Application of system-level root cause analysis for drug quality and safety problems: a case study

Area of Science:

• Health Services Research
• Patient Safety
• Medication Management

Background:

• Automated surveillance indicators identify potential drug therapy problems, including emergency department visits and hospitalizations.
• A prior study developed 39 indicators to assess drug use safety in a Florida healthcare coalition.
• This study focuses on a method to capture surveillance data for root cause analysis (RCA) to improve medication use systems.

Purpose of the Study:

• To apply findings from a computerized surveillance system with drug-related indicators to an RCA.
• To evaluate the effectiveness of RCA in identifying criteria for improving drug therapy quality and safety.
• To enhance systemic responses to various drug therapy problems.

Main Methods:

• A case study involving 6 healthcare coalition stakeholders.
• Evaluation of 4 indicators related to prescribing, adherence, and monitoring in ambulatory care.
• Root cause analysis procedures including brainstorming, grouping, prioritization, and tree diagramming.

Main Results:

• Three key themes emerged as significant contributors to drug-related problems: lack of patient knowledge, patient nonadherence, and inadequate medication management systems.
• These identified barriers were found to be interconnected and influenced by subsystem factors.
• Common system failures and defects contribute to the persistence of drug therapy problems.

Conclusions:

• Drug therapy problems identified by indicators share common system failures.
• Root cause analysis (RCA) is a valuable method for evaluating population-level indicator data.
• RCA can identify medication use system failures and inform the development of targeted interventions.