In the News
for the Week of 2-5-08
- Endovascular repair mostly safer for abdominal aortic aneurysms
- ACP asks candidates to commit to creating a better health care system
- Mistakes due to similarly named drugs on the rise
- Appropriate VTE prophylaxis often lacking in hospitalized patients, study reports
- Tight glucose control may protect kidneys in the critically ill
- Annals: Comparison of prostate cancer treatments shows little difference
- Diuretics are best in treating hypertension with metabolic syndrome
- Nine lots of heparin sodium injection recalled
- Antiepileptics associated with increased risk for suicidal thoughts, behavior
- March 1 deadline for NPI numbers approaching
ACP publishing news
- Caption contest: Put words in our mouth
- Regents update strategic plan
- ACP-ACP Foundation's Diabetes Initiative extended two years
- Call for award and Mastership nominations for 2008-09
- Bridges to Excellence announces support for patient-centered medical home
Endovascular repair mostly safer for abdominal aortic aneurysms.
Endovascular repair of abdominal aortic aneurysms results in better short-term survival than open surgery and similar rates of later complications, according to a large new study.
The observational study compared matched cohorts of Medicare beneficiaries who underwent repair between 2001 and 2004 and were followed until 2005. The researchers recorded perioperative rates of death and complications, long-term survival, rupture and reinterventions. The study included 22,830 patients, 80% male, with an average age of 76 years.
The endovascular repair group had significantly lower perioperative mortality than the open surgery group (1.2% vs. 4.8%), and this reduction in mortality was greater for older patients. Patients age 85 years or older had an 8.5% lower absolute risk of mortality if they were in the endovascular group. The endovascular group maintained a survival advantage for three years post-surgery, after which the survival curves of the two cohorts converged.
At four years, the endovascular group had higher rates of rupture (1.8% vs. 0.5%) and reintervention related to abdominal aortic aneurysm (9.0% vs. 1.7%). However, the open surgery group was more likely to require surgery for laparotomy-related complications (9.7% vs. 4.1%) or hospitalization without surgery for bowel obstruction or abdominal wall hernia (14.2% vs. 8.1%). The study was published in the Jan. 31 New England Journal of Medicine.
The study confirms the findings of previous research on the perioperative mortality of both methods, study authors said. The study did find a longer-lasting survival benefit for endovascular repair than had previously been seen, probably because older patients were not included in initial clinical trials, the authors said. They cautioned that, as an observational study, the research could have been confounded by unknown factors which influenced patients’ and physicians’ decisions about which procedure to choose, although the researchers attempted to minimize this problem by propensity-score matching the two cohorts.
The New England Journal of Medicine is online.
ACP asks candidates to commit to creating a better health care system.
All candidates running for office in 2008 should commit to an agenda to create a health care system for the U.S. that is second to none, ACP said last week in its annual report on The State of the Nation's Health Care. The report offers a five-point Candidate's Pledge designed to gain candidate commitments to support a series of recommendations.
The pledge asks the candidates to advocate policies to:
- Guarantee by law that everyone has access to affordable health coverage. Coverage should be without regard to their place of employment, place of residence within the U.S. or income.
- Provide every person with access to a primary care physician. Create workforce and payment polices to increase the numbers of primary care physicians, recognize the value of primary care, and support care organized through a patient-centered medical home.
- Increase public investment in health information technologies (HIT). Provide positive incentives to physicians to overcome the HIT cost barrier.
- Reduce administrative expenses. Create a uniform billing system for all health insurance transactions at the point of care. Reform the medical liability system using proven legal reforms.
- Increase funding for research. Fund basic and applied medical research, health services research, and independent research on the comparative effectiveness, costs and benefits of different treatments.
The recommendations result from a new ACP evidence-based policy paper, "Achieving a High-Performance Health Care System with Universal Access: What the United States Can Learn from Other Countries." Published in the Jan. 1 Annals of Internal Medicine, the paper noted that the U.S. health care system falls well below what residents of other industrialized nations receive from their health care systems.
ACP will send copies of the pledge to all of the announced Democratic and Republican presidential candidates as well as to all members of Congress who are running for re-election. ACP will ask for their endorsement of the pledge. ACP leaders noted that the report is a call to action to its members, the candidates, and U.S. elected leaders to commit to comprehensive health care reforms.
The full ACP annual report is online.
Also go online to use ACP's Web-based candidate comparison tool to evaluate the candidates' positions.
Mistakes due to similarly named drugs on the rise.
