Pharmacists improve diabetes outcomes: a randomized controlled trial.

BACKGROUND: There is a growing shortage of primary care physicians. Pharmacists can fill the gap, and interdisciplinary teams are being evaluated as part of health care reform. OBJECTIVE: This study aimed to determine whether adding a pharmacist to an interprofessional health team will improve diabetes outcomes. METHODS: In this 2-phase pilot study, Medicaid-eligible patients with diabetes were randomized to receive standard of care (control arm) or standard of care plus the care of a pharmacist (intervention arm) for 12 months (phase 1). The primary outcome was change in glycated hemoglobin (A1C) from baseline. Secondary outcomes included identifying and correcting medication therapy problems (MTPs) for comorbid conditions, adherence to preventive care visits, health care utilization, self-rated health, and satisfaction surveys. After phase 1, patients in the control arm who did not achieve an A1C of < 8% were eligible to enroll into phase 2 where they received treatment with a pharmacist for 6 months. RESULTS: Of the 239 patients enrolled, 122 completed phase 1. At 12 months, intervention patients' mean A1C was 1.85 percentage point (pp) below baseline versus 0.94 pp for control (between-group difference 0.91 pp; P = 0.0218). Most control patients (79%) who completed phase 1 and enrolled into phase 2 improved their A1C by more than 1 pp (P < 0.01). The pharmacists completed 806 patient visits and identified 2638 MTPs. Intervention patients were more adherent to preventive care visits with nutrition (P = 0.043), ophthalmology (P = 0.002), and dentistry (P = 0.007). For intervention patients, 78% rated their experience with the pharmacist as excellent whereas, for control patients, 37% rated their experience with their provider as excellent. CONCLUSION: Pharmacist comanagement of patients with diabetes can significantly improve glucose control and patient satisfaction. Creative payment models were used to include pharmacists in the interprofessional patient care team.

Survey of risk factors for osteoporosis and osteoprotective behaviors among patients with epilepsy.

The prevalence of risk factors for osteoporosis in persons with epilepsy, patients' awareness of their risk, and their engagement in osteoprotective behaviors were assessed in this study. Two hundred and sixty patients with epilepsy (F=51.5%, average age=42) completed a survey tool. Of 106 patients with a dual energy X-ray absorptiometry (DXA) result, 52% had low bone mineral density, and 11% had osteoporosis. The results suggest that the majority of patients with epilepsy do not engage in bone-protective behaviors. Those who have undergone a DXA scan may be more likely to take calcium and vitamin D supplementation compared with those who did not undergo a DXA scan, but they do not engage in other osteoprotective behaviors. Many patients did not accurately report their DXA results, indicating that better patient education is warranted.

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.

Post hoc depression analysis from a pharmacist-led diabetes trial.

Introduction: Diabetes and depression may present concurrently, and clinical pharmacists are well equipped to manage these conditions. Clinical pharmacists were grant funded to implement a diabetes-focused randomized controlled trial in a Federally Qualified Health Center. The objective of this analysis is to evaluate if glycemic control and depressive symptoms improve for patients with diabetes and depression with additional management from clinical pharmacists compared with those receiving the standard of care. Methods: This is a post hoc subgroup analysis of a diabetes-focused randomized controlled trial. Pharmacists enrolled patients with type 2 diabetes mellitus (T2DM) and a glycated hemoglobin (A1C) greater than 8% and randomly assigned them to 1 of 2 cohorts, one managed by the primary care provider alone and one with additional care from the pharmacist. Pharmacists completed encounters with patients who have T2DM with or without depression to comprehensively optimize pharmacotherapy while tracking glycemic and depressive outcomes throughout the study. Results: A1C improved from baseline to 6 months in patients with depressive symptoms who received additional care from pharmacists by -2.4 percentage points (SD, 2.41) compared with a -0.1 percentage point (SD, 1.78) reduction in the control arm (P .0081), and there was no change in depressive symptoms. Discussion: Patients with T2DM and depressive symptoms experienced better diabetes outcomes with additional pharmacist management compared with a similar cohort of patients with depressive symptoms, managed independently by primary care providers. These patients with diabetes and comorbid depression received a higher level of engagement and care from the pharmacists, which led to more therapeutic interventions.

