New Seasons Market Issues Allergy Alert on Undeclared Egg in Packaged Macaroni and Cheese - FDA Safety Alerts & Drug Recalls

New Seasons Market has initiated a voluntary recall of its New Seasons Market Grab and Go pre-packaged Macaroni and Cheese because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of an allergic reaction if they consume this product.

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Daisy’s Bakery Inc. Issues Alert On Undeclared Milk In “Gourmet Concha” - FDA Safety Alerts & Drug Recalls

Daisy’s Bakery Inc. of Clifton, New Jersey is recalling 4 ounce packages of Gourmet Concha, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA permits marketing of device to treat diabetic foot ulcers - FDA Press Releases

FDA permits marketing of device to treat diabetic foot ulcers

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Changing Healthcare Service Delivery to Improve Health Outcomes For Older Adults: Opportunities Not to Be Missed - American Geriatric Society

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, due to Presence White Particulate Matter that has been Identified as Mold - FDA Safety Alerts & Drug Recalls

AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls - FDA Press Releases

FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.

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Nodine's Smokehouse Inc. is Recalling Smoked Salmon 1.5 lbs, 8 oz Packages Due to Possible Listeria Monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

Nodine's Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are the most susceptible.

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Temporal Trends in Analgesic Use in Long-Term Care Facilities: A Systematic Review of International Prescribing - American Geriatric Society

Objectives

To explore global changes in the prescription of analgesic drugs over time in the international long-term care (LTC) population.

Design

Systematic review.

Setting

We included original research articles in English, published and unpublished, that included number of participants, country and year(s) of data collection, and prescription of analgesics (analgesics not otherwise specified, opioids, acetaminophen; scheduled only, or scheduled plus as needed (PRN)).

Participants

LTC residents.

Measurements

We searched PubMed, EMBASE, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Cochrane, Web of Science, Google Scholar, using keywords for LTC facilities and analgesic medication; hand-searched references of eligible papers; correspondence. Studies were quality rated using an adapted Newcastle-Ottawa scale. Pearson correlation coefficients were generated between percentage of residents prescribed an analgesic and year of data collection. If available, we investigated changes in acetaminophen and opioid prescriptions.

Results

Forty studies met inclusion criteria. A moderate correlation (0.59) suggested that scheduled prescription rates for analgesics have increased over time. Similar findings were reflected in scheduled prescriptions for acetaminophen and opioids. No increase was seen when analyzing scheduled plus PRN analgesics. Use of opioids (scheduled plus PRN) appears to have increased over time.

Conclusion

Worldwide, use of opioids and acetaminophen has increased in LTC residents. Research is needed to explore whether this reflects appropriate pain management for LTC residents and if PRN medication is used effectively.

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Voluntary Recall on Harris Teeter’s HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate - FDA Safety Alerts & Drug Recalls

Harris Teeter is notifying 153 shoppers who purchased HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate since Dec. 8, 2017. The company’s supplier, Mom’s Best Gourmet Foods, Inc., is issuing a voluntary recall due to potential undeclared almonds and hazelnuts. The company has notified the shoppers for which it has customer data via telephone and email; the company hopes this statement will reach any shoppers for which the company does not have customer data.

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FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response - FDA Press Releases

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

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Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that 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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FDA clears stereotactic radiotherapy system for use in treating breast cancer - FDA Press Releases

FDA clears stereotactic radiotherapy system for use in treating breast cancer

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Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial - American Geriatric Society

Background/Objectives

Telephone calls after discharge from the emergency department (ED) are increasingly used to reduce 30-day rates of return or readmission, but their effectiveness is not established. The objective was to determine whether a scripted telephone intervention by registered nurses from a hospital-based call center would decrease 30-day rates of return to the ED or hospital or of death.

Design

Randomized, controlled trial from 2013 to 2016.

Setting

Large, academic medical center in the southeast United States.

Participants

Individuals aged 65 and older discharged from the ED were enrolled and randomized into intervention and control groups (N = 2,000).

Intervention

Intervention included a telephone call from a nurse using a scripted questionnaire to identify obstacles to elements of successful care transitions: medication acquisition, postdischarge instructions, and obtaining physician follow-up. Control subjects received a satisfaction survey only.

Measurements

Primary outcome was return to the ED, hospitalization, or death within 30 days of discharge from the ED.

Results

Rate of return to the ED or hospital or death within 30 days was 15.5% (95% confidence interval (CI) = 13.2–17.8%) in the intervention group and 15.2% (95% CI = 12.9–17.5%) in the control group (P = .86). Death was uncommon (intervention group, 0; control group, 5 (0.51%), 95% CI = 0.06–0.96%); 12.2% of intervention subjects (95% CI = 10.1–14.3%) and 12.5% of control subjects (95% CI = 10.4–14.6%) returned to the ED, and 9% of intervention subjects (95% CI = 7.2–10.8%) and 7.4% of control subjects (95% CI = 5.8–9.0%) were hospitalized within 30 days.

Conclusion

A scripted telephone call from a trained nurse to an older adult after discharge from the ED did not reduce ED or hospital return rates or death within 30 days. Clinicaltrials.gov identifier: NCT01893931z.

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Improving Emergency Department Discharge Care with Telephone Follow-Up. Does It Connect? - American Geriatric Society

This editorial comments on the article by Biese et al.

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FDA approves drug to treat dangerously low blood pressure - FDA Press Releases

The FDA today approved the new drug Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.

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Corrected: Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall to include additional smoked fish and cream cheese products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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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Meijer Voluntarily Recalls Select Meijer Brand Fresh Packaged Products Containing Apples Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

As a result of the Fresh-Pak Inc. recall, Meijer is announcing a voluntary recall of select Meijer brand packaged products due to sliced apples within the products being potentially contaminated with Listeria monocytogenes. To date, there have been no known illnesses reported in connection with this recall.

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Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B - Journal of Antibiotics

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B, Published online: 20 December 2017; doi:10.1038/ja.2017.128

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B

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Winners of the 2016 JA Medals for excellence - Journal of Antibiotics

Winners of the 2016 JA Medals for excellence

Winners of the 2016 JA Medals for excellence, Published online: 20 December 2017; doi:10.1038/ja.2017.133

Winners of the 2016 JA Medals for excellence

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Acknowledgments - Journal of Antibiotics

Acknowledgments

Acknowledgments, Published online: 20 December 2017; doi:10.1038/ja.2017.134

Acknowledgments

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Influence of Poor Oral Health on Physical Frailty: A Population-Based Cohort Study of Older British Men - American Geriatric Society

Objectives

To investigate the associations between objective and subjective measures of oral health and incident physical frailty.

