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Purpose The 340B Drug Pricing Program is important to healthcare organizations that serve vulnerable communities. However, it is unknown whether healthcare providers in these organizations understand the 340B program and how it supports enhanced patient services. This study aims to characterize the knowledge, attitudes, and beliefs of healthcare providers toward the 340B program in a multisite federally qualified health center (FQHC). Methods This was a cross-sectional study. A 27-item survey designed to assess prescriber knowledge and perspectives toward the 340B program was developed and administered. Closed-ended items were summarized using descriptive statistics, and open-ended items were analyzed with qualitative methods. Results A total of 198 healthcare providers with prescribing authority received the survey; of those, 65 (32.8%) participated. The majority of respondents (66.2%) were female; 41.5% were 35 years of age or younger, and 49.2% were physicians. The majority of respondents agreed that patients benefited from access to the organization's 340B pharmacies (95.0%) and that 340B pricing is important to consider when prescribing medications (78.3%). However, knowledge of the 340B program was limited, with only half of respondents (54.0%) able to correctly answer at least 4 of 7 knowledge-focused items. Reponses to a patient case suggested that some providers may be unfamiliar with which drugs are available at reduced prices. Conclusion The findings suggest that providers believe the 340B program benefits patients and the organization but often lack a complete understanding of the program. Future research should focus on prescriber education as a strategy to help organizations optimize their 340B programs and facilitate patient access to medications. [ABSTRACT FROM AUTHOR]

Although most drugs currently approved are meant to treat specific diseases or symptoms, it has been hypothesized that some might bear a beneficial effect on lifespan in healthy older individuals, outside of their specific disease indication. Such drugs include, among others, metformin, SGLT2 inhibitors and rapamycin. Since 2006, the UK biobank has recorded prescription medication and mortality data for over 500′000 participants, aged between 40 and 70 years old. In this work, we examined the impact of the top 406 prescribed medications on overall mortality rates within the general population of the UK. As expected, most drugs were linked to a shorter lifespan, likely due to the life‐limiting nature of the diseases they are prescribed to treat. Importantly, a few drugs were associated with increased lifespans, including notably Sildenafil, Atorvastatin, Naproxen and Estradiol. These retrospective results warrant further investigation in randomized controlled trials. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Direct-to-consumer (DTC) pharmacies sell generic prescription drugs, often at lower prices than traditional retail pharmacies; however, not all drugs are available, and prices vary. Objective: To determine the availability and cost of generic drugs at DTC pharmacies. Design: Cross-sectional study. Setting: Five national DTC pharmacies in April and May 2023. Participants: Each qualifying form of 100 generic drugs with the highest cost-per-patient (expensive) and the 50 generic drugs with the highest number of patients (common) in Medicare Part D in 2020 Main Measures: Availability of these drugs and the lowest DTC pharmacy price for a standardized drug strength and supply (e.g., 30 pills), compared to GoodRx retail pharmacy prices. Key Results: Of the 118 expensive generic dosage forms, 94 (80%) were available at 1 or more DTC pharmacies; out of 52 common generic dosage forms, 51 (98%) were available (p < 0.001). Of the 88 expensive generics available in comparable quantities and strengths across pharmacies, 42 (47%) had the lowest cost at Amazon, 23 (26%) at Mark Cuban Cost Plus Drug Company, 13 (14%) at Health Warehouse, and 12 (13%) at Costco; for 51 common generic formulations, 16 (31%) had the lowest cost at Costco, 14 (27%) at Amazon, 10 (20%) at Walmart, 6 (12%) at Health Warehouse, and 5 (10%) at Mark Cuban Cost Plus Drug Company. For the 77 expensive generics with available GoodRx retail pharmacy prices, the median cost savings at DTC pharmacies were $231 (95% CI, $129–$792) or 76% (IQR, 53–91%); for 51 common generics, savings were $19 (95% CI, $10–$34) or 75% (IQR, 67–83%). Conclusions: Many of the most expensive generic drugs are unavailable at direct-to-consumer pharmacies. Meanwhile, less expensive, commonly used generics are widely available, but drug prices vary by pharmacy and savings are modest, requiring patients to shop around for the lowest cost. [ABSTRACT FROM AUTHOR]

Background No national study has evaluated changes in the appropriateness of US outpatient antibiotic prescribing across all conditions and age groups after the coronavirus disease 2019 (COVID-19) outbreak in March 2020. Methods This was an interrupted time series analysis of Optum's de-identified Clinformatics Data Mart Database, a national commercial and Medicare Advantage claims database. Analyses included prescriptions for antibiotics dispensed to children and adults enrolled during each month during 2017–2021. For each prescription, we applied our previously developed antibiotic appropriateness classification scheme to International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes on medical claims occurring on or during the 3 days prior to dispensing. Outcomes included the monthly proportion of antibiotic prescriptions that were inappropriate and the monthly proportion of enrollees with ≥1 inappropriate prescription. Using segmented regression models, we assessed for level and slope changes in outcomes in March 2020. Results Analyses included 37 566 581 enrollees, of whom 19 154 059 (51.0%) were female. The proportion of enrollees with ≥1 inappropriate prescription decreased in March 2020 (level decrease: −0.80 percentage points [95% confidence interval {CI}, −1.09% to −.51%]) and subsequently increased (slope increase: 0.02 percentage points per month [95% CI,.01%–.03%]), partly because overall antibiotic dispensing rebounded and partly because the proportion of antibiotic prescriptions that were inappropriate increased (slope increase: 0.11 percentage points per month [95% CI,.04%–.18%]). In December 2021, the proportion of enrollees with ≥1 inappropriate prescription equaled the corresponding proportion in December 2019. Conclusions Despite an initial decline, the proportion of enrollees exposed to inappropriate antibiotics returned to baseline levels by December 2021. Findings underscore the continued importance of outpatient antibiotic stewardship initiatives. [ABSTRACT FROM AUTHOR]

Obesity is a risk factor for anxiety and depression. Obesity is also a risk factor for severe COVID‐19 disease and therefore may have contributed to adverse mental health outcomes in this vulnerable population during the COVID‐19 pandemic. We compare the trajectory of mental health outcomes of people with obesity with normal‐weight people before and during the COVID‐19 pandemic using nationally representative individual‐level longitudinal data from the National Health Interview Survey and Difference‐in‐Difference regressions. Our results indicate that severe anxiety increased by 2.75 (95% CI: 0.0056–0.0494; p‐value 0.014) percentage points, representing a 31.3% relative increase, and anxiety‐related prescription drug usage increased by 2.75 (95% CI: 0.0076–0.0473; p‐value<0.01) percentage points, representing a 19.2% relative increase among people with obesity, compared to normal‐weight people. We conclude that people with obesity experienced an increase in the incidence of severe anxiety and anxiety‐related prescription drug usage during the COVID‐19 pandemic, which was not observed among normal‐weight individuals. Furthermore, women, less‐educated, and rural residents with obesity disproportionately bore the burden of the pandemic. [ABSTRACT FROM AUTHOR]

Introduction: Maternal demographics have evolved, and more women than ever enter pregnancy with preexisting comorbidity and with potentially complex medication exposure, including polypharmacy (concomitant intake of multiple medications). This study aims to describe the evolution of medication use in pregnancy in Denmark from 1998 to 2018 with special focus on polypharmacy, patterns of use, and underlying demographics. Material and methods: A Danish nationwide historical registry study based on all clinically recognized pregnancies with a gestation ≥10 weeks between 1998 and 2018. Medication use was estimated by redemption of prescriptions during pregnancy. Results: Among a total of 1 402 327 clinically recognized pregnancies, redemption of at least one prescription medication during pregnancy increased from 56.9% in 1998 to 63.3% in 2018, coinciding with an increased use of polypharmacy (from 24.8% in 1998 to 35.2% in 2018). The prevalence of pregnant women who used medications for chronic conditions increased more than the prevalence of women treated for occasional or short‐time conditions. Redemption of one or multiple prescription medications during pregnancy was mostly seen among pregnant women ≥35 years of age. However, pregnant women <25 years old exhibited the largest increase in medication use during the study period. Conclusions: Medication use in general, and polypharmacy in particular, increased from 1998 to 2008, possibly as the result of an increased prevalence of pregnant women with chronic conditions requiring pharmacological treatment. Notably, a marked maternal age‐based discrepancy in usage pattern was observed, highlighting the need for further research in this area. The rise in the prevalence of polypharmacy during pregnancy underscores the need for pharmacovigilance to monitor adverse effects. Future studies should investigate the patterns of polypharmacy and the accompanying maternal and fetal risks. [ABSTRACT FROM AUTHOR]

