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Drug‐resistant tuberculosis (TB) is a major public health concern and contributes to high morbidity and mortality. New evidence supports the use of shorter duration, all‐oral regimens, which represent an encouraging treatment strategy for drug‐resistant TB. As a result, the landscape of drug‐resistant TB pharmacotherapy has drastically evolved regarding treatment principles and preferred agents. This narrative review focuses on the key updates of drug‐resistant TB treatment, including the use of short‐duration all‐oral regimens, while calling attention to current gaps in knowledge that may be addressed in future observational studies. [ABSTRACT FROM AUTHOR]

Maternal and pediatric populations have historically been considered "therapeutic orphans" due to their limited inclusion in clinical trials. Physiologic changes during pregnancy and lactation and growth and maturation of children alter pharmacokinetics (PK) and pharmacodynamics (PD) of drugs. Precision therapy in these populations requires knowledge of these effects. Efforts to enhance maternal and pediatric participation in clinical studies have increased over the past few decades. However, studies supporting precision therapeutics in these populations are often small and, in isolation, may have limited impact. Integration of data from various studies, for example through physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) modeling or bioinformatics approaches, can augment the value of data from these studies, and help identify gaps in understanding. To catalyze research in maternal and pediatric precision therapeutics, the Obstetric and Pediatric Pharmacology and Therapeutics Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub. Herein, we provide an overview of the status of maternal–pediatric therapeutics research and introduce the Indiana University‐Ohio State University MPRINT Hub Data, Model, Knowledge and Research Coordination Center (DMKRCC), which aims to facilitate research in maternal and pediatric precision therapeutics through the integration and assessment of existing knowledge, supporting pharmacometrics and clinical trials design, development of new real‐world evidence resources, educational initiatives, and building collaborations among public and private partners, including other NICHD‐funded networks. By fostering use of existing data and resources, the DMKRCC will identify critical gaps in knowledge and support efforts to overcome these gaps to enhance maternal–pediatric precision therapeutics. [ABSTRACT FROM AUTHOR]

The HIV epidemic continues to pose a significant burden on the healthcare system. Although the incidence of annual new infections is decreasing, health disparities persist and most new infections remain concentrated into different racial, ethnic, and minority groups. Pre‐exposure prophylaxis (PrEP), which involves those at high risk of acquiring HIV to take chronic medications to prevent acquisition of the virus, is key to preventing new HIV infections. The purpose of this article is to review medication therapies for PrEP and examine their role in personalizing PrEP in different patient populations. Additionally, new medications currently under development for PrEP are reviewed, as well as treatment as prevention (TasP) and post‐exposure prophylaxis (PEP). There are currently four medications available for PrEP: the oral options of co‐formulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF); injectable long‐acting cabotegravir (CAB‐LA); and the vaginal ring dapivirine (DPV‐VR). FTC/TAF is not currently indicated for persons at risk for HIV through vaginal sex due to lack of studies, but trials are currently ongoing. DPV‐VR is available in Zimbabwe and South Africa and has been endorsed by the World Health Organization but is not currently available in the United States. Several agents are also in development for use in PrEP: the novel long‐acting injectable lenacapavir, a first‐in‐class capsid inhibitor, which has no cross‐resistance to any existing HIV drug class; the subdermal implant islatravir, a first‐in‐class translocation inhibitor; and VRC01, a broadly neutralizing antibody (bnAb) which has been evaluated in proof‐of‐concept studies that may lead to the development of more potent bnAbs. Overall, PrEP is highly effective at preventing HIV infection in high‐risk populations. Identifying optimal PrEP regimens in different patient populations is complex and must consider patient‐specific factors and medication cost and access considerations. Lastly, providers should consider individual patient preferences with regard to prevention to improve access, retention in care, and adherence. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVADs) have revolutionized the care of patients with advanced heart failure, yet still require concomitant medications in order to achieve the best possible clinical outcomes. Since the outset of routine placement of durable, continuous‐flow LVADs, much of the medication management of these patients to date has been based on International Society of Heart and Lung Transplantation (ISHLT) guidance, most recently published in 2013. Since 2013, numerous multidisciplinary pharmacotherapy publications have increased the LVAD community's understanding of best practices with respect to medications. We identified the major domains of LVAD medication management and conducted a comprehensive search of US National Library of Medicine MEDLINE® database using keywords chosen to identify medication‐related publications of significance dated 2013 or later. Trials pertaining to the HeartMate II™ and the HeartMate™ 3 LVADs (Abbott, Chicago, IL) and the HeartWare™ HVAD™ System (Medtronic, Minneapolis, MN) were chosen for inclusion. Highest priority for inclusion was given to prospective, randomized, controlled studies. Absent these, controlled trials (retrospective or prospective observational) were given next‐highest consideration, followed by retrospective uncontrolled studies, and finally case series. Reference lists of qualified publications were reviewed to find any other publications of interest that were not discovered on initial search. Case reports were generally excluded, except where the insight gained was deemed to be uniquely pertinent. This document serves to provide a comprehensive review of the current understanding of optimal medication management in patients with durable, continuous‐flow LVADs. [ABSTRACT FROM AUTHOR]

