Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Patient package inserts and the pharmacist's responsibility.

J L Fink

    American Journal of Hospital Pharmacy
    |February 1, 1979
    PubMed
    Summary

    Pharmacists must understand Food and Drug Administration (FDA) patient package insert (PPI) regulations. Evaluating alternatives to manufacturer-provided PPIs is crucial to mitigate legal, clinical, and administrative risks.

    Related Concept Videos

    You might also read

    Related Articles

    Articles linked to this work by shared authors, journal, and citation graph.

    Sort by
    Same author

    Emma & the med error.

    Journal of Christian nursing : a quarterly publication of Nurses Christian Fellowship·2002
    Same author

    Temporal gene regulation during HIV-1 infection of human CD4+ T cells.

    Genome research·2001
    Same author

    Resistance to cytotoxic drugs in DNA mismatch repair-deficient cells.

    Clinical cancer research : an official journal of the American Association for Cancer Research·1998
    Same author

    Human epidermal melanocyte and keratinocyte melanotropin receptors: visualization by melanotropic peptide conjugated macrospheres (polyamide beads).

    Experimental dermatology·1997
    Same author

    Melanotropic peptide receptors: membrane markers of human melanoma cells.

    Experimental dermatology·1996
    Same author

    Melanocortin receptors: identification and characterization by melanotropic peptide agonists and antagonists.

    Pigment cell research·1996

    Area of Science:

    • Pharmaceutical Law
    • Regulatory Affairs
    • Clinical Pharmacy

    Background:

    • Patient package inserts (PPIs) are mandated by the Food and Drug Administration (FDA).
    • Pharmacists play a critical role in ensuring patients receive and understand PPI information.
    • Non-compliance with PPI regulations can lead to significant legal consequences.

    Purpose of the Study:

    • To analyze the FDA's patient package insert regulations.
    • To examine the legal liabilities pharmacists face concerning PPIs.
    • To explore alternatives to manufacturer-provided PPIs and their implications.

    Main Methods:

    • Review of FDA regulations pertaining to patient package inserts.
    • Analysis of potential criminal and civil liability for pharmacists.
    • Evaluation of legal, clinical, and administrative aspects of alternative PPI strategies.

    Main Results:

    • Pharmacists have a defined responsibility under FDA PPI regulations.
    • Significant legal risks, including criminal and civil liability, exist for non-adherence.
    • Alternative approaches to PPI distribution present complex considerations.

    Conclusions:

    • Pharmacists must proactively manage PPI compliance.
    • Thorough assessment of alternative PPI strategies is essential.
    • Balancing administrative, clinical, and legal factors is key for prudent practice.

    Related Experiment Videos