Grading pharmacists' risk of complaints to a regulator: A retrospective cohort study

Abstract

Background: Tools to grade risk of complaint to a regulatory board have been developed for physicians but not for other health practitioner groups, including pharmacists. We aimed to develop a score that classified pharmacists into low, medium and high risk categories. Methods: Registration and complaint data were sourced from Ontario College of Pharmacists for January 2009 to December 2019. We undertook recurrent event survival analysis to predict lodgement of a complaint. We identified those variables that were associated with a complaint and included these in a risk score which we called PRONE-Pharm (Predicted Risk of New Event for Pharmacists). We assessed diagnostic accuracy and used this to identify thresholds that defined low, medium and high risk. Results: We identified 3,675 complaints against 17,308 pharmacists. Being male (HR = 1.72), older age (HR range 1.43-1.54), trained internationally (HR = 1.62), ≥1 prior complaint (HR range 2.83-9.60), and complaints about mental health or substance use (HR = 1.91), compliance with conditions (HR = 1.86), fees and servicing (HR = 1.74), interpersonal behaviour or honesty (HR = 1.40), procedures (HR = 1.75) and treatment or communication or other clinical issues (HR = 1.22) were all associated with lodgement of a complaint. When converted into the PRONE-Pharm risk score, pharmacists were assigned between 0 and 98 points with higher scores closely associated with higher probability of a complaint. A score of ≥25 had sufficient accuracy for classifying medium-risk pharmacists (specificity = 87.0%) and ≥45 for high-risk pharmacists (specificity = 98.4%). Conclusion: Distinguishing isolated incidents from persistent problems poses a significant challenge for entities responsible for the regulation of pharmacists and other health practitioners. The diagnostic properties of PRONE-Pharm (minimizing the false positives) means that the risk score is useful for "ruling-out" low risk pharmacists using routinely collected regulatory data. PRONE-Pharm may be useful when used alongside interventions appropriately matched to a pharmacist's level of risk.

Keywords: patient complaints; pharmacists; pharmacists regulation; quality and safety; risk prediction.