The Combined Relationship of Prescription Drug Monitoring Program Enactment and Medical Cannabis Laws with Chronic Pain-Related Healthcare Visits.

BACKGROUND: U.S. state electronic prescription drug monitoring programs (PDMPs) are associated with reduced opioid dispensing among people with chronic pain and may impact use of other chronic pain treatments. In states with medical cannabis laws (MCLs), patients can use cannabis for chronic pain management, reducing their need for chronic-pain related treatment visits and moderating effects of PDMP laws. OBJECTIVE: Given high rates of chronic pain among Medicaid enrollees, we examined associations between PDMP enactment in the presence or absence of MCL on chronic pain-related outpatient and emergency department (ED) visits. DESIGN: We created annual cohorts of Medicaid enrollees with chronic pain diagnoses using national Medicaid claims data from 2002-2013 and 2016. Negative binomial hurdle models produced adjusted odds ratios (aOR) for the likelihood of any chronic pain-related outpatient or ED visit and incident rate ratios (IRR) for the rate of visits among patients with ≥ 1 visit. PARTICIPANTS: Medicaid enrollees aged 18-64 years with chronic pain (N = 4,878,462). MAIN MEASURES: A 3-level state-year variable with the following categories: 1) no PDMP, 2) PDMP enactment in the absence of MCL, or 3) PDMP enactment in the presence of MCL. Healthcare codes for chronic pain-related outpatient and ED visits each year. KEY RESULTS: The sample was primarily female (67.2%), non-Hispanic White (51.2%), and ages 40-55 years (37.2%). Compared to no-PDMP states, PDMP enactment in the absence of MCL was not associated with chronic pain-related outpatient visits but PDMP enactment in the presence of MCL was associated with lower odds of chronic pain-related outpatient visits (aOR = 0.81, 95% CI:0.71-0.92). PDMP enactment was not associated with ED visits, irrespective of MCL. CONCLUSIONS: During a period of PDMP and MCL expansion, our findings suggest treatment shifts for persons with chronic pain away from outpatient settings, potentially related to increased use of cannabis for chronic pain management.

Impact of 30-day prescribed opioid dose trajectory on fatal overdose risk: A population-based, statewide cohort study.

BACKGROUND: Both increases and decreases in patients' prescribed daily opioid dose have been linked to increased overdose risk, but associations between 30-day dose trajectories and subsequent overdose risk have not been systematically examined. OBJECTIVE: To examine the associations between 30-day prescribed opioid dose trajectories and fatal opioid overdose risk during the subsequent 15 days. DESIGN: Statewide cohort study using linked prescription drug monitoring program and death certificate data. We constructed a multivariable Cox proportional hazards model that accounted for time-varying prescription-, prescriber-, and pharmacy-level factors. PARTICIPANTS: All patients prescribed an opioid analgesic in California from March to December, 2013 (5,326,392 patients). MAIN MEASURES: Dependent variable: fatal drug overdose involving opioids. Primary independent variable: a 16-level variable denoting all possible opioid dose trajectories using the following categories for current and 30-day previously prescribed daily dose: 0-29, 30-59, 60-89, or ≥90 milligram morphine equivalents (MME). KEY RESULTS: Relative to patients prescribed a stable daily dose of 0-29 MME, large (≥2 categories) dose increases and having a previous or current dose ≥60 MME per day were associated with significantly greater 15-day overdose risk. Patients whose dose decreased from ≥90 to 0-29 MME per day had significantly greater overdose risk compared to both patients prescribed a stable daily dose of ≥90 MME (aHR 3.56, 95%CI 2.24-5.67) and to patients prescribed a stable daily dose of 0-29 MME (aHR 7.87, 95%CI 5.49-11.28). Patients prescribed benzodiazepines also had significantly greater overdose risk; being prescribed Z-drugs, carisoprodol, or psychostimulants was not associated with overdose risk. CONCLUSIONS: Large (≥2 categories) 30-day dose increases and decreases were both associated with increased risk of fatal opioid overdose, particularly for patients taking ≥90 MME whose opioids were abruptly stopped. Results align with 2022 CDC guidelines that urge caution when reducing opioid doses for patients taking long-term opioid for chronic pain.

Association of state-level prescription drug monitoring program implementation with opioid prescribing transitions in primary care in Australia.

