News you can use: health & drug safety updates


  • 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
  • December 15, 2008
    The Center for Improving Medication Management
  • November 25, 2008
    Comments on a study examining the impact on consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) prescription drug television advertisements are being sought by FDA. The study will examine the placement of the toll-free statement and the length of time the statement is presented on-screen in a DTC television advertisement for a prescription drug. Federal Register Pre-Publication Notice
  • October 31, 2008
    More and more U.S. children are being given drugs to fight chronic conditions such as asthma and hyperactivity, according to a study published on Monday. From 2002 to 2005 prescriptions for medicines to treat type-2 diabetes doubled, asthma medications rose by more than 46 percent, medicines for attention-deficit hyperactivity disorder increased by more than 40 percent and prescriptions for cholesterol-lowering drugs were up by 15 percent. The study was conducted by Emily Cox of Express Scripts Inc. in St. Louis, a manager of pharmacy insurance