Rashes and other hypersensitivity reactions associated with antiepileptic drugs: A review of current literature.

This article provides an overview of the pathogenesis and risk factors associated with antiepileptic drug (AED) hypersensitivity reactions, provides prescribing guidelines that may minimize the risk of antiepileptic induced rashes, and discusses treatment options for rashes. Articles indexed in PubMed, Science Citation, and Google Scholar (January 1946-March 2019) were systematic searched using the following key terms: hypersensitivity, rash, antiepileptic, epilepsy, cross-sensitivity, desensitization, patch testing and supplemented with our clinical experiences. Additional references were identified from a review of literature citations. AEDs are associated with cutaneous adverse reactions. Aromatic AEDs and higher titration rates are associated with increased risk of hypersensitivity reaction. Patient characteristics, underlying health conditions, and genetic variations may increase the likelihood of a hypersensitivity reaction. Once a hypersensitivity reaction occurs, the likelihood of cross sensitivity to another AED increases, especially among other aromatic AEDs. Withdrawal of the causal agent and initiation of a lower risk agent usually leads to resolution of symptoms. Desensitization protocols may be an option for patients whose seizures only respond to the AED causing the rash.

Pilot Study for Implementing an Osteoporosis Education and Exercise Program in an Assisted Living Facility and Senior Community.

BACKGROUND: Project Healthy Bones (PHB) is a 24-week, peer-led exercise and education program for older adults at risk of osteoporosis. METHOD: Residents from an assisted living and senior community program were enrolled after medical clearance. Participant demographics, geriatric fitness assessments, exercise logs, quizzes, and surveys were collected at baseline and 24 weeks. Data were analyzed using paired t tests and ANOVA of change scores for the pooled data within the R statistical environment. RESULTS: Forty of the 53 enrolled participants completed the program. Participants improved their strength, balance, posture, and flexibility, resulting in a reduced risk of falls and fractures. In addition, their knowledge of bone health, nutrition, and fall prevention increased. CONCLUSION: Offering low-cost disease-specific programs such as PHB helps minimize the complications of osteoporosis and improve the overall health of participants. Implementing disease-specific public health programs in assisted living centers can increase access to programs.

Rapid eye movement sleep behavior disorder.

OBJECTIVE: To describe the clinical features of rapid eye movement (REM) sleep behavior disorder (RBD), evaluate treatment options, and discuss management of patients with comorbid diseases. DATA SOURCES: A MEDLINE search (1977-April 2007) using the terms REM sleep behavior disorder, narcolepsy, parkinsonian disorders, levodopa, dopamine agonists, clonazepam, benzodiazepines, and melatonin was used to retrieve relevant articles. The reference sections of all articles and texts were scanned for additional literature. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated. There were no specific criteria for inclusion of articles in this review. DATA SYNTHESIS: RBD is characterized by enactment of dream content resulting from the loss of normal skeletal muscle atonia during REM sleep. RBD occurs mainly in geriatric patients and in patients with neurodegenerative diseases, especially parkinsonian diseases. The presence of idiopathic RBD may be a sign of an underlying parkinsonian syndrome. Development of RBD may be one of the first manifestations of Parkinson's disease or other parkinsonian syndromes. An acute form of RBD can be drug-induced or occur on drug withdrawal. The potential for injury to the patient and his or her bed partner is as high as 96%. Controlled trials are unavailable for most agents used in the treatment of RBD, although clonazepam is an effective first-line agent and can provide rapid and complete symptom remission based on evidence from 3 large case series. Patients who cannot tolerate clonazepam or who have a suboptimal response may benefit from melatonin alone or as an adjunct. Both drugs are generally well tolerated when taken at bedtime. Management of patients with RBD becomes complicated due to the high incidence of neurologic comorbidity. CONCLUSIONS: Clonazepam is the treatment of choice for patients with RBD. The drug is efficacious and has a low incidence of adverse effects. Melatonin is a viable second-line or adjunctive treatment.

