News in Brief: Week of May 2-6

May 04, 2011 05:15 pm News Staff

This roundup includes the following news briefs:

Potency Issue Prompts Recall of Warfarin Sodium

Bristol-Myers Squibb is recalling one lot of 1,000-count bottles containing 5-milligram tablets of warfarin sodium, which is marketed as Coumadin, because of potency issues.

Bristol-Myers Squibb said in a May 2 news release(www.fda.gov) that bottles from lot 9H49374A were distributed to pharmacies for further dispensing to patients in prescription quantities. The company said patients who have 5-mg warfarin tablets should not interrupt their therapy but should contact their pharmacist to see if they have tablets from the affected lot. If so, the company said patients should consult their physician for appropriate medical advice.

Bristol-Myers Squib said a single tablet from the recalled lot was found to be higher in potency than expected during testing. Patients could be at increased risk of bleeding if there is too much active ingredient in their warfarin medication.

Adverse reactions should be reported to the FDA's MedWatch program(www.fda.gov).

Health Reform Makes Insurance Affordable for Most Families

About 90 percent of American families living above the poverty level will be able to afford health insurance because of subsidies arising from passage of the Patient Protection and Affordable Care Act, according to a new study from the Commonwealth Fund.

The study(www.commonwealthfund.org) notes that the majority of households have room in their budgets for the necessities, as well as for health insurance premiums and moderate levels of out-of-pocket costs established by the health care reform legislation.

Less than 10 percent of families living above the federal poverty level do not have the resources to pay for premiums and typical out-of-pocket costs, although affordability becomes a problem when families have high out-of-pocket spending, the study says.

FDA, FTC Target Fraudulent STD Products

The FDA and the Federal Trade Commission, or FTC, have announced a joint effort to remove products from the market that make unproven claims to treat, cure or prevent STDs.

The products, which have been sold online and in retail outlets, include Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak. The FDA said in a May 3 news release(www.fda.gov) that the products have not been evaluated by the agency for safety and effectiveness.

The FDA said some companies market the products as dietary supplements, but they are drug products under the terms of the Federal Food, Drug and Cosmetic Act because they are offered for the treatment of a range of STDs, including herpes, chlamydia, genital warts, HIV and AIDS.

The FDA said consumers and health care professionals should report complaints or problems with these products to the agency's MedWatch program(www.fda.gov).

Clinics Should Collect Racial, Ethnic Data to End Health Care Disparities

As a step toward ending health care disparities, ambulatory clinics should ask patients about their racial, ethnic and language backgrounds, says a report from the Commission to End Health Care Disparities(www.ama-assn.org), a coalition of 70 professional societies and organizations.

According to the report(www.ama-assn.org), ambulatory clinics are the best sites within the health care system to collect information about a patient's race and ethnicity. Practices then can use that information to provide better care.

The report proposes an initiative, called "Two Clicks to Equity," that would work with electronic health record system vendors to ensure that demographic data is being collected reliably and can be displayed usefully.

James Rohack, M.D., AMA immediate past president and co-chair of the commission, said in an AMA press release(www.ama-assn.org) that demographic data are important as a means to resolve health care disparities. "To ensure all patients are able to access and receive high quality care, basic demographic information needs to be collected so that we can better identify where disparities exist and, consequently, work more effectively to end these disparities."

AHRQ Posts Videos From International Primary Care Conference

The Agency for Healthcare Research and Quality, or AHRQ, has posted videos(www.ahrq.gov) from an AHRQ-hosted international primary care conference co-sponsored by the Commonwealth Fund and organized in partnership with the AAFP's Robert Graham Center.

The conference on international lessons in primary care system design and development was held in Washington in early April. It brought together leading thinkers, researchers and implementers from Australia, Canada, Denmark, the Netherlands, New Zealand, Great Britain and the United States to discuss models of care, system and community infrastructure, and health care financing, among other topics.

AHRQ plans to publish a summary of the conference and individual papers from each of the seven participating delegations later this year.