In the News for the Week of 3-7-06
Clinical news in the headlines
- ACP President urges Congress to pass key payment reforms
- Latest issue of Capitol Key newsletter now available
Medicare Part D
- Some seniors find themselves enrolled in two plans
- AQA pilot project will measure quality, reporting methods
- National IT group now calling for project volunteers
Clinical news in the headlines
A drug in the most widely prescribed class of antibiotics in the U.S. was found to have potentially serious side effects in a large study conducted by Canadian researchers.
The study, published early online by the New England Journal of Medicine (NEJM), found that gatifloxacin (Bristol-Myers Squibb’s Tequin) was associated with a higher risk of hypoglycemia and hyperglycemia than either macrolide antibiotics or other fluoroquinolones. The study, which looked at 1.4 million patient health records in Ontario, Canada, will be published in the March 30 NEJM.
The researchers identified patients age 66 or older who were treated between 2002-04 for hypoglycemia and hyperglycemia within 30 days after antibiotic therapy. Patients treated with gatifloxacin had four times the risk for hypoglycemia and 17 times the risk for hyperglycemia as those treated with macrolide antibiotics. Of the other fluoroquinolones, only levofloxacin carried a slightly increased risk of hypoglycemia, but not hyperglycemia. This increased risk of dysglycemic effects with gatifloxacin was observed in both diabetic and non-diabetic patients.
The researchers advised physicians to consider avoiding gatifloxacin because it has little therapeutic advantages over alternative quinolone antibiotics. When gatifloxacin is prescribed, physicians should be aware of the risk of potentially serious abnormalities in blood glucose, the authors said, and instruct patients to seek care if symptoms develop.
Bristol-Myers Squibb started selling gatifloxacin in 1999, the March 2 New York Times reported. Since then, regulators have ordered the company to add several warnings to the package insert, including one saying the drug should not be prescribed to patients with diabetes.
The NEJM is online.
The New York Times is online.
The following articles appear in the March 7 issue of Annals of Internal Medicine. Full text is available to College members and subscribers online.
Editors detail steps to correct research fraud. Two journal editors discuss scientific fraud and outline steps to correct scientific literature corrupted by fraudulent research. They show how key responsibilities in the aftermath of fraud—investigating the misconduct, correcting the scientific literature and preventing further fraud—should be shared among the offending researchers’ institution, their co-authors and the journal editors who published the fraudulent research.
Studies define scope of community-acquired MRSA. In one study, researchers examined 384 people who had acquired S. aureus skin or soft-tissue infections and found that 72% had community-acquired MRSA. Most clinicians did not recognize that community-acquired MRSA had become a leading cause of skin and soft-tissue infection in their community and recommended treatment with ineffective antimicrobial agents.
In another study, researchers looked at 2001-02 data from the most recent National Health and Nutrition Examination Survey and estimated that 84 million people in the United States—31.6% of U.S. adults—carry MSSA (S. aureus that is sensitive to methicillin), while 2 million, or 0.84%, carry MRSA, S. aureus that is methicillin resistant. An editorial describes the rise in the number of community-acquired MRSA cases here and elsewhere as "epidemic."
Aspirin more cost effective than statins in preventing heart disease in men. Using published information, researchers developed a computer model to estimate outcomes and costs for men with various risks for coronary heart disease (CHD) taking aspirin, statins, both drugs or neither. They found that among the four options, aspirin is the most cost effective for preventing CHD events in middle-aged men whose 10-year risk for CHD is 7.5%. Adding a statin to aspirin therapy becomes more cost effective when the patient’s 10-year CHD risk is 10% or higher.
Regulators last week approved a major cancer drug to treat rheumatoid arthritis (RA), giving new hope to patients who do not respond to current treatments.
Rituximab, sold by Genentech as Rituxan, was first approved in 1997 to treat lymphoma, said the March 1 Washington Post. In addition to its newly approved use for treatment of RA, researchers are testing its effectiveness against other immune diseases such as lupus and multiple sclerosis.
The approval signals the growing ability of biotechnology researchers to predict how drugs might be useful in treating more than one disease, the article said. Rituximab has become a best-selling cancer drug because it is more precise and less toxic than older chemotherapy treatments.
Rituximab, an artificial antibody created through genetic engineering, suppresses certain immune cells that are overactive in some types of cancer as well as in RA, the Washington Post reported. The drug is expected to help between 30% and 40% of RA sufferers who do not respond to other treatments.
The Washington Post is online.
