Advances in Treatment of Chronic Hepatitis C Virus (HCV) Infection

Hepatitis C virus (HCV) infection is a prominent cause of chronic liver disease and may lead to serious complications such as liver failure and need for a transplant. The virus is transmitted via exposure to blood and is classified into various genotypes based on genetic mutations in the virus. Current treatment options for HCV infection are not effective in all patients, and there are limited options for patients infected with a genotype other than genotype 1. Two new medications have been approved recently for treatment of HCV infection. Simeprevir (Olysio®) gained U.S. Food and Drug Administration (FDA) approval in November 2013, and sofosbuvir (Sovaldi®) was approved in December 2013. Information from clinical trials with each of the medications supports their safety and efficacy in appropriate patient populations. The adverse effects are generally tolerable; however, for some patients, the adverse effects, drug interactions and cost can be limiting factors

Implications for registry-based vaccine effectiveness studies from an evaluation of an immunization registry: A cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Population-based electronic immunization registries create the possibility of using registry data to conduct vaccine effectiveness studies which could have methodological advantages over traditional observational studies. For study validity, the base population would have to be clearly defined and the immunization status of members of the population accurately recorded in the registry. We evaluated a city-wide immunization registry, focusing on its potential as a tool to study pertussis vaccine effectiveness, especially in adolescents.</p> <p>Methods</p> <p>We conducted two evaluations – one in sites that were active registry participants and one in sites that had implemented an electronic medical record with plans for future direct data transfer to the registry – of the ability to match patients' medical records to registry records and the accuracy of immunization records in the registry. For each site, records from current pediatric patients were chosen randomly. Data regarding pertussis-related immunizations, clinic usage, and demographic and identifying information were recorded; for 11–17-year-old subjects, information on MMR, hepatitis B, and varicella immunizations was also collected. Records were then matched, when possible, to registry records. For records with a registry match, immunization data were compared.</p> <p>Results</p> <p>Among 350 subjects from sites that were current registry users, 307 (87.7%) matched a registry record. Discrepancies in pertussis-related data were common for up-to-date status (22.6%), number of immunizations (34.7%), dates (10.2%), and formulation (34.4%). Among 442 subjects from sites that planned direct electronic transfer of immunization data to the registry, 393 (88.9%) would have matched a registry record; discrepancies occurred frequently in number of immunizations (11.9%), formulation (29.1%), manufacturer (94.4%), and lot number (95.1%.) Inability to match and immunization discrepancies were both more common in subjects who were older at their first visit to the provider site. For 11–17-year-old subjects, discrepancies were also common for MMR, hepatitis B, and varicella vaccination data.</p> <p>Conclusion</p> <p>Provider records frequently could not be matched to registry records or had discrepancies in key immunization data. These issues were more common for older children and were present even with electronic data transfer. These results highlight general challenges that may face investigators wishing to use registry-based immunization data for vaccine effectiveness studies, especially in adolescents.</p

FDA Approves New Inhaled Insulin: Afrezza® (Technosphere® Insulin)

Diabetes is an endocrine disease caused by deficiency or malfunction of insulin that results in high blood glucose levels and places patients at higher risk for a number of complications. This chronic disease is difficult to manage and affects millions of people in the United States, costing the health care system billions of dollars a year. Of a variety of antidiabetic agents used to control blood glucose, insulin is perhaps the most effective, but until recently it was only available in injectable form. As of June 27, 2014, a new inhaled insulin called Afrezza® (Technosphere® insulin) was approved by the U.S. Food and Drug Administration (FDA) and will soon be coming to market. This rapid-acting insulin is administered through the lungs and offers an alternative to traditional dosage forms. This article further explores some background about Technosphere® insulin, its mechanism of action and literature regarding its efficacy

What is the SmartPill®?

The SmartPill® is a new, noninvasive technology to evaluate the gastrointestinal tract. It is a nondigestible capsule that migrates through the gastrointestinal tract to measure pH, pressure, and temperature. It was approved by the FDA in 2006 for the evaluation of colonic transit time in patients with chronic constipation and to evaluate gastric transit time in patients with suspected gastroparesis. Other currently used gastrointestinal monitoring systems have some disadvantages, and the SmartPill® is suggested as an alternative. The SmartPill® has also been used for research purposes in various studies and has the potential to be used in diagnosis and monitoring of other gastrointestinal diseases. The aim of this article is to evaluate the clinical significance of the SmartPill® by comparing it to other previous gastrointestinal monitoring methods, examining the FDA approved indications, assessing other possible uses for it and providing health care professionals with key counseling points for patients

Overview of Kalydeco® (Ivacaftor) for Treatment of Cystic Fibrosis

Cystic fibrosis (CF) is a genetic disease associated with specific gene mutations that presents with pulmonary inflammation and frequent lung infections, exocrine pancreatic insufficiency, altered sweat composition and declining lung function. Ivacaftor (Kalydeco®) was approved for treatment of cystic fibrosis in patients 6 years of age and older with a G551D mutation on the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a CFTR potentiator and does not work in patients with a mutation of the F508del. Efficacy has been demonstrated in several trials with a primary outcome of improved FEV1, improvements in pulmonary exacerbations, patient-reported decrease in respiratory symptoms and weight gain. Side effects that have been reported include oropharyngeal pain, nasal congestion, abdominal pain, upper respiratory tract infection, rash and dizziness. The drug is metabolized via the CYP3A4 enzyme system and should be monitored for potential drug interactions accordingly. Information on long-term safety is not yet available, but clearly this drug represents an advance in the management of a debilitating disease

Cannabinoids for the Treatment of Chronic Headaches

Species of the Cannabis plant genus were among the earliest medicinal plants cultivated by man, with historical accounts of their medicinal uses dating back before the Common Era. Despite its current legal status, Cannabis has garnered nationwide attention as a therapeutic agent for various disease states, including chronic headaches, due to its medical indications as an antispastic, analgesic, antiemetic, neuroprotective and anti-inflammatory agent. Since headaches have a high prevalence in the American population and greatly impair simple daily aspects of living, chronic headaches have become a particular point of interest in regard to the therapeutic potential of Cannabis. Clinical trials and case reports have shown that Cannabis administration for headaches has greatly improved the quality of life and decreased the use of adjuvant medications for some patients. Studies are limited and conflicting, mostly due to the legal issues associated with Cannabis. Pharmacists play a major role in managing patients who are treating their chronic headaches and need to be able to educate patients about Cannabis. Patients may consider trying to treat their headaches with Cannabis even though it has legal restrictions regarding its use and is not U.S. Food and Drug Administration (FDA) approved. Pharmacists should understand federal and state restrictions, drug interactions, potential health risks, psychoactive effects and types of delivery systems for Cannabis use