Teriflunomide for the treatment of relapsing multiple sclerosis: a review of clinical data.

OBJECTIVE: To review the pharmacology and clinical data for teriflunomide in relapsing multiple sclerosis (MS). DATA SOURCES: A literature search from 1966 to May 2013 using PubMed/MEDLINE, Web of Science, International Pharmaceutical Abstracts, Academic Search Premiere, Science Citation Index, and the national clinical trials registry was performed using the terms teriflunomide, HMR1726, and A771726. All articles containing human clinical trial data and relevant pharmacologic information were reviewed. STUDY SELECTION/DATA EXTRACTION: Phase 2 and phase 3 clinical trials for teriflunomide were evaluated. All peer-reviewed articles with clinically relevant information were reviewed. Priority for inclusion was placed on randomized controlled trials. DATA SYNTHESIS: Three phase 2 and three phase 3 clinical trials have evaluated teriflunomide as monotherapy or as adjunctive therapy in approximately 3000 patients with relapsing forms of MS. The phase 3 studies used annualized relapse rate, magnetic resonance imaging changes, and Expanded Disability Status Scale scores as outcome measures. One additional Phase 3 clinical study is ongoing. The annualized relapse rates and magnetic resonance imaging findings were improved compared to those with placebo and similar to or improved compared with those with subcutaneously administered interferon-ß-1a 44 µg thrice weekly. Durability of response is supported by open-label extension studies. Common adverse events include increased liver function enzymes, alopecia, diarrhea, influenza, nausea, and paresthesias. Treatment discontinuation was not common and occurred in approximately 10% of patients in phase 3 studies. CONCLUSIONS: Teriflunomide is an effective and safe oral treatment option for relapsing MS. It can be used as monotherapy or added to an interferon or glatiramer acetate. It reduces the rate of relapse and may slow disease progression. The advantages of this drug are the convenience of oral administration and good tolerability. The disadvantage is the lack of long-term safety data and data about the benefit of combination therapy.

Generic antiepileptic drug prescribing: a cross-sectional study.

The use of generic antiepileptic drugs (AEDs) in patients with epilepsy is controversial. The purpose of this study is to identify patient characteristics associated with increased odds of receiving a generic AED product. A large commercial database was used to identify patients with a primary diagnosis of epilepsy who were prescribed an AED during a three-month window. Data analysis found that those ≥65 years old had 15.7% greater odds of receiving a generic AED (OR = 1.157; 95% CI = 1.056-1.268). Patients with Medicaid were found to have 2.44 times the odds of having had a generic AED prescription (OR = 2.44; CI = 2.168-2.754). Patients residing in the Northeast had 12.6% decreased odds of receiving a generic AED (OR = 0.874; C I= 0.821-0.931). These patient characteristics could signify certain health care disparities and may represent potential confounders to future observational studies.

Learning with, about, and from COVID-19: An interprofessional global comparison of pandemic responses.

BACKGROUND AND PURPOSE: University of Kentucky developed a fully virtual course to educate global health learners about the COVID-19 pandemic and compare country responses to it. EDUCATIONAL ACTIVITY AND SETTING: Forty-three students participated in 13 weeks of synchronous interprofessional group meetings via Zoom (Zoom Video Communications, Inc) and asynchronous modules. Interprofessionality was intentional yet implicit, and a flipped classroom was utilized. Assessment was accomplished with one instrument measuring learning outcomes associated with select Consortium of Universities of Global Health Interprofessional Global Health Competencies, Association of American Colleges and Universities Global Learning Value Rubric competencies, and course satisfaction and effectiveness utilizing a retrospective pre-/post-methodology. FINDINGS: Positive pre-/post-change was observed in 10 survey items. Evaluation results concerning course structure and experience were uniformly high, with the key informant interview rated most helpful. Items with significant improvement included a better understanding of the student's place in the world; improved interprofessional communication skills; population health data skills; and understanding of health systems and entities that influence global health and development. Learners appreciated the value of interprofessional teamwork and gained a deeper understanding of the roles and training of colleagues from other programs, leading to a deeper understanding of the actions those professions may take within health systems. SUMMARY: The pivot to all online global health education was a viable solution to addressing the pause in global travel and study abroad experiences at University of Kentucky.

Qualitative Thematic Analysis of Pharmacy Student Blogs for International Advanced Pharmacy Practice Experiences.

