A call to look beyond prescription opioid supply-side restrictions and include health equity when predicting opioid policy effectiveness

We read with interest the study by Rao and colleagues on opioid policy effectiveness, which extends their previous modeling efforts to predict opioid-related overdose, life-years, and QALYs. This work presents a useful framework from which to investigate policy effectiveness

Co-utilization of opioids and nonbenzodiazepine hypnotic drugs in U.S. ambulatory care visits, 2006–2016

Objective(s): This study aimed to characterize the co-utilization of non-benzodiazepine sedative ‘Z’-drugs with opioids at ambulatory care visits in the United States. Design: A cross-sectional analysis of the National Ambulatory Medical Care Survey (NAMCS) from 2006 to 2016 was completed. Setting and participants: Ambulatory care visits in the United States involving adult patients with an opioid prescription were included in the analysis. Outcome measures: The primary outcome was initiation or continuation of a Z-drug (zolpidem, eszopiclone, or zaleplon) in a patient visit in conjunction with an opioid medication. Results: The authors analyzed 564,090,296 visits (weighted from a sample of 28,773) with a reported opioid prescription. Co-utilization of opioids with Z-drugs fluctuated during the study period beginning at 4.0% in 2006 (95% CI 2.2%–5.7%), 6.3% in 2012 (3.7%–8.9%), and 4.7% in 2016 (2.8%–6.5%). Among all opioid visits in the study period, co-utilization with a Z-drug was not significantly different among female patients compared with male patients (5.26% vs. 4.63%, P = 0.26). Among visits with concomitant opioid and Z-drugs, 7.0% reported new initiation of both medications in the same visit. Conclusion: At ambulatory care visits between 2006 and 2016, co-utilization of opioids and Z-drugs fluctuated with some differences by sex. Major regulatory advisories and policy changes during this period may have contributed to these varying rates of utilization. Additional work is needed to identify predictors of co-utilization and downstream consequences more widely

Changes in Opioid Use After Florida's Restriction Law for Acute Pain Prescriptions

Several US states have enacted laws to limit either opioid prescription days’ supply or morphine milligram equivalents for the treatment of acute pain. On July 1, 2018, Florida implemented House Bill 21 (HB21), which limits the days’ supply of Schedule II opioids to 3 days for acute pain prescriptions. Prescribers can extend to a 7-day supply if they document an exception. This quality improvement study aims to assess the outcomes associated with Florida’s restriction law on opioid prescribing by evaluating the number of new opioid users and the number of units dispensed per prescription before and after the policy change

Changes in Prescribing by Provider Type Following a State Prescription Opioid Restriction Law

Background: Many states have implemented opioid days’ supply restriction policies, leading to reductions in opioid prescribing. Although research within certain provider types exist, no study has evaluated a restriction policy by various provider types. Objective: To evaluate changes in opioid utilization following a days’ supply restriction policy stratified by provider type: surgery, emergency medicine, primary care, specialty care, and dentistry. Design: Interrupted time series (ITS) Participants: Opioid prescription claims of patients in a private health plan serving a large Florida employer from 1/1/2015 to 3/31/2019. Provider types were determined using the Healthcare Provider Taxonomy Code associated with the national provider identifier (NPI). Interventions: Florida’s opioid restriction policy implemented on July 1, 2018. Main Measures: Changes in mean morphine milligram equivalent (MMEs), mean days’ supply, and mean number of units dispensed per opioid prescription before and after policy implementation. Key Results: There were 10,583 opioid initial prescriptions dispensed. Treating providers were classified as surgery (16.4%; n = 1732), emergency care (14.3%; n = 1516), primary care (21.2%; n = 2241), specialty care (11.4%; n = 1207), and dentistry providers (23.7%; n = 2511). Significant reductions in mean days’ supply were observed across most provider types ranging from 14% reduction for dentistry providers to 41% reduction for specialty care providers. Significant changes were observed for emergency care and specialty care providers with a 30% (p = 0.001)and 29% (p < 0.001) reduction in mean MME, respectively, and a 27% (p = 0.040) reduction in mean number of units dispensed in emergency care providers, after implementation. Pre-implementation trends in opioid prescribing varied by provider type impacting the effects of the opioid days’ supply restriction policy. Conclusions: Pre-policy opioid prescribing varied by provider type with a differential impact on mean MMEs, mean days’ supply, and mean number of units dispensed per prescription following implementation