Design

Cross-sectional and longitudinal study with 3 years of follow-up using data from the British Regional Heart Study.

Setting

General practices in 24 British towns.

Participants

Community-dwelling men aged 71 to 92 (N = 1,622).

Measurements

Objective assessments of oral health included tooth count and periodontal disease. Self-reported oral health measures included overall self-rated oral health; dry mouth symptoms; sensitivity to hot, cold, and sweet; and perceived difficulty eating. Frailty was defined using the Fried phenotype as having 3 or more of weight loss, grip strength, exhaustion, slow walking speed, and low physical activity. Incident frailty was assessed after 3 years of follow-up in 2014.

Results

Three hundred three (19%) men were frail at baseline (aged 71–92). Having fewer than 21 teeth, complete tooth loss, fair to poor self-rated oral health, difficulty eating, dry mouth, and more oral health problems were associated with greater likelihood of being frail. Of 1,284 men followed for 3 years, 107 (10%) became frail. The risk of incident frailty was higher in participants who were edentulous (odds ratio (OR) = 1.90, 95% confidence interval (CI) = 1.03–3.52); had 3 or more dry mouth symptoms (OR = 2.03, 95% CI = 1.18–3.48); and had 1 (OR = 2.34, 95% CI = 1.18–4.64), 2 (OR = 2.30, 95% CI = 1.09–4.84), or 3 or more (OR = 2.72, 95% CI = 1.11–6.64) oral health problems after adjustment for age, smoking, social class, history of cardiovascular disease or diabetes mellitus, and medications related to dry mouth.

Conclusion

The presence of oral health problems was associated with greater risks of being frail and developing frailty in older age. The identification and management of poor oral health in older people could be important in preventing frailty.

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Oral Health in Healthy Aging - American Geriatric Society

This editorial comments on the articles by Ramsay et al, Kossioni et al, and Joseph M. Mylotte.

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Will Maintenance of Oral Hygiene in Nursing Home Residents Prevent Pneumonia? - American Geriatric Society

This article is an evaluation of the literature on oral hygiene as a risk factor for nursing home–associated pneumonia (NHAP) and with interventions to improve oral hygiene and reduce the incidence of NHAP. The background for this article is that studies that have evaluated interventions to improve oral hygiene and prevent NHAP have conflicting results. To try to understand the reason for these results, the objective was to examine risk factor and intervention studies and determine their methodological validity. Review of studies evaluating oral hygiene status as a risk factor for NHAP found multiple methodological problems, resulting in limited evidence to support this association. Studies of intervention methods, whether finding benefit or not in preventing NHAP, all had methodological limitations. Therefore, it is unclear whether oral hygiene is a risk factor for NHAP and whether improving oral hygiene decreases the incidence of this infection. A recommendation is made that future studies should carefully define the etiology of suspected NHAP using molecular techniques when evaluating methods to prevent this infection because viral pneumonia and aspiration pneumonitis may mimic bacterial pneumonia even though, at times, there may be coinfection with bacteria. In this latter situation, improving oral hygiene may not prevent pneumonia. Therefore, viral infection and pneumonitis with or without bacterial coinfection need to be excluded so that the focus is on prevention of bacterial pneumonia.

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An Expert Opinion from the European College of Gerodontology and the European Geriatric Medicine Society: European Policy Recommendations on Oral Health in Older Adults - American Geriatric Society

This is an expert opinion paper on oral health policy recommendations for older adults in Europe, with particular focus on frail and care-dependent persons, that the European College of Gerodontology (ECG) and the European Geriatric Medicine Society (EUGMS) Task and Finish Group on Gerodontology has developed. Oral health in older adults is often poor. Common oral diseases such as caries, periodontal disease, denture-related conditions, hyposalivation, and oral pre- and cancerous conditions may lead to tooth loss, pain, local and systemic infection, impaired oral function, and poor quality of life. Although the majority of oral diseases can be prevented or treated, oral problems in older adults remain prevalent and largely underdiagnosed, because frail persons often do not receive routine dental care, due to a number of barriers and misconceptions. These hindrances include person-related issues, lack of professional support, and lack of effective oral health policies. Three major areas for action are identified: education for healthcare providers, health policy action plans, and citizen empowerment and involvement. A list of defined competencies in geriatric oral health for non-dental healthcare providers is suggested, as well as an oral health promotion and disease prevention protocol for residents in institutional settings. Oral health assessment should be incorporated into general health assessments, oral health care should be integrated into public healthcare coverage, and access to dental care should be ensured.

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Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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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Gel Spice Company, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Beef Flavored Bouillon Cube Products. - FDA Safety Alerts & Drug Recalls

Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reaction(s) if they consume these products.

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial. - FDA Safety Alerts & Drug Recalls

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.

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Jack Brown Produce, Inc. Recalls Gala, Fuji, Honeycrisp and Golden Delicious Apples Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Jack Brown Produce, Inc. of Sparta, MI is recalling Gala, Fuji, Honeycrisp and Golden Delicious apples processed and shipped by one of its suppliers, Nyblad Orchards, Inc., on December 11 through December 16, 2017, 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.

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FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss - FDA Press Releases

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

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Meta-analysis of Interventions to Reduce Adverse Drug Reactions in Older Adults - American Geriatric Society

Objectives

To examine the effect of interventions to optimize medication use on adverse drug reactions (ADRs) in older adults.

Design

Systematic review and meta-analysis. EMBASE, PubMed, OVID, Cochrane Library, Clinicaltrials.gov, and Google Scholar were searched through April 30, 2017.

Setting

Randomized controlled trials.

Participants

Older adults (mean age ≥65) taking medications.

Measurements

Two authors independently extracted relevant information and assessed studies for risk of bias. Discrepancies were resolved in consensus meetings. The outcomes were any and serious ADRs. Random-effects models were used to combine the results of multiple studies and create summary estimates.

Results

Thirteen randomized controlled trials involving 6,198 older adults were included. The studies employed a number of different interventions that were categorized as pharmacist-led interventions (8 studies), other health professional-led interventions (3 studies), a brief educational session (1 study), and a technology intervention (1 study). The intervention group was 21% less likely than the control group to experience any ADR (odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.62–0.99). In the six studies that examined serious ADRs, the intervention group was 36% less likely than the control group to experience a serious ADR (OR = 0.64, 95% CI = 0.42–0.98).

Conclusion

Interventions designed to optimize medication use reduced the risk of any and serious ADRs in older adults. Implementation of these successful interventions in healthcare systems may improve medication safety in older adults.