Objective. The primary objective of this study was to gain an understanding of student pharmacist learning that occurs during international advanced pharmacy practice experiences (APPEs). The secondary objective was to direct the development of suitable predeparture orientation activities for pharmacy students.Methods. University of Kentucky College of Pharmacy students authored blogs between 2012 and 2019 describing patient care and non-patient care international APPEs. This study utilized inductive thematic analysis to analyze the blogs and define codes, categories, and themes from the data set. The entire data set was used to generate changes to an orientation program delivered to students before they study abroad (predeparture orientation).Results. The analysis included 47 blogs from which seven pictorial codes and 24 text codes were isolated to ultimately form four categories: Learning About Health Care; My Surroundings; Logistics; and Me, Myself, and I. Two overall themes emerged from the codes and categories: Everything Is Different and Here's What I Think and Feel. Through examining the data and reviewing other studies focusing on study abroad experiences, the results indicate that the themes isolated in this study parallel previously described benefits of studying abroad. Additionally, analysis of the blogs suggested that expanding the predeparture orientation for students and including follow-up discussions may facilitate student understanding prior to travel.Conclusion. This study gives unique insight into thoughts and the relative importance of pharmacy students' experiences while studying abroad. The resulting data, considered along with previously published studies, can guide educators in refining predeparture materials. Further studies are needed to evaluate the effectiveness of revised predeparture orientation.

Barriers to generic antiseizure medication use: Results of a global survey by the International League Against Epilepsy Generic Substitution Task Force.

The objective of this study was to identify and quantify barriers to generic substitution of antiseizure medications (ASM). A questionnaire on generic ASM substitution was developed by the International League Against Epilepsy (ILAE) Task Force on Generic Substitution. Questions addressed understanding of bioequivalence, standards for generic products, experiences with substitution, and demographic data. The survey was web-based and distributed to ILAE chapters, their membership, and professional colleagues of task force members. Comparisons in responses were between ILAE regions and country income classification. A total of 800 individuals responded, with 44.2% being from the Asia-Oceania ILAE Region and 38.6% from European Region. The majority of respondents had little or no education in generic substitution or bioequivalence. Many respondents indicated lack of understanding aspects of generic substitution. Common barriers to generic substitution included limited access, poor or inconsistent quality, too expensive, or lack of regulatory control. Increase in seizures was the most common reported adverse outcome of substitution. Of medications on the World Health Organization Essential Medication list, problems with generic products were most frequent with carbamazepine, lamotrigine, and valproic acid. Several barriers with generic substitution of ASM revolved around mistrust of regulatory control and quality of generic ASM. Lack of education on generic substitution is also a concern. Generic ASM products may be the only option in some parts of the world and efforts should address these issues. Efforts to address these barriers should improve access to medications in all parts of the world.

An Experimental Education Project for Consultations of Older Adults during the Pandemic and Healthcare Lockdown.

OBJECTIVE: To develop a mentor-supervised, interprofessional, geriatric telemedicine experiential education project in response to the COVID-19 pandemic. METHOD: Medical and pharmacy students collaborated via remote consultations to address the coexistence of multimorbidity and polypharmacy in geriatric patients. In-depth interviews of students and patients as well as Likert scale-based telephonic survey were performed for a comprehensive evaluation of the project's significance. RESULTS: To date, 49 consultations have been conducted. Remote consultations performed by medical and pharmacy students working collaboratively were beneficial for both students, participants. CONCLUSIONS AND PRACTICE IMPLICATIONS: This experimental education project provided students with authentic challenges while simultaneously delivering care to the older adults who are susceptible to disruption of care associated with the pandemic. Further development and expanded implementation of such approaches may be a post-pandemic practice to provide more accessible care for senior patients while incorporating interprofessional education.

Cannabidiol in epilepsy: The indications and beyond.

Epilepsy, although common, remains difficult to treat with as much as 30% of patients having treatment-resistant conditions. Lennox-Gastaut syndrome and Dravet syndrome are childhood-onset epilepsies and among the most difficult to treat. Cannabidiol has been approved by the Food and Drug Administration to treat these conditions in individuals over 2 years of age; however, there is a great deal of interest in off-label use. This article examines 3 cases: 1 of a patient with Lennox-Gastaut syndrome, 1 of off-label use of cannabidiol to treat epilepsy, and 1 of nonprescription forms of cannabidiol to treat epilepsy.

Medications Approved for Preventing Migraine Headaches.

