According to an FDA alert(www.fda.gov), Main Street Family Pharmacy LLC of Newbern, Tenn., has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy due to seven reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature.
The reports of adverse events are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. An FDA/CDC investigation into the exact source of the adverse events is ongoing. The compounded products that are subject to the recall are those with a "use by" date on or before Nov. 20.
The FDA recommends that physicians and other health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.
Adverse effects that may be related to use of these products can be reported via RxEvent, an adverse drug event reporting service that has partnered with the AAFP, or MedWatch(www.accessdata.fda.gov), the FDA's Safety information and Adverse Event Reporting Program.
The U.S. Preventive Services Task Force (USPSTF) issued a draft statement(www.uspreventiveservicestaskforce.org) on May 27 recommending that primary care clinicians screen for gestational diabetes mellitus (GDM) in asymptomatic pregnant women after 24 weeks of gestation. In addition, the USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for GDM in asymptomatic pregnant women before 24 weeks' gestation.
According to the statement, the prevalence of GDM in the United States is 1 percent to 25 percent, depending on patient demographics and diagnostic thresholds. Pregnant women with gestational diabetes are at increased risk for maternal and fetal complications, including pre-eclampsia, fetal macrosomia and neonatal hypoglycemia.
The task force found adequate evidence that treatment of screen-detected GDM with dietary modifications, glucose monitoring and insulin (if needed) can significantly reduce the risk of pre-eclampsia, fetal macrosomia and shoulder dystocia.
"When these outcomes are considered collectively, there is a moderate net benefit for both mother and infant," says the statement. "The benefit of treatment on long-term metabolic outcomes in women who are treated for GDM compared with those who are not treated is uncertain."
The AAFP's current recommendation posits that evidence is insufficient to assess the balance of benefits and harms of screening for GDM, either before or after 24 weeks' gestation. The Academy is reviewing the draft USPSTF recommendations and will update its own GDM recommendations after the USPSTF publishes its final conclusions.
The draft recommendation is available for comment(www.uspreventiveservicestaskforcecomments.org) until June 24 at 5 p.m. EDT.
The Center for Studying Health System Change (HSC) has published new research indicating that extreme geographic variations in Medicare costs are largely attributable to health differences in communities rather than inefficiencies in health care delivery.
According to a May 28 media advisory(www.hschange.org) issued by the HSC, the new study questions results of previous research that called on health care professionals to adopt treatment patterns found in low-cost regions of the country to reduce Medicare spending by as much as 30 percent.
The latest study, “Geographic Variation in Fee-for-Service Medicare Beneficiaries’ Medical Costs Is Largely Explained by Disease Burden,” is published online in Medical Care Research and Review; an abstract of the study is available for review at no charge.
The Senate recently confirmed Marilyn Tavenner, M.A., as CMS administrator, thus providing the agency with its first confirmed administrator in six years.
Tavenner served two stints as acting CMS administrator, from April 2010 to July 2010, before Donald Berwick, M.D., was appointed CMS head, and again following the December 2011 resignation of Berwick. As CMS administrator, Tavenner will play a major role in implementing the health care reform law.
In a prepared statement, AAFP President Jeff Cain, M.D., of Denver, praised the Senate for confirming Tavenner's nomination, saying "CMS requires a strong leader who brings expertise in both state and national health issues and in politics that will build and sustain the primary care physician workforce. With her background working in the private sector and her experience in the public sector, Marilyn Tavenner is just such a leader."
Tavenner was a former executive at the Hospital Corp. of America, a former secretary of health and human resources for the governor of Virginia and the former president of the Virginia Hospital Association before coming to CMS. She also served on the board of directors of the American Hospital Association.
The overwhelming majority of Americans abide by self-imposed nonsmoking rules in their homes and cars, but a high number of nonsmokers still are exposed to second-hand smoke in their homes and vehicles, says a new CDC survey(www.cdc.gov).
The National Adult Tobacco Survey found that 81 percent of U.S. adults report having smoke-free rules in their homes and 74 percent have smoke-free rules in their vehicles. Nearly 11 million nonsmoking adults continue to be exposed to second-hand smoke in their homes, and almost 17 million nonsmoking adults are exposed to second-hand smoke in their vehicles, according to the survey.
"While almost half of all U.S. residents are protected by 100 percent smoke-free policies in their worksites, restaurants and bars, overall, there are still an estimated 88 million nonsmoking Americans over the age of 3 who are exposed to second-hand smoke," said Brian Kin, Ph.D., a CDC epidemiologist in the CDC's Office on Smoking and Health and lead author of the study, in a CDC press release(www.cdc.gov).
The survey also found that second-hand smoke exposure in homes and vehicles was greatest among men, younger adults, non-Hispanic blacks and those with a lower level of education.