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FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs - FDA Press Releases

Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

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Handing Off the Older Patient: Improved Documentation of Geriatric Assessment in Transitions of Care - American Geriatric Society

Objectives

To improve assessment and documentation of function, cognition, and advance care planning (ACP) in admission and discharge notes on an Acute Care of the Elderly (ACE) unit.

Design

Continuous quality improvement intervention with episodic data review.

Setting

ACE unit of an 866-bed academic tertiary hospital.

Participants

Housestaff physicians rotating on the ACE unit (N = 31).

Intervention

Introduction of templated notes, housestaff education, leadership outreach, and posted reminders.

Measurements

Documentation of function, cognition, and ACP were assessed through chart review of a weekly sample of the ACE unit census and scored using predefined criteria.

Results

Medical records (N = 172) were reviewed. At baseline, 0% of admission and discharge notes met minimum documentation criteria for all 3 domains (function, cognition, ACP). Documentation of function and cognition was completely absent at baseline. After the intervention, there was marked improvement in all measures, with 64% of admission notes and 94% of discharge notes meeting minimum documentation criteria or better in all 3 domains.

Conclusion

A quality improvement intervention using geriatric-specific note templates, housestaff training, and reminders increased documentation of function, cognition and ACP for postacute care.

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Racial Disparities in Hospice Outcomes: A Race or Hospice-Level Effect? - American Geriatric Society

Objectives

To determine whether there is racial variation in hospice enrollees in rates of hospitalization and hospice disenrollment and, if so, whether systematic differences in hospice provider patterns explain the variation.

Design

Longitudinal cohort study.

Setting

Hospice.

Participants

Medicare beneficiaries (N = 145,038) enrolled in a national random sample of hospices (N = 577) from the National Hospice Survey and followed until death (2009–10).

Measurements

We used Medicare claims data to identify hospital admissions, emergency department (ED) visits, and hospice disenrollment after hospice enrollment. We used a series of hierarchical models including hospice-level random effects to compare outcomes of blacks and whites.

Results

In unadjusted models, black hospice enrollees were significantly more likely than white enrollees to be admitted to the hospital (14.9% vs 8.7%, odds ratio (OR) = 1.84, 95% confidence interval (CI) = 1.74–1.95), visit the ED (19.8% vs 13.5%, OR = 1.58, 95% CI = 1.50–1.66), and disenroll from hospice (18.1% vs 13.0%, OR = 1.48, 95% CI = 1.40–1.56). These results were largely unchanged after accounting for participant clinical and demographic covariates and hospice-level random effects. In adjusted models, blacks were at higher risk of hospital admission (OR = 1.75, 95% CI = 1.64–1.86), ED visits (OR = 1.61, 95% CI = 1.52–1.70), and hospice disenrollment (OR = 1.54, 95% CI = 1.45–1.63).

Conclusion

Racial differences in intensity of care at the end of life are not attributable to hospice-level variation in intensity of care. Differences in patterns of care between black and white hospice enrollees persist within the same hospice.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies - FDA Press Releases

FDA issues two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.

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Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil - FDA Safety Alerts & Drug Recalls

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

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Springfield Smoked Fish Recalls Smoked Salmon Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, Ma.is recalling its 1lb. packages Prescliced Nova Salmon because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious 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.

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FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care - FDA Press Releases

Today the FDA is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug.

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FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome - FDA Press Releases

FDA approves first drug for a rare autoimmune disease that causes an inflammation in the wall of blood vessels of the body. This is a new indication for a previously-approved drug.

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FDA warns companies for promoting alternatives to street drugs - FDA Press Releases

The FDA today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.

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Prospective Validation of a Screening Tool to Identify Older Adults in Need of a Driving Evaluation - American Geriatric Society

Objectives

To prospectively validate and refine the 5-item “CRASH” screening tool for identifying older drivers needing a behind-the-wheel (BTW) test.

Design

Prospective observational study.

Setting

Geriatric and internal medicine primary care clinics affiliated with a tertiary care hospital and a local BTW program.

Participants

Cognitively intact drivers aged 65 and older (N = 315).

Measurements

Participants completed baseline questionnaire (including CRASH tool) and assessments and BTW test (evaluator blinded to questionnaire results) and participated in 1-month telephone follow-up. Analysis included descriptive statistics and examination of predictive ability of the CRASH tool to discriminate normal (pass) from abnormal (conditional pass or fail) on the BTW test, with logistic regression and CART techniques for tool refinement.

Results

Two hundred sixty-six participants (84%) had a BTW test; of these, 17% had a normal rating and 83% an abnormal rating. Forty-five percent of those with an abnormal score were advised to limit driving under particular conditions. Neither the CRASH tool nor its individual component variables were significantly associated with the summary BTW score; in refined models with other variables, the best-performing tool had approximately 67% sensitivity and specificity for an abnormal BTW score. Most participants found the BTW test useful and were willing to pay a median of $50. At 1-month follow-up, no participants had stopped driving.

Conclusion

The CRASH screening tool cannot be recommended for use in clinical practice. Findings on older adults' perceived utility of the BTW test and the stability of driving patterns at 1-month follow-up could be useful for future research studies and for design of older driver programs.

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Symptoms Reported by Frail Elderly Adults Independently Predict 30-Day Hospital Readmission or Emergency Department Care - American Geriatric Society

Objectives

To assess the degree to which self-reported symptoms predict unplanned readmission or emergency department (ED) care within 30 days of high-risk, elderly adults enrolled in a posthospitalization care transition program (CTP).

Design

Retrospective cohort study.

Setting

Posthospitalization CTP at Mayo Clinic, Rochester, Minnesota, from January 1, 2013, through March 3, 2015.

Participants

Frail, elderly adults (N = 230; mean age 83.5 ± 8.3, 46.5% male).

Measurements

Charlson Comorbidity Index (CCI) and self-reported symptoms, measured using the Edmonton Symptom Assessment System (ESAS), were ascertained upon CTP enrollment.

Results

Mean CCI was 3.9 ± 2.3. Of 51 participants returning to the hospital within 30 days of discharge, 13 had ED visits, and 38 were readmitted. Age, sex, and CCI were not significantly different between returning and nonreturning participants, but returning participants were significantly more likely to report shortness of breath (P = .004), anxiety (P = .02), depression (P = .02), and drowsiness (P = .01). Overall ESAS score was also a significant predictor of hospital return (P = .01).

Conclusion

Four self-reported symptoms and overall ESAS score, but not CCI, ascertained after hospital discharge were strong predictors of hospital return within 30 days. Including symptoms in risk stratification of high-risk elderly adults may help target interventions and reduce readmissions.

