News you can use: health & drug safety updates


  • July 5, 2001
    The concept of “concordance,” a term preferred in the United Kingdom to that of medication “compliance,” is explored in depth in the International Journal of Pharmacy Practice (June 2001). Research from U.K. and U.S. experts in both concepts is presented, including the lead article, “From compliance to concordance,” and an assessment of whether “concordance” serves patient medication management.
  • May 26, 2001
    Pediatric inpatients, particularly those in the neonatal intensive care unit, are significantly at higher risk of a potential adverse drug event (ADE), according to a new study published in the April 25, 2001 JAMA. Researchers reviewed nearly 11,000 medication orders, and found an error rate of nearly 6%. Most potential ADEs occurred at the drug ordering stage. Computerized physician order entry could have prevented 93% of potential ADEs, and clinical pharmacists could have prevented 94% of potential ADEs.
  • April 25, 2001
    NCPIE Board member U.S. Pharmacopeia (Rockville, MD) recently released a set of principles to promote appropriate use of medicines. These address individualizing the drug selection; monitoring patients for therapeutic interventions; and adequately educating patients (and their caregivers) about their treatment program.
  • April 25, 2001
    NCPIE has been invited to serve on a panel at the April 23-24 “National Summit on Patient Safety Data Collection and Use,” to be held in Reston, VA. The program — co-sponsored by the Agency for Healthcare Research and Quality, CDC, FDA and the Health Care Financing Administration — will serve as a forum to discuss efforts to collect and use data to improve patient safety, and to minimize data collection burdens.
  • 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.