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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]

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]

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]

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]

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]

Purpose: We examined the association between polypharmacy—an established risk factor for nonadherence in the elderly—and medication fill nonadherence in a large national sample of adolescent and young adult cancer survivors (AYAs) in the USA. Methods: We pooled data (2008–2017) from the Medical Expenditure Panel Survey. We defined polypharmacy as ≥ 3 unique medications prescribed, based on self-report and pharmacy data, and medication fill nonadherence as self-reported delay or inability to obtain a necessary medication. We estimated prevalence of medication fill nonadherence among AYAs (age 18–39 years with a cancer history). We used logistic regression to estimate the association between (1) polypharmacy and medication fill nonadherence in AYAs, and (2) total number of medications prescribed and medication fill nonadherence, controlling for sex, number of chronic conditions, disability, and survey year. Results: AYAs (n = 598) were predominantly female (76.2%), age 30–39 years (64.9%), and non-Hispanic White (72.1%). Nearly half were poor (19.0%) or near-poor/low income (21.6%). One in ten AYAs reported medication fill nonadherence (9.75%). Of these, more than 70% cited cost-related barriers as the reason. AYAs with polypharmacy had 2.49 times higher odds of medication fill nonadherence (95%CI 1.11–5.59), compared to those without polypharmacy. Odds of medication fill nonadherence increased by 16% with each additional medication prescribed (AOR 1.16, 95% CI 1.07–1.25). Conclusions: Polypharmacy may be an important risk factor for medication fill nonadherence in AYAs in the USA. Implications for Cancer Survivors: Improving AYAs' medication adherence requires eliminating cost-related barriers, particularly for those with polypharmacy. [ABSTRACT FROM AUTHOR]

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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.

This article discusses the payments made by pharmaceutical companies to Australian doctors and healthcare professionals. These payments are typically in the form of consultancy fees, sponsorship for educational events, and coverage of travel and accommodation expenses. The article highlights that Medicines Australia, an industry body representing most pharmaceutical companies, requires its members to disclose the details of these payments. The data from the most recent three years shows that 4.9% of all registered doctors in Australia received payments totaling $33.44 million. The specialties receiving the highest total payments were haematology/oncology, cardiology, and endocrinology. The article emphasizes the need for greater transparency in reporting these payments and encourages doctors to reflect on their relationships with the pharmaceutical industry. [Extracted from the article]

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.

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]

Purpose: This study identified the relationships between health literacy, self-efficacy, and medication adherence among older people with polypharmacy and analyzed the factors affecting medication adherence. Methods: This was a cross-sectional study using a survey of 95 participants who were on five or more drugs, 65 years or older, and visited one community center in Seoul between August 5, 2019 and August 7, 2019. Data were collected using a questionnaire and analyzed with descriptive statistics, t-test, ANOVA, Tukey test, Pearson’s correlation coefficient, and multiple regression via the IBM SPSS 23.0 program. Results: The participants took on average 8.32±3.90 drugs daily. Their health literacy was very low at 3.53±2.07. Self-efficacy and medication adherence were high at 33.63±5.36 and 15.03±3.27, respectively. Health literacy differed based on age and education levels, whereas self-efficacy differed depending on the frequency of medication. No demographic or medication-related factors caused a difference in medication adherence. Health literacy did not correlate with self-efficacy and medication adherence. Self-efficacy showed a negative correlation with medication adherence (r=-.52, p<.001). However, as a lower medication adherence score indicates greater adherence, a negative correlation means higher self-efficacy is linked with better adherence. Self-efficacy influenced medication adherence (β=-0.52, p<.001) with an explanatory power of 27.0% (F=17.01, p<.001) in this group. Also, the negative regression coefficient means higher self-efficacy was associated with better adherence. Conclusion: Medication adherence was generally high, with self-efficacy being the main influencing factor. Hence, intervention programs that promote self-efficacy should be implemented for older people with polypharmacy. [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]

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]

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]

This paper investigates the effects of a mandatory, universal prescription drug insurance policy on health behaviors and outcomes within a public health care system providing physician and hospital services free of charge. Using Canadian longitudinal data, we show that the reform improved individuals' general health while reducing body mass index and smoking. However, the program also increased drinking and had no significant impact on mental health, physical activity, or preventive care. We also examine the mechanisms through which these effects can play a role, as well as the heterogeneous effects. Estimates suggest that the policy decreased SES‐based disparities in health. [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.

