests and chi-square tests were used. Continuous data (age, BMI, MME, and pill count) were evaluated for normality by visualizing the Normal QQ plot and by computing values for skewness and kurtosis. Differences in age and BMI between the two patient groups then were evaluated using t tests for independent samples. Chi-square tests of independence tested for differences between groups for the remaining categorical data: alcohol consumption, smoking status, diabetes, chronic pain syndrome, and preoperative opioid use. Data means with SD and frequencies were reported for continuous and categorical data, respectively.
A natural log transformation was applied to normalize the distribution of the MME prescribed and pill count prescribed in both groups. To test for an effect of the law, t tests for independent samples were used on the transformed MME and pill count values. The MME and pill count data were summarized by the median and interquartile range (IQR) of the raw data.
Significance was set at P<.05 for all tests. Analyses were performed using Statistical Package for the Social Sciences, version 23, software (IBM Corporation).
The study included 463 patients; no eligible patients were excluded. The prelaw cohort comprised 265 patients, and the post-law cohort comprised 198 patients. Patient demographics are listed in Table 1. There were no statistically significant differences between the two groups.
Physicians prescribed less narcotics following the inception of the New Jersey state law (Figures 1–2). Specifically, prior to the law, physicians prescribed a median of 1250 MME (IQR, 900–1800 MME), which was significantly greater than the median of 900 MME (IQR, 550–1050 MME) prescribed after the state law was enacted (P<.001). Pre-law, the range was 0 to 464,400 MME; however, with outliers excluded, the range was 0 to 3150. Post-law, the range was 0 to 180,450 MME; however, with outliers excluded, the range was 0 to 1800.
The prescribed morphine milligram equivalents (MME) for patients who underwent arthroscopic rotator cuff repair from June to December 2016 (pre-law) compared with patients who underwent arthroscopic rotator cuff repair from June to December 2017 (post-law). Box plot summarizes the median and interquartile range. Physicians prescribed a significantly (P<.001) higher MME in the pre-law cohort.
The prescribed number of pills for patients who underwent arthroscopic rotator cuff repair from June to December 2016 (pre-law) compared with patients who underwent arthroscopic rotator cuff repair from June to December 2017 (post-law). Box plot summarizes the median and interquartile range. Physicians prescribed a significantly (P<.001) higher number of pills in the prelaw cohort.
Similarly, prior to the law, physicians prescribed a median of 100 pills (IQR, 60–175 pills) to patients, which was significantly greater than the median of 60 pills (IQR, 60–90 pills) prescribed to patients after the state law was enacted (P<.001). Pre-law, the number of pills prescribed ranged from 0 to 4442; however, with outliers excluded, the range was 0 to 348. Post-law, the number of pills prescribed ranged from 0 to 1354; however, with outliers excluded, the range was 15 to 135.
This study examined whether New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, regulating the prescription of opioids, had an effect on the number of opioids prescribed after arthroscopic RCR. The state law was designed in an effort to decrease the amount of excess pills available for potential abuse or diversion. The law intended to vastly reduce the number of opioids prescribed to patients for all conditions by limiting the number of prescriptions—and therefore the number of pills—that physicians can prescribe. This study found that after inception of the law, there was a significant decrease in prescription of narcotic pain medication.
A review of the literature on government regulations and the effect on opioids prescribed reveals comprehensive mandatory use laws—laws that require prescribers to review patient prescription history of controlled substances prior to prescribing opioids in particular—for prescription drug monitoring programs have made significant improvements in the opioid epidemic.9 After implementation of a similar law in Rhode Island, investigators found a significant reduction in opioid use after 90 days across a variety of procedures, including RCR.10 Dowell et al11 reported a statistically significant decrease in the total opioid-related overdose death rates, prescription opioid-related death rates, and opioid prescribing in states with comprehensive mandatory use laws vs states without such laws.
