LTC Bulletin Board - December 2011

FDA News

FDA Approves Eylea for Wet Age-Related Macular Degeneration

On November 18, 2011, the FDA announced that it had approved Eylea (aflibercept) to prevent vision loss and blindness in patients 60 years of age and older who have wet (neovascular) age-related macular degeneration (AMD). Patients with AMD have an abnormal growth of blood vessels in the eye, which can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. An early symptom of wet AMD is the appearance of straight lines being wavy, the FDA press release noted.

“Eylea is an important new treatment option for adults with wet AMD,” said Edward Cox, MD, MPH, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, in an FDA press statement. “It is a potentially blinding disease and the availability of new treatment options is important.”

The safety and effectiveness of Eylea was established in two clinical trials, which randomized 2412 adult patients to receive either Eylea or ranibizumab injection. The primary end point in each study was a patient’s visual acuity following one year of treatment, and the studies showed that Eylea was as effective as ranibizumab in maintaining or improving visual acuity. The most commonly reported side effects in patients receiving Eylea included eye pain, conjunctival hemorrhage, the appearance of vitreous floaters, cataracts, and an increase in eye pressure.

Eylea is approved to be injected into the eye by an ophthalmologist either every 4 or 8 weeks. Eylea should not be used in individuals with an active eye infection or active ocular inflammation. Other FDA-approved treatment options for wet AMD include verteporfin for injection, approved in 2000; pegaptanib sodium injection, approved in 2004; and ranibizumab injection, approved in 2006. More information about Eylea can be found online at www.regeneron.com/eylea.html.

FDA Approves Xarelto to Reduce Risk of Stroke in People with Nonvalvular Atrial Fibrillation

On November 4, 2011, the FDA approved Xarelto (rivaroxaban), a once-daily, oral anticoagulant to reduce the risk of stroke and systematic embolism in patients with nonvalvular atrial fibrillation, a condition that affects approximately 2.2 million people in the United States. Xarelto was previously approved by the FDA to reduce the risk of blood clots, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery.

Studies have shown that patients with atrial fibrillation have a five-fold increased risk of stroke compared with the general population. “Approval of Xarelto offers physicians a new option to reduce stroke risk in patients who are living with atrial fibrillation and the continuous threat of strokes,” said Gerald V. Naccarelli, MD, professor of medicine, Pennsylvania State University College of Medicine, and chief, Division of Cardiology, Milton S. Hershey Medical Center, in a press release by Janssen Pharmaceuticals, Inc, the drug’s manufacturer. “A majority of my atrial fibrillation patients are on multiple medicines for conditions that further increase the risk of stroke,” he added.

Approval of Xarelto’s new indication was based on results from the phase 3 ROCKET AF (Rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for the prevention of stroke and embolism trial in atrial fibrillation) global clinical trial, which sought to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. The trial randomized 14,264 patients with atrial fibrillation and an increased risk of stroke to receive Xarelto 20 mg daily or dose-adjusted warfarin.

In ROCKET AF’s primary analysis, stroke or systemic embolism occurred in 188 patients in the rivaroxaban group and in 241 in the warfarin group (hazard ratio [HR] in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66-0.96; P<.001 for noninferiority). In the intention-to-treat analysis, stroke or systemic embolism occurred in 269 patients in the rivaroxaban group and in 306 patients in the warfarin group (HR, 0.88; 95% CI, 0.74-1.03; P<.001 for noninferiority; P=.12 for superiority). Although major and nonmajor clinically relevant bleeding occurred in slightly more patients in the rivaroxaban group than in the warfarin group (1475 vs 1449, respectively; HR, 1.03; 95% CI, 0.96-1.11; P=.44), significant reductions in intracranial hemorrhage (0.5% vs 0.7%, P=.02) and fatal bleeding (0.2% vs 0.5%, P=.003) were observed in the rivaroxaban group. Based on these findings, the study investigators concluded that rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism.

The FDA has approved Xarelto to be administered at a dose of 20 mg once daily, or 15 mg once daily for patients with moderate to severe renal impairment, and either dose is to be taken with the evening meal. The FDA has also required a Risk Evaluation and Mitigation Strategy (REMS) to communicate to patients the increased risk of thrombotic events if Xarelto is discontinued without introducing an adequate alternative anticoagulant, and the potential of decreased efficacy if the drug is not taken with the evening meal. More information on Xarelto, including its full prescribing information and medication guide, can be accessed at www.xareltohcp.com.

Medical News

Study Examines Error Disclosure in Nursing Homes

A new study found that a significant number of nurses reported error disclosure and responding to be a difficult process in the nursing home setting. In a cross-sectional descriptive study, 1180 nurses’ perceptions of error disclosure were collected via a mailed survey sent to registered nurses and registered practical nurses in Ontario, Canada. In the study, an error was defined as a nurse’s action that adversely affected, or could have adversely affected, a patient’s safety, quality of care, or both. Examples of nursing errors include lack of prevention (eg, breach of infection control precautions), misinterpreting a physician’s order, inappropriate use of judgment or attentiveness, or errors in documentation. Lead author Laura M. Wagner, PhD, RN, GNP, assistant professor of nursing, New York University College of Nursing, and colleagues found that multiple barriers exist in the nursing home workplace that inhibit disclosure of harmful events and errors. One-third of the respondents said they were less likely to disclose an event or error if they believed they could be sued or reprimanded for it. The authors also found that nurses’ personal experience and level of education were more likely to influence error disclosure than other factors, such as the institutional culture of their workplace; for example, nurses who had previously disclosed a serious error were more likely to disclose a serious error in the future.

