News in Brief: Week of Nov. 7-11

November 09, 2011 05:20 pm News Staff

This roundup includes the following news briefs:

Deadline to Enroll in Rosiglitazone Access Program is Nov. 17

The FDA is reminding physicians and patients with type 2 diabetes that they only have until Nov. 17, to enroll in the Avandia-Rosiglitazone Medicines Access Program. As of Nov. 18, physicians not enrolled in the program will no longer be able to prescribe rosiglitazone-containing medications -- Avandia, Avandamet and Avandaryl -- and patients who are not enrolled will not be able to receive the drugs.

The access program was mandated as part of a risk evaluation and mitigation strategy, or REMS, imposed by the FDA in the wake of study findings that linked use of rosiglitazone to an increased risk for cardiovascular events.

The agency specified in May that, according to the REMS, access to rosiglitazone-containing medications would be limited to patients already being successfully treated with these medications and patients whose blood sugar cannot be controlled with other diabetes medications and who, after consulting with their health care professional, do not wish to use medicine containing pioglitazone.

After the Nov. 17 cutoff, rosiglitazone will no longer be available through retail pharmacies. Instead, patients who enroll in the access program will receive their medications by mail from certified pharmacies.

FDA Issues Further Update on Cancer Associated With TNF Blockers

FDA officials are requiring the manufacturers of tumor necrosis factor, or TNF, blockers to perform enhanced safety surveillance(www.fda.gov) for these products after continuing to receive new reports of hepatosplenic T-cell lymphoma associated with these agents, as well as with azathioprine and/or mercaptopurine.

As part of this heightened surveillance, the manufacturers will conduct in-depth follow-up of reports of malignancy cases in children, adolescents and adults younger than 30 and will submit all such reports to the FDA within 15 days of becoming aware of the report. The manufacturers also will provide the agency with annual summaries and assessments of malignancies and TNF blocker usage data.

TNF blockers include infliximab, sold as Remicade; etanercept, sold as Enbrel; adalimumab, sold as Humira; certolizumab pegol, sold as Cimzia; and golimumab, sold as Simponi.

The FDA's recent action follows an agency ruling in 2009 that required manufacturers of TNF blockers to update boxed warnings in the drugs' prescribing information because of an increased cancer risk in children and adolescents who use the drugs to treat immune system diseases. Before that, the agency required manufacturers to strengthen their products' package label warnings to highlight potential risks for opportunistic fungal infections.

Physicians are asked to report adverse events involving TNF blockers, azathioprine or mercaptopurine to the FDA's MedWatch program(www.fda.gov).

CMS Expands Number of Medicare Preventive Services

Medicare is adding to its existing portfolio of free preventive services available to Medicare beneficiaries by including preventive services designed to reduce cardiovascular disease.

According to a CMS press release(www.cms.gov), Medicare will cover one face-to-face visit with a family physician or other primary care health professional each year to enable patients and their primary care physicians to determine the best way to prevent cardiovascular disease, the nation’s No. 1 killer.

The visits will give primary care physicians and other primary care health professionals an opportunity to screen for hypertension and other conditions that increase the risk of cardiovascular disease, CMS said in the release. Primary care physicians and other clinicians also will have the chance to promote healthy diets "as part of an overall initiative to reduce the burden of cardiovascular disease in the United States," said the release, referring to HHS' recent launch of its Million Hearts campaign.

Stay Active to Stay Healthy, Campaign Urges Older Adults

The NIH's National Institute on Aging has launched a new campaign, dubbed Go4Life(go4life.niapublications.org), that aims to motivate people 50 and older to maintain a healthy lifestyle by making physical activity a part of their everyday lives.

Forged from a public-private partnership that includes HHS agencies, as well as national organizations, corporations, insurers, health care providers and nonprofit groups, Go4Life seeks to remedy the fact that only 25 percent of people between the ages of 65 and 74 say they participate in physical activity regularly.

In a press release announcing the new campaign, U.S. Surgeon General and family physician Regina Benjamin, M.D., M.B.A., said, "If we want to become a healthy and fit nation, we need to increase the number of Americans who are healthy at every stage of life. Go4Life provides older adults with the tools and resources to get moving and keep moving."

Among tools and resources available from the Go4Life website are

  • tip sheets(go4life.niapublications.org) office staff can print and distribute to patients,
  • free posters and bookmarks(go4life.niapublications.org) for exam rooms and reception areas,
  • articles(go4life.niapublications.org) about exercise and physical activity that can be included in patient newsletters,
  • free copies of Exercise and Physical Activity: Your Everyday Guide from the National Institute on Aging(go4life.niapublications.org) (in English and Spanish), and
  • an accompanying Go4Life exercise video.

ONC Extends Temporary EHR Certification Program

The Office of the National Coordinator, or ONC, for Health Information Technology has extended a temporary electronic health record, or EHR, certification program until at least next summer. According to a notice(www.gpo.gov) in the Nov. 3 Federal Register, the temporary program was supposed to sunset on Dec. 31, but the final rule to establish a permanent program gave authority to the ONC to extend the temporary program as needed.

National Coordinator Farzad Mostashari, M.D., determined that there would not be a sufficient number of accredited testing laboratories to certify EHR systems until next summer. The ONC estimates that the permanent certification program will have six ONC-authorized certification bodies.

AHRQ Awards Grants to Support Preventive Services Research

The Agency for Healthcare Research and Quality, or AHRQ, has awarded grants totaling $4.5 million to three universities to support clinical preventive research. According to a news release(www.ahrq.gov), the three-year grants will fund research centers that focus on health equity, patient safety and health systems implementation.

The research centers will be located at Northwestern University in Chicago, the University of North Carolina at Chapel Hill, and the University of Colorado's Anschutz Medical Campus in Aurora. Grant funding was provided by the Prevention and Public Health Fund portion of the Patient Protection and Affordable Care Act.

A fourth grant award was given to an entity charged with coordinating and evaluating the research being conducted at the three centers.

RWJ Foundation Seeks Candidates for Clinical Scholars Program

The Robert Wood Johnson Foundation, or RWJF, is seeking resident physician applicants for its RWJF Clinical Scholars program. Successful applicants will have the opportunity to conduct research and work with communities, organizations, health care professionals and policymakers on health care issues.

According to information(rwjcsp.unc.edu) provided by the foundation, as many as 20 clinical scholars will be selected; 10 of those positions will be funded by the RWJF, with an additional 10 positions supported by Veterans Administration Medical Centers affiliated with the participating universities. Scholars train at one of four institutions: the University of California, Los Angles; the University of Michigan, Ann Arbor; the University of Pennsylvania, Philadelphia, and Yale University, New Haven, Conn.

The Clinical Scholars program involves two years of study. About 80 percent of a scholar's time is protected for research, and the remaining 20 percent is dedicated to clinical activities. Apply online(www.rwjfcsp.org) now through Feb. 29, 2012.


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