Migraine is the third-most prevalent disease in the world and affects approximately 39 million individuals in the United States alone. Migraine occurs in nearly 1 in 7 individuals between 15 and 49 years of age and is 3 times more frequent in women than in men. The Food and Drug Administration (FDA) recently approved 3 new humanized monoclonal antibodies that target calcitonin gene-related peptide (CGRP): erenumab, fremanezumab, and galcanezumab. The agents either bind to the CGRP receptor (erenumab) or bind to the CGRP ligand (fremanezumab and galcanezumab) and block its binding to the receptor. All 3 products are indicated for preventative treatment of episodic or chronic migraine in adults. The available studies to date document that these agents reduce migraine attacks. The CGRP monoclonal antibodies offer patients new options once they have exhausted other treatments.

Using Photovoice to Encourage Reflection in Health Professions Students Completing a Short-term Experience in Global Health.

Objective. To engage health professions students in a photo and caption sharing methodology to stimulate reflection and inculcate principles related to global health at a formative time in training. Methods. Undergraduate and graduate students from multiple colleges enrolled in a course that would prepare them for an in-country global health experience. As part of the course, participants took photos to illustrate one of three topics: global health ethics, interprofessional practice, or social determinants of health. The iterative and participatory photovoice process was used for students to analyze, discuss, and reflect on their work in country and upon return. Final photos with captions were displayed online. Researchers analyzed photos and captions using content analysis to identify unifying themes. All students were required to complete the photovoice assignment, but only those who gave informed consent were included in the qualitative analysis. Results. Twenty-six students were included in the analysis. Two overarching themes emerged: revelation and adaptation. Revelation encompassed novel elements that surprised the students, including differences and similarities between the United States and Ecuador. Coded segments related to adaptation discussed participants' resourcefulness while challenging work environments, and how they would apply this new perspective to their future practice in the United States. Conclusion. This global health photovoice project provided a unique medium for reflection for health care trainees. This project enhanced our understanding of the learners' perspectives and this new means of expression offered the learners a greater opportunity for deeper reflection. The assignment also revealed gaps in learning related to social determinants of health and areas of concern related to solidarity and privilege.

Drug treatment strategies for depression in Parkinson disease.

INTRODUCTION: Depression is a common non-motor symptom in Parkinson disease (PD), occurring in approximately 20% of patients with PD. While depression can occur anytime in the disease process, it predates PD diagnosis in about 30% of patients. Between 20% and 60% of depressed patients with PD are either without recognition or treatment of their depression. AREAS COVERED: The pathophysiology of depression in PD is unclear. There are several structural changes seen in depressed patients with PD that are also seen in patients with depression. In addition, the neurotransmitters dopamine, serotonin, and norepinephrine are all depleted in PD. This article covers the pharmacological treatment of depression in PD; this involves standard antidepressant treatment such as selective serotonin reuptake inhibitors, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors, and monoamine oxidase inhibitors. As with depression not associated with PD, most treatment is partially successful. Non-pharmacological approaches are also touched upon. EXPERT OPINION: Most antidepressant therapy shows partial efficacy in patients with PD. However, there is a need for better study design as well as more comparative studies for the treatment of depression in PD. Biomarkers will help identify patients with PD and depression earlier in the future.

Cultural Sensitivity and Global Pharmacy Engagement in Latin America: Argentina, Brazil, Ecuador, Guatemala, and Mexico.

To establish and maintain successful global pharmaceutical and health care partnerships, pharmacists, pharmacy educators, and students should first learn more about the political, cultural, economic and health care dynamics that affect all of the parties involved in these arrangements. This paper explores Latin America within the context of transnational pharmacy and health-based engagement, including pharmacy-related concepts, health care and cultural considerations, behavioral health perspectives, and common misconceptions. Expert knowledge and experience were used to support and corroborate the existing literature about cultural dynamics of health. Recommendations are provided for how schools and colleges of pharmacy can enhance engagement in culturally sensitive partnerships within Latin America. Health-based profiles of Argentina, Brazil, Ecuador, Guatemala, and Mexico are presented to serve as models for establishing, enhancing, and maintaining partnerships across Latin America.

Use of a Modified Delphi Process to Determine Course Objectives for a Model Global Health Course in a Pharmacy Curriculum.

