LTC Bulletin Board - January 2012

FDA News

FDA Approves Use of Prevnar 13 Vaccine in Older Adults

On December 30, 2011, the FDA expanded the use of Prevnar 13, a pneumococcal 13-valent conjugate vaccine, to include people 50 years and older. Prevnar 13 prevents against pneumonia and invasive disease caused by Streptococcus pneumoniae. Prevnar 13 was previously approved for use in children between 6 weeks and 5 years of age to protect against invasive disease caused by 13 different serotypes of the bacterium.

According to the FDA press statement, approximately 300,000 adults 50 years and older are hospitalized each year because of pneumococcal pneumonia. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group,” said Karen Midthun, MD, director, FDA Center for Biologics Evaluation and Research, in an FDA press statement.

The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which enables earlier approval of treatments for serious and life-threatening illnesses. The pathway enables effectiveness of a vaccine to be demonstrated using an immune marker that is reasonably likely to predict clinical benefit. Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit. Currently, an additional trial in 85,000 people aged 65 years and older is under way to confirm Prevnar 13’s efficacy in preventing pneumococcal pneumonia. For more information on Prevnar 13, including full prescribing information, visit www.prevnar13.com.

FDA Approves Generic Version of Lipitor

On November 30, 2011, the FDA granted approval to Ranbaxy Pharmaceuticals, Inc, and Watson Pharmaceuticals, Inc, to manufacture and market the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets). The companies were approved to manufacture the drug in 10-mg, 20-mg, 40-mg, and 80-mg doses.

Approximately 8.7 million people in the United States take Lipitor. “The medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Janet Woodcock, MD, director, FDA Center for Drug Evaluation and Research, in an FDA press statement.

In combination with a low-fat diet and exercise, atorvastatin lowers low-density lipoprotein cholesterol and triglyceride levels in the body by blocking HMG CoA reductase, an enzyme in the liver that is responsible for cholesterol production. The drug has also shown to raise high-density lipoprotein levels, helping to prevent cholesterol from building up in the arteries. Atorvastatin reduces the risk of myocardial infarction, stroke, and angina in patients who have heart disease, risk factors for heart disease, or have undergone certain types of cardiac surgery. In clinical trials for Lipitor, the most common reported adverse events were inflammation of the nasal passages, joint pain, diarrhea, and urinary tract infections.

Medical News

Study Finds Link Between Nursing Home Management and Resident Health

A new study has found empirical evidence that good work environment and management practices in nursing homes can positively affect residents’ health outcomes, specifically in the areas of incontinence and pressure ulcers. The study was conducted by Helena Temkin-Greener, PhD, and colleagues from the University of Rochester School of Medicine and University of California, Irvine, and published in the November 2011 issue of Health Services Research (www.ncbi.nlm.nih.gov/pubmed/22098384).

The study collected data from approximately 46,000 residents and 7400 workers in 162 nursing home facilities in New York State over a 1-year period. The Minimum Data Set (MDS) was used to develop risk-adjusted outcome measures, and the Online Survey Certification and Reporting system (OSCAR) was used to identify facility characteristics. A survey tool, which Temkin-Greener developed in a previous study, measured domains such as communication, coordination, conflict management, and perceived effectiveness. Specific areas included staff cohesion, defined as the extent to which staff view themselves as having common goals and values, and consistent assignment, defined as the percentage of staff who said they were mostly assigned to the same residents in carrying out their daily duties.

The principal findings of the study revealed that residents in facilities with worse staff cohesion had significantly greater odds of pressure ulcers and incontinence than residents in facilities with better cohesion scores. Residents in facilities with higher prevalence of self-managed teams had a lower risk of pressure ulcers, but not of incontinence. The prevalence of consistent assignment did not appear to affect these outcome measures.

In an interview with Annals of Long-Term Care, Temkin-Greener said the study focused on incontinence and pressure ulcers because of their high prevalence and wide variation of outcomes across nursing facilities. “Good management practices in nursing homes, aimed at improving the work environment for the staff, will also contribute to good outcomes for the residents,” she said.

Product Spotlight

Portable Device May Prevent Vascular Conditions

Deep venous thrombosis (DVT), which may lead to pulmonary embolism, is a serious issue affecting long-term care residents due to the risk factor of prolonged sitting and bed rest. Venous Health Systems, Inc, a developer of solutions for treating vascular insufficiency by enhancing blood circulation, has released the Vasculaire Compression System, a portable pneumatic device that may be used as prophylactic therapy to prevent DVT.

Venous Health Systems received clearance from the FDA in June 2011 to fully commercialize the new product in the United States. The battery-operated system works with a pneumatic controller attached to a patented multicell compression sleeve. When the activated sleeve is wrapped around the patient’s calf and foot, it provides compression and promotes circulation with a sequential rapid inflation “wave-like” motion.

The system is also indicated for reducing edema, diminishing postoperative pain and swelling, and reducing wound healing time. It may also be used in the treatment of stasis dermatitis, venous stasis ulcers, and arterial and diabetic leg ulcers. The system is contraindicated in patients with fresh or preexisting DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis, and in situations where increased venous and lymphatic return is not desired. For more information, visit https://venoushealth.com.

