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COPD and asthma are two of the most common chronic lung diseases, affecting over 545 million people globally and 34 million in the United States. Annual health care costs related to chronic lung disease are estimated at €380 billion in the European Union, and $24-$50 billion in the United States averaging to $4,000 in out-of-pocket costs per person in the U.S. A full-text literature search was conducted for English publications between January 1, 2005-March 18, 2024. It returned over 5,000 publications that were further narrowed using key search words, resulting in 172 peer-reviewed articles. Using their experience and subject expertise, the authors further narrowed the peer-reviewed articles to 55 that were in their opinion relevant. Also, 38 recently published industry reports and news articles specific to downstream effects of inhaler market changes and the future impact were included. The literature suggests that individuals with chronic lung disease face increased challenges with access to inhaled medication due to rising medication costs, discontinuation of branded medications, introduction of generic medications not covered by insurance, exclusionary preferred drug list tactics that force health care providers into non-medical switching of medication or devices, and ongoing medication shortages. Providers experience ongoing hurdles in prescribing appropriate inhaled medications for individuals with chronic lung disease, including increased time and costs spent on administrative tasks due to inhaler denials, a loss of patient trust, and limits on their ability to prescribe appropriate inhaled medication for individuals with chronic lung disease. [ABSTRACT FROM AUTHOR]

Background The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. Methods This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. Results Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P  < .001), and COWS scores, which decreased from 5.5 to 2.8 (P  < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P  < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. Conclusion TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. [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]

At the onset of the coronavirus (COVID-19) pandemic, hospitals experienced a demand surge for COVID-19–related medical care while simultaneously struggling to source prescription drugs needed to manage COVID-19 patients. This is worrisome as shortfalls in the supply of essential drugs can negatively impact patient outcomes. The popular press reporting on these challenges suggests that they are caused by supply chain disruptions. However, rigorous research on the relationship between the pandemic and prescription drug supply is limited. To address this gap, we leverage a quasi-experimental design and IQVIA's National Sales Perspectives™ data from 2018 to 2020. We focus on prescription drugs indicated for the management of COVID-19 patients and a set of control drugs (i.e., drugs not used for COVID-19). We find that in the early phases of the pandemic, hospitals stockpiled prescription drugs indicated for the management of COVID-19, making this behavior an under-recognized cause of the sourcing challenges. The sales volume of drugs indicated for COVID-19 management was concentrated in the first two months of the pandemic, after which sales decreased significantly despite a nationwide increase in COVID-19–related hospitalizations. We investigate another potential cause of stockpiling: expected price increases. Counter to concerns of price gouging, we find little evidence of price inflation for these drugs. An implication for drug manufacturers is that orders due to stockpiling by downstream buyers early on in a pandemic may need to be discounted when predicting future demand. Our results have implications for drug suppliers, hospitals, and policymakers interested in improving medical product supply chain resilience. This paper was accepted by Stefan Scholtes, healthcare management. Funding: R. M. Conti was supported by the National Science Foundation (Grant 1123649-463157) and the Sloan Foundation. Supplemental Material: The online appendices and data files are available at https://doi.org/10.1287/mnsc.2021.04150. [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]

Adilet Nazarbayev,1 Ardak Nurbakyt,1 Bibigul Omirbayeva,2 Anuar Akhmetzhan,1 Lyazzat Kosherbayeva1,3 1Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan; 2Salidat Kairbekova National Research Center for Health Development, Astana, Kazakhstan; 3Al-Farabi Kazakh National University, Almaty, KazakhstanCorrespondence: Anuar Akhmetzhan, Asfendiyarov Kazakh National Medical University, 88 Tole bi Street, Almaty, Kazakhstan, Email anuar.akh@bk.ruBackground and Objectives: Limited information is available regarding the distribution of increasing pharmaceutical expenditures within large representative samples of national populations globally. The aim was to investigate the distribution of pharmaceutical costs in outpatient treatment and analyze the primary characteristics of users of expensive drugs within the healthcare system of Kazakhstan.Methods: This study utilized data from the Information System for Outpatient Drug Supply, which includes nationally representative data from all regions of Kazakhstan, covering both rural and urban populations. The key explanatory variables in this study included age, gender, number of prescribed medications, disease categories based on ICD-10 codes, and insurance coverage status. These variables were selected to capture demographic, clinical, and healthcare access factors influencing prescription drug costs. In total, 2.2 million people, who were prescribed outpatient medications were included. High-cost users (HCUs) were characterized as individuals whose prescription drug expenses ranked within the highest 5%.Results: The distribution of pharmaceutical costs exhibits significant discrepancy, with 5% of the population receiving prescription drugs covered by the state budget and social medical insurance fund contributing to nearly three-quarters of all costs. Notably, these HCUs tended to be younger than low-cost drug users. HCUs, on average, consumed a greater quantity of medications compared to non-HCUs. Among children, the top diseases contributing to high costs were rare hereditary diseases and malignancies, while in adults, cancer and diabetes were the primary cost drivers.Conclusion: There is a concentration of public drug program spending within a small percentage of beneficiaries with high drug costs in Kazakhstan. This discovery offers valuable insights for shaping policies tailored to this specific population, aiming to mitigate escalating costs and enhance the optimal use of medications.Plain Language Summary: The pronounced skewness in the consumption of reimbursed outpatient drugs within the healthcare system of the Republic of Kazakhstan highlights the need for targeted cost containment strategies, in addition to broader measures such as price regulation and adjustments to reimbursement lists that impact the general population.The highest average costs in the high-cost group are observed in children under 5 years of age. Costs associated with chronic diseases (diabetes and others) rank in the top three, while when assessing costs in the high-cost user group, rare inherited diseases and cancer have a significant impact.Keywords: Pharmaceutical Expenditure, Prescription Drugs, Cost Distribution, Medicine user, High-cost patients

Abstract 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.

