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Summary: Background: Up to 50% of adolescents who undergo metabolic and bariatric surgery (MBS) have obesity 3 years post‐MBS, placing them at continued risk for the consequences of obesity. Objectives: We conducted an open‐label, 16‐week pilot study of liraglutide in adolescents with obesity after sleeve gastrectomy (SG) to investigate liraglutide effects on weight and body mass index (BMI) post‐SG. Methods: Adolescents aged 12–20.99 years with obesity and a history of SG ≥1 year prior were enrolled. Liraglutide was initiated at 0.6 mg/day, escalated weekly to a maximum of 3 mg/day, with treatment duration 16 weeks. Fasting laboratory assessments and an oral glucose tolerance test were performed at baseline and end‐treatment. Results: A total of 43 participants were screened, 34 initiated liraglutide (baseline BMI 41.2 ± 7.7 kg/m2), and 31 (91%) attended the end‐treatment visit. BMI decreased by 4.3% (p < 0.001) with liraglutide. Adolescents who had poor initial response to SG (<20% BMI reduction at BMI nadir) had less weight loss with liraglutide. Fasting glucose and haemoglobin A1C concentrations significantly decreased. There were no serious treatment‐emergent adverse events reported. Conclusions: Liraglutide treatment was feasible and associated with a BMI reduction of 4.3% in adolescents who had previously undergone SG, quantitatively similar to results obtained in adolescents with obesity who have not undergone MBS. [ABSTRACT FROM AUTHOR]

APhA PharmacyLibrary is an online platform from the American Pharmacists Association (APhA) created to provide web-based access to APhA's published books and other educational pharmacy resources. In addition to textbooks, the platform includes learning modules, a cultural toolkit, self-assessments, and a media library. APhA subscriptions are available for the individuals and institutions. This review will outline the design, resources, and other features of APhA PharmacyLibrary. [ABSTRACT FROM AUTHOR]

Summary: Background: Paediatric obesity disproportionately impacts individuals from minoritized racial and ethnic backgrounds. Recent guidelines support use of anti‐obesity pharmacotherapy for adolescents with obesity, but the potential impact on disparities in obesity prevalence has not been evaluated. Objectives: To model changes in obesity prevalence with increasing utilization of anti‐obesity pharmacotherapy among adolescents. Methods: Data representative of American adolescents ages 12–17 years were obtained from the National Health and Nutrition Examination Survey, cycles 2011 through pre‐pandemic 2020. A body mass index (BMI) reduction of 16.7% was applied to each participant based on clinical trial results of weekly subcutaneous semaglutide 2.4 mg among adolescents. Utilization disparities were based on utilization of the same medication class among adults. Obesity prevalence was calculated assuming utilization of 10%–100%, stratified by race and ethnicity. Results: Among 4442 adolescents representing 26 247 384 American adolescents, projected overall obesity prevalence decreased from 22.2% to 8.4% with 100% utilization. However, disparities increased relative to Non‐Hispanic White youth, with prevalence among Non‐Hispanic Black and Mexican American youth ranging from 40%–60% higher to 90%–120% higher, respectively. Conclusions: Increasing utilization of anti‐obesity pharmacotherapy may widen relative disparities in obesity, particularly if utilization is unequal. Advocacy for equitable access is needed to minimize worsening of obesity‐related disparities. [ABSTRACT FROM AUTHOR]

Purpose: To summarize the most noteworthy infectious diseases (ID) pharmacotherapy articles published in peer-reviewed literature in 2021. Summary: Members of the Houston Infectious Diseases Network (HIDN) nominated articles that were deemed to have significant contributions to ID pharmacotherapy in 2021. These nominations included articles pertaining to both general ID, including coronavirus disease 2019 (COVID-19), and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) pharmacotherapy. A total of 35 articles were nominated by HIDN: 30 articles pertaining to general ID pharmacotherapy and 5 articles with HIV/AIDS focus. To select the most influential articles of 2021, a survey was created and distributed to members of the Society of Infectious Diseases Pharmacists (SIDP). Of the 239 SIDP members who responded to the survey, there were 192 recorded votes for the top 10 general ID pharmacotherapy articles and 47 recorded votes for the top HIV/AIDS article, respectively. The top publications are summarized. Conclusion: Antimicrobial stewardship and the optimal management of infectious disease states continues to be a priority in the midst of the ongoing coronavirus disease 2019 (COVID-19) global pandemic. In light of the sheer volume of ID-related articles published in the past year, this review aims to aid clinicians in remaining up-to-date on key practice-changing ID pharmacotherapy publications from 2021. [ABSTRACT FROM AUTHOR]

Purpose To track and analyze the growth of 12 Board of Pharmacy Specialties (BPS) specialties from 2008 to 2020 and, subject to criteria, to project specialty numbers through 2025. The analysis considered residency data and Bureau of Labor Statistics projections. Methods BPS data were used to determine numeric growth, growth rates, and trends for 12 BPS specialties from 2008 to 2020. Specialties begun after 2008 were analyzed from their start date. For specialties with more than 2 data points and coefficients of determination greater than 0.80, we calculated projections through 2025. We also estimated the percentage of BPS-certified pharmacists with postgraduate year 1 training. Results BPS-certified pharmacists grew in number from 3,004 (2008) to 41,802 (2020), an over 13-fold increase. Currently, 4 of the 5 largest specialties (pharmacotherapy, ambulatory care, oncology, and critical care) continue to grow at a fast rate. Pharmacotherapy experienced the largest numeric growth (20,624) despite the ongoing introduction of new specialties. Critical care and infectious diseases had the highest growth rates (both 32%). We were able to make projections for 10 of 12 specialties, with greater than 62,000 certifications projected by 2025. Growth to these projected levels will require more residencies and more certification preparation opportunities. Residency-trained BPS specialists currently constitute slightly less than 50% of the BPS-certified population. Conclusion Specialization in the pharmacy profession is growing at a rapid pace. As more clinical privileges are approved, the demand for more specialized pharmacists will likely continue to increase. Data from this study document the growth of the pharmacy specialty workforce. The data and analysis can be used to estimate potential pharmacist contributions across the healthcare spectrum in clinical areas where BPS-certified pharmacists practice. [ABSTRACT FROM AUTHOR]

Background and Aims: Topiramate is a medication that is widely prescribed to treat a variety of conditions, including alcohol use disorder (AUD). We used electronic health record (EHR) data to measure topiramate's effects on drinking in individuals differentiated by a history of AUD. Design: Parallel‐groups comparison of patients prescribed topiramate and a propensity score‐matched comparison group. Setting: A large US integrated health‐care system. Participants: Patients with Alcohol Use Disorders Identification Test–Consumption (AUDIT‐C) scores prior to and after a minimum of 180 days of topiramate prescription for any indication and a propensity score‐matched group. The sample included 5918 patients with an electronic health record diagnosis of alcohol use disorder at any time (AUD‐hx‐pos) (1738 topiramate‐exposed and 4180 controls) and 23 614 patients with no EHR diagnosis of AUD (AUD‐hx‐neg) (6324 topiramate‐exposed and 17 290 controls). Measurements Regression analyses compared difference‐in‐difference (DiD) estimates, separately by AUD history. DiD estimates represent exposure‐group (i.e. topiramate versus control) differences on the pre–post difference in AUDIT‐C score. Effects of baseline AUDIT‐C score and daily topiramate dosage were also tested. Findings AUD‐hx‐neg patients who received topiramate had a greater reduction in AUDIT‐C score (−0.11) than matched controls (−0.04). This yielded a DiD score of −0.07 [95% confidence interval (CI) = −0.11,‐0.03; P = 0.002], with the greatest effect among AUD‐hx‐neg patients with a baseline AUDIT‐C score of 4+ (DiD = −0.35, 95% CI = –0.49, −0.21; P < 0.0001) and those prescribed > 150 mg/day of the medication (DiD = −0.15, 95%CI = –0.23, −0.07; P < 0.001). Discussion: Among individuals with no history of alcohol use disorder, topiramate appears to be associated with reduced drinking. This small effect is most evident among patients with higher baseline drinking levels and at a higher average daily topiramate dosage. [ABSTRACT FROM AUTHOR]

