Effects of State Law Limiting Postoperative Opioid Prescription in Patients After Cesarean Delivery.

BACKGROUND: The impact of the Florida State law House Bill 21 (HB 21) restricting the duration of opioid prescriptions for acute pain in patients after cesarean delivery is unknown. Our objective was to assess the association of the passage of Florida State law HB 21 with trends in discharge opioid prescription practices following cesarean delivery, necessity for additional opioid prescriptions, and emergency department visits at a large tertiary care center. METHODS: This was a retrospective cohort study conducted at a large, public hospital. The 2 cohorts represented the period before and after implementation of the law. Using a confounder-adjusted segmented regression analysis of an interrupted time series, we evaluated the association between HB 21 and trends in the proportions of patients receiving opioids on discharge, duration of opioid prescriptions, total opioid dose prescribed, and daily opioid dose prescribed. We also compared the need for additional opioid prescriptions within 30 days of discharge and the prevalence of emergency department visits within 7 days after discharge. RESULTS: Eight months after implementation of HB 21, the mean duration of opioid prescriptions decreased by 2.9 days (95% confidence interval [CI], 5.2-0.5) and the mean total opioid dose decreased by 20.1 morphine milligram equivalents (MME; 95% CI, 4-36.3). However, there was no change in the proportion of patients receiving discharge opioids (95% CI of difference, -0.1 to 0.16) or in the mean daily opioid dose (mean difference, 5.3 MME; 95% CI, -13 to 2.4). After implementation of the law, there were no changes in the proportion of patients who required additional opioid prescriptions (2.1% vs 2.3%; 95% CI of difference, -1.2 to 1.5) or in the prevalence of emergency department visits (2.4% vs 2.2%; 95% CI of difference, -1.6 to 1.1). CONCLUSIONS: Implementation of Florida Law HB 21 was associated with a lower total prescribed opioid dose and a shorter duration of therapy at the time of hospital discharge following cesarean delivery. These reductions were not associated with the need for additional opioid prescriptions or emergency department visits.

Opioid days' supply limits: an interrupted time-series analysis of opioid prescribing before and following a Massachusetts law.

Background: In 2016, Massachusetts passed the first-in-the-nation law limiting opioid naïve adults and all minors to a 7-day supply of opioids when prescribed in the outpatient setting.Objective: We hypothesized this policy would be associated with declines in the percent of opioid prescriptions with more than a 7-day supply among opioid naïve adults and minors for select prescriber groups.Methods: Interrupted time series analyses were conducted using measures from the Massachusetts Prescription Monitoring Program database for 2015 through 2017 (n = 13,672,325 opioid prescriptions; 54% to females). Outcomes were the monthly percent of opioid prescriptions greater than 7 days' supply in opioid naïve adults and in minors among select prescriber groups. Model estimates of the pre-policy trend, the average changes in the level pre/post-implementation, and the trend changes post-implementation were assessed.Results: Pre-policy trends showed significant monthly declines in the percent of opioid prescriptions greater than 7 days' supply for all prescriber groups. Policy implementation was associated with significant reduction in the level for opioid naïve adults among surgeons (-2.92%, p < .01), dentists (-0.23%, p < .01), and general medical providers (-2.22%, p = .04), and for minors among all-included prescribers (-2.97%, p < .01) and surgeons (-3.8%, p < .01). Post-implementation changes in trends were not significant except among opioid naïve adults for dentists (0.02%, p = .04).Conclusion: Within a context of significant reductions occurring in opioid prescriptions greater than 7 days' supply during this period, the Massachusetts policy was associated with further declines for opioid naïve adults and minors among select prescriber groups.

Opioid Prescribing Laws Are Not Associated with Short-term Declines in Prescription Opioid Distribution.

OBJECTIVE: To determine whether the adoption of laws that limit opioid prescribing or dispensing is associated with changes in the volume of opioids distributed in states. METHODS: State-level data on total prescription opioid distribution for 2015-2017 were obtained from the US Drug Enforcement Administration. We included in our analysis states that enacted an opioid prescribing law in either 2016 or 2017. We used as control states those that did not have an opioid prescribing law during the study period. To avoid confounding, we excluded from our analysis states that enacted or modified mandates to use prescription drug monitoring programs (PDMPs) during the study period. To estimate the effect of opioid prescription laws on opioid distribution, we ran ordinary least squares models with indicators for whether an opioid prescription law was in effect in a state-quarter. We included state and quarter fixed effects to control for time trends and time-invariant differences between states. RESULTS: With the exception of methadone and buprenorphine, the amount of opioids distributed in states fell during the study period. The adoption of opioid prescribing laws was not associated with additional decreases in opioids distributed. CONCLUSIONS: We did not detect an association between adoption of opioid prescribing laws and opioids distributed. States may instead wish to pursue evidence-based efforts to reduce opioid-related harm, with a particular focus on treatment access and harm reduction interventions.

