A narrative review of the well-being and burnout of U.S. community pharmacists.

OBJECTIVES: The purpose of this narrative review is to summarize the literature on well-being and burnout among community pharmacists in the U.S. and provide recommendations for future research. METHODS: Relevant literature was identified by searching PubMed for combinations of keywords such as "burnout" and "well-being" combined with "pharmacists." Titles and abstracts were reviewed for relevancy, and full text articles were reviewed when applicable. RESULTS: While burnout is defined by its 3 core symptoms of emotional exhaustion, depersonalization, and low personal accomplishment, well-being is more challenging to define and measure, which has led to it being less studied. Community pharmacists faced high rates of burnout, low quality of life (QOL), and extreme fatigue prior to the COVID-19 pandemic, a situation that has likely only worsened. Factors such as workload, the type of community pharmacy, the level of education or training of the pharmacist, and stress may be some of the contributors to high rates of burnout. Clinician burnout may be related to high rates of mental health disorders seen in pharmacists, may impact patient safety and satisfaction, and may affect productivity and costs to employers and the healthcare system overall. There has been no research into interventions or strategies to support well-being and reduce burnout among community pharmacists, but having a workplace that is perceived as supporting well-being may have some impact. Recommendations for future research include the following: (1) define well-being, (2) explore why various factors support well-being or contribute to burnout, (3) determine the impact of community pharmacists experiencing well-being or burnout, and (4) develop strategies to support well-being and reduce burnout that are specific to community pharmacy. CONCLUSION: There is a sparsity of evidence regarding community pharmacist well-being and burnout. Further research is needed to generate the evidence needed to support interventions that are specific to the unique work setting of community pharmacists.

Navigating the Path to Careers in Academic Pharmacy Administration.

The purpose of this commentary is to discuss the qualifications, responsibilities, and keys to success for pharmacy faculty considering a department (or division) chair (head) or dean (including assistant or associate dean) position. The perspectives are those of a department chair, vice dean, and past dean of colleges of pharmacy with extensive experience in pharmacy administration. The qualifications for these administrative positions vary by institution, particularly with respect to the institution's focus on research. Because the dean is the chief executive officer of a college of pharmacy, previous administrative experience is almost always a basic requirement for the position. For associate/assistant deans and department chairs, previous experience as a faculty member is a typical minimum requirement and may include experience as a department vice chair or director of a unit within the department or division. The dean has a fiduciary duty to university administration, as well as to other external and internal stakeholders, to educate and graduate competent pharmacists and to operate within budget. Associate/assistant deans often have responsibility for specific functions of the college, such as student or professional affairs, and it is common for deans to delegate authority, responsibility, and accountability to associate/assistant deans. Department chairs have a unique perspective with respect to college activities because they must not only think about the "big picture" when considering issues with other college administrators but must oversee the implementation and monitoring of strategic initiatives through the faculty and staff who report to them.

Drug Development for New Psychiatric Drug Therapies.

Drug development is an expensive, high risk, and highly regulated process. Only about 6.2% of new molecules tested for mental disorders eventually achieve Food and Drug Administration (FDA) approval. New molecular entities are produced, and extensive in vitro animal testing is performed before they are evaluated in humans. The compound is used in animals to predict clinical effects in humans, and studies addressing pharmacodynamics, pharmacokinetics, toxicology, and mutagenicity are conducted. Human research proceeds in three stages with the ultimate goal of proving that a new agent is efficacious and safe for a treatment of a specific disease in humans. If efficacy and safety are demonstrated in two Phase III studies, then the sponsor can submit a new drug application (NDA) to the FDA. The FDA oversees each step of the process to assure that good research practices are followed, data integrity is assured, and human research subjects are protected.

A psychometric evaluation of the clinician-rated Quick Inventory of Depressive Symptomatology (QIDS-C16) in patients with bipolar disorder.

