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Objective. To implement the Pharmacists' Patient Care Process (PPCP) in a medicinal chemistry course. Methods. Doctor of Pharmacy students in a medicinal chemistry course were challenged to apply the PPCP in a lesson on cholinesterase inhibitors and NMDA receptor antagonist in the treatment of Alzheimer's disease. A clinical faculty member with expertise in the topic reviewed the clinical information provided to ensure applicability to patient care. A pre- and post-course survey was administered to assess students' understanding of the PPCP and the effectiveness of the strategies used. Students' pre- and post-course responses were analyzed, and qualitative themes were identified. Results. Of the 141 students enrolled in the course, 96% and 97% completed the pre- and post-course surveys, respectively. Students' post-course responses were higher than pre-course answers to the question that they knew all the steps of the PPCP (96% vs 66%, respectively). Ninety one percent in the post-course survey compared to 62% in the pre-course survey listed the PPCP steps correctly. In addition, more than 90% of the students indicated that the strategies used in the class helped them understand and relate to the PPCP. Qualitative responses revealed themes with positive responses related to the course, course activities, PPCP goals and curriculum design based on the implementation of the PPCP. Conclusion. The introduction of the PPCP as a framework for all pharmacy practitioners is a worthy endeavor. Purposeful strategies to introduce the PPCP in a medicinal course were positively received by students. Formalized efforts to implement the PPCP in clinical, social and administrative, and science courses are critical to introduce the PPCP as a framework for all future pharmacy practitioners.

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Restless legs syndrome is a common neurological condition affecting a substantial portion of the population. It can be an idiopathic disorder, or one that is secondary to another cause. Given that the underlying pathophysiology of restless legs syndrome is not well understood, several drug classes have been studied for symptom control. While dopamine agonists have long been the mainstay of first-line treatment for restless legs syndrome, recently, the α2δ ligands have been increasingly used. These agents have proven both efficacious and safe in a number of clinical trials. Additionally, compared with the dopamine agonists, they have been associated with less augmentation, a phenomenon whereby symptoms emerge earlier in the day, become more severe, and may spread to areas of the body previously unaffected. Newer clinical guidelines for restless legs syndrome are increasingly recommending the α2δ ligands as a logical first-choice medication for patients needing drug therapy for symptom control.

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PURPOSE: Perampanel is a first-in-class antiepileptic medication approved for the treatment of partial (focal) seizures, and as adjunctive treatment for primarily generalized tonic-clonic seizures. The pharmacology, efficacy data, adverse-effect profile, pharmacokinetics and place in therapy are reviewed. SUMMARY: Perampanel is indicated for use in patients with epilepsy who are 12 years of age or older. It is the first medication designed specifically to be a non-competitive antagonist at post-synaptic α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate receptors. Efficacy in refractory seizures has been established, and ongoing efficacy demonstrated by post-marketing data. The drug is completely absorbed, and exhibits a half-life that allows for once-daily administration in doses up to 12 mg/day. Drug interactions are minimal, but increased doses may be necessary when given with strong inducers of cytochrome P450 enzymes, including when perampanel is co-administered with other antiepileptics that exhibit this property. The most common adverse effects noted in both clinical trials and post-marketing are dizziness and somnolence. Psychiatric and behavioral adverse events have been documented in both adult and pediatric patients, including those with no corresponding diagnostic history. CONCLUSION: Perampanel is a novel adjunctive antiepileptic medication that is an effective option for adolescents and adults with partial seizures, and primarily generalized tonic-clonic seizures uncontrolled with other medications.

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Clobazam is the newest medication approved by the US Food and Drug Administration (FDA) for the treatment of Lennox-Gastaut syndrome (LGS) in patients at least 2 years of age, although the medication has been available in countries around the world to treat epilepsy and anxiety disorders for many years. Though classified as a benzodiazepine, the drug differs structurally from other drugs in the class as it possesses nitrogen atoms at the 1 and 5 positions within the heterocyclic ring rather than at the 1 and 4 positions. This difference and the classification of clobazam as a partial agonist are believed to be responsible for the decreased incidence of sedative effects compared to other benzodiazepines. Adverse events associated with clobazam use in clinical trials have generally been mild to moderate in nature. Data from an open-label extension trial have confirmed that clobazam is efficacious for the treatment of seizures associated with LGS, particularly atonic seizures (drop seizures), over the long term. Tolerance to the drug's antiepileptic effects does not seem to be a common occurrence. The drug has proven to be a cost-effective option for therapy, particularly due to its ability to decrease the number of seizures that require medical treatment. Clobazam represents a welcome addition to the treatment options for LGS.