More than 1,400 commonly used pharmaceuticals were involved in medical errors from 2003-06 because their names look or sound like another drug name, according to a new report from U.S. Pharmacopeia (USP).
In a review of 26,000 records from the MEDMARX database, 1,470 look-alike/sound-alike errors were found, 1.4% of which resulted in patient harm. Seven errors may have caused or contributed to patient deaths. MEDMARX is run by the non-profit USP as an anonymous Internet program for hospitals to report, track and analyze medication errors.
Based on the report, USP compiled a list of 3,170 pairs of drug names that look or sound alike. The organization’s previous report on the topic had identified 1,750 pairs. All of the top 10 most prescribed drugs in the U.S. made the list.
To reduce the incidence of these errors, USP has called on physicians and pharmacists to include an indication for use on all prescriptions and convey the information again at several points along the health care continuum. Additional recommendations for avoiding errors included using "tall-man" lettering (highlighting the different letters in similar names to help distinguish between similarly named drugs), prohibiting verbal orders for drugs that sound alike, and not stocking similarly named medications in the same area, according to the Jan. 30 Orlando Sentinel.
The USP also recommended that physicians use online decision-support tools. For patients, the report suggested that they check the indication for use on the drug label or ask their pharmacist for the information and, when taking any new drug, exercise their right to receive counseling from a pharmacist.
The press release from MEDMARX is online.
The Orlando Sentinel is online.
Appropriate VTE prophylaxis often lacking in hospitalized patients, study reports.
Rates of appropriate prophylaxis for venous thromboembolism (VTE) in hospitalized patients are less than ideal, according to a new worldwide study.
The ENDORSE Investigators performed an observational cross-sectional study of medical and surgical patients to determine how many hospitalized patients were at risk for VTE and what proportion received appropriate prophylaxis, as recommended by 2004 guidelines from the American College of Chest Physicians. Patients were seen at 358 acute care hospitals in 32 countries between August 2006 and January 2007. The results of the study, which was industry-sponsored, appear in the Feb. 2 Lancet.
Of 68,183 patients, 55% were medical and 45% were surgical. Researchers determined that 35,329 patients (19,842 surgical and 15,487 medical) were at risk for VTE. Among at-risk surgical and medical patients, appropriate prophylaxis was administered in 11,613 (58.5%) and 6,119 (39.5%), respectively. Prophylaxis varied by type of surgery; for example, 88% of patients having knee or hip replacement received prophylaxis compared with 50% of those having urological surgery. Among medical patients, patients with acute noninfectious respiratory disease had the highest rate of prophylaxis (45%), while patients with active malignant disease or ischemic stroke had the lowest (37%).
The study used data from patient charts, which could have introduced some inaccuracies, and was not able to determine adherence to prophylaxis during the entire hospital stay, among other limitations. However, the authors wrote, their data have important implications for national health care and provide a "global overview" of the difference between evidence-based guidelines and actual practice. They called for the implementation of hospital-wide strategies to assess VTE risk and ensure appropriate prophylaxis.
The Lancet is online.
Tight glucose control may protect kidneys in the critically ill.
Intensive insulin therapy may have a renoprotective effect in critically ill patients, according to a new study.
Two previously published randomized, controlled trials have indicated that tight glucose control protects the kidneys in critically ill patients. Researchers reanalyzed data from these trials to more closely examine the effect of intensive insulin therapy on renal function. The results appear in the March Journal of the American Society of Nephrology.
The study involved data from 2,707 critically ill medical and surgical patients who did not have end-stage renal disease before hospital admission and were randomly assigned to receive intensive or conventional insulin therapy during hospitalization. Overall, the incidence of acute kidney injury was statistically significantly lower in patients receiving intensive insulin therapy than in those receiving conventional therapy (4.5% vs. 7.6%). A greater renoprotective effect was seen among patients who maintained normal glucose levels.
In surgical patients, oliguria and the need for renal replacement therapy were statistically significantly less common in those receiving intensive insulin therapy compared with conventional therapy (2.6% vs. 5.6% and 4.0% vs. 7.4%, respectively). Medical patients did not derive as much renoprotective benefit from intensive insulin therapy, possibly because patients in this group are usually sicker at hospital admission.
The authors acknowledged several limitations of their study, including examination of a secondary outcome and the limited sample size of some subgroups. However, they concluded that tight glucose control has a renoprotective effect in the critically ill, especially surgical patients.
The Journal of the American Society of Nephrology is online.
Annals: Comparison of prostate cancer treatments shows little difference.
