Interprofessional education in pharmacology using high-fidelity simulation.

BACKGROUND: This study examined the feasibility of an interprofessional high-fidelity pharmacology simulation and its impact on pharmacy and nursing students' perceptions of interprofessionalism and pharmacology knowledge. INTERPROFESSIONAL EDUCATION ACTIVITY: Pharmacy and nursing students participated in a pharmacology simulation using a high-fidelity patient simulator. Faculty-facilitated debriefing included discussion of the case and collaboration. To determine the impact of the activity on students' perceptions of interprofessionalism and their ability to apply pharmacology knowledge, surveys were administered to students before and after the simulation. Attitudes Toward Health Care Teams scale (ATHCT) scores improved from 4.55 to 4.72 on a scale of 1-6 (p = 0.005). Almost all (over 90%) of the students stated their pharmacology knowledge and their ability to apply that knowledge improved following the simulation. DISCUSSION: A simulation in pharmacology is feasible and favorably affected students' interprofessionalism and pharmacology knowledge perceptions. IMPLICATIONS: Pharmacology is a core science course required by multiple health professions in early program curricula, making it favorable for incorporation of interprofessional learning experiences. However, reports of high-fidelity interprofessional simulation in pharmacology courses are limited. This manuscript contributes to the literature in the field of interprofessional education by demonstrating that an interprofessional simulation in pharmacology is feasible and can favorably affect students' perceptions of interprofessionalism. This manuscript provides an example of a pharmacology interprofessional simulation that faculty in other programs can use to build similar educational activities.

Brivaracetam: An Adjunctive Treatment for Partial-Onset Seizures.

Brivaracetam is an analogue of levetiracetam that is Food and Drug Administration-approved for adjunctive treatment of partial-onset seizures in patients 16 years and older. In placebo-controlled trials adjunct brivaracetam demonstrated efficacy in reducing the frequency of seizures. The most commonly reported adverse effects are somnolence, dizziness, and fatigue. Clinical trials have evaluated brivaracetam for safety and efficacy in adjunctive treatment of partial-onset seizures in patients 16 years and older for up to 16 weeks. Brivaracetam's mechanism is similar to that of levetiracetam but with greater receptor binding affinity on synaptic vesicle protein 2A and inhibitory effects on sodium channels. Clinically significant differences between these agents are undetermined. Brivaracetam is available as oral tablets, oral solution, and intravenous solution. The Food and Drug Administration-approved dose is 50 mg twice daily, and titration is not required. Brivaracetam does not need dose adjustment for renal impairment and has minimal drug-drug interactions. Current limitations of brivaracetam include lack of head-to-head trials, limited long-term safety and efficacy data, and cost. Overall, brivaracetam is a viable adjunct therapeutic option for refractory partial-onset seizures in those who have failed conventional therapies.

Gabapentin enacarbil for treatment of restless legs syndrome in adults.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, precautions, dosing recommendations, and patient counseling for gabapentin enacarbil for the treatment of restless legs syndrome (RLS) in adults. DATA SOURCES: A literature search was conducted using the terms gabapentin enacarbil, XP13512/GSK1838262, and restless legs syndrome. MEDLINE, Books@Ovid, Journals@Ovid Full Text, BIOSIS Previews, and EMED databases were the primary search sites (2004-October 2011). All English-based articles and abstracts obtained from the literature searches were reviewed. Additional information was obtained from references cited in the articles. STUDY SELECTION AND DATA EXTRACTION: All gabapentin enacarbil information related to RLS was considered. Study selection included human trials evaluating safety and efficacy of gabapentin enacarbil for the treatment of RLS. DATA SYNTHESIS: Gabapentin enacarbil is a prodrug of gabapentin that is Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe primary RLS in adults. In placebo-controlled trials, gabapentin enacarbil demonstrated efficacy in reducing the symptoms of RLS. Most clinical trials assessed gabapentin enacarbil at dosages greater than the FDA-approved 600-mg dosage. For the approved dose of 600 mg, the most commonly reported adverse effects are somnolence and dizziness. CONCLUSIONS: Clinical trials have evaluated gabapentin enacarbil for safety and efficacy in treating moderate-to-severe RLS symptoms for up to 64 weeks. It offers a pharmacokinetic advantage over gabapentin by having improved absorption and a longer duration of action, but clinically significant differences are yet to be determined. Potential disadvantages of gabapentin enacarbil include cost, concerns of suicide risk and pancreatic cancer, and a lack of data for the FDA-approved 600-mg dosage. Overall, gabapentin enacarbil is a viable therapeutic option for adults with moderate-to-severe RLS for whom more conventional therapies have failed.

Dronedarone: a safety comparison to amiodarone.