Background: People with Alzheimer's disease (AD) often have multimorbidity and take multiple medicines. Yet few studies have examined medicine utilization for comorbidities comparing people with and without AD. Objective: The aim was to investigate the patterns of medication use for comorbidities in people with and without AD. Methods: An Australian population‐based study was conducted using the Pharmaceutical Benefits Scheme 10% sample of pharmacy claims data. People with AD were defined as those dispensed medicines for dementia (cholinesterase inhibitors, memantine, or risperidone for behavioral and psychological symptoms of dementia) between January 1, 2005, and December 31, 2015, who were aged 65 years or older and alive at the end of 2016. An age‐ and gender‐matched comparison cohort (5:1) of people without AD were identified. Medication use for comorbidities was identified using the validated comorbidity index, Rx‐Risk‐V. A χ2 test was used to compare differences in the pattern of medicine use between the two groups. Results: A total of 8280 people with AD and 41,400 comparisons without AD were included; 63.4% were female and the median age was 82 years. The median number of comorbidities was greater in people with AD {median [interquartile range (IQR)]: 5 [3–7]} than the comparison group (median [IQR]: 4 [3–6], p<0.0001). Medications for depression, pain (treated with opioid analgesics), anxiety, diabetes, hyperthyroidism, epilepsy, Parkinson's disease, and antipsychotics were used significantly more commonly in people with AD than in those without dementia. Medications for cardiac conditions, pain (treated with anti‐inflammatory medications), chronic airways disease, gout, glaucoma, renal disease, benign prostatic hyperplasia, cancer, and steroid‐responsive conditions were used significantly less commonly among people with AD than the comparison group. Conclusions: This study highlighted significant variations in medication use for comorbidities between people with and without AD. Future studies should evaluate the reasons for the disparity in medicine utilization for comorbidities in people with AD. [ABSTRACT FROM AUTHOR]

Neurodevelopmental disorders (NDDs), a group of disorders affecting ~1–2% of the general population, are caused by changes in brain development that result in behavioral and cognitive alterations, sensory and motor changes, and speech and language deficits. Neurodevelopmental disorders encompass a heterogeneous group of disorders including, but not limited to, Smith‐Magenis syndrome, Lesch‐Nyhan disease, cri du chat syndrome, Prader‐Willi syndrome, pervasive developmental disorders, fragile X syndrome, Rett syndrome, Cornelia de Lange syndrome, and Down syndrome. Self‐injurious behaviors (SIBs) are common in children with NDDs; depending on the specific NDD, the incidence of SIBs is nearly 100%. The management of SIBs in this population is complex, and little high‐quality data exist to guide a consistent approach to therapy. However, managing SIBs is of the utmost importance for the child as well as the family and caregivers. Behavior therapies must be implemented as first‐line therapy. If behavioral interventions alone fail, pharmacotherapy becomes an essential part of management plans. The limited available evidence for the use of common pharmacologic agents, such as second‐generation antipsychotics, and less common agents, such as clonidine, n‐acetylcysteine, riluzole, naltrexone, and topical anesthetics, is reviewed. Additional data from well‐designed studies in children with NDDs are needed to gain a better understanding of this common and troublesome problem including efficacy and safety implications associated with pharmacotherapy. Until then, clinicians must rely on the limited available data, clinical expertise, and ongoing systematic monitoring when managing SIBs in children with NDDs. [ABSTRACT FROM AUTHOR]

The objective of this trial, Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART), was to provide support and guidance for an evidence‐based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety. This randomized double‐blind parallel‐group study was conducted in three academic medical centers and a single private pediatric practice. Eighty children or adolescents (aged 6–17 yrs) with autistic disorder were enrolled, and 61 patients were randomized to the study drug. Of those patients, 51 completed the 10‐week trial, and 31 completed an optional 12‐week blinded extension phase. All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug dosing followed U.S. Food and Drug Administration (FDA) labeling, and weekly dosage adjustments were allowed until week 4; patients were then maintained on a fixed dose for 6 additional weeks. Safety, physical, and psychological assessments were recorded weekly or every 2 weeks. No significant differences in severity of illness between the aripiprazole and risperidone groups were noted at baseline. All patients significantly improved on the Aberrant Behavior Checklist‐Irritability subscale after 1 week and continued for the remaining 9 weeks and the extension phase. Improvement was greatest in the risperidone group at every assessment period and was statistically significantly better than that in the aripiprazole group at weeks 3 and 6 (p<0.05). No dose‐limiting adverse events occurred during the dose‐titration period. Mean weight gain in the aripiprazole group was significantly less than that in the risperidone group at week 4 (0.62 vs 1.38 kg, p=0.033) and week 10 (1.61 vs 3.31 kg, p<0.001), but the difference became nonsignificant for the 31 patients completing the 3‐month extension phase (4.36 vs 5.55 kg, p=0.26). Pharmacotherapy of patients with autism spectrum disorder resulted in behavioral improvement within 1 week and lasted at least 22 weeks. Weight gain occurred to a greater degree with risperidone than aripiprazole initially, but the differences became nonsignificant by the end of the trial. Our trial supports previous results of drug efficacy and safety in patients with autism spectrum disorder from other trials and extends the evidence‐based support for choosing an FDA‐approved drug for initial pharmacotherapy for autism spectrum disorder. [ABSTRACT FROM AUTHOR]

