A guide to the latest news, products, and resources for the long-term care community

FDA News

FDA Approves Duloxetine to Treat Chronic Musculoskeletal Pain On November 4, 2010, the FDA approved (Cymbalta) duloxetine hydrochloride to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain. Duloxetine was first approved to treat major depressive disorder in 2004. The FDA’s approval of this new indication for duloxetine was based on its efficacy in relieving chronic lower back pain and osteoarthritis pain in four double-blind, placebo-controlled, randomized clinical trials. At the end of these trials, patients taking duloxetine had a significantly greater pain reduction compared with those receiving placebo. The most common side effects reported with duloxetine include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. Serious side effects, reported in less than 1% of patients, include liver damage; allergic reactions, such as hives, rashes, or swelling of the face; pneumonia; depressed mood; suicide; and suicidal thoughts and behavior. The recommended dose of duloxetine to treat chronic musculoskeletal pain is a 60-mg capsule taken once daily with or without meals. The capsule should be swallowed whole, and not chewed, crushed, or opened and sprinkled on food or mixed with liquids. Full prescribing information can be found at www.cymbalta.com. Healthcare providers prescribing duloxetine should report any adverse events to the FDA’s MedWatch program at (800) FDA-1088 or online at www.fda.gov/medwatch/how.htm. 

-----

FDA Recalls Abbott Glucose Test Strips On December 22, 2010, the FDA announced that it is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips because the strips are unable to absorb enough blood to give accurate blood glucose results, leading to potentially falsely low blood glucose readings. The strips involved in the recall were manufactured between January 2010 and September 2010 and were marketed under the Precision Xceed Pro®, Precision Xtra®, Medisense® Optium™, Optium™, OptiumEZ™, and ReliOn® Ultima brand names; Abbott’s blood glucose monitoring systems that use these strips and other Abbott diabetes care products are not affected by the recall. Although the test strips were sold directly to consumers in both retail and online settings, they are also used in healthcare facilities. To determine if your facility has a product being recalled, you can call Abbott’s customer service at (800) 448-5234 or look up your test strip lot numbers by visiting precisionoptiuminfo.com. If you find your strips to be subject to the recall, the FDA outlines next steps at bit.ly/FDANextSteps. 

-----

FDA Moves to Remove Breast Cancer Indication from Avastin Label On December 16, 2010, the FDA announced its recommendation to remove the breast cancer indication from the label for Avastin (bevacizumab). The recommendation is based on the results of four clinical studies of Avastin in women with breast cancer that showed that the drug did not prolong overall survival or provide a sufficient benefit in slowing disease progression in these patients to outweigh the significant risks of this therapy, which included severe hypertension, bleeding and hemorrhage, myocardial infarction or heart failure, and the development of perforations in the body, including in the nose, stomach, and intestines. Removing the breast cancer indication from the Avastin label will be a process, noted the FDA in a press statement, as the manufacturer, Genentech, has not agreed to remove the breast cancer indication voluntarily and has requested a public hearing to contest the agency’s determination. Until the proceedings with the FDA conclude, Avastin will remain approved for use in combination with paclitaxel for the first-line treatment of metastatic HER2-negative breast cancer in the United States. Genentech plans on submitting documentation supporting a public hearing to the FDA by January 18, 2011. Healthcare providers with questions about the use of Avastin for managing metastatic breast cancer can call Genentech’s Medical Communications group at (800) 821-8590.

-----

Product Highlights Cavilon No Sting Barrier Film Protects Skin from Damage Preventing skin damage among residents is critical in the long-term care setting. 3M™ Skin & Wound Care’s Cavilon™ No Sting Barrier Film offers a fast-drying, nonsticky, alcohol-free liquid barrier film that forms a breathable, flexible, transparent coating on the skin that protects damaged or intact skin from bodily fluids, adhesive trauma, and friction. The film is hypoallergenic, noncytotoxic, and will not sting even when applied to damaged or denuded skin. At the Clinical Symposium on Advances in Skin & Wound Care, which took place at the Gaylord Palms Resort and Convention Center in Orlando, Florida, from September 30 to October 3, 2010, 3M released data on its Cavilon No Sting Barrier Film, noting that a study measuring skin friction—a source of discomfort for patients and a recognized risk factor for pressure ulcer development—showed that Cavilon No Sting Barrier Film dried more quickly and smoothly than a competitive topical product. It also reported that in durability testing of four barrier film products, Cavilon No Sting Barrier Film was more than twice as effective at preventing wash-off and wear-off after 72 hours of wear compared with the closest competitor. Cavilon No Sting Barrier Film, just like other products in the Cavilon product line, now comes in packaging that makes it easy for healthcare providers to identify the appropriate product for a specific need. For more information on Cavilon No Sting Barrier Film and other Cavilon products, visit https://bit.ly/CavilonBarrierFilm. Healthcare providers can request a complimentary Cavilon No Sting Barrier Film sample kit at https://bit.ly/CavilonSample.