Dronedarone is an oral Class III antiarrhythmic agent which was recently approved by the US Food and Drug Administration for use in nonpermanent atrial fibrillation. Structurally similar to amiodarone, dronedarone is a benzofuran derivative but it lacks the iodine moiety attached to amiodarone. Based upon the investigational clinical trials to date, it appears that dronedarone has an established efficacy when compared to placebo along with exhibiting a minimal adverse effect profile. The efficacy of dronedarone will need to be further evaluated in comparison trials with established antiarrhythmics for atrial fibrillation. The adverse profile of dronedarone appears to be substantially safer in comparison to amiodarone, although there is still little data available. The adverse effect profile of amiodarone necessitates close and extensive monitoring. Although a risk of pulmonary toxicity was identified in animals, long term studies in humans are needed to determine the significance of this adverse effect with dronedarone. One noted effect of dronedarone is an isolated increase in serum creatinine levels, and the clinical relevance of this effect needs further evaluation. Based on supporting evidence, the use of dronedarone is contraindicated in advanced or decompensated heart failure. Some clinically significant dronedarone drug interactions have been identified. Although the potential differences between dronedarone and amiodarone have been evaluated there have been no direct comparison trials published to date. This article reviews the chemistry, antiarrhythmic effects, pharmacokinetics, efficacy, adverse effects and drug interactions of dronedarone.

A review on the rationale and clinical use of concomitant rosuvastatin and fenofibrate/fenofibric acid therapy.

Mixed dyslipidemia, characterized by a lipid triad of elevated triglycerides (TG), elevated low-density lipoprotein-cholesterol (LDL-C) and reduced high-density lipoprotein-cholesterol (HDL-C), is a common and frequently difficult to manage condition. The use of combination medications is often needed to effectively treat the lipid triad. The co-administration of statins and fibrates may provide the desired endpoints but safety issues such as toxicity to the muscles, liver and kidneys are a concern. Given the potency of rosuvastatin to lower LDL-C and fenofibrate's effectiveness in lowering TG, the use of this specific combination may be desirable in treating mixed dyslipidemia. Pharmacokinetic studies revealed no significant interactions with the concomitant use of rosuvastatin and fenofibrate or its active metabolite fenofibric acid. Clinical studies evaluating the efficacy and safety of this combination therapy demonstrate significant reductions in TG and LDL-C levels, and elevations in HDL-C. Safety data from clinical trials reveal no major adverse reactions. However, case reports of adverse events have been published and monitoring for potential adverse reactions of the individual agents is advised. Overall, current data suggest the combination of rosuvastatin and fenofibrate or fenofibric acid is a safe combination to utilize when managing difficult to treat mixed dyslipidemia patients.

Individualized initiation of statin therapy determined by baseline LDL-C: Are you more likely to achieve goal LDL-C?

Cardiovascular disease remains the leading cause of death in the world. A significant amount of clinical data are available to demonstrate the positive influence that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy has on slowing the progression of cardiovascular disease and improving clinical outcomes. Achieving the treatment goals for cholesterol in cardiovascular disease continues to present challenges. Recent clinical trial information is available assessing the use of more aggressive initial doses of statin therapy based on initial low-density lipoprotein cholesterol (LDL-C) measurements in an attempt to reach treatment goals sooner. Six clinical trials assessed low-, moderate- and high-risk individuals as well as those with type 2 diabetes mellitus to determine if this treatment approach is both safe and effective. The studies concluded that initial dosing of statin therapy determined by a baseline LDL-C measurement demonstrates good achievement in reaching treatment goals and does not result in a higher rate of adverse effects.

Indiplon in the management of insomnia.

Indiplon is a novel pyrazolopyrimidine, nonbenzodiazepine gamma-aminobutyric acid (GABA) agonist studied for the treatment of insomnia. This article reviews the chemistry, pharmacology, clinical pharmacokinetics, drug interactions, clinical trials, safety, tolerability, contraindications, use in special populations, and dosing of indiplon. OVID, International Pharmaceutical Abstracts (IPA), and PubMed databases were searched (1966 to February 2009) for the keywords indiplon, NBI-34060, and insomnia. References of key articles were also reviewed to identify additional publications. Only English language articles were selected for review. Indiplon has been shown to have high affinity and selectivity for the GABAalpha(1) receptor subunit associated with sedation. In clinical studies, indiplon has demonstrated efficacy in improving latency to sleep onset, latency to persistent sleep, total sleep time, wake time after sleep onset, number of awakenings after sleep onset, and overall sleep quality when compared to placebo. Indiplon has a favorable safety profile with limited rebound insomnia and no tolerance. Neurocrine Biosciences, Incorporated received an Approvable Letter from the United States Food and Drug Administration in December 2007 for the indiplon IR 5 mg and 10 mg capsules based on meeting three additional requirements. At the time of this writing, indiplon remains unapproved.