The clinician-rated, 16-item Quick Inventory of Depressive Symptomatology (QIDS-C16) has been extensively evaluated in patients with major depressive disorder (MDD). This report assesses the psychometric properties of the QIDS-C16 in outpatients with bipolar disorder (BD, N = 405) and MDD (N = 547) and in bipolar patients in the depressed phase only (BD-D) (N = 99) enrolled in the Texas Medication Algorithm Project (TMAP) using classical test theory (CTT) and the Samejima graded item response theory (IRT) model. Values of coefficient alpha were very similar in BD, MDD, and BD-D groups at baseline (alpha = 0.80-0.81) and at exit (alpha = 0.82-0.85). The QIDS-C16 was unidimensional for all three groups. MDD and BD-D patients (n = 99) had comparable symptom levels. The BD-D patients (n = 99) had the most, and bipolar patients in the manic phase had the least depressive symptoms at baseline. IRT analyses indicated that the QIDS-C16 was most sensitive to the measurement of depression for both MDD patients and for BD-D patients in the average range. The QIDS-C16 is suitable for use with patients with BD and can be used as an outcome measure in trials enrolling both BD and MDD patients.

The use of psychotropic medication for children in foster care.

The use of psychotropic medication for foster children is in itself not unique; however, these children are of particular interest because of the stress associated with their life situations. A thorough assessment of the child and family should occur before beginning these medications, and in general, they should only be used in the presence of a Diagnostic and Statistical Manual, 4th edition, diagnosis of a mental disorder. Parents and caregivers need to be aware of principles of use, potential side effects, and monitoring parameters.

Antipsychotic medication utilization trends among Texas veterans: 1997-2002.

BACKGROUND: An antipsychotic utilization pattern has evolved substantially over the past 20 years or so due to the introduction of the second-generation antipsychotics (SGAs) and the increasing understanding of their adverse effect profile. OBJECTIVE: To understand antipsychotic utilization trends (including monotherapy, antipsychotic switching, and combination therapy) and to investigate factors associated with antipsychotic index medication selection (SGAs vs first-generation antipsychotics [FGAs]) among Texas veterans. METHODS: Data were taken from the Veterans Administration North Texas Health Care System (VANTHCS) and South Texas Veterans Health Care System (STVHCS) from January 1996 to December 2003. Adults with continuous enrollment (1 y before and after the index date) who had newly initiated antipsychotic therapy were included. Prescriptions were followed for up to 12 months. Descriptive analyses examined utilization trends; logistic regression evaluated factors associated with antipsychotic index medication selection. RESULTS: A total of 8096 patients were included in the study (VANTHCS n = 4477; STVHCS n = 3619), with the majority being male (93.6%) and white (62.6%) and nearly half aged 55 years or older (44.1%). Between 1997 and 2002, antipsychotic prescriptions changed from primarily FGAs (1997: 71.7%; 1999: 25.2%; 2002: 5.7%) to SGAs. Over the 6-year time frame, risperidone (31.0%) and olanzapine (30.7%) were most commonly prescribed. The overall combination therapy slightly increased over time (4.3%), switching to another antipsychotic remained stable (14.2%), and antipsychotic monotherapy remained dominant (81.5%). Hispanic and black patients were less likely than white patients to be initiated on SGAs. Patients who were older, had hypertension, and were in STVHCS were less likely to start on SGAs. Patients with dyslipidemia, bipolar disorder, and treatment in recent years were more likely to start on SGAs. CONCLUSIONS: SGAs have replaced FGAs as first-line medications for patients with mental disorders. Race, age, physical comorbidities (ie, dyslipidemia, hypertension), and treatment initiation year were important factors in index medication selection.

Attitudes Toward Medications and the Relationship to Outcomes in Patients with Schizophrenia.

The determinants of attitudes toward medication (ATM) are not well elucidated. In particular, literature remains equivocal regarding the influence of cognition, adverse events, and psychiatric symptomatology. This study evaluated relationships between those outcomes in schizophrenia and ATM. This is a retrospective analysis of data collected during the Texas Medication Algorithm Project (TMAP, n=307 with schizophrenia-related diagnoses), in outpatient clinics at baseline and every 3 months for ≥1 year (for cognition: 3rd and 9th month only). The Drug Attitude Inventory (DAI-30) measured ATM, and independent variables were: cognition (Trail Making Test [TMT], Verbal Fluency Test, Hopkins Verbal Learning Test), adverse events (Systematic Assessment for Treatment-Emergent Adverse Events, Barnes Akathisia Rating Scale), psychiatric symptomatology (Brief Psychiatric Rating Scale, Scale for Assessment of Negative Symptoms [SANS]), and medication adherence (Medication Compliance Scale). Analyses included binary logistic regression (cognition, psychiatric symptoms) and chi-square (adverse events, adherence) for baseline comparisons, and linear regression (cognition) or ANOVA (adverse events, adherence) for changes over time. Mean DAI-30 scores did not change over 12 months. Odds of positive ATM increased with higher TMT Part B scores (p=0.03) and lower SANS scores (p=0.02). Worsening of general psychopathology (p<0.001), positive symptoms (p<0.001), and negative symptoms (p=0.007) correlated with negative changes in DAI-30 scores. Relationships between cognition, negative symptoms, and ATM warrant further investigation. Studies evaluating therapies for cognitive deficits and negative symptoms should consider including ATM measures as endpoints. Patterns and inconsistencies in findings across studies raise questions about whether some factors thought to influence ATM have nonlinear relationships.

