The Institute of Medicine is mandated by Congress to "carry out a comprehensive study of drug safety and quality issues in order to provide a blueprint for system-wide change." The objectives of the study, as defined by Congress in the Medicare Modernization Act of 2003 (Section 107(c)), are to:

1. Develop a full understanding of drug safety and quality issues through an evidence-based review of literature, case studies, and analysis. This review will consider the nature and causes of medication errors, their impact on patients, the differences in causation, impact and prevention across multiple dimensions of health care delivery-- including patient populations, care settings, clinicians, and institutional cultures.
2. Attempt to develop credible estimates of the incidence, severity, costs of medication errors that can be useful in prioritizing resources for national quality improvement efforts and influencing national health care policy.
3. Evaluate alternative approaches to reducing medication errors in terms of their efficacy, cost-effectiveness, appropriateness in different settings and circumstances, feasibility, institutional barriers to implementation, associated risks, and the quality of evidence supporting the approach.
4. Provide guidance to consumers, providers, payers, and other key stakeholders on high-priority strategies to achieve both short-term and long-term drug safety goals, to elucidate the goals and expected results of such initiatives and support the business case for them, and to identify critical success factors and key levers for achieving success.
5. Assess the opportunities and key impediments to broad nationwide implementation of medication error reductions, and to provide guidance to policy-makers and government agencies (including the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the National Institutes of Health) in promoting a national agenda for medication error reduction.
6. Develop an applied research agenda to evaluate the health and cost impacts of alternative interventions, and to assess collaborative public and private strategies for implementing the research agenda through AHRQ and other government agencies.

Key Definitions

"Drug safety and quality issues" means issues relating to the safe, effective, appropriate, and efficient use of medications. This includes the quality of the five components or subsystems of the medication use system - including: selecting and procuring the drug by the pharmacy, prescribing and selecting the drug for the patient, preparing and dispensing it, administering the drug, and monitoring the patient for effect.

For the purposes of this study, a "drug" includes prescription drugs and biologics excluding blood and blood products and tissues for transplantation.

As used in this study, the phrase "drug safety and quality" does not include known risks associated with the medication itself, product purity, or integrity, that are the subject of extensive FDA oversight and regulation through the drug approval process and good manufacturing practice (GMP) regulations and guidance.

Contact information: aschultz@nas.edu, 202-334-2796