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

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