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LTC Bulletin Board - October 2011
Pharmacy News
FDA Approves Amphastar’s Generic Version of Lovenox
On September 19, 2011, Watson Pharmaceuticals, Inc (www.watson.com), announced that Amphastar Pharmaceuticals, Inc (www.amphastar.com), received FDA approval of its abbreviated new drug application for enoxaparin sodium injection in 100-mg/mL and 150-mg/mL strengths. Enoxaparin sodium injection, the generic equivalent to sanofi-aventis’
Lovenox, is a low-molecular-weight heparin indicated in the prophylaxis and treatment of deep vein thrombosis and as prophylaxis for ischemic complications in patients with unstable angina or those who have experienced a non-Q-wave myocardial infarction.
Amphastar will supply enoxaparin sodium injection to Watson Pharmaceuticals, which will market, sell, and distribute the product to the US retail pharmacy channel. Amphastar will market, sell, and distribute the product to all other channels. Amphastar anticipates launching its enoxaparin sodium injection product in the fourth quarter of 2011.
Study Shows Insulin Degludec’s Duration of Action Exceeds 26 Hours
In a randomized, double-blind, 2-period, crossover trial, researchers found the glucose-lowering effect of insulin degludec was evenly distributed in the first and second 12-hour periods in patients with type 2 diabetes. They also concluded that the drug had a duration of action beyond 26 hours. The study was presented as a late-breaking poster at the American Diabetes Association’s 71st Scientific Sessions, which took place in San Diego, CA, from June 24 to 28, 2011.
Insulin degludec, an ultra–long-acting basal insulin, is injected subcutaneously once daily in patients with type 2 diabetes and is slowly absorbed. According to the authors, the drug’s ultra-long glucose-lowering effect has exceeded 40 hours in previous trials.
The study examined insulin degludec’s glucose-lowering effect during a 24-hour dosing interval at steady state in 49 individuals with type 2 diabetes treated with insulin and no concomitant oral antidiabetic agents. Patients were randomly assigned to receive 0.4, 0.6, or 0.8 U/kg of insulin degludec administered once daily for 6 days. Between treatments, there was a washout period of 13 to 21 days. At the end of the treatment period, subjects underwent a 26-hour euglycemic clamp.
Of the 49 patients, 40 were men and all were white. The mean age of the patients was 59 years, mean body mass index was 29.6 kg/m2, mean duration of type 2 diabetes was 14 years, and mean hemoglobin A1c level at baseline was 7.6%.
During the 24-hour dosing interval, the total glucose-lowering effect increased with the increasing dose. The authors assessed the glucose-lowering effect by estimating the ratio between the area under the curve for the glucose infusion rate profiles compared with the total area under the curve during the 24 hours. In each of the three doses, the glucose-lowering effect was flat and stable.
Within the 26-hour euglycemic clamp, the blood glucose level did not reach the end of action of 150 mg/dL for any of the patients. In addition, the mean blood glucose levels remained at the target level until the end of the 26 hours. The clamp blood glucose level began at 90 mg/dL, and during the last 10 minutes of the dosing interval the mean blood glucose level was between 90 and 92 mg/dL at each of the doses. Thus, the authors concluded that insulin degludec’s duration of action lasted for >26 hours for all three doses.
When assessing insulin degludec’s safety profile, the authors did not identify any safety concerns and found the drug was well tolerated.
This study was supported by Novo Nordisk.
Medical News
New Technology May Detect Pain in Absence of Self-Report
The gold standard of measuring pain is commonly accepted as self-report, thus effective pain management is often hindered when a patient is unable to verbally express that he or she is experiencing pain. In a new study published in PLoS ONE (www.ncbi.nlm.nih.gov/pubmed/21931652), researchers from Stanford University discussed a tool that they are developing to accurately assess pain without relying on self-report. According to the authors, previous efforts have not been successful at substituting self-report with a clinically valid, physiology-based measure of pain. Justin E. Brown, a graduate student research assistant at Stanford, and colleagues have been studying the possibility of using a support vector machine (SVM) that is trained on functional magnetic resonance imaging (fMRI) data to assess cognitive states associated with pain. The SVM works by machine-learning and adapting to algorithms, which allow predictive models to be trained with a known set of stimuli, and then used to classify novel stimuli. The approach has previously been used in conjunction with fMRI data to determine what a person sees or hears, Brown and colleagues reported.
