Roger W. Sommi

Differences in health values among patients, family members, and providers for outcomes in schizophrenia.

Objective.The objectives of this study were to determine whether there are important differences in how patients, family members, and health care providers (HCPs) value health outcomes in schizophrenia and to assess the degree to which such differences, if they exist, could adversely affect clinical and policy decision making. Methods.Participants viewed videotaped depictions of simulated patients with mild and moderate symptoms of schizophrenia, with and without a common adverse drug effect (pseudoparkinsonism), and then provided standard gamble and visual analog scale ratings of desirability of these states. Subjects.A convenience sample of unrelated patients (n = 148), family members of patients (n = 91), and HCPs (nurses, psychologists, doctors of pharmacy, and doctors of medicine; n = 99) was drawn from geographically and clinically diverse environments. Results.Patients’ and family members’ utilities for health states averaged 0.1 to 0.15 units higher than those of HCPs (P <0.002 for differences between groups, ANOVA for multiple observations). The disutility of adverse drug effects was less for health professionals than patients and family members (P = 0.008). Health professionals tended to prefer states with mild symptoms with extrapyramidal side effects to states with moderate symptoms. Patients and family members found these states equally preferable (P <0.007 for differences between groups). Conclusions.There are systematic differences in values for health outcomes between patients and HCPs with regard to states with adverse effects of antipsychotic drugs. Family members of patients in general had values that were more similar to those of patients than were those of health professionals. The results emphasize the importance of participation by patients (or family member proxies) in clinical decision making and guideline development.

Consumer use of St. John's wort: a survey on effectiveness, safety, and tolerability.

Despite its poorly described pharmacology, effectiveness, and safety, use of St. Johns wort (SJW) is largely unsupervised and unexplored, and can potentially lead to adverse outcomes. We conducted a telephone survey of 43 subjects who had taken SJW to assess demographics, psychiatric and medical conditions, dosage, duration of use, reason for use, side effects, concomitant drugs, professional consultation, effectiveness, relapse, and withdrawal effects. Most subjects reported taking SJW for depression, and 74% did not seek medical advice. Mean dosage was 475.6 ± 360 mg/day (range 300–1200 mg/day) and mean duration of therapy was 7.3 ± 10.1 weeks (range 1 day‐5 yrs). Among 36 (84%) reporting improvement, 18 (50%) had a psychiatric diagnosis. Twenty (47%) reported side effects, resulting in discontinuation in five (12%) and one emergency room visit. Two consumers experienced symptoms of serotonin syndrome and three reported food‐drug interactions. Thirteen consumers experienced withdrawal symptoms and two had a depressive relapse. These data suggest the need for greater consumer and provider awareness of the potential risks of SJW in self‐care of depression and related syndromes.

Comparison of preferences for health outcomes in schizophrenia among stakeholder groups

BACKGROUND To determine the effectiveness of psychiatric interventions for use in cost-effectiveness analysis, we assessed the feasibility of using a multimedia computer survey to study preferences (utilities) for health outcomes among persons with schizophrenia, family members of persons with schizophrenia, health professionals, and the public. METHODS We developed videos depicting two patterns of mental health impairment in schizophrenia, both with and without pseudo-parkinsonism side-effects. These descriptions were integrated into a computer program that measured preferences using two psychometric methods: (1) standard gamble and (2) a visual analog scale. This program was used to compare preferences among potential stakeholder groups. RESULTS 20 persons with schizophrenia, 11 family members, 20 healthy volunteers and 14 health professionals participated in the computerized interview. All but one subject completed the survey. The correlation among ratings of various states was high (r=0.7-0.95) and ratings were internally consistent in 89% of participants. There were significant differences in values between groups for health states (p=0.024) and in values for the effects of pseudo-parkinsonism on quality of life (p<0.001). Persons with schizophrenia valued the disease states more highly and placed more significance than did other groups on the effects of pseudo-parkinsonism on quality of life. CONCLUSIONS Computer-based multimedia techniques can offer a feasible and valid approach to measure preferences for outcomes in schizophrenia. The study found significant differences in preferences among stakeholder groups for schizophrenia outcomes. Further work is needed to clarify how these differences affect clinical decision-making and policies for health resource allocation.