Texas Children's Medication Algorithm Project: update from Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder.

OBJECTIVE: To revise and update consensus guidelines for medication treatment algorithms for childhood major depressive disorder based on new scientific evidence and expert clinical consensus when evidence is lacking. METHOD: A consensus conference was held January 13-14, 2005, that included academic clinicians and researchers, practicing clinicians, administrators, consumers, and families. The focus was to review, update, and incorporate the most current data to inform and recommend specific pharmacological approaches and clinical guidance for treatment of major depressive disorder in children and adolescents. RESULTS: Consensually agreed on medication algorithms for major depression (with and without psychosis) and comorbid attention-deficit disorders were updated. These revised algorithms also incorporated approaches to address issues of suicidality, aggression, and irritability. Stages 1, 2, and 3 of the algorithm consist of selective serotonin reuptake inhibitor and norepinephrine serotonin reuptake inhibitor medications whose use is supported by controlled, acute clinical trials and clinical experience. Recent studies provide support that selective serotonin reuptake inhibitors in addition to fluoxetine are still encouraged as first-line interventions. The need for additional assessments, precautions, and monitoring is emphasized, as well as continuation and maintenance treatment. CONCLUSIONS: Evidence and expert clinical consensus support the use of selected antidepressants in the treatment of depression in youths. The use of the recommended antidepressant medications requires appropriate monitoring of suicidality and potential adverse effects and consideration of other evidence-based treatment alternatives such as cognitive behavioral therapies.

Effectiveness and tolerability of aripiprazole in child and adolescent inpatients: a retrospective evaluation.

The objective of this study was to evaluate the effectiveness and tolerability of aripiprazole use in child and adolescent psychiatric inpatients. This was a naturalistic, retrospective evaluation of the discharged patients treated with aripiprazole on the child and adolescent unit at the Austin State Hospital. To be included, patients had to be <18 years of age and treated with aripiprazole for at least two consecutive weeks during their hospital stay. We used a chart extracted Clinical Global Impression of Improvement, and a chart extracted Clinical Global Impression of Severity of Illness score to determine their effectiveness. Adverse events and side effects recorded in the physician or nursing notes were collected to establish tolerability. Forty-five patients met the criteria and were included in this analysis. Average clinical global impression of severity of illness scores at baseline and endpoint were 5.04+/-0.91 and 3.33+/-1.24 respectively. This difference was statistically significant (Wilcoxon's signed-rank test: Z=-5.179, P<0.001). Fifty-one percent of the youth had a clinical global impression of severity of illness score that was much improved or very much improved (clinical global impression of improvement score of 1 or 2). Significant reduction in clinical global impression of severity of illness scores suggests a decline in the symptom severity for patients treated with aripiprazole. On the basis of the reported adverse events and side effects, aripiprazole was generally well tolerated. Randomized controlled trials of aripiprazole in childhood mental disorders are warranted.