In fMRI experiments, 24 healthy individuals were presented with painful and nonpainful heat stimuli. The study showed the model could distinguish the brain’s response to painful and nonpainful stimuli with 81% accuracy (P<.0000001). The overall performance of the SVM model showed activity in pain-processing regions of the brain, including the primary and somatosensory cortex, secondary somatosensory cortex, insular cortex, primary motor cortex, and cingulate cortex. Region of interest analyses showed that whole-brain patterns of activity led to more accurate classification of pain than localized activity in individual brain regions. The authors concluded that deeper investigation is needed to develop the tool and determine whether the method can assess chronic pain rather than a single painful stimulus. “We are still very far from a physiology-based pain assessment tool that could be used in clinical, forensic, and other applied settings. However, we see the goal of an accurate, valid surrogate for self-reported pain as both attainable and worthy of effort,” the authors wrote.
Insulin Nasal Spray May Slow Cognitive Decline and Alzheimer’s Disease
Studies have shown that insulin serves many important roles in maintaining normal brain function and a healthy central nervous system. A team of researchers from Seattle, WA, is studying the relationship between reduced levels of insulin and a number of pathological processes that characterize cognitive decline and Alzheimer’s disease (AD). In a randomized, double-blind, placebo-controlled clinical trial, the researchers examined the effects of intranasal insulin on cognition, function, cerebral glucose metabolism, and cerebrospinal fluid biomarkers in 104 adults with mild to moderate AD (n=40) and amnestic mild cognitive impairment (aMCI; n=64), a condition thought to represent prodromal AD in many cases. The participants were divided into three groups to receive 20 international units (IU) of insulin (n=36), 40 IU of insulin (n=38), or placebo (n=30) for a period of 4 months. The primary methods of measuring outcomes included scores on delayed story recall and the Dementia Severity Rating Scale; secondary measures included the cognitive subscale of the AD Assessment Scale, and the AD Cooperative Study–Activities of Daily Living Scale. Among its most significant findings, the study demonstrated that treatment with 20 IU of insulin improved delayed memory (P<.05) and both doses of insulin preserved caregiver-rated functional ability (P<.01) and general cognition.
The authors wrote that intranasal administration was effective at providing rapid delivery of insulin to the central nervous system via bulk flow along the olfactory and trigeminal perivascular channels, as well as slower delivery via olfactory bulb axonal transport, without adversely affecting blood insulin or glucose levels. No severe treatment-related adverse events were observed.
The researchers concluded that intranasal insulin stabilized or improved cognition, function, and cerebral glucose metabolism in adults with aMCI or AD; however, they acknowledged the relatively short trial period as a limitation of the study and called for additional studies to evaluate the long-term effects of intranasal insulin. “Safety profiles and compliance were excellent for this short-term intervention. Taken together, these results provide an impetus for future clinical trials of intranasal insulin therapy and for further mechanistic studies of insulin’s role in the pathogenesis of AD,” the authors wrote. The study was published online in September in the Archives of Neurology (www.ncbi.nlm.nih.gov/pubmed/21911655).
Researchers Develop Fall Detection System Using Doppler Radar
Studies show that a delay in medical intervention after an elderly individual has had a fall contributes to death or serious injury. Although there are currently devices that alert medical personnel to a fall, timely fall detection with few false alarms continues to be a challenge, according to a team of researchers from the University of Missouri.