Objective: Ketamine is an N‐methyl‐D‐aspartate antagonist with emerging evidence assessing its use as a continuous infusion agent to provide concomitant analgesia and sedation. The role of ketamine as adjunctive therapy in mechanically ventilated patients is unclear. This study sought to investigate the impact of adjunctive continuous infusion ketamine on concomitant analgesic and sedative dosing while providing goal comfort in mechanically ventilated patients. Methods: This retrospective two‐center intrapatient comparison study included mechanically ventilated adult ICU patients who received continuous infusion ketamine with at least one other analgesic or sedative infusion. The primary outcome assessed percent relative change in concomitant analgesic‐sedative doses 24 hours after ketamine initiation. Secondary outcomes included percent of Richmond Agitation and Sedation Score (RASS) assessments at goal, adverse effects, and delirium incidence. Exploratory evaluation of independent factors associated with ketamine responders (50% or more relative reduction in analgesic‐sedative dosing requirements at 24 hrs) and nonresponders (less than 50% relative reduction) was performed using multivariate logistic regression. Results: Overall, 104 patients were included. A total of 160 concomitant analgesic‐sedative infusions were used in combination with ketamine, most commonly fentanyl (98 [61.3%]) and propofol (46 [28.8%]). A 20% (interquartile range [IQR] −63.6 to 0.0, p<0.001) relative reduction in total analgesic‐sedative infusion pharmacotherapy was achieved at 24 hours after ketamine initiation. Analgesic and sedative infusion doses decreased at 24 hours (fentanyl: pre, 175 μg/hr [IQR 100–200 μg/hr] vs post, 125 μg/hr [IQR 50–200 μg/hr], p<0.001; propofol: pre, 42.5 μg/kg/min [IQR 20.0–60.0 μg/kg/min] vs post, 20.0 μg/kg/min [IQR 3.8–31.3 μg/kg/min], p<0.001). Median percent time within goal RASS improved after ketamine initiation (pre, 7.1% [0–40%] vs post, 25% [0–66.7%], p=0.005). No differences were observed in secondary outcomes between responders and nonresponders, except a longer non‐ICU hospital length of stay in responders. Independent factors associated with ketamine response included a lower body mass index, higher starting dose of ketamine, lower severity of illness, and need for multiple concomitant analgesic‐sedative infusions before initiation of ketamine. Conclusions: Adjunctive continuous infusion ketamine promotes analgesic and sedative dose‐sparing effects in mechanically ventilated patients while improving time spent within goal sedation range. Further prospective research is warranted. [ABSTRACT FROM AUTHOR]

Tobacco use disorder is a chronic illness. With its high comorbidity rate, it is a major cause of years of life lost or years lived with disability; however, it is also considered the most preventable cause of death in developed countries. Since the development of nicotine replacement therapy (NRT) in 1978, treatment options have continued to evolve and expand. Despite this, currently available treatments remain insufficient, with less than 25% of smokers remaining abstinent 1 year after treatment. In this article, we review existing and emerging smoking cessation pharmacotherapies, with a special emphasis on the most promising agents that are currently being investigated. A search of the Cochrane Database of Systematic Reviews and the PubMed, Ovid, and ClinicalTrials.gov databases (August 2 to September 1, 2017) was undertaken for articles on smoking cessation pharmacotherapies, applying no language restrictions. More than 40 pharmacotherapies were reviewed including conventional pharmacotherapies—NRT, bupropion, and varenicline (all approved by the U.S. Food and Drug Administration as first‐line treatment of smoking cessation)—and novel therapies: cytisine, N‐acetylcysteine, cycloserine, memantine, baclofen, topiramate, galantamine, and bromocriptine. Studies of combination NRT and varenicline showed the greatest smoking cessation rates. Clonidine and nortriptyline are second‐line treatments used when first‐line treatments fail or are contraindicated, or by patient preference. Some novel therapies, especially acetylcholinesterase inhibitors, cytisine, and N‐acetylcysteine, display promising results. Because the results of randomized clinical trials were reported using varied end points and outcome measures, direct comparisons between different pharmacotherapies cannot easily be evaluated. Additional high‐quality randomized double‐blind placebo‐controlled trials with long‐term follow‐up, using validated sustained abstinence measures, are needed to find more effective smoking cessation aids. [ABSTRACT FROM AUTHOR]

Among various forms of hearing loss, there are acute (within 72 hrs) or subacute (weeks to months) presentations that may be reversible with early pharmacological intervention. The workup of a patient presenting with hypoacusia includes the usual history and physical examination in conjunction with an audiometric assessment in order to categorize the hearing loss as conductive, sensorineural, or mixed. Sudden sensorineural hearing loss and autoimmune inner ear disease are acute and subacute forms of sensorineural hypoacusia most likely to be reversed with prompt pharmacological intervention. Systemic or local corticosteroid therapy has the most evidence of benefit in patients with sudden sensorineural hypoacusia and is the best available first line therapy noted in clinical practice guidelines. Alternative immunosuppressant therapies have not been well studied, and many have serious toxicities that further complicate the benefit-risk assessment. There are no randomized comparisons of corticosteroid dosing regimens that evaluated clinically important outcomes, so expert opinion must serve as the basis for dosing recommendations. Clinicians need to involve patients with hypoacusia in the shared decision-making process, since partial or complete reversal of hearing loss can have substantial quality-of-life implications for affected patients. [ABSTRACT FROM AUTHOR]

