LTC Bulletin Board - August 2011

FDA News

FDA Approves New Drug to Treat Acute Coronary Syndromes

On July 20, 2011, the FDA approved Brilinta (ticagrelor), a blood-thinning drug, to reduce the risk of cardiovascular death and myocardial infarction (MI) in patients with acute coronary syndromes (ACS), after AstraZeneca provided additional trial data following rejection of the drug in December 2010. The FDA had initially rejected the drug because of a discrepancy in data from the landmark PLATO (A Study of Platelet Inhibition and Patient Outcomes) study, a superiority trial that compared Brilinta with clopidogrel in 18,624 ACS patients from 43 countries. In the trial, Brilinta reduced MI, strokes, and cardiovascular death by 16% in patients worldwide, excluding US patients, who represented 9% of the study population and experienced no benefit. Despite these findings, an FDA scientific advisory panel had voted 7 to 1 in favor of approving Brilinta in July 2010.

Brilinta works by preventing the formation of new blood clots, helping to maintain blood flow in the body. Brilinta’s boxed warning indicates, however, that concomitant daily use of higher doses of aspirin (>100 mg) decreases the efficacy of the medication. The boxed warning also indicates that Brilinta increases the rate of bleeding, which can be fatal. The most commonly reported adverse reactions in clinical trial patients taking Brilinta were bleeding and dyspnea.

Brilinta was approved with a Risk Evaluation and Mitigation Strategy (REMS), which is intended to ensure that the drug’s benefits outweigh its risks. As part of that plan, AstraZeneca must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, Brilinta will be dispensed with a medication guide that informs patients of the most important information about the medication. The guide will be distributed each time a patient fills a prescription for Brilinta.

FDA Approves Treatment to Prevent Tetanus, Diphtheria, and Pertussis

On July 8, 2011, the FDA approved the Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in adults ≥65 years of age. Currently, there are vaccines approved for the prevention of tetanus and diphtheria; however, Boostrix, which is given as a single-dose injection, is the first vaccine approved to prevent all three diseases in adults ≥65 years of age.

“Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals,” said Karen Midthun, MD, director, FDA Center for Biologics Evaluation and Research, in an FDA statement.

Clinical data from two studies supported the safety and efficacy of Boostrix in adults ≥65 years of age. Researchers compared Boostrix with Decavac, a tetanus-diphtheria vaccine, and found the antibody responses to the tetanus and diptheria components were comparable; the Boostrix group experienced slightly lower rates of local symptoms, but slightly higher rates of overall adverse events. The most common adverse reactions reported by the older adults who received Boostrix were headache, fatigue, and pain at the injection site. To demonstrate the vaccine’s ability to protect against pertussis, the antibody levels among participants were measured and found comparable to the levels in infants who received a closely related vaccine called Infanrix that has been shown to prevent pertussis.

Boostrix is manufactured by GlaxoSmithKline Biologicals. It was approved in 2005 for adolescents aged 10 to 18 years, and in 2008 for adults aged 19 to 64 years.

FDA Approves Vaccines for the 2011-2012 Flu Season

On July 18, 2011, the FDA approved the formulation for the 2011-2012 influenza vaccine, which will be used by the six manufacturers licensed to produce and distribute influenza vaccine in the United States (Table). The vaccine formulation protects against the three virus strains that surveillance indicates will be the most common during the upcoming flu season; the formulation includes the same three virus strains used for the 2010-2011 influenza season: A/California/7/09 (H1N1)-like virus (pandemic H1N1 2009 influenza virus); A/Perth /16/2009 (H3N2)-like virus; and B/Brisbane/60/2008-like virus.

“Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States,” said Karen Midthun, MD, director, Center for Biologics Evaluation and Research, in an FDA statement. “It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year.”

