title: Identifying systems failures in the pathway to a catastrophic event: an analysis of national incident report data relating to vinca alkaloids.
abstract: BACKGROUND
  Catastrophic errors in healthcare are rare, yet the consequences are so serious that where possible, special procedures are put in place to prevent them. As systems become safer, it becomes progressively more difficult to detect the remaining vulnerabilities. Using inadvertent intrathecal administration of vinca alkaloids as an example, we investigated whether analysis of incident report data describing low-harm events could bridge this gap.
  
  
  METHODS
  We studied nine million patient safety incidents reported from England and Wales between November 2003 and May 2013. We searched for reports relating to administration of vinca alkaloids in patients also receiving intrathecal medication, and classified the failures identified against steps in the relevant national protocol.
  
  
  RESULTS
  Of 38 reports that met our inclusion criteria, none resulted in actual harm. The stage of the medication process most commonly involved was 'supply, transport and storage' (15 cases). Seven cases related to dispensing, six to documentation, and four each to prescribing and administration. Defences most commonly breached related to separation of intravenous vinca alkaloids and intrathecal medication in timing (n=16) and location (n=8); potential for confusion due to inadequate separation of these drugs therefore remains. Problems involved in six cases did not align with the procedural defences in place, some of which represented major hazards.
  
  
  CONCLUSIONS
  We identified areas of concern even within the context of a highly controlled standardised national process. If incident reporting systems include and encourage reports of no-harm incidents in addition to actual patient harm, they can facilitate monitoring the resilience of healthcare processes. Patient safety incidents that produce the most serious harm are often rare, and it is difficult to know whether patients are adequately protected. Our approach provides a potential solution.
authors.affiliation: Centre for Medication Safety and Service Quality, Pharmacy Department, Imperial College Healthcare NHS Trust, London, UK Department of Practice and Policy, UCL School of Pharmacy, London, UK.
authors.forename: Bryony Dean
authors.initials: BD
authors.lastname: Franklin
authors.affiliation: Department of Primary Care and Public Health, Imperial College London, London, UK.
authors.forename: Sukhmeet S
authors.initials: SS
authors.lastname: Panesar
authors.affiliation: Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Vincent
authors.affiliation: Institute of Global Health Innovation, Imperial College London, London, UK.
authors.forename: Liam J
authors.initials: LJ
authors.lastname: Donaldson
mesh_terms: D016208:Databases, Factual; D004739:England / Q000453:epidemiology; D006801:Humans; D008508:Medication Errors / Q000009:adverse effects / Q000706:statistics & numerical data*; D061214:Patient Safety / Q000592:standards / Q000706:statistics & numerical data; D012308:Risk Management / Q000592:standards*; D014748:Vinca Alkaloids / Q000009:adverse effects*; D014852:Wales / Q000453:epidemiology
chemical_list: D014748:Vinca Alkaloids
keywords: Incident reporting; Medication safety; Risk management