LTC Bulletin Board - September 2011

FDA News

FDA Approves Botox to Treat Urinary Incontinence

 On August 25, 2011, the FDA approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence (UI) due to neurogenic detrusor overactivity in people with spinal cord injuries or multiple sclerosis (MS) who have had an inadequate response to or are intolerant of anticholinergic medications. Neurogenic detrusor overactivity affects approximately 80% of people with MS or spinal cord injuries, which includes about 340,000 people in the United States.

“Urinary incontinence due to detrusor overactivity in patients with a neurologic condition is a serious medical problem, and for people who do not respond to or cannot tolerate the side effects of an oral anticholinergic medication, Botox is a new, long-lasting treatment option to reduce urinary incontinence episodes and address a particularly burdensome issue,” said Scott Whitcup, MD, executive vice president, Research and Development, and chief scientific officer, Allergan, in a company press release.

The Botox neurotoxin temporarily prevents muscle contractions by blocking the transmission of nerve impulses to the muscle. In treating UI, Botox selectively prevents the release of the neurotransmitter acetylcholine at the neuromuscular junction in the bladder muscle.

Botox is the first neurotoxin approved by the FDA to treat a urological condition. Its safety and efficacy were demonstrated in two phase 3 clinical trials involving 691 patients with neurological conditions (381 with MS; and 310 with a spinal cord injury, T1 level or below) whose UI had not responded  to anticholinergics. Patients were randomized to receive 200u Botox or placebo, injected into the bladder via physician-administered cystoscopy. Within 2 weeks, patients in both trials who were given Botox experienced significant reductions in the frequency of UI episodes as compared with patients who received placebo (15.3 and 18 episodes/week vs 10 and 7.9/week, respectively), and patients treated with Botox  had approximately 20 fewer UI episodes at week 6 versus those taking placebo (19.9 and 19.6 episodes/week vs 10.6 and 10.8/week, respectively). The effects of Botox lasted for up to 10 months.

The most common adverse events following the initial Botox injection were urinary tract infections (UTIs) and urinary retention, which may require self-catheterization to empty the bladder. Botox is not approved for treating UI in patients with UTIs or who are not routinely catheterizing. To learn more about the Botox treatment, visit Allergan’s Website at agn.client.shareholder.com/releasedetail.cfm?ReleaseID=600958.

FDA Clears Antimicrobial Facemask

On August 3, 2011, Filligent Limited announced that the FDA had granted the company clearance to sell its range of virus-killing BioFriend™ BioMask™ surgical facemasks in the United States as a Class II medical device. In addition, to accommodate Filligent’s innovations in infection control and respiratory protection, the FDA gave the product a new medical device classification called “OUK,” which stands for antimicrobial/antiviral surgical facemasks.

BioMask is designed to reduce hospital-acquired infections, which are common in nursing homes and long-term care (LTC) facilities throughout the United States. Most masks are susceptible to so-called “bio-burdens,” which refers to bacteria that inhabit the surface prior to sterilization. In laboratory tests, the masks killed 99.99% of tested pandemic and seasonal strains of influenza A and B viruses, including swine flu and avian flu, within 5 minutes. The mask uses a proprietary hydrophillics antiviral coating on the outer layer that traps pathogens within a low pH environmental, wherein viruses become inactivate.

“Healthcare workers need protection that works with them, not against them,” said Melissa Mowbray-d’Arbela, CEO, Filligent, in a press release. “These masks are designed for real-life hard work and the reality of today’s infection control needs, especially pandemics.”

The Hong Kong-based company announced that its line of masks will soon become available to US healthcare providers and LTC facilities through Medline Industries (www.medline.com) and major retail chains nationwide.

Medical News

Sleep Apnea Linked to Risk of Cognitive Impairment in Older Women

 Sleep apnea—characterized by pauses in breathing or taking shallow breaths during sleep—is common among older adults. According to the National Heart, Lung, and Blood Institute, at least 1 in 10 adults aged ≥65 years has sleep apnea. Researchers have long suspected a connection between sleep-disordered breathing (SDB) and poor cognition, due to the resultant oxygen deprivation to organ systems from apnea (pauses in breathing) and hypopnea (shallow breaths). A new study lead by Kristine Yaffe, MD, chief, Geriatric Psychiatry, San Francisco VA Medical Center, CA, offers significant evidence that older women with SDB are more likely to develop mild cognitive impairment or dementia than those who do not have SDB.

“The study suggests that there is a biological connection between sleep and cognition and also suggests that treatment of sleep apnea might help prevent or delay the onset of dementia in older adults,” Yaffe said in a press release. The findings were published in the Journal of the American Medical Association in August (www.ncbi.nlm.nih.gov/pubmed/21828324).

The results support a significant cause-effect relationship because the researchers enrolled patients who had no dementia or measurable cognitive impairment. Previous studies have not limited participation to individuals with normal cognition at enrollment.

The study followed 298 women aged ≥65 years (mean age, 82.3 years), of whom 193 had SDB and 105 did not have SDB. Researchers measured the women’s sleep patterns and cognitive abilities at the start of the study and again nearly 5 years later. The researchers found that approximately 44.8% (47 of 105) of the women with SDB developed dementia or mild cognitive impairment, compared with 31.1% (60 of 193) who did not have the condition (adjusted odds ratio [AOR], 1.85; 95% confidence interval [CI], 1.11-3.08).

