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Related Experiment Videos

"Side" effects: a misnomer

C R Joyce

    Journal of Medical Ethics
    |September 1, 1976
    PubMed
    Summary
    This summary is machine-generated.

    The term "side effects" may understate drug impacts. Collecting patient and physician data is crucial for identifying unintended drug effects and improving drug safety.

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    Area of Science:

    • Pharmacovigilance and Drug Safety
    • Clinical Pharmacology
    • Medical Ethics

    Background:

    • The term "side effects" inadequately describes severe adverse drug reactions, as exemplified by thalidomide's tragic outcomes.
    • Current pre-market clinical trials cannot fully anticipate or eliminate all adverse drug effects.
    • There is a need for improved communication channels regarding drug effects observed post-marketing.

    Purpose of the Study:

    • To advocate for replacing the term "side effects" with "additional effects" to better reflect drug impacts.
    • To emphasize the importance of systematic collection and evaluation of data from patients and physicians.
    • To propose mechanisms for reassessing drug safety based on real-world observations.

    Main Methods:

    • Literature review and commentary on existing drug safety reporting and evaluation practices.

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  • Analysis of the limitations of pre-market drug testing.
  • Discussion of physician and patient reporting of drug effects to manufacturers.
  • Main Results:

    • Existing terminology may minimize the significance of adverse drug events.
    • Effective post-marketing surveillance requires robust data collection from healthcare providers and patients.
    • Current regulatory bodies may lack the capacity for continuous drug reassessment.

    Conclusions:

    • A shift in terminology from "side effects" to "additional effects" is proposed to enhance the perception of drug risks.
    • Establishing a dedicated panel for reassessing drugs based on post-marketing data is recommended.
    • The medical necessity of a drug should be established prior to its manufacture and widespread prescription.