Assessing suboxone access in community pharmacies: Secret shopper model.

Objective: To assess whether Maryland community pharmacies had Suboxone available for dispensing. Methods: This cross-sectional study used a secret shopper model to contact public-facing community pharmacies in Maryland. The secret shopper, guided by a script, asked whether a prescription for Suboxone was available for the same or next day pick-up. A small convenience sample of pharmacies who did not have Suboxone available received an in-person visit to inquire about medication availability and dispensing barriers. Results: After contacting 99% (n = 1046) of Maryland public-facing pharmacies, Suboxone was confirmed available for immediate pick-up in 31% (n = 326). The remaining did not have, would not disclose, or had limited access (existing patients or specific providers only). Significant differences in Suboxone availability were found for National Capital vs. Baltimore metro region and when pharmacist asked questions vs. no questions. Of the 11 pharmacy visits completed, 10 said they had Suboxone currently in stock, with one clarifying medication was for existing patients only. Conclusion: About 69% of patients may face challenges when calling to find out whether they can obtain Suboxone in Maryland pharmacies. Better patient education and more thorough pharmacy-level investigation of system and workflow barriers could offer solutions.

Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

Anti-aggressive effects of clozapine in involuntarily committed black patients with severe mental illness.

INTRODUCTION: Patients with severe mental illness are falsely characterized as aggressive by the media, perpetuating stigma. While exaggerated, some patients with severe mental illness are more aggressive without treatment. Clozapine may have a unique anti-aggressive effect in patients with schizophrenia-related disorders, independent of antipsychotic or sedative effects. Limited data in forensic and involuntary committed patients is currently available. PURPOSE: This study evaluates clozapine's effects on hostility and aggression in court-ordered Black patients. METHODS: This study analyzes a subgroup of Black patients from a larger prospective 24-week open-label clozapine study. All patients were involuntarily committed and enrolled from two participating state psychiatric hospitals. The primary outcome measured was total use of 'as needed' (PRN) or 'immediate need' (STAT) medications for aggression/hostility. Secondary outcomes included number and duration of seclusion and restraint (S/R) episodes, and changes in Brief Psychiatric Rating Scale (BPRS) hostility factor score. RESULTS: Sixty-nine patients were included in our analysis. Significant reductions were noted in PRN/STAT medication use over time (χ2 = 6.90; p = 0.008) and the BPRS hostility factor score was reduced by 30% over the 24 weeks (F = 4.34, df = 62, p = 0.002). CONCLUSIONS: Treatment with clozapine effectively reduced hostility and aggression within this cohort of involuntarily committed Black patients with mental illness compared to baseline. Specifically, it helped lower the total number of PRN/STAT medication administrations and improved clinician-rated hostility factor scores on the BPRS. Our findings are pertinent as data in forensic settings is lacking and Black patients have been infrequently included in large prospective clinical trials with clozapine. GOV IDENTIFIER: NCT02404155.

Implementation of academic detailing for pharmacists on opioid use disorder and harm reduction.

BACKGROUND: The United States is experiencing an opioid crisis, substantially worsened by the pandemic. Pharmacists play a critical role in expanding access to care through harm reduction efforts and medications to treat opioid use disorder (mOUD), yet lack necessary education and resources. Academic detailing is a one-on-one technique, which can effectively address educational gaps. OBJECTIVE: The purpose was to assess needs and equip pharmacy staff to address the health of people with substance use disorders (SUD). PRACTICE DESCRIPTION: Community pharmacists provide ongoing care for patients with SUD. PRACTICE INNOVATION: Based on needs' assessment findings, an academic detailing program was designed to provide education and resources for community pharmacies. The project sought to assess current practice and needs and address pharmacists' skills in managing patients with opioid use disorder (OUD) and/or at risk for overdose (OD). Visits were scheduled in high-risk regions. Coaching and materials were provided. EVALUATION METHODS: Detailers completed visits reports. Discrete variables were reported using descriptive statistics. Associations between discrete variables were detected with Chi-square or Fisher's exact test. RESULTS: Detailers visited 136 pharmacies. Most stocked naloxone (86.8%), mOUD (94.9%) and would sell syringes (64%) per state law. Fifty-seven percent of pharmacies provided all of these services. However, additional education and resources were needed. Only 27.9% had naloxone signage and/or handouts; 22.1% had supplemental materials; and 25% had referral information. When asked to explain barriers, frequently cited themes included providing resources/help, financial issues, stigma, and transportation. CONCLUSION: Pharmacists routinely care for patients at risk for OD and diagnosed with OUD. Academic detailing is a well-received strategy to disseminate education and materials, while gathering information about pharmacist needs and barriers. However, there remains room for expansion of services and opportunities for improved care. Further efforts should incorporate ongoing training and access to materials with visual cues, as well as referral and cost savings information.