Objective. To define course objectives for a model global health course in a pharmacy curriculum. Methods. A modified Delphi process was used to determine a consensus among proposed course objectives. A three-round email panel was sent to members of three special interest groups (SIGs) within the American Association of Colleges of Pharmacy (Public Health, Global Pharmacy Education, and Health Disparities and Cultural Competence) to recruit educators broadly interested or engaged in this area of education. An initial list of 80 potential course objectives across 11 domains was proposed for inclusion. Objectives that were cumulatively rated as either "extremely important" or "very important" by at least 75%, 80%, and 85% of respondents in each of the three rounds, respectively, were moved forward (first and second rounds) or accepted (third round). Results. Responses were received from 87, 73, and 70 faculty panel members in the three consecutive rounds. The initial list of proposed objectives was narrowed to 65 objectives (19% reduction), and 38 objectives (53%) after the first and second rounds, respectively. The final list was composed of 20 objectives from seven domains. Global burden of disease and social/environmental determinants of health contained the most objectives selected by consensus. Conclusion. The process identified a consensus for course objectives for a model global health education course. These objectives can be used by pharmacy faculty to align global health education in the profession.

Chronic inflammatory demyelinating polyneuropathy: considerations for diagnosis, management, and population health.

First described almost 50 years ago, chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune disorder characterized by progressive peripheral neuropathy. CIDP is difficult to diagnose, but early diagnosis can be crucial to prevent permanent nerve damage. Initial treatment options include corticosteroids, immunoglobulin given by intravenous administration, and therapeutic plasma exchange. Subcutaneous administration of immunoglobulin provides a new option for patients with CIDP that has the potential to increase independence and improve tolerability. This article reviews the epidemiology, diagnosis, treatment options for first- and second-line therapy, treatment guidelines, and monitoring parameters for CIDP.

A brief review of the pharmacologic and therapeutic aspects of memantine in Alzheimer's disease.

The past decade has seen an increase in therapeutic options for Alzheimer's disease (AD) that target neurotransmitters, such as acetylcholine, and research continues to target abnormal proteins in the AD brain. Recently, glutamate excitotoxicity has also become a target for AD treatment with the advent of memantine. Clinical trial data reviewed for memantine show good tolerability, low side-effect profiles and a positive therapeutic impact in moderate-to-severe AD, both as monotherapy and in conjunction with donepezil. However, additional data suggest variable benefits in the mild stages of AD. Furthermore, published reports support reduced dosing in patients with significant renal disease. However, the opportunity to target a second mechanism in the treatment of AD, thereby providing added symptomatic benefit, appears to be a useful consideration for clinicians who treat this devastating neurodegenerative disorder.

Systemic metabolic effects of combined insulin-like growth factor-I and growth hormone therapy in patients who have sustained acute traumatic brain injury.

OBJECT: Hypermetabolism, hypercatabolism, refractory nitrogen wasting, hyperglycemia, and immunosuppression accompany traumatic brain injury (TBI). Pituitary dysfunction occurs, affecting growth hormone (GH) and plasma insulin-like growth factor-I (IGF-I) concentrations. The authors evaluated whether combination IGF-I/GH therapy improved metabolic and nutritional parameters after moderate to severe TBI. METHODS: The authors conducted a prospective, randomized, double-blind study comparing combination IGF-I/GH therapy and a placebo treatment. Ninety-seven patients with TBI were enrolled in the study within 72 hours of injury and were assigned to receive either combination IGF-I/GH therapy or placebo. All patients received concomitant nutritional support. Insulin-like growth factor-I was administered by continuous intravenous infusion (0.01 mg/kg/hr), and GH (0.05 mg/kg/day) was administered subcutaneously. Placebo control group patients received normal saline solution in place of both agents. Nutritional and metabolic monitoring continued throughout the 14-day treatment period. The two groups did not differ in energy expenditure, nutrient intake, or use of insulin treatment. The mean daily serum glucose concentration was higher in the treatment group (123 +/- 24 mg/dl) than in the control group (104 +/- 11 mg/dl) (p < 0.03). A positive nitrogen balance was achieved within the first 24 hours in the treatment group and remained positive in that group throughout the treatment period (p < 0.05). This pattern was not observed in the control group. Plasma IGF-I concentrations were above 350 ng/ml in the treatment group throughout the study period. Overall, the mean plasma IGF-I concentrations were 1003 +/- 480.6 ng/ml in the treatment group and 192 +/- 46.2 ng/ml in the control group (p < 0.01). CONCLUSIONS: The combination of IGF-I and GH produced sustained improvement in metabolic and nutritional endpoints after moderate to severe acute TBI.

Restless legs syndrome.

