with structured patient education, improved the accuracy of medication management and overall quality of life. However, additional studies are needed to assess the impact of such self-monitoring on bleeding and thromboembolic complications. Given the growing prevalence of chronic conditions in the U.S. population, investment in the development of well-designed programs to assist patients with self-monitoring is essential to achieving improvements in medication safety. (See Box 2-5 for a summary of key problems with provider processes.)


Health care providers and safety agencies use error and adverse event reporting programs to learn about potential safety risks and the circumstances of individual errors (Smetzer and Cohen, 2006). Currently, a wide range of external reporting programs are available (IOM, 2004c; Smetzer and Cohen, 2006). Some of the systems are voluntary, and others are mandatory; some receive data only on adverse events, while others receive reports on all medication errors. These reporting programs include the following:

  • Institutional error reporting programs such as the Veterans Administration Patient Safety Reporting System and the U.S. Pharmacopeia’s MedMARx Program.

  • Mandatory state reporting programs, for which almost half of states require mandatory reporting of certain serious adverse events (Rosenthal and Booth, 2005).

  • Voluntary national reporting programs, such as the U.S. Pharmacopeia–Institute for Safe Medication Practice Medication Errors Reporting Program and the FDA’s MedWatch Program.

Reportable events include those due to practice-based errors (e.g., misadministered drug dosage), product safety issues (e.g., an adverse reaction to a drug), or hazardous situations (e.g., confusing labeling). All of these reporting systems currently utilize their own reporting formats. For a serious adverse event that occurs in a hospital, this means that several reports must be completed to meet the requirements for different reporting systems. The lack of a common reporting format and terminology is a significant factor that not only inhibits the reporting process, but also prevents comparison of data across health care organizations and pooling of data from different reporting programs. The IOM report, Patient Safety: Achieving a New Standard for Care, discussed extensively the need for common standards for patient safety reporting systems.

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