The objective of this review is to explain the science of metabolomics-a science of systems biology that measures and studies endogenous small molecules (metabolites) that are present in a single biological sample-and its application to the diagnosis and treatment of sepsis. In addition, we discuss how discovery through metabolomics can contribute to the development of precision medicine targets for this complex disease state and the potential avenues for those new discoveries to be applied in the clinical environment. A nonsystematic literature review was performed focusing on metabolomics, pharmacometabolomics, and sepsis. Human (adult and pediatric) and animal studies were included. Metabolomics has been investigated in the diagnosis, prognosis, and risk stratification of sepsis, as well as for the identification of drug target opportunities. Metabolomics elucidates a new level of detail when compared with other systems biology sciences, with regard to the metabolites that are most relevant in the pathophysiology of sepsis, as well as highlighting specific biochemical pathways at work in sepsis. Metabolomics also highlights biochemical differences between sepsis survivors and nonsurvivors at a level of detail greater than that demonstrated by genomics, transcriptomics, or proteomics, potentially leading to actionable targets for new therapies. The application of pharmacometabolomics and its integration with other systems pharmacology to sepsis therapeutics could be particularly helpful in differentiating drug responders and nonresponders and furthering knowledge of mechanisms of drug action and response. The accumulated literature on metabolomics suggests it is a viable tool for continued discovery around the pathophysiology, diagnosis and prognosis, and treatment of sepsis in both adults and children, and it provides a greater level of biochemical detail and insight than other systems biology approaches. However, the clinical application of metabolomics in sepsis has not yet been fully realized. Prospective validation studies are needed to translate metabolites from the discovery phase into the clinical utility phase. [ABSTRACT FROM AUTHOR]

The 2016 American College of Clinical Pharmacy ( ACCP) Educational Affairs Committee was charged with updating and contemporizing ACCP's 2009 Pharmacotherapy Didactic Curriculum Toolkit. The toolkit has been designed to guide schools and colleges of pharmacy in developing, maintaining, and modifying their curricula. The 2016 committee reviewed the recent medical literature and other documents to identify disease states that are responsive to drug therapy. Diseases and content topics were organized by organ system, when feasible, and grouped into tiers as defined by practice competency. Tier 1 topics should be taught in a manner that prepares all students to provide collaborative, patient-centered care upon graduation and licensure. Tier 2 topics are generally taught in the professional curriculum, but students may require additional knowledge or skills after graduation (e.g., residency training) to achieve competency in providing direct patient care. Tier 3 topics may not be taught in the professional curriculum; thus, graduates will be required to obtain the necessary knowledge and skills on their own to provide direct patient care, if required in their practice. The 2016 toolkit contains 276 diseases and content topics, of which 87 (32%) are categorized as tier 1, 133 (48%) as tier 2, and 56 (20%) as tier 3. The large number of tier 1 topics will require schools and colleges to use creative pedagogical strategies to achieve the necessary practice competencies. Almost half of the topics (48%) are tier 2, highlighting the importance of postgraduate residency training or equivalent practice experience to competently care for patients with these disorders. The Pharmacotherapy Didactic Curriculum Toolkit will continue to be updated to provide guidance to faculty at schools and colleges of pharmacy as these academic pharmacy institutions regularly evaluate and modify their curricula to keep abreast of scientific advances and associated practice changes. Access the current Pharmacotherapy Didactic Curriculum Toolkit at [ABSTRACT FROM AUTHOR]

Cannabis is the most commonly used illicit substance in the United States. Rates of cannabis use and cannabis use disorder (CUD) have increased in the past decade, paralleling changes in the legal and political climate favoring legalization. Almost 20 million people 12 years or older report past-month cannabis use, and 8 million report daily or near-daily use. Concurrently, the perception that cannabis use poses a significant risk of negative consequences has decreased. Contrary to this perception, heavy cannabis use is associated with cognitive impairment, increased risk for psychotic disorders and other mental health problems, lower education attainment, and unemployment. Clinical trials of various treatments for CUD have likewise increased, focusing primarily on psychotherapy treatments, specifically motivational enhancement therapy, cognitive behavioral therapy, and contingency management. Their findings suggest that a combination of these three modalities produces the best abstinence outcomes, although abstinence rates remain modest and decline after treatment. More recently, pharmacotherapy trials have been conducted as adjunctive interventions to psychosocial treatment. N-acetylcysteine and gabapentin are two of the most promising medications, although no pharmacologic treatment has emerged as clearly efficacious. In this review, we provide a detailed summary of clinical trials that evaluated psychotherapy and pharmacotherapy for treating CUD and discuss emerging areas of clinical research and cannabis-specific barriers to treatment. [ABSTRACT FROM AUTHOR]

