LTC Bulletin Board - November 2011

FDA News

FDA Approves Generic Olanzapine for Schizophrenia and Bipolar Disorder

On October 24, 2011, the FDA approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder, which affect 1% and 4% of the US population, respectively. Schizophrenia is a mental disorder characterized by disintegration of thought processes and of emotional responsiveness, which may manifest as auditory hallucinations, paranoid delusions, and/or disorganized speech and thinking. Bipolar disorder is characterized by periods of a very good or irritable mood and depression. Both conditions are debilitating and can increase an individual’s risk of abusing drugs and alcohol and of committing suicide.

“The approval of generic olanzapine offers greater access to a widely used treatment for mental illnesses,” said Keith Webber, PhD, deputy director, Office of Pharmaceutical Science, FDA Center for Drug Evaluation and Research, in an FDA press release. “Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed.”

Olanzapine is not approved to treat psychosis in elders with dementia, and its packaging contains a boxed warning indicating that use of the drug in this population can raise their risk of death. Olanzapine must be dispensed with a medication guide that outlines the drug’s risks and side effects, which include hyperglycemia, increased cholesterol and triglyceride levels, and weight gain. Clinicians should be familiar with the drug’s full prescribing information before administering it to their patients, noted the FDA news release.

Generic olanzapine tablets will be manufactured by Dr. Reddy’s Laboratories Ltd. and Teva Pharmaceuticals USA. Generic olanzapine orally disintegrating tablets will be manufactured by Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Par Pharmaceuticals Inc.

FDA Approves First Combination Drug to Treat Type 2 Diabetes and High Cholesterol

On October 7, 2011, the FDA approved Juvisync, a fixed-dose tablet that contains sitagliptin and simvastatin, which were previously approved to treat type 2 diabetes and high cholesterol levels in adults, respectively. The FDA approved Juvisync in three dosage strengths: all with sitagliptin 100 mg, and with simvastatin 10 mg, 20 mg, or 40 mg. The manufacturer, MSD International GmbH Clonmel, a Merck subsidiary, said it plans to develop additional dosages that combine sitagliptin 50 mg with simvastatin 10 mg, 20 mg, or 40 mg.

“This is the first product to combine a type 2 diabetes drug with a cholesterol-lowering drug in one tablet,” said Mary H. Parks, MD, director, Division of Metabolism and Endocrinology Products, FDA Center for Drug Evaluation and Research, in an FDA press release. “To ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

Sitagliptin is a dipeptidyl peptidase-4 inhibitor that works by enhancing the body’s ability to lower elevated blood glucose levels. It is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is an HMG-CoA reductase inhibitor that is approved for use with diet and exercise to reduce the amount of low-density lipoprotein cholesterol in the blood.

The FDA warns that statins may increase blood glucose levels in patients with type 2 diabetes, but notes that the risk appears to be “small and outweighed by the benefits of statins for reducing heart disease in diabetes.” MSD International GmbH Clonmel will conduct a postmarketing clinical trial to compare the glucose-lowering ability of sitagliptin alone with that of the sitagliptin–simvastatin combination. The most common side effects reported with use of Juvisync include upper respiratory infections, stuffy or runny nose, sore throat, headache, muscle and stomach pain, constipation, and nausea. Full prescribing information can be downloaded at www.merck.com/product/usa/pi_circulars/j/juvisync/juvisync_pi.pdf.

 FDA News

FDA Approves Cialis to Treat Benign Prostatic Hyperplasia

On October 6, 2011, the FDA approved Cialis (tadalafil) for once daily use to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged and causes urinary symptoms, such as difficulty in starting urination, weak urine stream, a sudden urge to urinate, and more frequent urination. The FDA also approved its use in men with BPH and erectile dysfunction (ED). Cialis was first approved in 2003 as an ED treatment.

“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director, Division of Reproductive and Urologic Products, FDA Center for Drug Evaluation and Research, in an FDA press release. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”

The FDA approved the new indications for Cialis based on the results of three placebo-controlled studies that involved 1989 men. In two of the studies, the men with BPH who took Cialis 5 mg experienced a significant improvement in their symptoms compared with the placebo group. In the third study, men who had both ED and BPH and took Cialis 5 mg showed improvement in symptoms of BPH and ED compared with the placebo group.