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INTRODUCTION: Parkinson's disease (PD) is among the most common of the neurodegenerative disorders. Treatment is primarily focused on correcting neurotransmitter imbalances. Several classes of medication are available for this purpose. AREAS COVERED: A Medline search was performed to gather information about the safety of the medications approved for the treatment of the motor symptoms of PD. This was supplemented with additional articles obtained from online sources and information provided by the FDA and the manufacturers. The focus of this review is the side-effect and safety profiles of carbidopa/levodopa, dopamine agonists, selective monoamine oxidase inhibitors, catechol-o-methyltransferase inhibitors, anticholinergics and amantadine. EXPERT OPINION: Though serious side-effects may occur, as a group, the medications used for the treatment of PD motor symptoms tend to produce side-effects that are mild to moderate in nature, and that primarily reflect the focus on dopaminergic therapies. Care plans for Parkinson's patients should be approached based on the needs of the individual as disease presentation, lifestyle, level of disability, concurrent disease states and the presence of non-motor symptoms make each case unique. Patients and caregivers must have realistic expectations about the use of PD medications.

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PURPOSE: The pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of perampanel are reviewed. SUMMARY: Perampanel, a first-in-class antiepileptic agent, was recently approved for use as adjunctive therapy for the treatment of resistant partial seizures in patients 12 years of age and older. It acts as a selective, noncompetitive antagonist at postsynaptic α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate (AMPA) receptors. Perampanel exhibits linear pharmacokinetics and has a half-life of approximately 105 hours. The drug is rapidly and nearly completely absorbed after oral administration, achieving its maximum serum concentration in approximately 1 hour. Its bioavailability is nearly complete. Several efficacy studies have consistently demonstrated the utility of perampanel as adjunctive therapy for the treatment of refractory partial seizures with or without secondary generalization. Drug interactions have been noted with agents that induce cytochrome P-450 hepatic enzymes, including other antiepileptics, and alterations in perampanel dosing may be necessary when these medications are used concurrently. Adverse effects associated with perampanel use are primarily related to the central nervous system, and slow dosage adjustment and bedtime administration are recommended to maximize patient tolerance. The drug's labeling includes a boxed warning about the possible induction of serious adverse psychiatric and behavioral reactions that necessitate close monitoring. Perampanel is not recommended for individuals with severe liver disease or severely compromised kidney function, including those undergoing hemodialysis. CONCLUSION: Perampanel is a novel antiepileptic agent specifically designed to exhibit selective noncompetitive antagonist activity at AMPA receptors. Perampanel has consistently demonstrated the ability to control treatment-refractory partial seizures in many patients.

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OBJECTIVE: To examine the use of various cardiovascular disease (CVD) risk estimation calculators in pharmacy practice. DESIGN: Longitudinal cohort study. SETTING: Midwestern university worksite from August 2008 through May 2012. PARTICIPANTS: University employees with hypertension, dyslipidemia, and diabetes. INTERVENTION: Risk estimation calculators were applied to data from a pharmacist-run chronic disease management program. MAIN OUTCOME MEASURE: Difference in estimated CVD risk from multiple estimation calculators. RESULTS: At baseline and 12 months, non-lab-based tools reported significantly higher 10-year CVD risk percentages compared with lab-based tools among the same cohort of patients (10.63% vs. 8.71% at baseline, P < 0.001; 9.34% vs. 7.31% at 12 months, P < 0.001). In addition, the electronic version of 10-year CVD risk reported significantly higher values than the paper version when applied to the same patient cohort (7.31% vs. 6.60% at 12 months, P = 0.018). CONCLUSION: CVD risk estimation tools report significantly different values and are not interchangeable. Pharmacists using non-lab-based tools should expect significantly higher risk estimates than estimates derived from lab-based tools and therefore should use the same version of the estimation tool over the long term.

