TY - JOUR
T1 - Patient safety incidents and medication errors during a clinical trial
T2 - experience from a pre-hospital randomized controlled trial of emergency medication administration
AU - England, Ed
AU - Deakin, Charles D
AU - Nolan, Jerry P
AU - Lall, Ranjit
AU - Quinn, Tom
AU - Gates, Simon
AU - Miller, Joshua
AU - O'Shea, Lyndsey
AU - Pocock, Helen
AU - Rees, Nigel
AU - Scomparin, Charlotte
AU - Perkins, Gavin D
PY - 2020/6/14
Y1 - 2020/6/14
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Drug administration
KW - Drug errors
KW - Medication errors
UR - http://www.scopus.com/inward/record.url?scp=85086457585&partnerID=8YFLogxK
U2 - 10.1007/s00228-020-02887-z
DO - 10.1007/s00228-020-02887-z
M3 - Article
C2 - 32535646
SN - 0031-6970
VL - 76
SP - 1355
EP - 1362
JO - European Journal of Clinical Pharmacology
JF - European Journal of Clinical Pharmacology
IS - 10
ER -