The World Health Organization has defined an adverse drug reaction as a response to a drug that is noxious and unintended and occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or modification of physiological function (WHO, 1975). This definition excludes injuries due to drugs that are caused by errors, which are of obvious interest. As a result, drug safety researchers coined the term adverse drug event to include both adverse drug reactions (which are nonpreventable), and preventable adverse drug events (Bates et al., 1995b). From the safety perspective, preventable adverse drug events are most important because they are known to be preventable today; adverse drug reactions are also important, however, since it may become possible to prevent them in the future by using new approaches, such as pharmacogenomic profiling.

Audiences for the Report

The committee sought to assess the roles of and make recommendations for all of the major stakeholders involved in the safe use of medications:

  • First and foremost, the consumer4 or patient who uses a medication, as well as family members, friends, and neighbors who may be involved in assisting the patient.

  • Individual health care providers—physicians, nurses, and pharmacists.

  • The organizations responsible for delivering care, for example, hospitals, nursing homes, ambulatory clinics, pharmacies, and pharmacy benefit managers.

  • Those responsible for salient policy (Congress and state legislators), payment (CMS and commercial insurers), regulation (for example, the FDA and state regulatory bodies), accreditation (for example, JCAHO), and professional education (for example, schools of nursing).

  • Manufacturers of medications and the systems used in medication delivery (for example, intravenous pumps and health information technology systems) and providers of value-added services (for example, tools that indicate harmful drug–drug interactions).

In carrying out the study, the committee took the view that the goal of all these stakeholders with regard to medication use should be to optimize the relationship between the patient and the health care provider(s) so as to meet the six aims set forth in the Quality Chasm report (care should be safe, effective, timely, patient-centered, equitable, and efficient) (IOM, 2001). In


In this report, the term consumers is often used in referring to patients to emphasize the active role individuals need to take in ensuring the quality of the health care services they are purchasing.

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