AIMS: This study aimed to evaluate whether voluntary and mandatory prescription drug monitoring program (PDMP) use in Victoria, Australia, had an impact on prescribing behaviour, focusing on individual patients' prescribed opioid doses and transition to prescribing of nonmonitored medications. METHODS: This was a retrospective cross-sectional study using routinely collected primary healthcare data. A 90-day moving average prescribed opioid dose in oral morphine equivalents was used to estimate opioid dosage. A Markov transition matrix was used to describe how patients prescribed medications transitioned between opioid dose groups and other nonopioid treatment options during 3 transition periods: transition between 2 control periods prior to PDMP implementation (T1 to T2); during the voluntary PDMP implementation (T2 to T3); and during mandatory PDMP implementation (T3 to T4). RESULTS: Among patients prescribed opioids in our study, we noted an increased probability of transitioning to not being prescribed opioids during the mandatory PDMP period (T3 to T4). This increase was attributed mainly to the ceasing of low-dose opioid prescribing. Membership in an opioid dose group remained relatively stable for most patients who were prescribed high opioid doses. For those who were only prescribed nonmonitored medications initially, the probability of being prescribed opioids increased during the mandatory PDMP when compared to other transition periods. CONCLUSION: The introduction of PDMP mandates appeared to have an impact on the prescribing for patients who were prescribed low-dose opioids, while its impact on individuals prescribed higher opioid doses was comparatively limited.

Trends in price for topical corticosteroids from 2017 to 2021 and the opportunity for cost savings identifiable at the point of care: A retrospective cross-sectional study.

BACKGROUND: Topical corticosteroids possess numerous generics and similar-strength substitutes. Affordability can impact obtaining the medication prescribed. OBJECTIVE: To determine recent trends in topical corticosteroid pricing and potential for cost saving. METHODS: A retrospective cross-sectional study analyzing all prescriptions dispensed for topical corticosteroids from January 1, 2017 through December 31, 2021, using a US all-payer pharmacy-claims database and commercial coupon dataset, was performed. RESULTS: Two hundred thirty-seven unique drug products (≥1 claim) were identified. Factors that predicted for higher cost (P < .05) were branded products (105% more expensive than generics) and ultrapotent class (55% more expensive than low potency) while ointments predicted for lower cost (19% less expensive than creams). Cash prices remained relatively stable, except for ultrapotent branded topical corticosteroids (63% increase). Cost savings were available for both brand-to-generic ($14.75 per unit) and generic-to-generic ($6.82 per unit) switching. Coupon prices were consistently lower than cash prices (r = 0.89). LIMITATIONS: Contracted rates through insurance plans were not included. CONCLUSIONS: Topical corticosteroid prices over the past 5 years have stabilized, the exception being branded ultrapotent corticosteroids. Savings from switching among similar-strength substitutes remain significant despite price stabilization. Coupon prices mirror the hierarchy of cash prices and can help assess real-time costs.

The effect of combat deployments on veteran opioid abuse.

Grim national statistics about the U.S. opioid crisis are increasingly well known to the American public. Far less well known is that U.S. servicemembers are at ground zero of the epidemic, with veterans facing an overdose death rate of up to twice that of civilians. Exploiting a quasi-experiment in overseas deployment assignment, this study estimates the causal impact of combat exposure among the deployed in the Global War on Terrorism on opioid abuse. We find that exposure to war theater substantially increased the risk of prescription painkiller abuse and illicit heroin use among active duty servicemen. The magnitudes of our estimates imply lower-bound combat exposure-induced healthcare costs of $1.04 billion per year for prescription painkiller abuse and $470 million per year for heroin use.

Auditing the prescription drug consumer price index in a changing marketplace.

Changes in the dynamics of prescription drug markets have raised issues regarding whether the United States Bureau of Labor Statistics' (BLS') Prescription Drug Consumer Price Index (CPI-Rx) has adequately kept up with the evolving marketplace. The CPI-Rx limits its sampling frame to retail outpatient outlets and excludes prescription pharmaceuticals dispensed in non-retail settings such as hospitals, physician/clinic outpatient facilities, and nursing homes. Thus, the CPI-Rx overlooks the increasingly important specialty pharmaceuticals dispensed in non-retail settings, whose transactions are instead captured in the overall hospital and professional services component of the medical care CPI. Specialty drugs now account for about 55% of all U.S. drug spending, double the share of a decade earlier. To the extent specialty drug price growth differs from that of traditional pharmaceuticals, the CPI-Rx could provide an inaccurate measure of overall drug price inflation. We calculate a chained Laspeyres CPI using data from the Merative™ MarketScan® Databases for the years 2010-2019 and IQVIA-designated specialty drugs and offer evidence showing that by not sampling specialty drugs in non-retail settings, the CPI-Rx has understated overall U.S. prescription drug inflation by just under 75 basis points annually. We discuss implications for health care policy and suggest the BLS examine the feasibility of publishing an overall pharmaceutical price index incorporating both traditional and specialty pharmaceuticals dispensed in retail and non-retail settings.