OBJECTIVE: Physicians of all specialties experienced unprecedented stressors during the COVID-19 pandemic, exacerbating preexisting burnout. We examine burnouts association with perceived and actionable electronic health record (EHR) workload factors and personal, professional, and organizational characteristics with the goal of identifying levers that can be targeted to address burnout. MATERIALS AND METHODS: Survey of physicians of all specialties in an academic health center, using a standard measure of burnout, self-reported EHR work stress, and EHR-based work assessed by the number of messages regarding prescription reauthorization and use of a staff pool to triage messages. Descriptive and multivariable regression analyses examined the relationship among burnout, perceived EHR work stress, and actionable EHR work factors. RESULTS: Of 1038 eligible physicians, 627 responded (60% response rate), 49.8% reported burnout symptoms. Logistic regression analysis suggests that higher odds of burnout are associated with physicians feeling higher level of EHR stress (odds ratio [OR], 1.15; 95% confidence interval [CI], 1.07-1.25), having more prescription reauthorization messages (OR, 1.23; 95% CI, 1.04-1.47), not feeling valued (OR, 3.38; 95% CI, 1.69-7.22) or aligned in values with clinic leaders (OR, 2.81; 95% CI, 1.87-4.27), in medical practice for ≤15 years (OR, 2.57; 95% CI, 1.63-4.12), and sleeping for

Background and Aim: Self-medication practices (SMPs) are a common phenomenon prevalent with both prescription and nonprescription medicines. Still, the availability of a valid and reliable instrument to assess the knowledge, attitude, and practices toward self-medication (SM) remains limited. The current pilot study aimed to develop and validate a tool that effectively evaluates these aspects among consumers in Delhi, India. Materials and Methods: The research involved 100 consumer participants from Delhi, India. Reliability and validity testing was conducted to assess reproducibility, internal consistency, and content validity. The questionnaire underwent validation by a panel of five experts to evaluate face and content validity. Results: Test–retest reliability was assessed using Karl Pearson’s correlation co-efficient yielding values of 0.841 (P = 0.002), 0.827 (P = 0.003), and 0.792 (P = 0.006) for the three domains of knowledge, attitude, and frequency of performing SM, respectively. Cronbach’s alpha statistics were used to determine internal consistency, yielding values of 0.775 and 0.839 for knowledge and attitude domains, respectively. The association between the demographic characteristics of respondents and knowledge, attitude, and frequency of SM was assessed using an independent sample t-test and one-way ANOVA, demonstrating satisfactory known group validity. Conclusions: The developed questionnaire proved valid and reliable for determining consumer’s knowledge, attitudes, and practices toward SM. The final tool could be valuable for future research and interventions to improve consumers’ understanding of SMP.

Background Polypharmacy is common among hospitalized patients with infectious infections owing to comorbidities or concomitant illnesses. This raises the likelihood of drug-drug interactions and creates uncertainty for healthcare providers. This study aimed to assess the potential drug-drug interactions (pDDIs) among hospitalized patients with infectious diseases in a secondary care hospital. Methods A prospective observational study was conducted in the internal medicine ward for six months after the ethics committee’s approval. Data were collected from patient case records, and prescriptions were screened for pDDIs from a portable electronic physician information database (PEPID) resource analyzed using SPSS, version 27.0. Results In total, 148 patient case records were analyzed, and 549 pDDIs were identified, with 66.8% having at least one or more DDIs. The mean number of drug interactions was 3.70 ± 4.58 per prescription. The most frequently encountered drug interactions were drug combinations such as bisoprolol with atorvastatin and aspirin with tazobactam/piperacillin. Bivariate analysis showed that age, comorbidities, length of hospital stay, and the number of drugs prescribed were risk factors associated with DDIs (p Conclusions This study observed the prevalence of DDIs in hospitalized patients with infectious diseases of ‘moderate’ severity. Prescription screening using a drug information database assists in early identification and prevention of DDIs, enhancing drug safety and quality of patient-centered care.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n  = 7) and supportive care (n  = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings. [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]

ImportancePrescription drug prices are a leading concern among patients and policy makers. There have been large and sharp price increases for some drugs, but the long-term implications of large drug price increases remain poorly understood.ObjectiveTo examine the association of the large 2010 price increase in colchicine, a common treatment for gout, with long-term changes in colchicine use, substitution with other drugs, and health care use.Design, setting, and participantsThis retrospective cohort study examined MarketScan data from a longitudinal cohort of patients with gout with employer-sponsored insurance from 2007 through 2019.ExposuresThe US Food and Drug Administration's discontinuation of lower-priced versions of colchicine from the market in 2010.Main outcomes and measuresMean price of colchicine; use of colchicine, allopurinol, and oral corticosteroids; and emergency department (ED) and rheumatology visits for gout in year 1 and over the first decade of the policy (through 2019) were calculated. Data were analyzed between November 16, 2021, and January 17, 2023.ResultsA total of 2 723 327 patient-year observations were examined from 2007 through 2019 (mean [SD] age of patients, 57.0 [13.8] years; 20.9% documented as female; 79.1% documented as male). The mean price per prescription of colchicine increased sharply from $11.25 (95% CI, $11.23-$11.28) in 2009 to $190.49 (95% CI, $190.07-$190.91) in 2011, a 15.9-fold increase, with the mean out-of-pocket price increasing 4.4-fold from $7.37 (95% CI, $7.37-$7.38) to $39.49 (95% CI, $39.42-$39.56). At the same time, colchicine use declined from 35.0 (95% CI, 34.6-35.5) to 27.3 (95% CI, 26.9-27.6) pills per patient in year 1 and to 22.6 (95% CI, 22.2-23.0) pills per patient in 2019. Adjusted analyses showed a 16.7% reduction in year 1 and a 27.0% reduction over the decade (P

BACKGROUND: 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. OBJECTIVES: 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 Acts 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. METHODS: This was a cross-sectional study of Medicare beneficiaries aged ≥65 years with ≥1 CV risk factor/condition from 2016 to 2019. RESULTS: 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. CONCLUSIONS: 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 Acts 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.

