Patterns of psychotropic medication prescribing and potential drug-hormone interactions among transgender and gender-diverse adults within 2 years of hormone therapy.

BACKGROUND: Transgender and gender-diverse (TGD) people have a high prevalence of psychotropic medication use, yet knowledge about the patient-level psychotropic medication burden is limited. TGD patients may take hormone therapy to meet their gender expression goals. Potential drug-hormone interactions exist between psychotropic medications and hormone therapy, requiring increased knowledge about psychotropic medication use for TGD adults undergoing hormone therapy. OBJECTIVES: The objective of this study was to examine the extent of psychotropic medication polypharmacy in a cohort of TGD adults within 2 years of starting hormone therapy. We also characterized potential drug-hormone interactions and the association with psychotropic polypharmacy. METHODS: Retrospective cross-sectional analysis of patients with ≥1 transgender health-related visit (2007-2017) in the University of Washington Medical System (Seattle, WA). Eligible patients had ≥1 psychotropic medication including antidepressants, antipsychotics, mood stabilizers, and sedative-hypnotics ordered within 2 years of starting hormone therapy (testosterone or estradiol with or without spironolactone, progesterone, finasteride, or dutasteride). We defined psychotropic polypharmacy as ≥2 psychotropic medication orders with overlapping treatment durations for at least 90 days and characterized potential drug-hormone interactions (Lexicomp, Hudson, OH). We descriptively summarized patients with and without polypharmacy (frequencies and percentages) and compared drug-hormone interactions using chi-square or Fishers exact tests (P < 0.05 considered significant). RESULTS: A total of 184 patients had ≥1 psychotropic medication order within 2 years of hormone therapy; 68 patients (37.0%) had psychotropic polypharmacy. The most frequent type of psychotropic polypharmacy was antidepressant+sedative-hypnotic (18 of 68, 26.5%). More patients had a potential drug-hormone interaction among those with psychotropic polypharmacy (23 of 68, 33.8%) versus those without (8 of 116, 6.9%, P < 0.001). CONCLUSION: Among TGD patients on psychotropic medications within 2 years of hormone therapy, one-third had psychotropic polypharmacy. Most polypharmacy types appeared to align with mental health treatment guidelines. The number of patients with a potential drug-hormone interaction was significantly higher among those with polypharmacy. Prospective studies are needed to characterize drug-hormone interactions.

Flibanserin (Addyi): The First FDA-Approved Treatment for Female Sexual Interest/Arousal Disorder in Premenopausal Women.

Flibanserin (Addyi) for female sexual interest/arousal disorder in premenopausal women.

Vortioxetine (brintellix): a new serotonergic antidepressant.

Vortioxetine (Brintellix): a new serotonergic antidepressant.

Modafinil Induced Psychosis in a Patient with Bipolar 1 Depression.

Modafinil has been used as an adjunctive medication in the treatment of bipolar 1 depression with reported success. Case reports have been published demonstrating modafinil induced mania in bipolar patients and modafinil induced psychosis in schizophrenic patients. To our knowledge, we report the only case of modafinil induced psychosis in a patient with bipolar depression treated with both mood stabilizers and antipsychotics. In addition, it is the quickest onset to psychosis (2 days) at the lowest dosage of modafinil (100 mg/day) reported in the literature. Although favorable outcomes using modafinil for treatment of bipolar depression have been reported in literature, clinicians should remain cautious of the potential to rapidly induce psychosis with modafinil at low dosages in patients with bipolar depression despite being treated with mood stabilizers and antipsychotics.

New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

PURPOSE: Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. METHODS: Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. FINDINGS: A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients relapsing on prior disease-modifying agents. Treatment emergent adverse effects were common with all new drug treatments. The cost of treating MS remains high, because MS therapies accounted for the highest spending growth of any specialty drug class in 2013. Most therapies cost, on average, US $6000/mo based on wholesale acquisition cost, and few cost-benefit studies are available for new treatments. IMPLICATIONS: With expansion of new treatments, patients and providers now have multiple options and improved flexibility in managing MS. The relative place in therapy of new treatments is unknown, and treatment decisions are largely based on patient preference, efficacy, and risk potential. The cost of treating MS continues to be high, even with more treatment options available.

