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Related Experiment Videos

Infovigilance: reporting errors in official drug information sources.

Isabelle Fusier1, Corinne Tollier, Marie-Caroline Husson

  • 1Centre National Hospitalier d'Information sur le Médicament, (CNHIM), Hôpital Bicêtre, 78, rue du Général Leclerc, BP 11, 94272, Le Kremlin Bicêtre Cedex, France. ifusier@wanadoo.fr

Pharmacy World & Science : PWS
|August 13, 2005
PubMed
Summary

The French drug database infovigilance identified inaccuracies in 2.7% of drug information, with over half potentially impacting patients. Continuous monitoring is crucial for improving drug safety information.

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Area of Science:

  • Pharmacovigilance
  • Drug Safety Information Systems
  • Health Informatics

Background:

  • The Centre National Hospitalier d'Information sur le Médicament (CNHIM) in France maintains the Thériaque drug database.
  • Pharmacists report inaccuracies in drug information sources to the French drug agency.
  • The concept of "infovigilance" was developed to describe the notification of errors or inaccuracies in information sources that could lead to medication errors.

Purpose of the Study:

  • To evaluate the impact of CNHIM's "infovigilance" activities on the content of Summary of Product Characteristics (SPCs).

Main Methods:

  • A prospective study was conducted from November 2001 to December 2002.
  • Information quality problems were classified into four types: inaccuracy/confusion, error/lack of information, discordance between SPC sections, and discordance between generic SPCs.

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  • Data collected included the number of notifications, number of SPCs, types of problems, potential patient impact, and subsequent corrections.

    • Main Results:

    • 2.7% of SPCs integrated into the database during the study period were associated with a problem notification.
    • The most common issues were inaccuracy/confusion (32%) and discordance between generic SPCs (28%).
    • 55% of reported problems were deemed likely to impact patients, and 22 reported issues led to corrected SPCs.

    Conclusions:

    • Continuous "infovigilance" is essential for improving the quality of drug information sources.
    • These efforts should be sustained and potentially expanded to encompass other information sources.
    • Proactive identification and correction of inaccuracies in drug information are vital for patient safety.