Bimbo Bakeries USA, Inc. has initiated a voluntary recall of Entenmann's Little Bites Fudge Brownies (5 pack), Chocolate Chip Muffins (5 pack and 10 pack boxes)and Variety Pack (20 pack) due to the presence of small pieces of plastic caused by a manufacturing failure at a contract manufacturer's bakery in Illinois.
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Wednesday, August 31, 2016
Voluntary Recall of Cartons of Entenmann’s Little Bites Fudge Brownies 5 Pack (Best By Date Oct 8, 2016), Chocolate Chip Muffins 5 Pack and 10 Pack (Best By Date Oct 8, 2016) and Variety 20 Pack – Fudge Brownies, Chocolate Chip Muffins and Blueberry Muffins (Best By Date Sep 24, 2016) due to Choking and/or Cutting Hazard from Presence of Small Pieces of Plastic - FDA Safety Alerts & Drug Recalls
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use - FDA Press Releases
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
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Tuesday, August 30, 2016
Snyder’s-Lance Issues Voluntary Recall of 4oz Diamond of California® Chopped Macadamia Nuts and 2.25oz Diamond of California® Macadamia Halves & Pieces Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Snyder's-Lance, Inc. is initiating a voluntary recall of Diamond of California Macadamia Nuts, distributed in retail stores nationwide, due to possible Salmonella contamination.
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FDA approves Erelzi, a biosimilar to Enbrel - FDA Press Releases
The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
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Ton Shen Health/Life Rising Expands Recalls of “DHZC-2 Tablet” to All Lots Purchased Before August 24 2016 Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Ton Shen Health/Life Rising Corporation of Chicago, IL, is expanding its recall of DHZC-2 Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead.
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Providing Acute Care at Home: Community Paramedics Enhance an Advanced Illness Management Program—Preliminary Data - American Geriatric Society
Models addressing urgent clinical needs for older adults with multiple advanced chronic conditions are lacking. This observational study describes a Community Paramedicine (CP) model for treatment of acute medical conditions within an Advanced Illness Management (AIM) program, and compares its effect on emergency department (ED) use and subsequent hospitalization with that of traditional emergency medical services (EMS). Community paramedics were trained to evaluate and, with telemedicine-enhanced physician guidance, treat acute illnesses in individuals’ homes. They were also able to transport to the ED if needed. The CP model was implemented between January 1, 2014, and April 30, 2015 in a suburban–urban AIM program. Participants included 1,602 individuals enrolled in the AIM program with high rates of dementia, decubitus ulcers, diabetes mellitus, congestive heart failure, and chronic obstructive pulmonary disease. Participants had a median age of 83 and an average of five activity of daily living dependencies (range 0–6). During the study period, there were 664 CP responses and 1,091 traditional EMS transports to the ED among 773 individuals. Only 22% of CP responses required transport; 78% were evaluated and treated in the home. Individuals that community paramedics transported to the ED had higher rates of hospitalization (82.2%) than those using traditional EMS (68.9%) (P < .001). Post-CP surveys showed that all respondents felt the program was of high quality. Results support the potential benefits of CP and invite further evaluation of this innovative care model.
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Interdisciplinary Approaches to Managing Pain in Older Adults - Geriatrics
An interdisciplinary approach to managing pain has been widely used in managing specific pain conditions (eg, lower back and fibromyalgia) but not reviewed specifically for older adults. Interdisciplinary approaches have been used in primary, residential long-term, and acute care settings, where a variety of health care professionals work on pain teams to manage pain in older adults. Given the multidimensional nature of pain in older adults, interdisciplinary approaches to managing pain are recommended in practice. This article reviews the rationale supporting an interdisciplinary approach to managing pain in older adults and summarizes studies that have evaluated this approach.
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Monday, August 29, 2016
Taking Action Now for a Stable Marketplace for the Long-Term - CMS Blog
By Kevin Counihan, CEO of the Marketplace
As we get ready for 2017 Open Enrollment and look to the future, one of our most important tasks is to continue to build a strong Health Insurance MarketplaceSM, where the millions of Americans who rely on the Marketplace can continue to find affordable plans that meet their needs. That is why today we are announcing a proposed rule with clear, substantive improvements that would help issuers deliver more affordable choices to consumers and will help strengthen the Marketplace for years to come. These proposed actions and others we have taken over the last six months would help to: support issuers with high-cost enrollees, while updating risk adjustment; strengthen the risk pool; promote additional enrollment; and support issuers in entering the Marketplace or growing their Marketplace business. While some of these changes are proposed for 2018, others could begin in 2017. And other, related improvements are already underway.
Supporting Issuers with High-Cost Enrollees and Updating Risk Adjustment for Everyone
Prior to the Affordable Care Act (ACA), millions of Americans with pre-existing conditions were locked out of health insurance, and one of the core tenets of the ACA has been that people with pre-existing conditions finally have access to the coverage they need. The ACA’s risk adjustment program plays an important role in ensuring that issuers have both the incentives and the financial support to design products to serve all Americans, and today’s rule proposes significant actions to strengthen the risk adjustment program. These changes will support issuers in serving the highest cost enrollees while also seeking to make risk adjustment more predictable and more effective at spreading risk for all issuers. Specifically:
- Beginning with the 2017 benefit year, the rule proposes a modification to risk adjustment regarding the cost of enrollees who do not stay with an issuer for the full plan year.
- In order to help reflect enrollees with serious conditions like Hepatitis C, HIV, or others, the rule proposes to use prescription drug utilization data as a source of information about enrollee’s health and the severity of their conditions beginning with the 2018 benefit year.
- The rule also proposes to modify risk adjustment as to costs associated with the most expensive enrollees. Under this proposal, a portion of costs exceeding $2 million for an individual would be shared among issuers. This type of risk sharing would reduce uncertainty for issuers who are not yet able to reliably predict the prevalence and nature of high-cost cases.
- The proposed rule also asks for comment on a number of approaches for addressing the costs of healthier enrollees. Our goal is to update risk adjustment for all types of enrollees, to ensure that issuers can have confidence in the program as they design products to attract all types of consumers.
- Lastly, separate from the risk adjustment program, we are seeking comment on whether and how to further support the successful transition of former Pre-Existing Condition Insurance Plan (PCIP) Program enrollees into the Marketplace to ensure that they do not experience a lapse in coverage.
These proposals would bring more certainty into the Marketplace, as they would enable issuers to account for the risk of all enrollees in their bottom line, while continuing to ensure that all Americans have access to the care they need.
Strengthening the Marketplace Risk Pool
Along with helping issuers cover enrollees with more serious health needs, we also recognize the importance of balancing the mix of enrollees in the Marketplace risk pool. Today’s rule builds on other steps already under way to strengthen the risk pool.
- Special enrollment periods (SEPs) exist to ensure that people who lose coverage or experience other qualifying events have the opportunity to enroll in coverage. We are committed to making sure that SEPs are available to those who are eligible for them and equally committed to avoiding any misuse or abuse of special enrollment periods. In 2016, we took a number of steps to ensure appropriate use of SEPs, such as introducing a confirmation process under which consumers enrolling through common SEPs are directed to provide documentation to confirm their eligibility. In the proposed rule, we are seeking information on additional steps related to SEP outreach or policy we could take as soon as the 2017 plan year to strengthen the SEP risk pool.
- We’re helping ensure consumers who turn 65 are moving into Medicare and off the Marketplace, and already this year we’ve begun to see the impact of the efforts we’ve made to do that, as we saw a precipitous drop in dual enrollment with those who just turned 65 in August.
- We’re seeking comments through our recently issued Request for Information regarding concerns that some third-party entities may be inappropriately steering their Medicare and Medicaid patients into the individual market in order to receive higher reimbursement rates.
- We seek comment in this proposed rule on coordination of benefit policy that, similarly, is intended to ensure individuals entitled to Medicare and Medicaid are appropriately enrolled in those programs.
