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Information about drug abuse and dependence from package inserts of centrally acting drugs was evaluated for content. Of the 77 labels reviewed, 40 were opiate agonists, 18 were stimulants, and the remainder fell into other selected categories. The amount of information ranged from 0-66 sentences, with greatest variability found in the opiate agonists (range 9-66). Information amount was significantly correlated with the year of drug approval (p < 0.001) but not with the latest label revision (p = 0.749). Information amount did not differ significantly with warning strength or schedule. While most package inserts explain physical dependence, tolerance, and withdrawal, there is a lack of information about psychological dependence. Variability in information about abuse and dependence potential is high and can affect prescribing by physicians and counseling by pharmacists, underscoring the need for further studies. [ABSTRACT FROM AUTHOR]

Healthcare practitioners must be trained to collaborate in a dynamic environment where patients are complex and teams can change from day-to-day, but choosing the right measures to assess the effectiveness of interprofessional teamwork among learners is challenging. This study used measures representing four different perspectives to assess student teams in a practice setting where team composition varied each day. We tested the strength of the relationships between these measures, and we examined the impact of additional variables on each measure. Participants were students from different health professions at a single university and patients in a community-based wellness program. We sampled 100 wellness visits where an interprofessional student team met with a patient, and we assessed team effectiveness using student perceptions of their team, patient ratings, observer ratings, and faculty assessments of team healthcare plans for the patient. We calculated bivariate correlations between the four measures and used regression analyses to assess the impact of predictors including student, patient, and clinic/site characteristics, on each measure of team effectiveness. There were small but significant negative correlations between the assessments of faculty and observers ( r  = - 0.23), as well as between faculty and patients ( r  = - 0.14). Conversely, a small but significant positive correlation was found between the assessments of patients and observers ( r  = 0.15). Among the regression models, faculty and patient ratings of team effectiveness were more strongly related to the predictors measured (R-squared = 53.6% and 41.7%, respectively). Patient age and number of clinic visits, team size, and clinic site were significant factors for predicting team effectiveness across the two measures. Our findings provide evidence that different perspectives of team effectiveness measure different constructs. While all approaches have value, in IPE practice settings, team effectiveness should be evaluated with multiple measures to understand performance and identify opportunities for improvement. Teamwork in dynamic healthcare environments is complex, and simple measurement approaches may mischaracterize learning and clinical outcomes.

Objective: To assess how department chairs/administrators define, measure, and evaluate faculty workload to better understand practices within the Academy., Methods: An 18-item survey was distributed to department chairs/administrators via American Association of Colleges of Pharmacy Connect. Participants identified if they are a primary decision maker for faculty workload, whether their program has a workload policy, how workload is calculated, and how faculty satisfaction with workload equity is measured., Results: Of 71 participants initiating the survey, data from 64 participants from 52 colleges/schools were eligible for analysis. Leaders of practice departments reported that their faculty spend an average of 38% of their time on teaching (compared to 46% for non-practice departments), 13% on research (vs 37%), 12% on service (vs 16%), and 36% on clinical practice (vs 0%). Most survey participants (n = 57, 89%) are at schools/colleges with a tenure system, and about 24 participants reported that faculty workload metrics differ across departments/divisions. Teaching assignments and service are reportedly negotiable between faculty and supervisors, and workload expectations are widely variable. The majority indicated they do not analyze faculty satisfaction with workload fairness (n = 35) and faculty do not provide evaluative feedback on how supervisors assign faculty workload (n = 34). Of 6 priorities considered when determining workload, 'support college/school strategies and priorities' ranked highest (1.92) and 'trust between the chair and faculty' ranked lowest (4.87)., Conclusion: Overall, only half of the participants reported having a clear, written process of quantifying faculty workload. The use of workload metrics may be needed for evidence-based decision-making for personnel management and resource allocation., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2023 American Association of Colleges of Pharmacy. Published by Elsevier Inc. All rights reserved.)