Abstract 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 Background The COVID‐19 pandemic has impacted healthcare behaviors, leading to fewer pediatric visits in Japan and potentially fewer visits by adult patients. However, existing Japanese studies on treatment interruptions have generally relied on questionnaire‐based methods. In this study, we assessed the impact of the pandemic on antihypertensive treatment interruption using real‐world prescription data. Methods We conducted an interrupted time series analysis using the National Health Insurance Database in Okayama Prefecture, Japan. Participants included individuals aged 40–69 years with at least one antihypertensive prescription between 2018 and 2020. Treatment interruption was defined as a 3‐month or longer gap in prescriptions after medication depletion. We used segmented Poisson regression with models unadjusted and adjusted for seasonality and over‐dispersion to assess monthly treatment interruptions before and after Japan's April 2020 emergency. Results During the study period, 23.0% of 55,431 participants experienced treatment interruptions. Cyclical fluctuations in interruptions were observed. The crude analysis indicated a 1.2‐fold increase in treatment interruptions following the pandemic; however, the adjusted models showed no significant changes. Even among higher‐risk groups, such as women, younger adults, and those with shorter prescriptions, no significant alterations were observed. Conclusion We found no significant impact of the COVID‐19 pandemic on antihypertensive treatment interruption in Okayama Prefecture. The less severe outbreak in the area or increased use of telemedicine and extended prescriptions may have contributed to treatment continuity. Further research is needed using a more stable and comprehensive database, broader regional data, and detailed prescription records to validate and extend our findings.

Background Polypharmacy is common among hospitalized patients with infectious infections owing to comorbidities or concomitant illnesses. This raises the likelihood of drug-drug interactions and creates uncertainty for healthcare providers. This study aimed to assess the potential drug-drug interactions (pDDIs) among hospitalized patients with infectious diseases in a secondary care hospital. Methods A prospective observational study was conducted in the internal medicine ward for six months after the ethics committee’s approval. Data were collected from patient case records, and prescriptions were screened for pDDIs from a portable electronic physician information database (PEPID) resource analyzed using SPSS, version 27.0. Results In total, 148 patient case records were analyzed, and 549 pDDIs were identified, with 66.8% having at least one or more DDIs. The mean number of drug interactions was 3.70 ± 4.58 per prescription. The most frequently encountered drug interactions were drug combinations such as bisoprolol with atorvastatin and aspirin with tazobactam/piperacillin. Bivariate analysis showed that age, comorbidities, length of hospital stay, and the number of drugs prescribed were risk factors associated with DDIs (p Conclusions This study observed the prevalence of DDIs in hospitalized patients with infectious diseases of ‘moderate’ severity. Prescription screening using a drug information database assists in early identification and prevention of DDIs, enhancing drug safety and quality of patient-centered care.

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 and Aim: Self-medication practices (SMPs) are a common phenomenon prevalent with both prescription and nonprescription medicines. Still, the availability of a valid and reliable instrument to assess the knowledge, attitude, and practices toward self-medication (SM) remains limited. The current pilot study aimed to develop and validate a tool that effectively evaluates these aspects among consumers in Delhi, India. Materials and Methods: The research involved 100 consumer participants from Delhi, India. Reliability and validity testing was conducted to assess reproducibility, internal consistency, and content validity. The questionnaire underwent validation by a panel of five experts to evaluate face and content validity. Results: Test--retest reliability was assessed using Karl Pearson's correlation co-efficient yielding values of 0.841 (P = 0.002), 0.827 (P = 0.003), and 0.792 (P = 0.006) for the three domains of knowledge, attitude, and frequency of performing SM, respectively. Cronbach's alpha statistics were used to determine internal consistency, yielding values of 0.775 and 0.839 for knowledge and attitude domains, respectively. The association between the demographic characteristics of respondents and knowledge, attitude, and frequency of SM was assessed using an independent sample t-test and one-way ANOVA, demonstrating satisfactory known group validity. Conclusions: The developed questionnaire proved valid and reliable for determining consumer's knowledge, attitudes, and practices toward SM. The final tool could be valuable for future research and interventions to improve consumers' understanding of SMP. [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]

Patients require important information when prescribed medications. For example, the U.S. Food and Drug Administration (FDA) requires that promotional information includes a fair balance of risks and benefits. This study evaluates how well legitimate online pharmacies (LOPs) and illegitimate online pharmacies (IOPs) comply with the spirit of the FDA's fair balance guidelines by examining the extent and equivalence of risk and benefit information on their websites. This study analyzed the content of 307 online pharmacy websites. Most (90.3%) communicated drug benefits, while 84.7% provided risks. Both risk and benefit information was moderately extensive. Presentation of risks and benefits differed between online pharmacy types. Compared to LOPs, IOPs were more likely to present risk information but also exaggerate benefits. Four in ten online pharmacies presented a fair balance of risks and benefits. However, LOPs (47.4%) were more likely to present a fair balance than IOPs (36.5%). Interestingly, IOPs were more likely to disclose instructions for use and overdose information than LOPs. These findings underscore the need for regulatory guidelines to encourage online pharmacies to present a fair balance of benefit and risk information. Also, pharmacists should develop online approaches to better fulfill their professional responsibility as drug information providers while maintaining their integrity and objectivity. [ABSTRACT FROM AUTHOR]

