News you can use: health & drug safety updates


  • 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
  • July 21, 2000
    Detailed draft standards for both format and content of written information have been developed by USP (U.S. Pharmacopeia). They are based on the “Action Plan for the Provision of Useful Prescription Medicine Information,” developed by NCPIE coalition members and other organizations in late 1996; and on USP-commissioned research to assess USP’s own patient information leaflets. Comments are due at USP by 11 August 2000.
  • July 5, 2000
    University of Michigan physicians, while noting that many psychiatric illnesses “hamper communication,” have found that a positive patient-physician relationship is especially important even during brief medication checks. Originally presented at the American Psychiatric Association annual meeting (May 2000), the research is summarized in JAMA.
  • June 28, 2000
    Nearly half of cancer patients are using unconvential medical therapies, but they only disclose that information to physicians if specifically asked about alternate therapies, notes the short brief, “Do Ask, Do Tell” in today’s Journal of the AMA.
  • May 23, 2000
    The AARP surveyed over 1300 adults about print (not broadcast) direct-to- consumer (DTC) pharmaceutical advertisements. They found that 66% of people surveyed in the 18-39 age group noticed the “small print” information about risks and side effects, compared to only 48% of consumers age 60 and older. In another part of their survey, while over half of all consumers said that their physicians “usually” talk to them about product risks or potential side effects, 17% of respondents age 60 and older reported “rarely” having such conversations.
  • April 19, 2000
    In late March, the FDA co-sponsored with the National Patient Safety Foundation a workshop for consumer and patient organizations (including NCPIE) to promote more direct patient involvement in their own medical care. NCPIE’s emphasis on consumers' role on their “Medicine Education Team” fits perfectly with the workshop message.