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, use requirements, and place in therapy of esketamine for treatment-resistant depression (TRD). Data Sources: A comprehensive PubMed search (1966 to October 2019) was conducted using the search terms depression, treatment-resistant, suicide, intranasal, esketamine , and JNJ-54135419 . Additional data were obtained from references of identified articles, governmental sources, manufacturer product labeling, and Clinicaltrials.gov . Study Selection and Data Extraction: All English-language trials evaluating intranasal esketamine for TRD were included and discussed. Data Synthesis: Intranasal esketamine was approved by the US Food and Drug Administration, in conjunction with an oral antidepressant, for treating TRD in adults. Two short-term trials (TRANSFORM-1 and -2) found statistically significant reduction in the Montgomery-Asberg Depression Rating Scale score at day 28 for the fixed 56-mg dose (-4.1; 95% CI = -7.69 to -0.49; P = 0.027 [exploratory]) and flexible-dosed arms (-4.0; 95% CI = -7.31 to -0.64; P = 0.02), though the fixed-dose 84-mg arm (-3.2; 95% CI = -6.88 to 0.45; P = 0.088) of TRANSFORM-1 and TRANSFORM-3 did not (-3.6; 95% CI = -7.2 to 0.07; P = 0.059). Two long-term trials (SUSTAIN-1 and -2) suggested maintenance of response with continued use. Esketamine's adverse effects include dizziness, dysgeusia, somnolence, dissociation, suicidal thoughts and behaviors, and increased heart rate and blood pressure. Relevance to Patient Care and Clinical Practice: Although providing a novel antidepressant mechanism and formulation for TRD, esketamine's role in treatment will likely be limited by cost, administration, and diversion concerns. Conclusion: Intranasal esketamine significantly reduced depression symptoms in TRD, though with tolerability issues.

Background: Poor medication adherence is common among individuals with Bipolar Disorder (BD). Understanding the sources of heterogeneity in clinical net benefit (CNB) and how it is related to psychotropic medications can provide new insight into ways to improve adherence., Methods: Data come from the baseline assessments of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Latent class analysis identified groups of CNB, and validity of this construct was assessed using the SF-36. Adherence was defined as taking 75% or more of medications as prescribed. Associations between CNB and adherence were tested using multiple logistic regression adjusting for sociodemographic characteristics., Results: Five classes of CNB were identified: High (24%), Moderately high (12%), Moderate (26%), Moderately low (27%) and Low (12%). Adherence to psychotropic medications did not differ across classes (71% to 75%, χ 2   = 3.43, p = 0.488). Medication regimens differed by class: 57% of the High CNB were taking ≤2 medications, whereas 49% of the Low CNB were taking ≥4. CNB classes had good concordance with the SF-36., Limitations: Missing data limited measures used to define CNB. Participants' perceptions of their illness and treatment were not assessed., Conclusions: This novel operationalization of CNB has construct validity as indicated by the SF-36. Although CNB and polypharmacy regimens are heterogeneous in this sample, adherence is similar across CNB. Studying adherent individuals, despite suboptimal CNB, may provide novel insights into aspects influencing adherence., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The question of whether outstanding leaders are born or made has been debated for years. There are numerous examples of historical figures that came naturally to leadership, while others developed their leadership skills through tenacity and experience. To understand leadership, both nature (the genetic component) and nurture (the environmental influences) must be considered. This article represents the work of two Academic Leadership Fellows Program groups who debated each position at the 2016 American Association of Colleges of Pharmacy (AACP) Interim Meeting in Tampa, Fla., in February 2016.

Background: Atypical antipsychotic use among children and adolescents is a cause for concern secondary to metabolic adverse effects. There have been reports of weight gain, metabolic syndrome, dyslipidemia, glucose abnormalities, and decreased insulin sensitivity in children aged 4 to 19 years using atypical antipsychotics., Objective: To determine the prevalence of antidiabetic and antilipidemic medication use among children and adolescents receiving atypical antipsychotics and to evaluate whether the odds of receiving antidiabetic and antilipidemic medication differs among atypical antipsychotic agents., Methods: This retrospective cross-sectional study included Virginia Medicaid beneficiaries (2-17 years) continuously enrolled from August 1, 2010, to July 31, 2011. The participants were categorized into atypical antipsychotic exposed and unexposed. The prevalence of antidiabetic and antilipidemic medication use within the groups was computed. Logistic regression was used to calculate the odds of receiving antidiabetic or antilipidemic medication after controlling for age, sex, and race., Results: A total of 299593 and 4922 beneficiaries were identified in unexposed and exposed groups, respectively. The prevalence of antidiabetic medication use was 0.32% in the unexposed and 1.40% in the exposed group (P < 0.0001). Prevalence of antilipidemic medication use was 0.09% in the unexposed and 0.35% in the exposed group (P < 0.0001). Risperidone and quetiapine users had lower odds than olanzapine users of receiving antidiabetic medication. No differences between the odds of receiving antilipidemic medication among the different antipsychotics (P = 0.1653) were observed., Conclusions: Prevalence of antidiabetic and antilipidemic medication use was significantly higher among children and adolescent atypical antipsychotic users in a Virginia Medicaid population., (© The Author(s) 2016.)