Objective: The authors examined racial/ethnic and socioeconomic disparities in receiving treatment for alcohol use disorder (AUD)., Methods: A retrospective cohort study was conducted that included adults (≥18 years) with AUD from the All of Us Controlled Tier database v7. Outcomes were lifetime receipt of FDA-approved medications (disulfiram, acamprosate, and naltrexone), psychotherapy (individual, family, and group-based session), and combination treatment (medication and psychotherapy). The study examined treatment receipt by race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, other), insurance (private, Medicare, Medicare and Medicaid, Medicaid, Veteran Affairs [VA], none), income (<$10K, $10-<$50K, $50-$100K, >$100K), and area deprivation index (ADI) quintiles. Multivariable logistic and multinomial logistic regressions were used to assess the association between patient characteristics and treatment receipt., Results: The cohort consisted of 18,692 patients (mean age=57.1 years; 60.7% were male; 47.1% were non-Hispanic White). Almost 70% received no treatment, 11.4% received medication, 24.0% received psychotherapy, and 4.9% received combination treatment. In adjusted analysis, non-Hispanic Black (aOR=0.78, 95% CI=0.69-0.89) and Hispanic (aOR=0.75, 95% CI=0.64-0.88) individuals were less likely to receive medication than non-Hispanic White counterparts. There was no association between race/ethnicity and receipt of psychotherapy or combination treatment. Compared with private insurance, dual eligibility was associated with less use of medication, Medicare and Medicaid with less use of medication and combination treatment, and VA and no insurance with more use of psychotherapy and combination treatment. Higher income and lower ADI were positively associated with all treatment types., Conclusions: There are disparities in AUD treatment by race/ethnicity, socioeconomic status, and insurance. Systematic approaches are required to improve equitable access to effective treatment., Competing Interests: Mr. Rich is a policy analyst at the Reason Foundation. Dr. Bernstein reports receiving funding support from an Institutional National Research Service Award (T32HP32715) and personal fees from Alosa. Dr. Glass facilitated a quality improvement pilot study for which Pear Therapeutics Inc provided digital therapeutic prescriptions at no cost to Kaiser Permanente Washington. Dr. Rothberg serves as a consultant for Blue Cross Blue Shield Association. The other authors report no financial relationships with commercial interests.

Introduction: Obsessive-compulsive disorder (OCD) is marked by a high rate of treatment resistance. Patients are often left trialing medications within multiple drug classes with little response, causing heterogeneity to emerge in prescribing patterns. This analysis seeks to investigate the selection and dosing of the pharmacotherapy utilized, to portray an overview of prescribing trends in the United States., Methods: This retrospective, single center, review of electronic medical records investigated the pharmacotherapy utilization of patients with a primary diagnosis of OCD. Two hundred and ninety-five patients who received OCD treatment at an urban, academic medical center were included in the study. Patients were included in the review if they were at least eighteen years of age and were assigned a diagnosis of OCD according to DSM-5 criteria., Results: Psychotropic pharmacotherapy was integrated into the care of 93% of patients. Selective serotonin reuptake inhibitors were the most utilized medication class at 85% followed by benzodiazepines (47%) and second-generation antipsychotics (37%). Tricyclic antidepressants and first-generation antipsychotics were the two medication classes utilized the least at 13% and 2% respectively. Additionally, mood stabilizers and serotonin-norepinephrine reuptake inhibitors were utilized at rates of 8% and 16%, respectively., Conclusions: Evidence-based treatment guidelines are being followed with varying augmentation strategies widely prevalent, thus displaying the heterogeneity in treating OCD. A high rate of benzodiazepine utilization highlights a practice trend with potential ties to clinical factors, such as the latency to treatment effect of other first-line pharmacotherapies. Future prospective studies are required to determine the cultural, pharmacoeconomic and pharmacogenomic factors that contribute to the variation in prescribing practices and whether these variations influence treatment outcomes., (© 2024 John Wiley & Sons Ltd.)

More than 40% of people with human immunodeficiency virus (PWH) in the United States smoke tobacco cigarettes. Among those on antiretroviral therapy, smoking decreases life expectancy more than human immunodeficiency virus (HIV) itself. Most PWH who smoke want to quit, but tobacco dependence treatment has not been widely integrated into HIV care. This article summarizes the epidemiology of tobacco use among PWH, health consequences of tobacco use and benefits of cessation in PWH, and studies of treatment for tobacco dependence among the general population and among PWH. We provide practical guidance for providers to treat tobacco dependence among PWH. A 3-step Ask-Advise-Connect framework includes asking about tobacco use routinely during clinical encounters, advising about tobacco cessation with emphasis on the benefits of cessation, and actively connecting patients to cessation treatments, including prescription of pharmacotherapy (preferably varenicline) and direct connection to behavioral interventions via telephone quitline or other means to increase the likelihood of a successful quit attempt. [ABSTRACT FROM AUTHOR]

Objective: Despite the availability of various treatment options, a large proportion of patients with asthma have uncontrolled asthma in the United States. Consequently, the economic burden of suboptimal asthma control is anticipated to substantially grow in the next 20 years, adversely impacting patients' quality of life. Therefore, there is an urgent need for effective treatments to achieve and maintain asthma control. The Global Initiative for Asthma recommends tiotropium as a controller medication for patients with asthma aged ≥6 years, based on evidence from several randomized controlled trials. However, more real-world data on the effectiveness of tiotropium are required to establish a broad picture of its use in everyday clinical practice.Methods: Herein, we present 3 case reports of patients diagnosed with uncontrolled or fixed obstructive asthma not responding to inhaled corticosteroids (ICS) or ICS + long-acting β2-agonists (LABAs) and/or leukotriene receptor antagonists (LTRAs).Results: All 3 patients were prescribed tiotropium, irrespective of their age. Tiotropium improved lung function and quality of life, as indicated by the forced expiratory volume in 1 s/forced vital capacity ratio and the Asthma Control Test score. Furthermore, the addition of tiotropium reduced the use of rescue medication. Conclusions: Hence, the results from these case reports highlight that tiotropium could be an effective and safe add-on treatment option for patients across a range of age groups with uncontrolled or fixed obstructive asthma receiving prior ICS or ICS + LABA and/or LTRA therapy. [ABSTRACT FROM AUTHOR]

Introduction: In the last two decades, our understanding of the therapeutic utility and medicinal properties of cannabis has greatly changed. This change has been accompanied by widespread cannabis use in various communities and different age groups, especially within the United States. With this increase, we should consider the potential effects of cannabis–hemp on general public health and how they could alter therapeutic outcomes. Material and Methods: The present investigation examined cannabis use for recreational and therapeutic use and a review of pertinent indexed literature was performed. The focused question evaluates "how cannabis or hemp products impact health parameters and do they provide potential therapeutic value in dentistry, and how do they interact with conventional medicines (drugs)." Indexed databases (PubMed/Medline, EMBASE) were searched without any time restrictions but language was restricted to English. Results: The review highlights dental concerns of cannabis usage, the need to understand the endocannabinoid system (ECS), cannabinoid receptor system, its endogenous ligands, pharmacology, metabolism, current oral health, and medical dilemma to ascertain the detrimental or beneficial effects of using cannabis–hemp products. The pharmacological effects of pure cannabidiol (CBD) have been studied extensively while cannabis extracts can vary significantly and lack empirical studies. Several metabolic pathways are affected by cannabis use and could pose a potential drug interaction. The chronic use of cannabis is associated with health issues, but the therapeutic potential is multifold since there is a regulatory role of ECS in many pathologies. Conclusion: Current shortcomings in understanding the benefits of cannabis or hemp products are limited due to pharmacological and clinical effects not being predictable, while marketed products vary greatly in phytocompounds warrant further empirical investigation. Given the healthcare challenges to manage acute and chronic pain, this review highlights both cannabis and CBD‐hemp extracts to help identify the therapeutic application for patient populations suffering from anxiety, inflammation, and dental pain. [ABSTRACT FROM AUTHOR]