Fourth Amendment Protections of Prescription Drug Monitoring Programs: Patient Privacy in the Opioid Crisis.

The opioid crisis is one of the largest public health problems in the history of the United States. Prescription drug monitoring programs ("PDMPs")-state databases containing the records of all prescriptions for controlled substances written in the state-have emerged as a means to track opioid prescribing and use. While PDMPs are typically used as a tool for physicians to inform their prescribing practices, many states also permit law enforcement to access PDMPs when investigating controlled substance distribution, often without prior judicial approval. Such law enforcement use of PDMPs raises serious questions of patient privacy. The Fourth Amendment protects individuals from unreasonable searches and seizures where they have a reasonable expectation of privacy and has been interpreted to require law enforcement have probable cause and a search warrant before infringing upon an individual's reasonable expectation of privacy. Several courts have held that patients have no reasonable expectation of privacy, or a severely diminished expectation of privacy, in their prescription drug records held in PDMPs. As support, courts rely on the third-party doctrine because the information is disclosed to physicians and then held by the state; the highly regulated nature of the prescription drug industry; and the statutory framework of the Controlled Substances Act. Such analysis disregards patients' expectation of privacy in their personal health information, the confidentiality in the physician-patient relationship, and the resulting patient incentives not to seek care. Therefore, this Article argues that law enforcement must have probable cause and a search warrant to access PDMPs because the exceptions to the Fourth Amendment's probable cause and warrant requirements do not apply.

Effect of a legislative mandate on opioid prescribing for back pain in the emergency department.

OBJECTIVE: A change in Arizona State law in 2017 required prescribers to review data from a prescription drug monitoring program (PDMP) prior to opioid prescribing. The objective was to determine the effect of this change on opioid prescribing for patients who presented to the emergency department (ED) for back pain. METHODS: This was a retrospective cohort study conducted in a 50-bed community ED in the United States. Consecutive adult patients who presented to the ED with back pain were included. Patients were categorized based on when they presented to the ED in reference to the law mandating PDMP review: 1) pre-PDMP and 2) post-PDMP. The outcome measures included the proportion of patients who were prescribed opioids upon discharge and the total amount of opioids prescribed per patient in oral morphine milligram equivalents (MME). RESULTS: A total of 268 patients were included (134 in pre-PDMP and 134 in post-PDMP). Opioid prescribing on discharge from the ED occurred in 46% (n = 62) of patients in the pre-PDMP group and 48% (n = 64) of patients in the post-PDMP group (difference 2%, 95% CI -11 to 13%). Of those who received opioid prescriptions, the median total prescribed MME was 75 mg (IQR 60-120 mg) in the pre-PDMP group and 75 mg (IQR 60-90) in the post-PDMP group (mean difference 8 mg, 95% CI -9 to 24 mg). CONCLUSION: A legislative requirement for provider PDMP review did not change opioid prescribing for patients in the ED who presented with back pain.

Regulating gabapentin as a drug of abuse: A survey study of Kentucky community pharmacists.

OBJECTIVES: As the number of gabapentin prescriptions has increased, so have reports of its misuse and diversion. This trend has led some states to closer monitoring of gabapentin dispensing through prescription drug monitoring programs (PDMPs). The objective of this study was to collect and analyze Kentucky community pharmacists' perceptions of gabapentin misuse and diversion, and their support or opposition to regulatory efforts to reclassify the drug as a controlled substance (CS). METHODS: Responses were collected using an online survey sent by e-mail to all pharmacists practicing in Kentucky in August 2016. The survey collected basic demographic characteristics and pharmacists' experience with gabapentin dispensing. Descriptive statistics were calculated using question response frequencies. Pearson's chi-squared statistics were calculated to examine the distribution of support for gabapentin as a CS in Kentucky across each of the categories of the individual variables. Logistic regression was used to estimate the effects of pharmacist demographic characteristics and experiences with gabapentin on their support of gabapentin reclassification as a CS. RESULTS: One thousand seven hundred sixty-nine surveys were collected (response rate = 34.2%). Responding community pharmacists (n = 1084) believe that the abuse and diversion of gabapentin are a problem in their communities, with 9 in 10 (89.6%) indicating that they agree or strongly agree. More than three-fourths (87.5%) indicated support for reclassifying gabapentin as a CS. Common reasons for opposition to gabapentin regulatory changes were that they would not reduce or eliminate abuse (45.8%) and that they would be an inconvenience to patients (17.0%). Pharmacists practicing in independent pharmacies and pharmacists in practice greater than 20 years were less likely to indicate support for gabapentin reclassification. CONCLUSION: Kentucky community pharmacists express considerable concern over the possible misuse and diversion of gabapentin and widely support regulatory changes reclassifying gabapentin as a CS.