The Feb. 5 issue of Annals of Internal Medicine includes systematic reviews of prostate cancer treatments and gene expression tests for breast cancer. This issue also has a study on the best time to begin HIV treatment and recommendations against screening pregnant women for bacterial vaginosis. This week's podcast features an audio summary of a commentary on Medicare Part D. The full text is available to College members and subscribers online.
Annals Audio Summary: The effects of the Medicare Part D prescription drug benefit. In this week's Annals audio summary, John Ayanian, MD, of Brigham and Women's Hospital and Harvard University discusses the effect of the Medicare Part D prescription drug plan on drug utilization and expenditures. The podcast, which also includes a summary of the articles in the current issue, is available at www.annals.org or on iTunes.
No clear winner in review of treatments for localized prostate cancer. About 197,000 men will be diagnosed with clinically localized prostate cancer (cancer confined to the prostate gland) in 2008. Common treatments include watchful waiting, surgery to remove the prostate gland, radiotherapy, and androgen deprivation. A review of these treatments concluded, “Accurately assessing comparative effectiveness and harms of localized prostate cancer treatments is difficult due to limitations in the evidence.” All treatments result in adverse events, primarily to urinary, bowel and sexual function, though the frequency, duration and severity may vary between treatments. This review is being released early online and will appear in the March 18, 2008 print edition.
Gene expression tests for breast cancer promising but limited. A review of three commercial gene expression-based prognostic breast cancer tests finds they have potential for improving prognostic and therapeutic prediction, but more data are needed about the level of improvement, which women will benefit, and how to use the test in decision making about current breast cancer treatment. This review is being released early online and will appear in the March 18, 2008, print edition.
New study refines thinking on best time to begin HIV treatment. Debate about the optimal time to begin HIV treatment continues, partly because current mathematical models that weigh harms and benefits over long horizons do not consider drug toxicity and side effects and accrual of HIV drug resistance mutations, which are the primary risks of initiating therapy early. A new computer simulation incorporates toxicity and side effects of combination antiretroviral therapy. It suggests that initiation of combination antiretroviral therapy when the CD4 count falls below 500 cells/mm3 may increase the life expectancy and quality-adjusted life expectancy of younger patients, particularly if they have higher viral loads. The simulation also strengthens the case for treating patients with CD4 counts between 200 and 350 cells/mm3 compared with current guidelines.
Expert group: Do not screen pregnant women for bacterial vaginosis. Bacterial vaginosis is the most common lower genital tract syndrome among women of reproductive age and has been associated with premature births or low birthweight. Because bacterial vaginosis is easy to screen for and treat, some favor screening all pregnant women for it. But the U.S. Preventive Services Task Force recommends against screening low-risk women for bacterial vaginosis because there is good evidence that treating the syndrome does not benefit pregnant women at low risk for premature delivery. The task force finds insufficient evidence to recommend either for or against screening for the syndrome in pregnant women at high risk for premature delivery.
Diuretics are best in treating hypertension with metabolic syndrome.
Diuretics offer greater protection against cardiovascular disease and are at least as effective as other drugs at lowering blood pressure in patients with hypertension as part of metabolic syndrome, a new study found.
The randomized, double-blind trial assigned 42,418 people to the diuretic chlorthalidone (n=15,255), calcium-channel blocker amlodipine besylate (n=9,048), ACE inhibitor lisinopril (n=9,054) or alpha-blocker doxazosin mesylate (n=9,061). Each drug was used to start treatment, but other drugs were added if needed to control blood pressure. Patients were age 55 years or older with blood pressure of 140/90 mm or higher, and had at least one other risk factor for heart disease. Among these, 23,077 had metabolic syndrome with diabetes or pre-diabetes when enrolled. Most patients were followed for an average of 4.9 years, but those in the alpha-blocker arm stopped after 3.2 years due to higher rates of cardiovascular disease.
Results showed chlorthalidone consistently controlled blood pressure and was just as beneficial in preventing heart attack and coronary heart disease death when compared with the other drugs. In addition, chlorthalidone was more protective against heart failure and against overall cardiovascular disease (coronary heart disease, stroke, heart failure, or peripheral arterial disease combined) than was lisinopril or doxazosin mesylate. Chlorthalidone was also more protective against heart failure than amlodipine besylate.
Results were most striking for the 35% of patients in the study who were black. Compared with those taking chlorthalidone, black patients with metabolic syndrome who received lisinopril had poorer blood pressure control and a 24% higher risk of overall cardiovascular disease, a 37% higher risk of stroke, and a 70% higher risk of end-stage renal disease. Black patients who took doxazosin had a 37% higher risk of overall cardiovascular disease and a 49% higher risk of stroke than those taking chlorthalidone. The study was published in the Jan. 28 Archives of Internal Medicine.