PURPOSE: The signs and symptoms, epidemiology, etiology, pathophysiology, diagnosis, pharmacologic and nonpharmacologic treatments, and options and guidelines for the treatment of restless legs syndrome (RLS) are reviewed. SUMMARY: RLS was first described in the 17th century and further characterized in 1945. RLS is a common disorder, occurring in about 10% of the population. Patients with RLS often describe the urge to move, uncomfortable sensations, and pain, which begin or worsen during rest or inactivity such as lying or sitting. Symptoms of RLS make sleeping difficult for many patients, and significant daytime difficulties result from the condition. RLS can either be primary or arise from secondary causes that lead to iron deficiency. There is a familial component in primary RLS, but its underlying mechanisms remain unknown. Of individuals with conditions associated with iron-deficiency states, including pregnancy, renal failure, and anemia, 25-30% may develop RLS. The goals of RLS treatment include improving its symptoms and the patient's quality of life. There are limited data on the treatment of RLS. Pharmacologic therapies include iron replacement, dopaminergic agents (e.g., levodopa), dopamine agonists, anticonvulsants, opioids, and benzodiazepines. There have been no systematic trials of nonpharmacologic therapies for RLS, but good sleep hygiene and avoidance of alcohol, caffeine, and nicotine may improve symptoms. CONCLUSION: RLS is a common disorder thought to involve abnormal iron metabolism and dopaminergic systems. Nonpharmacologic therapy should be suggested for all patients with RLS, but pharmacologic therapy may be required, and evidence is strongest for levodopa and dopamine agonists.

Characteristics of participants enrolled in a Quit and Win smoking cessation program.

Quit and Win smoking cessation incentive programs have been used to promote community-based smoking cessation in the United States and internationally. The Quit and Win contest has been offered annually by the Lexington-Fayette County Health Department since 2001. In order to engage in continuous quality assessment of the Quit and Win program, demographic analysis of program participants is critical to better extend the marketing message to target audiences. The goal of this analysis is to report various baseline parameters of the 2003 Lexington-Fayette County Quit and Win contest cohort. Of the 876 participants, most were white, had at least a high school education, smoked cigarettes for more than 10 years, and had multiple previous quit attempts. Most anticipated using nicotine replacement products to aid the current quit attempt. The demographic information from this analysis can be used to design future programs that target a wider segment of the population.

Current Practices in Global/International Advanced Pharmacy Practice Experiences: Preceptor and Student Considerations.

The objective of this article is to describe the key areas of consideration for global/international advanced pharmacy practice experience (G/I APPE) preceptors, students and learning objectives. At the 2013 Annual Meeting of the American Association of Colleges of Pharmacy (AACP), the GPE SIG prepared and presented an initial report on the G/IAPPE initiatives. Round table discussions were conducted at the 2014 AACP Annual Meeting to document GPE SIG member input on key areas in the report. Literature search of PubMed, Google Scholar and EMBASE with keywords was conducted to expand this report. In this paper, considerations related to preceptors and students and learning outcomes are described. Preceptors for G/I APPEs may vary based on the learning outcomes of the experience. Student learning outcomes for G/I APPEs may vary based on the type of experiential site. Recommendations and future directions for development of G/IAPPEs are presented. Development of a successful G/I APPE requires significant planning and consideration of appropriate qualifications for preceptors and students.

Seizures in HIV-seropositive individuals: epidemiology and treatment.

Seizures are a relatively common occurrence in patients with HIV infection. They may be a result of HIV infection of the CNS or a manifestation of an opportunistic infection. Because seizures are likely to recur in patients infected with HIV and because they are a poor prognostic indicator, it is generally recommended that all HIV-seropositive patients experiencing a first seizure without a recognisable and reversible cause be treated. Clinicians faced with treating seizures in HIV-seropositive patients often encounter a therapeutic dilemma since few data exist in this area. In selecting appropriate anticonvulsant therapy, clinicians must consider both therapy-compromising drug-drug and drug-disease interactions. Ideal anticonvulsants for this setting are those that do not effect viral replication, have limited protein binding and have no effects on the cytochrome P450 system, such as gabapentin, topiramate and tiagabine. Unless the benefits outweigh the risks, valproic acid (sodium valproate) should be avoided as it has been shown to stimulate HIV replication. Since few data exist, controlled trials examining pharmacokinetic and pharmacodynamic interactions between anticonvulsants and antiretrovirals are needed. Until such time, clinicians caring for these patients should examine existing data carefully and employ vigilant monitoring.