New advances in the treatment of Clostridium difficile infection (CDI).

Clostridium difficile infections (CDI) have increased in frequency throughout the world. In addition to an increase in frequency, recent CDI epidemics have been linked to a hypervirulent C. difficile strain resulting in greater severity of disease. Although most mild to moderate cases of CDI continue to respond to metronidazole or vancomycin, refractory and recurrent cases of CDI may require alternative therapies. This review provides a brief overview of CDI and summarizes studies involving alternative antibiotics, toxin binders, probiotics, and immunological therapies that can be considered for treatment of acute and recurrent CDI in severe and refractory situations.

Case report of hantavirus pulmonary syndrome and review.

A previously healthy 29-year-old male presented to the emergency department with pleuritic chest pain, nonproductive cough, and dyspnea. He was treated empirically for community acquired pneumonia and discharged to home. Two days later, the patient presented with respiratory distress along with neutrophilia, thrombocytopenia, elevated liver function tests, and hemoconcentration. Radiographs of his chest showed bilateral lung infiltrates and pleural effusions. He was admitted to the hospital and developed cardiopulmonary failure and died the following day. Serologic tests for hantavirus pulmonary syndrome confirmed the diagnosis.

Sodium oxybate for cataplexy.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, precautions, dosing recommendations, and patient counseling of sodium oxybate for the treatment of cataplexy in patients with narcolepsy. DATA SOURCES: OVID and PubMed databases were searched (1966-January 2006) using the key words sodium oxybate, gamma-hydroxybutyrate, narcolepsy, and cataplexy. Only English-language articles were selected. STUDY SELECTION AND DATA EXTRACTION: All information on sodium oxybate related to narcolepsy and cataplexy was considered. Study selection included human trials evaluating safety and efficacy of sodium oxybate for the treatment of cataplexy. DATA SYNTHESIS: Sodium oxybate is approved by the Food and Drug Administration for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. In placebo-controlled trials, sodium oxybate demonstrated efficacy in reducing the number of cataplexy attacks. The dosing regimen includes a split dose given at bedtime and 2.5-4 hours later due to its short elimination half-life. The drug is generally well tolerated, with headache, nausea, dizziness, pain, and somnolence being the most common adverse events. CONCLUSIONS: Sodium oxybate is safe and effective for the treatment of cataplexy. Potential disadvantages include a multiple dosing regimen, abuse potential, cost, and a closed distribution system. Potential advantages demonstrated in clinical trials include significant decreases in the number of weekly cataplexy attacks, improvement in daytime sleepiness, and improvement in the Clinical Global Impression of Change score and nighttime awakenings. Overall, sodium oxybate provides a new option for the treatment of cataplexy.

Ramoplanin: a lipoglycodepsipeptide antibiotic.

OBJECTIVE: To review the pharmacology, antimicrobial activity, pharmacokinetics, clinical applications, and safety of ramoplanin, a lipoglycodepsipeptide antibiotic. DATA SOURCES: Information was obtained from MEDLINE and BIOSIS databases (1984-August 2004) and Oscient Pharmaceuticals using the key words ramoplanin, A 16686, A 16686A, and MDL 62198. STUDY SELECTION AND DATA EXTRACTION: Available English-based articles and abstracts were reviewed, along with information from Oscient Pharmaceuticals. DATA SYNTHESIS: Ramoplanin exerts its bactericidal activity against gram-positive aerobic and anaerobic bacteria by blocking peptidoglycan synthesis via lipid II. In vitro susceptibility reports have demonstrated efficacy against antibiotic-resistant gram-positive pathogens. Cross-resistance has not been documented with vancomyin and other glycopeptides. Clinical trials are investigating ramoplanin's oral administration for treatment of Clostridium difficile-associated diarrhea. Previous clinical trials had evaluated the suppression of colonization of vancomycin-resistant Enterococcus with ramoplanin. Adverse effects are minimal, and drug-drug interactions have not been documented. CONCLUSIONS: The completion of clinical trials will determine whether ramoplanin has a promising role as a treatment option for diarrhea due to C. difficile.

Neuroleptic malignant syndrome induced by atypical antipsychotics.

A review of the English literature confirms that neuroleptic malignant syndrome (NMS) occurs with both traditional and atypical antipsychotic medications. Published reports of NMS induced by the traditional antipsychotics have given the practitioner valuable information on the prevention and treatment of this adverse effect. Case reports have also been published concerning NMS and clozapine, risperidone, olanzapine and quetiapine. By evaluating the case reports of atypical antipsychotic-induced NMS, valuable information may be obtained concerning similarities or differences from that induced by the traditional antipsychotics. The case reports of NMS with atypical antipsychotics were evaluated for diagnosis, age/sex of patient, risk factors, antipsychotic doses and duration of use, symptoms of NMS, and clinical course.