Abstract
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 language | English |
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Pages (from-to) | 1355-1362 |
Number of pages | 8 |
Journal | European Journal of Clinical Pharmacology |
Volume | 76 |
Issue number | 10 |
Early online date | 14 Jun 2020 |
DOIs | |
Publication status | Published - Oct 2020 |
Bibliographical note
Publisher Copyright:© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
Keywords
- Clinical trial
- Drug administration
- Drug errors
- Medication errors
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)