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FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes - FDA Press Releases

The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product.

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FDA launches public education campaign to encourage adult smokers trying to quit cigarettes - FDA Press Releases

Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations and convenience stores – retail locations where smokers face a multitude of triggers and that typically feature cigarette advertisements. The “Every Try Counts” campaign targets smokers ages 25-54 who have attempted to quit smoking in the last year but were unsuccessful. The two-year campaign launches next month in 35 U.S. markets and features print, digital, radio, and out-of-home ads, such as on billboards.

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My Mom is Dead (and that is OK) - American Geriatric Society

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Harvesters Issues Safety Alert on Bibi Frutix Candy Possible Chemical Contamination - FDA Safety Alerts & Drug Recalls

On Tuesday, December 5, a partner food pantry agency in Wamego, Kansas notified Harvesters—The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters' distribution program. The candy product is likely contaminated with a chemical substance and is potentially harmful if eaten.

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ALDI Voluntarily Recalls Choceur Dark Chocolate Bar Due to Undeclared Nut Allergen Products Could Contain Almond Pieces Not Listed on Packaging - FDA Safety Alerts & Drug Recalls

In cooperation with Hofer KG ZNL Schokoladefab, ALDI has voluntarily recalled Choceur Dark Chocolate Bars as a precautionary measure due to the potential presence of almond pieces not listed on packaging. The recall was initiated after an ALDI employee identified almond pieces in the product. This product may cause an allergic reaction in customers who have a nut allergy.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation - FDA Press Releases

FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act

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Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

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Creative Contract Packaging LLC Issues An Allergen Alert Regarding 4 Ounce Jars Of Herb-Ox® Beef Flavor Granulated Bouillon Due To Potential Presence Of Undeclared Milk - FDA Safety Alerts & Drug Recalls

Creative Contract Packaging LLC is voluntarily recalling 4,412 cases, or 13,236 total pounds, of two code dates of HERB-OX® Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.

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Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease - American Geriatric Society

Background

Diagnosing obstructive coronary artery disease (CAD) is challenging in elderly adults, and current diagnostic approaches for CAD expose these individuals to risks from contrast dye and invasive procedures.

Design

A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings (PRESET; NCT01677156), pragmatic clinical trial.

Setting

Community, 21 primary care practices.

Participants

Of 566 stable, nonacute outpatients presenting with symptoms suggestive of obstructive CAD, the 176 who were aged 65 and older (median age 70, 61% female) were the current study participants.

Intervention

Blood-based precision medicine test, incorporating age, sex, and gene expression score (ASGES) to improve clinical decision-making and quality of care.

Measurements

Information on demographic characteristics, clinical factors, ASGES results (range 1–40; low (≤15), high (>15)), referral patterns to cardiology and advanced cardiac testing, and major adverse cardiac events (MACEs) was collected in a subgroup analysis of elderly adults in the PRESET Registry. Follow-up was for 1 year after ASGES testing.

Results

Median ASGES was 25, and 40 (23%) participants had a low score. Clinicians referred 12.5% of participants with a low ASGES and 49.3% with a high ASGES to cardiology or advanced cardiac testing (odds ratio for referral = 0.12, P < .001, adjusted for participants demographics and clinical covariates). Higher scores were associated with greater likelihood of posttest cardiac referral. At 1-year follow-up, the incidence of a MACE or revascularization was 10% (13/136) in the high ASGES group and 0% (0/40) in the low ASGES group (P = .04).

Conclusion

The ASGES test showed potential clinical utility in the evaluation of elderly outpatients with symptoms suggestive of obstructive CAD. Test use may reduce unnecessary referrals and the risk of procedure-related complications in individuals with low ASGES, who are unlikely to benefit from further testing, while also identifying individuals who may benefit from further cardiac evaluation and management.

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Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues - FDA Safety Alerts & Drug Recalls

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

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Response to Dr. Clarfield - American Geriatric Society

This is a response to the article by Clarfield.

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Response to Dr. Olshansky - American Geriatric Society

This is a response to the article by Olshansky.

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Healthy Life Expectancy Is Expanding - American Geriatric Society

See the response from Olshansky.

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The Future of Health - American Geriatric Society

See the response from Clarfield.

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Recognition of Delirium Features in Clinical Practice: Data from the “Delirium Day 2015” National Survey - American Geriatric Society

Background/Objectives

Delirium is underrecognized in clinical practice. The primary aim of the present multicenter study was to compare the ability of nurses to identify delirium features with a standardized assessment. The secondary aim was to identify predictors of missed or incorrect identifications of delirium by nurses.

Design

Point prevalence study in 120 wards across Italy.

Setting

“Delirium Day 2015.”

Participants

Inpatients aged 65 and older (N = 1,867).

Measurements

Participants and nurses were asked specific questions to investigate their perceptions of the presence of delirium features (acute cognitive change, inattention, cognitive fluctuations, impaired arousal). Delirium was identified according to the results of the Assessment Test for Delirium and Cognitive Impairment (4AT), completed by a physician. Comorbidities including dementia, disability, drug treatments, and delirium motor subtype according to the Delirium Motor Subtype Scale were recorded.

Results

Delirium was present in 429 subjects (23%) according to the 4AT. Cognitive fluctuations was the delirium feature that the nurses most often recognized. Nurses’ perceptions of acute cognitive change, cognitive fluctuations, or impaired arousal had 84% sensitivity and 81% specificity for delirium. The nonmotor subtype of delirium was less likely to be recognized (80%) than the hyperactive (97%), mixed (92%), and hypoactive (90%) subtypes. Incorrect perception of delirium was more frequent in subjects with dementia (specificity 64%).

Conclusions

The delirium feature that nurses were best able to recognize was cognitive fluctuations. The nonmotor subtype was associated with a lower recognition rate. Routine observation and registration of delirium features by nurses in clinical practice might be helpful to increase formal diagnosis of delirium.

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FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride - FDA Safety Alerts & Drug Recalls

The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices - FDA Press Releases

The FDA is issuing final guidance on the technical considerations for the 3D printing of medical devices. The recommendations clarify what the FDA recommends manufacturers include in submissions for 3D printed medical products.