Between 5% and 20% of Americans develop influenza each year, leading to >200,000 hospitalizations from related complications, according to the US Centers for Disease Control and Prevention (CDC). Influenza-related deaths vary yearly, ranging from a low of about 3000 to a high of 49,000. Each year, experts from the FDA, CDC, World Health Organization, and other public health agencies study virus samples and patterns collected worldwide to identify virus strains that are likely to cause the most illness during the upcoming influenza season. There is always a possibility of a less-than-optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications. The CDC recommends that everyone ≥6 months of age receive an annual influenza vaccination.

For more information on the influenza virus vaccine, including safety and availability, visit www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm.  

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Tech Spotlight

Lexicomp Expands Service to HP TouchPad

From smartphones to tablet devices, technology is playing an increasingly critical role in healthcare management. By 2015, 500 million smartphone users worldwide will be using a healthcare application, according to a recent FDA statement. Mobile medical applications (“apps”) on smartphones and Internet-ready handheld devices are helping clinicians make timely and accurate prescribing decisions for patients by providing quick and easy access to drug information 24 hours a day, 7 days a week.

Lexicomp, a leading provider of medical information and clinical content solutions, already provides worldwide access to its electronic library of drug information to more than 1500 hospitals and thousands of clinicians worldwide. On July 13, 2011, the company expanded its reach further with the launch of Lexicomp On-Hand for the HP TouchPad tablet computer.

 “Our webOS app for TouchPad provides clinicians a larger, tablet-sized view for easily viewing our drug information resources and especially specific content areas like charts and special topics,” said Steven Kerscher, vice president and general manager, Lexicomp, in a press release. “The HP TouchPad also offers unique user interface features, such as multitasking and card stacking—which are not available on other platforms.”

The TouchPad is the most recent platform to use Lexicomp’s comprehensive medical software. The software, which provides point-of-care data to help ensure compliance and to improve patient safety and care, is also available to healthcare providers at their fingertips via the iPhone, iPad, iPod Touch, BlackBerry, Palm OS, Microsoft PocketPC, and Windows Mobile.

For a complete reference of more than 1200 laboratory tests and internal medicine and diagnostic radiology procedures, download the Lexi-Lab Diagnostic Procedures application. For a compressive and searchable database of drugs, download the Lexi-Drugs application (pictured), which conveniently lists all drugs by brand name and generic name, and contains up to 67 categories of information for each drug, including information on dosage, pricing, adverse reactions, and pregnancy risk factors. The Lexi-infectious Disease application is also useful, as it combines information on hundreds of disease syndromes, organisms, diagnostic tests, and therapies into one all-inclusive resource. Healthcare practitioners can learn more and download free 30-day trial versions of the products at https://webstore.lexi.com/ON-HAND.

New Tool Aims to Address Social Isolation Among Elderly

Among the elderly, loneliness is a health risk factor that is twice as detrimental as being obese and equal to the risk of smoking cigarettes and using alcohol, according to research presented in the Public Library of Science Medicine. Many other studies show that constant social interaction helps preserve the physical and mental health of aging seniors. On July 19, 2011, Intel-GE Care Innovations announced the launch of Care Innovations Connect, a new product designed to help older adults stay active and social, while helping professional caregivers monitor their changing needs.

Developed in partnership with seniors and senior service providers, the Connect is an easy-to-use and customizable device that combines a range of brain fitness games, medication compliance reminders, and wellness surveys that facilitate communication between patients and caregivers. The Connect also provides seniors with simple social networking tools, such as access to community news and social calendars. Professional caregivers have secure access to the resident’s wellness data, which enables them to proactively respond to potential issues. The system offers both an in-home digital device for seniors and an online portal for caregivers’ access.

The product’s first customer was the Evangelical Homes of Michigan, a leading senior service provider. It has been testing the Connect system with a home-based focus since 2010. Thus far, caregivers have reported significant improvements to residents’ well-being. “Since social isolation and loneliness are common experiences for many older adults, we chose Connect to assist us in enhancing the interaction and service between our lifestyle coaches and clients.  It lets our clients feel engaged and cared for on a daily basis, making it especially relevant and effective for our members,” said Denise Rabidoux, president and chief executive officer, Evangelical Homes.

