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  • 340b program A program created by the U.S. government and managed by the Health Resources and Services Administration that requires drug manufacturers to provide significant discounts to qualifying health organizations for outpatient medications.

  • a priori Determining specific study criteria prior to study initiation.

  • Abbreviated New Drug Application (ANDA) A version of a new drug application that is submitted to the FDA for the review and potential approval of a generic drug product.

  • absolute liability See strict liability.

  • absolute risk reduction The difference in the percentage of subjects developing the adverse event in the control group versus subjects in the intervention group. Also refers to the number of subjects spared the adverse event by taking the intervention compared to the control.

  • abstracting A literature cataloging activity that includes a brief description (or abstract) of the information provided by the article or resource cited.

  • abstracts A synopsis (usually of 250 words or less) of the most important aspect(s) of an article.

  • academia Pertaining to a college, school, or other educational institution.

  • academic detailing A process by which a health care educator visits physicians to provide a 15 to 20 minute educational intervention on specific topics. Information provided is based on prescribing patterns and evidence-based medicine.

  • accountable care organization (ACO) A collaborative group of hospitals, doctors, and other providers of health care who coordinate their patient care efforts for Medicare patients. An emphasis is placed on minimizing duplication of effort and on preventing medical errors, in particular, for the chronically ill.

  • ACO See accountable care organization.

  • action-guides A term coined by Beauchamp and Childress to refer to a hierarchical approach to analysis of an ethical issue when forming particular judgments about the issue.

  • active control A standard therapy or procedure (but not a placebo) used in a study to determine the difference in effect produced by the study intervention.

  • active pharmaceutical ingredient (API) The active portion of a medication, sometimes known as the “raw material.”

  • adaptive clinical trial A trial design, also known as group sequential design, that allows adaptation of various components such as inclusion/exclusion criteria, dosing, efficacy outcomes, and duration of trial based on continuously emerging knowledge throughout the study.

  • ADC See automated dispensing cabinet.

  • ADE See adverse drug event.

  • adjunctive therapy A therapy (e.g., medication, exercise, diet) that all subjects within a study receive; it is not considered a study bias since the effect of this therapy occurs among all subjects within the study.

  • ADR See adverse drug reaction.

  • adverse drug event (ADE) An ADE is defined as an injury from a medicine or lack of intended medicine. An ADE refers to all adverse drug reactions (ADRs), including allergic or idiosyncratic reactions, as well as medication errors that result in harm to a patient.

  • adverse drug event (ADE) monitoring Computer programs that use electronic data and predetermined rules to identify when an ADE may have occurred or is about to occur. May be done by manual methods in some places.

  • adverse drug ...

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