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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 13, 2016

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Bacterial Competition in the Nose
More Physical Activity Associated with Greater Reductions in Incident Disease
Early Breast Milk for Preemies Tied to Better Neurodevelopmental Outcomes
No Evidence that Lipid Screening Benefits Younger Adults
Shortages Causes the FDA to Allow Imports from 8 Companies Banned for
   Quality Shortcomings
Marijuana to Remain a Schedule I Substance
Poor Cardiovascular Health Common Among U.S. Children and Adolescents
Sleeping In: Delayed Postpartum Rounding and Patient Satisfaction
New Boxed Warnings for Fluoroquinolones
Excellent Hand Hygiene Tied to Even Lower Healthcare Infection Risk
Serious Infection Linked to Suicide Risk
Should Patients with Isolated DVT of the Calf Be Anticoagulated?

Nature 2016 Jul 28; 535:511
Bacterial Competition in the Nose
A common commensal, Staphylococcus lugdunensis, can produce an antibiotic that inhibits the growth ofStaphylococcus aureus in the nose.
Epidemiologic studies have consistently shown that although Staphylococcus aureus typically colonizes the human nares, it is not found there universally. Why S. aureus is not always present has not been clear, but German researchers have now found that a second human commensal, Staphylococcus lugdunensis, is a likely to be one factor affecting the colonization rate.
The investigators initially screened a variety of nasal Staphylococcus species for inhibitory activity towardsS. aureus and found that an S. lugdunensis strain produced an antimicrobial factor that prevented S. aureus growth. Further work found that the factor was a novel cyclic peptide antibiotic, lugdunin, that has activity against a wide variety of gram-positive bacteria including methicillin-resistant S. aureus. Production of lugdunin is due to a genetic operon that was common to all S. lugdunensis isolates available for screening.
In a mouse model, co-installation of S. aureus with wild-type S. lugdunensis led to decreased nasal S. aureus carriage compared with co-installation of S. aureus and a lugdunin-negative mutant S. lugdunensis strain. Also, studies of nasal swab samples from hospitalized patients found that 32% were colonized with S. aureus, and 9% were colonized with S. lugdunensis. All S. lugdunesis isolates could produce lugdunin, and the presence of S. lugdunesis decreased the S. aureus colonization rate 5.9-fold.
COMMENT: This is a truly exceptional study. It not only contributes to our understanding of S. aureuscolonization, it also provides the first direct evidence of bacterial competition in the human microbiome, and, still further, concurrently identifies a novel antimicrobial compound that may of therapeutic utility.
CITATION(S): Zipperer A et al. Human commensals producing a novel antibiotic impair pathogen colonization. Nature2016 Jul 28; 535:511.
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More Physical Activity Associated with Greater Reductions in Incident Disease
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Higher levels of physical activity than what is recommended by the World Health Organization are associated with lower risks for five diseases, according to a meta-analysis in The BMJ. Most benefits appeared to occur at 3000–4000 MET minutes per week; gains beyond that level of activity were minimal. (To achieve 3000 MET minutes/week, a person could climb stairs for 10 minutes, vacuum for 15, garden for 20, run for 20, and walk or bicycle for 25 minutes every day.)
Researchers analyzed 174 studies that examined disease incidence and total physical activity, including leisure time, occupation, active transportation, and domestic activity.
Compared with people who got less than the WHO’s recommendation of 600 MET minutes/week, even low activity (600–3999 MET minutes/week) was associated with significant risk reduction, but the greatest risk reductions came in the high activity group (8000 MET minutes/week or more).
High activity was associated with the following relative risk reductions:

