Hospital-level decision-making for exceptional drug access: a case study from a tertiary and quaternary care centre

Abstract Objectives Exceptional drug access programs in Quebec (Canada) hospitals, namely Medication of Medical Necessity and Exceptional Therapy programs (MMN/ET), provide access to treatments not listed on the provincial drug plan when standard options prove inadequate. Despite their essential role, MMN/ET raise significant procedural, decision-making, and ethical challenges for hospital Pharmacy and Therapeutics Committees. This paper aims to examine these challenges through a logic model–based implementation analysis of a single-centre case study in a tertiary and quaternary hospital in Quebec. Methods A logic analysis framework was applied to conduct a single-centre case study of MMN/ET assessment processes using internal institutional data sources. Ethical considerations were integrated to capture procedural, organizational, and equity-related dimensions of decision-making. Key findings Within this institutional context, mobilization of medical and pharmaceutical expertise supported timely access to necessary treatments. However, the evaluative scope of hospital Pharmacy and Therapeutics Committees was constrained by limited time, data, and analytical resources, particularly compared with provincial agencies such as the Institut national d’excellence en santé et en services sociaux. While local evaluations demonstrated agility and sensitivity to clinical context, they remained susceptible to bias. Key operational challenges included longitudinal monitoring burden and decision-making variability, raising concerns regarding consistency and equity. Introducing weighted criteria within request registries emerged as a promising strategy to strengthen procedural justice and mitigate bias. Conclusion This case study highlights the tension between clinical responsiveness and system-level consistency in hospital-based exceptional drug access programs. Strengthening governance frameworks and promoting harmonization across institutions are essential to support fair, transparent, and sustainable access to exceptional therapies.