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Related Experiment Videos

Generics: what's in a name?

L G Keith1, J J Oleszczuk, C S Stika

  • 1The Department of Obstetrics and Gynecology, Northwestern University Medical School, Prentice Women's Hospital and Maternity Center, Chicago, Illinois, USA.

International Journal of Fertility and Women'S Medicine
|August 6, 1998
PubMed
Summary
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Physicians must carefully consider brand-name versus generic drug prescribing. Factors beyond bioequivalence, like narrow therapeutic indices, are crucial for patient safety and effective treatment outcomes.

Area of Science:

  • Pharmacology and Therapeutics
  • Health Economics
  • Medical Ethics

Background:

  • Prescribing has evolved from compounding individualized prescriptions to selecting specific drugs.
  • The choice between brand-name and generic medications is a common clinical decision.
  • Generic drugs are often chosen for economic reasons, with an expectation of identical therapeutic effects.

Purpose of the Study:

  • To explore the multifaceted considerations in brand-name versus generic drug prescribing.
  • To highlight the limitations of relying solely on bioequivalence data.
  • To emphasize the need for prescribing vigilance in clinical practice.

Main Methods:

  • Review of current prescribing practices in the United States.
  • Analysis of factors influencing brand-name vs. generic selection.

Related Experiment Videos

  • Discussion of regulatory tools like the FDA's Orange Book for assessing bioequivalence.

    • Main Results:

    • Bioequivalence, while important, is insufficient for rational prescribing decisions.
    • Scientific, ethical, and economic factors must be integrated into the decision-making process.
    • Insufficient or controlling information often complicates prescribing choices.

    Conclusions:

    • Brand-name medications may be preferable for drugs with a narrow therapeutic index or high risk of generic switching.
    • Prescribing vigilance is essential to ensure optimal patient outcomes.
    • A comprehensive approach considering multiple factors is necessary for informed drug selection.