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Report and Research Agenda of the American Geriatrics Society and National Institute on Aging Bedside-to-Bench Conference on Urinary Incontinence in Older Adults: A Translational Research Agenda for a Complex Geriatric Syndrome - American Geriatric Society

The American Geriatrics Society, with support from the National Institute on Aging and other funders, held its ninth Bedside-to-Bench research conference, entitled “Urinary Incontinence in the Older Adult: A Translational Research Agenda for a Complex Geriatric Syndrome,” October 16 to 18, 2016, in Bethesda, Maryland. As part of a conference series addressing three common geriatric syndromes—delirium, sleep and circadian rhythm disturbance, and urinary incontinence—the series highlighted relationships and pertinent clinical and pathophysiological commonalities between these conditions. The conference provided a forum for discussing current epidemiology, basic science, and clinical and translational research on urinary incontinence in older adults; for identifying gaps in knowledge; and for developing a research agenda to inform future investigative efforts. The conference also promoted networking involving emerging researchers and thought leaders in the field of incontinence, aging, and other fields of research, as well as National Institutes of Health program personnel.

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FDA approves first biosimilar for the treatment of certain breast and stomach cancers - FDA Press Releases

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments

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FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder - FDA Press Releases

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

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Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico

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Virginia Diner, Inc. Issues Allergy Alert on Undeclared Peanut Allergen in Chocolate Covered Cashews 10 oz. cans - FDA Safety Alerts & Drug Recalls

Virginia Diner, Inc. is voluntarily issuing a recall of 10 oz. cans of Plow & Hearth Chocolate Covered Cashews at Plow & Hearth’s locations and nationwide (Mail Order) as a precaution because they may contain peanuts and peanut allergens. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. A label mix up was discovered by a consumer who received and opened a Cashew Tower Set (3 individual cashew cans) of which one can, the 10 oz. Chocolate Covered Cashews, were found to have Salted Peanuts.

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FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers - FDA Press Releases

FDA/CMS parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner

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CMS releases its Measures Under Consideration List for 2018 pre-rulemaking - CMS Blog

By: Kate Goodrich, M.D., M.H.S., Director, Center for Clinical Standards & Quality, CMS Chief Medical Officer

Medicare and other payers are rapidly moving toward a healthcare system that rewards high quality care while spending more wisely. Foundational to the success of these efforts is having quality measures that are meaningful to patients, consumers, and providers alike.  CMS recently announced the “Meaningful Measures” initiative to identify the most impactful areas for quality measurement and improvement and reflect core issues that are most vital to high quality care and better individual outcomes. Each year, CMS publishes a list of quality and cost measures that are under consideration for Medicare quality reporting and value-based purchasing programs, and collaborates with the National Quality Forum (NQF) to get critical input from multiple stakeholders, including patients, families, caregivers, clinicians, commercial payers and purchasers, on the measures that are best suited for these programs. Ultimately, these measures may help patients choose the nursing home, hospital, or clinician that is best for them, and can help providers to provide the highest quality of care across care settings.

I am happy to announce that CMS posted the Measures under Consideration (MUC) List for 2018 pre-rulemaking on the CMS website and has sent it to NQF in preparation for multi-stakeholder input.

This year’s MUC List contains 32 measures that have the potential to drive improvement in quality across numerous settings of care, including clinician practices, hospitals, and dialysis facilities. CMS is considering new measures to help quantify healthcare outcomes and track the effectiveness, safety and patient-centeredness of the care provided.  At the same time, CMS is taking a new approach to coordinated implementation of meaningful quality measures focused on the most critical, highly impactful areas for improvement while reducing the burden of quality reporting on all providers so they can spend more time with their patients.  In addition to other factors, CMS evaluated the measures on the MUC list to ensure that measures considered for adoption in a CMS program through rulemaking as necessary, focus on clearly defined, meaningful measure priority areas that safeguard public health and improve patient outcomes.  For example, to generate this year’s MUC list, CMS considered 184 measures submitted by stakeholders during an open call for measures.  Considering the meaningful measurement areas, CMS narrowed the list to 32 measures (17% of the original submissions) which focus CMS efforts to achieve goals of high quality healthcare and meaningful outcomes for patients, while minimizing burden. CMS will continue to use the Meaningful Measures approach to strategically assess the development and implementation of quality measure sets that are the most parsimonious and least burdensome, that are well understood by external stakeholders, and are most likely to drive improvement in health outcomes.

This year, approximately 40% of measures on the MUC list are outcome measures, including patient-reported outcome measures, which will help empower patients to make decisions about their own healthcare and help clinicians to make continuous improvements in the care provided. In addition, this year there are eight episode-based cost measures proposed that were developed by incorporating the insight and expertise of clinicians and specialty societies.  CMS is committed to working with clinicians, consumers, and other stakeholders on the development and use of measures that are most meaningful to patients and clinicians and our programs.

We invite you to review the MUC List in detail and to participate in the public process. We believe it is critical to hear a wide range of voices in the selection of quality and efficiency measures that are used for accountability and transparency purposes and look forward to another successful pre-rulemaking season. For more information regarding the NQF Measure Applications Partnership public stakeholder review meeting purpose, meetings, 2017 MUC List deliberations and voting, visit the NQF website at http://ift.tt/IXUWWv.

Filed under: Uncategorized

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Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients - FDA Safety Alerts & Drug Recalls

Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsules and Chao Jimengnan tablets unapproved new drugs.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH" - FDA Press Releases

FDA Commissioner Gottlieb provides testimony before the House Committee on Energy and Commerce on the agency’s implementation of the 21st Century Cures Act

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Stability and Change in Cognitive Status Classification of Black Older Adults - American Geriatric Society

Objectives

The purpose of this study was to determine whether stability and change in cognitive status are associated with sociodemographic characteristics and health function.

Design

Secondary analysis of data.

Setting

Baltimore Study of Black Aging—Patterns of Cognitive Aging.

Participants

Community-dwelling black adults (N = 407; mean age 68.6 ± 9.1).

Measurements

Baseline (n = 602) and 33-month follow-up (n = 450) assessments of cognition, health, and psychosocial function.

Results

For the present analyses, participants were grouped as being cognitively normal (n = 249), having stable mild cognitive impairment (MCI) (n = 32), or being MCI converters (n = 72; normal at baseline, MCI at follow-up) or reverters (n = 54; MCI at baseline, normal at follow-up). Multivariate analysis of variance showed that the groups differed significantly in education and lung function (P < .010). Post hoc analyses indicated that converters had fewer years of education than the other groups, whereas those who were cognitively normal had better lung function than converters and reverters (P < .050).

Conclusion

These results suggest that education and lung health are associated with patterns of cognitive status change and stability. Future research should account for sociodemographic and health factors when examining stability of cognitive status classifications.