For the first time after many decades, many new antidepressants have been approved and many more are under various stages of development and will soon be available in the market. The new drugs present a range of new mechanisms of action with benefits in terms of speed of action, tolerability and range of treatable disorders. Neurosteroids have been recently approved and their rapid benefit may extend from postpartum depression to anxious depression and bipolar depression, dextromethorphan and bupropion combination may prove useful in major depression but also in treatment resistant depression, dextromethadone is a possible augmentation in partial antidepressant response, psychedelic drugs have the potential of long lasting benefits after a single administration, though are still experimental treatments. Botulinum has the same advantage of psychedelics of a single administration and its antidepressant effects may last for weeks or more. Further potentially interesting new antidepressant mechanisms include new drug targets, drug repurposing and genetic or epigenetic manipulations. It is therefore important that clinicians are kept up to date with new evidence so that new evidence can be rapidly translated into clinical practice. [ABSTRACT FROM AUTHOR]

Background: Patients with schizophrenia (SZ) or bipolar disorder (BD) may have increased risk of complications from prescribed opioids, including opioid-induced respiratory depression. We compared prescription opioid pain medication dispensing for patients with SZ or BD versus controls over 5 years to assess dispensing trends. Methods: This retrospective, observational study analysed US claims data from the IBM® MarketScan® Commercial and Multi-State Medicaid databases for individuals aged 18–64 years with prevalent SZ or BD for years 2015–2019 compared with age- and sex-matched controls. Baseline characteristics, comorbidities, and medication use were assessed. Proportions of individuals dispensed prescription opioids chronically (ie, ≥70 days over a 90-day period or ≥ 6 prescriptions annually) or nonchronically (≥1 prescription, chronic definition not met) were assessed. Results: In 2019, the Commercial and Medicaid databases contained records for 4773 and 30,179 patients with SZ and 52,780 and 63,455 patients with BD, respectively. Patients with SZ or BD had a higher prevalence of comorbidities, including pain, versus controls in each analysis year. From 2015 to 2019, among commercially insured patients with SZ, chronic opioid-dispensing proportions decreased from 6.1% (controls: 2.7%) to 2.3% (controls: 1.2%) and, for patients with BD, from 11.4% (controls: 2.7%) to 6.4% (controls: 1.6%). Chronic opioid dispensing declined in Medicaid-covered patients with SZ from 15.0% (controls: 14.7%) to 6.7% (controls: 6.0%) and, for patients with BD, from 27.4% (controls: 12.0%) to 12.4% (controls: 4.7%). Among commercially insured patients with SZ, nonchronic opioid dispensing decreased from 15.5% (controls: 16.4%) to 10.7% (controls: 11.0%) and, for patients with BD, from 26.1% (controls: 17.5%) to 20.0% (controls: 12.2%). In Medicaid-covered patients with SZ, nonchronic opioid dispensing declined from 22.5% (controls: 24.4%) to 15.1% (controls: 12.7%) and, for patients with BD, from 32.3% (controls: 25.9%) to 24.6% (controls: 13.6%). Conclusions: The proportions of individuals dispensed chronic or nonchronic opioid medications each year were similar between commercially and Medicaid-insured patients with SZ versus controls and were higher for patients with BD versus controls. From 2015 to 2019, the proportions of individuals who were dispensed prescription opioids chronically or nonchronically decreased for patients with SZ or BD and controls. [ABSTRACT FROM AUTHOR]

Psychotropic and somatic medications are both used in treating severe mental disorders (SMDs). Realistic estimates of the prevalence of use across medication categories are needed. We obtained this in a clinical cohort of patients with SMD and healthy controls (HCs). Prescriptions filled at Norwegian pharmacies the year before and after admittance to the Thematically Organized Psychosis (TOP) study were examined in 1406 patients with SMD (mean age 32.5 years, 48.2% women) and 920 HC (34.1 years, 46.2% women). Using data from the Norwegian Prescription Database (NorPD), the number of users in different anatomical therapeutic chemical (ATC) categories was compared using logistic regression. Population estimates were used as reference data. Use of antipsychotics (N05A), antiepileptics (N03A), antidepressants (N06A), anxiolytics (N05B), hypnotics and sedatives (N05C), anticholinergics (N04A), psychostimulants, attention deficit hyperactivity disorder and nootropic agents (N06B) and drugs for addiction disorders (N07B) was significantly more prevalent in patients with SMD than HC. Use of diabetes treatment (A10), antithrombotic drugs (B01), beta blockers (C07), lipid modifiers (C10), and thyroid and endocrine therapeutics (H03) was also more prevalent in patients with SMD, but with two exceptions somatic medication use was comparable to the general population. Among HC, there was low prevalence of use for most medication categories. Patients were using psychiatric medications, but also several types of somatic medications, more often than HC. Still, somatic medication use was mostly not higher than in the general population. The results indicate that HC had low use of most medication types. [ABSTRACT FROM AUTHOR]

Context: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. Methods: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. Findings: During fiscal years 2006–2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. Conclusions: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation. [ABSTRACT FROM AUTHOR]

Prescription drug cost-sharing is a barrier to medication adherence, particularly for low-income and minority populations. In this systematic review, we examined the impact of prescription drug cost-sharing and policies to reduce cost-sharing on racial/ethnic and income disparities in medication utilization. We screened 2,145 titles and abstracts and identified 19 peer-reviewed papers that examined the interaction between cost-sharing and racial/ethnic and income disparities in medication adherence or utilization. We found weak but inconsistent evidence that lower cost-sharing is associated with reduced disparities in adherence and utilization, but studies consistently found that significant disparities remained even after adjusting for differences in cost-sharing across individuals. Study designs varied in their ability to measure the causal effect of policy or cost-sharing changes on disparities, and a wide range of policies were examined across studies. Further research is needed to identify the types of policies that are best suited to reduce disparities in medication adherence. [ABSTRACT FROM AUTHOR]

This study examined how interruptions in insurance coverage affect purchases of prescription drugs for young adults. It used data spanning 2014 to 2018 from Kentucky's prescription drug monitoring program, which tracked the universe of federally-regulated (Schedule II–V) prescription drugs dispensed in the state. The study employed a regression discontinuity design based on the age limit at 26 for dependent insurance coverage for children. At age 26, the probability of purchasing a prescription decreased by 5%, with all subcategories of prescriptions affected. The share of generic prescriptions increased for stimulants (the only category observed with substantial branded prescriptions). By age 27, prescription purchases returned to levels observed at 25, but the share purchased with public insurance and the generic share for stimulants remained higher. The findings suggest that interruptions in insurance coverage decrease prescription drug utilization by young adults and that public insurance programs such as Medicaid are important for resuming treatment. [ABSTRACT FROM AUTHOR]

ObjectivesMethodsResultsConclusionClinical ImplicationsTo investigate indicators of potentially hazardous alcohol use among older adults living in a region with high substance use stigma.Patients at a university-affiliated geriatrics clinic in the Deep South of theUS completed behavioral health screenings including self-reported alcohol use, symptoms of depression or anxiety, and cognitive functioning between 2018 and 2022.Participants (N = 278) averaged 76.04 years of age (SD = 9.25), were predominantly female (70.9%), and non-Hispanic white (84.5%), with an averageof 6.08 comorbid diagnoses (SD = 2.86). Race/ethnicity, age, and symptoms of anxiety were associated with alcohol use and hazardous alcohol use, with non-Hispanic whites, younger individuals, and those with more anxiety symptoms reporting more alcohol use. Notably, alcohol use and hazardous alcohol use were associated with cognitive functioning in the dementia range.Self-reported alcohol use is low in geriatric primary care in the Deep South, US, differs by race/ethnicity, and is predictive of cognitive impairment when alcohol use is hazardous. Issues of trust and stigma may play a role in self-report ofstigmatized behaviors.Self-reported alcohol intake must be considered within the cultural context of regional stigma. Recommendations to address this are provided. [ABSTRACT FROM AUTHOR]