Improving Enrollment Growth
We also are always looking for new opportunities to increase both the number of Marketplace enrollees and the share of enrollees who are young and healthy.
- We recognize that robust outreach and consumer assistance can help with enrollment growth. To that end, we see comment on whether a certain amount or percent of user fees for the Federally-facilitated Marketplace should be dedicated to outreach.
- Today’s proposed rule includes consumer protections intended to provide a transparent consumer experience when enrolling directly through online agents or brokers who are registered with the Marketplace, or directly through an insurance company’s website. We have been working hard on the technology behind this additional enrollment channel, and our proposals, if finalized, will further competition in the Marketplaces while providing another channel for consumers, including young, healthy consumers, to enroll.
Removing Obstacles to Issuer Entrance, Growth, and Innovation
Today’s proposed rule also contemplates further removing potential obstacles to issuers growing their business and entering more markets.
- We are seeking comment on whether we should eliminate a requirement that certain issuers participating in the individual market Federally-facilitated Marketplaces also offer coverage through the Federally-facilitated SHOP Marketplaces.
- The proposed rule offers more flexibility for innovation around plan design by issuers, particularly around bronze plan offerings, while still protecting the coverage upon which consumers rely.
- We also include proposals to give new and growing issuers more flexibility in calculating their medical loss ratios, and to avoid instances where issuers who are adjusting their individual market or group market portfolios would inadvertently trigger a ban on participating in the individual or group market.
In just a few weeks, Open Enrollment will begin for consumers to come and shop and find a wide variety of affordable choices. As the Marketplace continues to grow and mature, one of our most important priorities is to study data, listen to a range of market participants, test out different approaches, and adapt to what we see and hear. We have a number of tools to make adjustments like the ones we are proposing today, and are confident in our ability to make the Marketplace an even more attractive market for consumers and health plans alike.
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Impax Laboratories, Inc. Issues Voluntary, Nationwide Recall for One Lot of Lamotrigine Orally Disintegrating Tablet 200 mg Due to the Potential for 100 mg Blister Cards being Packaged in 200 mg Containers - FDA Safety Alerts & Drug Recalls
Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company had issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg.
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The Late Emeritus Professor Lester A Mitscher, a great scientist and teacher - Journal of Antibiotics
The Late Emeritus Professor Lester A Mitscher, a great scientist and teacher
The Journal of Antibiotics 69, 579 (August 2016). doi:10.1038/ja.2016.84
Author: James McAlpine
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Tribute to the late Emeritus Professor Lester A Mitscher - Journal of Antibiotics
Tribute to the late Emeritus Professor Lester A Mitscher
The Journal of Antibiotics 69, 580 (August 2016). doi:10.1038/ja.2016.83
Author: Gordon Cragg
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A tribute to the late Emeritus Professor Lester A Mitscher - Journal of Antibiotics
A tribute to the late Emeritus Professor Lester A Mitscher
The Journal of Antibiotics 69, 581 (August 2016). doi:10.1038/ja.2016.85
Author: David Newman
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The unique chemistry and biology of the piericidins - Journal of Antibiotics
The unique chemistry and biology of the piericidins
The Journal of Antibiotics 69, 582 (August 2016). doi:10.1038/ja.2016.71
Authors: Xuefeng Zhou & William Fenical
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A model to predict anti-tuberculosis activity: value proposition for marine microorganisms - Journal of Antibiotics
A model to predict anti-tuberculosis activity: value proposition for marine microorganisms
The Journal of Antibiotics 69, 594 (August 2016). doi:10.1038/ja.2016.87
Authors: Miaomiao Liu, Tanja Grkovic, Lixin Zhang, Xueting Liu & Ronald J Quinn
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In vitro susceptibility of β-lactamase-producing carbapenem-resistant Enterobacteriaceae (CRE) to eravacycline - Journal of Antibiotics
In vitro susceptibility of β-lactamase-producing carbapenem-resistant Enterobacteriaceae (CRE) to eravacycline
The Journal of Antibiotics 69, 600 (August 2016). doi:10.1038/ja.2016.73
Authors: Yunliang Zhang, Xiaoyan Lin & Karen Bush
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Paraphaeosphaeride D and berkleasmin F, new circumventors of arbekacin resistance in MRSA, produced by Paraphaeosphaeria sp. TR-022 - Journal of Antibiotics
Paraphaeosphaeride D and berkleasmin F, new circumventors of arbekacin resistance in MRSA, produced by Paraphaeosphaeria sp. TR-022
The Journal of Antibiotics 69, 605 (August 2016). doi:10.1038/ja.2016.70
Authors: Takuya Suga, Mayu Shiina, Yukihiro Asami, Masato Iwatsuki, Tsuyoshi Yamamoto, Kenichi Nonaka, Rokuro Masuma, Hidehito Matsui, Hideaki Hanaki, Susumu Iwamoto, Hideyuki Onodera, Kazuro Shiomi & Satoshi Ōmura
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Iminimycin A, the new iminium metabolite produced by Streptomyces griseus OS-3601 - Journal of Antibiotics
Iminimycin A, the new iminium metabolite produced by Streptomyces griseus OS-3601
The Journal of Antibiotics 69, 611 (August 2016). doi:10.1038/ja.2015.142
Authors: Takuji Nakashima, Rei Miyano, Masato Iwatsuki, Tatsuya Shirahata, Toru Kimura, Yukihiro Asami, Yoshinori Kobayashi, Kazuro Shiomi, George A Petersson, Yōko Takahashi & Satoshi Ōmura
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Pyrazinone protease inhibitor metabolites from Photorhabdus luminescens - Journal of Antibiotics
Pyrazinone protease inhibitor metabolites from Photorhabdus luminescens
The Journal of Antibiotics 69, 616 (August 2016). doi:10.1038/ja.2016.79
Authors: Hyun Bong Park & Jason M Crawford
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Interaction of the tetracyclines with double-stranded RNAs of random base sequence: new perspectives on the target and mechanism of action - Journal of Antibiotics
Interaction of the tetracyclines with double-stranded RNAs of random base sequence: new perspectives on the target and mechanism of action
The Journal of Antibiotics 69, 622 (August 2016). doi:10.1038/ja.2015.145
Authors: Chinwe U Chukwudi & Liam Good
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Haenamindole and fumiquinazoline analogs from a fungicolous isolate of Penicillium lanosum - Journal of Antibiotics
Haenamindole and fumiquinazoline analogs from a fungicolous isolate of Penicillium lanosum
The Journal of Antibiotics 69, 631 (August 2016). doi:10.1038/ja.2016.74
Authors: In Hyun Hwang, Yongsheng Che, Dale C Swenson, James B Gloer, Donald T Wicklow, Stephen W Peterson & Patrick F Dowd
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Quinovosamycins: new tunicamycin-type antibiotics in which the α, β-1″,11′-linked N-acetylglucosamine residue is replaced by N-acetylquinovosamine - Journal of Antibiotics
Quinovosamycins: new tunicamycin-type antibiotics in which the α, β-1″,11′-linked N-acetylglucosamine residue is replaced by N-acetylquinovosamine
The Journal of Antibiotics 69, 637 (August 2016). doi:10.1038/ja.2016.49
Authors: Neil PJ Price, David P Labeda, Todd A Naumann, Karl E Vermillion, Michael J Bowman, Mark A Berhow, William W Metcalf & Kenneth M Bischoff
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7-Chlorofolipastatin, an inhibitor of sterol O-acyltransferase, produced by marine-derived Aspergillus ungui NKH-007 - Journal of Antibiotics
7-Chlorofolipastatin, an inhibitor of sterol O-acyltransferase, produced by marine-derived Aspergillus ungui NKH-007
The Journal of Antibiotics 69, 647 (August 2016). doi:10.1038/ja.2016.27
Authors: Ryuji Uchida, Kento Nakajyo, Keisuke Kobayashi, Taichi Ohshiro, Takeshi Terahara, Chiaki Imada & Hiroshi Tomoda
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New cytotoxic trichothecene macrolide epimers from endophytic Myrothecium roridum IFB-E012 - Journal of Antibiotics
New cytotoxic trichothecene macrolide epimers from endophytic Myrothecium roridum IFB-E012
The Journal of Antibiotics 69, 652 (August 2016). doi:10.1038/ja.2016.86
Authors: Li Shen, Li Zhu, Qingwei Tan, Dan Wan, Ju Xie & Jiangnan Peng
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Friday, August 26, 2016
Country Fresh Recalls Product Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Country Fresh, LLC. of Conroe, Texas, is recalling 30,000 cases of various fresh-cut vegetable products (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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High-Risk Obtainment of Prescription Drugs by Older Adults in New Jersey: The Role of Prescription Opioids - American Geriatric Society
Objectives
To explore the high-risk ways in which older adults obtain prescription opioids and to identify predictors of obtaining prescription opioids from high-risk sources, such as obtaining the same drug from multiple doctors, sharing drugs, and stealing prescription pads.
