Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.
Ed EnglandCharles D DeakinJerry P NolanRanjit LallTom QuinnSimon GatesJoshua MillerLyndsey O'SheaHelen PocockNigel ReesCharlotte ScomparinGavin D PerkinsPublished in: European journal of clinical pharmacology (2020)
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.
Keyphrases
- patient safety
- adverse drug
- healthcare
- quality improvement
- clinical trial
- end stage renal disease
- randomized controlled trial
- study protocol
- phase ii
- open label
- newly diagnosed
- phase iii
- ejection fraction
- electronic health record
- chronic kidney disease
- emergency department
- prognostic factors
- peritoneal dialysis
- public health
- squamous cell carcinoma
- patient reported outcomes
- deep learning
- data analysis
- locally advanced
- acute care
- health insurance