News you can use: health & drug safety updates


  • September 10, 2003
    About Over-the-Counter Medicines
  • August 25, 2003
    "Better Informed Consumers” are just one part of a new five-part strategic plan unveiled by FDA Commissioner Mark B. McClellan, M.D., Ph.D. “Protecting and Advancing America’s Health: A Strategic Action Plan for the 21st Century,” also focuses on “patient and consumer safety.” These components of the FDA’s plan complement NCPIE’s mission to improve communication between consumers and health care professionals about the safe, appropriate use of medicines. According to the FDA, people’s everyday choices “can have a great impact on their own health and the health of the
  • August 1, 2003
    Addressing the Food and Drug Administration’s July 31 public meeting on improving written consumer medicine information (CMI) that accompanies prescriptions, NCPIE representatives laid the groundwork for a private sector initiative to meet by 2006 federal goals for CMI distribution and content. “NCPIE has stepped forward to serve as catalyst and convener to stimulate voluntary, private sector efforts” to meet these goals, noted NCPIE Chairperson Linda Golodner. “We encourage all organizations “ particularly consumer and patient groups “ to
  • June 6, 2003
    The Food and Drug Administration will hold a public meeting July 31 in Washington, DC on the private sector’s efforts to meet a year 2006 goal addressing the distribution and usefulness of consumer written prescription medicine information. The notice, which includes four questions the FDA wants addressed at the meeting, was published in the June 5, 2003 Federal Register. At issue is the pharmacy- distributed, computer-generated leaflet that accompanies most prescriptions. A 2001 FDA national evaluation of these leaflets found the
  • April 18, 2003
    One-fourth of outpatients studied at four adult primary care practices in Boston were found to experience adverse drug events during a three-month period, according to research published in the New England Journal of Medicine (April 17). Of these events, 13% were serious, and 39% were ameliorable or preventable. "Ameliorable adverse drug events were attributed to poor communication,” the authors found. They defined this as “the physician’s failure to respond to symptoms reported by the patient or the patient’s failure to report symptoms to the physician.”
  • March 5, 2003
    A rare study of non-institutionalized Medicare enrollees' prescription drug use, published in today’s Journal of the AMA, found that 42% of adverse drug events (ADEs) judged to be “serious, life-threatening or fatal” were deemed preventable. Of those preventable ADEs, over half occurred at the prescribing stage and at the monitoring stage. About one-fifth of the errors were due to patient adherence problems. The research involved an examination in 1999-2000 of nearly 28,000 Medicare enrollees in a New England medical group practice. To help reduce the
  • February 14, 2003
    An editorial in this week’s British Medical Journal observes that non- compliance “continues to represent a serious therapeutic deficit at the core of medical practice.” The authors note that “it is the patients' agendas” not those of healthcare professionals that determine whether or not patients will take medicines. The U.K.-preferred term for compliance, “concordance,” is defined as “an agreement between a patient and a health care professional about whether, when and how medicines are to be taken.” Further, the BMJ
  • February 6, 2003
    The Food and Drug Administration has mandated changes in labeling for antibiotics, according to a final rule issued today (Fed. Reg., pps. 6062-6081). The rule reflects “a growing concern in FDA” that unnecessary use of systemic antibacterials “has contributed to a dramatic increase in prevalence of drug- resistant bacterial infections.” According to the Centers for Disease Control and Prevention, half of the 100 million antibiotic prescriptions written by office- based U.S. physicians are unnecessary. The new rule also encourages physician
  • January 30, 2003
    Following up with the FDA’s recent warning about buying medicines from outside the U.S. and from certain on-line pharmacies (see 10 Dec. 2002 item below), the American Pharmaceutical Association offers questions and answers for persons considering importing medicines.
  • January 21, 2003
    The U.S. Pharmacopeia (Rockville, MD) today issued tips for parents to help prevent medicine errors in children, especially if a child is going to be admitted as an inpatient. Knowing a child’s weight in kilograms, not just pounds; and sharing with health care professionals information about a child’s allergies and the names of all medicines a child is taking, can be lifesaving safety tips, according to USP.