Background: Medications are one of the most easily modifiable risk factors for motor vehicle crashes (MVCs) among older adults, yet limited information exists on how the use of potentially driver‐impairing (PDI) medications changes following an MVC. Therefore, we examined the number and types of PDI medication classes dispensed before and after an MVC. Methods: This observational study included Medicare fee‐for‐service beneficiaries aged ≥67 years who were involved in a police‐reported MVC in New Jersey as a driver between 2008 and 2017. Analyses were conducted at the "person‐crash" level because participants could be involved in more than one MVC. We examined the use of 36 PDI medication classes in the 120 days before and 120 days after MVC. We described the number and prevalence of PDI medication classes in the pre‐MVC and post‐MVC periods as well as the most common PDI medication classes started and stopped following the MVC. Results: Among 124,954 person‐crashes, the mean (SD) age was 76.0 (6.5) years, 51.3% were female, and 83.9% were non‐Hispanic White. The median (Q1, Q3) number of PDI medication classes was 2 (1, 4) in both the pre‐MVC and post‐MVC periods. Overall, 20.3% had a net increase, 15.9% had a net decrease, and 63.8% had no net change in the number of PDI medication classes after MVC. Opioids, antihistamines, and thiazide diuretics were the top PDI medication classes stopped following MVC, at incidences of 6.2%, 2.1%, and 1.7%, respectively. The top medication classes started were opioids (8.3%), skeletal muscle relaxants (2.2%), and benzodiazepines (2.1%). Conclusions: A majority of crash‐involved older adults were exposed to multiple PDI medications before and after MVC. A greater proportion of person‐crashes were associated with an increased rather than decreased number of PDI medications. The reasons why clinicians refrain from stopping PDI medications following an MVC remain to be elucidated. [ABSTRACT FROM AUTHOR]

Medication guides (MGs) provide patients with important information about certain prescription drugs to help them take these drugs safely. We surveyed US residents about their perceptions of MG readability and understandability. We randomly sampled 5204 US residents (age 18+) from Ipsos's KnowledgePanel to complete a two-part survey. Only respondents who reported receiving an MG with their prescription drugs (n  = 3852) completed part 2, which included two key items: How easy to [(1) read/ (2) understand ] are the MGs that you have received from a pharmacy along with your prescription medicines? (1 =  Very easy, 5 =  Very difficult ; reverse-coded). Health literacy (HL) and demographic data were also collected. After weighting our data, we found that 85% of respondents who reported receiving an MG perceived this information as 'very easy' (27.3%), 'somewhat easy' (28.3%) or 'about average' (29.3%) to read. Eighty-seven percent of respondents who reported receiving an MG perceived it as 'very easy' (27.6%), 'somewhat easy' (30.2%) or 'about average' (29.5%) to understand. ANOVAs revealed higher average perceived MG reading and comprehension ease scores among respondents presumed to have adequate versus inadequate HL (ps  ≤ 0.0006). Younger or less-educated respondents and non-Hispanic Blacks perceived MGs as easier to read and understand, on average, than their counterparts (p s ≤ 0.0001). Many of these relationships remained intact in models predicting perceived MG reading and comprehension ease (p s ≤ 0.001). Adjusted R 2 values across models were small, however (≤0.06). Our findings suggest most US residents (18+) who received MGs perceived them to be 'about average' to 'very easy' to read and understand. [ABSTRACT FROM AUTHOR]

Objective Data Sources and Study Setting Study Design Data Collection/Extraction Methods Principal Findings Conclusions To determine whether annual changes in prices for clinician‐administered drugs are associated with changes in patient out‐of‐pocket costs.National commercial claims database, 2009 to 2018.In a serial, cross‐sectional study, we calculated the annual percent change in manufacturer list prices and net prices after rebates. We used two‐part generalized linear models to assess the relationship between annual changes in price with (1) the percentage of individuals incurring any out‐of‐pocket costs and (2) the percent change in median non‐zero out‐of‐pocket costs.We created annual cohorts of privately insured individuals who used one of 52 brand‐name clinician‐administered drugs.List prices increased 4.4%/yr (interquartile range [IQR], 1.1% to 6.0%) and net prices 3.3%/yr (IQR, 0.3% to 5.5%). The median percentage of patients with any out‐of‐pocket costs increased from 38% in 2009 to 48% in 2018, and median non‐zero annual out‐of‐pocket costs increased by 9.6%/yr (IQR, 4.1% to 15.4%). There was no association between changes in prices and out‐of‐pocket costs for individual drugs.From 2009 to 2018, prices and out‐of‐pocket costs for brand‐name clinician‐administered drugs increased, but these were not directly related for individual drugs. This may be due to changes to insurance benefit design and private insurer drug reimbursement rates. [ABSTRACT FROM AUTHOR]

BACKGROUND: The global COVID-19 pandemic has forced people to obtain health products and services from home. Similar to other e-commerce, medicines are bought online and delivered using a courier service. OBJECTIVE: By being fully concerned to patient safety, this study aims to determine development strategies to increase intention in purchasing prescription drugs through e-pharmacy. METHODS: Two stages of measurement are employed in this study, namely confirmatory factor analyis using PLS-SEM and pairwise comparison using AHP method. To discover consumer perception in using e-pharmacy, the basic model of Theory of Planned Behavior (TPB) is employed with several extensions. RESULTS: The results of PLS-SEM express that Trust has a major role as an intervening variable to enhance the indirect effect of Subjective Norms and Perceived Values on Purchase Intention. In general, PLS-SEM structural model is declared "fit" (GFI = 0.93 ≥ 0.90; RMSEA = 0.045 ≤ 0.08; SRMR = 0.033 ≤ 0.05). Measurement model test proves that all selected indicators are valid to represent their related constructs (Loading Factor ≥ 0.50), and all selected constructs are reliable to build the whole path model (CR ≥ 0.7; AVE ≥ 05). Meanwhile, the results of AHP indicate that strengthening government policies and regulations is prioritized to increase consumer intention of purchasing prescription drugs through e-pharmacy, followed by protection of user confidential data in the second place. Those two eigenvectors are 0.236 and 0.185 respectively. CONCLUSION: Future research is suggested to add perceived risk as latent variable in the study of consumer behavior for any high-risk products. [ABSTRACT FROM AUTHOR]

This study aimed to characterize products using pharmacy-pharmacy benefit manager (PBM) discounts and to estimate the association among such discounts, prescription utilization, and out-of-pocket costs. This is a retrospective cohort study using IQVIA's Formulary Impact Analyzer, which contains anonymized, individual-level pharmacy claims representing US retail pharmacy transactions. We focused on 20 products with the greatest number of transactions using a pharmacy-PBM discount. Our unit of analysis was a treatment episode, defined as the length of time from an incident fill to no continuous use for 60 consecutive days after allowing for indefinite stockpiling. Outcome measures included products with greatest pharmacy-PBM discount use, characteristics of treatment episodes, and out-of-pocket costs with and without pharmacy-PBM discount. Across all products, 3.82% of transactions and 7.69% of treatment episodes were accompanied by a pharmacy-PBM discount. Commonly discounted products included generic treatments for chronic disease (lisinopril, levothyroxine, metformin) and neuropsychiatric conditions (alprazolam, amphetamine, buprenorphine, hydrocodone). The median postdiscount out-of-pocket cost was >2.5-fold higher during treatment episodes with a discount than those without ($15.15, interquartile range [IQR] $8.53-32.00, vs $5.88, IQR $1.40-15.00). Median treatment episode duration was 249 days (IQR 132-418) with discount use compared with 236 days (IQR 121-396) without discount use, although treatment episodes that began with a discount had fewer transactions per treatment episode and were shorter (median 212 days, IQR 114-360) than those that did not (313 days, IQR 178-500). Pharmacy-PBM discounts may foster market competition and improve access for under- and uninsured individuals; however, these programs may not generate savings for many insured individuals. • Approximately half of drug discounts originate from pharmacy-pharmacy benefit manager (PBM) programs rather than drug manufacturers, yet little is known regarding the use and impact of these programs. • In this retrospective cohort of individuals using anonymized, longitudinal, patient-level pharmacy claims, pharmacy-PBM discounts were used for 3.82% of transactions. Across all treatment episodes, the median postdiscount out-of-pocket cost was >2.5-fold higher during treatment episodes with a discount than those without. Treatment episodes that began with a discount had fewer transactions per treatment episode and were shorter than those that did not. • Pharmacy-PBM discounts may foster market competition and improve access for under- and uninsured individuals; nevertheless, these programs may not generate savings for many insured individuals. [ABSTRACT FROM AUTHOR]

