Opioid Prescribing Patterns in Orthopaedic Surgery Patients: the Effect of New York State Regulations and Institutional Initiatives.

BACKGROUND: The opioid epidemic in the United States is a public health crisis. As a result, regulatory agencies, including state governments, have enacted initiatives to decrease the use of opioids in the perioperative setting. The purpose of this study was to compare opioid utilization in orthopaedic surgery patients at discrete points after implementation of State regulatory and institution/physician-led initiatives to decrease opioid utilization in the perioperative period. METHODS: We reviewed the electronic medication orders for all patients who underwent orthopaedic surgery procedures between September 2015 and June 2018 at our urban academic medical center. The outcome measures were the number of patients who were prescribed opioid medications, duration of prescription (days), and average milligram morphine equivalents prescribed. Patients were divided into three time cohorts to assess the effect of the NY State (NYS) policy and institutional initiatives to decrease opioid utilization. RESULTS: A total of 20,483 patients met the inclusion criteria over all three time cohorts. After the initiation of the NYS 7-day supply legislation, there was a decrease in the average supply of opioids prescribed from 10.1 to 7.6 days and the average daily milligram morphine equivalent decreased from 67.9 to 56.7 mg (P < 0.0001). However, with the combination of physician education and surgeon-led institutional initiatives, the percentage of patients who were prescribed opioids decreased by over 10% (96% to 84%), with continued decrease in duration of prescription by 1.0 to 6.4 days (P < 0.0001). CONCLUSIONS: The addition of institution-led initiatives and education programs to previously established government-led prescription limits produced a substantial reduction in the amount of opioids prescribed to orthopaedic surgery patients in the perioperative period. Although mandatory limits set by the state government resulted in a decreased amount of opioid medications being prescribed per patient, it was only after the introduction of educational programs and institution- and physician-led programs that perioperative patient exposure to opioids decreased. LEVEL OF EVIDENCE: Level III.

The opioid crisis: Origins, trends, policies, and the roles of pharmacists.

PURPOSE: The purpose of this review is to (1) provide information concerning the opioid crisis including origins, trends, and some important related laws/policies; and (2) summarize the current involvement and impact of pharmacists in helping to address the crisis, as well as examine practices in other healthcare disciplines from which pharmacists might derive guidance and strategies. SUMMARY: Contributors to the opioid crisis included campaigns to treat pain as a fifth vital sign and to use opioids in treatment of non-cancer-related pain, as well as aggressive marketing of opioid analgesics by pharmaceutical companies. To address the crisis, numerous strategies have been implemented at the policy/legislative, health-system, and patient levels, such as prescription drug monitoring programs (PDMPs), increased regulation of pain clinics, and expanded use of naloxone. Pharmacists have a critical role to play in interventions to address opioid misuse and reduce harm resulting from misuse. Such interventions include patient screening and risk stratification, patient and community education and outreach concerning appropriate pain management, medication reviews/medication therapy management, education on safe storage and disposal, distribution of naloxone/opioid rescue kits and training on their proper use, and referral of patients to addiction treatment, among other strategies. CONCLUSION: Pharmacists have multiple, complex roles in addressing the opioid crisis. Outcomes of several studies provide substantial evidence that pharmacists can make an impact through appropriate pain management, use of PDMPs, opioid overdose prevention training, and medication reviews and counseling, among other interventions.

Standardizing Opioid Prescribing Practices for Cancer-Related Pain Via a Novel Interactive Documentation Template at a Public Hospital.

