prevention of disease; intended to affect the structure or any function of the body (other than food); intended for use as a component of a medicine but not a device or a component, or a part or accessory of a device (FDA, 2004). Drugs are divided into those that require a prescription and those that do not. Nonprescription drugs are usually called “over-the-counter” (OTC) drugs (see below).
Error. The failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning). An error may be an act of commission or an act of omission (IOM, 2004).
Formulary. A schedule of prescription drugs that will be paid for by a health insurance plan and dispensed through participating pharmacies. A formulary can be an important safety tool since it can eliminate (for example, in hospitals) the use of drug products considered to be unsafe.
Hand-off. The process of moving patients and their information from one provider or site to another.
Health care professional. See clinician.
Managed Care Organization. A health care provider that attempts to manage the access, cost, and quality of health care.
Medication. See drug.
Medication error. Any error occurring in the medication-use process (Bates et al., 1995a).
Medication therapy management. A service or group of services that optimize therapeutic outcomes for individual patients to help ensure that the goals of drug therapy are achieved. These services can be provided in conjunction with or independently of the provision of a medication product by pharmacists or other qualified health care providers.
Nonformulary drug. A medication that has a preferred alternative listed in the drug formulary.
Off-label use. The Food and Drug Administration (FDA) permits the prescribing of approved medications for other than their intended indications. This practice is known as off-label use.
Orphan drug. A product that is used in the diagnosis or treatment of diseases or conditions that are considered rare in the United States.
OTC (“over-the-counter”) drug. A drug sold without a prescription. The product’s potential for misuse and abuse is low, consumers are successfully able to use it for self-diagnosable conditions, it can be adequately labeled for ease and accuracy of use, and oversight by health practitioners is not needed to ensure its safe and effective use (FDA, 2005).
Potential adverse drug event (ADE). An event in which an error occurred but did not cause injury (for example, the error was intercepted before the patient was affected, or the patient received a wrong dose, but no harm occurred) (Gandhi et al., 2000).