Time-course atherogenic blood lipid response to statin discontinuation in dyslipidemic adults.

BACKGROUND AND AIMS: Half of dyslipidemic patients sometimes discontinue statin medication. It is unclear if blood atherogenic risk increases right after statin discontinuation or if there is a lingering protective effect. We sought to determine if a legacy effect prevented blood lipid increases during the first stages of statin cessation. METHODS AND RESULTS: Atherogenic blood lipid profile was measured in 10 overweight (BMI 31 ± 3 kg m-2) middle-aged males (62 ± 7 years old), statin users, while fasted and postprandially. Trials were conducted before (i.e., Day 0) and after 4, 7, 15, and 30 days of statin withdrawal and 20 days after statins reloading (Day 50). Four days after statin discontinuation, blood fasting LDL-c, total cholesterol (CHOL), and triglyceride (TG) concentrations increased by 30%, 18%, and 17%, respectively (P < 0.05). The increases in LDL-c, CHOL, and TG peaked after 7-15 days at 79%, 48%, and 34% of basal levels (P < 0.001), respectively. There were no significant correlations between the increases in blood lipids and the dose or years under statin treatment (P = 0.156-0.575). Twenty days after resuming statins, blood LDL-c (2.79 ± 1.06 vs 2.20 ± 0.50 mmol L-1; P = 0.568), CHOL (4.85 ± 1.41 vs 4.25 ± 0.83 mmol L-1; P = 0.747), and TG (1.47 ± 0.60 vs 1.50 ± 0.68 mmol L-1; P = 0.782), returned to basal levels. CONCLUSIONS: Our data does not support a statin lingering/legacy effect in blood lipids since they dangerously increased after only 4 days of statin withdrawal in every patient, regardless of dose and years under treatment. Reloading statins restored blood lipids, evidencing a reproducible biological effect at the whole-body level.

Changes in opioid prescribing and prescription drug monitoring program utilization following electronic health record integration-Massachusetts, 2018.

OBJECTIVE: In this study, we explored key prescription drug monitoring program-related outcomes among clinicians from a broad cohort of Massachusetts healthcare facilities following prescription drug monitoring program (PDMP) and electronic health record (EHR) data integration. METHODS: Outcomes included seven-day rolling averages of opioids prescribed, morphine milligram equivalents (MMEs) prescribed, and PDMP queries. We employed a longitudinal study design to analyze PDMP data over a 15-month study period which allowed for six and a half months of pre- and post-integration observations surrounding a two-month integration period. We used longitudinal mixed effects models to examine the effect of EHR integration on each of the key outcomes. RESULTS: Following EHR integration, PDMP queries increased both through the web-based portal and in total (0.037, [95% CI = 0.017, 0.057] and 0.056, [95% CI = 0.035, 0.077]). Both measures of clinician opioid prescribing declined throughout the study period; however, no significant effect following EHR integration was observed. These results were consistent when our analysis was applied to a subset consisting only of continuous PDMP users. CONCLUSIONS: Our results support EHR integration contributing to PDMP utilization by clinicians but do not support changes in opioid prescribing behavior.

Prescription patterns of antibiotics and associated factors among outpatients diagnosed with respiratory tract infections in Jinja city, Uganda, June 2022-May 2023.