PURPOSE: Opioid misuse during cancer pain management places patients at risk for harm and physicians for legal liability. Identifying and monitoring patients who are at risk is challenging given the lack of validated clinical tools and evidence-based guidelines. In the current study, we aimed to standardize opioid prescribing practices at a community oncology clinic to help ensure patient safety and physician compliance with Texas state regulations. METHODS: We used the Plan-Do-Study-Act methodology. In the planning phase, current practices of assessing opioid efficacy, toxicity, and misuse were determined by surveying clinic physicians and reviewing patients' charts. We developed a new standardized process that incorporated published literature, the Texas Administrative Code, and expert opinion. Two interactive documentation templates (SmartPhrases) were designed to implement the standardized process. The intervention was studied using repeat physician surveys and chart reviews, which prompted action for refinement and sustainability. RESULTS: At baseline, 9% of providers followed a systematic approach to prescribing opioids and 86% expressed an interest in process standardization. We noted high interprovider variability in the opioid risk stratification and refill process. At 2 months and 6 months postimplementation, provider satisfaction with the intervention was 83% and 75%, whereas compliance with SmartPhrase use was 70% and 54%, respectively. The frequency of state database check improved from 36% to 94% at 6 months. Improvement was also noted in assessment and documentation of baseline risk, chemical coping, and toxicity. CONCLUSION: We implemented a systematic approach for assessing opioid misuse, toxicity, and efficacy during cancer pain management at a community oncology clinic. The approach resulted in notable improvement in provider practices and documentation compliance.

Mandatory Prescription Limits and Opioid Utilization Following Orthopaedic Surgery.

BACKGROUND: Since 2016, over half of the states in the United States have passed mandatory limits on opioid prescriptions, with limited evidence of effectiveness. In this study, we evaluated postoperative opioid prescriptions following orthopaedic surgery before and after the implementation of one of the earliest such laws. METHODS: Following the implementation of state legislation limiting opioid prescriptions for opioid-naïve patients, 2 patient cohorts (pre-law and post-law) were compared. Both opioid-tolerant and opioid-naïve patients undergoing 6 common orthopaedic procedures (total knee arthroplasty, rotator cuff repair, anterior cruciate ligament reconstruction, open reduction and internal fixation for a distal radial fracture, open reduction and internal fixation for an ankle fracture, and lumbar discectomy) met inclusion criteria. Patients undergoing >1 primary procedure in the same operative session were excluded. All benzodiazepine and opioid prescriptions from 30 days before to 90 days after the surgical procedure were recorded. Logistic regression was performed to determine risk factors for prolonged postoperative opioid use. RESULTS: In this study, 836 pre-law patients were compared with 940 post-law patients. The 2 groups were similar with regard to demographic variables, baseline opioid tolerance, and recent benzodiazepine use (all p > 0.05). Post-law, for all patients, there were decreases in the initial prescription pill quantity (49.65 pills pre-law and 22.08 pills post-law; p < 0.001) and the total morphine milligram equivalents (MMEs) (417.67 MMEs pre-law and 173.86 MMEs post-law; p < 0.001), regardless of patient preoperative opioid exposure (all p < 0.001). Additionally, there were decreases in the mean cumulative 30-day MMEs (790.01 MMEs pre-law and 524.61 MMEs post-law; p < 0.001) and the 30 to 90-day MMEs (243.51 MMEs pre-law and 208.54 MMEs post-law; p = 0.008). Despite being specifically exempted from the legislation, opioid-tolerant patients likewise experienced a significant decrease in cumulative 30-day MMEs (1,304.08 MMEs pre-law and 1,015.19 MMEs post-law; p = 0.0016). Opioid-tolerant patients required more postoperative opioids at all time points and had an increased likelihood of prolonged opioid use compared with those who were opioid-naïve preoperatively (odds ratio, 8.73 [95% confidence interval, 6.21 to 12.29]). CONCLUSIONS: A clinically important and significant reduction in opioid utilization after orthopaedic surgery was observed following the implementation of statewide mandatory opioid prescription limits. CLINICAL RELEVANCE: After implementation of mandatory opioid prescription regulations, a clinically important and significant decline in the volume of opioids dispensed in the short term and intermediate term following orthopaedic surgery was observed. Furthermore, important clinical predictors of prolonged postoperative opioid use, including preoperative opioid use and preoperative benzodiazepine use, were identified. These findings have important implications for public health, as well as the potential to influence policymakers and to change practice among orthopaedic surgeons.

