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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 30, 2013

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HIPAA Frequently Misinterpreted
Insufficient Vitamin D in Pregnancy Linked to Adverse Outcomes
Can Trauma Precipitate Shingles?
A Calculator to Estimate Risks and Benefits of Low-Dose Aspirin
Postpartum Maternal Anxiety: A Call for Attention
Prescriber-Dependent Antibiotic Treatment Course: Best for the Patient?
New, Albeit Expensive, Prostate Cancer Tests Might Reduce Unnecessary Treatments
The Diagnosis and Management of Acute Otitis Media
High Calcium Intake Is Associated with Earlier Mortality in Women
Drug Approved for Relapsing MS
The Role of Deep Gray Matter Volume Lesions in MS

HIPAA Frequently Misinterpreted
By Amy Orciari Herman
The Health Insurance Portability and Accountability Act is frequently misinterpreted and misused by healthcare professionals, with many inappropriately citing the law as a reason to withhold information, according to the New York Times blog, The New Old Age.
HIPAA does not prevent clinicians from sharing information with family members or friends unless the patient specifically objects, the blog explains. What's more, a patient's consent can be informal: a simple "I want you to share this with Billy" will suffice.
According to HIPAA, the blog adds, if a patient is unable to communicate (for example, if unconscious or inebriated), clinicians can still provide information if they judge that doing so is in the patient's best interest.
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Insufficient Vitamin D in Pregnancy Linked to Adverse Outcomes
By Kelly Young
Low maternal serum vitamin D levels are associated with adverse pregnancy and neonatal outcomes, according to a meta-analysis in BMJ.
Researchers analyzed results from 31 studies comprising over 22,000 pregnant women. Women with a serum concentration of 25-hydroxyvitamin D (25-OHD) below 75 nmol/L (about 30ng/ml, 1ng/ml = 2.496nmol/L)  were at increased risk for gestational diabetes (adjusted odds ratio, 1.49) and preeclampsia (OR, 1.79). A 25-OHD level lower than 37.5 nmol/L was associated with having an infant who was small for gestational age (OR, 1.85).
Editorialists write: "Although optimal maternal 25-OHD levels at different gestational times are not known, levels below 50 nmol/L are common during pregnancy, particularly in populations at high latitudes and in specific subpopulations. Evidence of a causal association between vitamin D deficiency and some maternal and neonatal outcomes is insufficient, but the evidence for bone health is clear cut. The findings of this meta-analysis support a goal of vitamin D sufficiency for all pregnant women."
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J Infect Dis 2013 Mar 15; 207:1007
Can Trauma Precipitate Shingles?
An analysis suggests a cause–effect relation, but this connection should be clinically confirmed.
Although clear risk factors exist for herpes zoster (HZ; age and immunosuppression foremost among them) many completely healthy people develop HZ for no apparent reason. Patients often wonder if recent trauma to the involved area could be responsible.
Researchers constructed a case-control study from Medicare claims data, matching each of 16,000 patients (age, ≥65) with diagnoses of HZ and no mention of immunosuppressive conditions with 10 age-matched controls who did not have HZ. HZ patients were significantly more likely than controls to have been evaluated for some kind of trauma in the year preceding HZ diagnosis (or the index date for controls). This risk peaked in the week preceding HZ diagnosis, especially when head or trunk was involved: The adjusted odds of cranial trauma in the week preceding HZ diagnosis were 27 times as high among cases with cranial HZ as among controls. The pattern held true for many trauma codes, including sprains and strains, open wounds, and contusions but not dislocations.
Comment: Reactivation of herpes simplex infection has been correlated repeatedly with antecedent trauma, so an association between zoster reactivation and trauma is biologically plausible. However, more clinically oriented data are necessary for confirmation: One can easily imagine patients who complain of pain and tingling in a body part before the characteristic zoster rash appears saying "I must've hit it on something" and being billed with a trauma ICD code when, in fact, no trauma actually occurred.
Abigail Zuger, MD Published in Journal Watch General Medicine March 26, 2013
Citation(s): Zhang JX et al. Association of physical trauma with risk of herpes zoster among Medicare beneficiaries in the United States. J Infect Dis 2013 Mar 15; 207:1007. (http://dx.doi.org/10.1093/infdis/jis937)
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MM: In patients with low CV risk the number of GI complications induced by low-dose aspirin may be greater than the number of CV events prevented. In patients with high CV risk, low-dose aspirin is recommended, but the number of GI complications induced may still overcome the CV events saved. The use of PPI reduces the number of complication events induced by low-dose aspirin, but the number of CV events saved may still be offset by the number of GI complications induced in patients at very high GI risk. The bottom line is that if you are NOT at risk of a CV event, you should NOT be using LDA.