The strength of evidence for specific ambulatory care prescribing cascades, in which a marker drug is used to treat an adverse event caused by an index drug, has not been well characterized. To perform a structured, systematic, and transparent review of the evidence supporting ambulatory care prescribing cascades. Ninety‐four potential prescribing cascades identified through a previously published systematic review. Systematic search of the literature to further characterize prescribing cascades. (1) Grading of evidence based on observational studies investigating associations between index and marker drugs, including: Level I—strong evidence [i.e. multiple high‐quality studies]; Level II—moderate evidence [i.e. single high‐quality study]; Level III—fair evidence [no high‐quality studies but one or more moderate‐quality studies]; and Level IV—poor evidence [other]. (2) Listing of the adverse event associated with the index drug in the product's United States Food and Drug Administration (FDA) label. (3) Synthesis of the evidence supporting mechanisms linking index drugs and associated adverse events. Of 99 potential cascades, 94 were supported by one or more confirmatory observational studies and were therefore included in this review. The 94 cascades related to 30 types of adverse drug reactions affecting 10 different anatomic/physiologic systems and were investigated by a total of 88 confirmatory studies, including prescription sequential symmetry analysis (n = 51), cohort (n = 30), and case–control (n = 7) studies. Overall, the evidence from observational studies was strong for 18 (19.1%) prescribing cascades, moderate for 61 (64.9%), fair for 13 (13.8%), and poor for 2 (2.1%). Although the evidence supporting mechanisms that link index drugs and associated adverse events was variable, FDA labels included information about the adverse event associated with the index drug for most (n = 86) but not all of the 94 prescribing cascades. Although we identified 18 of 94 prescribing cascades supported by strong clinical evidence and most adverse events associated with index drugs are included in FDA label, the evidentiary basis for prescribing cascades varies, with many requiring further evidence of clinical relevance. [ABSTRACT FROM AUTHOR]

Introduction: Pharmacological strategies are often central to chronic pain management; however, pain treatment among non-Hispanic Black men may differ because of their disease profiles and healthcare interactions. However, less is known about pain medication prescribing and patients' satisfaction with pain treatment and management among non-Hispanic Black men with self-reported chronic pain.Purpose: This study assessed factors associated with non-Hispanic Black men being prescribed/recommended narcotics/opioids for chronic pain and their satisfaction with pain treatment/management.Methods: Data were analyzed from 286 non-Hispanic Black men with chronic pain who completed an internet-delivered questionnaire. Participants were recruited nationwide using a Qualtrics web-based panel. Logistic regression was used to identify factors associated with being prescribed/recommended narcotics/opioids for pain management treatment. Then, ordinary least squares regression was used to identify factors associated with their satisfaction level with the pain treatment/management received.Results: On average, participants were 56.2 years old and 48.3% were prescribed/recommended narcotics/opioids for chronic pain. Men with more chronic conditions (Odds Ratio [OR] = 0.57, P = 0.043) and depression/anxiety disorders (OR = 0.53, P = 0.029) were less likely to be prescribed/recommended narcotics/opioids. Men who were more educated (OR = 2.09, P = 0.044), reported more frequent chronic pain (OR = 1.28, P = 0.007), and were allowed to participate more in decisions about their pain treatment/management (OR = 1.11, P = 0.029) were more likely to be prescribed/recommended narcotics/opioids. On average, men with more frequent chronic pain (B = − 0.25, P = 0.015) and pain problems (B = − 0.16, P = 0.009) were less satisfied with their pain treatment/management. Men who were allowed to participate more in decisions about their pain treatment/management reported higher satisfaction with their pain treatment/management (B = 0.55, P < 0.001).Conclusion: Playing an active role in pain management can improve non-Hispanic Black men's satisfaction with pain treatment/management. This study illustrates the importance of patient-centered approaches and inclusive patient-provider interactions to improve chronic pain management. [ABSTRACT FROM AUTHOR]

A series of structural constitutional arguments lodged in multiple cases against Centers for Medicare and Medicaid Services' (CMS) authorities to negotiate prescription drug prices via the 2022 Inflation Reduction Act threaten the legitimacy of CMS program and federal agency powers. [ABSTRACT FROM AUTHOR]

Policy PointsThe increasing number of drugs granted accelerated approval by the Food and Drug Administration (FDA) has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries.We recommend several administrative and legislative approaches for improving FDA–Centers for Medicare and Medicaid Services (CMS) coordination around accelerated‐approval drugs, including promoting earlier discussions among the FDA, the CMS, and drug companies; strengthening Medicare's coverage with evidence development program; linking Medicare payment to evidence generation milestones; and ensuring that the CMS has adequate staffing and resources to evaluate new therapies.These activities can help improve the integrity; transparency; and efficiency of approval, coverage, and payment processes for drugs granted accelerated approval. Context: The Food and Drug Administration (FDA)'s accelerated‐approval pathway expedites patient access to promising treatments. However, increasing use of this pathway has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We examined approaches to improve coordination between the FDA and Centers for Medicare and Medicaid Services (CMS) for drugs granted accelerated approval. Methods: We argue that policymakers have focused on expedited pathways at the FDA without sufficient attention to complementary policies at the CMS. Although differences between the FDA and CMS decisions are to be expected given the agencies' different missions and statutory obligations, procedural improvements can ensure that Medicare beneficiaries have timely access to novel therapies that are likely to improve health outcomes. To inform policy options and recommendations, we conducted semistructured interviews with stakeholders to capture diverse perspectives on the topic. Findings: We recommend ten areas for consideration: clarifying the FDA's evidentiary standards; strengthening FDA authorities; promoting earlier discussions among the FDA, the CMS, and drug companies; improving Medicare's coverage with evidence development program; tying Medicare payment for accelerated‐approval drugs to evidence generation milestones; issuing CMS guidance on real‐world evidence; clarifying Medicare's "reasonable and necessary" criteria; adopting lessons from international regulatory‐reimbursement harmonization efforts; ensuring that the CMS has adequate staffing and expertise; and emphasizing equity. Conclusions: Better coordination between the FDA and CMS could improve the transparency and predictability of drug approval and coverage around accelerated‐approval drugs, with important implications for patient outcomes, health spending, and evidence generation processes. Improved coordination will require reforms at both the FDA and CMS, with special attention to honoring the agencies' distinct authorities. It will require administrative and legislative actions, new resources, and strong leadership at both agencies. [ABSTRACT FROM AUTHOR]

Background: Prescription drug misuse among youth aged 12–18 remains high in the United States. Grounded in Social Norms Theory, school-based curricula have been shown to effectively challenge students' misperceptions of peer norms and safety regarding prescription drug misuse (PDM). Objective: The present study is a quasi-experimental evaluation of a brief, no cost, school-based prescription drug safety program. Methods: Participants included 94 teachers and their students (n = 2325) in grades 8 through 12. Teachers (and their students) were assigned to experimental or control conditions. Using a pre-/post-survey design, we examined whether the curriculum promoted growth in five key student outcomes: Personal Responsibility, Social Norms, Knowledge, Future Actions, and Refusal Skills. Student demographic characteristics and prescription drug history were examined as moderators of growth. Within the experimental group, variation in implementation factors such as teachers' prior experience with the program and perceptions of student engagement were examined as moderators of the effectiveness of the curriculum. Results: Multilevel models demonstrated equitable growth in Personal Responsibility, Social Norms, Knowledge, Future Actions, and Refusal Skills across gender, race, and other demographic characteristics. Students' prescription drug history was not associated with growth on the five key outcomes. Growth in Personal Responsibility, Social Norms, Knowledge, and Future Actions was maintained in a one-month follow-up survey. Teacher perceptions of student engagement were associated with lower growth in Social Norms. Conclusions: The findings suggest promising implications for the scalability of an effective, brief, no cost, technology-based intervention targeting adolescent PDM. [ABSTRACT FROM AUTHOR]

The ongoing opioid epidemic has been a global concern for years, increasingly due to its heavy toll on young people's lives and prospects. Few studies have investigated trends in use of the wider range of drugs prescribed to alleviate pain, psychological distress and insomnia in children, adolescents and young adults. Our aim was to study dispensation as a proxy for use of prescription analgesics, anxiolytics and hypnotics across age groups (0–29 years) and sex over the last 15 years in a large, representative general population. The study used data from a nationwide prescription database, which included information on all drugs dispensed from any pharmacy in Norway from 2004 through 2019. Age-specific trends revealed that the prevalence of use among children and adolescents up to age 14 was consistently low, with the exception of a substantial increase in use of melatonin from age 5. From age 15–29, adolescents and young adults used more prescription drugs with increasing age at all time points, especially analgesics and drugs with higher potential for misuse. Time trends also revealed that children from age 5 were increasingly dispensed melatonin over time, while adolescents from age 15 were increasingly dispensed analgesics, including opioids, gabapentinoids and paracetamol. In contrast, use of benzodiazepines and z-hypnotics slightly declined in young adults over time. Although trends were similar for both sexes, females used more prescription drugs than their male peers overall. The upsurge in use of prescription analgesics, anxiolytics and hypnotics among young people is alarming. Trial registration The study is part of the overarching Killing Pain project. The rationale behind the Killing Pain research was pre-registered through ClinicalTrials.gov on April 7, 2020. Registration number NCT04336605; https://clinicaltrials.gov/ct2/show/record/NCT04336605. [ABSTRACT FROM AUTHOR]