Protocol: mixed-methods study to evaluate implementation, enforcement, and outcomes of U.S. state laws intended to curb high-risk opioid prescribing.

BACKGROUND: The U.S. opioid epidemic has been driven by the high volume of opioids prescribed by healthcare providers. U.S. states have recently enacted four types of laws designed to curb high-risk prescribing practices, such as high-dose and long-term opioid prescribing, associated with opioid-related mortality: (1) mandatory Prescription Drug Monitoring Program (PDMP) enrollment laws, which require prescribers to enroll in their state's PDMP, an electronic database of patients' controlled substance prescriptions, (2) mandatory PDMP query laws, which require prescribers to query the PDMP prior to prescribing an opioid, (3) opioid prescribing cap laws, which limit the dose and/or duration of opioid prescriptions, and (4) pill mill laws, which strictly regulate pain clinics to prevent nonmedical opioid prescribing. Some pain experts have expressed concern that these laws could negatively affect pain management among patients with chronic non-cancer pain. This paper describes the protocol for a mixed-methods study analyzing the independent effects of these four types of laws on opioid prescribing patterns and chronic non-cancer pain treatment, accounting for variation in implementation and enforcement of laws across states. METHODS: Many states have enacted multiple opioid prescribing laws at or around the same time. To overcome this issue, our study focuses on 18 treatment states that each enacted a single law of interest, and no other potentially confounding laws, over a 4-year period (2 years pre-/post-law). Qualitative interviews with key leaders in each of the 18 treatment states will characterize the timing, scope, and strength of each state law's implementation and enforcement. This information will inform the design and interpretation of synthetic control models analyzing the effects of each of the two types of laws on two sets of outcomes: measures of (1) high-risk opioid prescribing and (2) non-opioid treatments for chronic non-cancer pain. DISCUSSION: Study of mandatory PDMP enrollment, mandatory PDMP query, opioid prescribing cap, and pill mill laws is timely given a dynamic policy environment in which numerous states pass, revise, implement, and enforce varied laws to address opioid prescribing each year. Findings will inform enactment, implementation, and enforcement of these laws in additional states.

Opioid Prescriptions by Specialty in Ohio, 2010-2014.

Background: The current US opioid epidemic is attributed to the large volume of prescribed opioids. This study analyzed the contribution of different medical specialties to overall opioids by evaluating the pill counts and morphine milligram equivalents (MMEs) of opioid prescriptions, stratified by provider specialty, and determined temporal trends. Methods: This was an analysis of the Ohio prescription drug monitoring program database, which captures scheduled medication prescriptions filled in the state as well as prescriber specialty. We extracted prescriptions for pill versions of opioids written in the calendar years 2010 to 2014. The main outcomes were the number of filled prescriptions, pill counts, MMEs, and extended-released opioids written by physicians in each specialty, and annual prescribing trends. Results: There were 56,873,719 prescriptions for the studied opioids dispensed, for which 41,959,581 (73.8%) had prescriber specialty type available. Mean number of pills per prescription and MMEs were highest for physical medicine/rehabilitation (PM&R; 91.2 pills, 1,532 mg, N = 1,680,579), anesthesiology/pain (89.3 pills, 1,484 mg, N = 3,261,449), hematology/oncology (88.2 pills, 1,534 mg, N = 516,596), and neurology (84.4 pills, 1,230 mg, N = 573,389). Family medicine (21.8%) and internal medicine (17.6%) wrote the most opioid prescriptions overall. Time trends in the average number of pills and MMEs per prescription also varied depending on specialty. Conclusions: The numbers of pills and MMEs per opioid prescription vary markedly by prescriber specialty, as do trends in prescribing characteristics. Pill count and MME values define each specialty's contribution to overall opioid prescribing more accurately than the number of prescriptions alone.

The US Opioid Crisis: Current Federal and State Legal Issues.