Background: The COVID‐19 pandemic has impacted healthcare behaviors, leading to fewer pediatric visits in Japan and potentially fewer visits by adult patients. However, existing Japanese studies on treatment interruptions have generally relied on questionnaire‐based methods. In this study, we assessed the impact of the pandemic on antihypertensive treatment interruption using real‐world prescription data. Methods: We conducted an interrupted time series analysis using the National Health Insurance Database in Okayama Prefecture, Japan. Participants included individuals aged 40–69 years with at least one antihypertensive prescription between 2018 and 2020. Treatment interruption was defined as a 3‐month or longer gap in prescriptions after medication depletion. We used segmented Poisson regression with models unadjusted and adjusted for seasonality and over‐dispersion to assess monthly treatment interruptions before and after Japan's April 2020 emergency. Results: During the study period, 23.0% of 55,431 participants experienced treatment interruptions. Cyclical fluctuations in interruptions were observed. The crude analysis indicated a 1.2‐fold increase in treatment interruptions following the pandemic; however, the adjusted models showed no significant changes. Even among higher‐risk groups, such as women, younger adults, and those with shorter prescriptions, no significant alterations were observed. Conclusion: We found no significant impact of the COVID‐19 pandemic on antihypertensive treatment interruption in Okayama Prefecture. The less severe outbreak in the area or increased use of telemedicine and extended prescriptions may have contributed to treatment continuity. Further research is needed using a more stable and comprehensive database, broader regional data, and detailed prescription records to validate and extend our findings. [ABSTRACT FROM AUTHOR]

Objective: Screening questionnaires are one option for identification of at-risk substance use and substance use disorder (SUD) during pregnancy. We report the experience of a single institution following universal implementation of a brief screening tool for self-reported substance use at the first prenatal encounter. Study Design: This is a prospective implementation study evaluating screening for substance use in pregnancy in a large safety net healthcare system. Universal screening with the National Institute of Drug Abuse (NIDA) Quick Screen V1.0 was integrated into the electronic medical record (EMR) and administered at the first point of contact with the healthcare system. SUD was identified initially with diagnosis within the EMR by a healthcare provider and was confirmed with toxicology (maternal or neonatal) results corroborating a pattern of substance use and maternal and neonatal ICD-10 codes for SUD. Patients identified with SUD were then classified as moderate or severe SUD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. We measured rates of NIDA implementation across different healthcare settings, evaluated NIDA concordance with ascertainment of SUD, and compared adverse pregnancy outcomes associated with moderate and severe SUD. Results: From July 28, 2021, through June 25, 2022, 14,634 unique pregnant individuals accessed care at ambulatory and acute care sites. Universal implementation of the NIDA Quick Screen identified at-risk substance use in 2146 (14.7%) of those who accessed our system, or 17.1% of 12,550 screened across the system, with greater screen completion in ambulatory over acute care settings. SUD was identified in 256 (1.7%) of 14,634 individuals and moderate or severe SUD was identified in 184 (1.3%). Among those with moderate or severe SUD, 90 (48.9%) were NIDA positive, 22 (12.0%) NIDA negative, and 72 (39.1%) unscreened. Of 94 individuals with NIDA discordance or who were unscreened 76 (81%) accessed initial care through an acute care setting. Of 96 individuals with opioid use disorder, 68 (70.8%) were treated with medication-assisted therapy, and 56 (58.3%) were screened with the NIDA Quick Screen. Among delivered individuals with available outcomes, those with moderate or severe SUD were less likely to seek prenatal care (71 (76%) vs 9852 (98%),

This work examined the use of over-the-counter drugs and its health implications in Awka South LGA of Anambra State, Nigeria. The objective of the study is to empirically interrogate the prevalence of over-the-counter drug use in Awka South LGA of Anambra State, Nigeria; the factors influencing it, and its health implications. The study used a mixed methods research approach, with 204 respondents selected through a multistage sampling procedure. The structured questionnaire and In-Depth Interview (IDI) guide acted as data-gathering tools. The quantitative data were coded and processed with SPSS version 20. Frequency tables were utilized to evaluate, characterize, and show the data, whereas quantitative data were manually transcribed and analyzed using content analysis. Two study hypotheses were developed and tested using chi-square inference statistics. This study revealed that various factors influence the use of OTC drugs in Awka South LGA. The study equally found that the use of OTC drugs is very prevalent in Awka South LGA. Moreover, the study also found that abusing OTC drugs has health implications. Based on these findings, this study recommended that the government should regulate the production, sale, and advertisement of OTC drugs. The study also recommended that sensitization and awareness programs should be carried out periodically to teach people when and when not to use OTC drugs.

Oluyomi Oloruntoba,1 Caroline D Bergeron,2 Lixian Zhong,3 Ashley L Merianos,4 Ledric D Sherman,5,6 Chung Lin Kew,5 R Kirby Goidel,7 Matthew Lee Smith5,6,8 1Department of Environmental and Occupational Health, School of Public Health, Texas A&M University, College Station, TX, USA; 2LIFE Research Institute, University of Ottawa, Ottawa, ON, Canada; 3Department of Pharmaceutical Sciences, Rangel School of Pharmacy, Texas A&M University, College Station, TX, USA; 4School of Human Services, University of Cincinnati, Cincinnati, OH, USA; 5Department of Health Behavior, School of Public Health, Texas A&M University, College Station, TX, USA; 6Center for Health Equity and Evaluation Research, Texas A&M University, College Station, TX, USA; 7Public Policy Research Institute, Texas A&M University, College Station, TX, USA; 8Center for Community Health and Aging, Texas A&M University, College Station, TX, USACorrespondence: Matthew Lee Smith, Email matthew.smith@tamu.eduIntroduction: 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.Keywords: chronic pain, African American, non-Hispanic Black, men, prescription drugs, opioids, treatment satisfaction