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INTRODUCTION: Complex-partial seizures are frequently resistant to antiepileptic therapy. Two new medications with mechanisms of action novel within the antiepileptic class have recently received approval for the adjunctive treatment of partial (focal) seizures. AREAS COVERED: A Medline search was conducted to identify preclinical and clinical studies of ezogabine and perampanel. This was supplemented with additional articles obtained from online sources and information provided by the FDA and the manufacturers. The focus of this review is on the safety profiles of ezogabine (retigabine), a novel antiepileptic that targets voltage-gated potassium channels, and perampanel, a noncompetitive α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate glutamate receptor antagonist. EXPERT OPINION: Central nervous system effects are predominant within the adverse event profiles of both ezogabine and perampanel. In addition, ezogabine exerts its inhibitory effects on potassium channels in the urogenital tract potentially resulting in urinary retention and related outcomes. Recent reports of blue discoloration of the skin and in the retinas of long-term ezogabine users have surfaced. Both drugs have demonstrated the ability to induce neuropsychiatric symptoms. Though both are welcome additions to the antiepileptic drug class, additional monitoring, appropriate counseling, and careful selection of patients are warranted to minimize adverse events.

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Seizures are a frequent complication associated with several neurogenetic disorders. Antiepileptic medications remain the mainstay of treatment in these patients. We summarized the available data associated with various antiepileptic therapies used to treat patients with neurogenetic disorders who experienced recurrent seizures. A MEDLINE search was conducted to identify articles and abstracts describing the use of antiepileptic therapy for the treatment of various neurogenetic syndromes. Of all the neurogenetic syndromes, only autism spectrum disorders, Angelman syndrome, Rett syndrome, Dravet syndrome, and tuberous sclerosis complex were identified as having sufficient published information to evaluate therapy. Some efficacy trends were identified, including frequent successes with valproic acid with clonazepam for epilepsy with Angelman syndrome; valproic acid, stiripentol, and clobazam (triple combination therapy) for epilepsy with Dravet syndrome; and vigabatrin for infantile spasms associated with tuberous sclerosis complex. Due to a paucity of information regarding the mechanisms by which seizures are generated in the various disorders, approach to seizure control is primarily based on clinical experience and a limited amount of study data exploring patient outcomes. Although exposure of the developing brain to antiepileptic medications is of some concern, the control of epileptic activity is an important undertaking in these individuals, as the severity of eventual developmental delay often appears to correlate with the severity of seizures. As such, early aggressive therapy is warranted.

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A recent increase in the incidence of diabetes and pre-diabetes is causing many employers to spend more of their healthcare benefit budgets to manage the conditions. A self-insured university in the USA has implemented an interprofessional diabetes mellitus risk reduction program using its own employee faculty and staff experts to help fellow employees manage their diabetes and pre-diabetes. The interprofessional team consists of five pharmacists, a dietitian, an exercise physiologist, a health educator and a licensed mental health practitioner. In addition, the participant's physician serves as a consultant to the program, as does a human resources healthcare benefits specialist and a wellness coordinator. The volunteer program takes place at the worksite during regular business hours and is free of charge to the employees. The faculty and staff delivering the program justify the cost of their time through an interprofessional educational model that the program will soon provide to university students.

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The FDA approved gabapentin enacarbil in 2011 as the first non-dopaminergic agent for the treatment of restless legs syndrome (RLS) symptoms. Although gabapentin enacarbil is a pro-drug of gabapentin, its pharmacokinetics differ. Absorption of gabapentin enacarbil is more predictable, and inter-patient variability in bioavailability is lower than that of gabapentin. Studies have demonstrated superiority of gabapentin enacarbil compared to placebo. Comparisons to currently available RLS treatments are lacking, but clinical trials demonstrate comparable improvement in RLS symptoms to the dopamine agonists ropinirole and pramipexole, which are usually considered first-line therapy for daily RLS symptoms. Gabapentin enacarbil was well tolerated in clinical trials. The role of the drug in RLS treatment remains undefined, although it will likely be used as an alternative for refractory RLS when other treatments have failed. Additionally, gabapentin enacarbil may be recommended for patients with daily RLS symptoms that are less intense or are associated with pain as an alternative to dopamine agonists.