LTC Resources

Interview

Modern medical technology is often praised as the gift of longer life; however, for caregivers watching loved ones suffer with late-stage dementia, end-of-life care becomes an emotional and ethical challenge. In “Late-Stage Dementia: Promoting Comfort, Compassion, and Care,” Michael Gordon, MD, MSc, FRCPC, and Natalie Baker, MSc, present common clinical scenarios for managing late- and end-stage dementia, with an emphasis on providing patient-centered care measures during the dying process. Gordon is medical program director of palliative care, Baycrest Geriatric Health Care System, Toronto, and professor of medicine, University of Toronto, Canada. Annals of Long-Term Care (ALTC) had the opportunity to interview Gordon about the goals and perspective of the book.

ALTC: What inspired you to write the book?

Gordon: It was my professional and personal experience with individuals in the later and end-stages of dementia who, rather than receiving palliative care directed to comfort measures, were sent to acute care settings where interventions occurred, such as intravenous antibiotics and sometimes admission to intensive care units (ICUs). Often, the end result was more suffering, as illnesses that are really part of the dying process were occurring with an inadequate focus on measures to decrease discomfort, agitation, difficulty breathing, and other symptoms. Healthcare staff were inadequately trained to address such situations within a framework of end-of-life care and palliation, and families were often unprepared for their relative’s process of dying under such circumstances. There was often an unrealistic expectation on the part of families of what was happening and insufficient explanation and support from healthcare professionals, coupled with a fear and reluctance to use medications often used in palliative situations in those with other end-of-life or terminal conditions.

How do family caregivers know when the time is right to forgo medical interventions and focus on providing comfort during the terminal phase?

Of course, it is never possible to absolutely know when the end is about to happen, but there are some very common scenarios that indicate the likelihood that the individual with late-stage dementia is on the rapid downward slope of the trajectory of dying. I hope that the book will help family members avoid subjecting their loved one to standard interventions for events, such as infections, which often result in transfer to emergency departments and acute care settings. When there is a crisis event, such as a sudden ceasing of respiration, often attempts at CPR are made or the patient is admitted to the ICU; eventually the patient dies, yet he or she has gone through a very uncomfortable last few days. One should not have to pass through the jaws of technology to die.

Emotions can be very powerful when it feels like you’re giving up on your loved one. What advice do you have for caregivers facing this difficult decision?

Losing a loved one is always hard. But balancing the “loss” with the knowledge of preventing unnecessary suffering and discomfort may allow family and healthcare professionals to understand that in fact they are doing the right thing, even though the medical technology is very enticing. As for ethics, the real issue is often whether the family’s wishes reflect what they believe would have been the wishes of their loved one rather than their own—as part of respecting the foundational principle of autonomy—but many people have never really discussed formally the issue, which is why I recommend in the book that people should discuss wishes of loved ones for the future, and not when there is a crisis. 

What other resources do you provide in the book?

There is also an appendix that contains detailed medication protocols for various symptoms that can occur in individuals in need of palliative care as part of end-stage dementia. My hope is that by educating healthcare professionals, who may not be as familiar with these medications or know what interventions are available that have demonstrated efficacy in various situations in palliative care, suffering can be relieved and care and dignity can be promoted during the dying process.

Late-Stage Dementia: Promoting Comfort, Compassion, and Care was published by iUniverse Publishing in August 2011. For more information, visit Gordon’s Website at www.drmichaelgordon.com.

Guidebook Offers Tips for Customizing Care to Older Adults

Providing superior individualized care to geriatric patients requires an eye for detail, from a practice’s design to staff management. The American Medical Association’s (AMA’s) “Geriatric Care by Design” is a guidebook to aid physicians in meeting the needs of geriatric patients in the areas of practice and patient room design, staffing and human resources, coordination of care, and patient education and literacy. For example, in the chapters about structural and environmental design, the authors note common barriers to functionality in older adults, such as presence of stairs, disabling glare on the floor, and a receptionist desk that is inaccessible from a wheelchair.

The book is clearly organized by presenting case studies, discussing the challenges per topic, and then presenting strategies for large- and small-scale changes, with take-home points and direction for further resources. “For example, because of age-related eye changes that include decreased papillary size and adaptation, patient materials should be printed with high-contrast colors and paper that minimizes glare,” wrote book editor-in-chief Audrey Chun, MD. “Most of us were never trained in some of these changes that occur with aging, much less how to translate them into daily practices to facilitate care.”

Other pertinent topics include the Program of All-Inclusive Care for the Elderly (PACE), medication management, transitional care, and the role of the family caregiver. Short chapters, tables, charts, checklists, and bulleted points create a pragmatic and convenient format. The guide, which is available as an e-book or hard copy, costs $34.95 or, for AMA members, $25.95. To order, visit www.ama-assn.org/geriatriccare or call (800) 621-8335.