The authors conclude that their findings “suggest that total physical activity needs to be several times higher than the current recommended minimum level of 600 MET minutes/week to achieve larger reductions in risks.”
Editorialists caution that this study did not look at the role of activity intensity.
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Early Breast Milk for Preemies Tied to Better Neurodevelopmental Outcomes
By Amy Orciari Herman
Very preterm infants who are fed primarily with breast milk during the first month of life have better neurodevelopmental outcomes at school-age, a Journal of Pediatrics study suggests.
Researchers in Australia studied 180 infants born before 30 weeks' gestation or weighing less than 1250 grams (~2.8 lb). Data were recorded on nutrition during the first 28 days of life, brain MRI was performed at term-equivalent and age 7 years, and cognitive and motor tests were performed at ages 2 and 7 years.
Each additional day that a baby received >50% enteral nutrition from the mother's breast milk was associated with better performance on tests of IQ (+0.5 points per breast-milk day), math, working memory, and motor function at age 7. Increased breast milk intake was also associated with increased deep nuclear gray matter volume at term-equivalent age (but not at 7 years).
The researchers say the findings reinforce recommendations for breast milk as the main nutrition for premature infants.
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No Evidence that Lipid Screening Benefits Younger Adults
By Kelly Young, Edited by David G. Fairchild, MD, MPH
There have been no studies that directly measure the benefits and harms of lipid screening in adults aged 21 to 39 years, concludes a review for the U.S. Preventive Services Task Force published in theAnnals of Internal Medicine.
In 2008, the USPSTF recommended that men aged 20 to 35 years and women aged 20 to 45 who had coronary heart disease risk factors undergo lipid screening. The guidance was based on evidence indicating that some of these adults may have a high 10-year cardiovascular risk, in part because of their lipid levels; lipid-lowering therapy might benefit such patients.
For the current review, the authors conclude: "Estimating the potential effects of screening for dyslipidemia in this population requires extrapolation from studies performed in older adults."
Of note, the USPSTF strongly recommends lipid screening in men 35 and older and in women 45 and older who are at increased CHD risk.
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Shortages Causes the FDA to Allow Imports from 8 Companies Banned
for Quality Shortcomings

Since the vast majority of drugs and drug ingredients are manufactured outside the U.S., the FDA has stepped up its international oversight and often bans products from plants that don't meet its standards. However, the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability. Companies in China or India often are a primary source of essential drugs, and the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. In the past 3 to 4 years, the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages. 
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Marijuana to Remain a Schedule I Substance
The U.S. Drug Enforcement Administration has denied a request to move marijuana from Schedule I, thereby preventing doctors from prescribing it widely. (Twenty-five states plus the District of Columbia have passed laws permitting some medical marijuana use.)
An FDA analysis found that marijuana is not yet proven to be safe and effective as a medicine, the Washington Post reports. This finding prevents the DEA from loosening restrictions on the drug.
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Poor Cardiovascular Health Common Among U.S. Children and Adolescents
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The vast majority of U.S. children don't meet the American Heart Association's seven criteria for ideal cardiovascular health, with bad diets being the biggest impediment, the AHA says in a scientific statement in Circulation.
Ideal childhood cardiovascular health comprises these elements:

While most children are born with ideal cardiovascular health, the authors conclude, "overall, it is clear that much of the benefit of ideal cardiovascular health factors is lost in childhood and adolescence. This is due in large part to the adoption of unhealthful diet and physical activity behaviors."
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Obstet Gynecol 2016 Aug; 128:381
Sleeping In: Delayed Postpartum Rounding and Patient Satisfaction
During the postpartum stay, women whose physicians visited the bedside later in the day were more satisfied with their experience.
Childbirth, the most common reason for inpatient hospitalization in the U.S., is most often a normal and natural process, but careful monitoring and assistance of women during their postpartum stay is essential. Although postpartum provider rounding traditionally occurs in the early morning, this timing may be disruptive for women and families, and may not facilitate meaningful communication and education. At one academic medical center, a randomized, controlled trial compared patient satisfaction with early (5:00–7:00 a.m.) versus delayed (8:00–10:00 a.m.) physician bedside rounding.
Over a 2-month period, 152 women were enrolled — almost double the number needed to detect a meaningful difference in satisfaction scores. Women randomized to delayed rounding were significantly more likely than the early group to rate highly the hospital (median scores on a 10-point scale, 9.0 vs. 7.0), patient–provider communication, and hospital experience (8.0 vs. 6.0 for both). Time of hospital discharge was unaffected by delayed rounding
COMMENT: Timing of provider rounds may seem trivial, but the negative effect of predawn attempts to evaluate and communicate with postpartum women and their families should not be underestimated. Although the authors did not mention effects of delayed rounding on other daily obstetrical activities (e.g., operating room flow, clinic start times), their focus on patient-centered outcomes and care is laudable. From postpartum rounding to birth plans and clinical decision-making about obstetrical interventions such as labor induction or prenatal genetic testing, clinicians and researchers must be mindful of the value of particular outcomes to women themselves. No longer can providers and policymakers remain inflexible about the care we deliver and how we deliver it. Too often, “business as usual” excludes the most important contributors to care planning: our patients.
CITATION(S): Roberts RP et al. Early compared with delayed physician rounds on patient satisfaction of postpartum women: A randomized controlled trial. Obstet Gynecol 2016 Aug; 128:381.
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New Boxed Warnings for Fluoroquinolones
Boxed warnings for fluoroquinolones now warn of disabling side effects and recommend restricting use.
The U.S. FDA has approved labeling additions to the boxed warnings for systemic fluoroquinolones to include disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Additionally, the boxed warning tells healthcare providers that because of these serious adverse reactions, fluoroquinolones should be reserved for use in patients with no alternative options for uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis. Otherwise, the risks outweigh the benefits for these indications. The FDA also updated warnings in other parts of the medication label and the patient medication guide.
Comment: These adverse effects were discussed in more detail previously in NEJM Journal Watch Infectious Diseases 
CITATION(S): U.S. Food and Drug Administration.FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. Drug Safety and Availability 2016Jul 26. (http://www.fda.gov/Drugs/DrugSafety/ucm511530.htm?source=govdelivery&utm_
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Excellent Hand Hygiene Tied to Even Lower Healthcare Infection Risk
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Increasing hand-hygiene compliance from high to very high was associated with a 6% lower infection rate at one hospital, according to a study published in Emerging Infectious Diseases.
A North Carolina academic hospital implemented a new hand-hygiene program that asked employees to clean their hands when entering and leaving patient rooms. All personnel were asked to provide immediate feedback to one another on compliance.
Over 17 months, hand-hygiene compliance increased 10% (to roughly 95% compliance) and the overall healthcare-associated infection rate decreased 6%. The authors estimate that this led to nearly 200 fewer infections, 22 fewer deaths, and a savings of $5 million. Of note, theClostridium difficile infection rate dropped 14%.
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Serious Infection Linked to Suicide Risk
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Severe infections are associated with increased risk for suicide, according to an observational study in JAMA Psychiatry. The findings suggested a dose-response relationship between infections and suicide risk.
Using Danish registries, researchers studied 7.2 million people and their history of infection-related hospitalizations and suicide. During 32 years’ follow-up, over 11% of participants were hospitalized for infection, and 0.45% of participants committed suicide.
After multivariable adjustment, infection hospitalization was associated with a 42% increased risk for suicide, compared with no infection. More days in treatment and more infections were tied to higher suicide risk. Patients with hepatitis and HIV/AIDS had the highest risks.
The authors suggest that 10% of suicides could be related to severe infection.
Editorialists conclude: “Both mild and severe infections may cause general inflammation, along with more specific effects on neurotransmission that lead to suicidal ideation and behavior.”
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JAMA Surg 2016 Jul20
Should Patients with Isolated DVT of the Calf Be Anticoagulated?
Despite increased bleeding risks, therapeutic anticoagulation for isolated calf deep venous thrombosis might be warranted, but we need randomized, controlled trials.
Approaches to managing acute isolated calf deep venous thrombosis (DVT) range widely and include no treatment, repeat imaging, and therapeutic anticoagulation of varying durations. In a single-center, observational study, researchers evaluated whether therapeutic anticoagulation after a diagnosis of isolated calf DVT decreases the risk for a proximal DVT or pulmonary embolism (PE).
Of the 384 patients with acute isolated calf DVT (mean age, 60; 58% men), 243 were intended for therapeutic anticoagulation and 141 were not (controls). Therapeutic anticoagulation consisted of warfarin in 75%, a low-molecular-weight heparin in 18%, heparin infusion in 6%, and a direct-acting oral anticoagulant in 1%.
Overall, a proximal DVT or PE occurred in 13 controls and 8 anticoagulated patients; median time to proximal DVT was 13 days, and median time to PE was 15.5 days. The relative risk with anticoagulation for progression to DVT or PE was 0.36. The analysis was similar in patients with provoked calf DVT (odds ratio, 0.35). Therapeutic anticoagulation was significantly associated with lower risk when calf DVT involved the muscular branch veins — the gastrocnemius and soleal veins (OR, 0.12) — and not the anterior or posterior tibial veins or peroneal veins. A higher percentage of patients in the anticoagulated group experienced clinically significant bleeding.
COMMENT: This retrospective observational study suggests that anticoagulation may reduce the risk for proximal venous thromboembolism in patients with isolated calf DVTs, especially in patients with calf DVT in the muscular branch veins. Randomized trials are needed for more definitive conclusions about the appropriateness of anticoagulation for calf DVT, and one such trial is currently under way.
CITATION(S): Utter GH et al. Therapeutic anticoagulation for isolated calf deep vein thrombosis. JAMA Surg 2016 Jul20; [e-pub].

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