Aliment Pharmacol Ther 2013 Apr; 37:738 2011 Aug 8/22; 171:1363
A Calculator to Estimate Risks and Benefits of Low-Dose Aspirin
A new tool aids clinicians in deciding whether or not to prescribe LDA.
Low-dose aspirin (LDA) provides demonstrated benefit for secondary prevention of cardiovascular (CV) events, but a possible benefit for primary prevention remains unproven. LDA therapy is also associated with an increased risk for upper gastrointestinal bleeding (UGIB), and various factors affect that risk. To aid clinicians in therapeutic decision-making, investigators developed a calculator to estimate the relative CV benefit and GI risk of LDA therapy in individual patients.
Researchers based the risk for cardiac events on 10-year event estimates from the Framingham Heart Study and the risk for UGIB on a baseline estimate of 1 event per 1000 person-years with adjustment for documented risks associated with individual factors. Sensitivity analysis was performed on the GI risk factors.
The resulting calculator (http://www.asariskcalculator.com) estimates the 10-year risk for a CV event with and without LDA therapy and the risk for UGIB with LDA therapy. It recommends for or against treatment with LDA. It further recommends use of proton-pump inhibitor therapy or eradication of Helicobacter pylori infection to reduce the risk for UGIB. To evaluate the calculator's performance in predicting bleeding events, researchers retrospectively assessed 904 patients who took long-term LDA, half of whom developed UGIB and an equal number of matched controls who did not. The calculator predicted a higher risk in the UGIB group based on data available prior to the bleed.
Comment: The calculator is easily accessed and used for individual patients. Data affecting both CV and GI risks are entered, and the calculator gives both the recommendations and numbers to support them. The potential weakness of the calculator rests with the relative uncertainty of the magnitude of risk carried by risk factors for UGIB (such as eradication of H. pylori infection). Even if the calculator is not precise, it provides an additional tool for clinicians to use in balancing the benefits and risks of LDA therapy, particularly for primary prevention of CV events.
David J. Bjorkman, MD, MSPH (HSA), SM (Epid.)  Published in Journal Watch Gastroenterology March 28, 2013
Citation(s): Lanas A et al. The aspirin cardiovascular/gastrointestinal risk calculator — a tool to aid clinicians in practice. Aliment Pharmacol Ther 2013 Apr; 37:738.
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MM: Although post-partum depression has become well recognized in the past decade, post partum anxiety may be similarly as debilitating and is unfortunately discounted in many new moms. Counseling is an avenue that may be beneficial but Bio-Identical Progesterone Cream available without a prescription from a compounding pharmacist may provide ready and rapid relief.
Pediatrics 2013 Mar 4
Postpartum Maternal Anxiety: A Call for Attention
Cesarean section, shorter breastfeeding duration, and unplanned healthcare use for mothers, but not infants, were significantly associated with positive anxiety screens in new mothers.
Although pediatric clinicians are encouraged to screen for postpartum depression (JW Pediatr Adolesc Med Aug 29 2005), they may not be as attuned and responsive to manifestations of maternal anxiety (characterized by apprehension, uncertainty, and irrational fear). Researchers examined postpartum anxiety in 1123 breastfeeding mothers (primarily white, educated, and middle class) enrolled in a randomized trial of two post-hospital discharge care models. Mothers were interviewed in person during the postpartum hospital stay and by telephone at 2 weeks, 2 months, and 6 months using standardized screening questionnaires for anxiety (State Trait Anxiety Inventory) and depression (Edinburgh Postnatal Depression Survey).
At the hospital interview, 192 mothers (17%) had positive anxiety screenings and 62 (6%) had positive depression screenings. A positive anxiety screen was significantly associated with cesarean section, shorter duration of breastfeeding, and more unplanned healthcare use for mothers at 2 weeks after delivery. Maternal anxiety was not associated with unplanned health care visits for infants. The prevalence of anxiety dropped from 17% to 7% at 2 weeks and remained stable until 6 weeks. In contrast, the prevalence of depression remained at 6% at baseline and 2 weeks and dropped below 3% at 2 months.
Comment: Giving birth to a child is both a remarkable and stressful event. It's not surprising that many women experience apprehension and fear at this time. Although a positive score on the anxiety screening test used in this study is highly correlated with a DSM-IV diagnosis of anxiety, I would not advocate another formal screening test for mothers at 2-week or 2-month well-child visits. Clinicians can inquire about anxiety by asking about excessive worries and fears and somatic symptoms of anxiety (restlessness, blushing, palpitations, muscle tension, sweating, and shaking). A recommendation for stress reduction or, in more impaired mothers, a referral for cognitive behavioral therapy can be made. At a minimum, talking about anxiety is often therapeutic.
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine March 27, 2013
Citation(s): Paul IM et al. Postpartum anxiety and maternal-infant health outcomes. Pediatrics 2013 Mar 4; [e-pub ahead of print].