-----

Riester Introduces New Infrared Thermometer Riester’ has introduced the ri-thermo® N, an ergonomic infrared thermometer for uncomplicated use in medical practices, hospitals, long-term care facilities, and at home. The thermometer’s infrared technology allows body temperature or the temperature of surfaces, rooms, and bathwater to be measured in a matter of seconds. The temperature values can be presented in Celsius or Fahrenheit, and are displayed on an LCD screen with backlighting, making the values easy to read under any lighting conditions. If a fever is detected, the ri-thermo N sounds a handy acoustic signal. Users can store up to 12 temperatures, allowing temperature curves to be plotted retrospectively and a patient’s progress to be monitored. As an energy-saving feature, ri-thermo N will automatically power off 1 minute after the last reading. The thermometer is clinically validated and comes with batteries, a hygienic storage container, and probe covers, which are essential to ensure an accurate reading. Riester also offers a wall-mounted version of ri-thermo N, allowing for neat storage and easier attachment of probe covers. For more information on the thermometer, including where to purchase, contact Riester USA at (866) 559-0095.

-----

Did You Know… 3 Percentage of leisure time Americans 65 years and older spend exercising. 16 Average number of medications prescribed annually to an American over age 60 years. 25 Percentage of black seniors who consider themselves to be very healthy. b>31 Projected number of centenarians alive in 2050 for every one centenarian alive in 1990. 40 Percentage of the older population with long-term care needs who live at or near the poverty level. 40 Percentage of white American seniors who consider themselves to be very healthy. 50 Percentage increase by 2040 in the number of elderly individuals requiring long-term care who have no children. 55 Percentage of leisure time that Americans 65 years and older spend watching TV. 78 Average age of an individual moving into a continuing care retirement community. 79 Average age of an individual moving into a nursing home. 84 Percentage of total long-term care hours that are provided by unpaid caregivers. 189 Average daily cost ($) for a semi-private room in a nursing home. 213 Average daily cost ($) or a private room in a nursing home. 904 Number of days that individuals requiring long-term care receive it. 76,680 Average cost ($) to stay in a US nursing home for 1 year. Sources: American Elder Care Research Organization. Disturbing Statistics about Long Term Care in the U.S. www.payingforseniorcare.com/longtermcare/statistics.html. Accessed December 28, 2010. Long-Term Care facts. 

-----

Medical News Vaccine for UTI One Step Closer Urinary tract infections (UTIs) have been reported to be the most common bacterial infection occurring in residents of long-term-care facilities. Not only are these infections painful, but they are becoming increasingly dangerous and costly as bacteria develop resistance to the most common pharmacotherapies, increasing morbidity and mortality and requiring the use of more expensive antibiotics. Scientists from the University of Michigan, however, have moved one step closer to developing a vaccine that could one day prevent UTIs caused by Escherichia coli, which is responsible for approximately 80% of infections. Using a novel genetic technique, the researchers studied how E. coli operates inside the human body versus how it behaves in mice. As noted by Harry L.T. Mobley, PhD, senior investigator and Frederick G. Novy Professor and chair, Department of Microbiology and Immunology, University of Michigan, Ann Arbor, MI, in a press statement, “If we want to prevent infections in humans, we need to look at what’s going on with the bacteria while it’s in humans,” adding “We’re not looking to make the world safer for mice.” The findings of the study, which are published in PLoS Pathogens (https://bit.ly/GeneExpressionUTI), confirmed many of the findings observed in earlier studies using murine UTI models, but also revealed several key host-specific differences. Of the eight human urine samples assessed in the study, all of which came from female subjects with UTI, six did not express type 1 fimbrial genes, which are among the most highly expressed genes in murine models and also serve as an indicator of virulence in these models. “[This finding] tells us it’s more complicated than we thought and that there are some important differences we need to study in human infections,” said research fellow Erin C. Hagan, another study investigator, in the press statement. In 2009, Mobley’s team published a study that showed that a vaccine they had developed prevented LUTTs and produced key types of immunity in mice. Although these researchers have now found differences in gene expression between mice and human samples, key targets of the vaccine related to iron acquisition were found in both human murinc models, indicating that the vaccine may still work in humans, however, developing and testing a vaccine for humans is still several years away.