Abstract Backgound Potentially inappropriate prescribing (PIP) has been evaluated in several countries, and several strategies have been devised for deprescribing drugs in older adults. The aim of this study was to evaluate the efficacy of a mobile application in reducing PIP for older adults in primary care facilities in Brazil. Methods This randomised, triple-blind, parallel-group trial was conducted in 22 public primary care facilities in Brazil. During the intervention phase, the general practitioners (GPs) were randomly allocated to the intervention (MPI Brasil app provides information about PIP, therapeutic alternatives and deprescribing) or control (MedSUS app provides general information about medications) group. All GPs were trained on the Clinical Decision-Making Process and how to access an Evidence-Based Health website. The GPs received an Android tablet with an installed mobile application depending on their allocated group, which they used when caring for older patients over at least 3 months. At the end of this period, a sample of older patients aged ≥ 60 years who had been awaiting medical consultation by the participating GPs were interviewed and their prescriptions analysed. The primary outcome was the frequency of PIP in and between the groups. Results Among 53 GPs who were administered the baseline survey, 14 were included in the clinical trial. At baseline, 146 prescriptions were analysed: the PIP overall was 37.7% (55/146), in the intervention group was 40.6% (28/69), and in the control group was 35.1% (27/77). After the intervention, 284 prescriptions were analysed: the PIP overall was 31.7% (90/284), in the intervention group was 32.2% (46/143), and in the control group was 31.2% (44/141) (RR: 1.16; 95% CI, 0.76–1.76). In the within-group analysis, the PIP reduced from before to after the intervention in both groups—more significantly in the intervention than in the control group (p

ObjectiveTo describe the reported prevalence of cannabis use and co-use with prescription medications among older adult patients attending primary care (PC) clinics in Los Angeles, CA.MethodsWe used electronic health record (EHR) data from sixty PC clinics part of a university-based, urban healthcare system. Patients' ≥50 years of age with an annual physical examination between July 2019 and May 2020 were eligible for inclusion (n = 42,555). Cannabis use was assessed by clinic staff at the time of the visit and recorded in the EHR. We also used EHR data on clinical characteristics including current prescriptions and comorbidities.ResultsThe median age was 63 years (range: 50-101) and 56% were female. Recent cannabis use was reported by 7.6%, which was higher than tobacco use (4.0%; p

Background Polypharmacy is common among hospitalized patients with infectious infections owing to comorbidities or concomitant illnesses. This raises the likelihood of drug-drug interactions and creates uncertainty for healthcare providers. This study aimed to assess the potential drug-drug interactions (pDDIs) among hospitalized patients with infectious diseases in a secondary care hospital. Methods A prospective observational study was conducted in the internal medicine ward for six months after the ethics committee’s approval. Data were collected from patient case records, and prescriptions were screened for pDDIs from a portable electronic physician information database (PEPID) resource analyzed using SPSS, version 27.0. Results In total, 148 patient case records were analyzed, and 549 pDDIs were identified, with 66.8% having at least one or more DDIs. The mean number of drug interactions was 3.70 ± 4.58 per prescription. The most frequently encountered drug interactions were drug combinations such as bisoprolol with atorvastatin and aspirin with tazobactam/piperacillin. Bivariate analysis showed that age, comorbidities, length of hospital stay, and the number of drugs prescribed were risk factors associated with DDIs (p Conclusions This study observed the prevalence of DDIs in hospitalized patients with infectious diseases of ‘moderate’ severity. Prescription screening using a drug information database assists in early identification and prevention of DDIs, enhancing drug safety and quality of patient-centered care.

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]

Backgound: Potentially inappropriate prescribing (PIP) has been evaluated in several countries, and several strategies have been devised for deprescribing drugs in older adults. The aim of this study was to evaluate the efficacy of a mobile application in reducing PIP for older adults in primary care facilities in Brazil. Methods: This randomised, triple-blind, parallel-group trial was conducted in 22 public primary care facilities in Brazil. During the intervention phase, the general practitioners (GPs) were randomly allocated to the intervention (MPI Brasil app provides information about PIP, therapeutic alternatives and deprescribing) or control (MedSUS app provides general information about medications) group. All GPs were trained on the Clinical Decision-Making Process and how to access an Evidence-Based Health website. The GPs received an Android tablet with an installed mobile application depending on their allocated group, which they used when caring for older patients over at least 3 months. At the end of this period, a sample of older patients aged ≥ 60 years who had been awaiting medical consultation by the participating GPs were interviewed and their prescriptions analysed. The primary outcome was the frequency of PIP in and between the groups. Results: Among 53 GPs who were administered the baseline survey, 14 were included in the clinical trial. At baseline, 146 prescriptions were analysed: the PIP overall was 37.7% (55/146), in the intervention group was 40.6% (28/69), and in the control group was 35.1% (27/77). After the intervention, 284 prescriptions were analysed: the PIP overall was 31.7% (90/284), in the intervention group was 32.2% (46/143), and in the control group was 31.2% (44/141) (RR: 1.16; 95% CI, 0.76–1.76). In the within-group analysis, the PIP reduced from before to after the intervention in both groups—more significantly in the intervention than in the control group (p < 0.001). In the stratified analysis of PIP frequency by GPs, there was a relative risk reduction in 86% (6/7) of GPs in the intervention group compared to 71% (5/7) in the control group. Conclusion: We found that the MPI Brasil app effectively reduced PIP, suggesting that it may be useful to incorporate this tool into clinical practice. Trial registration: The study was registered at ClinicalTrials.gov (NCT02918643). First registration on 22/09/2016. [ABSTRACT FROM AUTHOR]