Prescription Drug Monitoring Program: Registration and Use by Prescribers and Pharmacists Before and After Legal Mandatory Registration, California, 2010-2017.

OBJECTIVES: To estimate the effect of California's prescription drug monitoring program's (PDMP) registration mandate on use of the PDMP. METHODS: We evaluated the effect of California's mandatory PDMP registration law by fitting time series models on the percentage of clinicians registered for California's PDMP and the percentage of clinicians who were active PDMP users (users who created ≥ 1 patient prescription reports in a given month) from 2010 through 2017. We also compared PDMP use among early PDMP adopters (clinicians who registered > 8 months before the mandatory registration deadline) versus late adopters (clinicians who registered ≤ 8 months before the deadline). RESULTS: Mandatory registration was associated with increases in active PDMP users: 53.5% increase for prescribers and 17.9% for pharmacists. Early adopters were 4 times more likely to be active PDMP users than were late adopters. CONCLUSIONS: Mandatory registration was associated with increases in PDMP registration and use, but most new registrants did not become active users. Public Health Implications. Mandatory PDMP registration increases PDMP use but does not result in widespread PDMP usage by all clinicians prescribing controlled substances.

Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis.

PURPOSE: We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. METHODS: We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012. We identified 3 types of high-risk patients: (1) concomitant users: patients with concomitant use of benzodiazepines and opioids; (2) chronic users: long-term, high-dose, opioid users; and (3) opioid shoppers: patients receiving opioids from multiple sources. We compared changes in opioid prescriptions between Florida and Georgia before and after policy implementation among high-risk/low-risk patients. Our monthly measures included (1) average morphine milligram equivalent per transaction, (2) total opioid volume across all prescriptions, (3) average days supplied per transaction, and (4) total number of opioid prescriptions dispensed. RESULTS: Among opioid-receiving individuals in Florida, 6.62% were concomitant users, 1.96% were chronic users, and 0.46% were opioid shoppers. Following policy implementation, Florida's high-risk patients experienced relative reductions in morphine milligram equivalent (opioid shoppers: -1.08 mg/month, 95% confidence interval [CI] -1.62 to -0.54), total opioid volume (chronic users: -4.58 kg/month, CI -5.41 to -3.76), and number of dispensed opioid prescriptions (concomitant users: -640 prescriptions/month, CI -950 to -340). Low-risk patients generally did not experience statistically significantly relative reductions. CONCLUSIONS: Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients.

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 Role of Direct-Injury Government-Entity Lawsuits in the Opioid Litigation.

The opioid epidemic has ravaged the United States, killing over 100 Americans every day and costing the nation upward of $90 billion a year. All branches and levels of the government have pursued measures to combat the epidemic and reduce its societal costs. Perhaps the most interesting response is the emergence of direct-injury government-entity lawsuits, which seek to recover damages from opioid companies that facilitated prescription pill addictions. Cities, counties, and states across the country are suing opioid manufacturers and distributors in unprecedented numbers. This Note explores the role of direct-injury government-entity claims as compared to other forms of civil litigation employed in the opioid crisis. It highlights the obstacles faced by parens patriae actions, individual lawsuits, class actions, and aggregate actions in general. This Note argues that direct injury government claims have important advantages over other forms of civil litigation because they overcome certain defenses related to victim blame worthiness and because they function as inherently representative actions that bypass the certification requirements of traditional aggregate actions.

Opioid Use in Pelvic Fractures: The Impact of Opioid Prescribing Laws in Pennsylvania.

