News in Brief: Week of July 25-29

July 27, 2011 05:25 pm News Staff

This roundup includes the following news briefs:

FDA Issues Safety Information Regarding Dronedarone

The FDA is alerting physicians that they should not prescribe the antiarrhythmic drug dronedarone, which is marketed as Multaq, to patients with permanent atrial fibrillation.

A study sponsored by Sanofi Aventis, the drug's manufacturer, recently was stopped after preliminary data found a twofold increase in stroke, heart failure-related hospitalization and death in patients 65 years and older who were taking the medication for permanent atrial fibrillation compared with patients who received a placebo.

The FDA said in a July 21 safety alert(www.fda.gov) that it is evaluating whether and how the results of that study should be applied to patients taking dronedarone for paroxysmal or persistent atrial fibrillation or atrial flutter. The agency said patients taking the medication for nonpermanent atrial fibrillation should talk with their physicians about whether they should continue taking the drug.

Since dronedarone was approved by the FDA in 2009, about 241,000 U.S. patients have received the drug. In a safety alert(www.fda.gov) issued earlier this year, the agency linked the drug to cases of rare but severe liver injury. Physicians should report cases of adverse events involving dronedarone to the FDA's MedWatch program(www.accessdata.fda.gov).

AHRQ Brief Outlines Ways of Improving Patient Engagement in PCMH

The Agency for Health Care Research and Quality, or AHRQ, has issued a new brief that highlights opportunities to improve patient engagement in primary care through the patient-centered medical home, or PCMH.

The brief, "Patient-Centered Medical Home: Strategies to Put Patients at the Center of Primary Care(pcmh.ahrq.gov)", focuses on involvement at three levels: engagement of patients and families in their own care, quality improvement activities in the primary care practice, and the development and implementation of policy and research related to the PCMH. It also outlines the following six strategies decision-makers can use to help put patients at the center of the PCMH:

  • ask that practices demonstrate active engagement of patients and families in patient care and quality improvement activities to qualify as medical homes;
  • use payment strategies that support the engagement of patients and families in patient care and quality improvement activities;
  • provide practices with technical assistance, tools and shared resources to accomplish a variety of tasks, including the assessment of current patient engagement policies and practices and the development of improvement plans;
  • establish meaningful use and certification requirements to ensure health information technology promotes patient engagement;
  • ensure patients have substantive input in the design, implementation and evaluation of medical home programs; and
  • support additional research on the feasibility and effect of patient-engagement strategies.

Rhode Island Enacts PCMH Measure

Rhode Island has enacted a measure(www.rilin.state.ri.us) directing the state health commissioner to create an advisory council to develop standards and payment mechanisms for patient-centered medical homes, or PCMHs.

The state's major public and private payers are funding a PCMH pilot project in the state already, and the legislation, known as the Rhode Island All-Payer Patient-Centered Medical Home Act, is intended to build on the success of that project, according to state officials.

The council, which will be composed of health insurers, physicians and other clinicians, employers, representatives from the state health care program, relevant state agencies, community health centers, hospitals, and patients, will develop standards and payment mechanisms. According to the legislation, the health commissioner is required to report annually to the Rhode Island General Assembly on implementation and administration of the PCMH model.


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