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Dabigatran receives FDA approval

November 2010

Published in the November 2010 issue of Today’s Hospitalist

FDA approves dabigatran for A-fib patients

THE FDA LAST MONTH APPROVED DABIGATRAN (Pradaxa) to help prevent strokes and clots in patients with atrial fibrillation. Anticoagulation experts have been waiting for U.S. approval of the oral direct thrombin inhibitor, which has been already approved in Europe, because dabigatran does not require INR monitoring. That’s an advantage over warfarin treatment.

Results from the RE-LY trial, which were published last year in the Sept. 17, 2009, issue of the New England Journal of Medicine found that patients taking 110 mg of dabigatran had similar rates of stroke and embolism as patients on warfarin, but fewer major hemorrhages. Those taking 150 mg of dabigatran in the study had lower stroke and embolism rates but the same number of hemorrhages.

According to the FDA, the drug’s most common side effects include bleeding and gastrointestinal symptoms. Patients who are prescribed the drug will receive a medication guide that spells out their risk of serious bleeding.

The safety hazards of “presenteeism”

WHILE EMPLOYERS ARE WELL AWARE of the problems associated with absenteeism, a new study looks at the effects “in terms of disease transmission and outbreak severity “of “presenteeism,” where health care workers continue to come to work when ill.

The study looked at an outbreak of viral gastroenteritis in a nursing home in 2005 that was exacerbated when providers took sick but refused to stay home. Public health officials had to step in to mandate a stay-at-home-when- symptomatic policy. Workers who had been ill then needed to be cleared to return to work after being symptom-free for 48 hours.

The authors, writing in the November 2010 issue of the Journal of General Internal Medicine, recommended that facilities have clear policies requiring providers to stay home when sick. They also suggest that facilities institute programs to screen workers at the beginning of each shift during an outbreak.

The authors point out, however, that any such policies must be accompanied by unrestricted paid sick leave, or workers will feel financial pressure to report to work.

Aftermath of severe sepsis “underrecognized”

NEW RESEARCH FINDS that patients who survive severe sepsis are more than three times more likely to develop cognitive impairment and functional problems than patients with nonsepsis hospitalizations.

The study, which appeared in the Oct. 27 Journal of the American Medical Association, compared outcomes of patients with severe sepsis to nonsepsis admissions. Researchers found that in the aftermath of severe sepsis, patients had “significant increases” in functional and cognitive decline, caregiver burden, nursing home time, mortality and depression.

A related editorial points out that the prospective study was not able to conclude definitively that the sepsis caused patients’ deterioration, although that causal relationship makes sense. As for the study implications, the editorial suggests that doctors incorporate the findings into their care plans and discussions with severe sepsis patients and family members.

The editorial also recommends exploring ways for severe sepsis patients to receive the kind of physical rehabilitation available to patients with other cognitive difficulties. It also says that severe sepsis patients should be assessed for much longer-term outcomes than the standard endpoint of 28- day all-cause mortality.

IPC’s CEO named “Physician Executive of the Year”

ADAM SINGER, MD, chair and CEO of IPC The Hospitalist Company Inc., has been named the 2010 “Physician Executive of the Year” by both the MGMA and the American College of Medical Practice Executives (ACMPE). The award, which was presented to Dr. Singer at the MGMA’s national conference last month in New Orleans, recognizes group practice leadership and performance.

According to an IPC press release, this is the first time the award has gone to a physician executive in hospital medicine. In accepting the award, Dr. Singer noted that it was a recognition of the role that hospital medicine now plays in U.S. health care as well as a nod to the level of quality performance that independent physician practices can achieve.

The MGMA-ACMPE award acknowledged Dr. Singer’s leadership ability in terms of group performance and fostering team collaboratives, as well as his design and use of company-wide practice management software. Based in North Hollywood, Calif., IPC is the largest national physician group practice company, with 1,500 affiliated providers in 160 practice groups across 21 states.