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JAMA Intern Med 2013 Mar 18
Prescriber-Dependent Antibiotic Treatment Course: Best for the Patient?
A population-based survey of long-term care facilities indicates that antibiotic duration is based on physician preference rather than patient treatment needs.
Antibiotics are widely prescribed in long-term care facilities (LTCFs), often in courses exceeding 7 days. Shortening treatment duration might be an appropriate means of reducing antibiotic overuse in such facilities — and the consequences of this excess. In a recent study, researchers used linked population-based databases at the Institute for Clinical Evaluative Sciences to analyze the prescribing habits of physicians who care for residents of LTCFs in Ontario, Canada.
Among 66,901 adults aged ≥66 who resided in an Ontario LTCF in 2010, 50,061 (75%) received an incident treatment course of systemic antibiotics and were included in the cohort. Their median age was 86 years; 72% were female, and 57% had dementia. Of the 699 prescribers who were responsible for providing ≥20 antibiotic treatments to LTCF residents in 2010 and could be linked to the physician database, 83% were men and 98% were family/general practitioners, with a median of 31 years of practice.
Among these 699 prescribers, the median proportion of treatment courses lasting >7 days was 44%. In a logistic model that adjusted for all measured resident-related clinical variables, the prescriber was significantly associated (P<0.001) with the likelihood of a resident receiving an antibiotic course for >7 days. The relative odds of a prolonged course were 3.84 for a 75th-percentile prescriber compared with a 25th-percentile prescriber.
Comment: The authors describe findings reflective of those from previous studies and conclude that "physicians develop consistent prescribing patterns that may be independent of patient treatment needs." How much longer can we afford to have physician preference trump patient needs? Rising healthcare costs and increasing antibiotic resistance in numerous common bacterial pathogens mandate intervention.
Larry M. Baddour, MD  Published in Journal Watch Infectious Diseases March 20, 2013
Citation(s): Daneman N et al. Prolonged antibiotic treatment in long-term care: Role of the prescriber. JAMA Intern Med 2013 Mar 18; [e-pub ahead of print].
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MM: If one is going to have any testing done, shouldn't it be for tests that are meaningful? After all, if the test is inaccurate or gives bad data, then it becomes a very expensive test irrespective of how inexpensive it is on the front end. Insurance companies will often ignore this and deny more expensive, conclusive tests in preference to the cheap ones. In the long run, does this make any sense at all? Unfortunately we also do this as consumers when the bill is paid for out of our own pockets. Again, this seems penny wise and pound foolish.
New, Albeit Expensive, Prostate Cancer Tests Might Reduce Unnecessary Treatments
By Amy Orciari Herman
Over a dozen companies are releasing new prostate cancer tests that could help minimize the number of unnecessary biopsies and treatments that result from elevated prostate-specific antigen findings, the New York Times reports.
Many of the new tests measure multiple genes or molecular markers that help differentiate dangerous tumors from those that likely won't progress. The Times says cutting back on unnecessary treatments could lower the estimated $12 billion that's spent each year on prostate cancer, which might offset the high cost of the new tests (over $3000 in some cases).
"Experts caution that it is too early to tell how well most of the tests will perform and whether they will make a difference," according to the Times. "Although the tests are intended to help men make treatment decisions, the onslaught of so many could cause more confusion." Other experts, however, believe that "even if the new tests are not perfect, they are better than what is available now."
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Pediatrics 2013 Mar 1; 131:e964
The Diagnosis and Management of Acute Otitis Media
This revised, evidence-based guideline for managing uncomplicated acute otitis media in children aged 6 months through 12 years strengthens the wait-and-see option and increases the emphasis on prevention.
Target Population: Family practitioners, pediatricians, emergency department physicians, physician assistants, nurse practitioners, otolaryngologists
Sponsoring Organizations: American Academy of Pediatrics and American Academy of Family Physicians
Type: Evidence-based clinical practice guideline with grading of evidence
Background: Otitis media is the most common condition for which antibiotics are prescribed for children in the U.S. This document — a revision of the 2004 acute otitis media (AOM) guideline (JW Infect Dis Jun 4 2004) — is the product of a multidisciplinary committee's review of new AOM-related literature published since the initial evidence report of 2000. It provides recommendations to primary care clinicians for the management of uncomplicated AOM (AOM without otorrhea) in children aged 6 months through 12 years of age, focusing primarily on the appropriate diagnosis and initial treatment of this condition.
Key Points:

Comment: Most of these recommendations were part of the 2004 document but are now reinforced by additional evidence from the literature. The new guideline strengthens the wait-and-see option, which is still controversial, and increases the emphasis on prevention.
Robert S. Baltimore, MD Published in Journal Watch Infectious Diseases March 27, 2013
Citation(s): Lieberthal AS et al. Clinical practice guideline: The diagnosis and management of acute otitis media. Pediatrics 2013 Mar 1; 131:e964.