Objective: Pharmacotherapy for opioid use disorder is effective but underused from a clinical perspective, and average treatment duration is shorter than current recommendations. In this analysis, the authors examined factors associated with initiation of, engagement in, and duration of treatment among patients with opioid use disorder.Methods: Using the OptumLabs Data Warehouse (a large, national, deidentified database of commercial or Medicare Advantage plan enrollees), the authors identified a sample of 204,225 patients with opioid use disorder between July 1, 2010, and April 1, 2019. Factors associated with initial treatment type were identified with multinomial logistic regression. The odds of treatment engagement, defined as two claims for treatment and a treatment episode of ≥30 days, were estimated with logistic regression. The hazard ratios for treatment discontinuation were estimated with a Cox proportional hazards model.Results: Treatment initiation with pharmacotherapy (alone or in combination with psychosocial therapy) was associated with higher odds of treatment engagement and a lower hazard of treatment discontinuation. Patients with certain behavioral health conditions (e.g., anxiety or mood disorders) had higher odds of initiating treatment with pharmacotherapy and engaging in treatment and a lower hazard of discontinuing treatment. Patients with certain painful general health conditions (e.g., fibromyalgia or musculoskeletal disorders) had lower odds of initiating and engaging in treatment.Conclusions: Treatment initiation with pharmacotherapy was associated with treatment engagement and duration. Previous contact with behavioral health treatment may support initiating, engaging in, and remaining in treatment. Patients with painful conditions may benefit from provider support in initiating treatment for opioid use disorder. [ABSTRACT FROM AUTHOR]

Five medications are approved by the US Food and Drug Administration for chronic weight management, yet less than 2% of adults with obesity use these medications. The purpose of this study was to identify reasons nurse practitioners are reluctant to prescribe obesity pharmacotherapy. This was a cross-sectional study of a US sample of nurse practitioners. Questionnaires were administered online that evaluated practice patterns and attitudes concerning obesity pharmacotherapy. The survey was completed by 74 nurse practitioners, and of those, 17.6% prescribed obesity pharmacotherapy and 82.4% did not. Nurse practitioners who did and did not prescribe obesity pharmacotherapy had similar scores on weight bias. Nurse practitioners who did not prescribe obesity pharmacotherapy, compared with those who did, more often reported that patients do not ask for obesity pharmacotherapy (p =.01), patients did not want to use pharmacotherapy (p =.02), and that they were not familiar with obesity medications (p =.02). Although this survey was limited by a low response, we found many beliefs, opinions, and attitudes toward adults with obesity did not differ between the groups. However, nurse practitioners who did not prescribe obesity pharmacotherapy, compared with those who did, identified more barriers related to the lack of obesity pharmacotherapy awareness and education. [ABSTRACT FROM AUTHOR]

Background: Essential hypertension, a prevalent cardiovascular condition, poses a significant health burden worldwide. Based on the latest American clinical guidelines, half of adults in the United States have hypertension. Of these, only about a half are treated and about a quarter are adequately controlled for hypertension. Given its impact on morbidity and mortality, ensuring effective management of high blood pressure is crucial to reduce associated risks and improve patient outcomes. Objective: This review aims to provide a comprehensive and up-to-date summary of the latest cardiology guidelines and evidence-based research on essential hypertension, with a focus on guiding outpatient clinical practice. Methods: The review evaluates both non-pharmacological approaches and pharmacological interventions to offer clinicians practical insights. Notably, it emphasizes the importance of individualized treatment plans tailored to patients' specific risk profiles and comorbidities. Results: By consolidating the latest advancements in hypertension management, this review provides clinicians with an up-to-date reference, offering a nuanced understanding of treatment goals and strategies. Conclusion: Through the incorporation of evidence-based recommendations, healthcare practitioners can optimize patient care, mitigate potential complications, and improve overall outcomes in essential hypertension.

Summary: More than 40% of adults in the United States suffer from obesity. Obesity is inextricably linked to many chronic illnesses like type‐2 diabetes mellitus, hypertension, hyperlipidemia, heart disease, sleep apnea, stroke, and cancers. When used in combination with lifestyle modifications, pharmacotherapy has a vital role in treating obesity and improves short‐term and long‐term outcomes. A growing number of physicians are now interested in obesity medicine, and many of them are seeking guidance on how to treat complex patients with co‐morbidities. This review provides a practical guide to the use of anti‐obesity medications across various obesity‐related comorbidities. It provides a general review of the currently approved anti‐obesity medications and effective combinations. It discusses the highlights of the major trials and recent studies assessing the benefits of anti‐obesity medications in comorbid conditions such as type‐2 diabetes mellitus, psychiatric disorders, cardiovascular diseases, hypertension, renal diseases, and liver diseases. This review briefly examines the aspects of recognizing and addressing iatrogenic weight gain; discusses the precautions and prescribing considerations of anti‐obesity medications, including side effects and possible dose adjustments in various comorbid conditions; and provides an expert opinion on an individualized choice of the best anti‐obesity medication. [ABSTRACT FROM AUTHOR]

Purpose: Current guidelines recommend triple therapy maintenance inhalers for patients with recurrent exacerbations of chronic obstructive pulmonary disease (COPD); however, these maintenance therapies are underutilized. This study aimed to understand how physicians make COPD treatment decisions, and how combination maintenance therapies are utilized in a real-world setting., Patients and Methods: This exploratory, hypothesis-generating, non-interventional study used a cross-sectional online survey that was administered to a sample of practicing physicians in the United States. The survey included five fictitious vignettes detailing common symptoms experienced by patients with COPD. Survey questions included factors physicians consider in their decisions, and perceived barriers to prescribing treatments. Repeated measures multivariable analyses were conducted to evaluate how likely physicians were to switch to triple therapy versus no change to patient's current maintenance therapy or change to another maintenance therapy., Results: In total, 200 physicians completed the survey. Cost of treatment and patient access to treatment were reported as the most common barriers physicians consider in their prescribing decisions. Physicians were more likely to switch a patient's maintenance inhaler to triple therapy versus no change to maintenance inhaler if they considered the patient's history of new symptoms, insurance status, and clinical guidelines in their decision. Physicians with more experience treating patients with COPD, and those who treat more patients with COPD per week, were more likely to switch to triple therapy versus no change to maintenance inhaler., Conclusion: This study demonstrates the complexity of factors that can influence physicians' decisions when prescribing treatments for patients with COPD, including considerations of treatment cost, patient access and adherence, patient comorbidities, efficacy of current treatment, clinical guidelines, and provider's level of experience treating COPD. Further research may help elucidate the relative importance of the factors influencing physicians' decisions and inform what types of decision-support tools would be most beneficial., Competing Interests: KK-W is an employee of, and holds stocks/shares in, GSK. BKHB, KJM, MC, NSW, and CKM are employees of Optum, which received research funds from GSK to conduct this study, but not for manuscript development. JF was an employee of Optum, which received research funds from GSK to conduct this study, but not for manuscript development, at the time of this study. WDP and JMW are employees of DARTNet, which received funding from GSK to conduct this study. WDP also reports grants from Boehringer Ingelheim, AstraZeneca, Teva, and Circassia, outside the submitted work. The authors report no other conflicts of interest in this work., (© 2024 Kahle-Wrobleski et al.)

Between 1999 and 2017, nearly 400,000 individuals died from opioid-related overdoses in the United States. Nurse practitioners (NPs) can be instrumental in providing care for those with opioid use disorders (OUDs) but must be adequately prepared to do so. Currently, there is limited evidence regarding how NP programs are preparing their graduates to address opioid use. The purpose of this study was to evaluate how NP programs have addressed the opioid epidemic within their curricula, and to evaluate barriers to and facilitators of curricular modifications. Electronic surveys were distributed to all 444 NP program directors in the United States. The survey consisted of 10 questions and inquired about curricular modifications made in regard to OUDs, barriers and facilitators of such modifications, and perceived importance of addressing the opioid epidemic within NP programs. A total of 130 (29.3%) of program directors responded to the survey. Of the program directors who responded, 89 (76.1%) reported that curricular modifications were made to address OUDs. Barriers to curricular modification included limited time, lack of faculty expertise or confidence, and stigma in regard to opioid use. Facilitators included faculty champions, availability of external educational resources, student interest, and financial incentives. Nurse practitioners can treat patients with OUDs, mitigating significant barriers to care reported in light of the opioid epidemic. Graduate NP programs should assure that curricula adequately cover opioid use and related management. [ABSTRACT FROM AUTHOR]