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INTRODUCTION: Gabapentin enacarbil is a new treatment for restless legs syndrome (RLS). It is a prodrug of the anticonvulsant gabapentin. However, unlike gabapentin, gabapentin enacarbil does not demonstrate saturable absorption. This allows for once-daily dosing and less variability in serum levels. AREAS COVERED: This review focuses on therapies used to treat RLS, both historical and recent. Data from available trials are summarized, with a particular focus on the efficacy and safety of gabapentin enacarbil. Potential advantages and disadvantages of this therapy in comparison with other RLS treatment modalities are discussed. EXPERT OPINION: Placebo-controlled trials of gabapentin enacarbil demonstrate considerable efficacy in the treatment of RLS. However, head-to-head trials comparing gabapentin enacarbil with other medications used in the treatment of RLS, including gabapentin, are lacking. Potential advantages with gabapentin enacarbil related to its pharmacokinetic profile are thus difficult to ascertain. Efficacy of gabapentin enacarbil appears comparable with that of the dopamine agonists, long considered the therapy of choice in patients with RLS. Given the lack of direct-comparison trials, and the significant cost differential of gabapentin enacarbil versus established therapies, the drug is likely to be used for patients who have failed other medication trials, or those who experience prolonged symptoms and prefer once-daily dosing.

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Complex partial seizures are often refractory to current pharmacological therapies. These difficult to treat seizures are typically managed using multiple antiepileptic drugs (AEDs). AEDs as a group are frequently associated with significant adverse drug effects, multiple drug interactions, and numerous potential clinical complications due to their individual pharmacokinetic profiles and unique drug properties. Recently, the approval of vigabatrin by the US Food and Drug Administration has necessitated that clinicians re-evaluate these risk-benefit relationships and determine where the drug fits within the treatment scheme for the management of complex partial seizures. This review will facilitate that re-evaluation through a brief review of AEDs used in the treatment of complex partial seizures, followed by a focused discussion on vigabatrin.

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In 2009, vigabatrin became the first FDA approved medication for the treatment of infantile spasms in the United States. There are few well-designed prospective studies comparing the drug to placebo or other modalities used in the treatment of infantile spasms. The available data have demonstrated that vigabatrin is efficacious in the treatment of infantile spasms regardless of underlying etiology, but that it is particularly beneficial in patients with a diagnosis of tuberous sclerosis. Adrenocorticotropic hormone (ACTH), the only other medication with robust efficacy data, has been used as first line therapy for infantile spasms associated with other etiologies, and in general controls spasms sooner than vigabatrin, though relapse is common with both therapies. Vigabatrin is generally well tolerated. However, use has been associated with permanent loss of peripheral vision in some patients. In children with tuberous sclerosis, vigabatrin should be considered as initial therapy for infantile spasms. It is a viable alternative for patients with suboptimal response, contraindications or intolerance to ACTH.

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BACKGROUND: Vigabatrin (Sabril) was approved in the USA in mid-2009 for the adjunctive treatment of refractory complex partial seizures and as treatment of infantile spasms. Vigabatrin's more than 30-year history of research and development is condensed into a clinically relevant review pertaining to this 2009 approval. METHODS/DISCUSSION: A review of the scientific literature was conducted with special focus given to the drug molecule, its mechanism of action, its effects on living systems (e.g., pharmacokinetic, pharmacologic and toxicologic), and its anticipated role among antiepileptic drugs in the USA. CONCLUSIONS: The recent approval of vigabatrin makes a significant addition to antiepileptic drug options. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of severe adverse drug events.