Complications in Using Real-World Data to Study the Health of People Who Use Drugs

For the past two decades, the United States has suffered dramatic increases in a fatal drug overdose. Overdoses represent one major health concern facing people who use drugs, in a milieu including injection drug use-related infections. Accordingly, the use of real-world data to study drug-related harms, such as overdoses and injection drug-related infections, has become more common in the medical literature. Real-world data sources include electronic health records and administrative claims that can be leveraged to understand health needs and longitudinal health utilization patterns in specific groups of patients, including people who use drugs. Researchers developed various algorithms that use combinations of drug-related diagnosis codes for substance use disorders and overdoses. However, limited attention to date has been paid to the methodologic and ethical implications arising from the limitations of these algorithms

Socioeconomic and Demographic Characteristics of US Adults Who Purchase Prescription Drugs from Other Countries

Importance: Little is known about the current use of imported drugs and the factors associated with individual purchase of medications outside the US. Objective: To evaluate the proportion of the US adult population that purchases medications in other countries and the patient factors associated with the behavior. Design, Setting, and Participants: This retrospective cross-sectional study used data from the 2015-2017 National Health Interview Survey. The study sample included 61238 individuals 18 years or older who reported use of prescribed medication by a physician or other practitioner. Data analysis was performed in November 2019. Main Outcomes and Measures: Self-reported experience of purchasing prescription drugs from countries outside the US in the past 12 months. Internet use behaviors for health care included searches for health information and filling of a prescription online. Medication-taking behaviors included skipping or delaying filling a prescription and using alternative therapies to save money. Survey design-adjusted analysis was used to estimate and compare characteristics between those who purchased medications outside the US and those did not. Multivariable logistic regression was fitted to examine the association of medication purchases with internet use and medication-taking behavior factors. Results: Among 61238 US adults taking prescription medications (mean [SD] age, 50.5 [18.5] years; 56.5% female; 70.8% white), the estimated prevalence of purchasing of medication outside the US was 1.5% (95% CI, 1.4%-1.7%; 2.3 million US individuals). Those who purchased medications outside the US were more likely to be older (age >64 years; adjusted odds ratio [aOR], 1.68; 95% CI, 1.24-2.29), to be from Hispanic (aOR, 1.70; 95% CI, 1.23-2.35) or immigrant populations (aOR, 3.20; 95% CI, 2.44-4.20), and to have higher educational attainment (bachelor's degree; aOR, 1.79; 95% CI, 1.27-2.54), lower family income (low income; aOR, 1.41; 95% CI, 1.06-1.87), and lack of insurance (aOR, 3.14; 95% CI, 2.33-4.21). Data analyses indicated that online health information-seeking behavior (aOR, 1.62; 95% CI, 1.33-1.98) or use of an online pharmacy (aOR, 2.30; 95% CI, 1.83-2.90) was associated with a greater likelihood of medication purchases outside the US. Individuals who skipped medications (aOR, 3.86; 95% CI, 3.05-4.88) or delayed filling a prescription (aOR, 4.04, 95% CI, 3.23-5.06) also had higher odds of purchasing medication outside the US. Conclusions and Relevance: The findings suggest that patients are not using prescription purchases outside the US to meet their medication needs. However, monitoring to promote safe administration of medications imported into the US should be continued

Trends in Use of Prescription Nonsteroidal Anti-inflammatory Medications before vs after Implementation of a Florida Law Restricting Opioid Prescribing for Acute Pain