The results “overwhelmingly” support the choice of thiazide-type diuretics for black patients with hypertension and metabolic syndrome, the study’s lead author said. In general, the study’s outcome runs counter to current medical practices that favor ACE inhibitors, alpha-blockers and calcium-channel blockers for treatment of high blood pressure in patients with metabolic syndrome, an expert with the National Heart, Lung and Blood Institute (NHLBI) noted. “This new analysis … does not support the selection of the newer drugs over diuretics for preventing poor health outcomes related to hypertension or for lowering blood pressure,” she said.
The Archives of Internal Medicine is online.
The NHLBI release is online.
Nine lots of heparin sodium injection recalled.
Baxter Healthcare Corp is recalling nine lots of heparin sodium injection 1,000 units/mL 10 mL and 30 mL vials due to an increase in reports of adverse patient reactions, the FDA said.
The recalled lots are numbered 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, and 107111. Some of the adverse reactions are severe and life-threatening, and have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, dizziness, fainting, unresponsiveness, shortness of breath, strong or fast heartbeat, burning sensation, redness or paleness of skin, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth.
Heparin 1,000 units/mL multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. Baxter hasn’t observed a significant increase in adverse event reports with any other heparin presentations to date, the company said.
Patients and health care professionals should discontinue use of the recalled products, separate them from the rest of their inventory, then call Baxter at 1-800-667-0959 to arrange for return and a replacement product.
The FDA release is online.
Antiepileptics associated with increased risk for suicidal thoughts, behavior.
People who take antiepileptics have nearly twice the risk of suicidal thoughts and behaviors as those who take placebos, the FDA said last week.
In a review of 199 placebo-controlled trials of 11 antiepileptic drugs, patients who took the drugs had a 0.43% risk of suicidal thoughts and behaviors compared with a 0.22% risk for patients taking placebos. The higher risk was observed one week after starting the drug and persisted to at least 24 weeks, existed in all drugs tested, and was seen in all demographic subgroups.
The drugs in the analysis included: carbamazepine (brand names: Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakote ER, Depakene, Depacon), and zonisamide (Zonegran).
Although only the drugs listed above were part of the analysis, the FDA said it expects that all medications in the antiepileptic class share an increased risk of suicidality, and that anticipated labeling changes will apply to the whole class. The FDA will discuss the data at an upcoming meeting. Health care providers should notify patients, families and caregivers of the potential for an increased risk of suicidality so that patients can be observed for changes in behavior, the FDA said.
The FDA release is online.
March 1 deadline for NPI numbers approaching.
ACP was recently informed by the CMS that 300,000 claims a day are still being submitted without a National Provider Identifier (NPI) number.
The NPI is a standard that was created under the Health Insurance Portability and Accountability Act. NPI numbers are unique identifiers for health care providers that will be used by all health plans and health care clearinghouses.
Beginning March 1 all Medicare Fee-for-Service 837-P and CMS-1500 claims must use an NPI. If these claims are submitted after March 1 without an NPI they will be rejected as unprocessable and will not be paid.
CMS is urging providers who have not already done so to begin testing their Medicare claims using their NPI numbers. To do so providers must first submit claims containing both the NPI number and legacy identifiers. After these claims have been paid they should send a small batch of claims using only the NPI number. If these claims are successfully paid providers should begin using only the NPI number.
ACP publishing news
Caption contest: Put words in our mouth.
InternistWeekly wants readers to create captions for this cartoon--and help choose the winner.
E-mail all entries to firstname.lastname@example.org by Feb. 14. ACP staff will choose three finalists and post them in the Feb. 19 issue of InternistWeekly for an online vote by readers. The winner will appear in the Feb. 26 issue.
Pen the winning caption and win a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.
Regents update strategic plan.
The Board of Regents approved an updated Strategic Plan at its January meeting.
The approved new Strategic Plan details what the College will work to achieve in the next one to three years. The plan has 61 objectives grouped under the following seven themes:
- assure that the number of internal medicine specialists aligns with the number needed to meet U.S. health care needs,
- improve access to care and eliminate disparities, with a focus on expanding health insurance coverage,
- develop and implement effective models of health care delivery and financing, such as the patient-centered medical home,
- increase the number of new members and improve retention among current members, and focus on involving members in College programs,
- enhance the effectiveness and vitality of College chapters,
- develop and deliver innovative education and information resources that are essential for internal medicine specialists and emphasize professionalism, and
- increase international collaborations that foster learning from other perspectives and expansion of educational resources, health care delivery innovations, and membership beyond the U.S.
