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Related Experiment Videos

Quality control in drug measurement.

A Griffiths, S Hebdige, E Perucca

    Therapeutic Drug Monitoring
    |January 1, 1980
    PubMed
    Summary

    Quality control programs are essential for therapeutic drug monitoring, even with inconclusive evidence. Bartscontrol demonstrates that while feedback improves precision, some labs consistently perform poorly, highlighting the need for rigorous assay validation.

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    Area of Science:

    • Clinical Pharmacology
    • Laboratory Medicine
    • Quality Assurance

    Background:

    • Therapeutic drug monitoring (TDM) of serum concentrations is expanding in clinical pharmacology.
    • Evidence for TDM efficacy is inconclusive for most drugs, and drug assay reliability is often suboptimal.
    • The increasing use of routine TDM necessitates robust quality control (QC) programs.

    Purpose of the Study:

    • To describe the design and experience of the Bartscontrol quality control program.
    • To assess the impact of a QC scheme on laboratory performance in therapeutic drug monitoring.
    • To identify factors influencing the reliability of drug assays.

    Main Methods:

    • Implementation of the Bartscontrol (formerly St. Bartholomew's Hospital Quality Control Scheme for Antiepileptic Drugs) program.
    • Provision of feedback to participating laboratories on their assay performance.
    • Analysis of laboratory data to evaluate precision and identify method-specific issues.

    Main Results:

    • Feedback from the QC program generally encouraged an increase in assay precision among participants.
    • Some laboratories demonstrated consistently poor performance despite participation in the QC scheme.
    • The scheme identified specific analytical techniques, such as spectrophotometry for phenytoin, as inappropriate.

    Conclusions:

    • Quality control programs are necessary for therapeutic drug monitoring due to suboptimal assay reliability.
    • While QC feedback can improve overall precision, consistent poor performance in some labs remains a challenge.
    • QC schemes are valuable for identifying and rectifying inappropriate analytical methods in drug assays.

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