BACKGROUND: Most respiratory tract infections (RTIs) are viral and do not require antibiotics, yet their inappropriate prescription is common in low-income settings due to factors like inadequate diagnostic facilities. This misuse contributes to antibiotic resistance. We determined antibiotic prescription patterns and associated factors among outpatients with RTIs in Jinja City, Uganda. METHODS: We conducted a retrospective observational study that involved data abstraction of all patient records with a diagnosis of RTIs from the outpatient registers for the period of June 1, 2022, to May 31, 2023. An interviewer-administered questionnaire capturing data on prescribing practices and factors influencing antibiotic prescription was administered to drug prescribers in the health facilities where data were abstracted and who had prescribed from June 1, 2022, to May 31, 2023. We used modified Poisson regression analysis to identify factors associated with antibiotic prescription. RESULTS: Out of 1,669 patient records reviewed, the overall antibiotic prescription rate for respiratory tract infections (RTIs) was 79.8%. For specific RTIs, rates were 71.4% for acute bronchitis, 93.3% for acute otitis media, and 74.4% for acute upper respiratory tract infections (URTIs). Factors significantly associated with antibiotic prescription included access to Uganda Clinical Guidelines (Adjusted prevalence ratio [aPR] = 0.61, 95% CI = 0.01-0.91) and Integrated Management of Childhood Illness guidelines (aPR = 0.14, 95% CI = 0.12-0.87, P = 0.002), which reduced the likelihood of prescription. Prescribers without training on antibiotic use were more likely to prescribe antibiotics (aPR = 3.55, 95% CI = 1.92-3.98). Patients with common cold (aPR = 0.06, 95% CI = 0.04-0.20) and cough (aPR = 0.11, 95% CI = 0.09-0.91) were less likely to receive antibiotics compared to those with pneumonia. CONCLUSION: The study reveals a high rate of inappropriate antibiotic prescription for RTIs, highlighting challenges in adherence to treatment guidelines. This practice not only wastes national resources but also could contribute to the growing threat of antibiotic resistance. Targeted interventions, such as enforcing adherence to prescription guidelines, could improve prescription practices and reduce antibiotic misuse in this low-income setting.

Prescription drug monitoring programs and prescription pain medication misuse among U.S. high school students-2019.

BACKGROUND: Prescription drug monitoring programs (PDMPs) are state-level databases that track and inform prescribing practices to reduce prescription drug diversion and misuse. To our knowledge, only three studies have examined the impact of PDMPs on opioid-related outcomes among adolescents, and none have focused on prescription pain medication misuse among adolescents. METHODS: This study leveraged data from the 2019 National Youth Risk Behavior Survey (YRBS) to explore the associations between five categories of PDMP dimensions and the prevalence of self-reported prescription pain medication misuse. Demographic factors' associations with self-reported prescription pain medication misuse were also examined. RESULTS: In 2019, none of the PDMP dimensions were associated with self-reported prescription pain medication misuse among U.S. high school students, adjusting for gender, grade, race/ethnicity, and sexual orientation. CONCLUSIONS: None of the five PDMP dimensions were associated with lower prescription pain medication misuse, however further research is needed, especially as new YRBS data become available.

Prescription drug monitoring program in Australia: a qualitative study of stakeholders' experiences and perceptions of a state-wide implementation.

BACKGROUND: Prescription Drug Monitoring Programs (PDMPs) are increasingly implemented across the globe with aims of managing and mitigating risks relating to high-risk prescription medicines. There is limited research focused on identifying strategies or processes for large-scale PDMP implementation. This study aimed to identify strategies perceived as necessary for successful state-wide implementation of a PDMP by exploring the experiences and perceptions of stakeholders responsible for the implementation in New South Wales (NSW), Australia: to identify (1) the drivers of implementation; (2) perceived strategies that worked well; (3) barriers to implementation; and (4) the elements needed for long-term success of SafeScript NSW. METHODS: This study used a qualitative descriptive design. Theoretical frameworks used to design interview questions and guide thematic analysis were the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework and Quadruple Aim framework. Participants were stakeholders responsible for PDMP implementation in NSW. Recruitment and data collection were completed between March and April 2022. Semi-structured interviews were audio-recorded and transcribed. Two researchers independently reviewed transcripts, generated codes from the data, and mapped these to each NASSS domain. They came together multiple times during data analysis to review the codes and grouped them into higher level themes via a discussion and consensus process. Themes were then organised according to the four objectives of the study. RESULTS: Eight interviews were conducted and analysed after which thematic saturation was reached. All participants had a common understanding of the perceived benefits and drivers for PDMP implementation. Participants outlined ten key ingredients for perceived successful state-wide implementation. Strong and iterative engagement with a large number of stakeholder groups was viewed as critical, as was targeting user experience, ongoing monitoring and evaluation. These were facilitated by a phased roll-out strategy. Participants identified some barriers to implementation, particularly around poor usability and user experience of the tool. CONCLUSIONS: This is one of the first studies focused on strategies for what was perceived to be successful state-wide implementation of PDMP. Successful implementation requires significant time and resourcing, with the design and configuration of the technology being only one component of a multi-strategy process. Knowledge and insights gained from this study may be useful for other implementations of similar digital health tools in large-scale jurisdictions.