-----

Acid-suppressive Drugs Linked to Increased Pneumonia Risk According to a meta-analysis published in CMAJ by Korean researchers (https://bit.ly/CMAJPneumoniaRisk), use of proton pump inhibitors or histamine-2 receptor antagonists may increase the risk of both community- and hospital-acquired pneumonia. Previous studies have yielded inconsistent findings regarding an association between the use of such agents and pneumonia risk. The researchers searched three electronic databases—Medline [PubMed], Embase, and the Cochrane Library—to identify studies on acid suppressive therapies. They identified 31 such studies published between 1985 and 2009, including five case-control studies, three cohort studies, and 23 randomized controlled trials. In examining the studies, the researchers found that the overall risk of pneumonia was increased by 27% among individuals using proton pump inhibitors (95% confidence interval [CI], 1.11-1.46) and 22% higher among those using histamine-2 receptor antagonists (95% CI, 1.09-1.36). A meta-analysis of the hospital-based randomized controlled trials confirmed this finding, showing a 22% elevated relative risk of hospital-acquired pneumonia in individuals receiving histamine-2 receptor antagonists (95% CI, 1.01-1.48). Because this finding indicates that acid-suppressive drugs may result in an additional case of pneumonia among every 200 inpatients given acid-suppressive pharmacotherapies, the researchers conclude that “clinicians should use caution in prescribing acid-suppressive drugs for patients at risk.”

-----

Hand Hygiene and Environmental Disinfection have Dramatic Impact at Long-Term Care Facility During the APIC 2010 conference, which took place from July 11 to 15, 2010 in New Orleans, LA, Janice M. Schandel, RN, BSN, and Kimberly S. Thomas, RN, ADN, Mountainview Specialty Care Center, Greensburg, PA, presented a poster outlining the results of “Project Clean Sweep,” an infection control program that was found to have an even greater impact on reducing healthcare-associated infections (HAIs), employee absenteeism, healthcare costs, and hospital readmissions at their institution than anticipated. The program was implemented because of concerns over the potential effects of seasonal influenza and the reemergence of the H1N1 virus on the high-risk long-term care resident population, including individuals on ventilator support and those requiring chest tube management, postoperative care, and wound management. An interdisciplinary team was assembled to conduct a close review of current hand hygiene and environmental cleaning and disinfection practices to determine areas for improving education, product accessibility, and involvement of staff, residents, and the public in infection control. After a lack of convenient accessibility to both surface and hand germicidal products was identified, a variety of surface and hand hygiene wipes were trialed for 2 months. Hand hygiene wipes with 65.9% ethyl alcohol and germicidal wipes with 14.85% alcohol/quaternary ammonium were selected and made available throughout the facility via floor stands and wall brackets. They were also included on medication, treatment, and housekeeping carts and were placed in nursing stations and dining, therapy, activity, and public lounge areas. Standard protocols for the use of both surface and hand hygiene wipes were implemented, and the staff was educated on the wipes by the vendor. Facility educators reviewed proper use of the wipes with the residents and the public. In comparing facility data between June 2008 and November 2008 (before Project Clean Sweep) with those between June 2009 and November 2009 (Project Clean Sweep in place), Schandel and Thomas found an HAI rate of 2.42% versus 0.55%, respectively, demonstrating a variance of 1.87%. In addition, acute transfers due to infection were reduced by 22 days (30 vs 8 days, respectively), antibiotic costs were reduced by $33,665.40 ($81,046.50 vs $47,381.10, respectively), and employee absenteeism was reduced by 557 hours (1349 vs 792 hours, respectively) after Project Clean Sweep was implemented. Because pilot results hada preliminary review of the results demonstrated such a great impact, the program was permanently adopted in August 2009 3 months before the conclusion of the study. Schandel and Thomas provide several recommendations to facilities interested in adopting an infection control program. They stress that all clinical and nonclinical staff should be involved in the process, as this increases the likelihood of the program being embraced, which has a direct impact on a program’s ability to be successful. They also emphasize the importance of selecting high-quality, user-friendly sanitizers and disinfectants, and of educating everyone at the facility (ie, staff, residents, public) on proper use of the products.

-----

LTC Resource NJHA Unveils Pandemic Flu Planning Guide for Nursing Homes The New Jersey Hospital Association (NJHA), with grant funding from Hoffman-La Roche, has made a complimentary planning tool available to help the nation's nursing homes prepare for an influenza pandemic. “The H1N1 scare of last season provided a glimpse of the many challenges facing nursing homes if and when an influenza pandemic strikes,” said Diane Anderson, director of emergency preparedness for NJHA, in a press statement. “We are very excited about the opportunity to give nursing homes the tools they need to protect their residents and staff members in the event of an influenza outbreak,” she added.  The tool, dubbed “Planning Today for a Pandemic Tomorrow: A Tool for Nursing Facilities,” provides nursing homes with a detailed assessment and planning tool, complete with checklists, sample policies, sample forms, and helpful Web links, allowing facilities to review existing policies and procedures, identify gaps, develop new policies and procedures, and generate a pandemic influenza plan that will facilitate a more effective response during a crisis. This tool, which is modeled after NJHA’s original pandemic flu planning document created for acute care hospitals, contains detailed modules that address topics such as clinical considerations, operational issues, communications, legal issues, psychosocial concerns, and ethical considerations. NJHA is providing complimentary copies of the tool on CD to all New Jersey nursing homes, as well as to state long-term care associations across the country. Other nursing homes can download a complimentary copy of the guide on the NJHA Website at www.njha.com.