The role of paliperidone extended release for the treatment of bipolar disorder.

BACKGROUND: Bipolar disorder (BD) is a chronic, relapsing, episodic mental illness associated with other psychiatric comorbidities. There is a substantial economic burden with BD, which makes it challenging to treat. The aim of this review is to evaluate the pharmacology, clinical efficacy, and safety data related to paliperidone extended release (ER) for the treatment of BD. METHODS: A literature search was performed from January 1966 through January 2012 using PreMEDLINE, MEDLINE, EMBASE, IPA, and ClinicalTrials.gov to identify articles in English regarding the pharmacology, clinical efficacy, and safety of paliperidone ER in acute mania or mixed episodes or in the maintenance treatment of BD I. RESULTS: There are currently three published studies relating to the use of paliperidone ER for the treatment of BD. Two of these evaluated paliperidone ER as monotherapy for acute mania, while the other assessed its role as adjunct with a mood stabilizer. CONCLUSION: According to the limited available evidence, paliperidone at higher doses of ER 9-12 mg/day may be a safe and efficacious treatment option for acute episodes of mania in BD. A once-daily dose formulation may improve patient adherence to treatment; however, the cost of paliperidone ER, which is higher than that of generically available second-generation antipsychotics (such as olanzapine and risperidone), and a lack of alternative dosage forms (ie, liquid, intramuscular) compared with other agents may limit its usefulness in the treatment of BD. The role of paliperidone ER as an adjunctive agent or for long-term use requires further investigation.

Adverse Drug Events Related to Ziprasidone: A Meta-analysis of Randomized, Placebo-Controlled Trials.

STUDY OBJECTIVE: To assess the drug-related risk of adverse events associated with ziprasidone. DESIGN: Meta-analysis of 19 randomized, placebo-controlled trials. PATIENTS: A total of 4132 adults taking oral ziprasidone who had adverse-event data reported in the studies identified. MEASUREMENTS AND MAIN RESULTS: A systematic review (January 1996-October 2010) was conducted by using the EMBASE and MEDLINE databases to identify Cochrane reviews, controlled clinical trials, meta-analyses, randomized controlled trials, and systematic reviews; studies were limited to those published in English and those conducted in humans. The www.ClinicalTrials.gov Web site was also searched for ziprasidone studies. A total of 887 citations were reviewed; 31 articles met the criteria for inclusion, of which 19 were included in the final analysis. Data were combined for the meta-analysis by using the Mantel-Haenszel method, random-effects model at 95% confidence. The overall rate of treatment-emergent adverse events for ziprasidone was 73% compared with 60% for patients receiving placebo (p<0.0001). Adverse events with the greatest frequency included somnolence (21%), extrapyramidal symptoms (13%), headache (13%), insomnia (11%) and respiratory disorders (10%). Adverse events with highest risk, evaluated by using the risk difference (RD) summary statistic (adverse events due to the drug itself and not the placebo effect), were somnolence (RD 14, 95% confidence interval [CI] 7-21), extrapyramidal symptoms (RD 6, 95% CI 1-10), asthenia (RD 5, 95% CI 1-8), weight gain (RD 4, 95% CI 2-7), dizziness (RD 4, 95% CI 2-6), and dyspepsia (RD 4, 95% CI 1-6). Adverse events reported but likely not caused by ziprasidone included headache (RD 0, 95% CI -2-3), QTc interval greater than 480 msec (RD 0, 95% CI -1-1), diarrhea (RD 0, 95% CI -2-2, and abdominal pain (RD 0, CI -2-2). CONCLUSION: Ziprasidone use increased the risk of 18 specific adverse events when compared with placebo. Small reductions in risk for insomnia, pain, and agitation are likely among patients with schizophrenia but not those with bipolar disorder. The results of the study are limited by the concomitant use of other drugs allowed during the trials, underreporting of adverse events in the clinical trials, and the short length of the trials (most 3-6 wks).

Alcohol attitudes and behaviors among faculty at U.S. schools and colleges of pharmacy.