Individuals with spinal cord injuries (SCI) experience high rates of prescription opioid use, yet there is limited data on frequency of opioid use and specific medications being taken. To examine the frequency of self-reported prescription opioid use among participants with SCI and the relationship with demographic, injury, and socioeconomic characteristics. A cohort study of 918 adults with SCI of at least 1-year duration completed a self-report assessment (SRA) that indicated frequency of specific prescription opioid use based on the National Survey on Drug Use and Health (NSDUH). Forty-seven percent of the participants used at least one prescription opioid over the last year; the most frequently used was hydrocodone (22.1%). Nearly 30% used a minimum of one opioid at least weekly. Lower odds of use of at least one opioid over the past year was observed for Veterans (odds ratio [OR] = 0.60, 95% CI = 0.38, 0.96) and those with a bachelor's degree or higher (OR = 0.63, 95% CI = 0.44, 0.91). When restricting the analysis to use of at least one substance daily or weekly, lower odds of use was observed for those with a bachelor's degree or higher and those with income ranging from $25,000 to $75,000+. None of the demographic or SCI variables were significantly related to prescription opioid use. Despite the widely established risks, prescription opioids were used daily or weekly by more than 28% of the participants. Usage was only related to Veteran status and socioeconomic status indicators, which were protective of use. Alternative treatments are needed for those with the heaviest, most regular usage. [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]

In this review, we examine the impact of the Inflation Reduction Act (IRA) of 2022 on pharmaceutical drugs in the United States, drawing on a diverse range of sources to understand the perceptions of multiple stakeholders and professionals. Findings suggest that the Act, while aiming to control price inflation, has had a multifaceted impact on the pharmaceutical sector. Stakeholders, including pharmaceutical companies, healthcare providers, patient advocacy groups, and policymakers, offered varied perspectives: while some laud the Act for its potential in controlling runaway drug prices and making healthcare more accessible, others raise concerns about possible reductions in drug innovation, disruptions to supply chains, and the sustainability of smaller pharmaceutical companies. The review identified four underlying constructs (themes) in the literature surrounding healthcare stakeholders' perceptions of the IRA's impact upon prescription drugs: pricing and/or dictation pricing issues, topics related to patent law and pharmaceuticals, processes surrounding the IRA's (2022) rules and regulations, and potential threats to the pharmaceutical industry concerning the research and development of future medications. The complex interplay of the Act's implications underscores the importance of ongoing assessment and potential iterative policy refinements as implementation endures. [ABSTRACT FROM AUTHOR]

Background: Brand-name prescription drugs are an important driver of prescription drug spending, but different payers may bear these costs differentially necessitating different policy goals for each payer. But little is known about how the top 10 selling drugs in the U.S. impact spending across payers. Objective: To estimate the differential spending burden of top prescription drugs on Medicaid, Medicare, commercial coverage, and out-of-pocket (OOP) spending. Methods: The percentage of total prescription drug spending, total spending, total prescriptions, and average cost per prescription overall and for each of the following payers – Medicaid, Medicare, private insurance, and OOP – was calculated for each of the top 10 selling prescription drugs using 2017–2019 Medical Expenditure Panel Survey data. Results: These 10 prescription drugs accounted for average annual spending of $83.4 billion and 19.0% of all prescription drug spending. Medicare tended to contribute the highest fraction of spending. The average annual cost per prescription ranged from $500 for Advair to $7400 for Tecfidera. Significant variation in the average annual number of prescriptions filled was observed, ranging from 1.4 million for Tecfidera to 13.6 million for Lantus. Conclusions: The findings highlight the significant impact of the top 10 selling prescription drugs on U.S. prescription drug spending. The wide variation in per prescription cost as well as contribution to each payer's prescription drug burden emphasizes how policies targeting top-selling drugs may differentially impact payers as well as how payer-specific policies may differ substantially even for top selling drugs.

BackgroundA study has shown that industry payments to physicians for drugs are associated not only with higher drug prescriptions but also with higher non-drug costs due to additional utilization of healthcare services. However, the association between industry payments to cardiologists for antiplatelet drugs and the costs and number of percutaneous coronary interventions they perform has not been investigated.ObjectiveTo examine the association between industry payments to cardiologists for antiplatelet drugs and the costs and number of percutaneous coronary interventions they perform.DesignUsing the 2016 Open Payments Database linked to the 2017 Medicare Provider Utilization and Payment Data, we examined the association between the value of industry payments related to the antiplatelet drugs prasugrel and ticagrelor and healthcare spending and volume for cardiovascular procedures, adjusted for potential cofounders.SubjectsA total of 7456 cardiologists who performed diagnostic cardiac catheterizations on Medicare beneficiaries in 2017.Main measuresPrimary outcomes included (1) healthcare spending on cardiac procedures, (2) diagnostic cardiac catheterization volumes, and (3) rates of coronary stenting. Secondary outcomes were total expenditures for all drugs and for antiplatelet drugs.Key resultsIndustry payments for antiplatelet drugs were associated with higher healthcare spending on cardiac procedures (adjusted difference, +$50.9 for additional $100 industry payments; 95% CI, +$25.5 to +$76.2; P < 0.001), diagnostic cardiac catheterizations (+0.1 procedures per cardiologist; 95% CI, +0.03 to +0.1; P=0.001), and stent use (+0.5 per 1000 diagnostic cardiac catheterizations per cardiologist; 95% CI, +0.2 to +0.9; P=0.002). Industry payments for antiplatelet drugs were associated with higher total costs for all drugs and antiplatelet drugs.ConclusionsIndustry payments to cardiologists for antiplatelet drugs were associated with both prescribing of antiplatelet drugs and the use of cardiac procedures and stents. Further research is warranted to understand whether the observed associations are causal or reflect a greater propensity for higher volume proceduralists to have relationships with industry.

