News you can use: health & drug safety updates


  • November 29, 2000
    The Food and Drug Administration has pulled from the market the prescription medicine Lotronex, approved in early 2000 for treatment of irritable bowel syndrome in women. In August, it became the first prescription medicine to require a detailed instruction sheet for patients, or Medication Guide.
  • November 21, 2000
    The Agency for Healthcare Research and Quality invites non-profit groups to apply for new developmental grants and program project grants pertaining to patient safety and reduction of medical errors. Letters of intent are due at AHRQ by January 3, 2001.
  • November 6, 2000
    The Food and Drug Adminstration has asked manufacturers of products containing phenylpropanolamine (PPA) to stop marketing them. PPA, a common ingredient in many non-prescription and prescrption cough and cold medicines, and in non- prescription weight loss products, may increase the risk of hemorrhagic strokes in patients who use such products. FDA advises consumers “to discuss alternative over-the-counter and prescription products with their health care providers or pharmacists.”
  • October 25, 2000
    Based on their “National Summit on Medical Errors and Patient Safety” (held in Sept. 2000), the Agency for Healthcare Research and Quality has developed a new (draft) research agenda. It includes short and long-term objectives, and sections on “epidemiology of errors,” infrastructure, and information systems, among others. Further, AHRQ has published a meeting summary, and has posted testimony from all participants. To read NCPIE’s submitted testimony, which identifies a research agenda for ambulatory-based medication safety,
  • October 25, 2000
    “Physician Education of their Patient About Prescription Medicines,” adopted by the American Medical Association House of Delegates in late 1998, recently became accessible in full on the AMA website. The report, issued by the AMA Council on Scientific Affairs, includes a recommendation that state and specialty medical societies join NCPIE to “foster better medication use through improved communication between physicians and their patients.”
  • October 1, 2000
  • September 29, 2000
    A second prescription medicine will require an official, FDA-approved “Medication Guide.” Part of the strict distribution and extensive risk-management interventions associated with the FDA’s approval of Mifepristone, indicated for early termination of pregnancy, is that physicians who prescribe and dispense the medicine must talk to their patients about the Medication Guide.
  • August 25, 2000
    Patients who fill a prescription for Lotronex to treat a form of irritable bowel syndrome (IBS) will now receive an official “Medication Guide” from their pharmacist. The FDA developed the Guide to help patients (mostly female) understand “the rare but serious risks of Lotronex and how they can recognize those risks and take early action to prevent serious harm.” Information for health care professionals who prescribe Lotronex has also been updated.
  • August 25, 2000
    A study involving 18 community nursing homes found that over half of 546 adverse drug events were preventable, according to lead researcher Jerry Gurwitz, M.D., of the Meyers Primary Care Institute (Worcester, MA). The authors note that if their findings are extrapolated to the country’s 1.5 million nursing home residents, then at least 350,000 ADEs occur each year, and more than half are preventable. The research is slated for publication in the American Journal of Medicine this year.
  • July 26, 2000
    An extensive study reported in Archives of Internal Medicine (24 July 2000) found a 76% discrepancy rate of recorded vs. actual medication use in over 300 patients studied. Of these discrepancies, 51% were due to patients taking medications not recorded (with OTC meds accounting for the single largest category). Further, 29% of the discrepancies were due to patients not taking a recorded medication. The authors recommend regular, “compulsive, specific and systematic” review of patients' medications (Rx, OTC and herbal supplements), and improved