The Role of Board-Certified Psychiatric Pharmacists in Expanding Access to Care and Improving Patient Outcomes.

Although approximately 20% of adults in the United States experience a mental health condition annually, there continues to be a gap in the provision of care because of a shortage of behavioral health providers. The National Council for Behavioral Health Medical Director Institute has recommended that the number of board-certified psychiatric pharmacists (BCPPs), who are clinical pharmacists with advanced specialized training and experience in the treatment of patients with psychiatric and substance use disorders, be expanded to help meet this need. Although BCPPs currently assist in expanding care access, improving medication-related outcomes, and reducing health care costs by working collaboratively with physicians and other health care providers, BCPPs are often underutilized. This lack of utilization results in lost opportunity to better address the needs of persons with psychiatric or substance use disorders and to meet these needs in a timely manner. Here, the authors bring attention to five key areas-opioid use disorder, antipsychotic use among children, long-acting injectable antipsychotics, clozapine use, and transitions of care and care coordination-in which BCPPs, along with other pharmacists, provide evidence-based care and could be more extensively used as a collaborative solution to the mental health and substance use disorder crisis in the United States.

Comparison of Novel Immunoassay With Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) for Therapeutic Drug Monitoring of Clozapine.

BACKGROUND: Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia. Although serum clozapine levels can help guide treatment, they are underutilized owing to requirements for frequent venous blood draws and lack of immediate results. METHODS: Clozapine levels measured with a novel immunoassay technology (which enables point-of-care development) were compared with those measured by standard liquid chromatography/tandem mass spectrometry (LC-MS/MS). Frozen serum aliquots of 117 samples (N = 48 patients with schizophrenia on clozapine; N = 24 patients with schizophrenia not on clozapine; N = 45 healthy controls) were sent to a national reference laboratory (NRL) for clozapine level determination by LC-MS/MS, and matching samples were subjected to novel immunoassay (3 runs). At a later date, another frozen aliquot from the same date was sent to the NRL for repeat testing. RESULTS: The NRL obtained 18 false-positive clozapine results (mean 42.39 ± 32.06, range 21-159 ng/mL) in participants not on clozapine (N = 3) and healthy controls (N = 15). The immunoassay showed no false-positive clozapine results. The clozapine levels were correlated between both assays (r = 0.84, P < 0.0001), despite 16% higher clozapine levels with immunoassay (482.08 ± 270.88 ng/mL immunoassay, 414.98 ± 186.29 ng/mL LC-MS/MS [P = 0.03]). Agreement analysis using concordance correlation coefficient (CCC) for LC-MS/MS of the 2 aliquots yielded CCC = 0.869; 95% confidence interval = 0.690-0.970, whereas higher agreement results were observed for the 3 runs of immunoassay (CCC = 0.99; 95% confidence interval = 0.979-0.997). CONCLUSIONS: The lack of false positives observed with immunoassay, higher repeat performance agreement, and good correlation with LC-MS/MS may indicate the more robust performance of immunoassay than that of LC-MS/MS clozapine-level determination.

Effects of Cigarette Smoking and Clozapine Treatment on 20-Year All-Cause & Cardiovascular Mortality in Schizophrenia.

To estimate 20-year mortality risk in people with schizophrenia treated with second-generation antipsychotics (SGA) and examine the effects of cigarette smoking on mortality. Of the 1199 individuals with schizophrenia in the study, estimated 20-year all-cause mortality risk by Kaplan Meier Curve was 30% and leading causes of death included 27% cardiovascular disease, 13% cancer, 12% non-HIV infection, 5% respiratory causes, 20% other causes and 18% had unknown cause of death. For all-cause mortality, we found that white race and male sex were significant risk factors (HR = 1.5, p = 0.002 and HR = 1.33, p = 0.033, respectively). For cardiovascular mortality risk, we showed that cigarette smokers and white race were at higher risk (HR = 1.86, p = 0.017 and HR = 1.71, p = 0.045, respectively). Cardiovascular mortality risk at 20-years is 11%. Kaplan-Meier Survival Curve showed a statistical difference for smokers and non-smokers in cardiovascular mortality over the 20-year follow-up (Log rank chi-square = 5.35, df = 1, p = 0.02). 20-year all-cause mortality risk for individuals with schizophrenia was found to be 30% with cardiovascular disease as a leading cause. Cigarette smokers and white race were associated with an increased risk of death. Regarding cardiovascular mortality specifically, cigarette smoking increased risk by 86% over a 20-year period. Clozapine was neither a risk factor for all-neither cause nor cardiovascular mortality. This data suggests that long-term cardiovascular mortality continues to be increased in schizophrenia for those who are or have been cigarette smokers.