Prescription Painkiller Misuse in Hispanic and non-Hispanic Adults Ages 50 and Older: Trends and Correlates in a National Sample, 2015-2019.

Background: Older adults, an increasingly diverse segment of the United States population, are a priority population for prescription painkiller misuse. This study documents trends and correlates of prescription painkiller misuse among Hispanic and non-Hispanic adults ages 50 and older. Methods: A secondary analysis of adults 50 years and older across 5 cohorts using the 2015-2019 National Survey on Drug Use and Health (unweighted n = 16,181, 8.5% Hispanic, and 54% female). Logistic regression modeling with complex survey design was used to examine trends in prescription painkiller misuse. Results: Over time, the prevalence of past year painkiller misuse significantly decreased for Hispanic respondents (56.1% relative decrease, p = 0.02); elevated proportions were observed across strata of demographic characteristics. Conclusions: Variability in the prevalence of painkiller misuse may be explained by demographic characteristics. Further, these results emphasize the importance of addressing comorbid recreational marijuana use when designing interventions to address painkiller misuse for older adults.

Workplace access, burnout, and prescription drug misuse among Korean hospital nurses: a cross-sectional study.

BACKGROUND: Prescription drug misuse has been identified as a global issue of concern. Nurses' prescription drug misuse is linked to personal health problems and impaired nursing care. This study explored the level of South Korean hospital nurses' prescription drug misuse and examined associations with workplace access and burnout. METHODS: This cross-sectional study used data from 1142 nurses working in South Korean hospital settings. Nurses completed the online survey anonymously. Descriptive analysis, logistic regression, and Shapley value assessment were conducted. RESULTS: Pain relievers (44.2%), IV drips (26.8%), and antibiotics (13.5%) were the most commonly misused drugs among hospital nurses. Accessibility in the workplace was high, with nurses reporting frequent administration of IV drips, pain relievers, and antibiotics and perceiving these drugs as easily accessible. Logistic regression demonstrated that perceived availability was significantly related to misuse across all drug types. Burnout was associated with IV drips, sleeping pills, and steroids, increasing the likelihood of misuse. Shapley feature importance analysis highlighted perceived availability as the most influential factor for IV drips, pain relievers, and steroids, while burnout emerged as crucial for antibiotics and sleeping pills. Notably, age played a significant role in appetite suppressant misuse, distinguishing it from other drugs. CONCLUSION: Our results revealed that workplace access and burnout are associated with nurses' prescription drug misuse. Effective educational strategies are essential for enhancing nurses' willingness to seek help for personal health issues. Hospital organizations play a crucial role in facilitating access to healthcare and fostering a supportive environment for nurses to seek treatment when necessary. Additionally, governmental policies should prioritize the implementation of active surveillance systems to monitor medication usage in healthcare settings, thereby mitigating drug misuse among healthcare professionals. By addressing these issues, we can ensure the well-being of nurses and promote a safer healthcare environment.

Willingness to Provide Naloxone Resources for Patients at Risk of Opioid Overdose: A National Survey of Emergency Registered Nurses.

INTRODUCTION: Opioid-related events continue to claim lives in the United States at alarming rates. Naloxone-dispensing rates fall dramatically short of national expectations. Emergency registered nurses are uniquely poised to connect at-risk patients with naloxone resources. This study sought to (1) describe the emergency registered nurses' willingness to provide naloxone resources and (2) explore variables that may influence the nurse's willingness to provide resources. METHODS: A cross-sectional, survey-based design was deployed using an online branch logic approach to include a national sample of emergency registered nurses. The Willingness to Provide, a validated questionnaire, measured the registered nurse's willingness to provide naloxone resources for patients at risk of opioid overdose. Eight variables were assessed for potential influence on willingness. RESULTS: A total of 159 nurses from 32 states and the District of Columbia completed the online survey via the Research Electronic Data Capture platform. The results revealed a mean Willingness to Provide score of 38.64 indicating a willingness to provide naloxone resources. A statistically significant relationship was identified between the nurse's willingness and years of nursing experience (P = .001), knowledge (P = .015), desire (P = .001), and responsibility (P < .001). DISCUSSION: In this representative sample, emergency nurses are willing to provide naloxone resources; furthermore, results indicate that higher knowledge, desire, and responsibility scores increase the nurse's willingness to provide naloxone resources; with education and clear expectations, emergency nurses may be able to improve the connection of patients at risk of opioid overdose with naloxone, a potentially lifesaving connection.