Symptoms of attention-deficit/hyperactivity disorder in adults with restless legs syndrome.

OBJECTIVE: To determine the occurrence of symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults with restless legs syndrome (RLS), normal controls, and controls with insomnia. SETTING: University-based hospital. METHODS: The occurrence and severity of current ADHD symptoms were determined in a prospective study of sequential adult patients with RLS (n = 62) or insomnia (n = 32) and adult controls (n = 77) using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) ADHD criteria, the Brown Attention-Deficit Disorder (ADD) Scale for adults, and a structured psychological interview. RLS severity was assessed using the International RLS Study Group Rating Scale (IRLS). RESULTS: Only 1 experimental subject had previously been diagnosed with ADHD. More RLS patients (26%) than insomnia patients (6%) or controls (5%) had ADHD symptoms using age-adjusted total DSM-IV ADHD scores (P < .01). The mean Brown ADD score was greater in RLS patients (37 +/- 28) than in patients with insomnia (24 +/- 18) or controls (21 +/- 18) (P < .01). The RLS symptom severity (0-40 scale) was greater in RLS patients with ADD symptoms (26 +/- 9) than in those without ADD (21 +/- 10) (P < .04). Of the subjects with a Brown ADD score > 40, all reported ADD symptoms in 2 settings, and the majority had had ADHD symptoms since childhood. For subjects with a Brown ADD score > 40, there were no differences between the RLS, insomnia control, and normal control groups in quality of life or the level of anxiety or depression. CONCLUSIONS: ADHD symptoms are more common in RLS patients than in patients with insomnia or controls. RLS leg discomfort or poor quality of sleep may theoretically lead to hyperactivity and lack of concentration. Alternatively, RLS and ADHD may be part of a single symptom complex, and dopaminergic deficiency may play a role in both disorders.

Peer- and self-grading compared to faculty grading.

OBJECTIVES: To determine the reliability and value of peer- and self -reported evaluations in the grading of pharmacy students. METHODS: Mean student peer- and self- reported grades were compared to faculty grades in the advanced pharmacy practice experience (APPE) and seminar presentation courses. Responses from pharmacy school alumni regarding curricular peer- and self-reported evaluations were solicited using an online survey tool. RESULTS: Self-reported student grades were lower than the faculty-reported grade overall and for the formal presentation component of the APPE course grading rubric. Self-reported grades were no different than faculty-reported grades for the seminar course. Students graded their peers higher than did faculty members for both the seminar and APPE courses on all components of the grading rubric. The majority of pharmacy alumni conducted peer- and self-evaluations (64% and 85%, respectively) at least annually and considered peer- and self-evaluations useful in assessing students' work in group projects, oral presentations, and professional skills. CONCLUSION: The combination of self-, peer-, and faculty-assessments using a detailed grading rubric offers an opportunity to meet accreditation standards and better prepare pharmacy students for their professional careers.

L-Dopa improves Restless Legs Syndrome and periodic limb movements in sleep but not Attention-Deficit-Hyperactivity Disorder in a double-blind trial in children.

