Process changes to increase compliance with the universal protocol for bedside procedures.

out appropriate context is not helpful. Prescribers ignore vague, difficult-to-interpret warnings, even for risks that have been deemed serious. In addition, dizzying lists of all known and theoretical ADEs, regardless of severity, frequency, or causality may discourage prescribers and patients from using a valuable drug. As proof, risk communications have been shown to reduce prescribing of drugs, often with poor health outcomes. The FDA guidance document on the presentation of information in the “Adverse Reactions” section of the drug label offers a framework for selecting, characterizing and organizing adverse event information. The document suggests that ADEs that occur at the same rate as placebo, should generally not be included. Vague terms such as “common,” “rare,” “infrequent,” or “frequent” should be avoided unless linked to specific frequencies. An example of a specified frequency for “common” ADEs would be those that occurred in at least 10% of treated patients and at a rate at least twice that of placebo. Furthermore, ADEs should be reported in a hierarchical manner, with those that occurred with higher frequency first, followed by those that caused therapy discontinuation and those that occurred with lower frequency but were serious (eg, fatal, life threatening, or caused or prolonged hospitalization). In all cases, only those ADEs for which there is plausible causality should be included. Since these guidances are not legally binding, it is not known to what extent drug labels follow these recommendations. A consistent approach to the selection and risk characterization of ADEs in the drug label is needed, particularly with the documented proliferation of ADEs that now reside in the drug label. At the minimum, drug labels should present ADE information in a standardized format using common terminology and definitions so that health care providers can systematically process and manage the deluge of clinical data. The recommendations set forth by FDA guidance documents provide an excellent starting point. As with all quality health care improvement initiatives, a validation process for drug labels linked to outcomes—including health care provider comprehension, perception of drug benefits, and risks and usability—as a decision-making tool are needed. The information within the drug label must receive regular, rigorous evaluation for currency and clinical relevance to health care providers of varying background, training, and experiences. While studies exist evaluating modes of effective risk-benefit communications to patients, little has been published regarding communication of drug information to health care providers. Responsible oversight on the development and revision of drug labels is necessary to ensure the effective delivery of unbiased, comprehensive, accurate, up-to-date, and user-friendly drug information.