Design
Logistic regression analyses of cross-sectional survey data from the New Jersey Older Adult Survey on Drug Use and Health, a representative random-sample survey.
Participants
Adults aged 60 and older (N = 725).
Measurements
Items such as obtaining prescriptions for the same drug from more than one doctor and stealing prescription drugs were measured to determine high-risk obtainment of prescription opioids.
Results
Almost 15% of the sample used high-risk methods of obtaining prescription opioids. Adults who previously used a prescription opioid recreationally had three times the risk of high-risk obtainment of prescription opioids.
Conclusion
These findings illustrate the importance of strengthening prescription drug monitoring programs to reduce high-risk use of prescription drugs in older adults by alerting doctors and pharmacists to potential prescription drug misuse and interactions.
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Barriers to Mental Health Care for an Ethnically and Racially Diverse Sample of Older Adults - American Geriatric Society
Objectives
This study examined potential barriers to mental healthcare use of older adults from diverse ethnic and racial backgrounds.
Design
Data were obtained from the 2007, 2009, 2011–12, and 2013–14 California Health Interview Survey (CHIS), a population-based survey representative of California's noninstitutionalized population.
Participants
The total sample consisted of 75,324 non-Hispanic white (NHW), 6,600 black, 7,695 Asian and Pacific Islander (API), and 4,319 Hispanic adults aged 55 and older.
Results
Results from logistic regression analyses that controlled for multiple demographic and health status characteristics revealed ethnic and racial differences in reasons for not seeking treatment and for terminating treatment. Specifically, API and Hispanic adults had greater odds than NHWs of endorsing feeling uncomfortable talking to a professional as a reason for not seeking treatment. Hispanic respondents had lower odds of endorsing concerns about someone finding out than APIs, and APIs and blacks had significantly greater odds of endorsing this concern as a reason for not seeking treatment than NHWs. When asked about reasons for no longer receiving treatment, all respondents, irrespective of race or ethnicity, endorsed that they no longer needed treatment as the most frequent reason for terminating treatment, although specific ethnic and racial differences emerged with respect to perceptions of not getting better, lack of time or transportation, and lack of insurance coverage as reasons for no longer seeking treatment.
Conclusion
Understanding how barriers to mental health treatment differ for older adults from diverse ethnic and racial backgrounds is an important step toward designing interventions to overcome these obstacles and improve mental health outcomes.
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Willis Ocean Inc. Issues Allergy Alert on Undeclared Sulfites in Willis Eagle Brand Mut Gung Sweetened Ginger - FDA Safety Alerts & Drug Recalls
Willis Ocean Inc. of Brooklyn, NY, is recalling 30 cases of Willis Eagle brand MUT GUNG SWEETENED GINGER, because it contains undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA advises testing for Zika virus in all donated blood and blood components in the US - FDA Press Releases
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
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Thursday, August 25, 2016
Wednesday, August 24, 2016
Pathogenesis, Diagnosis, and Treatment of Venous Thromboembolism in Older Adults - American Geriatric Society
Older adults have a significantly greater risk of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, than younger adults. The cause of this greater risk is thought to be multifactorial, including age-related changes in hemostatic factors and greater comorbid conditions and hospitalizations, but is not completely understood. Moreover, VTE remains underrecognized in older adults and may present atypically. Thus, a low index of clinical suspicion is essential when evaluating older adults with possible VTE. Despite this underrecognition in older adults, the diagnostic approach remains similar for all age groups and includes estimation of pretest probability, measurement of the D-dimer, and imaging. Antithrombotic agents are the mainstay of VTE treatment and, when used appropriately, substantially reduce VTE recurrence and complications. The approval of novel oral anticoagulants (NOACs), including dabigatran, rivaroxaban, apixaban, and edoxaban, provide clinicians with new therapeutic options. In some individuals, NOACs may offer advantages over warfarin, including fewer drug interactions, more-predictable anticoagulation, and lower risk of bleeding. Nevertheless, anticoagulation of VTE in older adults should always be performed cautiously, because age is a risk factor for bleeding complications. Identifying modifiable bleeding risk factors and balancing the risks of VTE recurrence with hemorrhage are important considerations when using anticoagulants in older adults.
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FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops - FDA Safety Alerts & Drug Recalls
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to raw scallops.
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Differential cell line susceptibility to the emerging Zika virus: implications for disease pathogenesis, non-vector-borne human transmission and animal reservoirs
Differential cell line susceptibility to the emerging Zika virus: implications for disease pathogenesis, non-vector-borne human transmission and animal reservoirs
Emerging Microbes & Infections 5, e93 (August 2016). doi:10.1038/emi.2016.99
Authors: Jasper Fuk-Woo Chan, Cyril Chik-Yan Yip, Jessica Oi-Ling Tsang, Kah-Meng Tee, Jian-Piao Cai, Kenn Ka-Heng Chik, Zheng Zhu, Chris Chung-Sing Chan, Garnet Kwan-Yue Choi, Siddharth Sridhar, Anna Jinxia Zhang, Gang Lu, Kin Chiu, Amy Cheuk-Yin Lo, Sai-Wah Tsao, Kin-Hang Kok, Dong-Yan Jin, Kwok-Hung Chan & Kwok-Yung Yuen
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Tuesday, August 23, 2016
Baptista’s Bakery Issues Allergy Alert on Undeclared Milk in Snack Factory® Original Pretzel Crisps® - FDA Safety Alerts & Drug Recalls
Baptista’s Bakery, Inc. announced a voluntary recall of a limited number of 7.2 oz. Snack Factory® Original Pretzel Crisps® and 7.2 oz Snack Factory® Sriracha Lime Pretzel Crisps® packages because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected product.
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Monday, August 22, 2016
The Abuse Intervention Model: A Pragmatic Approach to Intervention for Elder Mistreatment - American Geriatric Society
Ten percent of older adults experience elder mistreatment, and it is much more common in older adults with dementia. It is associated with higher rates of psychological distress, hospitalization, and death and, in the United States, costs billions of dollars each year. Although elder mistreatment is relatively common and costly, it is estimated that fewer than 10% of instances of elder mistreatment are reported. Given these data, there is a great need for research on interventions to mitigate elder mistreatment and for a practical model or framework to use in approaching such interventions. Although many theories have been proposed, adapted, and applied to understand elder mistreatment, there has not been a simple, coherent framework of known risk factors of the victim, perpetrator, and environment that applies to all types of abuse. This article presents a new model to examine the multidimensional and complex relationships between risk factors. Theories of elder mistreatment, research on risk factors for elder mistreatment, and 10 years of experience of faculty and staff at an Elder Abuse Forensics Center who have investigated more than 1,000 cases of elder mistreatment inform this model. It is hoped that this model, the Abuse Intervention Model, will be used to study and intervene in elder mistreatment.