Neurodevelopmental disorders ( NDDs) are defined as a group of disorders caused by changes in early brain development, resulting in behavioral and cognitive alterations in sensory and motor systems, speech, and language. NDDs affect approximately 1-2% of the general population. Up to 80% of children with NDDs are reported to have disrupted sleep; subsequent deleterious effects on daytime behaviors, cognition, growth, and overall development of the child are commonly reported. Examples of NDDs discussed in this review include autism spectrum disorder, cerebral palsy, Rett syndrome, Angelman syndrome, Williams syndrome, and Smith-Magenis syndrome. The etiology of sleep disorders in children with NDDs is largely heterogeneous and disease specific. The diagnosis and management of sleep disorders in this population are complex, and little high-quality data exist to guide a consistent approach to therapy. Managing sleep disorders in children with NDDs is critical both for the child and for the family but is often frustrating due to the refractory nature of the problem. Sleep hygiene must be implemented as first-line therapy; if sleep hygiene alone fails, it should be combined with pharmacologic management. The available evidence for the use of common pharmacologic interventions, such as iron supplementation and melatonin, as well as less common interventions, such as melatonin receptor agonists, clonidine, gabapentin, hypnotics, trazodone, and atypical antipsychotics is reviewed. Further, parents and caregivers should be provided with appropriate education on the nature of the sleep disorders and the expectation for modest pharmacologic benefit, at best. Additional data from well-designed trials in children with NDDs are desperately needed to gain a better understanding of sleep pharmacotherapy including efficacy and safety implications. Until then, clinicians must rely on the limited available data, as well as clinical expertise, when managing sleep disorders in the population of children with NDDs. [ABSTRACT FROM AUTHOR]

Transgender and transsexual individuals have unique health care needs and risks compared with the population at large. It is estimated that 1 in 100,000 individuals in the United States is a transgender woman and 1 in 400,000 is a transgender man, although these estimates of prevalence are likely conservative. Transgender individuals are at an increased risk of tobacco, alcohol, and substance abuse; they have an increased lifetime suicide attempt risk; and they are more likely to experience significant stressors in their lives. Transgender patients may elect to transition their appearance to the gender with which they identify. Hormone treatment (and possibly sex reassignment surgery) is a significant part of this transition, and pharmacists must understand the pharmacotherapeutic principles involved so they can better recommend therapeutic agents, provide dosing recommendations, and anticipate and manage adverse effects. It is critical to be culturally sensitive when providing care for transgender patients including using their preferred gender identity, preferred names, and preferred pronouns. It is also essential to be able to identify transgender and transsexual patients correctly within electronic health records to ensure that appropriate care and monitoring are provided. For pharmacists, this means they should know the biologic sex for performing calculations such as creatinine clearance and to prevent teratogenic agents from reaching a transgender or transsexual man who could be pregnant or is capable of becoming pregnant. Promoting knowledge of transgender health issues will enable pharmacists to provide better, more holistic care to their transgender patients. [ABSTRACT FROM AUTHOR]

There has been a 10-year hiatus in the approval of a new pharmacotherapy for patients with chronic heart failure with a reduced ejection fraction ( HFr EF). Combining an angiotensin receptor blocker, valsartan, with sacubitril, an inhibitor of neprilysin, results in increasing levels of natriuretic peptides that counterbalance high circulating levels of neurohormones in HFr EF. This has resulted in the development of a new agent, LCZ696. A comprehensive overview of LCZ696, its pharmacology, its role in the pathophysiology of HFr EF, completed and future clinical trial information, specific critical issues, and the place of LCZ696 in HFr EF therapy are presented. [ABSTRACT FROM AUTHOR]

Heart failure with preserved ejection fraction ( HFp EF) constitutes ~50% of all heart failure diagnoses and is associated with considerable morbidity and mortality. The treatment of HFp EF can be challenging due to a lack of evidence supporting the benefit of various drug therapies. In practice, treatment can be divided into acute and chronic management. Acute therapy for decompensated heart failure is similar for both HFp EF and heart failure with reduced ejection fraction. The mainstay of treatment is diuretics to reduce volume overload and improve dyspnea. Patients with an acute exacerbation of HFp EF and rapid atrial fibrillation ( AF) should be rate controlled with negative chronotropic agents. For chronic therapy, patients with HFp EF should not be treated like patients with heart failure with reduced ejection fraction. Chronic management of HFp EF can be simplified by using three strategies based on applicability: treat precipitating conditions (e.g., hypertension, AF), control symptoms by maintaining euvolemia with diuretics, and avoid therapies that have been shown not to be beneficial unless another compelling indication exists. Nondrug interventions for HFp EF include salt and fluid restriction, regular physical activity, and referral to a heart function clinic, if appropriate. [ABSTRACT FROM AUTHOR]

The authors reply to the Hematology/Oncology Pharmacy Association's (HOPA) alternative viewpoint on the 2016 American College of Clinical Pharmacy (ACCP) Pharmacotherapy Didactic Curriculum Toolkit. They reiterate the need of pharmacy graduates to possess a foundation of oncology knowledge and they reject the oncology-related topics recommended by the HOPA task force for addition to the ACCP tier classification system of oncologic disorders.