BACKGROUND: In a previous open-label study, dopaminergic agents improved Restless Legs Syndrome (RLS) and Periodic Limb Movements in Sleep (PLMS), as well as Attention-Deficit-Hyperactivity Disorder (ADHD) in children with both disorders. We therefore conducted a double-blind placebo-controlled trial of L-DOPA in ADHD children with and without RLS/PLMS. METHODS: Two groups of patients (total n = 29), those with ADHD only or those with ADHD and RLS/PLMS, were randomized to L-DOPA or placebo therapy. At baseline and after therapy patients were assessed with Conners' parent and teacher rating scales; polysomnography; RLS rating scale; and neuropsychometric measures of memory, learning, attention, and vigilance. RESULTS: L-DOPA improved RLS/PLMS symptoms in all patients with those disorders compared with placebo (p = .007). When assessed by the Conners' Scales before therapy, ADHD was more severe in children without RLS/PLMS than in children with RLS/PLMS (p = 0.006). L-DOPA had no effect on Conners' scales, sleep, or neuropsychometric tests when all patients treated with the drug were compared to those on placebo or when patients with ADHD only were compared to those with ADHD and RLS/PLMS. CONCLUSIONS: In this first double-blind study of a dopaminergic therapy in children with RLS/PLMS, L-Dopa significantly improved RLS/PLMS but not ADHD. These results, however, should be interpreted carefully since they may have been influenced by the relatively small sample size and the baseline differences in severity of ADHD symptoms. Further work needs to be done to elucidate the relationship between dopamine, ADHD and RLS/PLMS.

Clinically significant but unsuspected restless legs syndrome in patients with sleep apnea.

In this prospective study, the prevalence of clinically significant restless legs syndrome (RLS) with symptoms at least 2 to 3 days per week was 8.3% in 60 sequentially polysomnographically studied patients with clinically significant sleep apnea (Apnea Index score > 5 or Respiratory Disturbance Index score > 10). Age-matched spouses were used as a control group and showed a comparable prevalence of RLS at 2.5% (not significant). Although RLS appears to be only slightly more common in sleep apnea patients than in controls, the importance of this study lies in the fact that clinically significant RLS occurred in 1 of every 12 patients with sleep apnea and, in every case, the RLS was unsuspected before polysomnography. We recommend that all patients undergoing polysomnography to rule out sleep apnea be screened for the symptoms of RLS. We have found the MEMO-NIH consensus conference questionnaire administered at the time of polysomnography to be useful in this regard.

Non-benzodiazepines for the treatment of insomnia.

Benzodiazepine hypnotics, the mainstay of pharmacological treatment for insomnia, have been associated with altered sleep architecture, psychomotor and memory impairment, rebound insomnia, withdrawal effects, tolerance, dependence, abuse potential and respiratory depression. Non-benzodiazepines, such as zolpidem, zopiclone and zaleplon, demonstrate hypnotic efficacy similar to that of benzodiazepines along with excellent safety profiles. Non-benzodiazepines generally cause less disruption of normal sleep architecture than benzodiazepines. Psychomotor and memory impairment may be less problematic with non-benzodiazepines, especially when compared to longer-acting benzodiazepines. Rebound insomnia and withdrawal symptoms occur infrequently upon discontinuation of non-benzodiazepines and may be less common and milder than those seen upon discontinuation of some benzodiazepines. For the long-term treatment of insomnia, which is generally not recommended, zolpidem and zopiclone are particularly good options because they do not develop tolerance rapidly and have a low abuse potential. Limited data indicate that zaleplon has low tolerance and abuse potential, although further experience is needed to determine its long-term efficacy and safety profile. Since non-benzodiazepines produce minimal respiratory depression, they may be safer than benzodiazepines in patients with respiratory disorders. The choice of which hypnotic to use should be based on the patient's primary sleep complaint, health history, adverse effects and cost.

Safety of selegiline with cold medications.

OBJECTIVE: To evaluate the safety of the coadministration of selegiline with cold medications. DATA SOURCES: Clinical literature accessed through MEDLINE (1965 -September 2002), IPA database, and Drug-Reax System. The following search terms were used: selegiline, pseudoephedrine, dextromethorphan, MAOI, and drug interactions. Somerset Pharmaceuticals, the marketers of Eldepryl (selegiline HCl), were also contacted. DATA SYNTHESIS: Despite a warning against its concomitant use with pseudoephedrine and dextromethorphan, interactions with selegiline have not been reported. However, there have been reports of patients experiencing adverse events with related agents. CONCLUSIONS: Patients taking selegiline should try to avoid pseudoephedrine and dextromethorphan or use drugs without interaction potential. If selegiline is used with these medications, watch for adverse events or replace selegiline with another drug.