Pennsylvania's Prescription Drug Monitoring Program (PDMP) was established in 2016, but its impact on opioid use for pelvic fractures is understudied. We compared opioid use in 277 pelvic fracture cases between two periods: 2015-2017 (T1) and 2018-2020 (T2). Outcomes included daily inpatient morphine milligram equivalents (MME), long-term opioid use (LOU) 60-90 days post-discharge, and intermediate-term opioid use (IOU) 30-60 days post-discharge. T1 and T2 had comparable baseline characteristics. T2 was associated with a decrease in average daily inpatient MME (58.6 vs 78.5, P = .02), particularly in younger patients. Regression analyses showed age and Injury Severity Score (ISS) were significant predictors for daily inpatient MME, while time period was not. Geriatric patients in T2 had significantly decreased IOU (30% vs 9%, P = .05). Pelvic fracture type and daily MME predicted IOU, while pelvic fracture type predicted LOU. This study suggests a modest impact of these laws, but further study is needed.

State-level policies and receipt of CDC-informed opioid thresholds among commercially insured new chronic opioid users.

OBJECTIVES: To evaluate the association of state-level policies on receipt of opioid regimens informed by Centers for Disease Control and Prevention (CDC) morphine milligram equivalent (MME)/day recommendations. DESIGN: A retrospective cohort study of new chronic opioid users (NCOUs). SETTING: Commercially insured plans across the United States using IQVIA PharMetrics® Plus for Academics database with new chronic use between January 2014 and March 2015. PARTICIPANTS: NCOUs with ≥60-day coverage of opioids within a 90-day period with ≥30-day opioid-free period prior to the date of the first qualifying opioid prescription. INTERVENTIONS: State-level policies including Prescription Drug Monitoring Program (PDMP) robustness and cannabis policies involving the presence of medical dispensaries and state-wide decriminalization. MAIN OUTCOME MEASURES: NCOUs were placed in three-tiered risk-based average MME/day thresholds: low (>0 to <50), medium (≥50 to <90), and high (≥90). Multinomial logistic regression was used to estimate the association of state-level policies with the thresholds while adjusting for relevant patient-specific factors. RESULTS: NCOUs in states with medium or high PDMP robustness had lower odds of receiving medium (adjusted odds ratio [AOR] 0.74; 95 percent confidence interval [CI]: 0.62-0.69) and high (AOR 0.74; 95 percent CI: 0.59-0.92) thresholds. With respect to cannabis policies, NCOUs in states with medical cannabis dispensaries had lower odds of receiving high (AOR 0.75; 95 percent CI: 0.60-0.93) thresholds, while cannabis decriminalization had higher odds of receiving high (AOR 1.24; 95 percent CI: 1.04-1.49) thresholds. CONCLUSION: States with highly robust PDMPs and medical cannabis dispensaries had lower odds of receiving higher opioid thresholds, while cannabis decriminalization correlated with higher odds of receiving high opioid thresholds.

Buprenorphine prescribing and treatment accessibility in response to regulation changes due to the COVID-19 public health emergency.

BACKGROUND: In 2021, over 80,000 fatal overdoses occurred in the United States. Since 2020, the federal government has enacted multiple regulatory changes around buprenorphine prescribing for opioid use disorder (OUD) to increase access to buprenorphine. This study aims to explore trends in buprenorphine treatment initiation pre- and post-public health emergency to evaluate changes in the context of X-waiver relaxations and telehealth allowances. METHODS: In a cross-sectional study, all RI residents who filled a buprenorphine prescription at a pharmacy in Rhode Island (RI), Massachusetts, and Connecticut between January 2017 and December 2023 were obtained from the RI Prescription Drug Monitoring Program (PDMP). The study excluded buprenorphine products not approved for OUD treatment from the analysis. Identified individuals had initiated buprenorphine for OUD during the study period if they did not have a prior prescription or if they had >30 days without buprenorphine exposure between their prescriptions. Spearman's rank correlation tests were used to identify significant associations between outcomes and regulation changes. RESULTS: The average number of patients dispensed buprenorphine did not significantly change over the study period, however the average number of initiates significantly decreased (ρ = -0.38255, p = .0003). The average number of providers prescribing CII-CV substances in RI has increased 3.4 % over the study period. The average percentage of prescribers in the PDMP prescribing buprenorphine for OUD doubled (ρ = 0.96075, p < .0001). CONCLUSION: Though efforts have been made to increase buprenorphine initiation, buprenorphine initiates remain well below pre-PHE levels. Efforts must continue to eliminate existing barriers to treatment and improve access to individuals seeking treatment.