Important drug interaction involving phenytoin and quetiapine.

OBJECTIVE: To describe a patient case in which a drug interaction involving quetiapine and phenytoin resulted in an absence of clinical response and serum quetiapine levels below the point of detection. CASE SUMMARY: This patient was on concurrent phenytoin, valproic acid, and quetiapine therapy for 10 months. Prior to discontinuing phenytoin, a serum quetiapine level was found to be less than 10 ng/mL. It took approximately 1 month after phenytoin's discontinuation for quetiapine levels to attain measurable concentrations. The patient's clinical response to quetiapine improved significantly after this interaction resolved. DISCUSSION: Phenytoin is an inducer of cytochrome P450 3A4, and quetiapine is a substrate of this enzyme. Patients on concurrent phenytoin and quetiapine therapy may require monitoring of quetiapine concentrations, which is often not routine practice, as this drug interaction can result in a clinically significant reduction in quetiapine levels contributing to a lack of efficacy.

Adjunctive Minocycline in Clozapine-Treated Patients with Schizophrenia: Analyzing the Effects of Minocycline on Clozapine Plasma Levels.

Clozapine is the sole antipsychotic agent effective for the treatment of refractory schizophrenia. Sixty percent of clozapine-treated patients, however, fail to adequately respond. Minocycline, a tetracycline antibiotic, possesses antiinflammatory and neuroprotective properties that may play a role in schizophrenia. Clozapine is mainly metabolized by CYP1A2 enzymes, and minocycline may potentially inhibit CYP1A2 as hypothesized by case report data. To date, no pharmacokinetic interaction has been reported between minocycline and clozapine. This is a secondary analysis of a 10-week controlled study of adjunctive minocycline to clozapine in treatment refractory schizophrenia. Clozapine plasma levels were collected every two weeks during the study. 28 participants assigned to receive minocycline and 22 assigned to placebo were included. No differences existed in baseline demographics, clozapine dose or plasma levels. Average changes from baseline in clozapine plasma level (p = 0.033) were significantly higher in the minocycline group despite maintenance of stable doses. No statistically significant treatment differences were found in the norclozapine (p = 0.754) or total clozapine (p = 0.053) changes in plasma levels, although possible changes in total clozapine levels require further investigation. This analysis suggests that minocycline administration may lead to increased clozapine plasma levels. Further study is needed to examine possible explanations.

Residents as preceptors and educators: What we can learn from a national survey to improve our residency programs.

INTRODUCTION: Developing pharmacy residents into effective preceptors is essential to meet the demands of pharmacy education. A survey was created to assess the availability of resident precepting educational opportunities, identify common barriers associated with developing preceptors' skills, and discover strategies to optimize programming. METHODS: An online survey focused on the development of residents as preceptors was e-mailed to all residency program directors (RPD) for American Society of Health-System Pharmacists accredited residencies in the United States. Information was collected on program demographics, level of support and precepting activities offered and resident employment outcomes. RESULTS: Five hundred thirty-eight responses were received. The majority were postgraduate year one RPDs and had less than six residents. Sixty-one percent of programs were affiliated with a college of pharmacy. Seventy-eight percent devoted 10hours or less per month in developing residents as preceptors with 33% providing less than five hours. Seventy-one percent of the residency programs did not offer a formal precepting rotation. However, 59% of respondents indicated that their residency graduates frequently accepted positions, which required teaching/precepting. The most common barriers to developing residents as preceptors included: lack of time for residents to precept within the residency structure (41%), availability of preceptors to mentor residents throughout experience (33%) and lack of preceptors' availability to mentor residents' precepting abilities over time (30%). DISCUSSION AND CONCLUSIONS: RPDs should prioritize training of residents as preceptors. Requiring residents to serve as primary preceptors in rotations dedicated to teaching is important to prepare for future job responsibilities.