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 time-consuming 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.How to cite: Gao M, Zhang Y, Xue L, et al. Screening microbially produced pentyl diacetic acid lactone using an Escherichia coli biosensor workflow. Electron J Biotechnol 2023;66. https://doi.org/10.1016/j.ejbt.2023.09.002.

Abstract Background The non-medical use of prescription drugs is a growing public health problem worldwide. Recent trends in Cameroon show that the use of psychoactive substances, among which are prescription drugs by adolescents is becoming a public health issue and is linked to juvenile delinquency and violence in schools. However, there is a paucity of data on the burden of this phenomenon among adolescent secondary school students in the country. The aim of this study was to determine the prevalence and factors associated with the use of non-prescription drugs in secondary schools in Buea, South West region of Cameroon. Methods We conducted a cross-sectional study from 1st February 2021 to 30th April 2021. Secondary school students were recruited using a multistage stratified cluster sampling. A modified and standardized version of the World Health Organization student drug-use survey model questionnaire was used. Ethical approval was obtained from the Institutional Review Board of the Faculty of Health Sciences, University of Buea (No. 2021/1273–02/UB/SG/IRB/FHS). The Statistical Package for Social Sciences, IBM SPSS Statistics for Windows, Version 25.0. was used for data analysis. Descriptive statistics were used to describe the sociodemographic characteristics of participants. Univariate and multivariate logistic regression models were used to explore associated factors of non-medical use of prescription drugs. Results A total of 570 participants were enrolled for the study, and 510 participants responded giving a response rate of 89.5%. The prevalence of non-medical use of prescription drugs was 15.3%, tramadol being the most used. Motivators for non-medical use of prescription drugs were “to work longer”, “to be courageous”, and “curiosity”. Logistic regression results showed that alcohol consumption [OR 3.68; 95% CI: 2.24–6.06; p

This cross-sectional study describes the price differences between capsule and tablet or ointment and cream forms of prescription drugs for insured patients.

ImportanceAntidepressant use may be associated with reduced levels of several proinflammatory cytokines suggested to be involved with the development of severe COVID-19. An association between the use of selective serotonin reuptake inhibitors (SSRIs)-specifically fluoxetine hydrochloride and fluvoxamine maleate-with decreased mortality among patients with COVID-19 has been reported in recent studies; however, these studies had limited power due to their small size.ObjectiveTo investigate the association of SSRIs with outcomes in patients with COVID-19 by analyzing electronic health records (EHRs).Design, setting, and participantsThis retrospective cohort study used propensity score matching by demographic characteristics, comorbidities, and medication indication to compare SSRI-treated patients with matched control patients not treated with SSRIs within a large EHR database representing a diverse population of 83 584 patients diagnosed with COVID-19 from January to September 2020 and with a duration of follow-up of as long as 8 months in 87 health care centers across the US.ExposuresSelective serotonin reuptake inhibitors and specifically (1) fluoxetine, (2) fluoxetine or fluvoxamine, and (3) other SSRIs (ie, not fluoxetine or fluvoxamine).Main outcomes and measuresDeath.ResultsA total of 3401 adult patients with COVID-19 prescribed SSRIs (2033 women [59.8%]; mean [SD] age, 63.8 [18.1] years) were identified, with 470 receiving fluoxetine only (280 women [59.6%]; mean [SD] age, 58.5 [18.1] years), 481 receiving fluoxetine or fluvoxamine (285 women [59.3%]; mean [SD] age, 58.7 [18.0] years), and 2898 receiving other SSRIs (1733 women [59.8%]; mean [SD] age, 64.7 [18.0] years) within a defined time frame. When compared with matched untreated control patients, relative risk (RR) of mortality was reduced among patients prescribed any SSRI (497 of 3401 [14.6%] vs 1130 of 6802 [16.6%]; RR, 0.92 [95% CI, 0.85-0.99]; adjusted P = .03); fluoxetine (46 of 470 [9.8%] vs 937 of 7050 [13.3%]; RR, 0.72 [95% CI, 0.54-0.97]; adjusted P = .03); and fluoxetine or fluvoxamine (48 of 481 [10.0%] vs 956 of 7215 [13.3%]; RR, 0.74 [95% CI, 0.55-0.99]; adjusted P = .04). The association between receiving any SSRI that is not fluoxetine or fluvoxamine and risk of death was not statistically significant (447 of 2898 [15.4%] vs 1474 of 8694 [17.0%]; RR, 0.92 [95% CI, 0.84-1.00]; adjusted P = .06).Conclusions and relevanceThese results support evidence that SSRIs may be associated with reduced severity of COVID-19 reflected in the reduced RR of mortality. Further research and randomized clinical trials are needed to elucidate the effect of SSRIs generally, or more specifically of fluoxetine and fluvoxamine, on the severity of COVID-19 outcomes.

ObjectiveTo improve food insecurity interventions, we sought to better understand the hypothesized bidirectional relationship between food insecurity and health care expenditures.Data sourceNationally representative sample of the civilian noninstitutionalized population of the United States (2016-2017 Medical Expenditure Panel Survey [MEPS]).Study designIn a retrospective longitudinal cohort, we conducted two sets of analyses: (a) two-part models to examine the association between food insecurity in 2016 and health care expenditures in 2017; and (b) logistic regression models to examine the association between health care expenditures in 2016 and food insecurity in 2017. We adjusted for demographic and socioeconomic variables as well as 2016 health care expenditures and food insecurity.Data collectionHealth care expenditures, food insecurity, and medical condition data from 10 886 adults who were included in 2016-2017 MEPS.Principal findingsFood insecurity in 2016, compared with being food secure, was associated with both a higher odds of having any health care expenditures in 2017 (OR 1.29, 95% CI: 1.04 to 1.60) and greater total expenditures ($1738.88 greater, 95% CI: $354.10 to $3123.57), which represents approximately 25% greater expenditures. Greater 2016 health care expenditures were associated with slightly higher odds of being food insecure in 2017 (OR 1.007 per $1000 in expenditures, 95% CI: 1.002 to 1.012, P =0.01). Exploratory analyses suggested that poor health status may underlie the relationship between food insecurity and health care expenditures.ConclusionsA bidirectional relationship exists between food insecurity and health care expenditures, but the strength of either direction appears unequal. Higher health care expenditures are associated with a slightly greater risk of being food insecure (adjusted for baseline food insecurity status) but being food insecure is associated with substantially greater subsequent health care expenditures (adjusted for baseline health care expenditures). Interventions to address food insecurity and poor health may be helpful to break this cycle.