Background: Sleep complaints and the consumption of medications for sleep are common in older adults. Falls are also a significant concern for older adults and sedative use has been identified as a risk factor for falls. Sleep quality is a potential confounder in studies evaluating the relationship between sleep medication use and falls. However, very few studies have assessed the combined impact of sleep medication use and sleep quality on the risk of falls., Objective: The objective of this study was to evaluate the association between sleep medication use, poor sleep quality, and falls in community-dwelling older adults., Methods: This was a multicenter, 6-month prospective cohort study conducted in senior housings settings in central Virginia, USA. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) and a medication review was conducted. Data regarding falls were collected over 6 months by use of a diary. Logistic regression modeling was used to examine the effects of poor sleep quality, sleep medication use, and both, on the risk of falls., Results: Among 113 independently living older adults (mean age ± standard deviation 81.1 ± 8.6), 46.9 % fell at least once during a 6-month period; 62.8 % (n = 71) had poor sleep quality, and 44.2 % (n = 50) used medications or treatments to aid sleep. Compared with participants reporting good sleep quality and no sleep medication use, those who reported poor sleep quality and sleep medication use had an increased risk of falls after adjusting for covariates (odds ratio 3.23, 95 % confidence interval 1.05-9.91). The group with good sleep quality and sleep medication use, as well as the group with poor sleep quality and no sleep medication use had no significantly greater risk for falls compared with the group with good sleep quality and no sleep medication use., Conclusion: A combined effect of sleep quality and sleep medication use on the risk of falls suggests that medication effectiveness may be an important factor to consider in understanding the risk of falls associated with sedative medications.

A 75-year-old white female with schizoaffective disorder was admitted to an inpatient psychiatry unit for uncooperativeness in refusing to take scheduled medications. She complained of anticholinergic adverse effects and had abnormal involuntary movements in the oral/buccal region. The patient had been prescribed six psychotropic medications (i.e., thiothixene, lithium, divalproex sodium, amitriptyline, benztropine, and trazodone effects. The treatment team determined that the patient was noncompliant and experienced the effects of polypharmacy. She had been prescribed two mood stabilizers and suffered from anticholinergic adverse effects and the movement disorder tardive dyskinesia (TD). Four medications were discontinued: thiothixene, amitriptyline, lithium, and benztropine. Quetiapine, a second-generation antipsychotic, was recommended, with a daily titration schedule to reach a target dose of 600 mg per day in divided doses. This agent has less propensity to cause movement disorders compared with first-generation antipsychotics. All medications with additive anticholinergic properties also were discontinued. Lithium was stopped secondary to subtherapeutic levels and potential drug interactions. The pharmacist educated the inpatient team on the additive anticholinergic effects of each medication, reduced the total number of medications prescribed, and assisted in appropriate conversion to quetiapine to reduce TD symptoms.

Objectives: To develop and implement a competency-based assessment process for the experiential component of a pharmacy education curriculum., Design: A consultative process was used in the development of new assessment forms and policies, and a survey regarding student and faculty satisfaction was conducted. Information received from the survey and from consultations with faculty preceptors resulted in revision of the forms in subsequent years., Assessment: Faculty and student perceptions of the assessment process were generally positive. We were moderately successful in reducing grade inflation. The new process also provides the school with data that can be used to evaluate the effectiveness of our curriculum in preparing students for practice., Conclusions: Development and implementation of a competency-based assessment process require a considerable amount of work from dedicated faculty members. With health professions schools under pressure to provide evidence of their graduates' clinical competence, this is a worthwhile investment.