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Despite efforts to decrease tobacco use, smoking continues to be a leading cause of preventable morbidity and premature death. The associated economic burden is substantial, both in the form of direct costs (healthcare expenditures) and indirect costs (lost productivity), regardless of whether the burden is assessed from the standpoint of an employer, a health plan, or society as a whole. Cessation programs are considered among the most cost-effective in healthcare, and are often used as a benchmark for other medical interventions. This analysis specifically considers the cost-effectiveness of varenicline, a novel α(4)ß(2) partial agonist used for smoking cessation, in comparison to other approved therapies. Clinical trial data have demonstrated that varenicline has the ability to decrease cravings and withdrawal symptoms, and lessen positive reinforcement associated with smoking. Varenicline's novel mechanism has translated into superior efficacy in comparison to other available therapies. For this reason, despite an initial cost that typically exceeds that of other medications, varenicline is a cost-effective option for smoking cessation.

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OBJECTIVE: To determine the prevalence, treatment, and control of hypertension (HTN) in elderly residents of skilled nursing facilities (SNFs). To determine variables that may influence the treatment and control of HTN in residents of SNFs. DESIGN: Concurrent medical record review of SNF residents who had resided at a facility for a minimum of 30 days. SETTING: Twelve SNFs in western Iowa and eastern Nebraska. PARTICIPANTS: All residents studied were living in one of the 12 SNFs, N=966. MAIN OUTCOME MEASURE(S): Data collected from each medical record included: demographic characteristics, past medical history, blood pressure (BP) taken over the preceding 30 days, and antihypertensive medications and their doses. The BP reading used to define BP control, or lack thereof, was based on the last recorded BP measurement in the medical record. RESULTS: The total percentage of patients with HTN was 77%. Of those with HTN, 71% had controlled BP and 29% had uncontrolled BP. The average number of antihypertensive drugs used was not significantly different between patients with controlled and uncontrolled BP. Multivariate analysis failed to identify any patient demographic characteristic or comorbidity that correlated with a higher rate of BP control. The number of antihypertensive drugs administered correlated significantly with BP control. The specific type of antihypertensive drug or drug combination did not correlate with BP control. Patients with controlled BP were significantly more likely to be receiving antihypertensive therapy at higher doses than patients with uncontrolled BP.

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PURPOSE: The effects of prednisone on the International Normalized Ratio (INR) values of a patient were examined. SUMMARY: A 66-year-old white man with a history of multiple myeloma was treated in an ambulatory care anticoagulation clinic for deep vein thrombosis. His INR values were normal during therapy with warfarin 14 mg weekly and thalidomide 300 mg daily. His INR values began to increase after three months of starting prednisone 10 mg daily. His weekly dose of warfarin was changed over the next two years, and his dietary intake of vitamin K was increased. For every INR value that was below the therapeutic goal, the patient was not taking prednisone; every time the INR value was above the therapeutic goal, he was taking prednisone. In November 2004, the prednisone and thalidomide were stopped and only the warfarin was continued. After a few dosage increases, ending with a weekly warfarin dose of 21 mg, the patient's INR values remained in the therapeutic range. Multiple variables must be examined when assessing INR values, as many things interact with warfarin. For example, tobacco use, alcohol consumption, and changes in vitamin K intake can affect the INR. Since this patient did not use tobacco or consume alcohol and had a fairly consistent dietary intake of vitamin K, these variables were ruled out as influencing the INR. In this case, the changes in his INR values corresponded to the addition or deletion of prednisone. CONCLUSION: A patient's INR values increased after the addition of prednisone to his warfarin regimen.

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The cost burden of COPD is substantial for patients and families, payers, and society as a whole. Smoking has been known for decades to be the leading cause of the disease. Numerous studies have been completed to address the cost-effectiveness of programs created to aid smokers in their efforts to quit. Because several assumptions must be made in order to conduct such a study, and because differences in study design are numerous, comparison of data is difficult. However, studies have consistently shown that regardless of the perspective from which the study was completed, or the methods used to help smokers abstain, the interventions are cost-effective. Although no study has been conducted specifically to assess the cost-effectiveness of smoking cessation interventions as they relate directly to patients with COPD, based on current data it can be concluded that smoking cessation programs are cost-effective for this population.

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