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Farrell Farms, Inc. Issues allergy alert on undeclared milk in Dark Chocolate Almonds, Dark Chocolate Cashews, and Dark Chocolate Pecans - FDA Safety Alerts & Drug Recalls

Farrell Farms, Inc. of Goldsboro, NC is recalling 7 oz Dark Chocolate Almonds, 7 oz Dark Chocolate Cashews, and 7 oz Dark Chocolate Pecans, because these products may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria - Journal of Antibiotics

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus <i>Halichondria</i>, Published online: 29 November 2017; doi:10.1038/ja.2017.145

Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

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Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster - Journal of Antibiotics

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster, Published online: 29 November 2017; doi:10.1038/ja.2017.146

Isolation and structure elucidation of lipopeptide antibiotic taromycin B from the activated taromycin biosynthetic gene cluster

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Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial - American Geriatric Society

Background/Objectives

Dementia-related behavioral symptoms and functional dependence result in poor quality of life for persons with dementia and their caregivers. The goal was to determine whether a home-based activity program (Tailored Activity Program; TAP-VA) would reduce behavioral symptoms and functional dependence of veterans with dementia and caregiver burden.

Design

Single-blind (interviewer), parallel, randomized, controlled trial (Clinicaltrials.gov: NCT01357564).

Setting

Veteran's homes.

Participants

Veterans with dementia and their family caregivers (N = 160 dyads).

Intervention

Dyads in TAP-VA underwent 8 sessions with occupational therapists to customize activities to the interests and abilities of the veterans and educate their caregivers about dementia and use of customized activity. Caregivers assigned to attention control received up to 8 telephone-based dementia education sessions with a research team member.

Measurements

Primary outcomes included number of behaviors and frequency of their occurrence multiplied by severity of occurrence; secondary outcomes were functional dependence, pain, emotional well-being, caregiver burden (time spent caregiving, upset with behaviors) and affect at 4 (primary endpoint) and 8 months.

Results

Of 160 dyads (n = 76 TAP-VA; n = 84 control), 111 completed 4-month interviews (n = 51 TAP-VA; n = 60 control), and 103 completed 8-month interviews (n = 50 TAP-VA; n = 53 control). At 4 months, compared to controls, the TAP-VA group showed reductions in number (difference in mean change from baseline = −0.68, 95% CI = −1.23 to −0.13) and frequency by severity (−24.3, 95% CI = −45.6 to −3.1) of behavioral symptoms, number of activities needing assistance with (−0.80, 95% CI = −1.41 to −0.20), functional dependence level (4.09, 95% CI = 1.06, 7.13), and pain (−1.18, 95% CI = −2.10 to −0.26). Caregivers of veterans in TAP-VA reported less behavior-related distress. Benefits did not extend to 8 months.

Conclusion

TAP-VA had positive immediate effects and no adverse events. Because TAP-VA reduces behavioral symptoms, slows functional dependence, and alleviates pain and caregiver distress, it is a viable treatment option for families.

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Leclerc Foods Issues Limited Voluntary Recall of Fit & Active Chocolatey Chip Protein Meal Bars – Due to Presence of Plastic Piece - FDA Safety Alerts & Drug Recalls

Leclerc Foods has initiated a limited voluntary recall of a single lot of Fit & Active Chocolatey Chip Protein Meal Bars packages with UPC Code 41498-18695 and only affected products with a “best by” date of May 24, 2018.

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Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity - American Geriatric Society

Objectives

To compare the effect of a 6-month community-based intervention with that of usual care on quality of life, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with type 2 diabetes mellitus (T2DM) and 2 or more comorbidities.

Design

Multisite, single-blind, parallel, pragmatic, randomized controlled trial.

Setting

Four communities in Ontario, Canada.

Participants

Community-dwelling older adults (≥65) with T2DM and 2 or more comorbidities randomized into intervention (n = 80) and control (n = 79) groups (N = 159).

Intervention

Client-driven, customized self-management program with up to 3 in-home visits from a registered nurse or registered dietitian, a monthly group wellness program, monthly provider team case conferences, and care coordination and system navigation.

Measurements

Quality-of-life measures included the Physical Component Summary (PCS, primary outcome) and Mental Component Summary (MCS, secondary outcome) scores of the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12). Other secondary outcome measures were the Generalized Anxiety Disorder Scale, Center for Epidemiologic Studies Depression Scale (CES-D-10), Summary of Diabetes Self-Care Activities (SDSCA), Self-Efficacy for Managing Chronic Disease, and healthcare costs.

Results

Morbidity burden was high (average of eight comorbidities). Intention-to-treat analyses using analysis of covariance showed a group difference favoring the intervention for the MCS (mean difference = 2.68, 95% confidence interval (CI) = 0.28–5.09, P = .03), SDSCA (mean difference = 3.79, 95% CI = 1.02–6.56, P = .01), and CES-D-10 (mean difference = −1.45, 95% CI = −0.13 to −2.76, P = .03). No group differences were seen in PCS score, anxiety, self-efficacy, or total healthcare costs.

Conclusion

Participation in a 6-month community-based intervention improved quality of life and self-management and reduced depressive symptoms in older adults with T2DM and comorbidity without increasing total healthcare costs.

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Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination - FDA Safety Alerts & Drug Recalls

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

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Transformation of a Geriatric Department in China - American Geriatric Society

China has the world's largest elderly population, and the oldest-old population, with a current disability rate greater than 50%, will triple in the next 35 years. The field of geriatrics is young, because almost all geriatric departments were established after 2000, and so faces many challenges. Management of diseases and hospital care is the focus. Senior physicians were trained in other subspecialties, such as pulmonary or cardiology, and junior physicians entered geriatrics departments as masters or doctorate students after medical school. The inadequacy of post-acute and long-term care facilities has caused long hospital stays. There are no national systematic geriatric training programs, national board examinations, or qualifications in geriatrics. These challenges were used as a framework for guiding changes in the Department of Geriatrics at West China Hospital, Sichuan University. These changes have included international experiences and collaboration for physicians and nurses, revision of departmental conferences, and special training for a unique group of caregivers called hugong (untrained caregivers hired by families to be at the bedside of hospitalized individuals). The most significant yet challenging part of the transformation has been to develop and modify Western-based geriatric models of care (e.g., Acute Care of the Elderly unit, delirium prevention and management models, palliative care). Lastly, the department established Tianxia (in the sky) Doctors, an internet-based platform to connect the department's interdisciplinary team to other hospitals, nursing institutions, home-based care service stations, community health service centers, and pharmacies throughout the region.

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Prevalence of Frailty and Associated Factors in the Community-Dwelling Population of China - American Geriatric Society

Background/Objectives

Frailty in older adults predicts dependence and mortality and is a major challenge for healthcare systems in countries with rapidly aging populations. Little is known about frailty in China. We investigated the prevalence and associated risk factors of frailty in older adults in China.