Objective: Disease modification in Parkinson disease (PD) has remained an elusive goal, in spite of large investments over several decades. Following a large meeting of experts, this review article discusses the state of the science, possible reasons for past PD trials' failures to demonstrate disease-modifying benefit, and potential solutions.Methods: The National Institute of Neurological Disorders and Stroke (NINDS) convened a meeting including leaders in the field and representatives of key stakeholder groups to discuss drug therapy with the goal of disease modification in PD.Results: Important lessons can be learned from previous attempts, as well as from other fields. The selection process for therapeutic targets and agents differs among various organizations committed to therapeutic development. The areas identified as critical to target in future research include the development of relevant biomarkers, refinements of the targeted patient populations, considerations of novel trial designs, and improving collaborations between all stakeholders.Conclusions: We identify potential barriers to progress in disease modification for Parkinson's and propose a set of research priorities that may improve the likelihood of success. [ABSTRACT FROM AUTHOR]

Aim: To assess the trends in the prescribing of antiobesity medications and the characteristics of patients recently initiating antiobesity drugs. Materials and Methods: We conducted a population‐based cohort study using claims data from commercial health insurances in the United States. Patients initiating an antiobesity drug between January 2004 and December 2018 were included. Trends in the utilization of antiobesity medications were plotted by year, as a proportion of any antiobesity treatment, and as initiation rates per 100 000. Descriptive statistics were used to summarize the characteristics of antiobesity initiators. Results: From 2004 to 2018, 626 216 patients started an antiobesity medication (two per 100 000). Phentermine was the most frequently prescribed (50% in 2018). In recent years (2015‐2018), among 227 692 patients who initiated an antiobesity drug, 51% started phentermine, 19% naltrexone‐bupropion, and 13% liraglutide 3.0 mg. Compared to other agents, the use of liraglutide 3.0 mg increased between 2015 and 2018. The average age of initiators was 45 years, 81% of initiators were female, 32% had hypertension, 25% had dyslipidaemia, and 6% had type 2 diabetes. Time on treatment was generally short (mean 81 days). Conclusion: The overall use of antiobesity medications remained low over the past 15 years and phentermine was the preferred antiobesity agent. Although the use of potentially safer antiobesity agents, for example, liraglutide 3.0 mg, has increased in recent years, phentermine remained the most frequently prescribed agent among middle‐aged adults with a moderate burden of comorbidities. [ABSTRACT FROM AUTHOR]

Recent research suggests that service dogs may have clinically relevant benefits for military veterans with posttraumatic stress disorder (PTSD). However, the effects of PTSD service dogs on veterans' medication use have been largely unexplored. The objective of this study was to quantify the effect of PTSD service dogs on medication use among a population of military veterans with PTSD. In a cross-sectional design (n = 96), United States post-9/11 military veterans with PTSD were recruited from a single service dog provider including veterans living with a PTSD service dog (n = 52) and veterans on the waitlist (n = 44). Both populations of veterans received treatment as usual. Participants completed an online survey of self-reported medication regimens and medication changes. Regression models quantified the effect of having a service dog on physical health, mental health, pain, and sleep medications while controlling for confounding variables (age, gender identity, relationship status, traumatic brain injuries, and physical health). Results indicated that there were no significant effects of having a service dog on overall self-reported medication use nor any specific medication category (p's > 0.06). However, veterans with a service dog were more likely than those on the waitlist to report that their doctor had decreased dosage or removed medications since getting their service dog. The results of this preliminary cross-sectional research should be interpreted with caution, as future within-subject and pharmacy-verified research is necessary to understand the causality of these findings. [ABSTRACT FROM AUTHOR]

Non‐alcoholic steatohepatitis (NASH) is a result of inflammation and hepatocyte injury in the presence of hepatic steatosis which can progress to cirrhosis. NASH is the most rapidly growing aetiology for liver failure and indication for liver transplantation in the United States. Non‐alcoholic fatty liver disease (NAFLD) is associated with obesity, type 2 diabetes, dyslipidaemia and metabolic syndrome. Because of the absence of approved pharmacotherapy, weight loss and lifestyle modifications remain the safest and most effective first‐line treatment. However, this may not be effective in patients with advanced fibrosis or cirrhosis and long‐term adherence is difficult to achieve. Therefore, effective drugs are urgently needed for the treatment of NASH. Drug development targeting pathological pathways in NASH have exploded in the past decade, with numerous new drugs under investigation. This review summarizes the results of pivotal finalized phase 2 studies and provides an outline of key active studies with trial data of drugs under development. [ABSTRACT FROM AUTHOR]

Background Emergency medicine (EM) pharmacists may be uniquely positioned to optimize discharge prescriptions for emergency department (ED) patients but the clinical significance of interventions and association with patient outcomes are not well-described. Objective To evaluate the clinical significance of EM pharmacist interventions completed during review of ED discharge prescriptions. Setting This study was conducted in an academic medical center ED. Methods: This was a retrospective observational study of patients discharged with prescriptions from the ED over two months. EM pharmacists reviewed discharge prescriptions and provided drug therapy recommendations. Two independent reviewers rated the clinical significance of interventions. High risk criteria were proposed a priori and included in a multivariable logistic regression analysis to identify variables independently associated with pharmacist intervention. Main Outcome Measure The primary outcome measure was the rate, type, and clinical significance of interventions associated with EM pharmacist review of discharge prescriptions. Results A total of 3107 prescriptions for 1648 patients were reviewed. Interventions occurred for 7.3% of patients with 29% of interventions rated as significant. The intervention rate was higher in patients with at least 1 high risk criteria versus those without (9.6% vs. 3.7%, p < 0.0001). An incremental increase in the number of discharge prescriptions was independently associated with pharmacist intervention. The 30 day readmission rates did not differ between patients with and without pharmacist review (27.4% vs. 26.2%, p = 0.38). Conclusion: Pharmacist review of discharge prescriptions resulted in clinically significant interventions but did not impact readmission rates. An incremental increase in the number of discharge prescriptions was associated with pharmacist intervention. [ABSTRACT FROM AUTHOR]

Pediatric obesity remains a public health crisis in the United States, exacerbated by the COVID-19 pandemic. There are recommended guidelines for multidisciplinary care, but they remain challenging to implement, even in tertiary care weight management programs. The aim of this analysis is to describe the implementation of these recommendations among four pediatric weight management programs in the United States. This report capitalizes on a convenience sample of programs participating in the Stay In Treatment (SIT) Study, a multicenter study to address attrition among pediatric weight management programs in tertiary care, academic institutions in diverse geographic locations. The programs were compared regarding structure, program offerings, and funding support. The four programs were interdisciplinary, offered individual and group treatment options, and were family-based. A range of clinicians provided interventions with nutrition, physical activity, behavioral and psychosocial components. Anti-obesity pharmacotherapy and bariatric surgery were offered, when appropriate. None of the programs were self-sustaining; they required institutional and philanthropic support to provide recommended, comprehensive treatment. Ongoing state and national advocacy are needed in the US to create consistent coverage for private and public insurance plans, so that high-risk children can have access to recommended treatment. [ABSTRACT FROM AUTHOR]

Objectives: Uncontrolled hypertension is a common cause of cardiovascular disease, which is the deadliest and costliest chronic disease in the United States. Pharmacists are an accessible community healthcare resource and are equipped with clinical skills to improve the management of hypertension through medication therapy management (MTM). Nevertheless, current reimbursement models do not incentivize pharmacists to provide clinical services. We aim to investigate the cost-effectiveness of a pharmacist-led comprehensive MTM clinic compared with no clinic for 10-year primary prevention of stroke and cardiovascular disease events in patients with hypertension.Methods: We built a semi-Markov model to evaluate the clinical and economic consequences of an MTM clinic compared with no MTM clinic, from the payer perspective. The model was populated with data from a recently published controlled observational study investigating the effectiveness of an MTM clinic. Methodology was guided using recommendations from the Second Panel on Cost-Effectiveness in Health and Medicine, including appropriate sensitivity analyses.Results: Compared with no MTM clinic, the MTM clinic was cost-effective with an incremental cost-effectiveness ratio of $38 798 per quality-adjusted life year (QALY) gained. The incremental net monetary benefit was $993 294 considering a willingness-to-pay threshold of $100 000 per QALY. Health-benefit benchmarks at $100 000 per QALY and $150 000 per QALY translate to a 95% and 170% increase from current reimbursement rates for MTM services.Conclusions: Our model shows current reimbursement rates for pharmacist-led MTM services may undervalue the benefit realized by US payers. New reimbursement models are needed to allow pharmacists to offer cost-effective clinical services. [ABSTRACT FROM AUTHOR]