The FDA last week approved the first skin patch for treating major depression. The patch, which delivers selegiline, a monoamine oxidase (MAO) inhibitor, into the bloodstream, offers an alternative to patients who must restrict their diet while taking oral MAO inhibitors.
Sold under the brand name Emsam by Bristol-Myers Squibb, the lowest patch dose—6 mg—does not require dietary restrictions, said a Feb. 28 FDA news release. Oral MAO inhibitors typically require dietary restrictions because patients who take them with certain foods have a higher risk of a hypertensive crisis, possibly leading to stroke or death. The release noted that symptoms of such a crisis include sudden onset of severe headache, nausea, stiff neck, rapid heartbeat or palpitations, sweating and confusion.
The patch will be sold in three sizes, delivering either 6 mg, 9 mg or 12 mg of selegiline per 24 hours, according to the release. Patients taking the higher doses should still follow dietary restrictions, such as avoiding aged cheese and wine.
The FDA news release is online.
ACP's President last week warned members of a Congressional subcommittee that the nation's primary care system would collapse if fundamental payment reforms aren't passed. Among the reforms he recommended in his testimony were correcting inequities in setting relative value unit reimbursement and changing care models for patients with chronic diseases.
ACP was the only physician group asked to testify before the House Ways and Means subcommittee on health. The hearing was called to consider the latest report from the Medicare Payment Advisory Commission (MedPAC), which advises Congress on Medicare.
In his testimony, College President C. Anderson Hedberg, FACP, said that ACP endorsed MedPAC recommendations to reconfigure relative value work unit reimbursement to shift payment from some overpriced medical services to primary care. Those reimbursement disparities, Dr. Hedberg said, are contributing to a looming collapse of primary care, at a time when the number of Americans age 85 and older—many of whom have multiple chronic diseases—is expect to increase 50% between 2000 and 2010.
He also noted that MedPAC is exploring ways to improve chronic care, and he urged Congress to move to pilot test ACP's advanced medical home model, which would substantially change chronic care delivery and reimbursement. Subcommittee chair, Rep. Nancy Johnson (R-Conn.), praised the advanced medical home model and ACP's work in developing it, and pledged to work with the College on the concept.
The complete testimony is online.
Members can now access the latest issue of Capitol Key, the bimonthly ACP Services advocacy newsletter that summarizes important College legislative issues on Capitol Hill.
This latest issue includes information on the more than 8,500 e-mails, faxes and letters sent by ACP members to Congress, urging representatives to halt Medicare payment cuts to physicians. Because of ACP's response—the largest on any advocacy issue—Congress took action in February to reverse that pay cut. The newsletter includes a table summarizing advocacy activity by state.
The issue also includes updates on other vital advocacy efforts, including:
Leadership Day 2006. The May 16-17 event provides chapter leaders with advocacy training, an update on ACP’s legislative priorities and time to meet with their federal legislators. Registration, which must be coordinated with chapter governors, is available online.
The "State of the Nation’s Health Care" report. This year’s annual report by the College included sweeping policy proposals to avert a looming crisis in access to primary care medicine.
Medicare physician payment cuts reversed. Passage of the budget reconciliation bill reversed the 4.4% physician pay cut that went into effect Jan. 1. Members are urged to go to the Legislative Action Center and write their legislators to acknowledge the one-year fix and urge them to take action to avoid cuts in 2007. A sample letter is provided for personalization.
Title VII health professions cut. The HHS budget passed in December slashed Title VII budgets for training, scholarships and more.
The latest Capitol Key is online.
Medicare Part D
Some Medicare beneficiaries are discovering that they are inadvertently enrolled in two prescription drug plans and may be charged two premiums or incorrect copays, the government acknowledged last week.
The beneficiaries, numbering in the tens of thousands, typically were assigned to one plan by the federal government but chose another plan on their own, said the March 1 New York Times. In a memo to insurers, the government acknowledged that enrollment and disenrollment information has not always been sent to the appropriate plans, causing beneficiaries who switched plans to show up as active members of multiple plans.
The errors are likely the result of computer glitches and can’t be fixed in one fell swoop, reported the New York Times. Officials fear that mass disenrollment would trigger more confusion and a rash of complaints by beneficiaries.
When a beneficiary switches plans, Medicare typically gives out information on low-income status to only one plan, said the New York Times. That has led to some beneficiaries receiving incorrect bills or being charged higher copays because one insurer does not know that the person is entitled to low-income subsidies.