Changes and challenges: managing ADHD in a fast-paced world.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) impairs the lives of both children and adults. Undiagnosed and untreated, ADHD may have serious lifelong consequences. Research has identified diagnostic clues, neurotransmitter pathways, and psychiatric comorbidities related to ADHD, as well as effective pharmacologic, behavioral, and psychosocial interventions. Stimulant agents have been the foundation of ADHD therapy for more than 50 years. Availability of new extended-release (XR or ER) and longer-acting (LA) formulations and novel agents allows for wider and more individualized treatment choices. Side effects of stimulants are generally mild, short lived, and responsive to adjustments in dosage or timing. Outcomes in ADHD treatment can be improved with the use of clear treatment guidelines and tools to aid clinicians in implementing them efficiently and effectively. The Texas Children's Medication Algorithm Project (CMAP) provides a system of algorithm-driven treatment decisions that is evidence based and easy to implement. OBJECTIVE: To (1) review the psychological components of attention, the neurotransmitter pathways associated with ADHD, and the array of therapeutic options for ADHD, with an emphasis on the most recent introductions to the therapeutic armamentarium; (2) discuss the rare psychiatric and cardiovascular side effects associated with stimulants; (3) review abuse liability, comorbidities, and suggested approaches to these issues; and (4) review the development and use of CMAP and offer resources for its implementation in clinical practice. CONCLUSION: The pathophysiology of ADHD is linked to dysfunction of fronto-subcortical networks and dysregulation of dopaminergic, noradrenergic, and nicotinic neurotransmitter systems. An additive effect of multiple genes as well as environmental influences contributes to the clinical picture. Treatment with stimulants and nonstimulants has proven effective in different subgroups, with the effectiveness of specific agents most likely related to the primary neurotransmitter involved. Availability of XR, ER, LA, and transdermal stimulant formulations, as well as alternative nonstimulant agents, offers new options for the pharmacotherapy of ADHD. Major concerns associated with abuse liability of stimulants have been allayed by the availability of ER formulations, which have reduced reinforcing effects associated with short-acting preparations. Medication outcomes in ADHD can be enhanced by the use of evidence-based algorithms such as CMAP. Keys to success are adequate initial assessment and diagnosis, the use of sustained-release products, sufficient dose titration, and the use of clinical rating scales with feedback from caregivers and teachers. Optimal treatment outcomes can be achieved by appropriate pharmacotherapy combined with psychosocial interventions.

Implementation of the Texas Medication Algorithm Project patient and family education program.

OBJECTIVE: This article describes the implementation and utilization of the patient and family education program (PFEP) component of the Texas Medication Algorithm Project (TMAP). The extent of participation, types of psychoeducation received, and predictors of receiving at least a minimum level of education are presented. METHOD: TMAP included medication guidelines, a dedicated clinical coordinator, standardized assessments of symptoms and side effects, uniform documentation, and a PFEP. The PFEP includes phased, multimodal, disorder-specific educational materials for patients and families. Participants were adult outpatients of 1 of 7 community mental health centers in Texas that were implementing the TMAP disease management package. Patients had DSM-IV clinical diagnoses of major depressive disorder, with or without psychotic features; bipolar I disorder or schizoaffective disorder, bipolar type; or schizophrenia or schizoaffective disorder. Assessments were administered by independent research coordinators. Study data were collected between March 1998 and March 2000, and patients participated for at least 1 year. RESULTS: Of the 487 participants, nearly all (95.1%) had at least 1 educational encounter, but only 53.6% of participants met criteria for "minimum exposure" to individual education interventions. Furthermore, only 31.0% participated in group education, and 42.5% had a family member involved in at least 1 encounter. Participants with schizophrenia were less involved in the PFEP across multiple indicators of utilization. Diagnosis, intensity of symptoms, age, and receipt of public assistance were related to the likelihood of exposure to minimum levels of individual education. CONCLUSION: Despite adequate resources and infrastructure to provide PFEP, utilization was less than anticipated. Although implementation guidelines were uniform across diagnoses, participants with schizophrenia experienced less exposure to psychoeducation. Recommendations for improving program implementation and modification of materials are discussed.

The Texas Children's Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder.

OBJECTIVE: In 1998, the Texas Department of Mental Health and Mental Retardation developed algorithms for medication treatment of attention-deficit/hyperactivity disorder (ADHD). Advances in the psychopharmacology of ADHD and results of a feasibility study of algorithm use in community mental health centers caused the algorithm to be modified and updated. METHOD: We convened a consensus conference of academic clinicians and researchers, practicing clinicians, administrators, consumers, and families to revise the algorithms for the pharmacotherapy of ADHD itself as well as ADHD with specific comorbid disorders. New research was reviewed by national experts, and rationales were provided for proposed changes and additions to the algorithms. The changes to the algorithms were discussed and approved both by the national experts and experienced clinicians from the Texas public mental health system. RESULTS: The panel developed consensually agreed-upon algorithms for ADHD with and without comorbid disorders. The major changes included elimination of pemoline as a treatment option, adding atomoxetine to the algorithm, and refining guidelines for treating ADHD with comorbid depression, aggressive behaviors, and tic disorders. CONCLUSIONS: Medication algorithms for ADHD can be modified to keep abreast of developments in the field. Although these evidence- and consensus-based treatment recommendations may be a useful approach to guide the treatment of ADHD in children, additional research is needed to determine how these algorithms can be used to maximally benefit child outcomes.