Obesity is a chronic, relapsing metabolic disease, linked to a number of health risks and serious complications. Although highly prevalent in adults in the United States, it is underdiagnosed and untreated. Primary care providers (PCPs) are uniquely poised to diagnose and treat patients with obesity, using a selection of treatment strategies including lifestyle modifications and pharmacotherapies. As a physiological regulator of appetite and energy intake, the glucagon-like peptide-1 receptor agonist (GLP-1 RA) liraglutide 3.0 mg is approved for chronic weight management in individuals with overweight (pre-obesity) or obesity. In this review, we provide an overview of the clinical data supporting the use of liraglutide 3.0 mg, as well as practical advice for PCPs on the initiation and maintenance of treatment over the long term. This also covers the management of side effects and how to manage patient expectations over time. [ABSTRACT FROM AUTHOR]

This review serves to compare contemporary clinical practice recommendations for the management of heart failure (HF), as codified in the 2021 European Society of Cardiology (ESC) guideline, the 2022 American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) guideline, and the 2023 focused update of the 2021 ESC document. Overall, these guidelines aim to solidify significant advances throughout the HF continuum since the publication of previous full guideline iterations (2013 and 2016 for the ACC/AHA and ESC, respectively). All guidelines provide new recommendations for an increasingly complex landscape of HF care, with focus on primary HF prevention, HF stages, rapid initiation and optimization of evidence-based pharmacotherapies, overlapping cardiac and noncardiac comorbidities, device-based therapies, and management pathways for special groups of patients, including those with cardiac amyloidosis. Importantly, the ACC/AHA/HFSA document features special emphasis on HF risk prediction and screening, cost/value, social determinants of health, and health care disparities. The review discusses major similarities and differences between these recent guidelines and guideline updates, as well as their potential downstream implications for clinical care., Competing Interests: Funding Support and Author Disclosures Dr DeFilippis serves on a clinical trial committee for Abiomed and has had speaker engagements with AstraZeneca. Dr Riello has served as a consultant for Alexion AstraZeneca, Boehringer Ingelheim, Janssen, Johnson & Johnson, PhaseBio, and Portola. Dr Bozkurt has received personal fees from Vifor for serving on the steering committee for the Care HF Trial; has received personal fees from Amgen, AstraZeneca, and Baxter for serving on advisory committees or for consulting outside the submitted work; has received consulting fees from Bristol Myers Squibb, scPharmaceuticals, Baxter Healthcare Corporation, Sanofi Aventis, Relypsa, and Amgen; has served on the clinical event committee for the GUIDE HF Trial sponsored by Abbott Vascular; and has served on the data safety monitoring committee of the ANTHEM trial sponsored by LivaNova. Dr Vaduganathan has received research grant support from, has served on advisory boards of, or has had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; and has participated on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: We appraised whether FDA registration trials for ADHD pharmacotherapy in adults provides comparable information to inform treatment expectations., Method: Comparison of ADHD outcome measure patterns in ADHD pharmacotherapy FDA drug label source studies., Results: Among stimulants, from fixed-dose titration data, amphetamine agents had numerically higher placebo-corrected symptom improvement and symptom effect sizes than methylphenidate agents. Symptom effect sizes were lower in the flexible dosing registration studies of atomoxetine and viloxazine. Varying responder definitions were analyzable, based on ≥30% symptom improvement and/or CGI-I improvement of "much" or "very much improved." Number of exposures needed to create these responses were lower for stimulants than for viloxazine., Conclusion: Heterogeneity in the design and analysis of FDA drug label source trials restricts implications for clinical practice. Research conducted using replicated designs, direct comparison of available treatments, and outcome analyses that generalize to clinical care could better inform clinical decision making., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Daniel Walsh reports no conflicts of interest. Dr. Bond reports no conflicts of interest. Dr. Surman has received, in his lifetime, consulting fees from Eisai, Ironshore, Kaylon, Mcneil, NLS Pharma, Neurocentria, Nutricia, Otsuka, Pfizer, Adlon/Purdue, Rhodes, Shire, Somaxon, Sunovion, Supernus, Takeda, and Teva. He has also received payments for lectures for Alcobra, Arbor, McNeil, Janssen, Janssen-Ortho, Novartis, Shire, and Reed/MGH Academy (funded by multiple companies) as well as GME CME (funded by multiple companies). Royalties have been given to Dr. Surman from Berkeley/Penguin for “FASTMINDS: How to Thrive if You have ADHD (or think you might)” and from Humana/Springer for “ADHD in Adults: A Practical Guide to Evaluation and Management.” Additionally, Dr. Surman has conducted clinical research at Massachusetts General Hospital supported by Abbot, Cephalon, Hilda and Preston Davis Foundation, Eli Lilly, Magceutics/Neurocentria, Jazz, Johnson & Johnson/McNeil, Lundbeck, Merck, The National Institutes of Health, Nordic Naturals, Shire, and Takeda.

The 2018 AHA/ACC/multisociety cholesterol guideline emphasizes the need for lipid monitoring more strongly than the previous 2013 guideline to ensure patients reach recommended percent low-density lipoprotein cholesterol reductions. Real-world compliance to monitoring recommendations is currently unknown. This study examined the proportion of patients with a lipid panel measured within 3 months of statin initiation. This retrospective cohort study evaluated University of Colorado Health primary care patients aged 18 to 89 years with a new statin prescription identified via the Epic Clarity database. Patients initiated on a statin during January 1, 2018 to June 30, 2018 and January 1, 2019 to June 30, 2019 were included in the pre-2018 guideline cohort and the post-2018 guideline cohort, respectively. Patients with active liver disease, pregnancy, or missing demographic data were excluded. A total of 13,726 patients were included, 7476 in the preguideline cohort and 6250 in the postguideline cohort. A total of 13.9% of patients in the preguideline cohort had a lipid panel completed within 3 months of statin initiation compared with 16.2% in the postguideline cohort (adjusted P <.001). In the postguideline cohort, 56% (n = 857) of patients with lipid monitoring warranted a therapeutic intensification as recommended by the 2018 guideline; however, only 5% had their lipid-lowering regimen changed. In a large integrated health system, lipid monitoring increased among patients newly started on statin therapy soon after release of the 2018 guideline but remains low. Clinical interventions are needed to improve lipid monitoring to optimize low-density lipoprotein cholesterol–lowering therapy and ensure that guideline-recommended goals are achieved. • Poststatin initiation lipid monitoring increased after the 2018 guideline. • One in 6 patients received monitoring in accordance with guideline recommendations. • A total of 56% of patients with lipid monitoring warranted therapy intensification. • One in 20 patients had a change in therapy when clinically warranted. [ABSTRACT FROM AUTHOR]

Purpose To describe our medical center's pharmacy services preparedness process and offer guidance to assist other institutions in preparing for surges of critically ill patients such as those experienced during the coronavirus disease 2019 (COVID-19) pandemic. Summary The leadership of a department of pharmacy at an urban medical center in the US epicenter of the COVID-19 pandemic proactively created a pharmacy action plan in anticipation of a surge in admissions of critically ill patients with COVID-19. It was essential to create guidance documents outlining workflow, provide comprehensive staff education, and repurpose non–intensive care unit (ICU)-trained clinical pharmacotherapy specialists to work in ICUs. Teamwork was crucial to ensure staff safety, develop complete scheduling, maintain adequate drug inventory and sterile compounding, optimize the electronic health record and automated dispensing cabinets to help ensure appropriate prescribing and effective management of medication supplies, and streamline the pharmacy workflow to ensure that all patients received pharmacotherapeutic regimens in a timely fashion. Conclusion Each hospital should view the COVID-19 crisis as an opportunity to internally review and enhance workflow processes, initiatives that can continue even after the resolution of the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society.Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.Results: After weighing the quality of evidence and balancing the desirable and undesirable effects, the guideline panel made the following recommendations: 1) a strong recommendation for the use of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy over LABA or LAMA monotherapy in patients with COPD and dyspnea or exercise intolerance; 2) a conditional recommendation for the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in patients with COPD and dyspnea or exercise intolerance who have experienced one or more exacerbations in the past year; 3) a conditional recommendation for ICS withdrawal for patients with COPD receiving triple therapy (ICS/LABA/LAMA) if the patient has had no exacerbations in the past year; 4) no recommendation for or against ICS as an additive therapy to long-acting bronchodilators in patients with COPD and blood eosinophilia, except for those patients with a history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization, for whom ICS is conditionally recommended as an additive therapy; 5) a conditional recommendation against the use of maintenance oral corticosteroids in patients with COPD and a history of severe and frequent exacerbations; and 6) a conditional recommendation for opioid-based therapy in patients with COPD who experience advanced refractory dyspnea despite otherwise optimal therapy.Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma. [ABSTRACT FROM AUTHOR]