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Evaluating Exercise Prescription and Instructional Methods Used in Tai Chi Studies Aimed at Improving Balance in Older Adults: A Systematic Review - American Geriatric Society
Objectives
To develop an evaluation instrument to determine to what extent Tai Chi interventions aimed at improving the balance of older adults disclosed their exercise prescription (Ex Rx) and instructional methods and met best-practice exercise recommendations for balance improvement.
Design
Review.
Setting
PubMed, Scopus, and CINAHL databases were searched from their inception until August 22, 2014.
Participants
Adults aged 60 and older without debilitating disease.
Measurements
Three electronic databases were searched to identify randomized controlled trials (RCTs) of Tai Chi interventions aimed at improving balance in older adults without severe debilitating diseases. Three Ex Rx (frequency, time, intervention length) and 10 instructional (e.g., style, number of forms) methods of the included RCTs were evaluated.
Results
Twenty-seven interventions were identified from 26 RCTs. On average, Tai Chi was performed for a mean 56.5 ± 14.4 minutes per session for 2.8 ± 1.4 sessions per week for 19.7 ± 12.7 weeks. Most interventions reported all three Ex Rx methods items, with a mean reporting rate of 92.6 ± 19.2%. For the 10 instructional methods items, the mean reporting rate was 41.1 ± 18.0%, significantly lower than for the Ex Rx methods items (P < .001). Fewer than half of the interventions reported unsupervised practice (15%), progression (22%), or the use of breathing (30%) and relaxation (15%) techniques. The instructional methods items most important for targeting Tai Chi practice to improve balance were not routinely disclosed, with only 15% reporting names of forms and 52% reporting movement principles.
Conclusion
Most Tai Chi interventions disclosed their Ex Rx methods yet routinely failed to report instructional methods. To increase the effectiveness of Tai Chi to improve balance in older adults, future RCTs should disclose their Ex Rx and instructional methods, especially methods that target balance.
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End-of-Life Discussions with Older Adults - American Geriatric Society
Objectives
To determine the prevalence of end-of-life (EOL) conversations with older adults.
Design
National Health and Aging Trends Study (NHATS), a prospective, longitudinal survey of Medicare beneficiaries.
Setting
Nationally representative.
Participants
A sample drawn from Wave 2 of the NHATS.
Measurements
The main outcome was the report of an EOL planning discussion, based upon the participant's response to the question “Have you talked to anyone about the types of medical treatment you would want or not want if you became seriously ill in the future?”
Results
Sixty-one percent of the sample (n = 1,993 individuals, weighted n = 11,123,910) responded that they had discussed EOL treatment preferences with someone. In multivariate regression, factors associated with reporting an EOL discussion included being younger (adjusted odds ratio (AOR) = 1.70, 95% confidence interval (CI) = 1.17–2.47), having more education (high school degree: AOR = 1.45, 95% CI = 1.02–2.07; some college: AOR = 2.03, 95% CI = 1.40–2.95), and having multiple chronic conditions (AOR = 1.25, 95% CI = 1.01–1.55). Black race was associated with lower odds of reporting a discussion (AOR = 0.46, 95% CI = 0.33–0.65).
Conclusion
Forty percent of a nationally representative sample of Medicare beneficiaries had not discussed their preferences regarding EOL medical treatment. Promoting these conversations in clinical and nonclinical settings will be important to ensure that health care is delivered to individuals in a person-centered manner.
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Informed Family Member Involvement to Improve the Quality of Dementia Care in Nursing Homes - American Geriatric Society
Objectives
To describe the extent to which nursing homes engaged families in antipsychotic initiation decisions in the year before surveyor guidance revisions were implemented.
Design
Mixed-methods study based on semistructured interviews.
Setting
U.S. nursing homes (N = 20) from five CMS regions (III, IV, VI, VIII, IX).
Participants
Family members of nursing home residents (N = 41).
Measurements
Family member responses to closed- and open-ended questions regarding involvement in resident care and antipsychotic initiation. Two researchers used a content analytical approach to code open responses to themes of family involvement in behavior management, decision-making, knowledge of risks and benefits, and informed consent.
Results
Fifty-four percent of family members felt highly involved in decisions about behavior management. Forty-two percent recalled being asked how to manage resident behavior without medication, and 17% recalled receipt of information about antipsychotic risks and benefits. Sixty-six percent felt highly involved in the process of initiating antipsychotic medication; 24% reported being asked for input into the antipsychotic initiation decision and knowing before the antipsychotic was started.
Conclusion
Under existing federal regulations but before guidance revisions were implemented in 2013, more than 40% of families reported being involved in nonpharmacological behavior management of family members, but fewer than one in four reported being involved throughout the entire antipsychotic prescribing process. Interventions that standardize family engagement and promote adherence to existing federal regulations are needed. This discussion builds on these findings to weigh the policy options of greater enforcement of existing regulations versus enactment of new legislation to address this challenging issue.
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Variation in the Presence of Simple Home Modifications of Older Americans: Findings from the National Health and Aging Trends Study - American Geriatric Society
Objectives
To investigate the association between sociodemographic and economic factors and the presence of simple home modifications (HMs) among older adults in the United States.
Design
Cross-sectional.
Setting
National Health and Aging Trends Study (2011, Round 1).
Participants
Community-dwelling Medicare enrollees aged 65 and older (N = 6,628).
Measurements
The primary dependent variable was the reported presence or absence of simple HMs (grab bars in the shower or near the toilet, shower seats, raised toilet seats).
Results
Of the individuals sampled, 60.7% reported having at least one HM of interest. Black (odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.68–0.91) and Hispanic (OR = 0.60, 95% CI = 0.45–0.78) respondents were less likely than white, non-Hispanic respondents to have HMs. Those with more education (high school graduate: OR = 1.20, 95% CI = 1.01–1.42; >high school: OR = 1.36, 95% CI = 1.14–1.62) and larger social networks (≥4 people; OR = 1.46, 95% CI = 1.12–1.89) were more likely to have at least one HM, whereas being divorced (OR = 0.57, 95% CI = 0.43–0.74) was associated with lower likelihood. Income (OR = 1.01, 95% CI = 0.97–1.05), Medicaid enrollment (OR = 0.98, 95% CI = 0.77–1.25), and living alone (OR = 1.02, 95% CI = 0.85–1.23) were not significantly associated with the presence of HMs.
Conclusion
Minorities, individuals with less education, and those with less social support are less likely to have HMs. Awareness of these disparities and the shortcomings of the HM delivery system is important to clinicians and policy-makers who seek to prevent falls and facilitate aging in place for all older Americans.
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Effect of Primary Care Involvement on End-of-Life Care Outcomes: A Systematic Review - American Geriatric Society
Objectives
To investigate the relationship between primary care involvement in end-of-life (EOL) care and health and utilization outcomes.
Design
Systematic review using MEDLINE and Web of Science.
Setting
All English literature published between 1994 and August 31, 2014, that included terms related to primary care providers (PCPs), continuity of care, EOL care, and palliative care.
Participants
Individuals receiving care from a PCP at the end of life.
Measurements
Study design, subject characteristics, study outcomes and results.
Results
Of 2,812 studies screened, 13 were included in this study. The studies were mostly conducted in the United States (n = 5) and Canada (n = 4) and analyzed data collected from 1989 to 2010. Almost all studies used different definitions of PCP involvement in care, but in general, individuals who received more care from PCPs were more likely to be discharged or die with supportive care (home or hospice) than those receiving less PCP care. A few studies indicated that individuals seeing a PCP were less likely to have hospital or emergency department admissions, although the evidence for this was mixed. Studies linking PCP involvement to resource use, symptom management, and survival had mixed results or showed no association.
