Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration

Research output: Contribution to journalArticlepeer-review


  • Ed England
  • Charles D Deakin
  • Jerry P Nolan
  • Ranjit Lall
  • Tom Quinn
  • Joshua Miller
  • Lyndsey O'Shea
  • Helen Pocock
  • Nigel Rees
  • Charlotte Scomparin
  • Gavin D Perkins

Colleges, School and Institutes

External organisations

  • South Central Ambulance Service NHS Foundation Trust, Otterbourne, UK.
  • South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK; NIHR Southampton Respiratory Biomedical Research Unit, Southampton, SO16 6YD, UK.
  • Royal United Hospital Bath NHS Trust, Royal United Hospital, Avon, Bath, Somerset, UK.
  • Warwick University
  • Kingston University and St George's, University of London
  • West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.
  • Welsh Ambulance Services NHS Trust
  • Sandwell and West Birmingham Hospitals (SWBH) and University Hospitals Birmingham (UHB) NHS Trust, Birmingham, United Kingdom.


AIM: To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials.

METHODS: The PARAMEDIC2 trial was undertaken across five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation were randomly assigned to 1 mg intravenous adrenaline or matching placebo. Records were reviewed to identify trial medication errors involving documentation and/or clinical protocol errors occurring in trial participants. Causes of medication errors, including root cause analysis where available, were reviewed to identify patterns and themes contributing to these errors.

RESULTS: Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.


Original languageEnglish
JournalEuropean Journal of Clinical Pharmacology
Publication statusE-pub ahead of print - 14 Jun 2020