Aneurysmal subarachnoid hemorrhage (aSAH) is responsible for 5% to 10% of all strokes in the United States annually and is a neurologic emergency with considerable morbidity and mortality. A common complication of aSAH is cerebral vasospasm (CVS) or narrowing of the cerebral arteries. While nearly 70% of aSAH patients will develop CVS, approximately 30% of those patients will go on to develop delayed cerebral ischemia, defined as symptomatic vasospasm or cerebral infarction demonstrated on imaging. While the pathophysiology of CVS is unclear, the prevention and treatment of this complication are a focus of ongoing research. Despite continued efforts, only one medication, nimodipine, is Food and Drug Administration approved for the improvement of neurologic outcomes by reducing the incidence and severity of ischemic deficits in patients with CVS during aSAH. This review provides nurse practitioners and the bedside nursing staff with a summary of the available literature on the pharmacologic management of CVS. It focuses on oral, intravenous, intra-arterial, and intraventricular medications available in the United States that may be utilized in the management of CVS. [ABSTRACT FROM AUTHOR]

Background: Nicotine replacement therapy (NRT) has been demonstrated to be an effective pharmacological treatment for smoking cessation, and most types of NRT have been approved as over-the-counter (OTC) medications. In an effort to create a fast-acting, flexible, and discreet NRT, a nicotine mouth spray (NMS) has been developed. This study was designed to assess the efficacy and safety of NMS in a naturalistic setting in the United States.Methods: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 26-week study in 1198 smokers motivated to quit. The study was designed to resemble an OTC environment, and thus included limited intervention, limited motivational screening, and no behavioral support. The primary efficacy endpoint was carbon monoxide-verified, self-reported continuous abstinence from smoking from week 2 until week 6. The safety of NMS was assessed by measuring vital signs, visual mouth inspection, and collection of subject-reported adverse events (AEs).Results: The percentage of subjects with carbon monoxide-verified continuous abstinence from week 2 to week 6 was statistically significantly greater in the NMS group compared with the placebo group (5.0% vs. 2.5%, p = .021). Statistically significant treatment effects for the NMS were maintained throughout the 26-week period. The study medications were generally well tolerated. The severity of AEs was similar for both treatment groups, and most AEs were of mild or moderate severity.Conclusions: These study results demonstrate that the NMS is an effective and safe smoking cessation option for smokers motivated to quit, even in a naturalistic setting and without behavioral support.Implications: This study demonstrated the safety, efficacy, and acceptability of an NMS in an OTC environment with no behavioral counseling or support. It provides an additional option for smokers motivated to quit.Trial Registration: ClinicalTrials.gov (number NCT02355665). [ABSTRACT FROM AUTHOR]

Pericarditis is the most common form of pericardial disease and may be associated with significant morbidity and mortality. Management of idiopathic pericarditis includes pharmacologic therapies, non-pharmacologic therapies, and surgery. This article describes the diagnosis and management of idiopathic causes of pericarditis, incorporating recommendations included in the European Society of Cardiology guidelines. [ABSTRACT FROM AUTHOR]

For decades, pharmacotherapy has been hampered by significant patient variability, and the inability to predict outcomes at the individual patient level has negatively affected its value. However, progress in molecular medicine has led to an increased understanding of the pathophysiology and mechanisms of action of drugs, thereby enabling the development of predictive biomarkers. Companion diagnostics (CDx) belongs to the group of predictive biomarkers, which the Food and Drug Administration (FDA) defines as an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. In September 1998, 25 years ago, the FDA approved the first CDx assay, the HercepTest, an immunohistochemical (IHC) assay for the detection of HER2 protein expression. This assay is linked to the use of the monoclonal antibody trastuzumab in the treatment of HER2 positive breast cancer. The HercepTest is not the only CDx developed. Currently, more than 60 drugs or drug combinations, primarily in hematology and oncology, have been approved by the FDA, with CDx assays linked to their use. The current article briefly discusses the subject of CDx and provides an overview of its evolution over the past 25 years, with particular emphasis on the United States.

Background: Substance use disorders (SUDs) are common in healthcare settings and contribute to poor outcomes, particularly in patients living with HIV. We assessed initiation, engagement, and retention in SUD treatment and pharmacotherapy following an index SUD episode in a national sample of HIV-infected and uninfected patients receiving care in the Department of Veterans Affairs (VA) healthcare system.Methods: We used electronic national VA data (years 2000-2015) from 52,995 HIV-infected and 111,229 age-, race-, gender-, and region-matched uninfected patients. We defined index SUD episodes as outpatient visits or inpatient/residential admissions with associated primary or secondary ICD-9 codes for substance use in patients without SUD-related services or pharmacotherapy in the preceding 5 months.Results: Overall, 57,428 (35%) patients had at least 1 index SUD episode. HIV-infected patients were more likely than uninfected controls to have at least one index SUD episode (35.7% vs. 34.6%; p < .001). Rates of initiation, engagement, and retention in SUD treatment after the index SUD episode were <17% for both groups. In adjusted models, HIV-infected patients were more likely than uninfected patients to be retained in SUD treatment at 6 months (Odds Ratio 1.10; 95% Confidence Interval 1.04-1.16). SUD pharmacotherapy initiation and engagement was uncommon in both HIV-infected and uninfected patients.Conclusions: In this national VA sample, initiation of SUD treatment and pharmacotherapy were uncommon for both HIV-infected and uninfected patients. Interventions to improve initiation, engagement, and retention in the full range of services, including SUD pharmacotherapy, are warranted for all patients with SUD in the VA. [ABSTRACT FROM AUTHOR]

Background: The number of diabetes patients is steadily increasing worldwide. Consequently, the social burden of diabetes is huge, requiring urgent countermeasures. We performed an intensive survey of antidiabetic drugs approved in Japan, the United States, and the European Union. Methods: Information about approved antidiabetic drugs was obtained by searching databases of regulatory authorities in the 3 regions. Other relevant information was also obtained from publicly available literature and documents. Results: No difference in the total number and types of approved drugs among the 3 regions was found (P =.173 by log-rank test). However, the numbers of approved dipeptidyl peptidase-4 and sodium-glucose cotransporter 2 inhibitors in Japan were almost double of those in the other regions. The average sample size in clinical trials used for antidiabetic drug approval in Japan (1134 patients) was much smaller than that in the other regions (P <.001 by analysis of variance repeated measures test adjusted by the Holm method). Currently, 6 drugs with known modes of action are being developed for type 1 diabetes in Japan, whereas at the end of 2016, nearly 7-fold more products with novel modes of action were in clinical development in the United States. Conclusion: Antidiabetic drug development in Japan costs less than that in the other regions, although novel development is less active because of regulatory differences. To achieve better pharmacotherapy for diabetes, the regulatory framework requires careful consideration. [ABSTRACT FROM AUTHOR]

Background: The ongoing drug crisis in the United States continues to be headlined with numbers of deaths related to opioid overdose. Less known to the public and health care providers is the rise in methamphetamine use, often in conjunction with opioids or adulterated with fentanyl. An old practice with a new twist is the use of methamphetamine in conjunction with an opioid such as heroin. Purpose: Although there are no Food and Drug Administration-approved medications to treat individuals with stimulant use disorders, a review of available studies suggests a few promising medications that may be helpful for patients in early recovery from methamphetamine. Outcome: Some individuals are more likely to respond to medications such as long-acting naltrexone, bupropion, and mirtazapine, who have light-to-moderate use of methamphetamine. Naloxone kits should be considered for all patients who are actively using stimulants because of a high potential of adulterated methamphetamine. [ABSTRACT FROM AUTHOR]