Conclusion
When PCPs are involved in EOL care, people are more likely to die out of the hospital. Thus, the relationship with the PCP may be particularly important in EOL care, because PCPs may help individual establish goals of care and determine treatment preferences.
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Dyspnea in Community-Dwelling Older Persons: A Multifactorial Geriatric Health Condition - American Geriatric Society
Objectives
To evaluate the associations between a broad array of cardiorespiratory and noncardiorespiratory impairments and dyspnea in older persons.
Design
Cross-sectional.
Setting
Cardiovascular Health Study.
Participants
Community-dwelling persons (N = 4,413; mean age 72.6, 57.1% female, 4.5% African American, 27.2% <high school education, 54.7% ever-smokers).
Measurements
Dyspnea severity (moderate to severe defined as American Thoracic Society Grade ≥2) and several impairments, including those established using spirometry (forced expiratory volume in 1 second (FEV1)), maximal inspiratory pressure (respiratory muscle strength), echocardiography, ankle–brachial index, blood pressure, whole-body muscle mass (bioelectrical impedance), single chair stand (lower extremity function), grip strength, serum hemoglobin and creatinine, Center for Epidemiologic Studies Depression Scale (CES-D), Mini-Mental State Examination, medication use, and body mass index (BMI).
Results
In a multivariable logistic regression model, impairments that had strong associations with moderate to severe dyspnea were FEV1 less than the lower limit of normal (adjusted odds ratio (aOR) = 2.88, 95% confidence interval (CI) = 2.37–3.49), left ventricular ejection fraction less than 45% (aOR = 2.12, 95% CI = 1.43, 3.16), unable to perform a single chair stand (aOR = 2.10, 95% CI = 1.61–2.73), depressive symptoms (CES-D score ≥16; aOR = 2.02, 95% CI = 1.26–3.23), and obesity (BMI ≥30; aOR = 2.07, 95% CI = 1.67–2.55). Impairments with modest but still statistically significant associations with moderate to severe dyspnea included respiratory muscle weakness, diastolic cardiac dysfunction, grip weakness, anxiety symptoms, and use of cardiovascular and psychoactive medications (aORs = 1.31–1.71).
Conclusion
In community-dwelling older persons, several cardiorespiratory and noncardiorespiratory impairments were significantly associated with moderate to severe dyspnea, akin to a multifactorial geriatric health condition.
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Associations Between Serum Inflammatory Markers and Hippocampal Volume in a Community Sample - American Geriatric Society
Objectives
To quantify associations between inflammatory biomarkers and hippocampal volume (HV) and to examine effect modification according to sex, race, and age.
Design
Cross-sectional analyses using generalized estimating equations to account for familial clustering; standardized β-coefficients adjusted for age, sex, race, and education.
Setting
Community cohorts in Jackson, Mississippi and Rochester, Minnesota.
Participants
The Genetic Epidemiology Network of Arteriopathy study.
Measurements
C-reactive protein (CRP), interleukin-6 (IL-6), and soluble tumor necrosis factor receptors 1 (sTNFR-1) and 2 (sTNFR-2) from peripheral blood were measured in a sample of 773 non-Hispanic whites (61% women, aged 60.2 ± 9.8) and 514 African Americans (70% women, aged 63.9 ± 8.1) who also underwent brain magnetic resonance imaging. Biomarkers were standardized and compared according to sex, race and age with HV.
Results
In the full sample, higher sTNFR-1 and sTNFR-2 were associated with smaller HV. Each standard deviation (SD) increase in sTNFR-1 was associated with 59.1 mm3 (95% confidence interval (CI) = −101.4 to −16.7 mm3) smaller HV and each SD increase in sTNFR-2 associated with 48.8 mm3 (95% CI = −92.2 to −5.3 mm3) smaller HV. Relationships were stronger for sTNFR-2 in men (HV = −116.6 mm3 for each SD increase, 95% CI = −201.0 to −32.1) than women (HV = −26.0 per SD increase, 95% CI = −72.4–20.5) and sTNFR-1 in non-Hispanic whites (HV = −84.7 mm3 per SD increase, 95% CI = −142.2 to −27.1) than African Americans (HV = −14.1 mm3 per SD increase, 95% CI = −78.3–50.1). Associations between IL-6 or CRP and HV were not supported.
Conclusion
Higher levels of sTNFRs were associated cross-sectionally with smaller hippocampi. Longitudinal data are needed to determine whether these biomarkers may help to identify risk of late-life cognitive impairment.
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Use and Interpretation of Propensity Scores in Aging Research: A Guide for Clinical Researchers - American Geriatric Society
Observational studies are an important source of evidence for evaluating treatment benefits and harms in older adults, but lack of comparability in the outcome risk factors between the treatment groups leads to confounding. Propensity score (PS) analysis is widely used in aging research to reduce confounding. Understanding the assumptions and pitfalls of common PS analysis methods is fundamental to applying and interpreting PS analysis. This review was developed based on a symposium of the American Geriatrics Society Annual Meeting on the use and interpretation of PS analysis in May 2014. PS analysis involves two steps: estimation of PS and estimation of the treatment effect using PS. Typically estimated from a logistic model, PS reflects the probability of receiving a treatment given observed characteristics of an individual. PS can be viewed as a summary score that contains information on multiple confounders and is used in matching, weighting, or stratification to achieve confounder balance between the treatment groups to estimate the treatment effect. Of these methods, matching and weighting generally reduce confounding more effectively than stratification. Although PS is often included as a covariate in the outcome regression model, this is no longer a best practice because of its sensitivity to modeling assumption. None of these methods reduce confounding by unmeasured variables. The rationale, best practices, and caveats in conducting PS analysis are explained in this review using a case study that examined the effective of angiotensin-converting enzyme inhibitors on mortality and hospitalization in older adults with heart failure.
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Potential Effect of Substituting Estimated Glomerular Filtration Rate for Estimated Creatinine Clearance for Dosing of Direct Oral Anticoagulants - American Geriatric Society
Objectives
To determine the potential effect of substituting glomerular filtration rate (GFR) estimates for renal clearance estimated using the Cockcroft–Gault method (CrCL-CG) to calculate direct oral anticoagulant (DOAC) dosing.
Design
Simulation and retrospective data analysis.
Setting
Community, academic institution, nursing home.
Participants
Noninstitutionalized individuals aged 19 to 80 from the National Health and Nutrition Examination Survey (NHANES) (2011/12) (n = 4,687) and medically stable research participants aged 25 to 105 (n = 208).
Measurements
Age, height, weight, sex, race, serum creatinine, CrCL-CG, and GFR (according to the Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration equations). Outcome measures were dosing errors if GFR were to be substituted for CrCL-CG.
Results
Renal clearance estimates according to all methods were highly correlated (P < .001), although at lower clearances, substitution of GFR estimates for CrCL-CG resulted in failure to recognize needs for dose reductions of rivaroxaban or edoxaban in 28% of NHANES subjects and 47% to 56% of research subjects. At a CrCL-CG of less than 30 mL/min, GFR estimates missed indicated dosage reductions for dabigatran in 18% to 21% of NHANES subjects and 57% to 86% of research subjects. Age and weight contributed to differences between renal clearance estimates (P < .001), but correction of GFR for body surface area (BSA) did not reduce dosing errors. At a CrCL-CG greater than 95 mL/min, edoxaban is not recommended, and GFR esimates misclassified 24% of NHANES and 39% of research subjects. Correction for BSA reduced misclassification to 7% for NHANES and 14% in research subjects.
Conclusion
Substitution of GFR estimates for estimated CrCl can lead to failure to recognize indications for reducing DOAC dose and potentially higher bleeding rates than in randomized trials.