Blood Pressure and Heart Rate Changes During Clozapine Treatment.

People with schizophrenia are 3-4 times more likely to die from cardiovascular disease than the general population. Clozapine (CLZ) is the gold standard of treatment for refractory schizophrenia. It has been associated with tachycardia and recent evidence shows individuals prescribed CLZ may develop blood pressure (BP) elevation and hypertension. The purpose of this study was to examine the effects of CLZ on BP and heart rate (HR). This was a retrospective chart review of patients 18-75 years old with a DSM IV diagnosis of Schizophrenia or Schizoaffective disorder. Primary outcomes were systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR measured 12 weeks before and 24 weeks during CLZ treatment. Eighteen patient records were included in this study. The mean stabilized CLZ dose was 441.7 ± 171.8 mg/day. DBP (t = 1.02, df = 79.5, = 2.00, 0.049) and HR (t = 1.32, df = 355  = -4.61, < 0.0001) were significantly higher after CLZ initiation. A trend was noted for increase in SBP (p = 0.071). 22 % of patients met criteria for hypertension before CLZ and 67 % during CLZ treatment (Chi Square = 6.25, df = 1, p = 0.0124). No significant changes in weight or renal function occured during CLZ treatment. No patients had evidence of cardiomyopathy. The data suggest CLZ may be associated with a rise in BP and HR. The results of this study support previous literature that found an increase in SBP/DBP regardless of CLZ dose, occurring early in treatment. Due to high risk of cardiovascular morbidity and mortality, more work is needed to determine risk factors and understand the mechanism of action that may cause this side effect.

Evaluation of the Safety of Clozapine Use in Patients With Benign Neutropenia.

OBJECTIVE: To determine if clozapine can be safely utilized in psychiatric patients with benign neutropenia. METHODS: A single-center, retrospective chart review study of records from 2001 to 2014 was conducted in an inpatient psychiatric hospital. Patients included had benign neutropenia prior to receiving clozapine and received clozapine using modified monitoring guidelines. All available laboratory values for absolute neutrophil count (ANC) before initiation and during treatment were evaluated. The primary endpoint was difference in ANC after initiation of clozapine from before clozapine. RESULTS: A total of 26 patients were reviewed. The mean age at clozapine initiation was 34 years. The majority were African-American (73% [n = 19]), with more men than women (73% [n = 19] vs 27% [n = 7]). The mean lowest ANC value was not significantly different after clozapine initiation compared to before (1.5× 10³ cells/mm³ and 1.4 × 10³ cells/mm³, respectively; P = .22). The overall mean ANC was significantly higher after initiation than before (2.63 × 10³ cells/mm³ and 2.13 × 10³ cells/mm³, respectively; P < .001). There were no cases of severe neutropenia (ANC < 0.5 × 10³ cells/mm³), and no patient was discontinued for falling below modified guideline limits. There were fewer occurrences of mild neutropenia (ANC < 2.0 × 10³ cells/mm³) after clozapine initiation than before (16.0% and 31.4%, respectively; P < .001). There were also fewer occurrences of moderate neutropenia (ANC < 1.5 × 10³ cells/mm³), with 2.1% after clozapine and 13.3% before (P < .001). CONCLUSIONS: Twenty-six patients with benign neutropenia were safely treated with clozapine. Pre-clozapine neutropenia did not predict increased risk for severe neutropenia with clozapine. Patients had significantly fewer episodes of mild and moderate neutropenia after receiving clozapine compared to before.

Urine testing for antipsychotics: a pilot trial for a method to determine detection levels.

OBJECTIVE: The goal of the present study was to demonstrate that the analytical assay of interest can detect antipsychotics in human urine specimens. METHOD: Forty inpatients treated with haloperidol, quetiapine, risperidone, or olanzapine were recruited to participate in a one visit study. During the study visit, demographic and clinical information was collected as well as one urine sample that was forwarded to the Ameritox Laboratory and assayed for the presence of antipsychotic medications and/or metabolites. Urine samples were analyzed to determine detection sensitivity for four antipsychotic medications and their metabolites (risperidone, quetiapine, olanzapine, and/or haloperidol) using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry. RESULTS: All urine samples produced positive results for the antipsychotic(s) the participants were known to be taking. Urine concentrations (level of quantification) for parent drugs ranged from <25-417 ng/mL for haloperidol, <25-4017 ng/mL for quetiapine, 0-997 ng/mL for risperidone, and 57-700 ng/mL for olanzapine. CONCLUSION: The analytical assay produced by Ameritox, Ltd using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry can qualitatively detect antipsychotics in human urine specimens. The present study highlights the potential utility of the urine assay to help monitor adherence to antipsychotic medications.