Background Emergency medicine (EM) pharmacists are increasingly recognized as integral team members in the care of emergency department (ED) patients but there is variability in the scope of direct patient care services. Objectives The primary objective was to categorize direct patient care activities and drug therapy recommendations. The secondary objectives were to categorize recommendations based on drug class and to determine the proportion of recommendations associated with Institute for Safe Medication Practices (ISMP) high-alert medications. Methods This retrospective, single-center, chart review was conducted in an academic ED with 65,000 annual visits. EM pharmacists documented direct patient care activities in the electronic health record. Documented activities from 1/1/2015 through 3/31/2015 were abstracted electronically for analysis by a trained reviewer. Results There were 3567 interventions and direct patient care activities documented. The most common activities were facilitation of medication histories (n = 1300) and drug therapy recommendations (n = 1165). Of 1165 drug therapy recommendations, 986 were linked to a drug class such as antimicrobial agents (31.9%), cardiovascular agents (16.6%), and analgesic agents (13.2%) and 20% of these interventions were associated with ISMP high-alert medications. Conclusion EM pharmacists documented several types of direct patient care activities with the majority being drug therapy recommendations and medication histories. [ABSTRACT FROM AUTHOR]

Objectives: To analyse actual long‐term medical treatment of benign prostatic hyperplasia (BPH) and compare the incurred cost with that of patients with BPH who underwent early surgery. Patients and methods: Patients who were first diagnosed with BPH from 1 January 2008 to 31 December 2010 were identified using the Clinical Data Warehouse. Hospital billing data generated by the electronic hospital management system were collected until December 2015. For outpatient care, only procedures, materials and drugs directly related to the management of BPH were selected for the analysis. For inpatient care, all procedures, materials and drugs ordered on dates with continuity with BPH surgery date were included. The primary endpoint of the study was the total treatment‐related direct costs of patients undergoing a long‐term curative medical therapy for BPH (Group 1), which was arbitrarily defined as any medical therapy including a 5α‐reductase inhibitor with a minimum medication possession ratio of 0.5 during ≥5 consecutive years, or ≥1 year until BPH surgery due to medical therapy failure. In all, 70 patients who underwent BPH surgery at <1 year of initial visit served as controls (Group 2). Results: Amongst 137 patients in the Group 1, four patients underwent BPH surgery at a median of 57.8 months after the initial visit (2.9%). At a median follow‐up of 76 months, the mean total treatment cost was significantly higher in Group 1 than in Group 2 ($3987 vs $3036 [USA dollars], P < 0.001). Similarly, the mean 'out‐of‐pocket' cost was significantly higher in Group 1 than in Group 2 ($1742 vs $1436, P = 0.005). When a linear increment of annual BPH treatment cost is assumed for Group 1 and all costs are assumed to be produced within the first year for Group 2, the total and out‐of‐pocket costs became equal at the end of the fifth year of medical treatment. For both total and out‐of‐pocket costs, medication‐related costs occupied the largest proportion, exceeding half of the costs. Conclusions: We suggest patient counselling at the beginning of BPH treatment should include the likelihood that the cumulative out‐of‐pocket cost at 5 years of continuous medication will exceed that of early surgery. Our cost study using hospital billing data extractable from the electronic hospital management system may be a good model for cost studies that could provide valuable information to health providers and payers. [ABSTRACT FROM AUTHOR]

Objective: Describe implementation and clinical impact of a "real world" School-Based Asthma Therapy (SBAT) Program serving an urban, largely Medicaid population in a large midwestern city in the United States. Methods: A retrospective, descriptive evaluation of SBAT was conducted. Students were referred by school nurses or providers, enrolled throughout the year, and could reenroll in subsequent years. A total of 286 students participated in the 2015-2016 school year. Kruskal-Wallis nonparametric testing compared Asthma Control Test™ (ACT) scores from enrollment (anytime between 2013 and 2015) to 2015-2016 for 198 students; and pre- and postenrollment asthma-related emergency department (ED), inpatient, and critical care (pediatric intensive care unit or PICU) utilization rates (events/student/year) for 98 students enrolled for a full year. Results: SBAT participation grew from 17 to 131 schools and from 38 to 268 students between 2013-2014 and 2015-2016. Mean ACT scores increased from 16.2 (SD = 4.89) to 21.37 (SD = 3.41) (K-W χ2 = 35.45, p = 0.008). Healthcare utilization rates from 1-year preenrollment to 1-year postenrollment decreased for ED (0.91-0.44; K-W χ2 = 18.61, p = 0.0002) and Inpatient (0.38-0.10; K-W χ2 = 7.68, p = 0.02). Reduction in PICU (0.27-0.02) was not statistically significant. Conclusions: SBAT, modeled after programs shown in controlled trials to improve asthma health markers (1-3), was successfully implemented in economically challenged, urban schools. Rapid growth and patient reenrollment reflect program acceptance by schools, providers, and caregivers. Improved ACT scores and healthcare utilization supported program efficacy. SBAT could be one solution to improved asthma control in underserved school-aged pediatric patients. [ABSTRACT FROM AUTHOR]

Objective: Pharmacotherapy is the most common strategies to reduce pain for osteoarthritis (OA) patients. To analyze the trend and pattern of prescription analgesic medication use in American OA patients. Besides, our study also tried to figure out the demographic characteristics of opioid use among OA population which may helpful for managing the use of opioids., Methods: We included 2214 OA patients from 2007 to 2018. We extracted data from National Health and Nutrition Examination Survey (NHANES) database. We compared analgesics and anti-depression medications use by category between survey participants with OA and without., Results: For OA patients, NSAIDs, acetaminophen and gabapentinoid were the mostly highly used analgesics (10.2%, 9.0% and 8.9%, respectively). However, we also found that opioids use was very common in OA patients (7.7%) and the duration of opioids use was significantly long. In addition, the opioids use did not decrease from 2007 to 2018, while gabapentinoid increased rapidly from recent decade (From 5.0% to 12.1%). The common analgesic combination used by OA population was opioids with acetaminophen and gabapentinoid with selective serotonin reuptake inhibitors (SSRIs) (2.9% and 2.7%, respectively)., Conclusion: The use of gabapentinoid increased rapidly from recent decade, while opioids use did not decrease. The long-term excessive use of opioids was also a serious problem for OA pain control. More improvements such as focusing more on healthcare education and paying more attention on non-pharmacotherapy and the psychological situation of patients are needed.

Objective: To describe differences in geographic, demographic, treatment, and substance use characteristics by pharmacotherapy receipt among pregnant women entering publically funded treatment for opioid use disorder (OUD) in the United States.Methods: 1996 to 2014 Treatment Episode Data Set-Admissions data from pregnant admissions with OUD, defined as reporting opioids as the primary substance of use leading to the treatment episode, were analyzed for this cross-sectional study. The proportion of all pregnant admissions with OUD who received pharmacotherapy was calculated by year and U.S. census region. Trends across time were assessed using the Cochrane-Armitage Trend test. Associations between demographic, substance use, and treatment characteristics and pharmacotherapy receipt were assessed using Chi-square tests and multivariable logistic regression.Results: The proportion of pregnant admissions where opioids were the primary substance of use increased from 16.9% to 41.6% during the study period, while the proportion of pregnant admissions with OUD who received pharmacotherapy remained relatively unchanged at around 50%. Overall, pharmacotherapy recipients were generally older and white, more likely to receive treatment in an outpatient setting, be self-referred, and report heroin as the primary substance, daily substance use, and intravenous drug use, and less likely to have a co-occurring psychiatric problem compared to those who did not receive pharmacotherapy. Regional differences in pharmacotherapy utilization exist; the South consistently had the fewest pregnant admissions with OUD receiving pharmacotherapy.Conclusion: Although the proportion of pregnant admissions to substance use treatment centers with OUD has increased since the mid-1990s, the proportion receiving pharmacotherapy has not changed. Significant variations in pharmacotherapy utilization exist by geography and demographic, substance use and treatment characteristics. Utilization of pharmacotherapy at publically funded treatment centers providing care for pregnant women with OUD should be expanded. [ABSTRACT FROM AUTHOR]