Other Momentary Substance Behaviors as Predictors of College Students' Prescription Drug Misuse in Daily Life: An Exploratory Study.

Background: Limited prior research to examine co-occurrence of prescription drug misuse with other substances among young adults has documented outcomes that are more problematic for those with higher rates of co-ingesting alcohol. There is a need to understand how college students in this period of heightened risk use other salient substances in moments of their prescription misuse in daily life. Method: Young-adult college students who engaged in recent prescription misuse (N = 297) completed ecological momentary assessment (EMA) over a 28-day period, resulting in 23,578 reports. Multilevel modeling examined within-person associations between other momentary substance use (including alcohol, nicotine, energy drinks, and marijuana) and prescription misuse in daily life. Analyses accounted for between-person characteristics, having a current focal prescription, and effects of reporting over time. Participant sex was also explored as a moderator. Results: In adjusted multilevel models, college students' momentary nicotine use and energy drink use each were associated with their greater likelihood of prescription misuse in daily life. In contrast, momentary marijuana use was linked with lower likelihood of misuse. Moderation results indicated that males (but not females) were less likely to engage in prescription misuse in moments of their alcohol use. Conclusions: Drawing from data obtained using EMA, findings provide novel insights about the real-world associations between prescription drug misuse and other salient substance behaviors during a developmental period that is important for establishing later substance use and health.

Family history of substance problems among African Americans: Associations with drug use, drug use disorder, and prescription drug misuse.

A family history of substance problems is a well-known risk factor for substance use and use disorders; however, much of this research has been conducted in studies with predominantly White subjects. The aim of this study was to examine the associations between family history density of substance problems and drug use, risk for drug use disorder, and prescription drug misuse in a sample of African American adults. Results indicate that family history density of substance problems increased the risk for all drug outcomes in the full sample. However, when subgroup analyses by gender were conducted, family history was not a risk factor among men for prescription drug misuse.

National Estimates and Physician-Reported Impacts of Prescription Drug Monitoring Program Use.

BACKGROUND: Despite widespread adoption of state prescription drug monitoring programs (PDMPs), it is unclear how often PDMPs are accessed through an electronic health record system (EHR-PDMP integration), or whether efforts to make PDMPs easier to access and use have improved their utility. OBJECTIVE: To produce national-level estimates on the use of PDMPs among office-based physicians and benefits associated with their use. DESIGN: We use nationally representative survey data to produce descriptive statistics on PDMP use and associated benefits among office-based physicians in the USA. PARTICIPANTS: 1398 office-based physicians who prescribe controlled substances. MAIN MEASURES: We examined physician-reported ease and frequency of PDMP use, and how EHR-PDMP integration affects frequency and ease of use. Multivariate models were used to assess whether characteristics of PDMP use were related to physician-reported benefits such as reduced prescribing of controlled substances and perceived improvements in clinical decision-making. KEY RESULTS: In 2019, two-thirds of office-based physicians in the USA reported frequent use of their state PDMP and over three-quarters reported they were easy to use. Both frequency and ease of use were positively correlated with PDMP integration status. Respondents who frequently checked their state's PDMP were 8.7 percentage points (95% CI -.4 to 17.8) more likely to report perceived benefits and reported 2.2 (95% CI 1.54 to 2.83) more benefits. Respondents who indicated their PDMP was easy to use were 12.7 percentage points (95% CI .040 to .214) more likely to report perceived benefits and reported 0.94 (95% CI 0.26 to 1.61) more benefits. CONCLUSIONS: Our findings suggest efforts to make PDMPs easier to access and use aided physicians in making informed clinical decisions that may not be captured by reduced prescribing alone. Efforts to further increase frequency and ease of use-including advancing a standards-based approach to PDMP and EHR data interoperability-may further increase the benefit of PDMPs.

Using Multiple Authorized Generics to Maintain High Prices: The Example of Entacapone.