The authors concluded that the study, which will be published in the January 2012 issue of the Journal of Nursing Care Quality, underscores the need to improve nursing education, policy, and communication, and, ultimately, to strengthen patient safety culture in nursing homes. “Regardless of the healthcare provider’s attitude about error disclosure, most patients or residents and their families want to know if an error has occurred, even if minor,” Wagner said in a press release. “If nurses do not acknowledge that errors occur and they are a serious problem, then improving patient safety in this setting will be even more difficult.” The study was funded by the Canadian Institutes of Health Research.

Technology Spotlight

New Device Aims to Reduce Nighttime Falls

Poor visibility is a major fall risk in long-term care residents who get out of bed at night and cannot easily see trip or fall hazards. On November 8, 2011, AliMed, Inc, a leading designer, manufacturer, and distributor of patient care products, announced the release of Motion Sensor Night Light, designed specifically for the nursing home setting to automatically turn on as soon as it detects motion.

“Patients who get up at night may not readily see mats, blankets, fluids, or other slip and trip hazards that may be on the floor. So having an automatically triggered night light that illuminates the area where the person will walk just makes sense,” said Jon Bretz, senior vice president, AliMed, in a press release. The device is wireless and battery-operated, so cords and plugs do not create a trip hazard for residents. Each kit contains three lights; one should be placed at the bedside, and the other two can be placed anywhere else in the room. The lights can be easily placed or mounted on walls, floors, or any stable surface. The energy-saving LED light bulbs project 9 to 12 feet of soft light with no added glare, which reduces disturbance to other residents in the room.

For more information or to order the Motion Sensor Night Light, call (800) 225-2900 or visit www.alimed.com.

CardioTeach™ iPad Application Helps Physicians Teach Cardiovascular Diseases to Patients

On October 27, 2011, Boston Scientific Corporation announced the launch of the CardioTeach, a free iPad “app” to help physicians educate patients and caregivers about cardiovascular and peripheral diseases and therapy options, enabling patients and families to make more informed decisions about their health. With graphics and patient-friendly language, the application provides an overview of normal heart function and common cardiovascular conditions, specifically atrial and ventricular arrhythmias, coronary artery disease, heart failure, heart rhythm disorders, and peripheral vascular disease. The application allows physicians to customize anatomical illustrations, for example, with a demonstration of cardiac devices, such as pacemakers and lead wires, and annotate the illustrations with notes for emphasis, clarification, or patient personalization. The completed graphics can then be e-mailed to patients, caregivers, and other healthcare professionals.

“A recent study shows that one in five physicians uses a tablet computer in their practice,” said Kenneth Stein, MD, chief medical officer, Cardio Rhythm Management, Boston Scientific, in a press release. “Creating an app that enables healthcare professionals to use this technology to enhance communication with patients and caregivers is a logical extension of our efforts to empower patients with information about Boston Scientific’s therapies.”

Leslie Saxon, MD, chief of cardiovascular medicine, University of Southern California, said in her experience with CardioTeach, clinicians are better able to educate patients about heart and vascular health. “I like CardioTeach because it allows patients to have something they can reference after they leave my office and when thinking about or explaining what went on during the office visit,” she said in a press release. “It also allows my patients and families to educate themselves prior to and between visits.”

Boston Scientific is a worldwide developer, manufacturer, and marketer of medical devices. For more information and to view a video about the CardioTeach app, visit www.multivu.com/mnr/43509-boston-scientific-cardioteach-ipad-app.

Product Spotlight

Prontosan Offers New Option in Wound Irrigation and Treatment

In the wound irrigation and moisturizing process, the surface of the wound is flooded with solution or gel; however, cell debris and fibrin coatings often create a stable wound coating that is difficult to release and remove. Prontosan Wound Irrigation Solution and Gel offers a new option to remove dirt and debris from acute and chronic wounds, skin ulcers, and abrasions, even when surfaces are difficult to access due to skin folds, fissures, or wound pockets. The solution and gel, manufactured by B. Braun Medical, Inc, are clear, sterile, and odorless.

Active ingredients in Prontosan solution and gel are undecylenamidopropyl betaine and polyhexanide, the latter of which is a cationic preservative that works by inhibiting the growth of microorganisms within the product. The gel also contains glycerol and hydroxyethylcellulose, and it can be used for cleansing and softening encrusted wound coatings, including removal of slough and necrotic tissue, between dressing changes. There is no limit to the length of time that Prontosan solution and gel can be used in the treatment of wounds, and both products may be used safely for the long-term treatment of hard-to-heal wounds. To obtain more information about Prontosan Wound Irrigation Solution and Gel, visit www.prontosan.bbraunusa.com.

ALTC Poll

January poll question:

Are nursing home residents at your institution educated on the importance of receiving flu vaccines?

Vote online at
www.annalsoflongtermcare.com.

Correction Statement

In the October 2011 AGS Viewpoint, “Understanding Subsyndromal Delirium: A Precursor to Delirium” (page 10), the number of residents who met the criteria for subsyndromal delirium (SSD 1) was listed incorrectly as 58 of 104. It should have indicated 68 of 104. The sentence, which appears in the last paragraph in the second column, should have read: “During the study, 68 of the 104 residents met the criteria for SSD 1, indicating an incidence of 5.2 per 100 person-weeks of observation.” We regret the error.