Background: Cannabinoid compounds have been approved as prescription drugs for treating various human ailments. However, the production using both microbial and plant-based sources is timeconsuming and expensive because their yield is extremely low. Tetraketide synthase (TKS), the key enzyme in the biosynthesis of cannabinoid compounds, produces only 4% of the intermediate compound olivetolic acid. However, it may be possible to rearrange the carbon metabolic flux of TKS using genetic methods to increase the overall yields of cannabinoid compounds. In this context, protein engineering is an economically beneficial and viable solution to improve the catalytic activity of TKS. However, the ability to produce enzyme variants significantly exceeds the capacity to screen and identify high producers, creating a bottleneck in the enzyme engineering process. Results: This study constructed an Escherichia coli-based biosensor workflow for detecting the byproduct pentyl diacetic acid lactone (PDAL). Rational design was used to generate E. coli strains with mutant regulatory protein AraC and an altered effector PDAL to control the transcription of gfp and kanamycin. The developed biosensor could detect PDAL at the concentrations of the operational range from microbial cell culture and cell-free catalytic system. Conclusions: The E. coli-based biosensor developed in this study efficiently detected PDAL with high throughput and low cost. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to present the first nation‐wide, systematic, repeated assessment of doctor‐shopping (i.e. visiting multiple physicians to be prescribed the same drug) during 10 years for more than 200 psychoactive prescription drugs in the 67 million inhabitants in France. Design: This was a nation‐wide, repeated cross‐sectional study. Setting and Participants: Data are from the French National Health Data System in 2010, 2015 and 2019 for 214 psychoactive prescription drugs (i.e. anaesthetics, analgesics, antiepileptics, anti‐Parkinson drugs, psycholeptics, psychoanaleptics, other nervous system drugs and antihistamines for systemic use). Measurements The detection and quantification of doctor‐shopping relied upon an algorithm that detects overlapping prescriptions from repeated visits to different physicians. We used two doctor‐shopping indicators aggregated at population level for each drug dispensed to more than 5000 patients: (i) the quantity doctor‐shopped, expressed in defined daily doses (DDD), which measures the total quantity doctor‐shopped by the study population for a given drug; and (ii) the proportion doctor‐shopped, expressed as a percentage, which standardizes the quantity doctor‐shopped according to the use level of the drug. Findings The analyses included approximately 200 million dispensings to approximately 30 million patients each year. Opioids (e.g. buprenorphine, methadone, morphine, oxycodone and fentanyl), benzodiazepines and non‐benzodiazepine hypnotics (Z‐drugs) (e.g. diazepam, oxazepam, zolpidem and clonazepam) had the highest proportions doctor‐shopped during the study period. In most cases, the proportion and the quantity doctor‐shopped increased for opioids and decreased for benzodiazepines and Z‐drugs. Pregabalin had the sharpest increase in the proportion doctor‐shopped (from 0.28 to 1.40%), in parallel with a sharp increase in the quantity doctor‐shopped (+843%, from 0.7 to 6.6 DDD/100 000 inhabitants/day). Oxycodone had the sharpest increase in the quantity doctor‐shopped (+1000%, from 0.1 to 1.1 DDD/100 000 inhabitants/day), in parallel with a sharp increase in the proportion doctor‐shopped (from 0.71 to 1.41%). Detailed results for all drugs during the study period can be explored interactively at: https://soeiro.gitlab.io/megadose/. Conclusions: In France, doctor‐shopping occurs for many drugs from many pharmacological classes, and mainly involves opioid maintenance drugs, some opioids analgesics, some benzodiazepines and Z‐drugs and pregabalin. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of different non-osteoporotic drugs on the increase or decrease in the risk of incident fragility fractures (vertebral, humerus or hip) in a cohort of patients diagnosed with osteoporosis on active anti-osteoporotic therapy. Methods: For this retrospective longitudinal study, baseline and follow-up data on prescribed non-osteoporotic treatments and the occurrence of vertebral, humerus or hip fractures in 993 patients from the OSTEOMED registry were analyzed using logistic regression models. The drugs evaluated with a possible beneficial effect were thiazides and statins, while the drugs evaluated with a possible harmful effect were antiandrogens, aromatase inhibitors, proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, GnRH agonists, thyroid hormones, and oral and inhaled corticosteroids. Results: Logistic regression analyses indicated that no treatment significantly improved fracture risk, with the only treatments that significantly worsened fracture risk being letrozole (OR = 0.18, p-value = 0.03) and oral corticosteroids at doses ≤ 5 mg/day (OR = 0.16, p-value = 0.03) and > 5 mg/day (OR = 0.27, p-value = 0.04). Conclusion: The potential beneficial or detrimental effects of the different drugs evaluated on fracture risk are masked by treatment with anabolic or antiresorptive drugs that have a more potent action on bone metabolism, with two exceptions: letrozole and oral corticosteroids. These findings may have important clinical implications, as patients receiving these treatments are not fully protected by bisphosphonates, which may imply the need for more potent anti-osteoporotic drugs such as denosumab or teriparatide. [ABSTRACT FROM AUTHOR]

Drug shortages make it difficult or impossible to meet the therapeutic needs of individual patients or populations. In the first part of this review we proposed an operational definition that incorporates the processes by which products are manufactured, the causes of shortages and stock‐outs (local shortages), and the contributory factors. Here we discuss causes and possible solutions. Drug shortages have complex causes, and a single cause cannot always be identified. Reasons include lack or shortage of raw materials, manufacturing difficulties, regulatory and political actions, voluntary recalls, just‐in‐time inventory systems, halts in production for financial or other business reasons, low demand (eg, orphan products, reduced usage), mergers, market shifts (eg, diversion to home markets) and unexpected increases in demand (eg, improved diagnosis, new trial information, epidemics and pandemics, inappropriate use, off‐label use). Potential solutions are as diverse as the potential causes. Prevention is hard, because shortages are not easily predicted. Everyone in the supply chain is involved in anticipating and managing shortages, with responsibilities for preventing them or at least trying to mitigate their effects. This includes manufacturers and suppliers, particularly of generic formulations, pharmacists, prescribers, patients and governments. Solutions can therefore be linked to the causes and classified according to where the responsibility for implementing them lies. [ABSTRACT FROM AUTHOR]

Drug shortages are repeatedly in the news. The earliest drug shortages were reported during the First World War, but the numbers of shortages have increased in recent years. In the first part of this two‐part review, we discuss definitions of drug shortages and so‐called stockouts, which are localized shortages, and the harms that they can cause. Drug shortages make it difficult or impossible to meet the therapeutic needs of individual patients or populations, but we lack an adequate definition. The problems are too complicated to be encompassed in a brief intensional dictionary‐style definition, and that is reflected in the many different attempts at definition that have been proposed. We therefore propose an extensional operational definition that incorporates the processes by which products are manufactured, the causes of shortages and the contributory factors. A definition of this sort allows one to identify the main causes of a particular drug shortage and therefore the remedies that might prevent, mitigate or manage it. In the second part of the review we discuss the causes and solutions in more detail. Adverse drug reactions and medication errors attributable to shortages occur but are not often reported. Adverse reactions to substitute medicines are possible, and errors can occur because of unfamiliarity or unnecessary treatment with replacement medicines. Other harmful outcomes include withdrawal reactions, undertreatment, treatment delays and cancellations, failure of alternatives and disruption of clinical trials. [ABSTRACT FROM AUTHOR]

Abstract Aim: Non-medical use of prescription opioids, such as tramadol, is a major health concern globally. In Sweden, non-medical tramadol use among young people is widely recognized. This study explores the central components that characterize drug use trajectories among young people with experiences of problematic tramadol use. Methods: 24 qualitative interviews were conducted with 13 young people (aged 19–24) with self-reported experiences of problematic tramadol use. The concepts of drug, set, and setting from Zinberg’s theoretical framework were applied to explore significant aspects of their drug use trajectories. Findings: Four themes corresponding to different stages in the young people’s drug use trajectories, were identified: (1) initiating tramadol use; (2) developing continuous tramadol use; (3) expanding the drug repertoire and; (4) starting to lose control. Overall there was a progression toward more severe drug use over time, where self-medication and dependence dynamics, as well as peer influence and other environmental factors were significant. Conclusion: The study demonstrates that the drug use trajectories of young people with problematic tramadol use involve a complex interaction between the drugs’ effects, personal circumstances, and environmental factors. Increasing the understanding of this process can be helpful in improving both preventive and therapeutic measures for this target group. [ABSTRACT FROM AUTHOR]

