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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Genetic polymorphisms in drug targets have emerged as critical determinants of interindividual variability in drug response and toxicity. Pharmacogenomic investigations increasingly focus on identifying these variations to personalize and optimize therapeutic interventions. A drug target may be a receptor, enzyme, or signaling protein involved in pharmacologic responses or disease-related pathways. While early pharmacogenetic studies focused primarily on drug metabolism, current research...
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A decade of Australian methotrexate dosing errors.

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Accidental daily dosing of methotrexate causes life-threatening toxicity. This study found continued dosing errors, highlighting the need for improved safety measures to prevent harm from this common medication.

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Area of Science:

  • Pharmacovigilance
  • Patient Safety
  • Drug Toxicology

Background:

  • Accidental daily dosing of methotrexate can lead to severe toxicity.
  • Previous safety initiatives have not fully eliminated methotrexate dosing errors.

Purpose of the Study:

  • To investigate methotrexate dosing errors reported to national safety databases.
  • To identify the frequency, causes, and outcomes of accidental daily methotrexate administration.

Main Methods:

  • Retrospective review of coronial cases (2000-2014).
  • Analysis of reports to the Therapeutic Goods Administration Database of Adverse Event Notifications (TGA DAEN) (2004-2014).
  • Examination of Australian Poisons Information Centres (PICs) data (2004-2015) for accidental daily dosing errors.

Main Results:

  • Seven deaths linked to erroneous daily methotrexate dosing were identified in coronial cases.
  • The TGA DAEN reported 10 medication errors, including two deaths.
  • Australian PICs documented 92 cases, with an increase observed in 2014-2015, attributed to patient misunderstanding and packaging errors.

Conclusions:

  • Methotrexate dosing errors remain a significant and potentially lethal problem.
  • Enhanced strategies, including packaging changes, clear labeling, and software alerts, are crucial for preventing harm.
  • Ongoing vigilance and evaluation of safety interventions are necessary.