title: The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management.
abstract: OBJECTIVE
  This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management.
  
  
  METHODS
  The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks.
  
  
  RESULTS
  Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest-ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy.
  
  
  CONCLUSIONS
  The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success.
authors.affiliation: Physiatrist, MossRehab, Elkins Park, PA, USA.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Saulino
authors.affiliation: Senior Medical Science Liaison, Northeast, Mallinckrodt Pharmaceuticals, Hazelwood, MO, USA.
authors.forename: Teresa
authors.initials: T
authors.lastname: Patel
authors.affiliation: Co-Director, Saint Luke's Marion Bloch Neuroscience Institute, Kansas City, MO, USA.
authors.forename: Stanley P
authors.initials: SP
authors.lastname: Fisher
mesh_terms: D016503:Drug Delivery Systems / Q000009:adverse effects* / Q000379:methods; D000067495:Healthcare Failure Mode and Effect Analysis; D006801:Humans; D007278:Injections, Spinal / Q000379:methods*; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*; D011336:Probability; D012449:Safety
keywords: Chronic pain; intrathecal drug delivery; intrathecal pump; intrathecal therapy; safety