News you can use: health & drug safety updates


  • January 29, 2001
    Pharmacists must distribute to all Accutane patients a new Medication Guide (MedGuide) each time a prescription is dispensed. Further, a detailed Informed Consent / Patient Agreement must be signed by both patients and their physician. The form includes statements addressing risks associated with being pregnant while on Accutane, and the potential for psychiatric events.
  • January 24, 2001
    A Canadian study of over 140,000 elderly and welfare recipients who were subject to a new prescription coinsurance and deductible cost-sharing policy was conducted by researchers at McGill University. They found that after the new policy was implemented, use of essential medicines decreased by over 9% in the elderly, and by 14% in welfare recipients. There were also substantial increases in the rate of serious adverse drug events, and in emergency department visit rates, in both groups. The article, authored by R. Tamblyn et. al., appears in JAMA, Vol. 285, No. 4, Jan. 24/31, 2001.
  • January 22, 2001
    The CDC, NIH, FDA, AHRQ, HCFA and other federal agencies have developed a comprehensive action plan addressing: surveillance, prevention and control, research, and product development for antimicrobial resistance. HHS plans to launch a national public education campaign “to reduce the overuse and misuse of antimicrobial drugs and to improve antibiotic use.” NCPIE recently reported on this problem and this multi-agency action plan; click here for NCPIE’s background paper.
  • January 22, 2001
    Over half (51%) of Americans take two or more medications each day, while those aged 65 and olderaverage four each day, according to the American Society of Health-System Pharmacists. Further, 58% of respondents said they took an average of two nonprescription medicines in the past week. ASHP’s survey also found that nearly 10% of respondents do not inform hospital personnel about medications they are taking.


  • December 26, 2000
    The FDA proposed a new format for prescription medicine package inserts that would allow practitioners “to quickly find the most important information about the product,” according to HHS. The redesigned information should “enhance the safe and effective use of prescription drugs and reduce medical errors caused by inadequate communication.” Comments on the Dec. 22 Federal Register notice are due March 22, 2001.
  • 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
    “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 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,