Analysis of Cost Avoidance From Pharmacy Students' Clinical Interventions at a Psychiatric Hospital

Objective. To analyze the cost avoidance resulting from clinical interventions made by pharmacy students completing an advanced pharmacy practice experience (APPE) at a psychiatric hospital. Methods. A retrospective database review of documented clinical interventions by pharmacy students was conducted to classify interventions by type and significance. Interventions were assigned a cost avoidance value determined by an evaluation of the literature. Results. Three hundred-twenty interventions were documented by 15 pharmacy students during the 1-year study period. The majority of interventions were related to psychiatric medication classes and most (n = 197; 61.6%) were classified as being of moderate significance. The most common interventions included patient education (13.1%), order clarification (11.6%), therapeutic dosing adjustments (10.9%), and laboratory order monitoring (8.8%). The estimated cost avoidance from all interventions made by pharmacy students was approximately

Historical Review of Carbamazepine for the Treatment of Bipolar Disorder

23,000. Conclusions. Pharmacy students completing APPEs at a psychiatric hospital contributed to a variety of significant clinical interventions and provided considerable cost avoidance value to the institution.

Long-acting injectable vs oral risperidone for schizophrenia and co-occurring alcohol use disorder: a randomized trial.

The management of bipolar disorder has seen significant evolution in terms of the number of treatment options now approved for both the acutely manic phase and the maintenance stages of the illness. In addition, new formulations of traditional agents are available for clinicians to use in their treatment approach. One such example is carbamazepine, which has approval by the United States Food and Drug Administration for the treatment of acute and mixed mania in an extended‐release formulation that uses a three‐bead delivery system. Although the parent compound has been available for decades, its approval for bipolar disorder is recent despite numerous clinical trials that have supported its use in both the acute and maintenance phases of bipolar disorder. Advantages of the new formulation include less fluctuation in plasma concentration and, in general, improved tolerability. However, issues remain with regard to cytochrome P450 drug‐related interactions and the need for therapeutic drug monitoring (e.g., drug concentrations, epoxide metabolite concentrations, hematology, and liver function tests) as part of the treatment and monitoring process. We review the current body of literature describing the use of carbamazepine in bipolar disorder during both the acute and maintenance phases of the disorder, including trials of both monotherapy and combination therapy, as well as findings from trials that included patients with rapid cycling and mixed episodes.

A Longitudinal Analysis of Factors Associated With Morbidity in Cocaine Abusers With Psychiatric Illness

OBJECTIVE Alcohol use disorders worsen the course of schizophrenia. Although the atypical antipsychotic clozapine appears to decrease alcohol use in schizophrenia, risperidone does not. We have proposed that risperidones relatively potent dopamine D2 receptor blockade may partly underlie its lack of effect on alcohol use. Since long-acting injectable (LAI) risperidone both results in lower average steady-state plasma concentrations than oral risperidone (with lower D2 receptor occupancy) and encourages adherence, it may be more likely to decrease heavy alcohol use (days per week of drinking 5 or more drinks per day) than oral risperidone. METHOD Ninety-five patients with DSM-IV-TR diagnoses of schizophrenia and alcohol use disorder were randomized to 6 months of oral or LAI risperidone between 2005 and 2008. Explanatory (efficacy) analyses were carried out to evaluate the potential benefits of LAI under suitably controlled conditions (in contrast to real-world settings), with intent-to-treat analyses being secondary. RESULTS Explanatory analyses showed that heavy drinking in the oral group worsened over time (P = .024) and that there was a statistical trend toward significance in the difference between the changes in heavy drinking days in the oral and LAI groups (P = .054). Furthermore, the 2 groups differed in the mean number of drinking days per week (P = .035). The intent-to-treat analyses showed no difference in heavy drinking but did show a difference in average drinking days per week similar to that obtained from the explanatory analyses (P = .018). Neither explanatory nor intent-to-treat analyses showed any between-group differences in alcohol use as measured by intensity or the Alcohol Use Scale. The plasma concentrations of the active metabolite 9-hydroxyrisperidone were significantly lower in patients taking LAI (P < .05), despite their significantly (overall) better treatment adherence (P < .005). CONCLUSION For the population considered here, schizophrenia patients with alcohol use disorder appear to continue drinking some alcohol while taking either form of risperidone. Nonetheless, our data suggest that injectable risperidone may be a better choice than the oral form for these dual diagnosis patients. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00130923.

