Pharmacovigilance - Terms Commonly Used in Drug Safety

Terms Commonly Used in Drug Safety

  • Benefits are commonly expressed as the proven therapeutic good of a product but should also include the patient’s subjective assessment of its effects.
  • Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population; the probability of an occurrence.
  • Harm is the nature and extent of the actual damage that could be caused. It should not be confused with risk.
  • Effectiveness is used to express the extent to which a drug works under real world circumstances, i.e., clinical practice (not clinical trials).
  • Efficacy is used to express the extent to which a drug works under ideal circumstances (i.e., in clinical trials).

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