Depression is a common psychiatric comorbidity in Parkinson's disease ( PD) and contributes to significant impairments in cognitive, functional, motor, and social performance. This results in reduced quality of life, higher levels of care dependency, and increased caregiver burden. When treating depression, it is important to ensure that the patient's response to treatment will be adequately monitored. This can be accomplished in neurology or primary care settings, or in clinical settings with interdisciplinary treatment teams. Mental health services should be engaged early as a component of ongoing comprehensive care. This article reviews a general approach to treating the pharmacotherapy of depression in PD. Ultimately, clinicians should rely on empiric assessments of known risks and putative benefits to guide treatment decisions and should include a targeted and individualized multimodal approach that utilizes psychotherapeutic interventions along with pharmacologic therapies. [ABSTRACT FROM AUTHOR]

Hypoactive sexual desire disorder ( HSDD) affects nearly 1 in 10 women. Thus, it is essential for pharmacists and other health care providers to be comfortable when discussing a patient's sexual health to ensure appropriate triage so that the specific causes of HSDD can be identified and potential recommendations provided. HSDD is defined as the absence or deficiency of sexual interest and/or desire, leading to significant distress and interpersonal difficulties. As health care providers, pharmacists have a critical role in assessing the presence of HSDD and providing education on available treatment options. This article will review the potential causes of HSDD and low sexual desire, the screening tools available, and the significant role of health care professionals in communicating with patients about their sexual health. An overview of the importance of behavioral modifications, the current pharmacologic options being investigated, and the use of complementary and alternative therapies will also be explored. Currently, buproprion is the primary pharmacologic agent that has shown positive results in treating patients with HSDD. The use of testosterone therapy will not be addressed in this article, as this therapy is described in greater detail elsewhere. [ABSTRACT FROM AUTHOR]

Study Objective To compare pharmacist and prescriber perceptions of the clinical and financial outcomes of pharmacy services in the intensive care unit ( ICU). Design ICU pharmacists were invited to participate in the survey and were asked to invite two ICU prescriber colleagues to complete questionnaires. Setting ICUs with clinical pharmacy services. Methods The questionnaires were designed to solicit frequency, efficiency, and perceptions about the clinical and financial impact (on a 10-point scale) of pharmacy services including patient care (eight functions), education (three functions), administration (three functions), and scholarship (four functions). Basic services were defined as fundamental, and higher-level services were categorized as desirable or optimal. Respondents were asked to suggest possible sources of funding and reimbursement for ICU pharmacy services. Results Eighty packets containing one 26-item pharmacy questionnaire and two 16-item prescriber questionnaires were distributed to ICU pharmacists. Forty-one pharmacists (51%) and 46 prescribers (29%) returned questionnaires. Pharmacists had worked in the ICU for 8.3 ± 6.4 years and devoted 50.3 ± 18.7% of their efforts to clinical practice. Prescribers generally rated the impact of pharmacy services more favorably than pharmacists. Fundamental services were provided more frequently and were rated more positively than desirable or optimal services across both groups. The percent efficiencies of providing services without the pharmacist ranged between 40% and 65%. Both groups indicated that salary support for the pharmacist should come from hospital departments of pharmacy or critical care or colleges of pharmacy. Prescribers were more likely to consider other sources of funding for pharmacist salaries. Both groups supported reimbursement of clinical pharmacy services. Conclusion Critical care pharmacy activities were associated with perceptions of beneficial clinical and financial outcomes. Prescribers valued most services more than pharmacists. Fundamental services were viewed more favorably than desirable or optimal services, possibly because they occurred more frequently or were required for safe patient care. Substantial inefficiencies may occur if pharmacy services disappeared. Considerable support existed for funding and reimbursement of critical care pharmacy services. [ABSTRACT FROM AUTHOR]

More than 1 million people in the United States experience an acute coronary syndrome ( ACS) every year, and almost 600,000 undergo percutaneous coronary intervention ( PCI) for treatment of cardiovascular disease. There is a large amount of evidence-based literature to guide appropriate management of these patients. There have been a number of advances in the treatment of these patients over the last several years. Due to the large amount of rapidly available literature concerning the care of patients with ACS or undergoing PCI, clinicians can often find it difficult to keep up with the information needed for optimizing care of these patients. Therefore, we provide the second update to the first compiled bibliography of key articles and guidelines relative to patients with ACS published in Pharmacotherapy in 2004. The initial update was published in Pharmacotherapy in 2007 and also included bibliographies concerning management of patients undergoing PCI. A number of guidelines and practice-changing literature have been published since the update in 2007. Specific areas included in this review are updated summaries of clinical practice guidelines and clinical trials of anticoagulants, antiplatelets, platelet aggregation testing, pharmacogenomics testing in patients taking clopidogrel, clopidogrel loading dose comparisons, clopidogrel and proton pump inhibitor drug interactions, the impact of bleeding in ACS, and statins. As with previous versions of this document, we hope that this compilation will serve as a resource for pharmacists, physicians, nurses, residents, and students responsible for the care of patients with coronary heart disease. [ABSTRACT FROM AUTHOR]