Background and purpose To review the currently available pharmacotherapies for obesity management with a particular focus on the United States. Methods Narrative review based on literature searches and the latest prescribing information (up to July 2017). Conclusions Obesity pharmacotherapies may assist those individuals who have obesity, or overweight with comorbidities, who have failed to maintain weight loss with lifestyle modifications alone (caloric restriction and increased physical activity). Currently approved options in the United States include phentermine for short-term use and five obesity pharmacotherapies that can be used long-term (orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion, and liraglutide 3.0 mg). If the use of an obesity pharmacotherapy is indicated, treatment should be selected to provide the most appropriate option for each individual and their circumstances. Variables such as contraindications, individual comorbidities, patient choice, patient readiness to incorporate additional behavioral changes (e.g., alcohol prohibition), and cost should guide choices. Implications for Practice Each of the obesity pharmacotherapies has advantages and disadvantages that can help guide treatment choice. Those receiving treatment may also have individual preferences based on factors such as administration route, frequency of dosing, and/or safety profile. In addition, some options may be particularly appropriate for patients with common obesity-related complications such as depression or diabetes. [ABSTRACT FROM AUTHOR]

Background and purpose More than one third of American adults are obese. Extreme obesity is rapidly rising. Nine medications are approved for weight loss yet they remain underutilized with the focus primarily on lifestyle modifications. The objective was to determine current prescribing patterns and attitudes of weight loss medications in the management of obesity among primary care providers (PCPs). Methods PCPs were surveyed to determine practice patterns, attitudes, barriers, and facilitators for prescribing weight loss medications. Conclusions Ninety-four surveys were analyzed. Seventy-six percent of all PCPs did not prescribe weight loss medications for long-term weight loss and 58% of PCPs had negative perceptions of pharmacotherapy. Differences existed between prescribing patterns and attitudes of advanced practice clinicians and physicians. Safety concerns were the greatest barrier. Having 2+ comorbidities and severe obesity were facilitators for prescribing weight loss medications. Underutilization of pharmacotherapy suggests that PCPs may not have sufficient knowledge about medication safety profiles and efficacy. Delaying treatment until patients have reached a high level of morbidity may be less efficacious than earlier treatment. Implications for practice Education regarding effectiveness and risks of weight loss medications for obesity management is needed and earlier interventions with pharmacotherapy may prevent significant morbidity and mortality. [ABSTRACT FROM AUTHOR]

Objective: Pharmacologic treatment is recommended for alcohol use disorders (AUD), but most patients do not receive it. Although racial/ethnic minorities have greater AUD consequences than whites, whether AUD medication receipt varies across race/ethnicity is unknown. We evaluate this in a national sample.Methods: Electronic health records data were extracted for all black, Hispanic, and/or white patients who received care at the U.S. Veterans Health Administration (VA) during Fiscal Year 2012 and had a documented AUD diagnosis. Mixed effects regression models, with a random effect for facility, determined the likelihood of receiving AUD pharmacotherapy (acamprosate, disulfiram, topirimate or oral or injectable naltrexone ≤180days after AUD diagnosis) for black and Hispanic patients relative to white patients. Models were unadjusted and then adjusted for patient- and facility-level factors.Results: 297,506 patients had AUD; 26.4% were black patients, 7.1% were Hispanic patients and 66.5% were white patients; 5.1% received AUD medications. Before adjustment, black patients were less likely than white [Odds Ratio (OR) 0.77; 95% Confidence Interval (CI) 0.75 -0.82; (p<0.001)], while Hispanic patients were more likely than white (OR 1.09; 95% CI 1.01-1.16) to receive AUD medications. After adjustment, black patients remained less likely than white to receive AUD medications (OR 0.68; 95% CI 0.65-0.71; p<0.0001); no difference between Hispanic and white patients was observed (OR 0.94; 95% CI 0.87-1.00; p=0.07).Conclusions: In this national study of patients with AUD, blacks were less likely to receive AUD medications than whites. Future research is needed to identify why these disparities exist. [ABSTRACT FROM AUTHOR]

Heart failure is a chronic, progressive illness that is increasing in prevalence in the USA. Patients with advanced heart failure experience a high symptom burden that is comparable to patients with advanced cancer. Palliative care, however, is underutilized in patients with heart failure, and symptoms may go untreated as the disease progresses. A combination of pharmacologic and non-pharmacologic interventions should be used to address symptoms and maintain quality of life. While there have been significant advances in evidence-based heart failure treatments in recent years, selection of appropriate palliative medications as symptoms progress is challenging due to limited clinical studies in this patient population. Medications that are commonly used for symptom management in other life-limiting illnesses may have little to no evidence in heart failure, or have undesirable cardiac effects that preclude use. Clinicians must extrapolate available clinical evidence and prescribing considerations relevant to heart failure to palliate symptoms as well as possible. The objectives of this paper are to review the most common and distressing symptoms in heart failure, analyze evidence, or lack thereof, for pharmacologic management of symptoms, and provide prescribing considerations based on side effect profiles and comorbid conditions. [ABSTRACT FROM AUTHOR]

Objective: Given the high prevalence of smoking among substance use disorder (SUD) patients, the specialty SUD treatment system is an important target for adoption and implementation of tobacco cessation (TC) services. While research has addressed the impact of tobacco control on individual tobacco consumption, largely overlooked in the literature is the potential impact of state tobacco control policies on availability of services for tobacco cessation. This paper examines the association between state tobacco control policy and availability of TC services in SUD treatment programs in the United States.Methods: State tobacco control and state demographic data (n=51) were merged with treatment program data from the 2012 National Survey of Substance Abuse Treatment Services (n=10.413) to examine availability of TC screening, counseling and pharmacotherapy services in SUD treatment programs using multivariate logistic regression models clustered at the state-level.Results: Approximately 60% of SUD treatment programs offered TC screening services, 41% offered TC counseling services and 26% offered TC pharmacotherapy services. Results of multivariate logistic regression showed the odds of offering TC services were greater for SUD treatment programs located in states with higher cigarette excise taxes and greater spending on tobacco prevention and control.Conclusions: Findings indicate cigarette excise taxes and recommended funding levels may be effective policy tools for increasing access to TC services in SUD treatment programs. Coupled with changes to insurance coverage for TC under the Affordable Care Act, state tobacco control policy tools may further reduce tobacco use in the United States. [ABSTRACT FROM AUTHOR]

Pharmacotherapies for tobacco cessation are efficacious and recommended during quit attempts. Racial/ethnic minorities in the United States are less likely to use medication-based aids for tobacco cessation, despite greater difficulty achieving long-term abstinence. The reasons for this include, among others, provider- and patient-level considerations. Primary care clinicians play an important role in encouraging racial/ethnic minority tobacco users to use cessation pharmacotherapy. To better understand pharmacotherapy use, we conducted a narrative review of patient-level factors that may determine uptake and adherence. This review indicates that social and cultural factors impact pharmacotherapy use, including health care experiences, beliefs, perceptions, and norms. The proportion of individuals using pharmacotherapy during quit attempts and adhering to the full course of treatment may be enhanced with greater attention to the ethnocultural concerns of these groups. Culturally appropriate assessment and brief advice delivered by primary care providers could yield significant benefits in population health. Recommendations for treating racial/ethnic tobacco users with pharmacotherapy for cessation are offered. [ABSTRACT FROM AUTHOR]

Among US military veterans, alcohol use disorder (AUD) is prevalent and in severe cases patients need intensive AUD treatment beyond outpatient care. The Department of Veterans Affairs (VA) delivers intensive, highly structured addiction and psychosocial treatment through residential programs. Despite the evidence supporting pharmacotherapy among the effective treatments for AUD, receipt of these medications (e.g., naltrexone, acamprosate) among patients in residential treatment programs varies widely. In order to better understand this variation, the current study examined barriers and facilitators to use of pharmacotherapy for AUD among patients in VA residential treatment programs. Semi-structured qualitative interviews with residential program management and staff were conducted and the Consolidated Framework for Implementation Research was used to guide coding and analysis of interview transcripts. Barriers to use of pharmacotherapy for AUD included cultural norms or philosophy against prescribing, lack of access to willing prescribers, lack of interest from leadership, and perceived lack of patient interest or need. Facilitators included cultural norms of openness or active promotion of pharmacotherapy; education for patients, program staff and prescribers; having prescribers on staff, and care coordination within residential treatment and with other clinic settings in and outside VA. Developing and testing improvement strategies to increase care coordination and consistent support from leadership may also yield increases in the use of pharmacotherapy for AUD among residential patients. [ABSTRACT FROM AUTHOR]