Loneliness is an emerging public health problem in developed countries. The objective was to establish the prevalence in a representative sample of a large city and its relationship with mental health indicators. Using stratified random sampling, a sample of 8,828 was obtained. The degree to which they had felt lonely during the last year and other questions and questionnaires related to their mental health were asked. A total of 10.2% reported feeling lonely during the last year. Those who felt lonely were four times more likely to develop more symptoms of poor mental health (63% vs. 16%), to receive a diagnosis of anxiety/depression, and to be prescribed psychotropic drugs. The structural model suggests that loneliness worsens mental health, leading to greater prescription of drugs, which increases feelings of loneliness. Loneliness tends to remain in anonymity and intimacy and is addressed mainly through the prescription of psychotropic drugs that aggravate the problem, plunging the subject into a vicious circle that is difficult to escape. The results make it necessary to offer more effective responses than a mere pharmacological approach. [ABSTRACT FROM AUTHOR]

Objective: To investigate the use and timing of market introduction of authorized generics (AGs), which unlike independent generics are sold by the brand‐name drug manufacturer under a generic label. Data Sources: This study used public Medicaid prescription drug use data from 2014 to 2020. Study Design: This cross‐sectional study measured the percentage of filled prescriptions for AGs, compared with brand‐name and independent generic versions. We also identified the frequency and characteristics of AGs marketed at least 1 year before independent generics. Data Extraction Methods: Drugs were classified based on manufacturer‐reported data to Medicaid. Principal Findings: From 2014 to 2020, 1023 AGs accounted for 175 million filled Medicaid prescriptions. These represented 4% of Medicaid prescription drug use, and 16% of medication use among products with AGs available. Among 393 AGs for drugs without generic competition before 2014, 139 (35%) were marketed at least 1 year before independent generics or had no independent generic competition through December 2020. Conclusions: AGs represented a small share of Medicaid prescription drug use from 2014 to 2020, but when AGs were available, they accounted for sizeable market share. Among the minority of cases in which AGs were marketed a year or more before independent generics, manufacturers may be using AGs to bolster brand‐name drug prices or to undermine independent generic competition, meriting further attention by regulators. [ABSTRACT FROM AUTHOR]

Objective: To compare the Medicare Part D market share of brand drugs with their net‐to‐list price ratio. Data Sources and Study Setting: SSR Health Brand Net Price Tool and Medical Expenditure Panel Survey, 2007–2019. Study Design: For each drug, we calculated the ratio of net to list price and the percent of users that were Medicare‐eligible. We compared these cross‐sectionally in each year and estimated a difference‐in‐differences model comparing drugs with high or low Medicare market shares (MMS) after following changes to program incentives in 2010. Data Collection/Extraction Methods: The sample included brand drugs without generic competitors appearing in both datasets. Principal Findings: Net‐to‐list price ratios were negatively correlated with MMS in the later years of our sample. In 2019, a 10% increase in MMS was associated with a significant 4.6% [95% CI: 2.1%, 7.1%] decrease in net‐to‐list ratio. Difference‐in‐differences showed net‐to‐list price ratios of drugs with above median MMS fell relative to those with below median MMS. By 2019, we observe an absolute reduction of −0.2 [95% CI: −0.29, −0.11], representing 28% reduction relative to the average ratio in 2010. Conclusions: Greater exposure to the Medicare Part D market was associated with larger differences between net and list prices of drugs. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To analyze recent trends in initiate pediatric opioid prescriptions dispensed in Rhode Island. METHODS: All Rhode Island residents aged 0-17 years with an initiate opioid prescription dispensed between January 1, 2017 and December 31, 2021 were obtained from the Rhode Island Prescription Drug Monitoring Program. Analyses were conducted to investigate trends related to patient demographics, prescription characteristics, diagnosis codes, and prescriber type. RESULTS: From 2017-2021, there was a decrease in the number of unique pediatric patients dispensed an initiate prescription, the number of initiate pediatric opioid prescriptions, and the initiate prescription dosage. Initiate opioid prescriptions were primarily related to dental-related diagnoses, and dentists and oral and maxillofacial (OMF) surgeons comprised the largest category of prescriber type. CONCLUSION: Initiate pediatric opioid prescriptions have decreased in Rhode Island in recent years. However, there remain opportunities to educate prescribers on reducing opioid exposure to vulnerable populations, including the use of alternate analgesics. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to examine and compare the use of energy drinks, over-the-counter (OTC) painkillers and misuse of prescription drugs in two cohorts of Norwegian adolescents entering high school (i.e. grade 11) immediately prior to and during the initial year of the COVID-19 pandemic. Methods: Accelerated longitudinal design and multi-cohort sampling enabled identification of the two socio-demographically comparable cohorts of grade 11 students: (a) COVID-19 cohort assessed in the autumn of 2020 (n =915) and (b) pre-COVID-19 cohort assessed in the autumn of 2018/19 (n =1621). Unadjusted and adjusted logistic and Poisson models were used to estimate the proportion of (mis)users and use frequencies among (mis)users in two cohorts. Results: Energy drinks use was both more common in the COVID-19 cohort (60.8% vs. 52.5%; adjusted odds ratio=1.40, 95% confidence interval (CI) 1.18–1.66, p <0.001) and more frequent among users from this cohort than among their pre-COVID-19 counterparts (9.58 vs. 7.79 days past month, adjusted incidence risk ratio (aIRR)=1.23, 95% CI 1.14–1.32, p <0.001). No cohort differences were observed in OTC painkillers use. Prescription drugs misuse was equally common in the two cohorts but was more frequent among misusers from the COVID-19 cohort than among their pre-COVID-19 counterparts (18.94 vs. 12.45 times past year, aIRR=1.52, 95% CI 1.10–2.10, p <0.001). Conclusions: Norwegian adolescents from the COVID-19 cohort were more likely to use energy drinks and, once engaged in these behaviours, to use energy drinks and misuse prescription drugs more frequently than their pre-COVID-19 counterparts. [ABSTRACT FROM AUTHOR]

This study aimed to establish criteria to identify priority drugs for CalRx, a California-sponsored initiative to support the manufacture and distribution of affordable generic drugs. A web-based ranking exercise was implemented with key stakeholders in August 2020, using pricing, spending, and public health criteria identified through a review of academic literature and public health agency reports. A total of 39 of 40 invited stakeholders in 4 different categories—patient advocates, healthcare providers, health insurers, and health policy and economic experts—participated in this study (98% response rate). Drugs that treat large populations, drugs that represent high cost to payors, and drugs that represent high cost to consumers were ranked a priority, receiving > 10% of ranking weights. Drugs that treat conditions with high morbidity or mortality, drugs without therapeutic alternatives, and drugs treating vulnerable populations represented criteria of further interest (9%-10% of weights). Shortage risk and curative effect (8%-9% of the weights), high price increases, communicable disease treatments, and high unit prices (< 8% of the weights) represented the bottom of the priority distribution. This study suggests that drugs that treat large populations, drugs that represent large costs to payors, and drugs that represent large costs to consumers should be the priority for California's CalRx generic drug initiative. A prioritizing algorithm will assist California in determining top drugs to target from a public health and spending perspective as it plans the rollout of the CalRx initiative and negotiates with drug manufacturers. • In January 2020, Governor Gavin Newsom announced the creation of CalRx, a California-sponsored generic drug label. CalRx aims to lower prices and increase access to pharmaceuticals in California. The question became how to establish criteria to identify priority drugs for CalRx. • This article describes the development of prioritization criteria to CalRx based on a review of the literature and a ranking exercise with key stakeholders. We found that drugs that treat large populations, drugs that represent large costs to payors, and drugs that represent large costs to consumers should be the priority for California's CalRx generic drug initiative. • By detailing the collaborative process involved in developing the CalRx prioritization criteria, this article models inclusive policy design and implementation in public health decision making. The final set of criteria identified can also help inform prioritization efforts for future initiatives targeting prescription drugs at the state level and beyond. [ABSTRACT FROM AUTHOR]

