News in Brief: Week of Dec. 31-Jan. 4

January 03, 2013 05:30 pm News Staff

This roundup includes the following news briefs:

[News in Brief]

Combination Hydrocodone-Acetaminophen Tablets Recalled

According to an FDA news release(, Mylan Inc. has announced a voluntary nationwide recall of three lots of combination hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.

"Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose" the release said.

The three lots -- 3037841, 3040859 and 3042573 -- were manufactured by Qualitest Pharmaceuticals and repackaged and distributed by Mylan under the UDL Laboratories label.

The FDA is asking consumers, as well as physicians and other health care professionals, who have tablets from the affected lots to contact Qualitest at (800) 444-4011. Those unsure if they have product from the affected lot number should consult their physician or pharmacy professional.

Adverse events that may be related to use of these products also may be reported to the FDA's MedWatch program(

CCHIT Expands Reach into ACO Realm

The Certification Commission for Health Information Technology( (CCHIT) recently announced that it would expand its work into the realm of accountable care organizations (ACOs).

CCHIT is known for its expertise in helping accelerate the growth of interoperable health information technology, and, for the past six years, the organization has been at the forefront of testing and certifying electronic health record systems.

According to a CCHIT press release, the reach into ACO territory would revolve around development of an IT framework for ACOs. That framework would identify the specific IT components that ACOs require to function effectively. A second objective would be to identify gaps in health IT that potentially could prevent an ACO from functioning at its highest capacity.

Vaccine Program Allows Confidential Error Reporting

The Institute for Safe Medication Practices (ISMP) has launched a Vaccine Error Reporting Program( (VERP).

According to a press release( from the institute, the ISMP developed the program with the assistance of the California Department of Public Health to allow physicians and other health care professionals to confidentially report vaccine administration errors and near-misses to better quantify sources of errors and advocate product changes to ensure patient safety.

"The purpose of VERP is to capture the unique causes and consequences of vaccine-related errors," the release said. "By collecting and quantifying information about these errors, ISMP will be better able to advocate for changes in vaccine names, labeling or other appropriate modifications that could reduce the likelihood of vaccine errors in the future."

The reporting system asks for detailed information about the occurrence, including

  • a description of what went wrong,
  • identification of any known causes or contributing factors,
  • how the event was discovered or intercepted, and
  • outcomes.

VERP should not be confused with the CDC's and FDA's joint Vaccine Adverse Events Reporting System (VAERS), which serves as the location for reporting adverse events that occur following the administration of a vaccine to a patient.

"VAERS reports should be submitted whether or not the reporter believes the adverse event was vaccine-related," the release said.

Houston Clinic Named First Accredited ACO in Nation

The Kelsey-Seybold clinic in Houston, a multispecialty group practice employing more than 370 physicians at 20 locations, recently was touted by the National Committee for Quality Assurance (NCQA) as the nation's first accredited accountable care organization (ACO).

In a press release( from the clinic, the organization noted that it underwent a rigorous assessment that focused on the evaluation of 14 standards and 65 elements. The accreditation is valid for three years.

According to an NCQA fact sheet(, the ACO accreditation process scores how well an ACO is able to perform certain tasks such as ensuring access to care, maintaining availability of care, protecting patient rights, preparing a foundation of patient-centered primary care, maintaining care management and patient-coordination capabilities, using performance data to improve quality, and using decision support to enable patients and health care professionals to identify the best care.

CDC Study Documents New HIV Infections Based on Race, Ethnicity

More than 47,000 people became infected with HIV in 2010, and black Americans continued to bear the brunt of new HIV infections, accounting for nearly half of newly diagnosed HIV cases, according to a CDC analysis(

Blacks accounted for 20,900 -- or 44 percent of -- HIV infections in 2010, according to the CDC. HIV infection rates among blacks were nearly eight times higher than those for whites, a disparity that has remained virtually unchanged since 2008. The overall incidence of HIV has remained virtually the same, at about 50,000 cases, since the mid-1990s.

Black women accounted for 13 percent of all new HIV infections in the United States in 2010 and nearly 64 percent of all new infections in the United States. According to the CDC, most black women (87 percent) were infected through heterosexual sex.

The CDC analysis also found that

  • about 78 percent of all new HIV infections in 2010 were among men who have sex with men;
  • the number of new infections among men who have sex with men in the 13- to 24-year-old age group increased 22 percent from 2008 to 2010;
  • the largest percentage of new infections in 2010 (31 percent) occurred among people ages 25-34;
  • heterosexuals accounted for 25 percent of estimated new HIV infections in 2010, and about 66 percent of those infected through heterosexual sex were women; and
  • injection drug users accounted for 8 percent of estimated new HIV infections in 2010, roughly the same number of new infections as in 2008.