Objective: To review the pharmacology, pharmacokinetics, efficacy data, and adverse effects of eszopiclone in the treatment of transient and chronic insomnia in adult and geriatric patients., Data Sources: A MEDLINE literature search (1966-May 2005) was conducted to retrieve articles and abstracts involving eszopiclone. The manufacturer of the drug provided a general summary of clinical data and abstracts of unpublished Phase III clinical trials., Study Selection and Data Extraction: All articles identified from the data sources were reviewed, and information deemed relevant was included for this review., Data Synthesis: Food and Drug Administration approval of eszopiclone was based on 6 double-blind, placebo-controlled trials. Five trials published in abstract or study form were reviewed. The sixth trial was not available for evaluation. An open-label continuation trial was also reviewed. All studies showed statistically significant improvements in sleep parameters in adult and elderly patients treated for insomnia with eszopiclone., Conclusions: The results of the 5 available double-blind, placebo-controlled studies (and 1 open-label, 6-month extension) showed that eszopiclone was safe and effective in the treatment of transient and chronic insomnia in adult and geriatric patients. Tolerance with long-term exposure (6 mo) and rebound insomnia were not observed. The results of the 6-month, open-label extension trial demonstrated that improvements in sleep parameters were sustained. Future studies comparing eszopiclone with other non benzodiazepine sedative-hypnotics (eg, zolpidem, zaleplon) are needed with cost data to clearly define the role of eszopiclone in the pharmacotherapy of chronic insomnia.

Objective: To evaluate the literature on the pharmacotherapy of psychosis in the elderly., Data Sources: Searches of MEDLINE (1996-April 2002) and the Cochrane Database using the terms psychosis, elderly, geriatric, dementia, Alzheimer's disease, Parkinson's disease, antipsychotics, atypical antipsychotics, clozapine, risperidone, olanzapine, quetiapine, ziprasidone, and haloperidol were performed. An updated search of psychosis, risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole occurred in April 2003., Study Selection: Reviews, case reports, and open-labeled and controlled trials were selected., Data Synthesis: Psychotic symptoms in the elderly can occur in the context of psychiatric disorders, medical conditions, or as a medication complication. Behavioral problems (e.g., agitation, aggression) can accompany psychosis and may not respond to nonpharmacological strategies. Pharmacological management of psychosis in the elderly with typical antipsychotics (e.g., haloperidol, chlorpromazine) can result in intolerable adverse effects (e.g., sedation, anticholinergic effects, extrapyramidal symptoms, tardive dyskinesia, and orthostatic hypotension). The atypical antipsychotic agents (e.g., risperidone, olanzapine, quetiapine, ziprasidone) and the dopamine-serotonin system stabilizer aripiprazole offer more tolerable adverse effects profiles. Most information supporting the use of the atypical antipsychotics is derived from open-label trials involving patients with dementia or Parkinson's disease; however, data from large randomized, controlled trials is emerging. In general, psychosis in elderly patients responds to low doses of antipsychotics. Patients must be monitored closely for adverse effects, especially in light of the new information associating cerebrovascular adverse events with risperidone in patients with dementia. Further trials are required to determine if this is a disease- or drug-specific phenomenon., Conclusion: Psychosis in elderly patients can be managed with antipsychotic agents. The atypical antipsychotics are effective and offer advantages over typical antipsychotics with regard to a reduced rate of adverse effects.

Objective: To review current issues in the pharmacologic and nonpharmacologic management of insomnia., Data Sources: Controlled trials and case studies identified via MEDLINE for 1990 through April 1999 under the search terms insomnia, hypnotics, flurazepam, quazepam, estazolam, temazepam, triazolam, zolpidem, zaleplon, L-846, CL-284,846, melatonin, and valerian., Data Synthesis: Insomnia is a common, undertreated disorder. Nonpharmacologic management strategies (e.g., stimulus control, relaxation therapy, sleep hygiene) are therapeutic options that, compared with medication use, provide more sustained effects. The benzodiazepines and zolpidem are the most commonly prescribed hypnotic agents, but their use is associated with tolerance and central nervous system adverse effects. A new nonbenzodiazepine hypnotic agent, zaleplon, was very recently approved in the United States. Because of its short half-life, zaleplon will be useful in patients experiencing difficulty in falling asleep and in those who wake up at night and have trouble falling back to sleep. Antidepressants, antihistamines, and alternative medications are other treatment options. To avoid complications of therapy, hypnotic agents should be used at their lowest possible doses and for limited treatment durations., Conclusion: Pharmacotherapy is currently the most common treatment modality for insomnia, but long-term use of hypnotic agents can become complicated by drug tolerance, dependence, or rebound insomnia. Nonpharmacologic options--including combinations of behavioral interventions, sleep-restriction therapy, and patient education--provide longer-lasting benefits.