Background: Inappropriate use of medications is a global health concern, and this is attributed to the increased accessibility to prescription and non-prescription (over-the-counter) drugs at community pharmacies. We investigated the inappropriate use of prescription and non-prescription drugs in community pharmacies based on the perspectives of the community pharmacists in Saudi Arabia. Methods: This was a questionnaire-based, cross-sectional survey which employed convenient sampling (snowball technique) to recruit participants. Being a licensed practicing pharmacist in a retail chain or an independent community pharmacy was the inclusion criteria. Participants were asked to report the drugs they suspected of being inappropriately used along with the frequency, age and gender of the suspected customers. Pharmacists were also asked to mention the action taken to limit inappropriate use at their pharmacy. Results: A total of 397 community pharmacists completed the questionnaire (86.9 % response rate). 86.4% of the pharmacists suspected some level of abuse or misuse to have occurred. After receiving the questionnaire, the pharmacists reported suspected inappropriate use as encountered during the past three months. Cumulative inappropriate use was reported 1069 times (prescription drugs – 530; non-prescription drugs – 539). The top three inappropriately used prescription-drug categories were gabapentinoids (22.5%), antipsychotics (17.5%) and topical corticosteroids (12.1%). Among non-prescription drugs, cough products (33.2%) ranked first, followed by cold and flu products (29.5%) and first-generation antihistamines (10.8%). The cross tabulations revealed that being in the age range of 26–50 years and being a male was significantly associated (p

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has triggered a rise in the global phenomenon of self-medication. The use of medicines with unsubstantiated claims of benefit for the prevention and/or treatment of infected people has been widely adopted. Objective: To determine the factors associated with the use of medicines and self-medication by Latin American populations during the COVID-19 pandemic. Methods: This analytical cross-sectional study was conducted via an analysis of secondary data collected from 8777 responses from 12 Latin American countries obtained from a survey on the use of medicines and self-medication during the pandemic. Results: Respondents who reported using Paracetamol, Ibuprofen, or antibiotics (ABx) disclosed this as self-medication in 26.9%, 16.6%, and 9.7% of cases respectively. In our multivariate analysis, significant associations were found between: self-medication by individual choice and the use of Hydroxychloroquine, ABx, or non-steroidal anti-inflammatory drugs (NSAIDs) (p = 0.026, = 0.003, and

Targeted analysis of contaminants in water are often focused on a narrow range of chemicals, falling short of the true pollution status of water bodies. Non targeted screening presents several advantages in identifying less prioritized pollutants, entirely unknown compounds and transformation products. In this study we employed a non-targeted screening workflow established on a high-resolution quadrupole time-of-flight mass spectrometer coupled to an ultrahigh performance liquid chromatograph (UHPLC-QTOF-MS) to identify known and unknown pollutants in South African waste and surface waters. Level two confidence identification of 315 compounds was achieved based on mass accuracy, isotope patterns and MS/MS spectra match. Pharmaceuticals, drugs, and metabolites made up 40% of the detected compounds, biological compounds and industrial chemicals along with their metabolites constituted 24 and 18% respectively, while personal care products, pesticides and food additives made up approximately 5, 4 and 4% respectively. Several antiretroviral drugs were confirmed with level one confidence using isotope labelled standards. A wide range of “new” pharmaceuticals, pesticides and metabolites were documented in South African waters for the first time. Seventeen (17) pharmaceuticals were reported for the first time in South African waters, of which four are reported for the first time ever in surface water.The result of this exploratory study highlights the presence of several contaminants of public health concern that have hitherto received little to no attention in previous wastewater-based epidemiological studies. We provide a detailed list of priority contaminants for future studies on targeted-analysis.

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]

Prescription drug use has reached historic highs in the United States--a trend linked to increases in medicalization, institutional factors relating to the health care and pharmaceutical industries, and population aging and growing burdens of chronic disease. Despite the high and rising prevalence of use, no estimates exist of the total number of years Americans can expect to spend taking prescription drugs over their lifetimes. This study provides the first estimates of life course patterns of prescription drug use using data from the 1996-2019 Medical Expenditure Panel Surveys, the Human Mortality Database, and the National Center for Health Statistics. Newborns in 2019 could be expected to take prescription drugs for roughly half their lives: 47.54 years for women and 36.84 years for men. The number of years individuals can expect to take five or more drugs increased substantially. Americans also experienced particularly dramatic increases in years spent taking statins, antihypertensives, and antidepressants. There are also important differences in prescription drug use by race and ethnicity: non-Hispanic Whites take the most, Hispanics take the least, and non-Hispanic Blacks fall in between these extremes. Americans are taking drugs over a wide and expanding swathe of the life course, a testament to the centrality of prescription drugs in Americans' lives today. [ABSTRACT FROM AUTHOR]

A short primer for students entering the health professions, this article provides an overview of the history of therapeutic drugs, from antiquity to modern pharmacology.

An illustrated history of drugs developed for medicinal use from antiquity to modern pharmaceuticals. A primer for health professional students.