Computational models based on recent maps of the RBC proteome suggest that mature erythrocytes may harbor targets for common drugs. This prediction is relevant to RBC storage in the blood bank, in which the impact of small molecule drugs or other xenometabolites deriving from dietary, iatrogenic, or environmental exposures ("exposome") may alter erythrocyte energy and redox metabolism and, in so doing, affect red cell storage quality and posttransfusion efficacy. To test this prediction, here we provide a comprehensive characterization of the blood donor exposome, including the detection of common prescription and over-the-counter drugs in blood units donated by 250 healthy volunteers in the Recipient Epidemiology and Donor Evaluation Study III Red Blood Cell-Omics (REDS-III RBC-Omics) Study. Based on high-throughput drug screenings of 1366 FDA-approved drugs, we report that approximately 65% of the tested drugs had an impact on erythrocyte metabolism. Machine learning models built using metabolites as predictors were able to accurately predict drugs for several drug classes/targets (bisphosphonates, anticholinergics, calcium channel blockers, adrenergics, proton pump inhibitors, antimetabolites, selective serotonin reuptake inhibitors, and mTOR), suggesting that these drugs have a direct, conserved, and substantial impact on erythrocyte metabolism. As a proof of principle, here we show that the antacid ranitidine - though rarely detected in the blood donor population - has a strong effect on RBC markers of storage quality in vitro. We thus show that supplementation of blood units stored in bags with ranitidine could - through mechanisms involving sphingosine 1-phosphate-dependent modulation of erythrocyte glycolysis and/or direct binding to hemoglobin - improve erythrocyte metabolism and storage quality.

BackgroundThe Affordable Care Act expanded Medicaid eligibility allowing low-income individuals greater access to health care. However, the uptake of state Medicaid expansion has been variable. It remains unclear how the Medicaid expansion was associated with the temporal trends in use of evidence-based cardiovascular drugs.MethodsWe used the publicly available Medicaid Drug Utilization and Current Population Survey to extract filled prescription rates per 1000 Medicaid beneficiaries of statins, antihypertensives, P2Y12 inhibitors, and direct oral anticoagulants. We defined expander states as those who expanded Medicaid on or before January 1, 2014, and nonexpander states as those who had not expanded by December 31, 2018. Difference-in-differences (DID) analyses were performed to compare the association of the Medicaid expansion with per-capita cardiovascular drug prescription rates in expander versus nonexpander states.ResultsBetween 2011 and 2018, the total number of prescriptions among all Medicaid beneficiaries increased, with gains of 89.7% in statins (11.0 to 20.8 million), 76% in antihypertensives (35.3 to 62.2 million), and 37% in P2Y12 inhibitors (1.7 to 2.3 million). Medicaid expansion was associated with significantly greater increases in quarterly prescriptions (per 1000 Medicaid beneficiaries) of statins (DID estimate [95% CI]: 22.5 [16.5-28.6], P75% of the expander states had increases in prescription rates of both statins and antihypertensives. In contrast, 44% of nonexpander states saw declines in statins and antihypertensives. The Medicaid expansion was not associated with higher direct oral anticoagulants prescription rates (DID estimate [95% CI] 0.9 [-0.3 to 2.1], P=0.142).ConclusionsThe 2014 Medicaid expansion was associated with a significant increase in per-capita utilization of cardiovascular prescription drugs among Medicaid beneficiaries. These gains in utilization may contribute to long-term cardiovascular benefits to lower-income and previously underinsured populations.

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 OBJECTIVE To analyze the consumption of drugs for Alzheimer’s disease on the Brazilian private market and its geographical distribution from 2014 to 2020. METHODS National data from the Brazilian National System of Controlled Product Management were used, regarding sales of donepezil, galantamine, rivastigmine, and memantine from January 2014 to December 2020. Sales data were used as a proxy for drug consumption and expressed as defined daily dose/1,000 inhabitants/year at national, regional, federative unit and microregion levels. RESULTS Drug consumption went from 5,000 defined daily doses/1,000 inhabitants, in 2014, to more than 16,000/1,000 inhabitants, in 2020, and all federative units showed positive variation. The Brazilian Northeast had the highest cumulative consumption in the period but displayed microregional disparities while the North region had the lowest consumption. Donepezil and memantine were the most consumed drugs, with the highest growth in consumption from 2014 to 2020. CONCLUSION The consumption of medicines indicated to treat Alzheimer’s disease tripled in Brazil between 2014 and 2020, which may relate to the increase in the prevalence of the disease in the country, greater access to health services, and inappropriate use. This challenges managers and healthcare providers due to population aging and the increased prevalence of chronic-degenerative diseases.