Cialis works by inhibiting phosphodiesterase type 5 (PDE5), increasing the amount of cyclic guanosine monophosphate in the corpus cavernosum, pulmonary arteries, and smooth muscle of the prostate, bladder, and their vascular supply, leading to vasodilation and increased blood flow. While it is understood how the drug enables erections through its vasodilatory effects, its mechanism for alleviating BPH symptoms is not yet understood, said Eli Lilly Co, Cialis manufacturer, in a press release.

The FDA warns that Cialis should not be used in patients taking nitrates because the combination can cause an unsafe decrease in blood pressure. It should also not be used in combination with alpha blockers because the combination has not been adequately studied for the treatment of BPH and there is a risk of lowering blood pressure. Full prescribing information for Cialis can be accessed at https://pi.lilly.com/us/cialis-pi.pdf.

Medical News

Exercise May Prevent Falls in People With Parkinson’s Disease

Each year, as many as two-thirds of people with Parkinson’s disease (PD) experience falls. In individuals with PD, falls and resultant injuries are a leading cause of hospital admissions. A new study conducted by the Primary Care Research Group, Peninsula College of Medicine and Dentistry, Plymouth, UK, and published in the August issue of the Journal of Neurology, Neurosurgery, and Psychiatry (https://bit.ly/q5zVXB), found that exercise interventions and physiotherapy may be helpful in preventing falls in people with PD.

In a randomized controlled trial, the researchers conducted an exercise program in 130 adults (aged 50-87 years; median age, 71 years) with PD who had a history of falls. The program was comprised of strength and balance training, delivered in a group setting by a physical therapist once a week for 10 weeks, plus unsupervised home exercise twice a week. Lead researcher Victoria Goodwin, PhD, and colleagues reported a reduction in falls, significant improvements in balance, a decrease in the fear of falling, and increased levels of physical recreational activity at the end of the 10-week intervention period and then again 10 weeks later.

“Ours is one of the first studies to seek evidence for the effectiveness of interventions, and as such it is an important step towards understanding the best ways in which to help those with Parkinson’s disease both deal with and prevent further falls. As well as the physical effects of a fall, people with Parkinson’s also suffer psychologically, often reporting a lack of confidence across the spectrum of everyday life activities, thus affecting quality of life,” Goodwin said in a press release.

Goodwin said the study did not demonstrate a statistically significant difference between group difference in falls, though the difference could be considered clinically significant, and that additional studies are needed that involve more people with PD and have a longer follow-up period. The study was supported by the National Institute for Health Research (NIHR) and NIHR Peninsula Collaboration for Leadership in Applied Health Research and Care.

Emergency Evacuations Have Health Risks for LTC Residents

Federal law requires that Medicare- and Medicaid-certified facilities have written plans and procedures to meet all potential emergencies and provide training to employees in emergency procedures. While emergency and disaster preparedness plans strive to protect long-term care (LTC) residents from harm, a study published in the September issue of the Journal of Gernotological Nursing shows that displacement of residents during emergency evacuations can nevertheless place them at risk of illness, injury, and death.

The study describes the outcomes of 17 LTC residents (mean age, 86 years) who were evacuated from their nursing home for 5 days because of widespread power outages due to a severe summer storm. These residents were seen the day of the storm and followed-up with three times per week for 2 weeks upon returning to the nursing home. Of these residents, more than half had significant changes in their Neecham Confusion Scale scores (n=11) and modified Confusion Assessment Method scores (n=9) scores, suggesting the onset of delirium. In addition, two participants were hospitalized within 2 weeks of the evacuation, and one participant died unexpectedly.

“[Healthcare providers] should be aware of the potential difficulties older adults may experience as a result of a natural disaster, especially when evacuations and relocations occur,” said lead author Pamela Cacchione, PhD, associate professor of geropsychiatric nursing, University of Pennsylvania School of Nursing, Philadelphia, in a press statement. “Basic physical care, ongoing assessment of chronic conditions, medication management, the return to familiar surroundings, and the return of valued objects should be facilitated as soon as possible.”