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Effects of a Health and Social Collaborative Case Management Model on Health Outcomes of Family Caregivers of Frail Older Adults: Preliminary Data from a Pilot Randomized Controlled Trial - American Geriatric Society
Family caregiving is an important form of informal care provided to frail, community-dwelling older adults. This article describes a health and social collaborative case management (HSC-CM) model that aims to optimize the support given to caregivers of frail elderly adults. The model was characterized by a comprehensive assessment to identify the caregiver's needs; a case management approach to provide integrated, coordinated, continued care; and multidisciplinary group-based education customized to the caregiver's individualized needs. A pilot study using a randomized controlled trial study design was conducted to evaluate the effects of the HSC-CM on caregiver burden and health-related quality of life of family caregivers of frail elderly adults. Sixty family caregivers (mean age 61.3 ± 15.5) of frail older adults recruited from a community center for elderly adults in Hong Kong were randomly assigned to receive a 16-week HSC-CM intervention or usual care. Case managers who conducted a comprehensive assessment of the care dyads to identify caregiver needs using a case management approach to optimize care coordination and continuity led the HSC-CM. These case managers served as liaisons for multidisciplinary efforts to provide group-based education according to caregiver needs. Family caregivers who participated in the HSC-CM had significantly greater improvement on the Caregiver Burden Index (p = .03) and on the Medical Outcomes Study 36-item Short-Form Survey subscales, including vitality (p = .049), social role functioning (p = .047), and general well-being (p = .049). This study provides preliminary evidence indicating that client-centered care, a case management approach, and multidisciplinary support are crucial to an effective caregiving support initiative. A full-scale study is required to validate these findings.
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Racial Differences in Hospitalizations of Dying Medicare–Medicaid Dually Eligible Nursing Home Residents - American Geriatric Society
Objectives
To examine whether racial differences in end-of-life (EOL) hospitalizations vary according to the presence of advance directives, specifically do-not-hospitalize (DNH) orders, and individual cognitive status in nursing home (NH) residents.
Design
National data, including Medicare data and Minimum Data Set (MDS) 2.0, between January 1, 2007, and September 30, 2010, were linked. EOL hospitalizations were hospitalizations in the last 30 days of life. Linear probability models with an interaction term (between race and DNH) and NH fixed-effects were estimated. The analyses were stratified according to cognitive status.
Setting
Nursing homes in the United States.
Participants
Dually eligible Medicare–Medicaid decedents enrolled in Medicare fee-for-service plans and long-stay NH residents (in NHs ≥ 90 days before death) (N = 394,948).
Measurements
Racial difference in EOL hospitalizations from a NH.
Results
End-of-life hospitalization rate was 31.7% for whites and 42.8% for blacks. For participants without DNH orders, adjusted probability of EOL hospitalization was higher for blacks than for whites: 2.7 percentage points in those with moderate cognitive impairment (P < .001) and 4.7 percentage points in those with severe cognitive impairment (P < .001). For those with DNH orders, adjusted racial differences in EOL hospitalization were not statistically significant in those with moderate (P = .25) or severe (P = .93) cognitive impairment, but blacks had a higher probability of EOL hospitalization than whites if they had relatively intact cognitive status.
Conclusion
Racial differences in EOL hospitalization varied with DNH orders and cognitive status in dying residents. Future research is necessary to understand the reasons behind these variations.
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Racial and Ethnic Differences in Initiation and Discontinuation of Antidementia Drugs by Medicare Beneficiaries - American Geriatric Society
Objectives
To examine racial and ethnic differences in initiation and time to discontinuation of antidementia medication in Medicare beneficiaries.
Design
Retrospective cohort study.
Setting
Secondary analysis of 2009–10 enrollment, claims, and Part D prescription data for a 10% national sample of U.S. Medicare fee-for-service beneficiaries.
Participants
Beneficiaries aged 65 and older with Alzheimer's disease or related dementia (ADRD) before 2009 and no fills for antidementia medications in the first half of 2009 (N = 84,043).
Measurements
Initiation was defined as having one or more fills for antidementia medication in the second half of 2009 and discontinuation as a gap in coverage of 30 days or more during the year after initiation. The Andersen Behavioral Model was used to guide covariate selection.
Results
Overall, 3,481 (4.1%) of previous nonusers initiated antidementia medication in the second half of 2009. Of those initiating one drug class (acetylcholinesterase inhibitors (AChEIs) or memantine), 9% later added the other class, and 2% switched classes. Of initiators, 23% discontinued within 1 month, and 62% discontinued within 1 year. Hispanic beneficiaries were more likely than white beneficiaries to initiate (adjusted odds ratio = 1.25, 95% confidence interval (CI) = 1.10–1.41). Black and white beneficiaries did not differ in likelihood of initiation. Hispanic (adjusted hazard ratio (aHR) = 1.56, 95% CI = 1.34–1.82) and black (aHR = 1.25, 95% CI = 1.08–1.44) beneficiaries discontinued at a faster rate than white beneficiaries.
Conclusion
Initiation of antidementia medications was no different in black and white beneficiaries and more likely in Hispanic beneficiaries; black and Hispanic beneficiaries discontinued at a faster rate. More research into reasons explaining these differences is needed.
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Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Nonclinician Sleep Coaches: Randomized Controlled Trial - American Geriatric Society
Objectives
To test a new cognitive behavioral therapy for insomnia (CBT-I) program designed for use by nonclinicians.
Design
Randomized controlled trial.
Setting
Department of Veterans Affairs healthcare system.
Participants
Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159).
Intervention
Nonclinician “sleep coaches” delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education.
Measurements
Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency (SOL-D), wake after sleep onset (WASO-D), total wake time (TWT-D), and sleep efficiency (SE-D); Pittsburgh Sleep Quality Index (PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index (ISI), depressive symptoms (Patient Health Questionnaire-9 (PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 (SF-12v2)).
Results
Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2.
Conclusion
Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia.
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Getting Patients Walking: A Pilot Study of Mobilizing Older Adult Patients via a Nurse-Driven Intervention - American Geriatric Society
Objectives
To develop a system-based intervention including five components that target barriers to nurse-initiated patient ambulation.
Design
Pilot study of Mobilizing Older adult patients VIa a Nurse-driven intervention (MOVIN).
Setting
Twenty-six bed general medical unit.
Participants
Nursing staff (registered nurses and certified nursing assistants) were recruited to participate in focus groups.
Measurements
Information on frequency and distance patients ambulated and nursing staff documentation of patient ambulation were retrieved from the electronic medical record. Regression discontinuity analysis was used to determine a difference between the preintervention and intervention periods in ambulation occurrence, ambulation distance, and percentage of numeric documentation of ambulation. Thematic analysis was used to analyze focus group interviews.
Results
A statistically significant increase in number of occurrences (t = 4.18, P = .001) and total distance (t = 2.75, P = .01) and a significantly higher positive slope in percentage of numeric documentation was found during the intervention than before the intervention. Thematic analysis identified three central categories (shifting ownership, feeling supported, making ambulation visible) that describe the effect of MOVIN on nursing staff behaviors and perceptions of the intervention.
Conclusion
Decreasing loss of independent ambulation in hospitalized older adults requires new and innovative approaches to addressing barriers that prevent nurse-initiated patient ambulation. MOVIN is a promising system-based intervention to promoting patient ambulation and improving outcomes for hospitalized older adults.
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FDA Statement on Medical Device User Fee Agreement (MDUFA) - FDA Press Releases
The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
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Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination - Second Expansion - FDA Safety Alerts & Drug Recalls
Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail and consumer/user levels. The recall is being initiated due to potential product contamination with the bacteria, Burkholderia cepacia.
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FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury - FDA Press Releases
The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.
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Friday, August 19, 2016
Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination - FDA Safety Alerts & Drug Recalls
In cooperation with the U.S. Food and Drug Administration (FDA), Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.
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Cambridge Farms, LLC Recalls Three Brands Of Frozen Cut Corn Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Cambridge Farms, LLC of Lancaster, PA is recalling the below products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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Oriental Packing Co. Inc. Issues Alert On Lead In Curry Powder - FDA Safety Alerts & Drug Recalls
Oriental Packing Co., Inc., Miami, Florida is recalling approximately 377,000 lbs. of the following blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences.