Design

Cross-sectional.

Setting

Data were obtained from the China Comprehensive Geriatric Assessment Study, conducted in 2011–12, which was the first uniform comprehensive assessment system adopted in China.

Participants

Older adults from 7 cities were selected based on well-established cluster, stratification, and random selection statistical sampling techniques (N = 5,844).

Measurements

The Comprehensive Geriatric Assessment-Frailty Index was measured based on demographic characteristics, physical health, physical function, living behavior and social function, mental health, and cognitive function.

Results

The overall weighted prevalence of frailty was 9.9%: 12.7% in southwestern China, 11.0% in northern China, 5.9% in northwestern China, 5.0% in south-central China, 2.5% in eastern China, and 2.3% in northeastern China. The prevalence of frailty increased with age and was significantly higher in women and those living in rural areas. After adjusting for sex, age, area, region, and education, activity of daily living impairment was the strongest risk factor for frailty. Chronic diseases, depression, poor lifestyle, and geriatric syndromes were also independent risk factors.

Conclusion

Our study provides epidemiological characteristics and the risk factors of frailty in China; the findings indicate greater regional disparities. Efforts to promote physical, psychological, and social health in older adults are a core objective of health policy, especially in women and those living in rural areas.

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Cost-Effectiveness of a Care Transitions Program in a Multimorbid Older Adult Cohort - American Geriatric Society

Background/Objectives

Facing penalties for preventable 30-day hospital readmissions, many provider groups have implemented programs to remedy this problem, but the cost efficacy and value of such programs are not well delineated. The objective was to compare total cost of care over 30 days of individuals enrolled in the Mayo Clinic Care Transitions (MCCT) program and individuals not enrolled.

Design

Retrospective cohort study using secondary data analysis of a previously published cohort study.

Setting

Mayo Clinic, Rochester, Minnesota.

Participants

MCCT participants (n = 363) and individuals in a propensity-matched referent cohort (n = 365).

Intervention

MCCT program enrollment.

Measurements

The primary outcome was total cost of care over 30 days after hospital discharge. A 2-part modeling strategy was used to analyze 30-day costs: whether individuals had non-zero costs during the 30 days after discharge and a generalized linear model for individuals who incurred costs. Potential heterogeneous effects of the MCCT program were examined according to decile of 30-day costs using quantile regression.

Results

Mean age was 83 in both groups. Adjusted mean 30-day cost after hospitalization was $3,363 (95% confidence interval (CI) = $2,512−4,213) in the MCCT group and $4,161 (95% CI = $3,096−5,226) in the control group (P = .25). Cost savings of $2,744 (P = .008) at the eighth decile and $3,388 (P = .20) at the ninth decile were demonstrated. Thus, the only statistically significant differences were in the post hoc subgroup analysis in the highest-cost subgroups.

Conclusion

We did not find a difference in overall mean costs between the MCCT group and the control group, although intervention participants in the upper deciles of costs appeared to experience lower costs than controls. A larger study cohort might better determine the value of the intervention.

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Food Co. Issues Allergy Alert on Undeclared Allergen (E.G. Milk) in Product - FDA Safety Alerts & Drug Recalls

Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, because they may contain undeclared Milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients - FDA Press Releases

FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

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Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults - American Geriatric Society

Background/Objectives

Little is known about cost savings of programs that reduce disability in older adults. The objective was to determine whether the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) program saves Medicaid more money than it costs to provide.

Design

Single-arm clinical trial (N = 204) with a comparison group of individuals (N = 2,013) dually eligible for Medicaid and Medicare matched on baseline geographic and demographic characteristics, chronic conditions, and healthcare use. We used finite mixture model regression estimates in a Markov model.

Setting

Baltimore, MD

Participants

Individuals aged 65 and older with reported difficulty with at least one activity of daily living.

Intervention

CAPABLE is a 5-month program to reduce the health effects of impaired physical function in low-income older adults by addressing individual capacity and the home environment. CAPABLE uses an interprofessional team (occupational therapist, registered nurse, handyman) to help older adults attain self-identified functional goals.

Measurements

Monthly average Medicaid expenditure and likelihood of high- or low-cost use of eight healthcare service categories.

Results

Average Medicaid spending per CAPABLE participant was $867 less per month than that of their matched comparison counterparts (observation period average 17 months, range 1–31 months). The largest differential reduction in expenditures were for inpatient care and long-term services and supports.

Conclusion

CAPABLE is associated with lower likelihood of inpatient and long-term service use and lower overall Medicaid spending. The magnitude of reduced Medicaid spending could pay for CAPABLE delivery and provide further Medicaid program savings due to averted services use.

Clinical trial registration

CAPABLE for Frail dually eligible older adults NCT01743495 http://ift.tt/2hV1wX4

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Targeting Function at Home in Older Adults: How to Promote and Disseminate Promising Models of Care? - American Geriatric Society

This editorial comments on the article by Szanton et al.

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Square Pegs; Round Holes: Our Healthcare System Is Failing Seriously Ill Older Americans in Their Last Years - American Geriatric Society

This editorial comments on the article by Thomas M. Gill et al.

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Frequency of Leaving the House and Mortality from Age 70 to 95 - American Geriatric Society

Objectives

To determine the association between frequency of leaving the house and mortality.

Design

Prospective follow-up of an age-homogenous, representative, community-dwelling birth cohort (born 1920–21) from the Jerusalem Longitudinal Study (1990–2015).

Setting

Home.

Participants

Individuals aged 70 (n = 593), 78 (n = 973), 85 (n = 1164), and 90 (n = 645), examined in 1990, 1998, 2005, and 2010, respectively.

Measurements

Frequency of leaving the house, defined as daily (6–7/week), often (2–5/week), and rarely (≤1/week); geriatric assessment; all-cause mortality (2010–15). Kaplan-Meier survival charts and proportional hazards models adjusted for social (sex, marital status, financial status, loneliness), functional (sex, self-rated health, fatigue, depression, physical activity, activity of daily living difficulty), and medical (sex, chronic pain, visual impairment, hearing impairment, diabetes mellitus, hypertension, ischemic heart disease, chronic kidney disease) covariates.

Results

At ages 70, 78, 85, and 90, frequency of going out daily was 87.0%, 80.6%, 65.6%, and 48.4%; often was 6.4%, 9.5%, 17.4%, and 11.3%; and rarely was 6.6%, 10.0%, 17.0%, and 40.3% respectively. Decreasing frequency of going out was associated with negative social, functional, and medical characteristics. Survival rates were lowest among those leaving rarely and highest among those going out daily throughout follow-up. Similarly, compared with rarely leaving the house, unadjusted mortality hazard ratios (HRs) were lowest among subjects leaving daily and remained significant after adjustment for social, functional and medical covariates. Among subjects leaving often, unadjusted HRs showed a similar effect of smaller magnitude, with attenuation of significance after adjustment in certain models. Findings were unchanged after excluding subjects dying within 6 months of follow-up.