“The wearable devices are inexpensive but they have two main drawbacks: they can’t be activated when a loss of conscience occurs after a fall and they may be not be worn at all times (for example, during night time),” the authors wrote in the study. The team, led by Liang Liu, doctoral student, is building a Doppler radar-based fall detection system that would use motion-sensing technology to alert care providers of a patient’s need for assistance more quickly than other devices. “Falls are especially dangerous for older adults, and if they don’t get help immediately, the chances of serious injury or death are increased. If emergency personnel are informed about a fall right away, it can significantly improve the outcome for the injured patient,” said Liu in a press release.
The study used melfrequency cepstral coefficients to represent the Doppler “signatures” of a variety of human activities, including walking, bending down, and falling. Since falls combine a series of body movements, the radar can recognize the “signature” of a fall based on these unique images. In the pilot dataset, the system detected 109 falls and 341 non-fall human activities of 450 samples. The system is currently being tested among residents at TigerPlace, an independent living community in Columbia, MO. The authors concluded that the results were “encouraging,” though additional work is needed to reduce the false alarm rate and analyze the data of its usage among the residents of TigerPlace. The study was presented at the Pervasive Health Conference, Ireland, in May. It is available for download at bit.ly/q0bZqR.
Product Spotlight
Device Measures Subepidermal Moisture for Earlier Pressure Ulcer Detection
Pressure ulcers are often preventable, yet an estimated 60,000 people die each year from complications related to pressure ulcers. The current standard for assessing pressure ulcer damage is a visual inspection of the patient’s skin to detect color changes. But this approach is ineffective, according to Barbara Bates-Jensen, PhD, RN, professor, University of California Los Angeles School of Nursing. “By the time you see damage on the skin, it’s already occurred underneath the skin,” she said in a press video online. Bates-Jensen and colleagues in conjunction with Bruin Biometrics, LLC, a wireless health technology company, have developed the Sub-Epidermal Moisture (SEM) scanner (pictured), a handheld device to measure the risk of pressure ulcer formation in skin tissue water before skin damage becomes visible.
In a pilot study involving nursing home residents, Bates-Jensen used surface electrical capacitance technology to measure the relationship between SEM and early pressure ulcer damage (www.ncbi.nlm.nih.gov/pubmed/19448508). In her clinical studies, she concluded that as the level of visible skin damage increased, so did SEM. Bates-Jensen explained that the concept of the electronic scanner was born after observing a wide variety of measurement techniques being used in the clinical work. The SEM scanner works by measuring the dielectric properties of the soft tissue being assessed and provides an estimation of the SEM that is indicative of risk of pressure ulcer formation. “This is exciting because it gives us a chance to detect skin problems before they’re visible on the surface of the skin, and thus an opportunity to intervene with prevention methods so that patients might not experience pressure ulcers,” Bates-Jensen said in the video.
The scanner is intended for use in a point-of-care environment. It can wirelessly store, analyze, and track data in real-time for clinicians to identify trends and conditions in individual patients. The SEM scanner was unveiled in April and is expected to be commercially launched in the coming months. More information about the product is available at www.bruinbiometrics.com/pointofcare.html.
Photography Guide Standardizes Wound Care Documentation
As wound litigation becomes more prevalent and expensive each year, there isan increasing need to improve patient care documentation. The Mayo Foundation for Education and Research estimated in 2004 that there were more than 17,000 lawsuits related to pressure ulcers annually. Additionally, the Centers for Medicare & Medicaid Services have recently expanded the goals of Section M: Skin Conditions in the Version 3 Minimum Data Set, which calls on clinicians to provide a more accurate clinical picture of a resident’s condition. Kiss Healthcare, Inc, has introduced its new Wound Photo Guide, designed to improve patient care and reduce wound litigation through the use of its standardized, color-coded 360˚ rulers (pictured) and 25-cm linear rulers. The 360˚ rulers are ideal for measuring circular or elliptical-shaped wounds, whereas the linear rulers are well suited for measuring length and width of wounds. Both kinds of rulers are adhesive and conform easily to the shape of the body, and they can be used to establish a baseline on admission and discharge to track wounds that increase or decrease during the patient’s stay at a facility.