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Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Oxacillin for Injection, USP, 10g Due to Presence of Iron Oxide Particulate Matter - FDA Safety Alerts & Drug Recalls
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent.
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Thursday, August 18, 2016
FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery - FDA Press Releases
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.
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Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack - FDA Safety Alerts & Drug Recalls
Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.
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Patterns of Functional Disability in the Oldest Adults in China - American Geriatric Society
This study examined patterns of onset of activity of daily living (ADL) disability in a nationally representative sample of older adults in mainland China. Using longitudinal data from the Chinese Longitudinal Healthy Longevity Survey from 1998 to 2008 (N = 5,570), nonparametric methods were used to evaluate median age at onset of various ADL disabilities and differences in the incidence of disabilities according to sex. The sampled older Chinese adults developed ADL disabilities, on average, between the ages of 89 and 94. Women were likely to experience later onset than men. The results also show that the oldest adults generally lose bathing ability, followed by toileting, transferring, dressing, eating, and finally, continence. This order—derived from estimated median age at onset—was also found to be highly prevalent in subsequently disabled respondents in the sample. The disability experience of older adults in China is somewhat similar to that of older adults in Western developed countries; elderly adults tend to lose ability in activities that require lower extremity strength earlier than those that require upper extremity strength. The relative importance of the various ADL items in the hierarchical ordering has implications for early intervention to reduce the risk of functional disability in older adults and those at risk of transitions of care.
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Detained and Distressed: Persistent Distressing Symptoms in a Population of Older Jail Inmates - American Geriatric Society
Distressing symptoms are associated with poor function, acute care use, and mortality in older adults. The number of older jail inmates is increasing rapidly, prompting calls to develop systems of care to meet their healthcare needs, yet little is known about multidimensional symptom burden in this population. This cross-sectional study describes the prevalence and factors associated with distressing symptoms and the overlap between different forms of symptom distress in 125 older jail inmates in an urban county jail. Physical distress was assessed using the Memorial Symptom Assessment Scale. Several other forms of symptom distress were also examined, including psychological (Generalized Anxiety Disorder Scale, Patient Health Questionnaire), existential (Patient Dignity Inventory), and social (Three Item Loneliness Scale). Information was collected on participant sociodemographic characteristics, multimorbidity, serious mental illness (SMI), functional impairment, and behavioral health risk factors through self-report and chart review. Chi-square tests were used to identify factors associated with physical distress. Overlap between forms of distress was evaluated using set theory analysis. Overall, many participants (74%) reported distressing symptoms, including having one or more physical (44%), psychological (37%), existential (54%), or social (45%) symptoms. Physical distress was associated with poor health (multimorbidity, functional impairment, SMI) and low income. Of the 93 participants with any symptom, 49% reported three or more forms of distress. These findings suggest that an optimal model of care for this population would include a geriatrics–palliative care approach that integrates the management of all forms of symptom distress into a comprehensive treatment paradigm stretching from jail to the community.
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Place of Death of Individuals with Terminal Cancer: New Insights from Medicare Hospice Place-of-Service Codes - American Geriatric Society
Objectives
To use place-of-service (POS) codes in the Medicare hospice claims files to document where elderly hospice users with cancer die.
Design
Retrospective cohort study.
Setting
Surveillance, Epidemiology, and End Results (SEER) cancer registry areas.
Participants
Elderly Medicare beneficiaries who died of lung, breast, colorectal, or pancreatic cancer in 2007 and 2008 (N = 46,037).
Measurement
Use of hospice, place of service at death (home, nursing home, hospital, inpatient hospice, other), length of stay in hospice.
Results
Two-thirds of the beneficiaries used hospice. Younger, male, black, Asian, and unmarried beneficiaries and those enrolled in fee-for-service Medicare or from areas with lower income were less likely to use hospice. Hospice enrollment also varied significantly according to SEER registry. Thirty percent of the hospice users were not receiving home-based care at the time of death, and 17% were enrolled for less than 3 days. Factors associated with hospice death in the home mirrored those associated with hospice use. Individuals dying in hospitals (odds ratio (OR) = 5.13, 95% confidence interval (CI) = 4.63–5.69), inpatient hospice (OR = 1.86, 95% CI = 1.70–2.02), and nursing homes (OR = 1.19, 95% CI = 1.10–1.28) had greater odds of a short hospice stay (≤7 days) than those dying at home, after controlling for all other measured factors, whereas those dying in nursing homes had greater odds of long stays (>180 days) (OR = 1.46, 95% CI = 1.28–1.67).
Conclusion
New hospice POS codes are useful for understanding place of death for hospice users. Hospice deaths cannot be assumed to happen at home.
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Wednesday, August 17, 2016
Bakers of Paris Recalls Croissants Sold at Whole Foods Market® Stores in Northern California Due to Undeclared Allergen - FDA Safety Alerts & Drug Recalls
Bakers of Paris (Brisbane California), is recalling plain and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list.
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Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination - FDA Safety Alerts & Drug Recalls
Cary, IL, Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.
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Converting monoclonal antibody-based immunotherapies from passive to active: bringing immune complexes into play
Converting monoclonal antibody-based immunotherapies from passive to active: bringing immune complexes into play
Emerging Microbes & Infections 5, e92 (August 2016). doi:10.1038/emi.2016.97
Authors: Jennifer Lambour, Mar Naranjo-Gomez, Marc Piechaczyk & Mireia Pelegrin
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High diversity of picornaviruses in rats from different continents revealed by deep sequencing
High diversity of picornaviruses in rats from different continents revealed by deep sequencing
Emerging Microbes & Infections 5, e90 (August 2016). doi:10.1038/emi.2016.90
Authors: Thomas Arn Hansen, Sarah Mollerup, Nam-phuong Nguyen, Nicole E White, Megan Coghlan, David E Alquezar-Planas, Tejal Joshi, Randi Holm Jensen, Helena Fridholm, Kristín Rós Kjartansdóttir, Tobias Mourier, Tandy Warnow, Graham J Belsham, Michael Bunce, Eske Willerslev, Lars Peter Nielsen, Lasse Vinner & Anders Johannes Hansen
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Endogenous nitric oxide accumulation is involved in the antifungal activity of Shikonin against Candida albicans
Endogenous nitric oxide accumulation is involved in the antifungal activity of Shikonin against Candida albicans
Emerging Microbes & Infections 5, e88 (August 2016). doi:10.1038/emi.2016.87
Authors: Zebin Liao, Yu Yan, Huaihuai Dong, Zhenyu Zhu, Yuanying Jiang & Yingying Cao
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Transmissible colistin resistance encoded by mcr-1 detected in clinical Enterobacteriaceae isolates in Singapore
Transmissible colistin resistance encoded by mcr-1 detected in clinical Enterobacteriaceae isolates in Singapore
Emerging Microbes & Infections 5, e87 (August 2016). doi:10.1038/emi.2016.85
Authors: Jeanette WP Teo, Ka Lip Chew & Raymond TP Lin
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Monday, August 15, 2016
Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue - FDA Safety Alerts & Drug Recalls
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016.
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Saturday, August 13, 2016
Friday, August 12, 2016
Oriental Packing Co., Inc. Issues Alert on Lead in Curry Powder - FDA Safety Alerts & Drug Recalls
Oriental Packing Co., Inc., Miami, Florida is recalling approximately 377,000 lbs. of the following blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences
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Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls
Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.
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Thursday, August 11, 2016
Rabbit Creek Products recalls certain flavors of bread, muffin and brownie mixes because of a possible health risk - FDA Safety Alerts & Drug Recalls
Rabbit Creek Products of Louisburg, KS is recalling certain flavors of Bread mixes, Muffin mixes and Brownie mixes under the Rabbit Creek Products and other Private label brand names due to the potential presence of Escherichia coli O:121 (E. coli O:121). People usually get sick from E. coli O: 121, also referred to as STEC O:121, 2-8 days (average of 3-4 days) after swallowing the bacteria. Most people develop diarrhea (often bloody) and abdominal cramps.
