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Abstract: The Centers for Disease Control and Prevention’s 2022 Clinical Practice Guideline for Prescribing Opioids for Pain cautioned that inflexible opioid prescription duration limits may harm patients. Information about the relationship between initial opioid prescription duration and a subsequent refill could inform prescribing policies and practices to optimize patient outcomes. We assessed the association between initial opioid duration and an opioid refill prescription. Using data drawn from a multi-site prescription opioid registry developed by CTN-0084, conducted a retrospective cohort study of adults =19 years of age in 10 US health systems between 2013 and 2018 from outpatient care with a diagnosis for back pain without radiculopathy, back pain with radiculopathy, neck pain, joint pain, tendonitis/bursitis, mild musculoskeletal pain, severe musculoskeletal pain, urinary calculus, or headache. Generalized additive models were used to estimate the association between opioid days’ supply and a refill prescription. Overall, 220,797 patients were prescribed opioid analgesics upon an outpatient visit for pain. Nearly a quarter (23.5%) of the cohort received an opioid refill prescription during follow-up. The likelihood of a refill generally increased with initial duration for most pain diagnoses. About 1 to 3 fewer patients would receive a refill within 3 months for every 100 patients initially prescribed 3 vs. 7 days of opioids for most pain diagnoses. The lowest likelihood of refill was for a 1-day supply for all pain diagnoses, except for severe musculoskeletal pain (9 days’ supply) and headache (3-4 days’ supply). Conclusions: Long-term prescription opioid use increased modestly with initial opioid prescription duration for most but not all pain diagnoses examined. Related protocols: CTN-0084

Abstract:

In response to the opioid crisis in the United States, population-level prescribing of opioids has been decreasing; there are concerns, however, that dose reductions are related to potential adverse events. The purpose of this study was to examine associations between opioid dose reductions and risk of 1-month potential adverse events (emergency department (ED) visits, opioid overdose, benzodiazepine prescription fill, all-cause mortality).

This observational cohort study used electronic health record and claims data from eight United States health systems in a prescription opioid registry (Clinical Trials Network protocol CTN-0084). All opioid fills (excluding buprenorphine) between 1/1/2012 and 12/31/2018 were used to identify baseline periods with mean morphine milligram equivalents daily dose of = 50 during six consecutive months. Researchers identified 60,040 non-cancer patients with = one 2-month dose reduction period (600,234 unique dose reduction periods). Analyses examined associations between dose reduction levels (1-<15%, 15-<30%, 30-<100%, 100% over 2 months) and potential adverse events in the months following a dose reduction using logistic regression analysis, adjusting for patient characteristics.

Overall, dose reduction periods involved mean reductions of 18.7%. Compared to reductions of 1–<15%, dose reductions of 30–<100% were associated with higher odds of ED visits (OR 1.14, 95% CI 1.10, 1.17), opioid overdose (OR 1.41, 95% CI 1.09–1.81), and all-cause mortality (OR 1.39, 95% CI 1.16–1.67), but lower odds of a benzodiazepine fill (OR 0.83, 95% CI 0.81–0.85). Dose reductions of 15–<30%, compared to 1–<15%, were associated with higher odds of ED visits (OR 1.08, 95% CI 1.05–1.11) and lower odds of a benzodiazepine fill (OR 0.93, 95% CI 0.92–0.95), but were not associated with opioid overdose and all-cause mortality.

Conclusions: Greater dose reductions were associated with elevated odds of potential adverse events, relative to smaller dose reductions. Dose reductions for patients on long-term opioid therapy require careful planning and monitoring, particularly soon after a reduction.

Related protocols: CTN-0084

Abstract:

This is the primary outcomes article for CTN-0084.

This project aimed to develop and implement a prescription opioid registry in 10 diverse health systems across the U.S. and describe trends in prescribed opioids between 2012 and 2018.

Using electronic health record and claims data, researchers identified patients who had an outpatient fill for any prescription opioid, and/or an opioid use disorder diagnosis, between January 1, 2012 and December 31, 2018. The registry contains distributed files of prescription opioids, benzodiazepines and other select medications, opioid antagonists, clinical diagnoses, procedures, health services utilization, and health plan membership. Rates of outpatient opioid fills over the study period, standardized to health system demographic distributions, are described by age, gender, and race/ethnicity among members without cancer.

The registry includes 6,249,710 patients and over 40 million outpatient opioid fills. For the combined registry population, opioid fills declined from a high of 0.718 per member-year in 2013 to 0.478 in 2018, and morphine milligram equivalents (MMEs) per fill declined from 985 MMEs per fill in 2012 to 758 MMEs in 2018. MMEs per member declined from 692 MMEs per member in 2012 to 362 MMEs per member in 2018.

Conclusions: This study established a population-based opioid registry across 10 diverse health systems that can be used to address questions related to opioid use. Initial analyses showed large reductions in overall opioid use per member among the combined health systems. The registry will be used in future studies to answer a broad range of other critical public health issues relating to prescription opioid use.

Related protocols: CTN-0084