Importance: Previous research has shown an immediate reduction in new opioid users and use after implementation of the opioid supply restriction laws. Assessment of the association between opioid restrictions and alternative treatment options, such as nonsteroidal anti-inflammatory drugs (NSAIDs), is needed to evaluate potential unintended consequences for patients requiring analgesia. Objective: To evaluate the association between an opioid restriction law in Florida and use of prescription NSAIDs. Design, Setting, and Participants: This quality improvement study used interrupted time series analyses accounting for autocorrelation to estimate immediate and trend changes in the prescribing and use of prescription NSAIDs in Florida before and after implementation of a state law limiting opioid prescriptions to a 3-day supply. Participants were enrollees in a single private health plan of a large university and health system employer in Florida from January 2015 to June 2019. Exposures: Prescriptions for NSAIDs, ascertained from pharmacy claims data. Main Outcomes and Measures: The following outcomes were calculated monthly per 1000 plan enrollees: (1) number of NSAID users; (2) mean days' supply of NSAIDs per prescription; and (3) mean number of NSAID prescriptions. Individuals were classified as NSAID users if they had at least 1 NSAID prescription in a given month. Analysis was stratified by route of NSAID administration (oral or nonoral). Results: Among 46783 NSAID users with 79089 NSAID prescriptions during the study period, the median age was 47 years (interquartile range, 35-57 years). After implementation of the opioid restriction law, the number of NSAID users immediately increased, but the difference was not significant (change, 0.82 per 1000 patients; 95% CI, -0.67 to 2.30 per 1000 patients). No significant change in the days' supply of oral NSAID users occurred (change, 0.21 days per prescription; 95% CI, -1.66 to 2.08 days per prescription). Before implementation of the law, there was a nonsignificant decreasing trend in NSAID prescriptions (rate of change, -0.03 per month per 1000 enrollees; 95% CI, -0.13 to 0.07 per month per 1000 enrollees; after implementation, there was a nonsignificant increase in the number of oral and nonoral NSAID prescriptions (change, 1.49 per 1000 enrollees; 95% CI, -3.38 to 6.37 per 1000 enrollees). Conclusions and Relevance: In this quality improvement study, prescribing and use of prescription NSAIDs did not increase after implementation of a law restricting opioid analgesic prescriptions in Florida. These findings suggest possible greater use of over-the-counter NSAIDs after implementation of the law, but further research is needed to evaluate changes in the use of nonopioid analgesics and alternative pain therapies

Buprenorphine Use Trends Following Removal of Prior Authorization Policies for the Treatment of Opioid Use Disorder in 2 State Medicaid Programs

Importance: State Medicaid programs have implemented initiatives to expand treatment coverage for opioid use disorder (OUD); however, some Medicaid programs still require prior authorizations (PAs) for filling buprenorphine prescriptions. Objective: To evaluate the changes in buprenorphine use for OUD among Medicaid enrollees in states that completely removed buprenorphine PA requirements. Design, Setting, and Participants: This retrospective cross-sectional study analyzed the immediate and trend changes on buprenorphine use during 2013 to 2020 associated with removal of PA requirements using a controlled interrupted time series analysis to account for autocorrelation. Data were collected from Medicaid State Drug Utilization Data for 2 states (California and Illinois) that completely removed a buprenorphine PA during the study period, and buprenorphine prescriptions for OUD treatment were identified among Medicaid enrollees. Main Outcomes and Measures: Quarterly total number of buprenorphine prescriptions for each state was calculated, and stratification analyses were conducted by dosage form (films and tablets). Results: Among the 2 state Medicaid programs (California and Illinois) that removed buprenorphine PAs, there was a total of 702643 and 415115 eligible buprenorphine prescription claims, respectively. After removing PA requirements for buprenorphine, there was an immediate increase that was not statistically significant (rate ratio [RR], 1.11; 95% CI, 0.76-1.61) in the number of all buprenorphine prescriptions in California and a statistically significant increase (RR, 6.99; 95% CI, 4.67-10.47) in the number of all buprenorphine prescriptions in Illinois relative to the change in the control states (Alabama, Florida, Idaho, Kansas, Mississippi, Nevada, South Dakota, and Wyoming). Additionally, there was a statistically significant decreasing trend in the number of all buprenorphine prescriptions in California (RR, 0.88; 95% CI, 0.82-0.94) and a statistically significant increasing trend in Illinois (RR, 1.11; 95% CI, 1.05-1.19) relative to the trend in control states. Conclusions and Relevance: In this cross-sectional study, removal of buprenorphine PA requirements was associated with a statistically significant increase in the number of buprenorphine prescription fills among Medicaid populations in 1 of the 2 included states

Trends in sexually transmitted infections in united states ambulatory care clinics from 2005–2016