UNLABELLED: Despite attempts to control college-aged drinking, binge and underage drinking continues at colleges and universities. Although often underutilized, faculty have the potential to influence students' behaviors and attitudes towards drinking. Little information is available pertaining to college faculty drinking patterns, views on drinking, or their influence on college drinking. What little information is available predates the economic crisis, mandates for increased alcohol education, and the American Pharmacists Association's call for increased alcohol awareness in pharmacists. OBJECTIVE: This study was designed to determine alcohol use patterns and viewpoints among faculty at U.S. colleges of pharmacy, in particular, to identify alcohol practices among faculty, use of alcohol with their students, mentioning alcohol in classroom as a social norm, and perceived drinking norms within their colleagues. METHODS: Following Institution Review Board approval, 2809 invitations were emailed to U.S. pharmacy faculty for this survey-based study. The survey consisted of demographic questions, the World Health Organization Alcohol Use Disorders Identification Test (AUDIT), and questions pertaining to personal and institution attitudes on drinking and on drinking with students. RESULTS: More than 96% of 753 respondents had a total AUDIT score <8. Males and preceptors were more likely to have higher AUDIT scores. More than 75% of faculty reported never drinking with students. CONCLUSIONS: In order to help pharmacy students address the extent of their alcohol use and misuse, pharmacy faculty must address their own use, along with their own and their institutions attitudes and behaviors towards alcohol use.

Prevalence of hazardous alcohol use among pharmacy students at nine U.S. schools of pharmacy.

UNLABELLED: Hazardous use of alcohol continues to be recognized as a problem at the university level. Knowledge regarding alcohol consumption in healthcare professional students is limited, especially in regards to pharmacy students. Much of the information available focuses on pharmacy student drinking patterns in specific geographic regions or is simply outdated. OBJECTIVE: This study was designed to assess levels of alcohol consumption and estimate the level of hazardous drinking among pharmacy students in a larger sample size that is representative of US pharmacy schools. METHODS: An anonymous survey regarding alcohol usage was offered to students at nine schools of pharmacy across the United States. The survey consisted of demographic questions, the World Health Organization Alcohol Use Disorders Identification Test (AUDIT), and questions that assess particular alcohol-induced behaviors. RESULTS: More than 25% of 1161 respondents had a total AUDIT score ≥ 8, which indicates a risk of alcohol-related problems. Students that were male, in their first or second professional year of school, not married, and without children were statistically more likely to have AUDIT scores in the hazardous drinking range. Grade point average and student housing did not statistically affect student's AUDIT scores. CONCLUSIONS: These results indicate that over one-fourth of pharmacy students surveyed have indicators of harmful alcohol use. Pharmacy schools should continue to address and confront hazardous alcohol use on campuses in order to curtail heavy alcohol consumption and reduce the risk of alcohol-related problems in pharmacy students.

Tolerability of paliperidone: a meta-analysis of randomized, controlled trials.

Balancing tolerability and efficacy of medications can be problematic for clinicians when assessing appropriate therapy for patients. For antipsychotic therapy, this can be especially challenging because of the hazardous movement and metabolic effects associated with them. Paliperidone is an atypical antipsychotic used for the treatment of schizophrenia and schizoaffective disorder. A systematic review of the literature for the tolerability of the drug, paliperidone, was performed. A total of 15 articles met the criteria for inclusion representing a total of 3779 patients. Data combination was conducted using the Mantel-Haenszel method, random effects model at 95% confidence. Adverse events with the greatest incidence in the paliperidone population were any treatment emergent adverse event (68%), extra-pyramidal symptoms (23%), headache (14%), insomnia (11%), somnolence (9%), tachycardia (9%) and weight gain (8%). Reported events most likely related to paliperidone [largest attributable risks (AR)] were extra-pyramidal symptoms (AR=10), reduction in acute psychosis (AR=8), any treatment emergent adverse event (AR=6), tachycardia (AR=4), and weight gain (AR=4). Events where incidence was entirely because of paliperidone (incidence equals AR) were hypersalivation (3), dysarthria (2), and sexual dysfunction (1). Reported events totally unrelated to paliperidone (AR=0) included anxiety, asthenia, constipation, depression, dyspepsia, glucose related events, and vomiting. Overall, a 50% reduction in treatment emergent psychosis was seen in schizophrenic patients treated with paliperidone, however the reduction of a psychotic event is about equal to the occurrence of an adverse event with paliperidone.