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]

Purpose: We examined prescription medication use and identified correlates of polypharmacy—taking multiple medications—in adolescent and young adult cancer survivors (AYAs), who experience early-onset chronic conditions. Methods: Our cross-sectional study pooled data (2008–2017) from the national Medical Expenditure Panel Survey. We estimated prevalence of polypharmacy (≥ 5 unique prescription medications over an approximate 1-year period) in AYAs (age 18–39 years with a history of cancer) and age- and sex-matched controls, overall and by sociodemographics, clinical factors, and health indicators. We compared survivors' and controls' medication use across therapeutic classes. To identify correlates of polypharmacy among AYAs, we included factors with p < 0.20 in bivariable analysis in a multivariable logistic regression model. Results: AYAs (n = 601) had a higher prevalence of polypharmacy than controls (n = 2,402), overall (31.5% vs. 15.9%, p <.01) and by all sociodemographics, clinical factors, and health indicators. A majority of AYAs with multiple chronic conditions (58.8%, 95% CI 47.3–70.4) or disability (61.3%, 95% CI 52.6–70.0) had polypharmacy. Patterns of AYAs' medication use across therapeutic classes were consistent with their chronic conditions. Nearly one-third used opioid/narcotic analgesics (32.2% vs. 13.7% of controls, p < 0.01). Among AYAs, multiple chronic conditions (aOR 4.68, 95% CI 2.23–9.83) and disability (aOR 3.70, 95% CI 2.23–6.14) were correlated with polypharmacy. Conclusions: Chronic conditions and disabilities, including aftereffects of cancer treatment, may drive polypharmacy in AYAs. Future research should examine adverse outcomes of polypharmacy and opioid/narcotic use in AYAs. Implications for Cancer Survivors: AYAs with chronic conditions or disabilities should be monitored for polypharmacy. [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]

Background: Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs. Methods: This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality. Results: About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors. Conclusion: Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted. [ABSTRACT FROM AUTHOR]

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. 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. 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 < 0.001) with abuse/misuse of antipsychotics, antidepressants, gabapentinoids, cough products and first-generation antihistamines. Eye products (Bimatoprost) and skin products abuse/misuse had significant association with female gender (p < 0.001) The results of our study provide crucial information to the healthcare authorities regarding the medications that can be inappropriately used at the community pharmacies in Saudi Arabia which necessitates implementation of stringent dispensing regulations. Educational programs can be implemented to increase the awareness among public regarding the harmful effects of inappropriate use of drugs. [ABSTRACT FROM AUTHOR]

Background This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in the context of direct-to-consumer television ads. Although there is little research on this topic, initial evidence suggests that people can misinterpret these endpoints. We hypothesized that understanding of ORR and PFS would be improved by adding a disclosure ("We currently do not know if [Drug] helps patients live longer") to ORR and PFS claims. Methods We conducted 2 online studies with US adults examining television ads for fictional prescription drugs indicated to treat lung cancer (N  = 385) or multiple myeloma (N  = 406). The ads included claims about OS, ORR with and without a disclosure, or PFS with and without a disclosure. In each experiment, we randomized participants to view 1 of 5 versions of a television ad. After viewing the ad twice, participants completed a questionnaire that measured understanding, perceptions, and other outcomes. Results In both studies, participants correctly differentiated between OS, ORR, and PFS via open-ended responses; however, participants in the PFS conditions (versus ORR conditions) were more likely to make incorrect inferences about OS. Supporting the hypothesis, adding a disclosure made expectations around living longer and quality-of-life improvements more accurate. Conclusion Disclosures could help reduce the extent to which people misinterpret endpoints like ORR and PFS. More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways. [ABSTRACT FROM AUTHOR]