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Over-Reliance on Patient Information Sheets

      To the Editor:
      A recent Food and Drug Administration Drug Safety and Risk Management Advisory Committee on stimulant medications recommended mandatory provision of patient information sheets in filled prescriptions to warn against cardiovascular risks.

      Food and Drug Administration. Drug Safety and Risk Management Advisory Committee Meeting, February 9 and 10, 2006: table of contents. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4202_00_toc.htm. Accessed May 26, 2006.

      Similarly, antidepressants dispensed to children and adolescents must now include information sheets on suicide risk.

      Food and Drug Administration. Psychopharmacologic Drugs Advisory Committee meeting, September 13 and 14, 2004: summary minutes. Available at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugs. Accessed May 26, 2006.

      Although well-intentioned, implementation of mandatory patient guides at the point of dispensing provides a false sense of security.
      Effectiveness of these guides relies on at least 2 challenging assumptions. First, we assume that patients will receive and look at the materials. Most pharmacies provide this information as separate inserts, which may be omitted by overworked pharmacists. Secondly, we assume that written materials communicate the enclosed information effectively. In 2004, the Institute of Medicine estimated that nearly half of the adult American population has difficulty understanding complex texts, and 40 million Americans cannot read them at all.
      Even when written in simplified language, patient information sheets can be difficult to understand.
      Use of written materials to communicate health information reflects decreasing patient-provider time while increasing the need for health literacy.
      • Grumbach K.
      • Bodenheimer T.
      A primary care home for Americans: putting the house in order.
      Because of managed care time constraints and increasing responsibility for preventative services, providers who sufficiently discuss risks of pharmacologic interventions are the minority. Similarly, community pharmacists are coping with rapidly escalating pharmaceutical demand and inadequate staffing imposed by chain pharmacies.
      • Cooksey J.A.
      • Knapp K.K.
      • Walton S.M.
      • Cultice J.M.
      Challenges to the pharmacist profession from escalating pharmaceutical demand.
      Despite these challenges, patient information handouts should be viewed neither as effective public health interventions nor a transfer of ethical or legal liability.
      Effective programs in risk communication require individualized discussions with written materials used sparingly and secondarily. For many provider practices, such an interaction is not feasible. One solution is the adoption of a team-based pharmaceutical care model in which patients see a clinical pharmacist during office visits. These collaborative practices allow for specialized pharmaceutical care to optimize drug therapy and reduce risk of adverse events.

      References

      1. Food and Drug Administration. Drug Safety and Risk Management Advisory Committee Meeting, February 9 and 10, 2006: table of contents. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4202_00_toc.htm. Accessed May 26, 2006.

      2. Food and Drug Administration. Psychopharmacologic Drugs Advisory Committee meeting, September 13 and 14, 2004: summary minutes. Available at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugs. Accessed May 26, 2006.

      3. Nielsen-Bohlman L. Panzer A.M. Kindig D.A. Health Literacy: A Prescription to End Confusion. National Academies Press, Washington, DC2004
        • Grumbach K.
        • Bodenheimer T.
        A primary care home for Americans: putting the house in order.
        JAMA. 2002; 288: 889-893
        • Cooksey J.A.
        • Knapp K.K.
        • Walton S.M.
        • Cultice J.M.
        Challenges to the pharmacist profession from escalating pharmaceutical demand.
        Health Aff (Millwood). 2002; 21: 182-188