We examined the prevalence trends of non-human immunodeficiency virus (HIV) sexually transmitted infections (STI) and associated patient characteristics in U.S. ambulatory-care settings from 2005–2016. We conducted a retrospective repeated cross-sectional analysis using data from the National Ambulatory Medical Care Survey (NAMCS) for individuals aged 15–64 with a non-HIV STI-related visit. Data were combined into three periods (2005–2008, 2009–2012, and 2013–2016) to obtain reliable estimates. Logistic regression was used for analysis. A total of 19.5 million weighted, non-HIV STI-related ambulatory visits from 2005–2016 were identified. STI-related visits per 100,000 ambulatory care visits increased significantly over the study period: 206 (95% CI = 153–259), 343 (95% CI = 279–407), and 361 (95% CI = 277–446) in 2005–2008, 2009–2012, and 2013–2016, respectively (Ptrend = 0.003). These increases were mainly driven by increases in HPV-related visits (56 to 163 per 100,000 visits) from 2005–2008 to 2009–2012, followed by syphilis-or gonorrhea-related visits (30 to 67 per 100,000 visits) from 2009–2012 to 2013–2016. Higher odds of having STI-related visit were associated with younger age (aged 15–24: aOR = 4.45; 95% CI = 3.19–6.20 and aged 25–44: aOR = 3.59; 95% CI = 2.71–4.77) vs. 45–64-year-olds, Black race (aOR = 2.41; 95% CI = 1.78–3.25) vs. White, and HIV diagnosis (aOR = 10.60; 95% CI = 5.50–20.27) vs. no HIV diagnosis. STI-related office visits increased by over 75% from 2005–2016, and were largely driven by HPV-related STIs and syphilis-or gonorrhea-related STIs

Medicare Bundled Payment Policy on Anemia Care, Major Adverse Cardiovascular Events, and Mortality among Adults Undergoing Hemodialysis

Background and objectives In 2011, the Centers forMedicare & Medicaid Services implemented bundling of all services for patients receiving dialysis, including erythropoietin-stimulating agents use, and the Food and Drug Administration recommended conservative erythropoietin-stimulating agent dosing. Design, setting, participants, & measurements This retrospective cohort study investigated anemia care and clinical outcomes before and after the Centers for Medicare & Medicaid Services bundled payment and the revised Food and Drug Administration–recommended erythropoietin-stimulating agent labeling for Medicareinsured adults receiving hemodialysis using data from the United States Renal Data System from January 1, 2006 to December 31, 2016. Clinical outcomes included major adverse cardiovascular event (stroke, acute myocardial infarction, and all-cause mortality), cardiovascular mortality, and heart failure. Measurements were compared between prepolicy (2006–2010) and postpolicy (2012–2016) implementation using interrupted time series and Cox proportional hazards regression models. Results Of 481,564 patients, erythropoietin-stimulating agent use immediately decreased by 84.8 per 1000 persons (P11 g/dl decreased from 68% in January 2006 to 28% in December 2016, whereas those with hemoglobin >9 g/dl increased from 5% to 9%. Overall major adverse cardiovascular event (adjusted hazard ratio, 0.95; 95% confidence interval, 0.94 to 0.96), stroke (adjusted hazard ratio, 0.83; 95% confidence interval, 0.80 to 0.86), all-cause mortality (adjusted hazard ratio, 0.87; 95% confidence interval, 0.86 to 0.89), cardiovascular mortality (adjusted hazard ratio, 0.81; 95% confidence interval, 0.79 to 0.83), and heart failure (adjusted hazard ratio, 0.86; 95% confidence interval, 0.84 to 0.88) risks were lower. Acute myocardial infarction risk (adjusted hazard ratio, 1.04; 95% confidence interval, 1.01 to 1.06) was higher after policies changed. Conclusions The Medicare reimbursement policy and Food and Drug Administration–recommended erythropoietin-stimulating agent dosing changes were associated with lower erythropoietin-stimulating agent use and lower hemoglobin levels. These changes in anemia care were associated with lower risks of major adverse cardiovascular event, stroke, mortality, and heart failure but higher risk of acute myocardial infarction among adults receiving hemodialysis