Off-Label Prescription and Challenges in Clinical Practice: An Abridged Review

    Deepika Tikoo, Manisha Gupta
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    TLDR The review suggests doctors should carefully weigh risks and benefits of off-label drug use, involve patients in decisions, and calls for better regulations and monitoring.
    The 2020 review article discusses the complexities of off-label drug prescribing, which is common in vulnerable populations such as children, psychiatric patients, pregnant women, and cancer patients due to limited data or treatment options. While off-label use can be beneficial, it also carries safety risks because of the absence of thorough efficacy and safety studies. The review calls for careful risk/benefit assessments by physicians, uniform regulations, and informed decision-making involving all stakeholders. It highlights the need for patient autonomy and informed consent, with patients being encouraged to discuss their treatment's approved and unapproved uses. Regulatory bodies are urged to monitor off-label use and establish guidelines to ensure drugs are used safely and effectively based on risk/benefit evaluations.
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