The study concluded that an elevated oxygen desaturation index (≥15 events/hour) and a high percentage of sleep time affected by apnea or hypopnea were key factors associated with development of mild cognitive impairment (AOR, 1.71; 95% CI, 1.04-2.83) or dementia (AOR, 2.04; 95% CI, 1.10-3.78). The analysis found no independent association between dementia and the number of times a patient was awakened from sleep or the length of time that a patient slept.

Better Mattresses May Reduce Costs by Preventing Pressure Ulcers

 The Centers for Disease Control and Prevention says more than 1 in 10 nursing home residents has had a pressure ulcer, even though the wounds may be  preventable in many cases. A recent study published in the Annals of Emergency Medicine (www.ncbi.nlm.nih.gov/pubmed/
21820208) found that hospital emergency departments could reduce the incidence of pressure ulcers among elderly patients and their related costs if they  upgraded to pressure-redistribution foam mattresses for beds and stretchers.

Led by Ba’ Pham, MSc, PhD, University of Toronto, the study calculated the average incremental cost to upgrade to the foam mattresses at $0.30 per patient, but predicted that hospitals would save $32 per patient by preventing pressure ulcers.

“Most pressure ulcers are preventable, which is why they are considered a ‘never event’ by the Centers for Medicare & Medicaid Service (CMS),” said Pham in a press release. “Upgrading to better mattresses will not only save money, but it will prevent needless suffering among elderly patients.”

The study adopted a health payer perspective when projecting the incremental difference at 1 year in effectiveness (quality-adjusted life-days gained) and costs (hospital and home care costs) between an emergency department (ED) model using the new mattresses as a form of early prevention of  pressure ulcers and one using current practices (ie, standard hospital mattresses). The authors projected the incidence of ED-acquired pressure ulcers at 1.90% with current practices and 1.48% with the early prevention intervention and said 238 patients would have to use the new mattresses to prevent 1 pressure ulcer.

The study showed that, at a rate of  $50,000 per quality-adjusted life-year gained, early prevention would be cost-effective even for patients admitted to the ED for ≤1 hour or at low risk for hospital-acquired pressure ulcers and even if each pressure-redistribution mattresses cost $3775. The researchers concluded that early prevention was likely to be cost-effective 81% of the time.

LTC Bookshelf

Modern medicine has given many families the gift of time to spend with loved ones diagnosed with a terminal illness; however, psychologists Barbara Okun, PhD, professor of counseling psychology, Northeastern University, and Joseph Nowinski, PhD, professor of psychology, University of Connecticut, argue that this blessing can often complicate the traditional process of grieving. In their book, Saying Goodbye: How Families Can Find Renewal Through Loss, which was published earlier this year by Harvard Health Publications, Okun and Nowinski explain what they see as the new paradigm of bereavement in today’s world.

“The ‘new grief’ refers to the family crisis that begins when a loved one receives a terminal diagnosis. It includes the process that families experience as they navigate their way through what is increasingly becoming an extended crisis lasting for months to years,” the authors said in an interview with Harvard Health Publications.

After interviewing dozens of people who went through the extended grieving process of a loved one with a terminal illness, the authors found that many of these families went through five similar stages: crisis, unity, upheaval, resolution, and renewal. The authors, however, stated that their research is not meant to debunk the widely accepted work of Elizabeth Kübler-Ross on the five stages of grief, which she identified as denial, anger, bargaining, depression, and acceptance, in her 1969 book On Death and Dying. Rather, the authors consider their work a supplement to the Kübler-Ross model. “At the time this paradigm for grief appeared, sudden and unexpected death was much more common than it is today,” the authors said.

The authors hope that patients and their families will use the book to help them navigate the prolonged emotional pain and new challenges caused by extended grieving. Specifically, the authors address how to cope with setbacks during periods of seeming remission, how to talk with a dying loved one about mortality, how to make time for grieving despite lifestyles that are busier than those of earlier generations, and how to confront unresolved family issues that may surface during the process. The authors suggest that healthcare providers can help by recommending the book and similar resources to these families and encouraging the patient to be an active participant in the end-of-life decision-making process.

“Once a loved one is diagnosed with a terminal illness, families can use Saying Goodbye as a ‘road map’ for anticipating what lies ahead and getting prepared to act,” the authors said.

Product Spotlight

 Indoor Gardens Stimulate Alzheimer’s Patients

 For patients with Alzheimer’s disease in long-term care facilities, therapeutic activities are successful when they are structured, individualized, and evoke the patient’s senses, skills, memories, and habits. Research indicates that gardening provides excellent motivation for exercise, sunlight exposure, and social interaction among patients with Alzheimer’s disease and offers them a visual and physical connection to nature, which may reduce stress and help calm some of the behavioral symptoms of the condition, such as anger and calling out. However, when physical limitations or logistics prevent patients from gardening outside, StandUp Gardens, a New Hampshire-based company, offers another option.

“The key impediment to involving Alzheimer’s residents in gardening has been logistics. These residents require high levels of supervision and staff time, can be difficult to move to different activity areas (especially outdoors), and safety is always a major concern. Many of the residents have health or physical limitations, which means that they cannot garden in the traditional way,” said the company in a press statement.

StandUp Gardens produces mobile indoor garden kiosks, which are ideal for the nursing home setting. Each set comes with a full-spectrum grow light, built-in drainage, and swivel casters for easy placement, and each is large enough to allow several people to work simultaneously. The hardwood kiosks are also easily accessible from a wheel chair. The company’s indoor gardens were recently endorsed by the American Horticultural Therapy Association and were recognized by the American Institute for Architects’ Design for Aging competition.

For more information on the gardens, visit www.standupgardens.com or call (800) 867-8263.