Conclusion

In community-dwelling elderly adults aged 70 to 90, leaving the house daily was associated with lower mortality risk, independent of social, functional, or medical status.

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FDA approves first two-drug regimen for certain patients with HIV - FDA Press Releases

FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse - FDA Press Releases

FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse

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Cognitive Outcomes After Transcatheter Aortic Valve Implantation: A Metaanalysis - American Geriatric Society

Objectives

To quantitatively summarize changes in cognitive performance in individuals with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI).

Design

Metaanalysis.

Participants

Individuals undergoing TAVI (N = 1,065 (48.5% male) from 18 studies, average age ≥80).

Measurements

The MEDLINE, EMBASE, and Cochrane Central databases were searched for original peer-reviewed reports assessing cognitive performance using standardized cognitive tests before and after TAVI. Data were extracted for cognitive scores before TAVI; perioperatively (within 7 days after TAVI); 1, 3, and 6 months after TAVI, and 12 to 34 months after TAVI (over the long term). Standardized mean differences (SMDs) were generated using random-effects models for changes in cognition at each time point. Metaregression analyses were conducted to assess the association between population and procedural characteristics and cognitive outcomes. Risk of bias was assessed.

Results

There were no significant changes from baseline in perioperative cognitive performance (SMD = 0.05, 95% confidence interval (CI) = −0.08–0.18; z = 0.75, P = .46), although overall cognitive performance had improved significantly 1 month after TAVI (SMD = −0.33, 95% CI = −0.50 to −0.16; z = 3.83, P < .001). There were no differences in cognitive performance 3 and 6 months after TAVI or over the long term. Cognitive outcomes were not associated with any covariates in regression analyses.

Conclusion

Cognitive performance is preserved after TAVI, suggesting TAVI is not detrimental to cognition.

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Cognitive Function After Transcatheter Aortic Valve Replacement: Reassuring Findings For Now - American Geriatric Society

This editorial comments on the article by Khan et al.

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Goya Voluntary Recall of Adobo Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Goya de Puerto Rico is recalling 28 ounces Adobo with Cumin Seasoning and 28 ounces Adobo with Pepper Seasoning because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system.

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CMS announces a new user-centered resource to help improve alignment: the CMS Measures Inventory Tool (CMIT) - CMS Blog

By Kate Goodrich, MD
Director, CMS Center for Clinical Standards and Quality & CMS Chief Medical Officer

CMS is actively working to move the needle on improving quality in healthcare without additional burden to those providers on the frontlines. CMS recently launched a new initiative, ‘Meaningful Measures,’ which will streamline current measure sets – so providers can focus on the measures that are most impactful – and will move from process measures to outcome measures where possible. A great deal of attention has also been focused on alignment of quality measures within CMS and with commercial payers, and we are committed to working towards alignment of these measures to ensure delivery of high quality care to all Americans while minimizing burden on providers.

I am pleased to announce that CMS is deploying an innovative tool that provides all stakeholders improved visibility into the portfolio of CMS measures. The CMS Measures Inventory Tool (CMIT), an interactive web-based application that contains the same information that is currently included on the  Excel spreadsheet, provides a comprehensive list of measures that are currently under development, implemented for use, and have been removed from a CMS quality program or initiative.  The intuitive and user-friendly functions allow you to find measures quickly and to compile and refine sets of related measures. The tool increases transparency and can be used to identify measures across the continuum of care and will help coordinate measurement efforts across all conditions, settings, and populations.  We have expanded the information contained in the inventory to better answer questions we have heard from the public; the CMIT lists each measure by program, dates of measure consideration and implementation, and measure specifications including, but not limited to, numerator, denominator, exclusion criteria, measure type, and National Quality Forum (NQF) endorsement status.

CMIT is an innovative approach that will help to promote the goal of increased alignment across programs and with other payers.  We believe it is an easy to use valuable resource to various stakeholders, including commercial payers, clinicians, patients and measure developers.

For more information about CMIT and to access the tool, please visit the CMS.gov website.

Filed under: Uncategorized

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Reply to: Neutrophil to Lymphocyte Ratio As a Risk Stratification Tool for Older Adults with Pneumonia - American Geriatric Society

This letter comments on the letter by Karakonstantis et al.

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Neutrophil to Lymphocyte Ratio As a Risk Stratification Tool for Older Adults with Pneumonia - American Geriatric Society

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Nursing Home Regulations Redefined: Implications for Providers - American Geriatric Society

The Centers for Medicare and Medicaid Services (CMS) finalized a comprehensive update to nursing home requirements of participation in October 2016. Nearly 10,000 public comments were received regarding the proposed rule, and CMS made multiple modifications based on comments from providers, advocacy organizations, and others before issuing the final rule. The final rule describing nursing home requirements of participation modernizes nursing home regulation. It is being implemented in three phases—beginning in November 2016, November 2017, and November 2019. There are multiple provisions that have implications for clinicians caring for nursing home residents, particularly in terms of management of infections, medication prescribing and monitoring, and delegation of medical orders.

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Individualizing Prevention for Older Adults - American Geriatric Society

Prevention can help older adults avoid illness by identifying and addressing conditions before they cause symptoms, but prevention can also harm older adults if conditions that are unlikely to cause symptoms in the individual's lifetime are identified and treated. To identify older adults who preventive interventions are most likely to benefit (and most likely to harm), we propose a framework that compares an individual's life expectancy (LE) with the time to benefit (TTB) for an intervention. If LE is less than the TTB, the individual is unlikely to benefit but is exposed to the risks of the intervention, and the intervention should generally NOT be recommended. If LE is longer than the TTB, the individual could benefit, and the intervention should generally be recommended. If LE is similar to the TTB, the individual's values and preferences should be the major determinant of the decision. To facilitate the use of this framework in routine clinical care, we explored ways to estimate LE, identified the TTB for common preventive interventions, and developed strategies for communicating with individuals. We have synthesized these strategies and demonstrate how they can be used to individualize prevention for a hypothetical beneficiary in the setting of a Medicare annual wellness visit. Finally, we place prevention in the context of curative and symptom-oriented care and outline how prevention should be focused on healthier older adults, whereas symptom-oriented care should predominate in sicker older adults.

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