The prescriptive appropriateness of Proton Pump Inhibitors (PPIs) in polypharmacy is controversial. PPIs are often overprescribed and the risk of prescribing errors and adverse drug reactions increases for each additional drug added to therapy. Hence, guided deprescription should be considered and easily implementable in ward practice. This observational prospective study evaluated the implementation of a validated PPIs deprescription flow chart to real-life internal ward activity through the presence of a clinical pharmacologist as an enhancing additional factor by assessment of inhospital prescriber's adherence to the proposed flow chart. Patients' demographics and prescribing trends of PPIs prescriptions were analyzed by descriptive statistics. The final analysis of data included ninety-eight patients (forty-nine male and forty-nine female), aging 75.6 ± 10.6 years; 55.1% of patients had home-PPIs prescriptions, while 44.9% received inhospital-PPIs prescriptions. Evaluation of prescriber's adherence to the flow chart revealed that the percentage of patients with a prescriptive/deprescriptive pathway conforming to that of the flow chart was 70.4%, with low symptomatologic recurrences. The clinical pharmacologists' presence and influence in ward activity may have contributed to this finding, since continuous training of the prescribing physicians is deemed a success-related factor in the deprescribing strategy. Multidisciplinary management of PPIs deprescription protocols shows high adherence by prescribers in real-life hospital settings and low recurrence events. [ABSTRACT FROM AUTHOR]

Background: Prescription drug use including pain relievers and stimulants has been a growing problem in young adults and the issue has been a public health concern for years. Methods: This Quantitative Cross-sectional study aimed to collect preliminary data regarding prescription opioid use, prescription stimulant drug use and overdose treatment knowledge in young adults between 18 and 24 years old in a southern New Jersey university through administering an online survey. Results: Of the 1663 students who completed the survey, 33% reported using prescription pain relievers and 15% reported using prescription stimulant drugs. Stimulant drug users were found to be more likely to use prescription pain relievers (49%) as compared to non-stimulant users (30%). Furthermore, students with overdose treatment knowledge of opioids were more likely to report misuse of prescription drugs (15%) than students with less knowledge (8%). Conclusions: This study reiterates the increasing usage of prescription drugs and stimulant use among college students. There is a need for effective education strategies to inform students about the prescription medication uses and misuse to reduce nonmedical use of prescription medications. [ABSTRACT FROM AUTHOR]

High out-of-pocket prescription drug costs contribute to financial toxicity, medication nonadherence, and adverse cardiovascular (CV) outcomes. Policymakers recently passed the Inflation Reduction Act, which will cap Medicare out-of-pocket drug costs at $2,000/year and expand full low-income subsidies (LIS). It is unclear how these provisions will affect Medicare beneficiaries with CV risk factors and/or conditions. The authors sought to characterize the population of Medicare beneficiaries with CV risk factors/conditions experiencing out-of-pocket prescription drug costs >$2,000/year and estimate their potential savings under the Inflation Reduction Act's spending cap; identify sociodemographic characteristics associated with out-of-pocket costs >$2,000/year; and characterize beneficiaries newly eligible for LIS under the Inflation Reduction Act. This was a cross-sectional study of Medicare beneficiaries aged ≥65 years with ≥1 CV risk factor/condition from 2016 to 2019. An annual estimated 34,056,335 ± 855,653 Medicare beneficiaries (mean ± SE) had ≥1 CV risk factor/condition, of whom 1,020,484 ± 77,055 experienced out-of-pocket drug costs >$2,000/year. The likelihood of experiencing out-of-pocket drug costs >$2,000/year was lower among adults ≥75 years vs 65 to 74 years (adjusted OR: 0.67; 95% CI: 0.49-0.93) and for low-income vs higher-income adults. Among beneficiaries currently spending >$2,000/year, estimated median out-of-pocket drug savings would be $855/year and total annual savings $1,723,031,307 ± $91,150,609 under the Inflation Reduction Act. An estimated 1,289,861 beneficiaries would also become newly eligible for LIS. More than 1 million older adults with CV risk factors and/or conditions spend >$2,000/year out-of-pocket on prescription drugs and will likely benefit from the Inflation Reduction Act's cap, with estimated total out-of-pocket savings of $1.7 billion/year, while another 1.3 million will also become newly eligible for LIS. [Display omitted] [ABSTRACT FROM AUTHOR]

Concerns about the misuse of gabapentin and pregabalin and an increase in related deaths led to these drugs being classified as controlled substances in the United Kingdom (UK) in April 2019. This study investigates the online availability of gabapentin and pregabalin, from the perspective of a UK-based consumer, and whether the change in legislation was associated with any change in availability. An internet snapshot survey for the availability and prescription requirements of gabapentin and pregabalin was undertaken, using established European methodology, two months before (February 2019) and two months after (June 2019) the legislation change. A total of 70 websites selling gabapentin and/or pregabalin to UK-based customers were identified in February 2019 compared to 56 websites in June 2019. No significant difference was observed for the proportion of websites requiring a prescription before and after legislation change for either gabapentin (p = 0.574) or pregabalin (p = 0.223). Despite legislation change, 22 (47.8%) gabapentin websites and five (33.3%) pregabalin websites specifically stated no prescription was required to purchase the drugs in June 2019. The change in legislation was associated with a decrease in online availability with fewer websites offering drugs for sale. However, these drugs remain widely available to purchase via some online pharmacies without a prescription which has significant public health implications. [ABSTRACT FROM AUTHOR]

Opioids are killing America's youth. New data confirms that children under 18 who are prescribed opioids by a medical doctor develop a heightened risk of future drug addiction. Currently, there are no national prescribing guidelines for opioids in the pediatric population. However, doctors recently started to administer an over‐the‐counter medicine combination of Advil and Tylenol to patients because it is more effective at relieving pain than prescription opioids and prevents addiction. Thus, drafting national legislation to limit the circumstances under which a child is eligible to receive an opioid prescription will save countless children from a life of future addiction. Key Points for the Family Law Community: Pediatric medical practices have been largely derived from adult practices.Dentists are the second‐highest prescribers of opioids in the medical profession.20% of American children take at least one prescription medication for pain management.6% of people who misuse prescription opioids transition to heroin.A 2017 study revealed a 33% drop in opioid prescriptions by oncologists. [ABSTRACT FROM AUTHOR]

Objective: To evaluate patient reported measures in patients undergoing endourologic procedures and robotic assisted radical prostatectomy (RARP) to demonstrate the efficacy of non-opioid postoperative pain management strategies.Materials and Methods: A prospective cohort study performed at an academic medical center included a patient telephone questionnaire and chart review. Opioid prescriptions, opioid use, and patient reported outcomes were recorded. Bivariate analyses were used to compare patients who did and did not use opioids in the RARP cohort while overall trends were reported for the endourologic procedures.Results: Of the 68 patients undergoing endoscopic intervention, 14 (21%) were prescribed an opioid and 6 (9%) reported any opioid use. 58 (85%) reported their pain was very well or well controlled while 9 reported their pain was poorly controlled. 59 (87%) were satisfied or very satisfied with their pain control. Fifty-three (93%) of the 57 patients undergoing RARP received an opioid prescription and only 23 reported any opioid use. All but 1 patient reported that their pain was well or very well controlled and almost all (54) of the patients were satisfied with their level of pain control. 36 (63%) reported their pain was less than expected while only 7 (12%) reported it was more than expected.Conclusion: Most patients undergoing endourologic procedures do not use postoperative opioids and report favorable outcomes regarding their pain control. Similarly, after RARP, most patients do not use opioids even when they are prescribed and are satisfied with their pain control. [ABSTRACT FROM AUTHOR]

Background Nonadherence to antiviral therapy can lead to poor clinical outcomes among patients with chronic hepatitis B (CHB). We used a claims database to evaluate risk factors for nonadherence to antiviral therapy among commercially insured patients with CHB in the United States. Methods We obtained data for commercially insured adult patients with CHB prescribed entecavir or tenofovir disoproxil fumarate (TDF) in 2019. Primary outcomes were adherence to entecavir and adherence to TDF. Enrollees with a proportion of days covered (PDC) ≥80% were considered adherent. We presented adjusted odds ratios (AORs) from multivariate logistic regressions. Results Eighty-three percent (n = 640) of entecavir patients were adherent, and 81% (n = 687) of TDF patients were adherent. Ninety-day supply (vs 30-day supply; AOR, 2.21; P <.01), mixed supply (vs 30-day supply; AOR, 2.19; P =.04), and ever using a mail order pharmacy (AOR, 1.92, P =.03) were associated with adherence to entecavir. Ninety-day supply (vs 30-day supply; AOR, 2.51; P <.01), mixed supply (vs 30-day supply; AOR, 1.82; P =.04), and use of a high-deductible health plan (vs no high-deductible health plan; AOR, 2.29; P =.01) were associated with adherence to TDF. Out-of-pocket spending of >$25 per 30-day supply of TDF was associated with reduced odds of adherence to TDF (vs <$5 per 30-day supply of TDF; AOR, 0.34; P <.01). Conclusions Ninety-day and mixed-duration supplies of entecavir and TDF were associated with higher fill rates as compared with 30-day supplies among commercially insured patients with CHB. [ABSTRACT FROM AUTHOR]