For more information on Care Innovations Connect, visit the Website at www.careinnovations.com.  

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Product Spotlight

Bleach Wipes Offer New Option for Safe and Effective Disinfection

Healthcare-associated infections (HAIs), a significant cause of morbidity and mortality, are caused by any infectious agent, including a wide variety of common and unusual bacteria, fungi, and viruses, during the course of receiving medical care. According to the US Department of Health and Human Services, 1 in 20 hospital patients has an HAI at any given time and HAIs account for between $28 billion and $33 billion in preventable healthcare expenses annually.

To protect the health of patients and to reduce healthcare costs, Professional Disposables International (PDI) has introduced the Sani-Cloth Bleach wipes into its line of disinfection products. Sani-Cloth Bleach wipes have been proven effective against 39 clinically relevant microorganisms within 4 minutes of contact. Using a stabilized, EPA-registered bleach formula equivalent to 1:10 dilution, the wipes were shown to be safe and effective in all areas of a healthcare facility, including high risk and sensitive areas, during general and everyday use.

“Due to the evolving changes within microorganisms, facilities are now faced with significant challenges in preventing the transmission of HAIs on a daily basis. Because of the addition of the PDI Sani-Cloth Bleach disposable wipe, PDI can now offer customers a pathogen-specific product solution that meets the Centers for Disease Control and Prevention’s (CDCs) Guidelines for Disinfection for those most aggressive pathogens” said Dr. J. Hudson Garrett Jr., director, Clinical Affairs, in a press release.

The CDC reported that urinary tract infections (UTIs) and bloodstream infections are among the most common HAIs. In clinical testing, the efficacy of the Sani-Cloth Bleach wipes was proven for various multidrug-resistant bacteria, mycobateria, enveloped and nonenveloped viruses, bloodborne pathogens, and pathogenic fungi. Specifically, they were proven effective against Escherichia coli—one of the leading causes of UTI—within 1 minute of contact, as well as the hepatitis B and hepatitis C viruses.

The disposable wipes are premoistened and ready to use without mixing or measuring. They were proven safe only on hard and nonporous surfaces, such as countertops, tables, and carts and for any equipment that requires the use of bleach. Sani-Cloth Bleach wipes are expected to be approved in all 50 states by December 31, 2011. 

Resources

Dog Licks Loneliness at Long-Term Care Facility

For years, researchers have suspected that pet ownership may lower blood pressure and stress levels and promote a more active lifestyle. In the clinical setting, researchers nationwide are just beginning to realize potential benefits of bringing specially trained animals into hospitals and nursing homes. Riderwood, a retirement community in Silver Spring, MD, is putting these suggested findings to the test. The Renaissance Gardens, an assisted living/skilled nursing facility located within Riderwood, welcomed a new resident in August—an 8-year-old beagle named Ginger. The dog was certified through the Pets on Wheels program (www.petsonwheels.org), a Baltimore-based volunteer organization that provides animal visits to nursing homes, assisted living communities, and facilities for the physically and mentally challenged, including those with impaired cognitive abilities (ie, Alzheimer’s disease). According to Ginger’s owner, Karen Spicer, a community resources coordinator at Riderwood, the beagle is sweet, compliant, and obedient. She said that the dog has already put smiles on the faces of residents and staff and has been building community bonds. “She loves to tell people that they are great,” Ms. Spicer said in a press release. “One guy asked what her name is,” she added. “After I replied, ‘Ginger,’ he quipped, ‘She looks more like a Maryanne to me.’  We had a good laugh from that.”

Interested in finding a pet visitation program to come to your long-term care facility? Rochelle Lesser, a golden retriever enthusiast, maintains a comprehensive nationwide group listing of pet visitation programs arranged by state at www.landofpuregold.com/rxb.htm.

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