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Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance.

Victoria Newbould1, Steven Le Meur2, Thomas Goedecke3

  • 1Inspections, Human Medicines Pharmacovigilance and Committees Division, Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA), London, E14 5EU, UK. victoria.newbould@ema.europa.eu.

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Medication error reports in EudraVigilance increased significantly from 2002-2015. This trend may stem from heightened awareness, improved terminology, and new regulations, alongside increased medication availability.

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Area of Science:

  • Pharmacovigilance and drug safety research.
  • Regulatory science and medication error analysis.

Background:

  • Medication errors are a growing concern in public health.
  • Regulatory bodies are increasing focus on pharmacovigilance for error prevention.

Purpose of the Study:

  • To analyze trends in spontaneously reported medication errors within the EudraVigilance database.
  • To characterize medication errors reported between 2002 and 2015, prior to EU guidance.

Main Methods:

  • Utilized EudraVigilance case reports from 2002-2015.
  • Identified medication errors using Standardised MedDRA Queries (SMQ).
  • Categorized cases by MedDRA terms, region, age, and drug classification.

Main Results:

  • Over 147,000 case reports were identified, with a notable increase in medication error reports over time.
  • European Economic Area (EEA) cases peaked around 2005 and 2012.
  • Adults comprised 52% of cases with age data, followed by the elderly (30%) and children (18%).

Conclusions:

  • Medication error reporting in EudraVigilance showed a steady rise from 2005-2015.
  • Potential contributing factors include increased awareness, MedDRA terminology updates, and 2012 EU pharmacovigilance legislation.
  • The expanding availability of medications may also contribute to a higher risk of errors.