Comparison of self-report and clinician ratings on two inventories of depressive symptomatology.

OBJECTIVE: This study evaluated the concordance between the self-report and the clinician-rated versions of the Inventory of Depressive Symptomatology (IDS-30) and between the two versions of the briefer 16-item Quick Inventory of Depressive Symptomatology (QIDS-16). METHODS: Data were gathered for 544 adult outpatients with psychotic (N = 106) or nonpsychotic (N = 438) major depressive disorder at 14 public sector mental health clinics in the Texas Medication Algorithm Project. Data for the QIDS-16 were extracted from the IDS-30. Baseline scores and scores from the final study visit at or before month 12 were analyzed. The clinician-rated and the self-report versions of each scale were compared in their identification of response to treatment and remission. RESULTS: The average baseline IDS-SR-30 total score was 2.2 points higher (indicating greater severity) than the IDS-C-30 score; the average QIDS-SR-16 total score was only .3 points higher than the QIDS-C-16 score. The IDS-SR-30 and the IDS-C-30, as well as the QIDS-C-16 and QIDS-SR-16, agreed substantially in classifying response and remission for patients, regardless of whether the patients had psychotic features. None of a large number of clinical and demographic features accounted for differences between the QIDS-SR-16 and QIDS-C-16 total scores. CONCLUSIONS: Either the IDS-30 or the QIDS-16 self-report adequately assesses depressive symptom severity among public-sector outpatients with major depressive disorder. The briefer QIDS-16 may be preferred to save time and cost.

An empirical analysis of cost outcomes of the Texas Medication Algorithm Project.

OBJECTIVE: Disease management systems that incorporate medication algorithms have been proposed as cost-effective means to offer optimal treatment for patients with severe and chronic mental illnesses. The Texas Medication Algorithm Project was designed to compare health care costs and clinical outcomes between patients who received algorithm-guided medication management or usual care in 19 public mental health clinics. METHODS: This longitudinal cohort study for patients with major depression (N=350), bipolar disorder (N=267), and schizophrenia (N=309) applied a multi-part declining-effects cost model. Outcomes were assessed by the Inventory of Depressive Symptomatology and the Brief Psychiatric Rating Scale. RESULTS: Compared with patients in usual care, patients in algorithm-based care incurred higher medication costs and had more frequent physician visits, although these differences often became smaller with time. For major depression, algorithm-based care achieved better outcomes sustainable with time but at higher agency and non-agency costs (mixed cost-effective). For bipolar disorder, patients in algorithm-based management achieved better outcomes at lower agency costs (cost-effective). For schizophrenia, patients in algorithm-based care achieved better outcomes that diminished with time, with no detectable difference in health care costs (cost-effective). CONCLUSIONS: Cost outcomes of algorithm-based care and usual care varied by disorder and over time. For bipolar disorder and schizophrenia, algorithm-based care improved outcomes without higher costs for health care services. For major depression, substantively better and sustained outcomes were obtained but at greater costs.

The Texas implementation of medication algorithms: update to the algorithms for treatment of bipolar I disorder.

BACKGROUND: A panel consisting of academic psychiatrists and pharmacist administrators of the Texas Department of State Health Services (formerly Texas Department of Mental Health and Mental Retardation), community mental health physicians, advocates, and consumers met in May 2004 to review new evidence in the pharmacologic treatment of bipolar I disorder (BDI). The goal of the consensus conference was to update and revise the current treatment algorithm for BDI as part of the Texas Implementation of Medication Algorithms, a statewide quality assurance program for the treatment of major psychiatric illness. The guidelines for evaluating possible medications, the criteria for selection and ranking, and the updated algorithms are described. METHOD: Principles from previous consensus conferences were reviewed and amended. Medication algorithms for the acute treatment of hypomanic/manic or mixed and depressive episodes in BDI were developed after examining recent efficacy and safety and tolerability data. Recommendations for maintenance treatments were developed. RESULTS: The panel updated the 2 primary algorithms (hypomanic/manic/mixed and depressive) based on clinical evidence for efficacy, tolerability, and safety developed since 2000. Expert consensus was utilized where clinical evidence was limited. Prevention of new episodes or prophylaxis treatment recommendations were developed based on recent data from longer-term trials. Maintenance recommendations are provided as levels versus a specified staged algorithm, as for acute treatment, due to the relatively limited database to inform treatment. CONCLUSIONS: These algorithms for the treatment of BDI represent the recommendations based on the most recent evidence available. These recommendations are meant to provide a framework for clinical decision making, not to replace clinical judgment. As with any algorithm, treatment practices will evolve beyond the recommendations of this consensus conference as new evidence and additional medications become available.