Adverse Drug Reactions: A Retrospective Review of Hospitalized Patients at a State Psychiatric Hospital

We conducted a study to characterize a population of cocaine users who were referred to a state psychiatric institution, identify treatment problems including reasons for relapse, and develop strategies to improve treatment outcome. Using a data base system from a tertiary‐care hospital emergency department, we identified a sample of 80 patients with a cocaine‐related presentation who came to the emergency department and were referred to the psychiatric facility. Forty‐six percent had consumed crack cocaine, and 65% reported ingesting cocaine with other drugs, half of them with alcohol. Suicidal ideation or attempt was the most common reason for referral. A retrospective review of 58 of the 80 referrals to the psychiatric facility showed that over half of the patients were given a concurrent psychiatric diagnosis and required hospitalization on an acute‐care psychiatric unit. Sixty‐two percent of those admitted had prior hospitalizations at the psychiatric facility, yet only five patients had received treatment for substance abuse. Seventy‐four percent were readmitted to the psychiatric facility within 1 year of their index episode, with a higher rate of relapse among persons with dual diagnoses compared to cocaine users without dual diagnoses (p<0.05). Possible reasons for relapse included lack of referral for substance abuse treatment, nonintegrated treatment of psychiatric illness and substance abuse, lack of psychosocial support, and unresolved financial or job‐related stressors. The data support increased funding to facilities that treat persons with dual diagnoses, and suggest the need to develop comprehensive treatment approaches involving a multidisciplinary team to address issues of mental illness and substance abuse concomitantly, and to identify and resolve stressors leading to relapse.

Inconsistency in risperidone long-acting injection steady-state plasma levels when switching from deltoid to gluteal administration.

Background There is a paucity of information regarding adverse drug reactions (ADRs) in psychiatric patients. Information on common and preventable ADRs (pADRs) in psychiatric patients will allow for targeted improvement projects. Objective To characterize reported ADRs and pharmacist interventions to prevent ADRs in an extended-care state psychiatric hospital. Methods Four years of ADR reports were assessed for probability, reaction severity, pharmacological class of medication involved, preventability, change in therapy, and transfers to a medical facility. The pharmacist intervention database was queried for interventions classified as “prevention of ADR.” The interventions were assessed for type of medication and recommendation acceptance. Results Medication classes responsible for ADRs included mood stabilizers (30%), typical antipsychotics (25%), atypical antipsychotics (25%), and antidepressants (8%). Nine percent resulted in transfer to a medical facility. Of all ADRs, 34.4% were pADRs; mood stabilizers (41%) and atypical antipsychotics (27%) were the most common pADRs. The most common causes of pADRs were supratherapeutic serum concentrations, drug-drug interactions, and history of reaction. There were 87 pharmacist interventions that were classified as “prevention of ADR,” and the acceptance rate of pharmacists’ recommendations was 96.5%. Mood stabilizers (20%), atypical antipsychotics (17%), and typical antipsychotics (11%) were commonly associated with prevented ADRs. Lithium accounted for 13.8% of prevented ADRs; these ADRs were most often due to a drug–drug interaction with a nonsteroidal anti-inflammatory drug. Conclusions ADRs were most commonly associated with mood stabilizers and antipsychotics, and pADRs were common. There is an opportunity to provide education to medical staff on therapeutic drug monitoring and drug–drug interactions for these classes, particularly lithium.

Preliminary Comparison of Predictive and Empiric Lithium Dosing: Impact on Patient Outcome

721 2010 50 721-724 R long-acting injection (RLAI) is a second-generation antipsychotic (SGA) administered intramuscularly every 2 weeks for the treatment of schizophrenia. RLAI is the first SGA to come to market in the United States as a long-acting injectable dosage formulation targeted to improve medication adherence. RLAI is an aqueous suspension of microspheres containing risperidone in a copolymer matrix. The copolymer undergoes gradual hydrolysis at the injection site to allow a slow and steady release of risperidone over a period of several weeks, resulting in stable plasma concentrations of risperidone and its active metabolite, 9-hydroxy-risperidone. The release profile of RLAI following a single intramuscular injection consists of a small initial release of drug (<1% of the dose), followed by a lag time of approximately 3 weeks. The main release of drug begins in the third week and is maintained from week 4 to 6 and subsides by week 7. Steady-state plasma concentrations are achieved after 4 injections. Following multiple doses of RLAI, plasma concentrations of risperidone and 9-hydroxy-risperidone demonstrate linear kinetics. At the time RLAI was initially approved in 2003, it was approved only for gluteal muscle (GM) injection. In October 2008, the drug received approval for deltoid muscle (DM) administration. It is thought that DM injection may be preferred over GM injection by many patients and clinicians and allows for a choice between administration sites, thus potentially increasing patient acceptance. A literature search was performed to validate this claim, which produced no publications directly addressing patient or clinician preference for one injection site over another. Regardless, many patients will be switched from RLAI GM to DM administration, and under some circumstances, some patients may be switched from DM to GM administration. Although one study demonstrated that GM and DM injections of RLAI were bioequivalent routes of administration and thus interchangeable, we report a case of a patient switched from DM and GM injection resulting in inconsistent risperidone and 9-hydroxy-risperidone levels. To our knowledge, this is the first case reporting a difference in steady-state levels between RLAI DM and GM administration.