Physician-pharmacist collaborative care model for buprenorphine-maintained opioid-dependent patients.

OBJECTIVES: To develop a physician-pharmacist collaborative practice for opioid-dependent patients designed to increase access to treatment, optimize patient care, reduce cost, minimize physician burden, and prevent diversion. SETTING: Suburban health department. PRACTICE DESCRIPTION: Physician-pharmacist buprenorphine/naloxone maintenance practice. PRACTICE INNOVATION: Traditionally, health department buprenorphine/naloxone patients have been referred to community physicians at considerable cost with varying outcomes. In this pilot project, patients were managed using a drug therapy management model. Intake assessments and follow-up appointments were conducted by the pharmacist. The pharmacist debriefed with the physician and documented each interaction, allowing for efficient assessment completion. The physician appended notes, when applicable, and cosigned each patient's record. The pharmacist prevented diversion by gathering data from outside providers, pharmacies, and laboratories. RESULTS: This health department program improved care by producing structure and expanding treatment options. A total of 12 patients completed full intakes with 135 follow-up appointments equating to an estimated savings of $22,000. The program demonstrated a 91% attendance rate, 100% 6-month retention rate, and 73% 12-month retention rate. Overall, 127 (98%) urine toxicology screens were positive for buprenorphine and 114 (88%) were positive for buprenorphine and negative for opioids. CONCLUSION: Physician and pharmacist collaboration optimized care of buprenorphine-maintained patients. Data from this pilot were used to develop a permanent physician-pharmacist program and to obtain approval for the first state-approved opioid use disorder drug therapy management protocol.

Failure to fill electronically prescribed antidepressant medications: a retrospective study.

OBJECTIVE: Nonadherence to antidepressants has been reported to range widely from 10% to 60%. Most adherence studies focus on persistence of use and do not include prescriptions that are not picked up by the patient. The objectives of this study were to determine the rate of unfilled antidepressant prescriptions as well as to identify factors associated with failure to fill these prescriptions. METHOD: This retrospective study used administrative and pharmacy data from a mid-Atlantic managed care organization serving 3.3 million medical members and 1.2 million pharmacy members. Electronic prescriptions for citalopram, duloxetine, sertraline, and venlafaxine sent to pharmacies from July 1, 2007, to June 30, 2009, were matched to pharmacy claims to determine the rate of unfilled antidepressant prescriptions. Patients were ≥18 years of age and had continuous pharmacy coverage from July 1, 2006, to July 31, 2009. Logistic regression was used to assess whether clinical and demographic factors were associated with unfilled electronic prescriptions. RESULTS: There were 557 electronically prescribed antidepressants for 267 patients. The rate of unfilled electronic prescriptions was 13.1%, which affected 19.9% of patients. Electronic prescriptions for new users of the antidepressant were 5 times more likely to be unfilled (odds ratio [OR]=5.13; 95% CI, 2.66-9.91; P<.001) than those for previous users. Antidepressant prescriptions for patients aged 18-34 years were most likely to be unfilled (OR=3.72; 95% CI, 1.81-7.67; P<.001). CONCLUSIONS: Nonadherence to antidepressants is a significant problem with one-fifth of patients never receiving their electronically prescribed antidepressant. Prescriptions for patients without a previous antidepressant claim and aged 18-34 years were least likely to be filled. Interventions targeting patients who fail to fill their antidepressant prescription are needed.

An elective psychiatric course to reduce pharmacy students' social distance toward people with severe mental illness.

OBJECTIVE: To determine whether an elective course on mental health could reduce pharmacy students' social distance toward people with severe mental illness. DESIGN: Course activities included assigned readings, class discussions, student presentations, review of video and other media for examples of social distance, presentations by patients with mental illness, and visits to hospitalized patients in a variety of psychiatric settings. ASSESSMENT: The Social Distance Scale (SDS) was administered at the beginning and end of the semester to students enrolled in the elective and to a comparator group of students not enrolled in the course. Pharmacy students who did not complete the elective had significantly higher SDS scores than students who completed the elective (18.7 vs. 15.6, p < 0.001). Students enrolled in the course had lower precourse SDS scores, were more likely than their peers to have a personal association with mental illness, and had a decrease in precourse to postcourse scores. CONCLUSION: A course designed to reduce stigma towards the mentally ill can reduce pharmacy students' social distance.

