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Adverse drug reaction reporting system: developing a well-monitored program.

D J Kilarski, B Ziegler, J Coarse

    Hospital Formulary
    |August 8, 1986
    PubMed
    Summary
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    Implementing a new adverse drug reaction (ADR) reporting system at two hospitals significantly increased documented ADRs. This proactive monitoring enhances healthcare professional awareness and aids in early identification of drug-related problems.

    Area of Science:

    • Pharmacovigilance
    • Hospital Pharmacy
    • Patient Safety

    Background:

    • Spontaneous reporting of adverse drug reactions (ADRs) was suboptimal at St. John's Hospital and Memorial Medical Center compared to literature benchmarks.
    • Existing ADR reporting procedures were reviewed to identify areas for improvement.

    Purpose of the Study:

    • To develop and implement an improved system for reporting adverse drug reactions within hospital settings.
    • To enhance the detection and documentation of ADRs.

    Main Methods:

    • A new ADR reporting program was developed and approved by a joint Pharmacy & Therapeutics (P&T) Committee.
    • The program incorporated concurrent monitoring of most hospital inpatients.
    • Retrospective review of all emergency room patient cases was also implemented.

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    Main Results:

    • Following program implementation, 162 ADR reports were documented within one year.
    • A cluster of serious ADRs associated with a specific drug agent was identified.
    • These serious ADRs were reported to the Food and Drug Administration and the drug manufacturer.

    Conclusions:

    • A comprehensive ADR monitoring program can elevate physician and nurse awareness of potential drug-related issues.
    • Proactive monitoring systems may facilitate earlier identification of ADRs.
    • Improved ADR detection has the potential to reduce morbidity among hospitalized patients.