Buchmueller and Carey12 found significant effects of the mandatory use law on decreasing rates of prescriber and pharmacy shopping behaviors, overlapping opioid prescriptions, and continuous opioid supply of at least 7 months. Win-stanley et al13 reported the law's implementation was associated with significant decreases in opioid prescriptions and multiple provider episodes. Review of the literature supports the current authors' results that New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, has imparted a decreased rate in the prescription for postoperative opioids.
Although there was a reduction in opioid prescriptions following the passage of New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, there are potential downsides to a universal state opioid regulation. Nociceptive pain follows a bell-shaped distribution curve. No two patients experience pain in a similar manner. Likewise, patients respond differently to varying pain management strategies. The development of different pain management strategies, including patient education, multimodal pain management protocols, and nerve blocks, has helped reduce opioid consumption; however, opioids continue to be an effective analgesic.14–16 Limiting opioids in certain patient cohorts may lead to unnecessary suffering, illicit acquisition, and poor patient satisfaction. These laws may interfere with a physician's ability to provide individualized patient care.
A second potentially negative outcome is the creation of a legislative onus on physicians to monitor, educate, and either manage or prevent opioid dependence among their patients. Physicians are mandated to monitor patients whenever providing opioid medication using the New Jersey Prescription Monitoring Program Aware Drug Database to ensure patients show no patterns of opioid abuse. Physicians must provide documentation that patients have been educated about potential risks and alternative treatment options. Furthermore, the initial opioid script cannot exceed 5 days. Additional scripts can be prescribed but require justification, a documented conversation with the patient, and on the third script, the patient must enter an opioid contract. Failure to comply can lead to punitive action from the state, including suspension of medical license. The letter of the law also is detailed precisely, and physician error in documentation can lead to considerable medical legal risk if any patient were to abuse or become dependent on opioids.8
This study had several limitations. First, the primary outcome method was distribution of opioids and not patient consumption. No formal pill count was performed. The authors decided on this outcome because the opioid epidemic is fueled by the availability of pills for both patient consumption and diversion to the public. Second, the two cohorts occurred consecutively as the authors were unable to design a method simultaneously. The reduction in opioid prescription is multifactorial, and it is possible opioid prescribing trends may have decreased during a similar time period without the legislation. However, during the authors' investigative period, the most significant postoperative pain protocol change was compliance with the New Jersey law. To become compliant, a physician work-flow change was required. This included mandatory monitoring of the New Jersey Prescription Monitoring Program Aware Drug Database, appropriate documentation, patient education, and no more than a 5-day supply for opioid-naive patients. Without practice-wide compliance, the effectiveness of the law would be jeopardized.
Postoperative opioid prescriptions after RCR dropped precipitously following the passage of New Jersey State Law, P.L. 2017 Chapter 28 22, C.24:21–15.2, in one large compliant orthopedic group. Although state legislation and regulations appear to be beneficial for reduction of opioid use, it requires significant resources and practice management to become compliant. Successful implementation requires a thorough understanding of the law and practice-wide workflow adjustments.
- Manchikanti L, Helm S II, Fellows B, et al. Opioid epidemic in the United States. Pain Physician. 2012;15(3 suppl):ES9–ES38.
- Calculating total daily dose of opioids for safer dosage. cdc.gov. Accessed March 19, 2018. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf
- 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. doi:10.2106/JBJS.15.00614 [CrossRef]. PMID:27869630
- Sabesan VJ, Petersen-Fitts GR, Sweet MC, Katz DL, Lima DJL, Whaley JD. The impact of preoperative opioid use on outcomes after arthroscopic rotator cuff repair. JSES Open Access. 2018;2(3):155–158. doi:10.1016/j.jses.2018.05.001 [CrossRef]. PMID:30675587
- Westermann RW, Anthony CA, Bedard N, et al. Opioid consumption after rotator cuff repair. Arthroscopy. 2017;33(8):1467–1472. doi:10.1016/j.arthro.2017.03.016 [CrossRef]. PMID:28571723
- Williams BT, Redlich NJ, Mickschl DJ, Grindel SI. Influence of preoperative opioid use on postoperative outcomes and opioid use after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2019;28(3):453–460. doi:10.1016/j.jse.2018.08.036 [CrossRef]. PMID:30503333
- An Act Concerning Substance Use Disorders and Revising and Supplementing Various Parts of the Statutory Law. February15, 2017. P.L. 2017. Chapter 28. C.24:21-15.2.