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MM: Just a reminder that more is not necessarily better. The best source of calcium continues to be from the foods we eat.
BMJ 2013 Feb 13; 346:f228
High Calcium Intake Is Associated with Earlier Mortality in Women
Higher death rates occurred with daily intakes exceeding 1400 mg.
Oral calcium supplementation is associated with elevated risk for adverse cardiovascular (CV) events such as myocardial infarction (e.g., JW Gen Med May 12 2011). Moreover, in a recent study (JW Gen Med Feb 26 2013), high-dose calcium supplementation was associated with excess CV-related mortality in men. In this prospective cohort study, Swedish investigators assessed the associations between long-term calcium intake and all-cause and CV-related death in 61,000 women born between 1914 and 1948.
Researchers estimated dietary, supplemental, and total calcium intake from food-frequency questionnaires that were completed at baseline (1987–1990) and in 1997. Median follow-up was 19 years. Compared with dietary calcium intakes of 600 to 999 mg daily, daily intakes of ≥1400 mg were associated with significantly higher rates of death from all causes (multivariate adjusted hazard ratio, 1.4), CV disease (AHR, 1.5), and ischemic heart disease (AHR, 2.1), but not from stroke. Similar results were obtained for total calcium intake. Vitamin D intake did not modify the associations.
Comment: In this study, high calcium intake was associated with excess risk for all-cause and CV-related mortality but not from stroke-related death. Although these results do not prove causality, they — along with the results of prior studies — suggest that people avoid excessive calcium intake (i.e., ≥1400 mg daily) and that high calcium intake should be reserved for situations in which benefits clearly outweigh risks.
Paul S. Mueller, MD, MPH, FACP  Published in Journal Watch General Medicine February 28, 2013
Citation(s): Michaëlsson K et al. Long term calcium intake and rates of all cause and cardiovascular mortality: Community based prospective longitudinal cohort study. BMJ 2013 Feb 13; 346:f228.
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Drug Approved for Relapsing MS
By The Editors
The FDA has approved dimethyl fumarate (Tecfidera) capsules for adults with relapsing multiple sclerosis.
In two trials, patients taking dimethyl fumarate had fewer relapses of MS relative to those taking placebo. The drug may reduce a patient's lymphocyte count, so the FDA recommends that healthcare providers assess lymphocyte counts before beginning treatment and then annually
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Mult Scler 2013 Mar 5
The Role of Deep Gray Matter Volume Lesions in MS
Measuring deep gray matter lesions in patients with multiple sclerosis may provide a measure of axonal loss from demyelinated plaques.
The clinical–radiologic paradox of MS is that T2-weighted white-matter lesions (WMLs) correlate only weakly with clinical outcomes. Proposed explanations have involved structures outside the white matter, such as deep gray matter (DGM), cortex, meningeal follicles, and spinal cord. In this study, investigators sought to answer whether DGM lesions are independent or dependent on these WMLs in multiple sclerosis (MS).
Participants included 249 patients with relapsing–remitting MS and at least two clinically silent cerebral WMLs, and 49 healthy controls (HCs). MS patients were relatively young (mean age, 36.8 years), early in disease (81 had clinically isolated syndromes), mildly affected (mean Expanded Disability Status Scale [EDSS] score, 1.4), and had a low WML volume (median, 2.1 mL). The volume of DGM structures was significantly lower in MS patients compared with controls. EDSS score was associated with WML volume but not total DGM lesion volume. The authors also analyzed whether gray matter volumes in the caudate and pulvinar of the thalamus correlated with peak distributions of WML probability maps. Caudate volumes decreased with increasing WMLs in the frontal lobe, and pulvinar volumes decreased with increasing WMLs in the posterior parietal lobe.
Comment: This manuscript adds to a growing body of literature that white-matter lesions are indeed important in multiple sclerosis. In patients with early MS, these authors discovered an increasing probability of white-matter lesions within the white-matter fibers serving deep gray matter structures with lesions, suggesting that WMLs directly influence the DGM in MS. DGM volume was not associated with disability within this cohort but has been linked to cognition in MS (JW Neurol Dec 9 2008). DGM may serve as a surrogate of axonal loss from adjacent white matter. Measuring DGM volume offers the advantage over measuring white matter of not being affected by short-term pseudoatrophy with treatment. Confirmation in a more heterogeneous group at later stages of disease will be important, as will longitudinal studies to demonstrate a temporal association between GM atrophy and increase in WMLs.
Robert T. Naismith, MD  Published in Journal Watch Neurology March 26, 2013
Citation(s): Mühlau M et al. White-matter lesions drive deep gray-matter atrophy in early multiple sclerosis: Support from structural MRI. Mult Scler 2013 Mar 5; [e-pub ahead of print].

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