Study Objectives To estimate the treated prevalence of bipolar disorder in a privately insured population, describe the characteristics of children and adolescents receiving these diagnoses, and describe patterns of their psychotropic drug therapy. Design Retrospective, repeated cross-sectional study. Data Source Market Scan Commercial Claims and Encounters inpatient, outpatient, and pharmacy claims databases. Patients A total of 22,360 children and adolescents (aged 0-17 yrs) with one inpatient or two or more outpatient claims for any bipolar spectrum disorder between January 1, 2005, and December 31, 2007. Measurements and Main Results Annual cross-sections were used to estimate the treated prevalence of bipolar disorder diagnoses, patient characteristics, and psychotropic drugs used 30 days after a child's latest recorded bipolar disorder diagnosis within each year. The annual treated prevalence of any bipolar spectrum disorder in this privately insured population was 0.24% in 2005 and 0.26% in 2006 and 2007. Approximately 25% of diagnoses were for children younger than 13 years. Approximately 30% of children had coexisting attention-deficit-hyperactivity disorder during the year. In each year, 35% of patients used no psychotropic drug therapy in the 30-day period after their most recent diagnosis. Twenty-five percent used one psychotropic drug, and 40% used two or more drugs. The most common drug regimens were antipsychotic or mood stabilizer (lithium or anticonvulsant) monotherapy and the combination of mood stabilizers and antipsychotics. Conclusion Drug therapy patterns suggest that children and adolescents with bipolar diagnoses receive complex treatment regimens, often involving multiple classes of psychotropic drugs. Research on treatment combinations, particularly antipsychotic and mood stabilizer combinations, should be prioritized to better understand the safety and effectiveness of commonly prescribed treatments. [ABSTRACT FROM AUTHOR]

This commentary from the 2010 Task Force on Acute Care Practice Model of the American College of Clinical Pharmacy was developed to compare and contrast the 'unit-based' and 'service-based' orientation of the clinical pharmacist within an acute care pharmacy practice model and to offer an informed opinion concerning which should be preferred. The clinical pharmacy practice model must facilitate patient-centered care and therefore must position the pharmacist to be an active member of the interprofessional team focused on providing high-quality pharmaceutical care to the patient. Although both models may have advantages and disadvantages, the most important distinction pertains to the patient care role of the clinical pharmacist. The unit-based pharmacist is often in a position of reacting to an established order or decision and frequently is focused on task-oriented clinical services. By definition, the service-based clinical pharmacist functions as a member of the interprofessional team. As a team member, the pharmacist proactively contributes to the decision-making process and the development of patient-centered care plans. The service-based orientation of the pharmacist is consistent with both the practice vision embraced by ACCP and its definition of clinical pharmacy. The task force strongly recommends that institutions pursue a service-based pharmacy practice model to optimally deploy their clinical pharmacists. Those who elect to adopt this recommendation will face challenges in overcoming several resource, technologic, regulatory, and accreditation barriers. However, such challenges must be confronted if clinical pharmacists are to contribute fully to achieving optimal patient outcomes. [ABSTRACT FROM AUTHOR]

Abnormal uterine bleeding in women with a blood dyscrasia, such as leukemia, or who experience thrombocytopenia secondary to myelosuppressive chemotherapy is a clinical condition associated with significant morbidity. Consequently, effective management is necessary to prevent adverse outcomes. Prevention of menorrhagia, defined as heavy regular menstrual cycles with more than 80 ml of blood loss/cycle or a cycle duration longer than 7 days, in this patient population is the goal of therapy. Gonadotropinreleasing hormone analogs (e.g., leuprolide) are promising therapies that have been shown to decrease vaginal bleeding during periods of thrombocytopenia and to have minimal adverse effects other than those associated with gonadal inhibition. In patients who experience menorrhagia despite preventive therapies, or in patients who have thrombocytopenia and menorrhagia at diagnosis, treatment is indicated. For these women, treatment options may include platelet transfusions, antifibrinolytic therapy (e.g., tranexamic acid), continuous high-dose oral contraceptives, cyclic progestins, or other therapies for more refractory patients such as danazol, desmopressin, and recombinant factor Vlla. Hormonal therapies are often the mainstay of therapy in women with menorrhagia secondary to thrombocytopenia, but data for these agents are sparse. The most robust data for the treatment of menorrhagia are for tranexamic acid. Most women receiving tranexamic acid in randomized trials experienced meaningful reductions in menstrual bleeding, and this translated into improved quality of life; however, these trials were not performed in patients with cancer. Further clinical trials are warranted to evaluate both preventive and therapeutic agents for menorrhagia in premenopausal women with cancer who are receiving myelosuppressive chemotherapy. [ABSTRACT FROM AUTHOR]

The available pharmacotherapies for Parkinson's disease address symptomatology because no agent has been demonstrated to provide definite neuroprotection against the disease. Choice of pharmacotherapy must include consideration of short-term benefits as well as long-term consequences. Patients with mild Parkinson's disease often function adequately without symptomatic treatment. However, recent data suggest that initiation of treatment with a well-tolerated agent (e.g., the monoamine oxidase [MAO]-B inhibitor rasagiline) in the absence of functional impairment is associated with improved long-term outcomes. Consideration should also be given to many patient-specific factors, including patient expectations, level of disability, employment status, functional as well as chronologic age, expected efficacy and tolerability of drugs, and response to previous Parkinson's disease therapies. Increasingly, initial monotherapy begins with a nondopaminergic agent or, if the patient is considered functionally young, a dopamine agonist. Since Parkinson's disease is a progressive disorder, adjustments to pharmacotherapy must be expected over time. When greater symptomatic relief is desired, or in the more frail elderly patient, levodopa therapy should be considered. If motor fluctuations develop, addition of a catechol-O-methyltransferase inhibitor or MAO-B inhibitor should be considered. For management of levodopa-induced dyskinesias, addition of amantadine is an option. Surgery may be considered when patients need additional symptomatic control or are experiencing severe motor complications despite pharmacologically optimized therapy. [ABSTRACT FROM AUTHOR]