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Assessment and Measurement of Pain in Adults in Later Life - Geriatrics
Pain in aging adults is a global health problem requiring a proactive and consistent assessment approach. Pain assessment is critical to detecting pain and developing a collaborative and adaptive pain management plan. Getting health providers to assess and measure pain even in older adults who are communicative and can self-report remains a challenge. Self-report is the best method for identifying pain. Using a validated pain assessment scale is key to evaluate pain intensity. This article discusses techniques to obtain self-report and describe appropriate self-report pain tools for a focused pain assessment and reassessment in adults in later life.
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Delivering on the Promise of Better Care for Older Adults - CMS Blog
By Andy Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services (CMS)
Since becoming acting administrator, I have spoken frequently about to the importance of moving to the next chapter in implementing the Affordable Care Act. This new chapter goes beyond providing people with quality, affordable coverage – but making sure that we are delivering patient-centered care to all consumers at critical stages of their lives.
What does that look like? It looks like more individualized care – care that allows people to heal, recover, and age in their homes and communities; care that is coordinated so we avoid people falling through the cracks; and care that includes family members and the realities of all the things that impact our health like culture, nutrition, and other social factors. For the growing number of aging and frail Americans, many living with Alzheimer’s, it looks like PACE.
The Programs of All-inclusive Care for the Elderly (PACE) is a Medicare and Medicaid program that helps people meet their health care needs in the community in which they live instead of a nursing home or other care facility. The focus is on the participant. A team of health care professionals works to make sure that care is coordinated in the home, the community, and at a PACE center.
Today, CMS proposed the first major update to the PACE program in a decade. This proposal will help the program reflect the latest advances in caring for frail elders and changes in the use of technology. The goal of this proposal is to strengthen beneficiary protections and provide PACE organizations with more administrative and operational flexibilities so they can do what they do best – caring for our nation’s most vulnerable individuals. While PACE serves a relatively small number of people today, our proposal is intended to encourage states to further expand these programs.
Our proposals aim to offer the kind of common sense supports to allow older adults to get the best care possible. For example, individual care team members would be able to serve more than one role in addressing the wide spectrum of a participant’s needs, rather than just the one role they are permitted to occupy today. This would help better coordinate services, while providing important flexibility to care providers.
We also propose more modern and simplified administrative and operational rules to enhance PACE organizations’ ability to do a number of things more easily, including a more automated application process to speed up and customize services to participants.
Over the last six years, since the onset of the Affordable Care Act, we have been taking significant steps to care for more people, care for them better, and make health care more affordable. But for us to be successful, we need to work hand-in-hand with patients and their families, physicians and clinicians, and other actors to support new approaches to care. Team-based models that put the individual in the center, like PACE, will be a vital part of the fabric of our system.
We must work hard to support these approaches so our country can continue to provide our people with the care they need in the years ahead.
Learn more about the proposed rule to update and modernize PACE at http://ift.tt/2aOXrjO.
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Building on Premium Stabilization for the Future - CMS Blog
By Kevin Counihan, Health Insurance Marketplace CEO
The Affordable Care Act (ACA), the Medicare Part D prescription drug benefit, and a number of states’ insurance plans include reinsurance programs as a way to promote stable, affordable health coverage. Because high-cost enrollees and events are rare, they create disproportionate uncertainty in setting health insurance premiums: it is hard for any given issuer to predict how many people with very high-cost conditions will enroll, or how many expensive but unusual events will occur. By protecting against some of this risk, reinsurance programs help stabilize health insurance markets, promote issuer participation, and reduce premiums for consumers. Reinsurance programs also reduce insurers’ incentives to discourage enrollment by people with very high-cost conditions, thereby helping ensure those individuals can access the care they need.
The three-year, transitional reinsurance program established under the ACA was designed to buffer the new individual market as new federal reforms were implemented, enrollment grew, and issuers gained experience pricing and planning for new consumers. New data released today show that per-enrollee costs in the ACA individual market were essentially unchanged from 2014 to 2015, falling by 0.1 percent, even as per-enrollee costs in the broader health insurance market grew by at least 3 percent.
This finding suggests a year-over-year improvement in the ACA individual risk pool, with the Marketplaces gaining healthier, lower-cost consumers as it expanded. Meanwhile, independent researchers recently estimated that 2016 Marketplace premiums are between 12 percent and 20 percent below what the Congressional Budget Office (CBO) initially predicted. At the same time, the Health Insurance Marketplace remains a young, maturing market, one where all participants – insurers, consumers, providers, states, and we as federal regulators – are still learning.
Given this evolution and as part of our ongoing efforts to strengthen the Marketplace, we are exploring options to modify the ACA’s permanent risk adjustment program to better adjust for the highest-cost enrollees and their actuarial risk, which would achieve some of the same risk-sharing benefits as the reinsurance program. The ACA’s risk adjustment program plays an important role in distributing the costs of sicker, more expensive enrollees, and data show that the program worked as intended in its first two years.
But as described in a white paper released this spring, the current HHS risk adjustment methodology cannot easily adjust for certain high-cost enrollees. In future rulemaking, we plan to propose modifying the risk adjustment program to absorb some of the cost for claims above a certain threshold (e.g. $2 million), funded by a small payment from all issuers. This type of risk sharing would reduce uncertainty for issuers who are not yet able to reliably predict the prevalence and nature of high-cost cases in their Marketplace business, while also protecting access to robust coverage options for people with very high-cost conditions.
Some states are also considering creating their own reinsurance programs to help stabilize and strengthen their markets. Recently, Alaska enacted a law to allocate $55 million from an existing premium tax to provide reinsurance for the individual market and to pursue a State Innovation Waiver under the ACA. Alaska had previously collected funds for the state’s high-risk pool that is no longer needed because the ACA guarantees coverage to individuals with pre-existing conditions; about 35 states had high-risk pools prior to the ACA as well and may have similar opportunities.
Alaska’s health insurance market has struggled for many years with the highest health care costs in the country, low levels of insurance market competition, and other challenges, which are likely related, at least in part, to its very low population density and unique geography. But after Alaska’s governor signed the reinsurance bill into law, Premera, the state’s Blue Cross Blue Shield plan, reduced its requested 2017 rate increase to 9.8 percent, less than the previous two years’ increases, well below the 40 percent increase the company had previously considered. According to media reports, this difference reflected the fact that nearly a quarter of Premera’s claims costs in the first half of 2015 came from just 37 high-cost enrollees and the plan expects these high claims costs to be partially covered under the state’s reinsurance program.
Alaska’s reinsurance legislation also includes authority for Alaska to seek a State Innovation Waiver from CMS. Innovation Waivers may be granted for changes that waive specific existing ACA policies and meet four statutory guardrails: maintaining or improving access to coverage, affordability of coverage, comprehensiveness of coverage, and not adding to federal deficits.
While the details of Alaska’s waiver will not be clear until the state submits an application, a reinsurance program has the potential to improve access and affordability by strengthening the state’s insurance market and buffering risk for insurers. In addition, to the extent a reinsurance program reduces individual market premiums, it could also reduce federal costs for the Premium Tax Credit. If an Innovation Waiver is approved, the state may receive federal pass-through funding based on any savings realized in Marketplace financial assistance. Thus, a waiver – in Alaska or other states considering creating state reinsurance programs – could potentially provide pass-through funding that would in effect cover part of the cost of a reinsurance program.
Our door is always open to new ideas that help spread the risk of providing coverage for people with significant health care needs. These ideas contribute to our ongoing work in promoting Marketplace stability and help ensure affordable options for consumers.
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