- An Act Concerning Substance Use Disorders and Revising and Supplementing Various Parts of the Statutory Law. February15, 2017. P.L. 2017. Chapter 28. C.17B:27A-19.25, n.
- Strickler GK, Zhang K, Halpin JF, Bohnert ASB, Baldwin GT, Kreiner PW. Effects of mandatory prescription drug monitoring program (PDMP) use laws on prescriber registration and use and on risky prescribing. Drug Alcohol Depend. 2019;199:1–9. doi:10.1016/j.drugalcdep.2019.02.010 [CrossRef]. PMID:30954863
- Reid DBC, Shah KN, Shapiro BH, Ruddell JH, Akelman E, Daniels AH. Mandatory prescription limits and opioid utilization following orthopaedic surgery. J Bone Joint Surg Am. 2019;101(10):e43. doi:10.2106/JBJS.18.00943 [CrossRef]. PMID:31094987
- Dowell D, Zhang K, Noonan RK, Hockenberry JM. Mandatory provider review and pain clinic laws reduce the amounts of opioids prescribed and overdose death rates. Health Aff (Millwood). 2016;35(10):1876–1883. doi:10.1377/hlthaff.2016.0448 [CrossRef]. PMID:27702962
- Buchmueller TC, Carey C. The effect of prescription drug monitoring programs on opioid utilization in Medicare. Am Econ J Appl Econ. 2018;10:77–112. doi:10.1257/pol.2016009477 [CrossRef]
- Winstanley EL, Zhang Y, Mashni R, et al. Mandatory review of a prescription drug monitoring program and impact on opioid and benzodiazepine dispensing. Drug Alcohol Depend. 2018;188:169–174. doi:10.1016/j.drugalcdep.2018.03.036 [CrossRef]. PMID:29778769
- Syed UAM, Aleem AW, Wowkanech C, et al. Neer Award 2018. The effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg. 2018;27(6):962–967. doi:10.1016/j.jse.2018.02.039 [CrossRef]. PMID:29599038
- Patel MA, Gadsden JC, Nedeljkovic SS, et al. Brachial plexus block with liposomal bupivacaine for shoulder surgery improves analgesia and reduces opioid consumption: results from a multicenter, randomized, double-blind, controlled trial. Pain Med. 2020;21(2):387–400. doi:10.1093/pm/pnz103 [CrossRef]. PMID:31150095
- Cho C-H, Song K-S, Min B-W, et al. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc.2011;19(10):1744–1748. doi:10.1007/s00167-010-1294-y [CrossRef] PMID:20957469
Demographics for Patients Who Underwent Arthroscopic Rotator Cuff Repair Pre-Law and Post-Law
|Characteristic||Pre-law (n=265)||Post-law (n=198)||P|
|Age, mean (SD), y||57 (10)||58 (10)||.677|
|Body mass index, mean (SD), kg/m2||30.7 (5.8)||29.9 (5.3)||.119|
| Male||159 (60%)||108 (55%)||.280|
| Female||106 (40%)||90 (45%)|
|Alcohol use, No.a|
| Yes||115 (57%)||95 (58%)||<.999|
| No||86 (43%)||70 (42%)|
| Yes||47 (19%)||31 (17%)||.616|
| No||195 (81%)||151 (83%)|
| Yes||12 (5%)||13 (7%)||.452|
| No||253 (95%)||185 (93%)|
|Preoperative prescription, No.a|
| Yes||101 (40%)||86 (47%)||.223|
| No||149 (60%)||98 (53%)|
|Chronic pain syndrome, No.|
| Yes||2 (1%)||0 (0%)||Not applicable|
| No||263 (99%)||198 (100%)|