Trends in the use of typical and atypical antipsychotics in children and adolescents.

OBJECTIVE: To estimate prevalence rates of antipsychotic use in children and adolescents from 1996 to 2001 in three state Medicaid programs (midwestern [MM], southern [SM], and western [WM]) and one private managed care organization (MCO). METHOD: Prescription claims were used to evaluate antipsychotic prevalence, defined as the number of children and adolescents up to the age of 19 years with at least one prescription claim for an antipsychotic per 1,000 enrolled youths. RESULTS: From 1996 to 2001, the prevalence of total antipsychotic use increased in each program (MM: 4.7 to 14.3 per 1,000; SM: 6.3 to 15.5; WM: 4.5 to 6.9; and MCO: 1.5 to 3.4). Typical antipsychotic use decreased (MM: 3.7 to 2.0 per 1,000; SM: 4.6 to 1.5; WM: 4.4 to 1.3; and MCO: 1.2 to 0.9), while atypical antipsychotic use dramatically increased (MM: 1.4 to 13.1 per 1,000; SM: 2.5 to 14.9; WM: 0.3 to 6.2; and MCO: 0.4 to 2.7). CONCLUSIONS: The increased prevalence of antipsychotic use in children and adolescents from 1996 to 2001 was attributed to increased use of atypical antipsychotics. Given the limited data with atypical antipsychotics in youths, this emphasizes the need for additional studies of these agents and other treatment modalities in this population.

Duloxetine hydrochloride: a new dual-acting medication for the treatment of major depressive disorder.

BACKGROUND: Duloxetine hydrochloride has recently been approved by the US Food and Drug Administration for the treatment of major depressive disorder (MDD). Duloxetine is a potent inhibitor of serotonin and norepinephrine reuptake, with weak effects on dopamine reuptake. OBJECTIVE: This article reviews the literature on duloxetine with regard to its pharmacodynamics, pharmacokinetics, clinical efficacy, and tolerability. METHODS: A comprehensive search of MEDLINE was performed using the terms duloxetine, Cymbalta, and major depressive disorder, with no restriction on year. The Eli Lilly and Company clinical trial registry, and abstracts and posters from recent American Psychiatric Association meetings were also reviewed. RESULTS: Duloxetine exhibits linear, dose-dependent pharmacokinetics across the approved oral dosage range of 40 to 60 mg/d. No dose adjustment appears to be needed based on age. Duloxetine has shown efficacy in reducing depressive symptoms compared with placebo, and duloxetine recipients have shown significant improvements in global functioning compared with placebo (both, P < 0.05). Response and remission rates have been comparable to or greater than those seen with fluoxetine or paroxetine. Duloxetine is generally well tolerated, with nausea, dry mouth, and fatigue being the most common treatment-emergent adverse effects. Cardiovascular adverse effects do not appear to result in sustained blood pressure elevations, QTc-interval prolongation, or other electrocardiographic changes. CONCLUSIONS: Based on the available evidence, duloxetine is a well-tolerated and effective treatment for MDD in adults. Randomized head-to-head comparisons against established antidepressants are needed to determine the relative safety and efficacy of duloxetine.

Clinical results for patients with major depressive disorder in the Texas Medication Algorithm Project.