Background Antiretroviral (ARV) medications to treat human immunodeficiency virus (HIV) are a major contributor to Medicaid prescription drug spending. Despite having been used for over 3 decades, the first generic ARVs only recently became available, and many newer versions continue to be sold at high prices despite within-class competition. We estimated Medicaid spending on ARVs from 2007 through 2019. Methods Using public Medicaid State Drug Utilization data, we identified trends in ARV spending and use from 2007 through 2019. We estimated net spending and average prices (spending per 30-day supply), accounting for statutory Medicaid rebates, including a 15%–23% base rebate plus additional rebates if a drug's price increased faster than inflation. Results Among 48 ARVs, estimated net Medicaid spending from 2007 through 2019 was $25 billion for 17 million 30-day supplies. Annual use increased 118%, from 0.7 million 30-day supplies in 2007 to 1.6 million in 2019. During this time, estimated annual net spending increased 178%, from $1.1 billion to $3.0 billion, and average net prices increased 28%, from $1432 to $1830 per 30-day supply. Conclusions Annual Medicaid net spending on ARVs nearly tripled from 2007 to 2019, due to a combination of expanded use and rising prices. Medicaid did not extract expected benefits from its mandatory inflationary rebates because they were offset by use of newer, more expensive ARVs. To better control spending related to products with incremental innovation, the US government should be authorized to assure that launch prices for new drugs are aligned with the added benefit they offer over existing therapies. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine the effect of Medicaid expansion on asthma-related health care services utilization and expenditures among low-income adult patients with asthma aged 26–64. Using a pooled dataset from 2007 to 2018 Medical Expenditures Panel Surveys (MEPS), we implemented a multivariate difference-in-differences analysis, which compared changes in utilization and expenditures for asthma-related health care services among adult patients with asthma with income below 133% Federal Poverty Level (FPL) vs. above 133%–400% FPL, before and after Medicaid expansion in 2014. We used negative binomial models to analyze utilization outcomes. Expenditures were estimated using two-part models with logit as the first part and generalized linear models as the second part. Estimates were weighted for the complex multi-stage sampling design of MEPS. Medicaid expansion was associated with increases in both utilization and expenditures for asthma-related prescription drugs among low-income patients with asthma, by 1.8 prescription fills (p < 0.05) and $233 (p < 0.05) per year, respectively. No statistically significant association was detected for other asthma-related health care services. Medicaid expansion led to an increase in accessibility of prescription drugs among low-income asthma patients, but had no effect on other asthma-related health care services. [ABSTRACT FROM AUTHOR]

The initial purposes of regulation of medicines in England, and latterly in the United Kingdom, were principally to raise government revenue, to discourage murder by poisoning and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to curtail misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics. [ABSTRACT FROM AUTHOR]

BACKGROUND: Prescription drug use including pain relievers and stimulants has been a growing problem in young adults and the issue has been a public health concern for years. METHODS: This Quantitative Cross-sectional study aimed to collect preliminary data regarding prescription opioid use, prescription stimulant drug use and overdose treatment knowledge in young adults between 18 and 24 years old in a southern New Jersey university through administering an online survey. RESULTS: Of the 1663 students who completed the survey, 33% reported using prescription pain relievers and 15% reported using prescription stimulant drugs. Stimulant drug users were found to be more likely to use prescription pain relievers (49%) as compared to non-stimulant users (30%). Furthermore, students with overdose treatment knowledge of opioids were more likely to report misuse of prescription drugs (15%) than students with less knowledge (8%). CONCLUSIONS: This study reiterates the increasing usage of prescription drugs and stimulant use among college students. There is a need for effective education strategies to inform students about the prescription medication uses and misuse to reduce nonmedical use of prescription medications. [ABSTRACT FROM AUTHOR]

Study Design.: This was a prospectively captured cohort study. Objective.: To explore associations between the preoperative opioid-specific NarxCare Scores (NCS) (NCS-opioids) as well as sedative-specific NCS (NCS-sedatives) as measures of patients' prescription drug use and (1) 90-day postoperative readmission; (2) ED visits; (3) reoperation; (4) prolonged (>2 d) hospital length of stay (LOS); and (5) nonhome discharge. In addition, we sought to evaluate the previously suggested 300+ threshold as a cutoff for moderate/high-risk designation. Background.: The association between preoperative opioids and sedative use and healthcare utilization after nonemergent spine surgery is not well quantified. The NCS is a weighted scalar measure of opioids and sedatives that accounts for the number of prescribing providers, dispensing pharmacies, milligram equivalence doses, and overlapping prescription days. Methods.: A total of 4680 nonemergent spine surgery cases were included. Preoperative NCS-opioids/sedatives were captured. Bivariate and multivariable regression models were constructed to analyze associations between NCS-opioids/sedatives ranges and outcomes while accounting for baseline differences. Spline regression and propensity score matching (PSM) analyses were also implemented. Results.: For NCS-opioid, multivariable regression demonstrated higher odds of prolonged LOS starting in the 400 to 499 NCS-opioids category [odds ratio (OR): 1.44; 95% confidence interval (CI): 1.05–1.97; P =0.026] going into the 500+ category (OR: 1.94; 95% CI: 1.29–2.93; P =0.002]. The 500+ categories exhibited higher odds of 90-day readmission (OR: 1.77; 95% CI: 1.01–3.09; P =0.045). PSM comparison demonstrated that patients within the 300+ category had higher incidence of prolonged LOS [n=455 (44%) vs. n=537 (52%); P <0.001], 90-day readmission [n=118 (11%) vs. n=155 (15%); P =0.019] and 90-day reoperation [n=51 (4.9%) vs. n=74 (7.2%); P =0.042]. For NCS-sedative; there was higher odds of prolonged LOS (OR: 1.73; 95% CI: 1.14–2.63; P =0.010) and nonhome discharge(OR: 2.09; 95%CI: 1.22–3.63; P =0.008) within the 400 to 499 NCS-sedatives category. PSM comparison demonstrated significantly higher rates of prolonged LOS within the 300+ NCS-sedative cohort (vs. scores <300), [n=277 (44%) vs. 319 (50%); P =0.021]. Conclusion.: Spine surgery continues to advance toward patient-specific care. Higher NCS-opioids/sedatives values may predict up to a twofold increase in postoperative healthcare utilization. High values should prompt an interdisciplinary approach to mitigate deleterious prescription drug use. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic, and its associated social distancing measures, gave profound changes to the everyday and academic life of students in higher education. The current study is the first to use nation-wide data to evaluate the long-term effect of the pandemic and its countermeasures on university students' mental health care use. Methods: Using nation-wide individual-level data, we studied mental health consultations in primary care (data available from January 2017 to February 2022) and dispensed prescription drugs used to treat anxiety, depression, and sleep disturbances (data available from October 2018 to February 2021) for first-year undergraduate university students. We compared changes over time in mental health care use in a pandemic cohort (12,501 first-year students enrolled in 2019) to the same change in a pre-pandemic cohort (25,990 first-year students enrolled in 2017 and 2018). Event study and difference-in-difference models allowed us to separate the impact of the pandemic, experienced by the pandemic cohort only, from secular and seasonal changes experienced by all cohorts. Results: The percentage of students with a mental health consultation temporarily decreased during the first period of strict social distancing measures in March 2020. At the end of the second round with strict measures in April 2021, the level of mental health consultations increased by 73% (95% CI 40–106.3). There was also a 42% (95% CI 5.7–79.5) increase in mental health consultations in November 2021. No similar increases were observed for dispensed prescription drugs between March 2020 and February 2021. Conclusions: The COVID-19 pandemic was associated with increases in mental health consultations in primary care among students, especially during/after longer periods of strict social distancing measures. The benefits of social distancing measures in future pandemic preparedness should be weighed against the cost of potentially worsening mental health in vulnerable groups. [ABSTRACT FROM AUTHOR]