A link to the strategic plan is available online. Click on the section entitled “Who We Are,” then click on “Strategic Planning” on the left side menu.
ACP-ACP Foundation's Diabetes Initiative extended two years.
Following the successful execution of a three-year grant, Novo Nordisk has extended funding for the ACP and ACP Foundation Diabetes Initiative for two additional years, through December 2009.
The initiative was launched in 2005 to increase awareness of the gap between current practice and acceptable standards of diabetes care among internists; increase internists’ awareness of what constitutes high-quality, evidence-based diabetes care; and provide educational tools to improve diabetes treatment.
Many resources and practice-based training programs were developed and put to use toward this goal. For example, 60 team participants from 19 physician practices participated in ACP’s “Closing the Gap” module for diabetes, which resulted in statistically significant improvements in many clinical measures, including a nearly 50% improvement in the average number of days between patient office visits for the disease (from 115 to 58). And last year, three educational tools were introduced for practicing internists as well as other health care providers and their patients: “Living with Diabetes: An Everyday Guide for You and Your Family,” a patient guide; The ACP Diabetes Care Guide, a physician guide; and the Diabetes Portal, a free, Web-based resource for physicians and patients.
The distribution and marketing of these resources have been equally effective. To date, ACP and ACP Foundation have distributed over 500,000 patient guides and 80,000 clinical care guides, and more than 20,000 unique users have visited the Diabetes Portal since its launch in June 2007. Additionally, visibility and awareness of the initiative have been heightened by professional organizations and societies, federal and state agencies, private health systems, practices, academic centers and residency programs that have used its resources.
More information about the ACP-ACP Foundation Diabetes Initiative is online.
Call for award and Mastership nominations for 2008-09.
The ACP Awards Committee invites your help in recognizing the accomplishments of distinguished individuals and organizations through the College’s awards and Masterships. Each year, ACP bestows 18 awards and a number of Masterships during Convocation at the annual Internal Medicine meeting. These honors recognize outstanding contributions in medical practice, teaching, research, public service, leadership and volunteerism. ACP is now accepting nominations for the 2008-09 awards cycle.
Nominations are encouraged for the Stengel Award (outstanding service to ACP), Loveland Award (contribution to the health field), Menninger Award (contributions to the science of mental health), and Claypoole Award (extraordinary devotion to the care of patients). Other high-profile awards include the Rosenthal Awards, the Outstanding Volunteer Clinical Teacher Award and the Joseph E. Johnson Leadership Award.
The Awards and Mastership Booklet containing complete criteria for ACP awards and Masterships, as well as detailed instructions for writing nominating and supporting letters, is available online. www.acponline.org/awards Print copies are being mailed to ACP leadership, and will be sent to others on request.
For additional information and to request copies of the booklet, contact Martha Cornog, staff liaison to the Awards Committee, at email@example.com, 800-523-1546 ext. 2696, or Meghann Williams, Coordinator, Awards-Convocation and Diversity, at firstname.lastname@example.org, 800-523-1546 ext. 2714.
A list of this year’s awardees is online.
Bridges to Excellence announces support for patient-centered medical home.
Bridges to Excellence announced the launch of a medical home program. The initiative will reward physicians who adopt systems and processes of care to deliver positive results in the management of their patients--particularly patients with chronic conditions.
Bridges to Excellence is a nonprofit coalition-based organization created to encourage advances in quality of care by recognizing and rewarding health care providers who demonstrate that they deliver safe, timely, effective and patient-centered care.
Recognized physicians will be awarded a Bridges to Excellence Medical Home distinction when they have demonstrated that they have adopted and are effectively using advanced systems of care to produce good results for their patients. Through participation in the Bridges to Excellence Medical Home, doctors can receive an annual bonus payment of $125 for each patient covered by a participating employer, with a suggested maximum yearly incentive of $100,000.
“The ACP, with our physician colleagues, believes the patient-centered medical home (PCMH) can serve as a framework for improving the U.S. health care delivery system. Practices electing to become a PCMH commit to providing care that recognizes the true value of partnership between patients and their personal physicians--who in turn accept the accountability and responsibility of improving the quality of care,” said David C. Dale, FACP, president of ACP. “The Bridges to Excellence Medical Home program is designed to support this transformation of health care and ACP welcomes the opportunity to work with BTE as the program evolves.”
More information about the Bridges to Excellence program is online.
About ACP InternistWeekly
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Copyright 2008 by the American College of Physicians.
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