This roundup includes the following news briefs:
The CDC is reiterating its stance(www.cdc.gov) on the use of so-called single-dose or single-use drug vials, stressing that these products should be administered to only one patient. According to the agency, these medication formulations typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection if used inappropriately.
"CDC routinely investigates and is apprised of infectious disease outbreaks involving single-dose/single-use vials being used for multiple patients," says the agency's website. "These outbreaks cause extensive harm to patients, and they are associated with significant health care and legal expenses." As to whether single-use-only guidelines and policies contribute to drug shortages, the CDC holds that "such shortages are a result of manufacturing, shipping and other issues unrelated to (such) guidelines."
According to a study(clinicaltrials.gov) sponsored by the National Heart, Lung and Blood Institute (NHLBI), infants and young children with cystic fibrosis (CF) cannot reduce how often they need antibiotics for respiratory symptoms by inhaling concentrated saline mist.
Published online in JAMA: The Journal of the American Medical Association, "Inhaled Hypertonic Saline in Infants and Young Children with Cystic Fibrosis(jama.jamanetwork.com)" is the largest study of concentrated saline therapy in infants and preschoolers to date.
"This is one more study that illustrates the importance of conducting clinical research in children because medicine is not 'one size fits all' -- therapies that benefit adults or even teenagers do not always benefit younger children in the same way," Susan Shurin, M.D., acting director of the NHLBI, said in a May 20 news release(www.nhlbi.nih.gov).
The AAFP needs solid data to provide effective support to its members. With that in mind, the Academy is asking that all members who have not already done so take the Member Census. Information gleaned from the 12-question survey will be used to focus the Academy's advocacy efforts, ensure that products and services are both relevant and timely, and better educate legislators and other decisionmakers on the issues affecting family medicine. To access the online survey, members will need to log in to the members-only area of the website.
CMS' Center for Medicare and Medicaid Innovation has released an online eligibility tool(cmsgov.secure.force.com) that will enable primary care practices to determine whether they are eligible to apply for a multipayer primary care initiative.
The tool is made up of a series of questions, allowing users to determine whether their practice qualifies for the Comprehensive Primary Care Initiative, a four-year, multipayer project that will pay participating practices based on a blended payment model that includes fee-for-service and a per-patient, per-month fee. Participating practices also may have the opportunity to share in any Medicare savings generated by the program.
States or areas chosen to participate are
- Arkansas (statewide),
- Colorado (statewide),
- New Jersey (statewide),
- New York (Capital District-Hudson Valley region),
- Ohio (Cincinnati-Dayton region),
- Oklahoma (Greater Tulsa region), and
- Oregon (statewide).
The FDA is recommending(www.fda.gov) that patients with certain cardiac risk factors should not take the oral multiple sclerosis drug fingolimod, marketed as Gilenya.
According the drug's prescribing information, fingolimod is contraindicated(www.accessdata.fda.gov) in patients who have experienced
- myocardial infarction,
- unstable angina,
- stroke or transient ischemic attack,
- decompensated heart failure requiring hospitalization, or
- Class III/IV heart failure in the past six months.
Fingolimod also is contraindicated in patients with a history of Mobitz type II second- or third-degree atrioventricular block or sick sinus syndrome, unless the patient has a pacemaker, and in those with a baseline QTc interval greater than or equal to 500 milliseconds. Treatment with Class Ia or Class III antiarrhythmic drugs also constitutes a contraindication.
In addition, the FDA recommends that all patients on the drug be monitored for at least six hours after taking the first dose and that cardiovascular monitoring be "extended past six hours in patients who are at higher risk for or who may not tolerate bradycardia."
Extended monitoring should include continuous electrocardiogram (ECG) monitoring that continues overnight. The FDA also recommends performing hourly pulse and blood pressure measurements for all patients starting the drug, as well as ECG testing performed before dosing and at the end of the observation period.
HHS has launched a new Web-based tool to help Americans monitor and measure key U.S. health system indicators, such as access to care, cost and affordability, prevention, and use of health information technology.
The initiative, known as the Health System Measurement Project(healthmeasures.aspe.hhs.gov), pulls together multiple federal data sets and presents key indicators based on population characteristics, including age, sex, income level, insurance coverage and geography.
According to an HHS press release(www.hhs.gov), the website "will allow policymakers, providers and the public to develop consistent data driven views of changes in critical U.S. health system indicators. ... For example, an individual could use the measure project to monitor the percentage of people who have a specific source of ongoing medical care or track avoidable hospitalizations for adults and children by region or ethnic group."