The company proposes that the rulers be used as a consistent scaling guide when digital photography documentation is undertaken. Often, a numeric scaling system can be illegible and problematic in a photograph if there is poor lighting; discrepancies in wound size also occur when photographs are taken at various distances. The company proposes that the color-coded rulers are easily recognizable at any distance in a photograph, and they also eliminate the need for caregivers to describe wounds subjectively (eg, “the wound was the size of an orange”). Each ruler comes with additional adhesive decals for documenting other details of the wound (eg, date, location on body), and a stick-figure decal to show the alignment of the wound in the photograph regardless of the angle at which the photograph was taken. The company states the use of this standardized method strengthens the reliability of digital photography documentation and is easy to implement in one facility or across a hospital system. For more information or to order the products, visit the company Website at www.kisshealthcare.com.
LTC Bookshelf
Author Focuses on Caregiver Well-being in New Book On Dementia
While there are numerous resources in the long-term care community to help clinicians and nurse practitioners manage individuals with dementia, there are few resources that offer support to family members who are going through the difficult and heartbreaking process of caring for their loved one with dementia. Caregiver Survival 101: Strategies to Manage Problematic Behaviors Presented in Individuals with Dementia by Lisa Byrd, PhD, CFNP-BC, GNP-BC is a resource for caregivers and families to better understand dementia and its problematic behaviors so that they may avoid or mitigate the problems of dementia while preserving their loved one’s dignity. The book begins with Byrd’s recollection of her mother’s own battle with dementia. “Children never want to think there is anything wrong with their parents and attribute a lot of the idiosyncrasy as a normal part of aging,” Byrd writes in the introduction. She recalls her mother—an emergency room nurse and single parent of two children—as remarkably “strong-willed,” “proud,” and “independent” until she began to experience lapses in memory that worsened over time until she passed away in 2009. As many adults who have parents with dementia may have experienced, dementia often begins with “hints that something just wasn’t right,” Byrd writes.
Byrd, who has an extensive background in the care of older adults in nursing homes and outpatient clinics, presents various behavioral management approaches based on research, best practices, and personal experience in her book, which was published by PESI Healthcare in April 2011. It includes a discussion on the causes, presentations, diagnoses, and management strategies for the various kinds of dementia, including Alzheimer’s disease, and other neurodegenerative diseases, such as Parkinson’s disease. The book also outlines the differences among dementia, normal signs of aging, depression, and delirium. Ultimately, she emphasizes to caregivers that they have no control over the debilitating physical and psychological effects that their loved ones may experience in the aging process, but that they can act strategically to manage and lessen the problems caused by dementia. Byrd advises, “To meet these challenging situations, use creativity, flexibility, patience, and compassion.”
LTC Resource
Free Guide Seeks to Improve Resident Care
In October 2010, the Picker Institute (www.pickerinstitute.org) and Planetree (www.planetree.org) posted an interactive edition of their Long-Term Care Improvement Guide online as a free resource. The Guide serves as “a compendium of best practices that incorporates the perspectives of long- and short-term care residents into a one-of-a-kind guide to the ways and means of approaching and implementing positive change in the culture of aging,” noted a press release announcing that the Guide had accumulated almost half a million views and 25,000 downloads through July 2011.
“Based on the success of the Patient-Centered Care Improvement Guide, which Picker Institute and Planetree published in 2008, we knew the LTC guide would be a popular destination,” said Loie Hanscom, executive director, Picker Institute. “But we’re very impressed with the degree to which it has established its place in the long-term care archive, and we expect it will continue to make significant contributions to the long-term care field.”
The Guide includes three main parts: “Making the Case for Change,” which tackles many of the myths and misconceptions that prevent institutions from progressing to a model of resident-centered care; “Building Community–A Process of Transformation,” which outlines strategies for implementing and sustaining change; and “Practical Approaches for Building a Resident-Centered Culture,” which focuses on strategies for making long-term care residents more comfortable in their environments, such as by fostering a sense of community and making mealtimes more enjoyable by liberalizing their diets and giving residents more control over their meals. The Long-Term Care Improvement Guide can be downloaded at https://bit.ly/LTCImprovementGuide.