Psychiatric pharmacy residency training.

The role of the psychiatric pharmacist in the care of the mentally ill has continually evolved since the late 1960s and early 1970s. Pharmacists in the field of psychiatric pharmacy work to improve the health, safety, and welfare of those impacted by one or more psychiatric conditions. Specialty residency training programs are accredited to establish minimum training standards and a board-certification process ensures that individuals provide a high level of quality of care. It is the position of the College of Psychiatric and Neurologic Pharmacists (CPNP) that Psychiatric Pharmacy residency programs obtain American Society of Health-System Pharmacy (ASHP) accreditation and help the profession move forward as a recognized specialty.

Intramuscular haloperidol versus intramuscular olanzapine for treatment of acute agitation: a cost-minimization study.

STUDY OBJECTIVES: To investigate prescribing patterns for antipsychotic regimens based on intramuscular haloperidol or intramuscular olanzapine for treating acute agitation; to compare the costs of each drug regimen, which included adjunctive anxiolytics and/or anticholinergics; and to compare the effectiveness and safety of each drug regimen. DESIGN: Retrospective medical record review. SETTING: State psychiatric facility. PATIENTS: Twenty-seven patients who received intramuscular haloperidol to treat 47 episodes of acute agitation and 26 patients who received intramuscular olanzapine to treat 38 episodes. MEASUREMENTS AND MAIN RESULTS: Data from patients receiving the antipsychotic regimens between August 2004 and March 2007 were reviewed. Mean +/- SD doses were 6.4 +/- 2.4 mg (range 2.5-10 mg) for haloperidol and 8.1 +/- 2.3 mg (range 5-10 mg) for olanzapine. The mean +/- SD cost of treating an episode of agitation with haloperidol was significantly lower at $4.06 +/- 3.98 (range $1.74-18.35) versus $27.84 +/- 10.40 (range $21.58-52.46) for olanzapine (p<0.0001). Significantly fewer patients who received haloperidol than patients who received olanzapine required additional pharmacotherapy to manage agitation (41% vs 69%, chi(2)=4.34, p=0.04). No significant differences were found between groups in the mean number of repeat doses of psychotropic drugs needed/episode (0.6 [range 0-5] for haloperidol vs 0.8 [range 0-3] for olanzapine, p=0.47), in the percentages of patients who required seclusion and/or restraints (59% for haloperidol vs 58% for olanzapine, chi(2)=0.01, p=0.91), or in time spent in seclusion and/or restraints (3.7 +/- 7.1 for haloperidol vs 3.6 +/- 6.5 hrs for olanzapine, p=0.92). No adverse events were documented with either drug. CONCLUSION: For the treatment of acute episodes of agitation, regimens based on intramuscular haloperidol were significantly less expensive than and at least as effective as those based on intramuscular olanzapine.

Worsening psychosis induced by varenicline in a hospitalized psychiatric patient.

Varenicline is a novel treatment for smoking cessation; however, the agent has not been well studied in a population with severe mental illness. Varenicline can reportedly cause neuropsychiatric adverse effects, some resulting in hospitalizations and/or suicides. We describe a case of clinician-observed, worsening psychotic symptoms in a patient with chronic mental illness who was receiving varenicline. A 45-year-old woman with bipolar disorder, mixed type with psychotic features, was admitted to a psychiatric hospital due to acute decompensation after she discontinued her drug therapy. Because of the facility's smoke-free policy, the patient was not permitted to smoke cigarettes during her hospitalization. Over the next several weeks, her condition was stabilized with psychotropic drugs. Her symptoms improved, and plans were made for her discharge. Varenicline was prescribed to manage her nicotine cravings. After 2 days of treatment, staff members noted worsening of the patient's psychotic symptoms and agitation. Varenicline was discontinued, the patient's mental status returned to baseline, and she was subsequently discharged. Use of the Naranjo adverse drug reaction probability scale indicated a probable relationship (score of 7) between the patient's worsening psychosis and her varenicline therapy. This case report provides valuable support of previously published cases that demonstrate the risk of exacerbation of psychotic symptoms with varenicline use in patients with severe mental illness. With proper assessment and management of varenicline-induced neuropsychiatric effects, health care professionals can provide an important role in helping to prevent and manage worsening psychiatric symptoms.