News you can use: health & drug safety updates


  • March 13, 2009
    The U.S. Food and Drug Administration today announced agreements with five partners to study the effects of anesthetics and sedatives on the neurocognitive development of infants and young children. The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year. The FDA’s research partners in the SAFEKIDS Initiative include:
  • March 12, 2009
    According to a study recently completed by the Tufts Center for the Study of Drug Development, (CSDD), 75 percent of all health plans in the United States now reimburse patients for off-label prescription drug treatments. Of health plans that reimburse for off-label uses, over half impose conditions, including step therapy, indication restrictions, prior authorization, and quantity limits, and nearly 90% rely on pharmaceutical compendia to inform their off-label use reimbursement decisions, the study found. The findings were based on a Tufts CSDD survey of
  • February 12, 2009
    Americans with financial worries because of the ailing economy may be skipping needed prescription drugs in an attempt to save money, according to a survey released on Tuesday. Nearly 95 percent of doctors surveyed by Epocrates Inc. said they have some concern that patients may not be taking a prescribed drug correctly because of the economic climate. The biggest concern among the 700 doctors surveyed was that patients were simply not filling prescriptions or skipping doses. The doctors also said they believed some patients were splitting pills. The healthcare information company
  • February 10, 2009
    The Food and Drug Administration (FDA) has notified manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA, drug manufacturers, and others have taken a number of steps in the
  • February 4, 2009
    The Drug Enforcement Administration (DEA) is soliciting information on the disposal of controlled substances dispensed to individual patients as well as to long-term care facilities. DEA is seeking options for the safe and responsible disposal of dispensed controlled substances in a manner consistent with the Controlled Substances Act and its implementing regulations. Currently, prescription drug take- back programs are not permitted to accept controlled substances. DEA is accepting comments on this issue through March 23, 2009. More information is
  • January 22, 2009
    Clinical pharmacy services can significantly help curb prescription drug spending and other healthcare costs, according to a new study. According to the University of Illinois at Chicago, for every dollar spent by hospitals and health systems to provide clinical pharmacy services, $4.81 was saved by the resulting lower drug costs, reductions in adverse drug events and medication errors, and other savings. The researchers examined 93 studies on clinical pharmacy services from 2001 through 2005. “This is pretty consistent with the savings we have seen in
  • January 14, 2009
    The Centers for Medicare & Medicaid Services (CMS) launched the Medicare PHR Choice Pilot in Arizona and Utah. This pilot program will offer beneficiaries with Original Medicare the opportunity to choose one of the personal health record (PHR) products offered by the companies selected for the pilot. PHRs will allow beneficiaries to maintain their health record information electronically and Medicare will add claims data directly to the PHRs for this pilot. PHRs are tools that can help consumers keep track of information that will make it easier to manage their health
  • January 6, 2009
    More Americans are burdened by chronic illnesses such as diabetes and high blood pressure, often having more than three at a time, and this has helped fuel a big rise in out-of-pocket medical expenses. With prescription drugs playing a key role, average annual out-of-pocket medical costs — those not covered by health insurance — rose from $427 per American in 1996 to $741 in 2005, researchers wrote in the journal Health Affairs. The findings were based on nationally representative surveys of about 32,000
  • January 5, 2009
    In this study of community-dwelling older adults, prescription and nonprescription medications were commonly used together, with nearly 1 in 25 individuals potentially at risk for a major drug-drug interaction. Design, Setting, and Participants: Three thousand five community-residing individuals, aged 57 through 85 years, were drawn from a cross-sectional, nationally representative probability sample of the United States. In-home interviews, including medication logs, were administered between June 2005 and


  • December 16, 2008
    A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications. The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as