This overview of Parkinson's disease is designed to serve as a background to the discussion elsewhere in this supplement on the pharmacotherapy used in its management. Parkinson's disease is a common progressive neurodegenerative condition associated with significant disability and negative impact on quality of life. Although the cause of Parkinson's disease is unknown, the pathologic manifestation involves the loss or dysfunction of dopaminergic neurons in the substantia nigra pars compacta. Characteristic clinical manifestations include difficulty with coordinated movement such as asymmetric resting tremor, rigidity, and bradykinesia. These symptoms and their response to levodopa constitute the basis for a clinical diagnosis of Parkinson's disease. Postural instability and gait abnormalities occur in more advanced disease. Although there is no cure for Parkinson's disease, a number of pharmacologic treatments are available for managing the motor and nonmotor symptoms. Research is under way to assess the disease-modifying ability of both standard and newer treatments. [ABSTRACT FROM AUTHOR]

Tobacco use claims more than 440,000 lives each year, making it one of the leading causes of mortality in the United States. Although nearly half of all people who smoke die prematurely from tobacco-related illnesses, those who quit may be able to reverse many of the adverse effects of tobacco. Approximately 47.5 million adults use tobacco; nearly 70% of them want to quit, and 42.5% attempt to quit each year. The most effective smoking-cessation programs involve a combination of pharmacotherapy and behavioral and/or cognitive counseling to improve abstinence rates. Approved treatments include nicotine replacement therapies and bupropion, a nonnicotine option. Varenicline, the most recent agent approved for tobacco cessation, is the first drug in a new class that binds to the nicotinic receptors to release dopamine and alleviate withdrawal symptoms. It has demonstrated superior efficacy in clinical trials when compared with placebo and bupropion, with minimal adverse effects. It provides smokers and clinicians with an alternative therapy to assist in quitting tobacco. [ABSTRACT FROM AUTHOR]

Cardiac arrest and sudden cardiac death remain major causes of mortality. Early intervention has been facilitated by emergency medical response systems and the development of training programs in basic life support and advanced cardiac life support (ACLS). Despite the implementation of these programs, the likelihood of a meaningful outcome in many life-threatening situations remains poor. Pharmacotherapy plays a role in the management of patients with cardiac arrest, with new guidelines for ACLS available in 2005 providing recommendations for the role of specific drug therapies. Epinephrine continues as a recommended means to facilitate defibrillation in patients with pulseless ventricular tachycardia or ventricular fibrillation; vasopressin is an alternative. Amiodarone is the primary antiarrhythmic drug that has been shown to be effective for facilitation of defibrillation in patients with pulseless ventricular tachycardia or fibrillation and is also used for the management of atrial fibrillation and hemodynamically stable ventricular tachycardia. Epinephrine and atropine are the primary agents used for the management of asystole and pulseless electrical activity. Treatment of electrolyte abnormalities, severe hypotension, pulmonary embolism, acute ischemic stroke, and toxicologic emergencies are important components of ACLS management. Selection of the appropriate drug, dose, and timing and route of administration are among the many challenges faced in this setting. Pharmacists who are properly educated and trained regarding the use of pharmacotherapy for patients requiring ACLS can help maximize the likelihood of positive patient outcomes. [ABSTRACT FROM AUTHOR]

Study Objective. To develop and evaluate a peer review group (PRG) meeting using feedback data on a patient level to improve the quality of drug therapy for prevention of recurrent myocardial infarction. Design. Prospective follow-up study. Data Source. General practitioners' computerized patients records (intervention patients) and the PHARMO record linkage system (controls). Patients. Forty patients in the intervention group and 1030 control patients; both groups had documented myocardial infarction. Intervention. The intervention, which was based on the principles of group academic detailing, consisted of scoring current cardiovascular treatment on separate forms for each patient, presenting an overview of, and discussing, evidence-based treatment after myocardial infarction, defining the target population, formulating a binding consensus, and identifying patients who were eligible for improvement of pharmacotherapy. Measurements and Main Results. Drug therapy and adherence to the newly formulated PRG consensus were assessed at baseline and 1 year after the intervention. Of the patients who received the intervention and were not treated according to the PRG consensus at baseline, 40% received treatment according to the consensus 12 months after the PRG meeting. In the control group, the proportion of patients was 9.5% (prevalence ratio 4.2, 95% confidence interval 1.8-9.7). Conclusion. Peer review group meetings can be a valuable tool for improving pharmacotherapy after myocardial infarction. [ABSTRACT FROM AUTHOR]

Most health care practitioners are challenged to maintain knowledge of contemporary practice issues in many therapeutic disciplines. Like many other areas, infectious diseases pharmacotherapy continues to evolve because of new information regarding disease epidemiology and new treatment options. Emerging infections and resistance further compound the need for information. To assist clinicians in identifying such important new information, we compiled a list of key references on infectious diseases pharmacotherapy published over the last 2 years. [ABSTRACT FROM AUTHOR]

Reflects on the twenty-fifth anniversary of the journal "Pharmacotherapy" in 2006. Information on the Institute for Scientific Information impact factor; Development by "Pharmacotherapy" of the use of Internet tools; Information on the Manuscript Central computer software; Institution by "Pharmacotherapy" of a publication charge.