Intended and unintended consequences: Changes in opioid prescribing practices for postsurgical, acute, and chronic pain indications following two policies in North Carolina, 2012-2018 - Controlled and single-series interrupted time series analyses.

BACKGROUND: The potential misapplication of current opioid prescribing policies remains understudied and may have substantial adverse implications for patient safety. METHODS: We used autoregressive integrated moving average models to assess level and trend changes in monthly 1) prescribing rates, 2) days' supply, and 3) daily morphine milligram equivalents (MME) of incident opioid prescriptions relative to 1) a state medical board initiative to reduce high-dose and -volume opioid prescribing and 2) legislation to limit initial opioid prescriptions for acute and postsurgical pain. We examined outcomes by pain indication overall and by cancer history, using prescribing patterns for benzodiazepines to control for temporal trends. We used large private health insurance claims data to include North Carolina residents, aged 18-64, insured at any point between January 2012 and August 2018. RESULTS: After the medical board initiative, prescribing patterns for chronic pain patients did not change; conversely, acute and postsurgical pain patients experienced immediate declines in daily MME. Post-legislation prescription rates did not decline for those with acute, postsurgical, and non-cancer pain, but instead declined among cancer patients with chronic pain. Chronic pain patients experienced the largest days' supply declines post-legislation, instead of acute and postsurgical pain patients. CONCLUSIONS: We found mixed evidence on the potential impact of two opioid prescribing policies, with some observed declines in a group not intended to be impacted by the policy. This study provides evidence of the need for clearer opioid prescribing policies to ensure impacts on intended populations and avoid unintended consequences.

Association of Opioid Dose Reduction With Opioid Overdose and Opioid Use Disorder Among Patients Receiving High-Dose, Long-term Opioid Therapy in North Carolina.

Importance: Rapid reduction or discontinuation of long-term opioid therapy may increase risk of opioid overdose or opioid use disorder (OUD). Current guidelines for chronic pain management caution against rapid dose reduction but are based on limited evidence. Objective: To characterize the association between rapid reduction or abrupt discontinuation of opioid therapy (vs maintained or gradual reduction) and incidence of opioid overdose and OUD among patients prescribed high-dose, long-term opioid therapy (HDLTOT). Design, Setting, and Participants: This retrospective cohort study was conducted among patients aged 18 to 64 years who were prescribed HDLTOT (≥90 daily morphine milligram equivalents for ≥90% of 90 days) from January 2006 to September 2018, with follow-up up to 4 years after cohort entry. Claims data were drawn from a large private health insurer in North Carolina and analyzed from March 1, 2006, to September 30, 2018. Exposures: Time-varying exposure of rapid dose reduction or discontinuation (>10% dose reduction/week) vs maintenance, increase, or gradual reduction or discontinuation. Main Outcomes and Measures: The main outcome was incident opioid overdose (fatal or nonfatal) or diagnosed OUD. Inverse probability-weighted cumulative incidence of outcomes were estimated using the cumulative incidence function and hazard ratios (HRs) using marginal structural Fine-Gray models as a function of rapid dose tapering or discontinuation (vs gradual reduction or discontinuation or maintained or increased), accounting for competing risks. Results: A total of 19 443 patients (median [IQR] age, 49 [41-55] years; 10 073 [51.8%] men) who received HDLTOT were identified. Rapid reduction or discontinuation was associated with higher risk of fatal and nonfatal overdoses compared with gradual reduction after the first year (year 1: HR, 1.43; 95% CI, 0.94-2.18; years 2-4: HR, 1.95; 95% CI, 1.31-2.90). There was no association between rapid reduction or discontinuation and diagnosed OUD through 2 years of follow-up; however, the hazard of incident OUD among patients exposed to rapid tapering or discontinuation was greater 25 to 48 months after the start of follow-up (HR, 1.28; 95% CI, 1.01-1.63). Conclusions and Relevance: In this cohort study, rapid dose reduction or discontinuation was associated with increased risk of opioid overdose and OUD during long-term follow-up. These findings reinforce prior concerns about safety of rapid dose reductions for patients receiving HDLTOT and highlight the need for caution when reducing opioid doses.

Association Between Statewide Opioid Prescribing Interventions and Opioid Prescribing Patterns in North Carolina, 2006-2018.

OBJECTIVE: To examine the impact of three sequential statewide policy and legislative interventions on opioid prescribing practices among privately insured individuals in North Carolina. METHODS: An interrupted time series approach was used to examine level and trajectory changes of new and prevalent opioid prescription rates, days' supply, and daily morphine milligram equivalents before and after implementation of a 1) prescription drug monitoring program, 2) state medical board initiative, and 3) legislative action. Analyses were conducted using individual-level claims data from a large private health insurance provider serving North Carolina residents, ages 18-64 years, from January 2006 to August 2018. RESULTS: Rates of new and prevalent prescription opioid patients were relatively unaffected by the prescription monitoring program but sharply declined in the months immediately following both medical board (-3.7 new and -19.3 prevalent patients per 10,000 person months) and legislative (-14.1 new and -26.7 prevalent patients) actions. Among all opioid prescriptions, days' supply steadily increased on average over the study period but declined after legislative action (-1.5 days' supply per year). CONCLUSIONS: The voluntary prescription drug monitoring program launched in 2010 only marginally affected opioid prescribing patterns on its own, but its redeployment as an investigative and clinical tool in multifaceted public policy approaches by the state medical board and legislature later in the decade plausibly contributed to notable declines in prescription rates and days' supply. This study lends new emphasis to the importance of enforcement mechanisms for state and national policies seeking to reverse this critical public health crisis.

State Medical Board Policy and Opioid Prescribing: A Controlled Interrupted Time Series.

INTRODUCTION: In March 2016, the Centers for Disease Control and Prevention issued opioid prescribing guidelines for chronic noncancer pain. In response, in April 2016, the North Carolina Medical Board launched the Safe Opioid Prescribing Initiative, an investigative program intended to limit the overprescribing of opioids. This study focuses on the association of the Safe Opioid Prescribing Initiative with immediate and sustained changes in opioid prescribing among all patients who received opioid and opioid discontinuation and tapering among patients who received high-dose (>90 milligrams of morphine equivalents), long-term (>90 days) opioid therapy. METHODS: Controlled and single interrupted time series analysis of opioid prescribing outcomes before and after the implementation of Safe Opioid Prescribing Initiative was conducted using deidentified data from the North Carolina Controlled Substances Reporting System from January 2010 through March 2017. Analysis was conducted in 2019-2020. RESULTS: In an average study month, 513,717 patients, including patients who received 47,842 high-dose, long-term opioid therapy, received 660,912 opioid prescriptions at 1.3 prescriptions per patient. There was a 0.52% absolute decline (95% CI= -0.87, -0.19) in patients receiving opioid prescriptions in the month after Safe Opioid Prescribing Initiative implementation. Abrupt discontinuation, rapid tapering, and gradual tapering of opioids among patients who received high-dose, long-term opioid therapy increased by 1% (95% CI= -0.22, 2.23), 2.2% (95% CI=0.91, 3.47), and 1.3% (95% CI=0.96, 1.57), respectively, in the month after Safe Opioid Prescribing Initiative implementation. CONCLUSIONS: Although Safe Opioid Prescribing Initiative implementation was associated with an immediate decline in overall opioid prescribing, it was also associated with an unintended immediate increase in discontinuations and rapid tapering among patients who received high-dose, long-term opioid therapy. Better policy communication and prescriber education regarding opioid tapering best practices may help mitigate unintended consequences of statewide policies.