LTC Resources

Pioneer Network Publishes New Standards of Dining for LTC Residents

Malnutrition and undernutrition continue to be serious issues affecting residents of long-term care (LTC) facilities. Weight loss, often attributed to restricted or unappetizing diets in LTC facilities, is associated with poor clinical outcomes, such as pressure ulcers and increased risk of mortality. Satisfaction with food and dining experience are core components of quality of life in LTC residents. In an effort to change the culture of LTC dining, the Pioneer Network Food and Dining Clinical Standards Task Force published New Dining Practice Standards, a guide of recommended practices that supports individualized care and self-directed living versus the traditional diagnosis-focused treatment.

The document, released in August 2011, is based on evidence-based research available to-date and current thinking on various food policies and dining trends in LTC. The guide discusses such diets as diabetic/calorie-controlled, low-cholesterol, low-sodium, and altered-consistency food; examines the ethics of honoring patient choices; and tackles issues of tube feeding. For example, the guide presents evidence that low-sodium diets are not shown to be effective overall in the LTC elderly for reducing blood pressure; instead, a low-sodium diet should only be implemented when a benefit to the individual patient has been documented. The guide argues that the elderly are entitled to a liberalized diet, or even a diet without restrictions; diet should be determined by caregivers with the individual person and in accordance with his or her informed choices, goals, and preferences, rather than solely by diagnosis. Other recommendations include giving residents’ choices of not only what to eat, but also when and where (eg, buffet-style, 24-hour access to food).

“Person-centered care encourages both older adults and their caregivers to express choice and practice self-determination in meaningful ways at every level of daily life,” Pioneer Network says in the guide. This philosophy promotes values of choice, dignity, respect, self-determination, and purposeful living. Because of the link between eating and quality of life, “resident’s satisfaction with quality of food and dining should be a home’s priority,” the guide says.

Pioneer Network hopes to establish these dining guidelines as a national standard. In a press release, the group said it expects to submit the guide to the Centers for Medicare & Medicaid Services, the US Food and Drug Administration, the Centers for Disease Control and Prevention, and to the LTC community at-large. The guide has already been endorsed and adopted by many national clinical standard-setting associations, including AMDA.

The guide can be downloaded at www.pioneernetwork.net/Data/Documents/
NewDiningPracticeStandardsfinal8-26-11.pdf.

Product Spotlight

New Compression Hose Prevents Heel Pressure Ulcers

Compression hosiery helps prevent pooling of blood in the legs and can play a significant role in preventing pressure sores and deep vein thrombosis in recumbent patients and in those with limited mobility. However, compression hosiery can exert pressure onto the heel that sometimes results in pressure ulcers. HeelSafe DVT Hose is a new graduated compression hose product from DM Systems, Inc., featuring a unique open-heel “window” design that relieves pressure on the heel and the Achilles tendon and allows easy visualization for pressure ulcer prevention.

The HeelSafe hose is graduated with the highest compression value around the ankle and progressively decreases to the knee (in the knee-high model) or to the thigh (in the thigh-high model). The gradient improves venous return and helps prevent clot formation in the legs. The HeelSafe knee-high style has a compression rating of 20 mm Hg to 12 mm Hg, decreasing from the ankle to the calf; and the thigh-high style has a rating of 20 mm Hg to 9 mm Hg, decreasing from the ankle to the thigh. The nominal compression values are in the range of 15 mm Hg to 20 mm Hg at the ankle, 12 mm Hg to 16 mm Hg at the calf, and 9 mm Hg to 12 mm Hg at the thigh.

The HeelSafe hose is latex-free and made of super-stretch material with moisture-wicking yarn to keep moisture away from the body. In the product instructions, the company advises the hose not be worn by patients with peripheral vascular disease or edematous, breached, or compromised skin. Heels, especially around the rim of the hose over the Achilles tendon, should be checked every 8 to 12 hours to prevent pressure ulcer formation. For more information or to order HeelSafe DVT Hose, call (800) 254-5438 or visit www.heelift.com/heelsafe-dvt-hose.html.