The United States is in the midst of a devastating opioid misuse epidemic leading to over 33,000 deaths per year from both prescription and illegal opioids. Roughly half of these deaths are attributable to prescription opioids. Federal and state governments have only recently begun to grasp the magnitude of this public health crisis. In 2016, the Centers for Disease Control and Prevention released their Guidelines for Prescribing Opioids for Chronic Pain. While not comprehensive in scope, these guidelines attempt to control and regulate opioid prescribing. Other federal agencies involved with the federal regulatory effort include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Department of Justice. Each federal agency has a unique role in helping to stem the burgeoning opioid misuse epidemic. The DEA, working with the Department of Justice, has enforcement power to prosecute pill mills and physicians for illegal prescribing. The DEA could also implement use of prescription drug monitoring programs (PDMPs), currently administered at the state level, and use of electronic prescribing for schedule II and III medications. The FDA has authority to approve new and safer formulations of immediate- and long-acting opioid medications. More importantly, the FDA can also ask pharmaceutical companies to cease manufacturing a drug. Additionally, state agencies play a critical role in reducing overdose deaths, protecting the public safety, and promoting the medically appropriate treatment of pain. One of the states' primary roles is the regulation of practice of medicine and the insurance industry within their borders. Utilizing this authority, states can both educate physicians about the dangers of opioids and make physician licensure dependent on registering and using PDMPs when prescribing controlled substances. Almost every state has implemented a PDMP to some degree; however, in addition to mandating their use, increased interstate sharing of prescription information would greatly improve PDMPs' effectiveness. Further, states have the flexibility to promote innovative interventions to reduce harm such as legislation allowing naloxone access without a prescription. While relatively new, these types of laws have allowed first responders, patients, and families access to a lifesaving drug. Finally, states are at the forefront of litigation against pharmaceutical manufacturers. This approach is described as analogous to the initial steps in fighting tobacco companies. In addition to fighting for dollars to support drug treatment programs and education efforts, states are pursuing these lawsuits as a means of holding pharmaceutical companies accountable for misleading marketing of a dangerous product.

Opioid analgesics and heroin: Examining drug misuse trends among a sample of drug treatment clients in Kentucky.

BACKGROUND: In an effort to mitigate Kentucky's prescription drug misuse, legislative intervention efforts were introduced in 2012 and 2013 to better regulate pain clinics, prescribed use of opioid analgesics, and to expand the monitoring of opioid prescriptions. The focus of this paper is primarily on opioid analgesics and heroin and the relationship of use/misuse patterns of these drugs to state drug policy initiatives. METHODS: A secondary data analysis of drug treatment clients (N=52,360) was conducted to project illicit drug use trends in Kentucky. This study describes temporal and geographic trends of self-reported illicit drug use among individuals in state-funded treatment in Kentucky between fiscal year 2010 and fiscal year 2013. RESULTS: Significant reductions in the prevalence of illicit opioid use, declined from fiscal year 2010 to fiscal year 2013 (p<.01, CI=-.298 to -.215). However, heroin use rates significantly increased over the years studied, suggesting there may be a transition from prescription opioids to heroin (p<.01, CI=.143 to .178). The analysis suggests these trends may continue. CONCLUSIONS: Findings suggest Kentucky's legislative efforts were effective in reducing illicit prescription opioid use, but heroin use has increased. One possible explanation for this relationship is that as prescription opioids became more difficult to obtain, users turned to heroin as a substitute. The finding of rising heroin use suggests a need for further policy initiatives to reduce heroin use, but the potential effectiveness of this policy remains unclear. Understanding trends may help to guide future policy efforts and pain management treatment strategies to where they might have their greatest impact.

Barriers to access to opioid medicines: a review of national legislation and regulations of 11 central and eastern European countries.

Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. Potential barriers were identified in all countries, ranging from 22 potential barriers (Cyprus) to 128 potential barriers (Lithuania). The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.