CONTEXT: The Texas Medication Algorithm Project is an evaluation of an algorithm-based disease management program for the treatment of the self-declared persistently and seriously mentally ill in the public mental health sector. OBJECTIVE: To present clinical outcomes for patients with major depressive disorder (MDD) during 12-month algorithm-guided treatment (ALGO) compared with treatment as usual (TAU). DESIGN: Effectiveness, intent-to-treat, prospective trial comparing patient outcomes in clinics offering ALGO with matched clinics offering TAU. SETTING: Four ALGO clinics, 6 TAU clinics, and 4 clinics that offer TAU to patients with MDD but provide ALGO for schizophrenia or bipolar disorder. Patients Male and female outpatients with a clinical diagnosis of MDD (psychotic or nonpsychotic) were divided into ALGO and TAU groups. The ALGO group included patients who required an antidepressant medication change or were starting antidepressant therapy. The TAU group initially met the same criteria, but because medication changes were made less frequently in the TAU group, patients were also recruited if their Brief Psychiatric Rating Scale total score was higher than the median for that clinic's routine quarterly evaluation of each patient. MAIN OUTCOME MEASURES: Primary outcomes included (1) symptoms measured by the 30-item Inventory of Depressive Symptomatology-Clinician-Rated scale (IDS-C(30)) and (2) function measured by the Mental Health Summary score of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) obtained every 3 months. A secondary outcome was the 30-item Inventory of Depressive Symptomatology-Self-Report scale (IDS-SR(30)). RESULTS: All patients improved during the study (P<.001), but ALGO patients had significantly greater symptom reduction on both the IDS-C(30) and IDS-SR(30) compared with TAU. ALGO was also associated with significantly greater improvement in the SF-12 mental health score (P =.046) than TAU. CONCLUSION: The ALGO intervention package during 1 year was superior to TAU for patients with MDD based on clinician-rated and self-reported symptoms and overall mental functioning.

Assessment of adherence measures with different stimulants among children and adolescents.

STUDY OBJECTIVE: To examine adherence measures with different stimulants in children and adolescents. DESIGN: Retrospective analysis. DATA SOURCE: Texas Medicaid prescription claims database. PATIENTS: A total of 9549 patients aged 5-18 years with attention-deficit-hyperactivity disorder. MEASUREMENTS AND MAIN RESULTS: Paid prescription claims for newly started stimulants during the 2001-2002 school year were extracted from a database; 28,344 prescriptions (9549 patients) were available for analysis. Adherence was evaluated based on the drug therapy prescribed (i.e., mixed amphetamine salts, immediate-release methylphenidate, and extended-release methylphenidate-OROS [oral-osmotic formulation]) and the age and sex of the patient. Adherence measures were persistence and medication possession ratio (MPR). Persistence was higher for extended-release methylphenidate-OROS (0.50 +/- 0.33) than for mixed amphetamine salts (0.42 +/- 0.29) or immediate-release methylphenidate (0.37 +/- 0.26; p < 0.001). The MPR was also higher for extended-release methylphenidate-OROS (0.76 +/- 0.37) than for mixed amphetamine salts (0.73 +/- 0.37) or immediate-release methylphenidate (0.69 +/- 0.37; p < 0.001). Patients aged 5-9 years had equal or better persistence and MPR than those aged 10-14 and 15-18 years (p < 0.001). No sex-related differences in adherence were observed. CONCLUSION: Adherence measures in our study were low. Although they were significantly better for extended-release methylphenidate-OROS than the other stimulants, the clinical significance of these differences are unclear. Further research should be conducted regarding pharmaceutical products, administration methods, and clinical interventions that may enhance adherence.

Drug adherence: effects of decreased visit frequency on adherence to clozapine therapy.

OBJECTIVE: To study the effects of visit frequency on drug-adherence parameters subsequent to the change in the United States Food and Drug Administration (FDA)-mandated monitoring of white blood cell counts from weekly to every 2 weeks (biweekly) after 6 months of clozapine therapy. METHODS: Paid prescription claims records for clozapine from September 1, 1995-August 31, 2001, were extracted from the Texas Medicaid Vendor Drug Program database. Two groups of subjects were identified: subjects treated before and those treated after the FDA labeling change in monitoring frequency, which occurred on April 1, 1998. Prescription claims records for each subject were assessed for 365 days after the initial 6 months of therapy. Adherence measures included persistence, medication possession ratio (MPR), and time taking clozapine. RESULTS: Subjects receiving weekly hematologic monitoring had significantly higher rates of persistence (0.79 +/- 0.35 vs 0.70 +/- 0.38, p < 0.001) and MPRs (0.75 +/- 0.36 vs 0.66 +/- 0.38, p < 0.001) and continued to take clozapine longer (p < 0.002) compared with subjects receiving biweekly monitoring. Fewer subjects in the weekly monitoring group discontinued clozapine therapy during the 1-year study period (49.4% vs 57.9%, p = 0.008). Similar results were observed when cohorts were matched according to age, sex, and index clozapine dosage. CONCLUSION: Significant effects of visit frequency on adherence to clozapine therapy were noted. For patients inadequately adherent to therapy, an increase in visit frequency may improve adherence, and based on these results, the extra visits do not need to be with a physician or have any specific purpose other than contact with a provider.