The confusion has caused some plans to ignore disenrollment notices because they could not verify them, the New York Times said. Insurers also have complained about the accounting problems triggered by paying claims for people who are no longer enrolled with their plan.
The New York Times is online.
The Ambulatory Care Quality Alliance (AQA) has announced a pilot project that will, for the first time, combine public and private information to measure and report on physician practice.
ACP is one of the four original convening organizations of the AQA, a national coalition of more than 125 organizations. The coalition seeks to improve health care quality through a process in which key stakeholders—physicians, consumers, employers and insurers—agree on strategies for measuring, reporting and improving physician performance.
The pilot project, funded by the CMS and the Agency for Healthcare Research and Quality, will take a comprehensive look at physician practices by aggregating data from public and private sources, said a March 1 AHRQ news release.
That data will be consolidated into consumer report cards. Until now, various public and private plans have had separate measurement sets and reporting programs, confusing consumers and making it difficult for physicians to participate.
The project is expected to provide a national measurement and reporting framework, the release said. The program will measure quality of care as well as cost efficiency.
The six pilot participants were selected because they have the infrastructure and experience necessary to support combining various data sources, according to the release. Participants include:
- California Cooperative Healthcare Reporting Initiative, San Francisco
- Indiana Health Information Exchange, Indianapolis
- Massachusetts Health Quality Partners, Watertown, Mass.
- Minnesota Community Measurement, St. Paul, Minn.
- Phoenix Regional Healthcare Value Measurement Initiative, Phoenix
- Wisconsin Collaborative for Healthcare Quality, Madison, Wis.
The AHRQ news release is online.
The Certification Commission for Healthcare Information Technology (CCHIT) is seeking volunteers to act as co-chairs and workgroup members for several different projects. The CCHIT is a voluntary, private-sector group working to certify information technology products. Applications for those positions must be filed by March 10.
The CCHIT needs members to help maintain and extend CCHIT's work in ambulatory and inpatient electronic health records, as well as in its continued development of interoperability, security and certification inspection processes. John Tooker, FACP, the College's EVP/CEO, and David W. Bates, FACP, are both CCHIT commissioners.
Through its different workgroup projects, the commission wants to reduce the risk of investing in information technology and to advance technology interoperability.
All applications must be submitted online by March 10, 2006. Workgroup descriptions and more information about volunteering are also online.
ACP's popular MKSAP for Students is now available in a new third edition that includes a fully searchable CD-ROM. This new edition has been produced in collaboration with the Clerkship Directors in Internal Medicine (CDIM).
MKSAP for Students 3 includes more than 400 patient-centered self-assessment questions and answers. Designed for medical students on their clerkship rotation, the questions provide a focused, concise review of important internal medicine information. Questions cover the content included in the 33 "Training Problem" categories from the "Core Medicine Clerkship Curriculum Guide," a publication of the CDIM and the Society of General Internal Medicine that defines competencies, knowledge, attitudes and skills that medical students are expected to master by the end of their clerkship.
The accompanying CD-ROM includes all 408 patient-centered self-assessment questions with complete answers and critiques of all correct and incorrect responses, and complete references, linked directly to PubMed. It automatically tracks progress, assesses areas for further focus, and enables both category-based and random question ordering.
The package, which includes the CD-ROM and a 240-page book, is available to ACP Student Members for $30.00 plus shipping. (Non-member students pay $44.50.) For more information or to order, go online or contact ACP Customer Service at 800-523-1546, ext. 2600, or 215-351-2600 (Monday-Friday, 9 a.m.-5 p.m., ET). Product code: 190350010.
Non-member medical students can qualify for the discounted rate by registering to become ACP Student Members.
The College's Center for Practice Innovation (CPI) is now accepting applications for practices to participate in its premier project.
The CPI will select between 25 and 50 small- and medium-sized practices from among the applicants to participate. The project will offer customized support and resources to test innovative approaches to practice redesign.
Innovations will focus on four priority areas: clinical quality improvement, practice management, physician education and patient safety/disease management. Participants will be chosen to represent diverse practice settings, size, stage of technology implementation, and patient and payer mix.
The center has posted an online application as well as additional information. The first 100 practices to complete the online application will receive a $50 honorarium. Practices that would like a paper-based application should contact the CPI via e-mail.
Additional funding will permit the Center to expand operations so practices not selected in this first phase will be considered for future projects.
For more information about CPI, see "Help is on the way for small physician practices" in the January-February ACP Observer.
About ACP ObserverWeekly
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Copyright 2006 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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