OBJECTIVES: Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other manufacturers. The brand-name manufacturer of entacapone, a treatment for Parkinson's disease, established 4 AGs before IGs emerged. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition. METHODS: Using public Food and Drug Administration and court records, we identified the regulatory and legal history for generic entacapone products marketed through 2021. We used Medicare Part D data to estimate trends in use, prices, and spending on entacapone products from 2011 to 2020, comparing actual spending with projected spending if IG competition had begun after expiration of the key patent protecting entacapone (October 2013) and prices had fallen consistent with levels observed for other generic drugs. RESULTS: From 2012 to 2014, 3 potential entacapone IG manufacturers instead launched AG versions after settlement agreements with the brand-name manufacturer; the brand-name manufacturer additionally introduced its own AG. Four different IG versions were marketed beginning in 2015. From 2011 to 2020, average Medicare prices declined by 62%, less than the projected 74% to 92% price decline expected for a drug with 8 generics. Over this period, Medicare spent $1.1 billion on entacapone products, which could have been reduced by an estimated $137 to $449 million through typical IG competition. CONCLUSIONS: The case of entacapone demonstrates how licensing multiple AGs in place of IG competition can increase spending. Government regulators should more rigorously monitor AGs to prevent such strategies.

Attention to risk information in direct-to-consumer prescription drug print ads: An eye-tracking study.

PURPOSE: FDA regulations state print ads for prescription drugs must provide a true statement of information "in brief summary" describing "side effects, contraindications and effectiveness." To fulfill these requirements, these ads typically display risk information both as important safety information (ISI) on the "main" ad page with the product claims and on a separate "brief summary" page. The ISI can be lengthy and may repeat brief summary content. METHODS: The authors tested two versions of the ISI (short versus long) and the presence or absence of a brief summary in direct-to-consumer prescription drug print ads for two medical conditions: overactive bladder (N = 181) and rheumatoid arthritis (N = 179). Attention was measured with eye-tracking and self-report methods. Risk retention and perceptions were self-reported. RESULTS: Participants spent more time viewing ads with a long ISI or a brief summary and in some instances, recalled more risks. The combination of a long ISI and a brief summary did not increase or decrease attention to or retention of risk information. CONCLUSION: A long ISI and a brief summary may perform similar functions.

Parental drinking, mental health and educational level, and offspring's subsequent prescription drugs treatment for sleep problems. A longitudinal HUNT survey and registry study.

BACKGROUND: Parental drinking, mental health and family socioeconomic status are all associated with offspring sleep problems, but there is a paucity of research that considers the effect of risk factors, as they co-occur within and across families. Also, sleep problems are closely linked with mental health problems. Disentangling the effects on one or the other are important. We examined whether parental risk constellations are differently associated with offspring's subsequent prescription drug use for sleep problems during nine years with or without prescription drug use for anxiety and/or depression. METHODS: The sample included 8773 adolescent offspring of 6696 two-parent families who participated in the Nord-Trøndelag Health Study in Norway. The exposures were five parental risk constellations, previously identified via Latent Profile Analysis, characterized by drinking frequencies and quantities, mental health, and years of education. The outcomes were dispensed prescription drugs in offspring during 2008-2016 for (a) only sleep problems (b) sleep problems and anxiety/depression or (c) only anxiety/depression. We used multinomial logistic regression to model the odds of the outcomes. RESULTS: Compared to the overall low-risk parental constellation, none of the risky constellations were significantly associated with increased risk of being dispensed prescription drugs only for sleep problems. Offspring from two different risk profiles were at increased risk for being dispensed both sleep and anxiety/depression prescription drugs. These were parental profiles marked by (1) low education, symptoms of mental health problems and weekly binge drinking in both parents (OR 1.90, CI = 1.06;3.42); and (2) frequent heavy drinking in both parents and symptoms of mental health problems in fathers (OR 3.32, CI = 1.49;7.39). Offspring from the risk profile with lowest parental education had increased risk of only anxiety/depression prescription drugs (OR 1.25, CI = 1.05;1.49). CONCLUSION: Our findings suggest that parental risk constellations are not associated with increased risk of offspring receiving sleep medications without also receiving anxiety/depression medications, as two risk constellations were associated with increased risk of dispensation of both sleep and anxiety/depression prescription drugs. Receiving both may be an indication of severity. The findings underscore the importance of including measures of mental health problems when investigating sleep problems to avoid misattribution of effects.