News you can use: health & drug safety updates

2001

  • August 27, 2001
    Since 1999, a European directive has madated the provision of patient leaflets inside the boxes of prescribed medicines. NCPIE member Theo Raynor (Univ. of Leeds, UK) and a colleague found that one-fifth of patients failed to notice the package insert; of those who did, only 21% read the entire leaflet. Raynor notes that the U.S. system of computer- generated leaflets, which promotes customization and the opportunity for direct patient counseling by the pharmacist, is much better aligned with promoting “concordance” among patients and health care professionals.
  • August 23, 2001
    Despite specific warnings about pregnancy prevention while using Accutane, thousands of Accutane patients became pregnant from 1982-2000, the Centers for Disease Control reported last week. In particular, a pictogram with a line across an image of a pregnant woman was misinterpreted by many women to mean that the drug served as birth control. In Jan. 2001, the FDA had issued more explicit warnings in an Accutane Medication Guide.
  • July 12, 2001
    While physicians and surgeons may ask patients about use of prescription medicines prior to surgery, they need to also inquire about patients' use of common herbal or dietary supplements, according to research in the July 11 Journal of the AMA. Researchers at the University of Chicago found that use of echinacea, ephedra, garlic, ginkgo, ginseng, kava, St. John’s wort and valerian may cause complications during surgery. These could include: irregular heart rhythms, increased bleeding, and dangerous interactions with prescription medicines.
  • 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.

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