Objective: To review the clinical presentation and management of cognitive impairment associated with central nervous system HIV type 1 (HIV-1) infection., Data Sources: A MEDLINE search pertaining to HIV-related dementia (HIV-D) and pharmacologic management was performed. Additional literature was obtained from reference lists of the identified articles., Study Selection and Data Extraction: All clinical trials and case reports evaluating pharmacologic efficacy in terms of clinical response, cerebrospinal fluid (CSF) changes, and neuropathology were considered for inclusion. Selection was not restricted by study design because most information consists of open uncontrolled trials and case reports., Data Synthesis: HIV-D is characterized by a triad of disturbances in cognition, motor performance, and behavior in adults. Children present with developmental delay, cognitive impairment, poor brain growth, and other neurologic symptoms. The exact pathophysiologic mechanisms of HIV-D are not known. Numerous pharmacologic agents (e.g., nucleoside reverse transcriptase inhibitors, pentoxifylline, nitroglycerin, memantine, nimodipine, peptide T) are under investigation for management of HIV-D. Zidovudine is the most thoroughly investigated medication, with patients developing HIV-D less frequently and showing improvement on neuropsychological, CSF, and neuropathologic evaluations. Sustained response to zidovudine lasts 6 months to 1 year and optimal response is achieved at higher, but less tolerated, dosages. HIV-D patients frequently have comorbid psychiatric disorders requiring psychopharmacologic agents and are sensitive to the adverse effects of these medications., Conclusions: HIV-D is a devastating complication of HIV-1 infection. Zidovudine is the therapy of choice for prevention and management of cognitive impairment in symptomatic HIV-infected patients and patients with AIDS. Recommendations for other medications cannot be made secondary to lack of data. The management of HIV-D may include multiple agents as more data become available regarding combination therapy. Well-designed controlled trials are needed to evaluate the efficacy of established treatments and investigational medications in the management of HIV-D.

In this pilot study, we compared the economic impact of paroxetine and imipramine treatment of depressed outpatients from a university teaching hospital and a community mental health center. A 12-month retrospective chart review of patients was performed. Clinical outcomes including clinic usage, death, relapse, function, adverse effects, psychiatrist visits, and drug costs were evaluated. We analyzed drug costs, psychiatrist costs, and total direct costs using the Mann-Whitney U Test. The incidence of clinic usage, death, function, adverse effects, and psychiatrist visits was similar in patients treated with paroxetine (n = 12) and imipramine (n = 13). Two patients in the imipramine group were hospitalized once for a total of 5 days compared with none in the paroxetine group. Paroxetine drug costs were significantly higher than imipramine drug costs. Direct total costs (i.e., drug, psychiatrist visits, blood levels, and hospitalization costs) did not differ significantly between the groups based on actual drug usage (paroxetine: median $1,432.50 per patient per year; imipramine: median $1,425.81 per patient per year). Although the median direct total cost per patient per year for patients who received 12 months of therapy was lower in the paroxetine group ($1,479.90, n = 8) than the imipramine group ($1,503.61, n = 8), the difference was not significant. Our cost minimization analysis revealed no significant difference in the total cost between the two groups. However, the major cost in the paroxetine group was drug cost, whereas the major cost in the imipramine group was hospitalizations. Future large prospective trials are needed to validate these findings.

The single-dose bioavailabilities of two extended-release lithium carbonate products and an immediate-release product were compared. Nonsmoking healthy volunteers ages 20-31 (n = 12) were randomly assigned to one of three groups and given three treatments, each separated by a one-week period. The treatments, which were given to each group in a different sequence, consisted of three 300-mg immediate-release lithium carbonate tablets (Lithotab), two 450-mg extended-release lithium carbonate tablets (Eskalith CR), and three 300-mg extended-release lithium carbonate tablets (Lithobid). Blood samples were collected just before drug administration and at intervals up to 48 hours afterward. Urine was collected for 96 hours. Plasma and urine lithium concentrations were determined by flame-emission spectrophotometry, and lithium pharmacokinetic values and the cumulative urinary excretion of lithium were computed. Mean maximum plasma lithium concentration (Cmax) differed significantly among all three lithium carbonate products. Eskalith CR produced a 40% lower Cmax and Lithobid a 25% lower Cmax than Lithotab; Lithobid produced a 23% higher Cmax than Eskalith CR. Lithotab had a significantly shorter mean time to maximum plasma lithium concentration than either extended-release product. Mean cumulative urinary excretion of lithium did not differ significantly among the three products. Two extended-release lithium carbonate products were not bioequivalent when given in single doses to healthy volunteers.